Transcatheter Tricuspid Valve Replacement (TTVR)

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group 
Centers for Medicare & Medicaid Services (CMS)
7500 Security Blvd 
Baltimore, MD 21244 

RE: National Coverage Analysis (NCA) for Transcatheter Tricuspid Valve Replacement (TTVR) (CAG-00467N) 

Dear Ms. Syrek Jensen:

As an experienced transcatheter valve operator and heart surgeon, as well as an investigator in the TRISCEND trial, I am writing to express my strong support for the development of a National Coverage Determination (NCD) for Transcatheter Tricuspid Valve Replacement (TTVR) devices, including the recently FDA-approved EVOQUE device.

To ensure a successful launch and maximize the potential benefits for patients in need, we should draw on the experience of Transcatheter Aortic Valve Replacement (TAVR), one of the most successful device launches in cardiovascular medicine. The TAVR model, involving cardiac surgeons and interventional cardiologists as co-primary operators with the support of cardiac imagers, has achieved a flattened learning curve, a strong sense of community within the cardiovascular field, and, most importantly, broad adoption with excellent patient outcomes.

Given this experience, I fully support the recommendations of the joint societies—The American Association for Thoracic Surgery (AATS), Association of Black Cardiologists (ABC), American College of Cardiology (ACC), American Society of Echocardiography (ASE), Heart Rhythm Society (HRS), Society for Cardiovascular Angiography and Interventions (SCAI), and Society of Thoracic Surgeons (STS)—including the specific recommendations requiring an intraprocedural team composed of an interventional cardiologist and heart surgeon as co-operators along with imaging guidance provided by an interventional echocardiographer.

While the early results with TTVR are very encouraging and many patients are in desperate need of effective therapy, the clinical experience with TTVR remains quite limited. To suggest that TTVR could now be characterized simply as a single-operator procedure is naive fails to consider the complexity of this disease state and the components of the procedure, and ignores nearly 15 years of success with the MDHT.

Tricuspid disease is complicated, with patients typically having numerous co-morbid conditions, and experience with tricuspid repair/replacement is limited even at higher-volume centers. The inclusion of cardiologists, cardiac surgeons (given their understanding its anatomy and surgical experience with tricuspid disease), cardiac imagers (given the inherent need for pre- and intraprocedural imaging), heart failure specialists (given their experience managing the sequelae of the disease), and other key professionals in a multidisciplinary heart team (MDHT) is crucial for ensuring patient safety and improving outcomes. Far from restricting access to care, mandating that multiple disciplines be integral to the procedure will enhance results and allow more patients to be considered and, thus, appropriately gain access to these therapies. 

Further, TTVR must be performed in hospitals with appropriate infrastructure and experienced personnel. Detailed qualifications for hospitals and operators to start and maintain TTVR programs should be established. These requirements should build on providers' and centers' experience with treating complex valvular disease and performing catheter-based procedures.

Finally, I strongly advocate that all TTVR procedures be documented in the STS/ACC TVT Registry. Collecting data on outcomes and quality will provide valuable insights to the medical community and support the provisions of coverage with evidence development.

Thank you for considering my comments. Please do not hesitate to contact me at 732-235-7231 or mr1533@rutgers.edu if you have any questions or require further information.

Mark J. Russo, MD, MS
Professor of Surgery
Chief, Cardiac Surgery
Director, Structural Heart Disease
Rutgers-Robert Wood Johnson Medical School

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As a resident entering a future career in cardiology, I would like to advocate for more thoughtful consideration of the value of the TTVR. It is my understanding there is a lack of rigor in the TRICSEND II trial including it being unblinded, making all subjective outcomes susceptible to placebo effect and bias. Additionally outcomes were only evaluated at 30 days and 6 months; 12-month visits were ompleted for less than half of the device and control groups. While there was a high 30-day major adverse events (MAE) rate - 27.4% - MAE rates were not reported for the control group. I do not think it is rigorous to compare to a performance goal of 70% based on safety outcomes for isolated tricuspid valve replacement surgery. 

This is important because there are real consequences to such procedures including the fact that now 22.6% of patients that did not already have pacemarkers/ICDs now require permanent pacemakers after the procedure. 10% of trial participants had severe bleeding. Lastly, 12 out of 96 patients in the device group died by 12 months, vs. 4 out of 54 in the control gorup. 

It is my belief, MEDCAC should be convened to review this evidence before any NCA is completed. 

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On behalf of Doctors for America, I would like to urge CMS to postpone Medicare coverage for the Edwards Evoque transcatheter tricuspid valve replacement (TTVR) device.
Although we recognize that there is a need for advancement in therapy for tricuspid regurgitation, we have several concerns about having Medicare cover this device at this time.
The first concern is the strength of the TRICSEND II trial used to received FDA premarket approval for the device. Some of these issues include:
• The study was unblinded, making all subjective outcomes susceptible to placebo effect and bias
• Outcomes were evaluated only at 30 days and 6 months
o Missing data – 12-month visit completed for less than half of the device and control groups, need complete 12 month data
• High 30-day major adverse events (MAE) rate - 27.4%.
o MAE rate not reported for control group – Instead compared to performance goal of 70% based on safety outcomes for isolated tricuspid valve replacement surgery
o 22.6% of patients that did not already have pacemarkers/ICDs now require permanent pacemakers –
o 10% had severe bleeding
• 12 out of 96 patients in the device group died by 12 months, vs. 4 out of 54 in control
• Data not reviewed by FDA panel before PMA
•  MEDCAC should be convened to review this evidence before any NCA is completed
Another concern is that there is already a TTVR available. Abbott’s TriClip was approved in April with data that were based on a larger number of patients, longer follow-up and better outcomes/safety data.
So, in summary we feel that Medicare coverage for this device is premature and that MEDCAC should be convened to review this evidence before any NCA is completed.

For Doctors for America,
Gilead Lancaster, MD, FACC, FACP
Associate Clinical Professor of Medicine, Yale University School of Medicine

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July 19, 2024 
Tamara Syrek Jensen, JD 
Director, Coverage & Analysis Group 
Centers for Medicare & Medicaid Services 
7500 Security Blvd. 
Baltimore, MD 21244 
Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR) 
Dear Ms. Syrek Jensen,
As a practicing cardiac surgeon, I can attest to the fact that tricuspid regurgitation (TR) is a significant medical condition afflicting the Medicare population. I have substantial clinical experience managing patients with TR by performing surgical tricuspid valve repair and replacement over the past 31 years. Most cardiac surgeons have extensive experience treating TR especially when it is associated with mitral regurgitation and other cardiac conditions necessitating heart surgery. Isolated TR surgery is less commonly performed but a significant surgical experience exists. Recently published contemporary data from The Society of Thoracic Surgeons’ National Database, shows that between 2017 and 2023, there were 13,587 isolated tricuspid valve operations performed in the US, the majority in the Medicare population, with an overall operative mortality of 5.5% for tricuspid valve repair and 5.7% for tricuspid valve replacement.  
Surgery for TR was until recently the only option for treating patients with right ventricular heart failure and severe TR. Recently the US Food and Drug Administration (FDA) has approved the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR). As an additional less invasive option for treating these ill patients with severe TR, I am fully supportive of CMS coverage of the procedure under a National Coverage Determination with Coverage with Evidence Development (CED). However, due to the advanced medical condition of these patients as well as multiple options available for management, I advocate strongly for the management by a multi-disciplinary heart team (MDHT) approach for all options including surgery, TTVR, medical and/or palliative therapy and potentially tricuspid transcatheter edge to edge repair (T-TEER). 
As the clinical experience with TTVR is quite limited at the current time as well as the fact that there are likely large numbers of patients with advanced disease presenting, an approach similar to the introduction of transcatheter aortic valve replacement (TAVR) is warranted. This includes comprehensive assessment for all treatment options by the MDHT including interventional cardiologist and cardiac surgeon, but importantly in addition, imaging specialists, heart failure experts, and electrophysiologists. All patients should undergo risk assessment using the just published STS tricuspid surgery risk algorithm. This new risk calculator is specifically calibrated to help assess the TTVR population. This tool provides the best available evidence for clinical decision-making, ensuring that patient selection and risk assessment are based on contemporary data. It is essential that the use of this risk calculator be integrated into the coverage determination to support informed clinical decisions by the heart team.
TTVR is a complex transcatheter procedure that requires multidisciplinary expertise. Surgeons bring a unique perspective and important view of tricuspid valve intervention. Valve surgeons have in-depth three-dimensional knowledge of the tricuspid anatomy, its mechanistic function, as well as knowledge of the detailed anatomic relationship to the conduction system, and other cardiac structures, as well as the valve specific elements of clefts and chordal structures that all go into safe procedural device delivery.
Based on the experience with the TAVR NCD that included both a cardiac surgeon and an interventional cardiologist performing the procedure, the success and safety of this program should be the template for a TTVR NCD also. As TTVR has an evolving but as yet unclear safety profile, I feel that this inclusive aspect of intraprocedural participation as was utilized with TAVR, but not mandated for M-TEER, will assure the safest rollout of this new technology to Medicare beneficiaries. Surgeons are integral members of the heart team and should therefore serve as co-operators in TTVR procedures, similar to how we participate in the very successful model used for TAVR. Surgeons are uniquely qualified to mitigate risks and complications, which are essential for ensuring patient quality and safety. As a surgeon, I remain committed to enhancing patient access to these technologies and my practice and my specialty’s leadership remains focused that this safely occurs with TTVR.
Furthermore, I urge that all procedures should be collected in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage with evidence development.
I urge CMS to adopt a conservative approach in establishing coverage at this early stage in the clinical development of TTVR. While the initial clinical profile of TTVR is compelling, the FDA approval is based on data from fewer than 100 patients treated at experienced medical centers. This limited and under representative dataset is insufficient to draw broad conclusions on the safety of commercial implementation, particularly in less experienced centers. Therefore, I feel strongly that CMS take a cautious approach to ensure patient safety and optimal deployment of this device. While all providers are committed to enhancing open access, protecting public trust is paramount, and the rollout of this technology must be executed thoughtfully. I believe that a team-based approach to both pre-procedural and operator/procedural care is essential, and that cardiac surgeons must be required as co-operators in these procedures to ensure the highest quality patient care and safety possible.
In summary:
We support a National Coverage Determination for TTVR
Multidisciplinary Heart Teams function best when surgeons participate in the procedure (TAVR vs. M-TEER)
Including surgeons in the procedure will not restrict access to care
TTVR experience is limited, and this approach will maximize safety for Medicare beneficiaries
Tricuspid surgery is a viable option, and use of the STS tricuspid calculator should be mandated. 
While the TTVR technology is very promising, and I fully support its roll out, the initial approval was based on a very small patient cohort and may not be representative of the wider real-world patient population. CMS should proceed cautiously, treating this under-treated group with careful oversight. Ensuring that surgeons are part of the process from the pre-operative stage through the actual procedure to post procedure care is crucial for patient safety and quality outcomes. I feel that this multidisciplinary approach, mirroring the well planned and executed TAVR rollout, will be of great importance for the success of TTVR without in any way negatively impacting patient access.
Respectfully submitted,
Kevin D. Accola, MD
Executive Medical Director Cardiothoracic Surgery
Surgical Director, Health Lung Vascular Institute
Surgical Director, Structural Heart 
AdventHealth Orlando

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July 19, 2024
Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244
Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)
Dear Ms. Syrek Jensen,
We are collectively writing this letter regarding the national coverage determination for TTVR.  Our background information can be found below:
Tom C. Nguyen, MD: I am the Chief Medical Executive of the Miami Cardiac & Vascular Institute.  We have 12 hospitals throughout South Florida and I lead cardiology, cardiac surgery, interventional radiology, and vascular surgery.  I am also a busy practicing cardiac and transcatheter surgeon.
Nish Patel, MD: I am the Director of Structural Heart with extensive experience in complex transcatheter therapies for the aortic and mitral valve.  I’ve been involved with most of the landmark trials in this space.
As practicing physicians, we can attest to the fact that tricuspid regurgitation (TR) is a significant medical condition afflicting the Medicare population. We have substantial clinical experience managing patients with TR by performing surgical tricuspid valve repair and replacement over the past 20 years. Most cardiac surgeons have extensive experience treating TR especially when it is associated with mitral regurgitation and other cardiac conditions necessitating heart surgery. Isolated TR surgery is less commonly performed but a significant surgical experience exists. Recently published contemporary data from The Society of Thoracic Surgeons’ National Database, shows that between 2017 and 2023, there were 13,587 isolated tricuspid valve operations performed in the US, the majority in the Medicare population, with an overall operative mortality of 5.5% for tricuspid valve repair and 5.7% for tricuspid valve replacement.
Surgery for TR was until recently the only option for treating patients with right ventricular heart failure and severe TR. Recently the US Food and Drug Administration (FDA) has approved the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR). As an additional less invasive option for treating these ill patients with severe TR, we  am fully supportive of CMS coverage of the procedure under a National Coverage Determination with Coverage with Evidence Development (CED). However, due to the advanced medical condition of these patients as well as multiple options available for management, we advocate strongly for the management by a multi-disciplinary heart team (MDHT) approach for all options including surgery, TTVR, medical and/or palliative therapy and potentially tricuspid transcatheter edge to edge repair (T-TEER).
As the clinical experience with TTVR is quite limited at the current time as well as the fact that there are likely large numbers of patients with advanced disease presenting, an approach similar to the introduction of transcatheter aortic valve replacement (TAVR) is warranted. This includes comprehensive assessment for all treatment options by the MDHT including interventional cardiologist and cardiac surgeon, but importantly in addition, imaging specialists, heart failure experts, and electrophysiologists. All patients should undergo risk assessment using the just published STS tricuspid surgery risk algorithm. This new risk calculator is specifically calibrated to help assess the TTVR population. This tool provides the best available evidence for clinical decision-making, ensuring that patient selection and risk assessment are based on contemporary data. It is essential that the use of this risk calculator be integrated into the coverage determination to support informed clinical decisions by the heart team.
TTVR is a complex transcatheter procedure that requires multidisciplinary expertise. Surgeons bring a unique perspective and important view of tricuspid valve intervention. Valve surgeons have in-depth three-dimensional knowledge of the tricuspid anatomy, its mechanistic function, as well as knowledge of the detailed anatomic relationship to the conduction system, and other cardiac structures, as well as the valve specific elements of clefts and chordal structures that all go into safe procedural device delivery.
Based on the experience with the TAVR NCD that included both a cardiac surgeon and an interventional cardiologist performing the procedure, the success and safety of this program should be the template for a TTVR NCD also. As TTVR has an evolving but as yet unclear safety profile, I feel that this inclusive aspect of intraprocedural participation as was utilized with TAVR, but not mandated for M-TEER, will assure the safest rollout of this new technology to Medicare beneficiaries. Surgeons are integral members of the heart team and should therefore serve as co-operators in TTVR procedures, similar to how we participate in the very successful model used for TAVR. Surgeons are uniquely qualified to mitigate risks and complications, which are essential for ensuring patient quality and safety. As a surgeon, I remain committed to enhancing patient access to these technologies and my practice and my specialty’s leadership remains focused that this safely occurs with TTVR.
Furthermore, we urge that all procedures should be collected in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage with evidence development.
We urge CMS to adopt a conservative approach in establishing coverage at this early stage in the clinical development of TTVR. While the initial clinical profile of TTVR is compelling, the FDA approval is based on data from fewer than 100 patients treated at experienced medical centers. This limited and under representative dataset is insufficient to draw broad conclusions on the safety of commercial implementation, particularly in less experienced centers. Therefore, we feel strongly that CMS take a cautious approach to ensure patient safety and optimal deployment of this device. While all providers are committed to enhancing open access, protecting public trust is paramount, and the rollout of this technology must be executed thoughtfully. we believe that a team-based approach to both pre-procedural and operator/procedural care is essential, and that cardiac surgeons must be required as co-operators in these procedures to ensure the highest quality patient care and safety possible.
In summary, while the TTVR technology is very promising, and we fully support its roll out, the initial approval was based on a very small patient cohort and may not be representative of the wider real-world patient population. CMS should proceed cautiously, treating this under-treated group with careful oversight. Ensuring that surgeons are part of the process from the pre-operative stage through the actual procedure to post procedure care is crucial for patient safety and quality outcomes. We feel that this multidisciplinary approach, mirroring the well planned and executed TAVR rollout, will be of great importance for the success of TTVR without in any way negatively impacting patient access.
Respectfully submitted,

Tom C. Nguyen, MD
Chief Medical Executive | Miami Cardiac & Vascular Institute
Professor of Surgery Herbert Wertheim College of Medicine
Director of Minimally Invasive Valve Surgery
Barry Katzen Endowed Chair

Nish Patel, MD
Director of Structural Heart at Baptist Hospital
Associate Professor at FIU

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July 19, 2024 

Tamara Syrek Jensen, JD 
Director, Coverage & Analysis Group 
Centers for Medicare & Medicaid Services 
7500 Security Blvd. 
Baltimore, MD 21244 

Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR) 

Dear Ms. Syrek Jensen,

I have been an adult cardiac surgeon for the past 16 years at three large academic health systems. While always being employed in academic teaching environments, my clinical practice within that setting has been diverse and has included tertiary academic settings, a large public health hospital, and community/regional hospitals. My expertise includes advanced heart failure, with specialized training and current practice in heart transplantation and mechanical circulatory support. I thus have extensive experience with end-stage tricuspid valve disease, which is a significant medical concern for the Medicare population.

Isolated tricuspid valve surgery is not very common in this population, however, untreated, it is highly morbid. Despite this, contemporary results with surgical therapy in this population are improved from what is often stated.  Recently published contemporary data from The Society of Thoracic Surgeons National Database shows that between 2017 and 2023, there were 13,587 isolated tricuspid valve operations performed in the US, with the majority in the Medicare population [REF 1,2]. The overall operative mortality rates were 5.5% for tricuspid valve repair and 5.7% for tricuspid valve replacement.  While these mortality rates are higher than seen with isolated aortic or mitral valve surgery [REF 3], these mortality rates are lower than often reported rates of 10-15% in this patient population in less robust or contemporary studies. Mortality in this population is related to the severity of medical comorbidities and sequelae of severe tricuspid regurgitation, generally not the surgical procedure itself, regardless of approach [REF 4].  

The recent approval of the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR) by the United States Food and Drug Administration offers a less invasive option for treating patients with severe tricuspid regurgitation. This approval increases our therapeutic options for these patients. While I strongly support the CMS coverage of transcatheter tricuspid valve replacement under a National Coverage Determination with Coverage with Evidence Development (CED), several important points should be considered with the approval.

First, I strongly recommend managing severe tricuspid regurgitation in this patient population using a multi-disciplinary heart team approach that considers all options, including surgery, TTVR, medical and/or palliative therapy, and potentially tricuspid transcatheter edge-to-edge repair (T-TEER). Due to the limited clinical experience with TTVR and the large number of potentially eligible patients with advanced heart failure due to severe tricuspid regurgitation, it is imperative to utilize an approach like transcatheter aortic valve replacement (TAVR). This approach should involve a comprehensive assessment of all treatment options by the multidisciplinary heart team, including interventional cardiologists and cardiac surgeons, imaging specialists, heart failure experts, electrophysiologists, and in some cases, palliative care.

Second, all patients should undergo risk assessment using the published STS tricuspid valve surgery risk calculator.1 This new risk calculator is specifically calibrated to help assess the TTVR population and is publicly available at https://www.sts.org/resources/isolated-tricuspid-valve-surgery-risk-calculator. This tool provides the best evidence for clinical decision-making, ensuring that patient selection and risk assessment are based on contemporary data. This risk calculator must be integrated into the coverage determination to support informed clinical decisions by the heart team.

Third, for the TTVR procedure, it is essential to have an adult cardiac surgeon as a co-operator. This procedure is complex and requires expertise from multiple disciplines. Surgeons bring a unique perspective and essential knowledge of tricuspid valve intervention. They have a thorough understanding of tricuspid anatomy, its mechanistic function, the anatomic relationship of the tricuspid valve to the conduction system, and the valve-specific elements of clefts and chordal structures. This in-depth anatomical knowledge, obtained from open tricuspid valve surgery, is crucial to ensure the safe delivery of procedural devices.

As TTVR has an evolving but unclear safety profile, it is also important to include an adult cardiac surgeon to ensure the safe rollout of this new technology to Medicare beneficiaries. Surgeons are uniquely qualified to mitigate risks and complications, which are essential for ensuring patient quality and safety. As an adult cardiac surgeon practicing at a center where TTVR is performed, I have unfortunately seen severe complications that can occur with TTVR deployments, such as rupture of the inferior vena cava, right atrium, and right ventricle, as well as mal-deployment and unplanned device migration. While uncommon, when these events occur, they are highly fatal, even with rapid surgical intervention. The absence of a surgeon at the bedside when a catastrophic event occurs during TTVR ensures only one thing: the death of the patient. From a safety standpoint, a surgeon must be present and at the bedside during TTVR deployment. To put it more bluntly, I would refuse to allow any of my family members to have this procedure unless this condition was met. The lack of the presence of a practicing adult cardiac surgeon competent in the establishment of emergent mechanical support and valve repair/replacement during TTVR is a threat to patient safety.

Fourthly, I recommend that all procedures be included in the STS/ACC TVT Registry. This will provide the community with further information about the outcomes and quality of this groundbreaking device under the coverage provisions with evidence development.

I fully support the coverage of transcatheter tricuspid valve replacement by CMS under a National Coverage Determination with Coverage with Evidence Development. However, I recommend that CMS take a cautious approach to establishing coverage in this early stage of TTVR clinical development. Approval should be contingent on several requirements, including the involvement of a multi-disciplinary heart team, the use of the STS Tricuspid Valve Risk Calculator, the recording of procedures in the STS/ACC TVT Registry, and the presence of an adult cardiac surgeon as a co-operator during the TTVR. These measures are essential to ensure patient safety and the optimal use of this device. While we are committed to expanding access, it is crucial to prioritize public trust, and the introduction of this technology must be done with careful consideration. I believe that a team-based approach to both pre-procedural and procedural care is necessary, and cardiac surgeons must be required to be co-operators in these procedures to ensure the highest quality patient care and safety.

Sincerely, 
 
Michael E. Bowdish, MD MS FACS
Vice Chair, Clinical Chief, and Professor
Department of Cardiac Surgery
Smidt Heart Institute
Cedars-Sinai Medical Center
Los Angeles, CA

Chair, Society of Thoracic Surgeons Adult Cardiac Surgery Database Taskforce
Senior Editor, The Annals of Thoracic Surgery

REFERENCES

1. Thourani VH, Bonnell L, Wyler von Ballmoos MC, et al. Outcomes of Isolated Tricuspid Valve Surgery: A Society of Thoracic Surgeons Analysis and Risk Model. Ann Thorac Surg. Published online May 7, 2024:S0003-4975(24)00339-4. doi:10.1016/j.athoracsur.2024.04.014
2. Chen Q, Bowdish ME, Malas J, et al. Isolated Tricuspid Operations: The Society of Thoracic Surgeons Adult Cardiac Surgery Database Analysis. Ann Thorac Surg. 2023;115(5):1162-1170. doi:10.1016/j.athoracsur.2022.12.041
3. Bowdish ME, D’Agostino RS, Thourani VH, et al. STS Adult Cardiac Surgery Database: 2021 Update on Outcomes, Quality, and Research. Ann Thorac Surg. 2021;111(6):1770-1780. doi:10.1016/j.athoracsur.2021.03.043
4. Bowdish ME. Do not underestimate the tricuspid valve. J Surg Res. 2018;221:222-223. doi:10.1016/j.jss.2017.08.015

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July 20, 2024 
Tamara Syrek Jensen, JD 
Director, Coverage & Analysis Group 
Centers for Medicare & Medicaid Services 
7500 Security Blvd. 
Baltimore, MD 21244 
Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR) 

Dear Ms. Syrek Jensen:

The FDA’s decision to approve the current transcatheter tricuspid valve interventions (TTVI) brings excitement and a vision of what might be.  This journey started with surgical concepts (both edge-to-edge and valve replacement) and teams of cardiovascular experts who translated these ideas into transcatheter technologies in union with the device industry.  At no point in this evolution did one entity exist in a vacuum.  The concerted efforts of trial, evaluation, alteration, iteration, and re-trial always required a multidisciplinary approach focused on advancing care with a focus on safety for the betterment of patients.  As a result, I fully support a national coverage determination for TTVI that maintains at its core the principle of multidisciplinary evaluation, management, and delivery of care.

Over the past 15 years, I dedicated my practice to the care and advancement of treatment for patients with structural heart disease.  My practice advanced and grew because of our team approach to care, a concept bred into us from our mentors Drs. Mike Mack and David Brown who successfully navigated the Syntax trial and TAVR trials together.  We advanced our outcomes in surgical tricuspid valve intervention with our own development and popularization of a perioperative optimization strategy (“pre-hab”), and now with TTVI, we work together in patient evaluation and in the device implantation procedures.  We were involved in some of the earliest compassionate care cases of EVOQUE, worked with industry in early feasibility trials (both in TRISCEND and CLASP TR) and pivotal trials (TRISCEND II and CLASP TR II), and with academia to develop structure through the Heart Valve Consortium (TV-ARC) on how to further evaluate and test the promise of this field. My experiences as an implanter are like some others expressed.  I have seen miraculous improvements in how some patients feel after intervention.  In these notable improvements, our team senses the way care becomes easier.  Makes sense.  At the same time, we experienced cases where despite perfect technical results, we saw no improvement, and possibly decrement, showing there is no room for hubris in this complex category of disease.  Consequently, given the considerable unknowns of these interventions, I cannot support simplifying the team structure just because of some advancements in device delivery.  Our ability as a team to deliver our best care in almost every case to date required the shared experiences we all brought as interventionalists, imagers, heart failure experts, electrophysiologists, cardiac anesthesia, and, not least and not most, surgeons.

My sentiments regarding this field are not ones I have shied from expressing.  TTVI is in its nascency, and experience is limited.  These interventions have yet to show a mortality benefit, thus any shared decision must be thoughtfully discussed, and all options must truly be considered.  The multidisciplinary heart team approach remains central to the process.  Tricuspid valve surgery, as demonstrated by our group and several others in reported series, has improved considerably in outcomes over the years.  This was recently corroborated as a generalization by the STS’s recent publication on outcomes, which were vastly improved compared to historical results.  Fortunately, one of the most striking and amazing aspects of our healthcare delivery experience is the collective goal of moving the needle to make care better — better surgery, more minimally invasive surgical options, and now TTVI.  We cannot dismiss these advances in our discussions with patients to allow them to consider all options, which with surgery also includes the ability to address concomitant conditions, an issue that is removed from trials but in the real world affects a considerable number of patients. 

Lastly, I want to address the issue of the actual implanting team.  There are few lingering questions about the impact of TAVR on the treatment of aortic stenosis.  I believe this is the direct result of putting all the players on one team.  The results are hard to argue and are generally supported by all cardiovascular societies.  How about that: flagrant agreement!  Why change the recipe?  Surgeons having a role on the implanting team is not the rate limiting step to TAVR access.  (In fact, at our institution, we have four surgeons who attend the heart team clinic, participate in the conferences, and scrub and perform the cases in conjunction with the interventionalists while maintaining their own surgical practices.)  Surgeons will not be the rate limiting step for access to care in TTVI.  (In fact, at our institution, we have four different surgeons who already do exactly as above for transcatheter mitral interventions and will do so for TTVI.)  I want to see TTVI’s success for patient care, for advancing our specialties into new methods of care planning and delivery.  We must do this with eyes wide open to the limitations of what is currently available, so, in the end, we as a group of physicians who care for patients with tricuspid valve disorders will unanimously support the direction this journey takes us — hopefully just like TAVR: safe, effective, and accessible.

In conclusion, I want to acknowledge and thank the FDA for their thoughtful and deliberate evaluation and approval of the TTVI platforms under consideration for CMS approval.  I truly believe in the teamwork between science and industry to generate these seismic impacts in care like TAVR has shown can happen and like what we possibly will see in TTVI.  I believe a National Coverage Determination that includes a multidisciplinary heart team with active cardiac surgeon participation in the clinic and in the procedure allows for optimal shared decision making with Medicare beneficiaries for delivering safe, effective, and appropriate treatments of tricuspid valve disorders without restricting access to new technologies.  Careful and complete data gathering into a joint database (like the STS/ACC TVT Registry) will allow us to see and adjust the future patient selection and device advances all the while garnering the greatest support from the entire cardiovascular community.  This is a bright future.

Most respectfully,

Robert L.  Smith II, MD

Chair of Cardiovascular Surgery, Baylor Scott and White: The Heart Hospital Plano (Plano, TX)
Assistant Medical Director of Cardiovascular Surgery, Baylor Scott and White Healthcare System

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July 19, 2024 

Tamara Syrek Jensen, JD 
Director, Coverage & Analysis Group 
Centers for Medicare & Medicaid Services 
7500 Security Blvd. 
Baltimore, MD 21244 
Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR) 
Dear Ms. Syrek Jensen,

It is my pleasure to write my thoughts regarding Transcatheter Tricuspid Valve Replacement (TTVR).  I have been a practicing cardiac surgeon for over 25 years with extensive experience with surgical and transcatheter therapies used to treat patients with cardiovascular disease.  Although open heart surgery for tricuspid regurgitation is not as common as heart surgery for aortic or mitral valve diseases, the surgical repair or replacement of a disease tricuspid valve causing right ventricular failure are safe and effective treatments for appropriate patients. In my practice, I have personally performed open heart surgery on several hundreds of patients suffering from acquired and/or congenital tricuspid valve regurgitation.  I have been fortunate to practice cardiac surgery as an active member of multidisciplinary “heart teams” in several centers and cities across the country including Boston, Houston and Washington, DC.

I commend and congratulate CMS for the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR).  In my observation, the insistence of the multidisciplinary heart team (MDHT) requiring equal partnership and full participation of both cardiologists and cardiac surgeons during the evaluation, procedure and peri-procedural care has been the most effective component to ensure procedural safety and optimal outcomes for patients undergoing TAVR.  By working together while caring for individual patients, the heart teams of cardiologists and surgeons have rapidly advanced the innovation of techniques and technologies beyond select centers to broad access to TAVR across the country.  Because of the guidance provided by the NCD, over the last decade approximately 800,000 patients with aortic stenosis have been safely and effectively treated with TAVR.  Furthermore, TAVR is now safely available in over 800 sites across the United States allowing ready access to most communities.  
This is very exciting time for patients afflicted with structural heart diseases!  For 50 years, open heart surgery had been the only available treatment for heart valve diseases which continues to be a common cause of heart failure, disability and death.  Although open heart surgery is very safe and effective treatment for many patients, it is very invasive and continues to have some risks.  Over the last 10-20 years, innovative transcatheter therapies have rapidly evolved to manage many heart valve diseases.  The NCD for TAVR has proven to be a very successful paradigm to rapidly but safely expand access to patients across the country.  Although the transcatheter therapies are less invasive, they may not prove to be safer or more effective than heart surgery for all types of valvular heart disease. 

TTVR is a complex transcatheter procedure that requires multidisciplinary expertise. Surgeons bring a unique perspective and important view of tricuspid valve intervention. Valve surgeons have in-depth three-dimensional knowledge of the tricuspid anatomy, its mechanistic function, as well as knowledge of the detailed anatomic relationship to the conduction system, and other cardiac structures, as well as the valve specific elements of clefts and chordal structures that all go into safe procedural device delivery.
While the initial clinical profile of TTVR is compelling, the FDA approval is based on data from fewer than 100 patients treated at experienced medical centers. This limited and under representative dataset is insufficient to draw broad conclusions on the safety of commercial implementation, particularly in less experienced centers.
Some colleagues have questioned the need for more than one operator to deploy a transcatheter valve suggesting that the incidence of complications requiring a surgeon will be low.  As with TAVR, the expansion of TTVR to less experienced centers will likely increase the risk of major risks requiring time-sensitive emergency surgical intervention to rescue patients.  Surgeons are uniquely qualified to mitigate risks and complications, which are essential for ensuring patient quality and safety. Surgeons are integral members of the heart team and should therefore serve as co-operators in TTVR procedures mirroring the very successful model used for TAVR. 

The concern has been raised that surgeons are not interested or willing to participate in TTVR and that this apathy of surgeons will limit the access of TTVR to patients and communities.  As an individual surgeon, as a leader of institution and as a national leader in the specialty of cardiac surgery, I steadfastly remain committed to participating in TTVR to ensure safe, effective and timely access to the best treatments for all patients.

Furthermore, I urge that all procedures should be collected in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage with evidence development.

In summary, I believe that TTVR is a very promising procedure and I fully support its expansion to more centers across the country.  I urge CMS to adopt a National Coverage Determination (NCD) with Coverage with Evidence Development (CED) for TTVR similar to TAVR requiring that a heart team including both interventional cardiologists and cardiac surgeons are equal participants in the pre-procedural evaluation, intra-operative procedural deployment and post-procedural care. I feel that this multidisciplinary approach will be of critical importance for the safe and successful treatment of patients with TTVR without negatively impacting patient access.  Thank you for allowing me to provide my opinion.

Thomas E. MacGillivray, M.D.
Chair, Cardiac Surgery, MedStar Washington Hospital Center
Physician Executive Director, Cardiac Surgery, MedStar Health
Vice President of Medical Operations, MedStar Heart and Vascular Institute
Immediate Past President, The Society of Thoracic Surgeons

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July 19, 2024 
Tamara Syrek Jensen, JD 
Director, Coverage & Analysis Group 
Centers for Medicare & Medicaid Services 
7500 Security Blvd. 
Baltimore, MD 21244 
Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR) 
Dear Ms. Syrek Jensen,
As a practicing cardiac surgeon specialized in structural heart disease and transcatheter valve therapy, I have had extensive experience to attest that tricuspid regurgitation (TR) is a significant medical condition afflicting the Medicare population. I work in a tertiary academic center with top-notched experience treating patients with mitral and tricuspid valve disease, both surgically and via a transcatheter approach. I was the site PI for the TRILUMINATE early feasibility study, a co-investigator and screening committee member for the TRILUMINATE pivotal trail, a co-investigator of the APOLLO transcatheter tricuspid valve replacement (TTVR) early feasibility study, and most recently have adopted the commercial use of the Evoque TTVR system. Most cardiac surgeons have extensive experience treating TR especially when it is associated with mitral regurgitation and other cardiac conditions necessitating heart surgery. Isolated TR surgery is less commonly performed but a significant surgical experience exists including at our center. Recently published contemporary data from The Society of Thoracic Surgeons’ National Database, shows that between 2017 and 2023, there were 13,587 isolated tricuspid valve operations performed in the US, the majority in the Medicare population, with an overall operative mortality of 5.5% for tricuspid valve repair and 5.7% for tricuspid valve replacement.  
Surgery for TR was until recently the only option for treating patients with right ventricular heart failure and severe TR. Recently the US Food and Drug Administration (FDA) has approved the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR). As an additional less invasive option for treating these ill patients with severe TR, I am fully supportive of CMS coverage of the procedure under a National Coverage Determination with Coverage with Evidence Development (CED). However, due to the advanced medical condition of these patients as well as multiple options available for management, I advocate strongly for the management by a multi-disciplinary heart team (MDHT) approach for all options including surgery, TTVR, medical and/or palliative therapy and potentially tricuspid transcatheter edge to edge repair (T-TEER). 
As the clinical experience with TTVR is quite limited at the current time as well as the fact that there are likely large numbers of patients with advanced disease presenting, an approach similar to the introduction of transcatheter aortic valve replacement (TAVR) is warranted. This includes comprehensive assessment for all treatment options by the MDHT including interventional cardiologist and cardiac surgeon, but importantly in addition, imaging specialists, heart failure experts, and electrophysiologists. All patients should undergo risk assessment using the just published STS tricuspid surgery risk algorithm. This new risk calculator is specifically calibrated to help assess the TTVR population. This tool provides the best available evidence for clinical decision-making, ensuring that patient selection and risk assessment are based on contemporary data. It is essential that the use of this risk calculator be integrated into the coverage determination to support informed clinical decisions by the heart team.
TTVR is a complex transcatheter procedure that requires multidisciplinary expertise, and my experience as an interventional surgeon can attest to that, not just in terms of the actual procedure, but also preprocedural and postprocedural management, given the significant risks of acute right ventricular dysfunction requiring inotropic support, pacemaker risk due to new persistent conduction abnormalities, and bleeding risk due to anticoagulation post procedure. We have seen acutely new right ventricular dysfunction immediately after TTVR in the operating room or cath lab, requiring immediate inotropic support. While interventional cardiologists seldom encounter this situation, as surgeons we face this situation not infrequently during open heart surgery. Given our surgical and ICU experience, CT surgeons bring a unique perspective and important view of tricuspid valve intervention in multiple ways. Valve surgeons have in-depth three-dimensional knowledge of the tricuspid anatomy, its mechanistic function, as well as knowledge of the detailed anatomic relationship to the conduction system, and other adjacent cardiac structures, as well as the valve specific elements of clefts and chordal structures that all go into safe procedural device delivery. In addition, surgeons can contribute to the MDHT in terms of the preprocedural intraprocedural and post procedural management of these sick patients with multiple morbidities.
Based on the experience with the TAVR NCD that included both a cardiac surgeon and an interventional cardiologist performing the procedure, the success and safety of this program should be the template for a TTVR NCD also. As TTVR has an evolving but as yet unclear safety profile, I feel that this inclusive aspect of intraprocedural participation as was utilized with TAVR, but not mandated for M-TEER, will assure the safest rollout of this new technology to Medicare beneficiaries. Surgeons are integral members of the heart team and should therefore serve as co-operators in TTVR procedures, similar to how we participate in the very successful model used for TAVR. Surgeons are uniquely qualified to mitigate risks and complications, which are essential for ensuring patient quality and safety. As a surgeon, I remain committed to enhancing patient access to these technologies and my practice and my specialty’s leadership remains focused that this safely occurs with TTVR.
Furthermore, I urge that all procedures should be collected in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage with evidence development.
I urge CMS to adopt a conservative approach in establishing coverage at this early stage in the clinical development of TTVR. While the initial clinical profile of TTVR is compelling, the FDA approval is based on data from fewer than 100 patients treated at experienced medical centers. This limited and under representative dataset is insufficient to draw broad conclusions on the safety of commercial implementation, particularly in less experienced centers. Therefore, I feel strongly that CMS take a cautious approach to ensure patient safety and optimal deployment of this device. While all providers are committed to enhancing open access, protecting public trust is paramount, and the rollout of this technology must be executed thoughtfully. I believe that a team-based approach to both pre-procedural and operator/procedural care is essential, and that cardiac surgeons must be required as co-operators in these procedures to ensure the highest quality patient care and safety possible.
In summary, while the TTVR technology is very promising, and I fully support its roll out, the initial approval was based on a very small patient cohort and may not be representative of the wider real-world patient population. CMS should proceed cautiously, treating this under-treated group with careful oversight. Ensuring that surgeons are part of the process from the pre-operative stage through the actual procedure to post procedure care is crucial for patient safety and quality outcomes. I feel that this multidisciplinary approach, mirroring the well planned and executed TAVR rollout, will be of great importance for the success of TTVR without in any way negatively impacting patient access.
Respectfully submitted,
Gilbert Tang, MD, MSc, MBA
Surgical Director Structural Heart Program
Mount Sinai Health System
Professor, Department of Cardiovascular Surgery
Icahn School of Medicine at Mount Sinai, New York

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Thank you for the opportunity to make comments regarding TTVR NCD reimbursement.
TTVR represents a significant advance in the care of patients with TR who are not able to undergo surgery.  We have seen patients benefit tremendously, and I am certain that TTVR will play an important role in valve therapy, in addition to surgical replacement/repair, and transcatheter repair. 
As a surgeon who has significant experience in both transcatheter and open surgery, I am fully conscious of how adoption  of new technology occurs, particularly in a vulnerable population.  There is a significant amount of judgement involved in taking care of TR patients, much more so than AS in which the diagnosis and management are much more linear.  In TR, patients require medical optimization, careful assessment of anatomy and physiology, and then discussion of 1)whether to treat, 2) how to treat (surgery, transcatheter, repair, replacement), and 3) how to deal with complications.  All of these require multiple specialty inputs, such as cardiology, surgery, heart failure physicians, EP, imagers, and others.  More so than any other valve, the tricuspid valve is truly a unifying heart team valve, given its complexity.   It is, therefore, imperative to make the correct decision in terms of operator involvement for TTVR, for the wrong decision can have catastrophic consequences in new devices, specifically TTVR.
It is important to remember the outstanding quality that has been established with TAVR through the use of heart valve teams and co-operator groups.  The risk of open surgery during TAVR is rare but does occur, and surgical presence is often life-saving.  I recall a TTVR case which this very specific valve in question, Evoque, in which we caused a catastrophic injury that immediately resulted in cardiac tamponade.  I was engaged in the case and immediately opened the chest, placed the patient on bypass, repaired a large injury to the heart, and the patient recovered without incident. Similar cases have occurred in TAVR, TMVR and now TTVR, and my presence in the room has been vital to giving patients the best chance to live.  
Second, this technology is in its infancy, and it is worth examining the 30d metrics in a highly selected group of world class operators for the Evoque valve .  In the 30d EFS data for Evoque TTVR in 56 patients, 2 valves embolized, and 1 patient required emergency surgery.  The valve is challenging to deploy and requires a high level of imaging expertise – expansion of this technology without proper care would be irresponsible. Careful analysis of early real world outcomes in the TVT registry, internal Edwards data, and other sources is mandatory at the very least before making any decisions on anything.  Having two skilled operators provides an important safety component to the procedure itself.
Third, the careful system of checks and balances created by a heart team and co-operators cannot be understated. To make a technology single operator automatically incentivizes implantation without any form of control.  Most physicians are responsible, but the price tag and potential upside reimbursement of TTVR is massive – the device is priced 12K more than TAVR - this is an attractive procedure, making it an opportunity for abuse.  Making the procedure a single operator  instead of co-operator creates the potential for large scale misuse (similar to PCI) without regulation. The last thing we need is another field of PCI performed by a small group of unethical physicians: patients lose trust in medical systems, the field is harmed, and patients are hurt. This has not happened in TAVR because of surgoen involvement. 

In conclusion, co-operator for TTVR is mandatory to ensure patient safety, high quality outcomes, and prevent unregulated misuse of the device. Anything short of that would be reckless and a deviation from what has been established with TAVR and TMVR. 

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Patients with severe, symptomatic tricuspid regurgitation (TR) often present to our multidisciplinary heart team (MDHT).  Medical therapy for TR is limited to diuretics and is palliative with no proven effect on the poor outcomes associated with this condition.  Surgical repair or replacement for isolated TR is uncommon because it carries a high risk of mortality (5.5% for repair; 5.7% for replacement in the most recent STS database) and morbidity (heart block requiring pacemaker, bleeding, etc). Thus, patients with symptomatic severe TR have an unmet need for transcatheter options which include transcatheter tricuspid valve replacement (TTVR) with the Evoque system which recently FDA approval in the Breakthrough Device Designation.  I have long been involved in structural heart disease and served as Executive Director of the Echocardiography Core Laboratory for the TRISCEND EFS, TRISCEND II and TRISCEND JAPAN studies.  As such, I have analyzed echocardiograms in over 1,000 Evoque devices placed for treatment of TR under these protocols.  It is remarkable that unlike transcatheter repair devices, the Evoque TTVR nearly eliminates TR.  TR was reduced from severe, massive or torrential in all patients (as confirmed by our core laboratory) to none/trace or mild in over 95%.  Importantly, studies of normal volunteers have shown mild TR in roughly 75% of normal healthy subjects.  This marked reduction in TR severity was accompanied by a significant improvement in quality of life as determined by the KCCQ overall summary score.  Importantly, the baseline KCCQ overall summary score was > 50, indicating that these patients, who were 79 years old and mostly women, were severely symptomatic.  While there was no sham control group nor blinding in TRISCEND II, the magnitude of improvement was higher than would be anticipated by placebo and was durable. Based on these data, which were thoroughly vetted by FDA, I support the NCD for TTVR with appropriate Coverage with Evidence Development (CED).  While long-term outcomes are needed, the evidence base is sufficient to allow shared decision making between experienced MDHT and the patients and their families. This decision making includes the tradeoff of an upfront risk of procedure mortality and complications (both of which are lower than surgery) against the opportunity to alleviate symptoms and improve quality of life.
In setting the guidelines for performance of TTVR in patients with severe, symptomatic TR, it is important to consider both clinical expertise and patient preferences. In general, I concur with what has been outlined in the multi-society letter from AATS, ABC, ACC, ASE, HRS, SCAI, and STS.  The NCD needs mandate an experienced MDHT to provide care for the patient pre-procedure, intra-procedurally and long-term post-procedurally. This team must include interventional cardiologists with expertise in structural heart valve procedure and device-specific training for TTVR; cardiac surgeons experienced in heart valve surgery; interventional echocardiographers (cardiologist or anesthesiologist) with expertise in structural heart valve procedures. I do not agree that this requires Level III training; it requires experience and expertise in intraprocedural imaging of structural heart interventions with specific training on TTVR device placement.  When needed, the team should also include an electrophysiologist experienced in lead management and potential post-procedural arrhythmias and a heart failure cardiologist.  For the TTVR procedure itself, procedural expertise includes operation of the device itself and imaging the tricuspid valve anatomy for appropriate device placement and assessment of leaflet capture, device positioning and potential complications prior to release.  In our center, TTVR is performed by cardiac surgeons and structural heart interventionalists, both of whom have been trained on the device.  However, the TRISCEND II protocol did not specify that both operators needed to be present for each procedure.  Thus, either could perform the TTVR procedure independently or together depending on best practice for their MDHT and hospital. 
To reiterate, I strongly support the proposed NCD for TTVR with appropriate CED because this is a condition for which there is a true unmet need for Medicare beneficiaries.  Thank you for the opportunity to comment.

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We appreciate the opportunity to comment on the request for coverage for transcatheter tricuspid valve replacement (TTVR) for tricuspid regurgitation (TR) for Medicare beneficiaries. Given the lack of evidence showing clinically meaningful benefit to beneficiaries and the high rate of adverse events, we have significant concerns about TTVR and do not think that is meets the statutory “reasonable and necessary” criterion for Medicare beneficiaries. We strongly recommend that CMS convene a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to review the available evidence. Furthermore, there should be evidence that meaningful clinical benefit exceeds harms for the Medicare population before any coverage and thus meet the criteria of  “reasonable and necessary”.  We note that although the NCA was requested by Edwards for their valve, this consideration would apply to TTVR as a class, as future TTVR valves enter the market.
Significant Concerns with the Quality of the Available Evidence
There is a lack of high-quality evidence of benefit and much evidence of patient harms for TTVR technologies. FDA’s premarket approval of EVOQUE, the only currently FDA-approved device, relied on data from a small number of enrolled patients, a “breakthrough” subset from the TRISCEND II trial with 30-day and 6-month endpoints. The data for this subset (or the larger cohort) have not been published in a peer-reviewed journal. Full data and analysis of the TRISCEND II cohort and 1-year outcomes are not available. Given that TTVR involves permanent  implantation of  a high-risk device, it is essential for patient safety to have complete data, and beyond a 6 month follow up. We strongly urge CMS to await evaluation of the full analysis of the TRISCEND II 1-year outcomes before commencing the NCA. 
Current standard of care for Tricuspid regugitation
It is important to state that replacement or repair of tricuspid valve for tricuspid  regurgitation (TR) in no way addresses the severe and irreversible conditions that cause severe TR. TR occurs due to right ventricular dilatation, which either occurs from right ventricular failure, which is the endstage of congestive heart failure of any cause, or from pulmonary hypertension. The underlying conditions of endstage heart failure with right ventricular failure or pulmonary hypertension are NOT addressed or improved by replacement or repair of the tricuspid valve. Thus, this procedure, either surgical or percutaneous subjects patients to multiple harms, and little or no benefit.  The standard of care for TR is medical therapy, and not tricuspid valve surgery as benefits are not obtained with tricuspid valve replacement  Presumably, that is why TRISCEND II uses a medical therapy control group. 

We also note that any planned data on the longer-term outcomes is  compromised severely in quality by the large loss of patients to follow-up in the Breakthrough Pathway Cohort – less than half of the device (44 of 96) and control (26 of 54) group participants were available at 1 year. Furthermore, the unblinded nature of TRISCEND II means there is no value to subjectively measured endpoints, such as the Kansas City Cardiomyopathy Scale (KCCQ)  or other endpoints highly vulnerable to placebo effects. Also, an
Additionally, the TRISCEND II trial results presented in the SSED were not reviewed by Circulatory Systems Devices panel. It is highly unusual for the FDA to evaluate a new technology and not seek the counsel of an expert FDA advisory committee which allows public discussion of the risks and benefits of this device. This raises concerns over rushing to imperfect decision based on incomplete information. Finally, on the topic of public discussion of risks and benefits, it is essential that the data collected on these valves including this tricuspid valve be publicly available. Currently, all of the data about the many transcatheter valves that Medicare pays for is kept hidden from physicians and patients in the Transcatheter Valve Therapy (TVT) registry. Any use of the TVT Registry data must be specifically requested, can be denied, and if allowed, charges high fees for access. It is not publicly available.
Lack of Evidence of Benefit for Medicare Beneficiaries
In order for TTVR to be reasonable and necessary for beneficiaries with TR, there must be evidence of clinically meaningful benefit that outweighs the risks of the procedure. The available evidence does not show any clinically meaningful benefit. There is no evidence of reduction in mortality and the unblinded nature of the trial subjects the effectiveness endpoints to bias. Furthermore, tricuspid valve regurgitation is not a meaningful endpoint. Replacing a leaky tricuspid valve will reduce the amount of TR, that is what the new valve does. The clinically important question is, are patients better off or worse off if we do that. That requires a blinded study with quality of life endpoints and/or objective enpoint of all-cause mortality which has not been done.
This data on benefit is especially important as available evidence shows a high 30-day major adverse events (MAE) rate for TTVR in the TRISCEND II trial – 27.4% experienced a major adverse event, with 10.5% in the device group experiencing severe bleeding and 22.6% developing new-onset arrythmia and conduction disorder requiring permanent pacing, and there were 3 device- and procedure-related deaths. Furthermore, this 30-day MAE rate does not capture the 9 deaths that occurred between 30 days and 1 year - in total, 12 of 96 (12.5%) individuals in the device group died within 1 year, compared to 4 of 54 (7.4%) in the control group. The single-arm TRISCEND study had similarly high 1-year cardiovascular mortality (9.4%) and MAE rate (30.2%).  While preliminary presentation of 1-year mortality data from the full TRISCEND II cohort may be better, a final analysis of these results is not yet available. Consequently, the currently available safety data raises significant concerns on the safety of TTVR compared to optimal medical therapy, which must be resolved before Medicare coverage is provided. There are many clincal questions left unanswered in the data in the Summary of Safety and Effectiveness presented to the FDA. Additionally, the numbers do not add up, as on page 19 of SSED, it statesThe Breakthrough Pathway Cohort included a sample size of 150 patients (100 in the device group and 50 in the control group), which provided >80% power to test the hypotheses for the primary safety and effectiveness endpoints. Later in the SSED it states,  “A total of 153 patients were randomized at 30 investigational sites in the U.S. and Germany” and reports  on 99 in the device group and 53 in the control group. It is not explained what happened to explain the difference in the numbers between the sample size statement and the actual randomized patient numbers.

While the 30-day MAE rate primary safety endpoint was met in TRISCEND II, this endpoint was measured against a performance goal of 70% — it was not compared to the MAE rate in the control grop of medical therapy standard of care. In fact, the MAE rate in the control group was not stated. This use of a low performance goal, instead of comparison to control for MAE rate does not provide a meaningful assurance of safety. We understand that this performance goal was based on adverse event rates for isolated tricuspid valve surgery using a noninferiority margin advised by FDA guidance;  however, in order to assess whether TTVR is reasonable and necessary for Medicare beneficiaries, TTVR should be compared to the standard of care - optimal medical therapy (or no intervention), not another high-risk intervention (i.e., surgery) that is rarely performed because it has not been shown to improve outcomes. The equivalent MAE rate for the optimal medical therapy control group is not reported in the TRISCEND II results included in EVOQUE’s SSED; this key data point is necessary for CMS to consider as it prepares this NCA. 
This mortality and adverse events data are concerning given the lack of evidence of clinically meaningful benefit from TTVR. The results of TRISCEND II are considerably weakened as the trial was unblinded, and  the effectiveness endpoints are subjective  – TR grade reduction, 6-minute walk distance (6MWD), NYHA functional class, KCCQ score – and open to bias. While TRISCEND II reported improved TR grade, this is a surrogate measure. We note it is impossible to blind the echo readers, who will see the TTVR device in place post procedure.  Clinically meaningful outcomes to patients would be  NYHA functional class and KCCQ score, and it is difficult to assess to what extent these improvements were driven by placebo effect since KCCQ score is self-reported study was unblinded. Additionally, study personnel assessing NYHA functional class were not blinded to the individual’s treatment assignment. Furthermore, improvement in 6MWD, a more direct measure of clinical benefit, fell short of its target of 30 meters (mean 6WMD improved 25 meters, from 232.2 to 257.6 meters, in the device group).   
Need for Medicare Evidence Development and Coverage Advisory Committee Review 
The various concerns outlined above at the very least necessitate MEDCAC review in order to obtain unbiased, expert review of the evidence for TTVR. 
• Even the most robust data available is from one cohort of an unblinded trial whose full results have yet to be finalized 
• Data not reviewed by FDA panel
CMS should call for high quality clinical data to determine risks and benefits of TTVR and convene a MEDCAC meeting to review, even if the timeline for the NCA is delayed.  The first priority is to protect patient safety and not rush to cover a potentially harmful implanted device.
Conclusion 
CMS should call for high quality clinical data to determine risks and benefits of TTVR and convene a MEDCAC meeting to review, even if the timeline for the NCA is delayed.  The first priority is to protect patient safety and not rush to cover a potentially harmful implanted device.

Sincerely,

Rita F. Redberg, MD
UCSF
Sarah Bitter, MA
UCSF
Steven Woloshin, MD
Dartmouth

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Transcather tricuspid therapy is so important as there is essentially no alternative therapy.  When TAVR was first approved the alternative was surgical AVR and so the therapy was first approved for patients who were not surgical candidates.  With tricuspid regurgitation, the patients are rarely surgical candidates and the therapy is basically only diuretics.  Many patients are confined to home due to intractable and limiting edema.   That said, this therapy should be offered and made available broadly to provide for these chronically ill patients who are currently severely under treated.  This will also be cost beneficial with reduced hospitalizations in treated patients.  

I am a structuralist in practice in an underserved community in New Mexico with the majority of our treated patients being Latino or Native American.  There is an immense disparity in the ability to offer structural interventions compared with other states due to the DRG payments which barely cover the implant costs with no margin for the other costs of the inpatient admission.   This disparity then affects availability of structural heart interventions to minority populations in our state.  I would highly urge CMS to consider this healthcare equity issue as the national coverage determination is being considered for tricuspid interventions so that we are able to provide equal care to all patients.  Thank you for your attention to these comments.   

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July 19, 2024

Dear Administrator Brooks-LaSure:

As nonprofit organizations that are members of the Patient, Consumer, and Public Health Coalition, we appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) National Coverage Analysis on Transcatheter Tricuspid Valve Replacement (TTVR).
 
Our coalition includes nonprofit organizations representing millions of patients, consumers, researchers, and doctors united to ensure that medical treatments are safe and effective. None of the organizations that have signed this comment have financial conflicts of interest on this topic.
 
The Evoque system designed by Edwards for transcatheter tricuspid valve replacement (TTVR) was recently approved by the Food and Drug Administration (FDA) based on 6-month findings from their TRICSEND II trial. As CMS considers coverage for TTVR, we share the concerns of many experts that the FDA approval was premature and the data are inadequate to support the safety and effectiveness of TTVR for the Medicare population. Our major concerns are as follows:
 
1. Poor research design:
The trial was unblinded, and therefore all subjective outcomes are vulnerable to bias. Moreover, severe, irreversible conditions lead to severe tricuspid regurgitation, usually either end-stage congestive heart failure or pulmonary hypertension.  Neither of these is reversed or reduced by TTVR or the other surgical procedure used as a safety comparison group, and we question the appropriateness of the effectiveness outcome measures that were used instead.  In addition, all the comparison safety data (including MAEs) should be based on data for patients receiving the current standard of care — a medical control group, not a surgical one.
 
2. Incomplete data:
Complete data is only available at 30 days and 6 months, which is much too short a time to provide reasonable assurance of safety or effectiveness for Medicare beneficiaries. Fewer than half the participants in the TTVR group and control group completed the 12-month follow-up visit. 12 months should be the minimum required for all or nearly all of the participants, to avoid a biased assessment.
 
3. High rate of Major Adverse Events (MAE):
The 30-day rate of Major Adverse Events (MAE) was notably high at 27.4%, and the MAE rate for the control group wasn't reported. Instead, the TTVR MAE rate was compared to a performance goal of 70% based on isolated tricuspid valve replacement surgery outcomes. However, as the control group for TRISCEND II is medical therapy, and that is the standard of care alternative to TTVR, the MAE rates should be from the medical therapy control group, not surgical patients. It is misleading to use a surgical control group, which of course will have higher MAE rates in the first 6 months. Additionally, almost one fourth (22.6%) of participating TTVR patients who did not previously have pacemakers or ICDs required permanent pacemakers after the procedure, and 10% of TTVR patients experienced severe bleeding.
 
4. Mortality rates:
The 30-day MAE rate is misleading because of the large number of deaths between 30 days and 1 year: By 12 months, 12 out of 96 (12.5%) patients in the TTVR group were reported to have died, compared to 4 out of 54 (7.4%) in the control group. This indicates a need to complete the 12-month data collection on all patients and suggests that longer follow up would be even more meaningful.
 
The FDA made its approval decision without convening an FDA Advisory Committee panel to review the data, none of which have been published in a peer-reviewed journal. Given the flaws of the study, the problem with missing data, and of the lack of vetting by the FDA Advisory Committee, we strongly urge a thorough MEDCAC review to determine if the evidence is robust and persuasive enough to support Medicare coverage for TTVR.
 
Sincerely,

AMSA Wisconsin 

Doctors for America

Jacobs Institute of Women’s Health 

MedShadow Foundation 

Mothers Against Medical Error 

National Center for Health Research 

National Women’s Health Network 

Patient Safety Action Network 

SCAD Alliance 

TMJ Association 

Washington Advocates for Patient Safety 

Woody Matters

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Re: CAG-00467N - Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Ms. Syrek Jensen,

On behalf of VDyne, we are writing to express our strong support for the initiation of a National Coverage Analysis for Transcatheter Tricuspid Valve Replacement (TTVR). As a manufacturer of a new TTVR technology we are deeply invested in the advancement of cardiovascular health. VDyne received Breakthrough Device Designation and approval of our early feasibility study (EFS) from the FDA for the VDyne TTVR System in 2021. Enrollment in our EFS (IDE G210172 / NCT 05848284) is underway. 

We believe that TTVR represents a significant advancement in the treatment of tricuspid valve disease, offering a minimally invasive alternative to traditional surgical methods. The advent of TTVR provides a much-needed option for these patients, improving their quality of life and reducing the morbidity and mortality associated with untreated tricuspid valve disease.

Current data from clinical trials have shown promising results, demonstrating the safety and efficacy of TTVR. For example, the TRISCEND II clinical trial has highlighted significant improvements in symptoms and functional status among patients who have undergone this procedure. These findings underscore the importance of making TTVR accessible to those in need. However, with limited commercial treatment options available for these patients at this time, there remains a need to ensure patients who are clinically suitable for TTVR have access to a variety of TTVR devices and indications. Therefore, we would encourage comprehensive coverage of a variety of transcatheter therapies intended to treat TR.

Given the substantial potential benefits of TTVR, we strongly urge CMS to prioritize a comprehensive national coverage analysis for this procedure. By doing so, CMS will take a pivotal step in ensuring that patients with tricuspid valve disease have access to the most advanced and effective treatment options available. We appreciate CMS’ consideration of our comments and are confident that a favorable decision to cover TTVR will lead to significant advancements in the care and outcomes of patients suffering from tricuspid valve disease.

Sincerely,
Laura Moffett 
Director of Regulatory & Clinical Affairs
VDyne, Inc.

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July 19, 2024
Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244
Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Ms. Syrek Jensen,

It is with great excitement for me to see the technology for transcatheter tricuspid valve (TV) disease move forward.  I would congratulate the US Food and Drug Administration (FDA) for their extensive review of these early trials in bringing this technology to practicing physicians.  Over my 19 years as a cardiac surgeon who actively performs both surgical and transcatheter procedures, the addition of transcatheter TV repair and replacement is a major advance to the management of TV disease.  I have been fortunate to be in the leadership position of both innovative surgical and transcatheter technologies and understand these procedures well.  
While most high- to extreme-patients with severe tricuspid regurgitation (TR) had traditionally been treated with medical therapy, some low-risk patients undergo surgery.  Cardiac surgeons are well versed in the management of TV disease, especially understand the anatomy of the TV.  Whilst, TV surgery is most commonly performed with concomitant mitral valve disease, over ~2000 isolated TV surgeries are performed in the U.S. per year.  A recent publication in the Annals of Thoracic Surgery (2024) from The Society of Thoracic Surgeons’ (STS) National Database in over 13,000 patients from 2017 and 2023 revealed good overall outcomes in both TV repair or replacement.  Furthermore, this analysis led to a new STS TV surgery risk model which has been released in 2024 and allows a more accurate prediction for short term outcomes and should be routinely used in clinical practice.  Clearly, surgeons have had an intimate understanding of the anatomy and pathophysiology of TR and for decades have performed successful treatment of the tricuspid valve.  
Higher risk patients with isolated TV regurgitation are commonly older and more often in the Medicare population.  These patients may not be good candidates for surgery and newer transcatheter technologies are important advancement in helping these patients.  Recently, the FDA has approved the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR).  Our center and I participated in the U.S. Early Feasibility Study and also the pivotal trial (TRISCEND II) for approval for this device.  The impact for this device on patient care was incredible and is truly a major breakthrough in modern medicine.  Having been an early adopter of transcatheter technology for valve disease since 2006, it reminds me transcatheter aortic valve replacement (TAVR) was introduced as a treatment for severe aortic stenosis.  Therefore, I am fully supportive of CMS coverage of the procedure under a National Coverage Determination (NCD) with Coverage with Evidence Development (CED) for TTVR. 
Similar to the beginnings of TAVR in high-risk patients, those with TR have an advanced medical condition in which the patients have multiple co-morbidities.  The FDA approval and CMS pathway for reimbursements for TAVR has been one of the most powerful and successful stories in cardiovascular medicine.  These decisions have saved and improved thousands of lives in the U.S.  The ideology adopted by CMS for reimbursement was that these patients are not only seen by a multi-disciplinary team (MDT) of interventional cardiologists and cardiac surgeons, but also performed by this team jointly has led to the successful implementation and superb outcomes associated with TAVR.  In 2023, nearly 100,000 patients in 800 sites will undergo TAVR in the U.S.  The access for TAVR procedures has not been stymied by the assessment and treatment by both interventional cardiologists and cardiac surgeons together.  With the TAVR NCD, the U.S. has built the most robust and carefully structured heart valve program infrastructure in the world.  The implementation of TTVR will easily follow within the domains of this national infrastructure that is already in place.  These patients are complex and for one person to be allowed to decide on the pathway for the treatment of these patients deviates from the collaborative national heart valve teams that are already in place and have been successfully implemented, like as is for TAVR.  This MDT should include all options including surgery, TTVR, medical and/or palliative therapy and potentially tricuspid transcatheter edge to edge repair.  In addition, cardiologists (non-invasive, heart failure, and imaging) and electrophysiologists should be involved in addition to the interventional cardiologists and cardiac surgeons.  Tools that will be essential in the assessment of these patients include the use of the STS risk calculator which can be integrated into the coverage determination to support informed clinical decisions by the heart team. 
TTVR this an eloquent, but complex transcatheter procedure that is best performed with a multidisciplinary expertise.  An inclusive aspect of intraprocedural participation as is utilized with TAVR will assure the safest rollout of this new technology to Medicare beneficiaries.  Surgeons are integral members of the heart team and should therefore serve as co-operators in TTVR procedures, similar to how we participate in the very successful model used for TAVR.  Surgeons are uniquely qualified to mitigate risks and complications, which are essential for ensuring patient quality and safety.  As a surgeon involved in transcatheter valve therapies, I remain committed to performing these procedures.  Furthermore, the leadership of cardiac societies remain focused, as in TAVR, to advocate for patient safety and superlative outcomes.
One of the other major success stories for the TAVR NCD has been the recording of all procedures to be collected in the STS/ACC TVT Registry.  This will allow the scientific community to understand the real-world outcomes outside of the randomized trials which are in expert sites and with highly controlled and vetted patients in the breakthrough device coverage.  This cautious approach by the CMS will ensure patient safety and optimal rollout of this innovative technology.
In summary, The FDA and CMS should be congratulated on the pathway for approval and the NCD of the TTVR technology!  I am extremely supportive of the NCD for the TTVR; since this will undoubtedly benefit thousands of patients in the U.S. by improving quality of life and survival.  Emulating the extremely successful TAVR NCD has been proven in over 800 sites in the U.S. without limiting access to patients and resulting in outstanding results.  Ensuring that surgeons are part of the preoperative process and also as co-operators with our interventional cardiologists colleagues will provide the most comprehensive care in these complex patients.

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As authors of "A Roadmap for Improving Medicare's Application of Coverage With Evidence Development" recently published in Value in Health (1), we are writing to comment on the National Coverage Analysis (NCA) for Transcatheter Tricuspid Valve Replacement (TTVR) and, more broadly, on the application of the Coverage with Evidence Development (CED) policy (2).  The principles outlined in the tracking sheet for this NCA align with several key recommendations we made for improving CED policy across all cases.

Clarifying the Process for Ending CED Requirements
The lack of clarity around the process and timeline for reconsidering CED requirements is a significant issue in all CED cases. The collaborative approach taken in developing the Evidence Development Plan (EDP) for TTVR, involving the sponsor, CMS, and the Agency for Healthcare Research and Quality (AHRQ), appears to address this concern. This proactive, upfront collaboration could serve as a model for all future CED implementations, providing a clear pathway for transitioning from CED coverage.

We recommend that CMS explicitly articulate how the EDP will guide the eventual reconsideration of CED requirements in all cases. This process should include:

1. Developing objective, upfront criteria or findings from the data collected—based on priorities that matter to patients—that would trigger various CED outcomes (extension of CED, removal of CED, revocation of NCD, etc.).

2. Specifying a preliminary review date—ideally within 3 years—to evaluate whether the evidence generated meets those criteria.

3. Including an option to amend the coverage decision earlier if significant new evidence arises.

4. Establishing a formal process for periodic review of evidence generated under CED, with pre-specified criteria for determining when sufficient evidence has been gathered to warrant reconsideration of the CED requirements.

Clear Criteria for Applying CED
The adoption of clear and predictable criteria for when CED should be applied is essential across all potential applications. While the TTVR NCA could serve as a model, these criteria should be consistently applied to all technologies under consideration for CED. We encourage CMS to explicitly state the rationale for applying CED in each case and how it aligns with broader CED policy goals. Possible high-level criteria for applying CED could include situations where:

1. Peer-reviewed evidence suggests an item or service offers meaningful outcomes that matter to patients or the healthcare system.

2. Significant questions exist about the items or services that can be addressed through further data collection, with the level of significance of each question (and subsequent data requirements) aligned with outcomes that are prioritized by patients.

Prioritizing Patient Preferences
Incorporating patient-centered outcomes and preferences in CED is crucial for any technology under consideration. We are pleased to see indications that patient preferences may play a role in the TTVR NCA and encourage this approach for all CED decisions. We urge CMS to use validated patient preference information throughout the CED process, from the initial application of CED to the design of evidence collection activities and the evaluation of generated evidence.

Timely and Equitable Access
A primary goal of CED is to expedite beneficiary access to promising new technologies while ensuring appropriate safeguards. This principle should be applied universally, including in the TTVR NCA. We urge CMS to carefully consider how any coverage requirements, including potential center of excellence criteria, might impact equitable access to technologies under CED. Particular attention should be paid to avoiding undue barriers for underserved populations, rural areas, and other patient groups that may face challenges in accessing care. By thoughtfully designing CED requirements, CMS can help ensure that the benefits of new technologies are accessible to all Medicare beneficiaries, regardless of their geographic location or socioeconomic status.

Minimizing Burden on Providers and Patients
CED data collection activities have sometimes placed unnecessary burdens on clinicians, facilities, and patients. In designing evidence collection requirements for all CED cases, we encourage CMS to prioritize approaches that minimize these burdens while still addressing key evidence gaps.

In conclusion, it is crucial that CMS implement an improved approach to CED that aligns with our recommendations across all cases. We recommend that CMS continue to refine and enhance its CED policy, incorporating principles such as clear criteria for application and termination, patient-centered approaches, minimized burdens, and equitable access considerations. These improvements to the CED process could not only provide timely access to promising new technologies for Medicare beneficiaries but also set a positive precedent for all future applications of CED.

As policy researchers, we appreciate the opportunity to comment on this important NCA and the broader implications for CED policy as CMS may need to apply it going forward. We would be happy to provide any additional information or clarification that might be helpful in improving the CED process across all applications.

Respectfully,

Darius Lakdawalla, PhD
Quintiles Chair in Pharmaceutical Development and Regulatory Innovation, University of Southern California Schaeffer Center for Health Policy & Economics

Sean Tunis, MD
Founder and Senior Strategic Advisor, Center for Medical Technology Policy

Peter Neumann, ScD
Director, Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center

Danielle Whicher, PhD
Senior Researcher, Mathematica

Emily Zeitler, MD MHS
Assistant Professor of Medicine, The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth

Barry Liden, JD
Director of Public Policy, USC Schaeffer Center for Health Policy & Economics

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(1) Darius Lakdawalla et al., “A Roadmap for Improving Medicare’s Application of Coverage With Evidence Development,” Value in Health 0, no. 0 (May 22, 2024), https://doi.org/10.1016/j.jval.2024.05.008
(2) The opinions expressed herein represent those of the authors and do not represent the positions of any of their affiliated organizations.

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July 19, 2024
Administrator Chiquita Brooks-LaSure
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Brooks-LaSure,

As members of the Heart Valve Disease Policy Task Force, a national group of 30 leaders including clinician and patient advocates, we appreciate the opportunity to comment on the NCD Tracking Sheet regarding the Transcatheter Tricuspid Valve Replacement (TTVR) and want to emphasize the critical importance of establishing a comprehensive Medicare coverage policy that includes all FDA-approved minimally invasive transcatheter devices to improve quality of life and functional status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical therapy. Such a policy is not only pivotal in addressing the unmet needs of Medicare beneficiaries suffering from tricuspid regurgitation but also in facilitating timely access to innovative and life-saving technologies.

Importance of Establishing a Comprehensive Coverage Policy
Recent advancements, notably the FDA approvals of two transcatheter tricuspid therapies two months apart earlier this year, including the EVOQUE Tricuspid Valve Replacement System, mark significant progress in the field. These innovations promise substantial improvements in patient outcomes, as evidenced by patient-reported outcomes from clinical trials. For instance, 53% of patients treated with EVOQUE expressed a desire to regain independence in self-care post-intervention, highlighting the transformative potential of these technologies in enhancing quality of life. Coverage policies for these technologies would ensure that a broader range of patients have access to these life-changing treatments, thereby improving overall public health and reducing long-term healthcare costs associated with untreated or poorly managed tricuspid valve disease.

Role of Evolution and Previous Coverage Policies in Determining New Policy
The landscape of transcatheter valve procedures has evolved considerably over the past decade, characterized by deeper clinical experience and the establishment of expert Heart Teams. It is imperative that Medicare coverage policy for minimally invasive transcatheter devices in the treatment of TR reflects this evolution, ensuring that patients have access to these advancements without unnecessary delay or undue restrictions.

In formulating this policy, we urge CMS to act as swiftly as possible to incorporate lessons learned from previous coverage policies such as those for TAVR and M-TEER, as well as insights gained during the COVID-19 public health emergency. These insights underscore the need for balanced coverage policies that prioritize patient access while maintaining rigorous standards for safety and efficacy. For example, the temporary flexibilities introduced during the COVID-19 public health emergency, such as waiving face-to-face evaluation requirements and relaxing provider volume requirements, demonstrated that patient outcomes for TAVR procedures remained excellent even under these more flexible criteria. Additionally, the M-TEER determination includes use of interventions in patients with either functional or degenerative mitral regurgitation, with slightly different coverage requirements for each. These examples highlight how adaptable policies can effectively maintain high standards of care while expanding access to critical treatments, particularly in rural and underserved areas.

Patient-Centered Care in Coverage Determination
Furthermore, we emphasize the importance of patient-centered care in the coverage determination process. Requirements for pre-intervention evaluations should be streamlined to minimize burden on patients, avoiding unnecessary barriers that could hinder access to care. A single evaluation by a qualified member of the Heart Team, whether conducted in-person or via telehealth, should suffice to assess procedural suitability and ensure comprehensive patient evaluation. We also request that CMS refrain from layering on any required shared clinical decision-making (SCDM) requirements to this coverage determination, as we requested on TAVR. The use of SCDM as a condition of coverage creates confusion, and in effect, serves as a form of utilization management.   

We understand that CMS will look to the specialty society consensus clinical treatment guidelines as the Medicare coverage determination process advances. While we support the structural heart team approach overall, we hope that as CMS crafts coverage requirements, it also considers the needs of patients with closer proximity to smaller and rural hospitals. 

Considerations regarding the experience of medical providers and equitable geographic access must be carefully weighed to safeguard patient safety and ensure consistently high-quality care across diverse healthcare settings. Ensuring health equity is critical; thus, policies must incorporate the needs of underserved populations, including those in rural or economically disadvantaged areas, to prevent disparities in access to these advanced treatments. By addressing these inequities, we can ensure that all patients, regardless of their socioeconomic status or geographic location, can benefit from these medical advancements.

In conclusion, we strongly advocate for an inclusive and forward-thinking coverage policy that prioritizes patient access, integrates lessons from past experiences, and upholds the principles of patient-centered care to minimally invasive transcatheter valve devices. We appreciate the opportunity to provide input on this critical matter and look forward to continuing our collaboration with CMS to advance patient-centered policies.

Thank you for your attention to this important issue.

Sincerely,

Members of the Heart Valve Disease Policy Task Force

Alliance for Patient Access
Caregiver Action Network
Conquering CHD
HealthyWomen
Heart Valve Voice US
Hypertrophic Cardiomyopathy Association
Men’s Health Network
The Mended Hearts, Inc.
National Minority Quality Forum
Partnership to Advance Cardiovascular Health
RetireSafe

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July 19, 2024 

Submitted online via www.CMS.gov

RE: CAG-00467N, Transcatheter Tricuspid Valve Replacement (TTVR) 

Dear Administrator Chiquita Brooks-LaSure:

Thank you for accepting public comment on the formal request to provide coverage for the EVOQUE tricuspid valve replacement system (EVOQUE system) and the clinical indications for use among Medicare beneficiaries. 

Doctors for America (DFA) applauds innovative efforts to treat tricuspid regurgitation (TR) and associated comorbidities, but we have serious concerns with the recent premarket approval by the U.S. Food and Drug Administration (FDA) of this new Transcatheter Tricuspid Valve Replacement (TTVR) system. The evidence that is currently available is not adequate to merit national coverage for all Medicare beneficiaries, let alone the premarket approval it received. Doctors for America’s (DFA) FDA Task Force is committed to patient safety and ensuring the highest evidentiary standards are used in any market or coverage determination. 

Doctors for America mobilizes doctors and medical students to be leaders in putting patients over politics to improve the health of our patients, communities, and nation. We are 27,000 physicians and medical students in all 50 states, representing all areas of specialization. Our impact areas focus on access to affordable care, community health and prevention, and health justice and equity. The FDA Task Force educates, mobilizes, and empowers a multispecialty group of DFA members and clinicians to provide unbiased expertise in evaluating and responding to the FDA regulatory process in a way that maximizes meaningful clinical outcomes for our patients. We strive to support and strengthen an FDA that puts patients first. The Task Force is committed to keeping patients safe by ensuring that therapeutic approvals are based on the highest evidentiary standards, providing us reassurance when we prescribe them that FDA has done its due diligence in evaluating safety and efficacy.
Evidence Protects Patients and Physicians
As a group of clinicians and concerned citizens, we are submitting this comment to share our significant concern that the evidence presented by Edwards Lifesciences is severely lacking and as such this request for coverage should be denied.

Earlier this year, Edwards received FDA premarket approval for its Evoque system based on 6 month results from the TRICSEND II trial. We have significant concerns with the TRICSEND II trial design and available evidence. 
The study was unblinded, and outcomes were only evaluated at the 30-day and 6-month mark. This is concerning because unblinded studies can be impacted by placebo effect and bias, ultimately rendering such a study and its results to be inconclusive and subjective. Furthermore, there is missing data on the outcomes of the 12-month visit as currently, only less than half of the enrolled patients in the control and device arm completed these visits. To truly understand the longitudinal effects of this device intended for a chronic condition, complete data from enrolled participants at the 12-month visit is needed.

The major adverse events (MAE) were not reported for the control group and were worryingly high for the enrolled patients that received the device. At the 30-day mark, the MAE rate was  27.4%. Instead of tracking the same MAE rate for the control group to allow for a clear comparison, those who received the device were compared to the performance goal of 70% based on safety outcomes for isolated tricuspid valve replacement surgery. Additionally, 10% of participants had severe bleeding and 22.6% of the patients who did not have pacemakers at the start of the trial now require them permanently. Furthermore, 12 out of 96 (12.5%) patients in the device group died by 12 months compared to 4 out of 54 (7.4%) in the control group. 

Given the lack of clinical trial evidence substantiating the applicant’s claims around efficacy, the concerning high rate of MAEs, the fact that the data was not reviewed by an independent expert advisory committee before FDA approval, and that no data was published in a peer-reviewed journal we are requesting that Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) convene to review this evidence before any national coverage assessment is completed.

Regards, 

Doctors for America FDA Task Force

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I am writing to share my experience as the [PHI Redacted] and caregiver of my [PHI Redacted], who has been deeply affected by torrential tricuspid regurgitation (TTVR) and the incredible impact of the EVOQUE valve replacement device.

For two years, I watched my [PHI Redacted] endure the debilitating effects of TTVR while in hospice. The constant fatigue, shortness of breath, and swelling made even the simplest tasks incredibly difficult for her. Watching her struggle to walk around our home or spend time with our family was heartbreaking. The emotional toll was heavy on both of us, as our lives were filled with worry and stress.

When we heard about the EVOQUE valve replacement, it felt like a glimmer of hope. After she had the procedure, the change was nothing short of amazing. The device didn’t just help her heart function better—it gave her back her life. She went from being constantly exhausted to having newfound energy. She could finally enjoy activities like playing with grandchildren, gardening, and taking long walks without getting worn out.

This transformation did wonders for her mental and emotional health, too. She got her independence and confidence back, which had been worn down by years of dealing with TTVR. The strain on our family also eased. We didn’t have to worry about her health all the time, and we could enjoy more activities together.

As her [PHI Redacted] and caregiver, I’ve seen firsthand how the EVOQUE device has changed our lives for the better. It’s important for CMS to recognize the life-changing benefits of this treatment for patients like my [PHI Redacted]. Approving and supporting the EVOQUE valve replacement can bring hope and healing to many others who suffer from TTVR. 

Thank you for considering our story and the profound impact the EVOQUE device has had on us.

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July 19, 2024

Re: Transcatheter Tricuspid Valve Replacement (TTVR), CAG-00467N, Public Comment

To Whom It May Concern,

As a cardiologist specializing in advanced heart failure management, I frequently encounter patients with advanced stages of tricuspid regurgitation (TR). This patient population often presents with numerous underlying conditions, multiple comorbidities, and advanced TR-related symptoms and disabilities. Traditional surgical repair or replacement of the tricuspid valve is associated with high perioperative risks, particularly for those with severe or greater TR, limiting the application of this approach to treatment.

Transcatheter Tricuspid Valve Replacement (TTVR) has emerged as a less invasive therapeutic option, demonstrating promising efficacy in reducing TR severity, improving hemodynamics, and enhancing clinical outcomes. TTVR is proving to be a viable alternative for non-surgical patients, with excellent early outcomes.

I believe that TTVR should be offered to patients as a treatment option, and therefore I support Edward’s request to facilitate Medicare coverage of TTVR.
However, I would like to highlight that TTVR is not limited to orthotopic solutions (devices situated on the tricuspid valve/annulus), but rather include tricuspid valve devices which are situated upstream of the tricuspid annulus, namely heterotopic solutions, which also fall under the TTVR scope. While no such heterotopic solution is currently commercially available in the US, there are some solutions (e.g. TricValve®, Trillium™, Unica™, and more…) that have undergone clinical trials and have demonstrated clinical safety, feasibility, and benefit to patients. Moreover, among the very few devices commercially available in Europe today, is the TricValve heterotopic TTVR system which has already reached thousands of patients with apparent clinical benefit. Such TTVR systems will reach the US market as well, and CMS policy should be flexible enough to facilitate access to these promising alternative approaches as they become available.

In conclusion, as TTVR emerges as a promising treatment option for TR patients, I believe CMS should consider coverage of such devices and the importance of making room in the future for multiple technologies.

Sincerely,
 
William T. Abraham, MD, FACP, FACC, FAHA, FESC, FRCPE
Professor of Medicine, Physiology, and Cell Biology
College of Medicine Distinguished Professor
Division of Cardiovascular Medicine
The Ohio State University

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July 19, 2024

Tamara Syrek Jensen, JD 
Director, Coverage & Analysis Group 
Centers for Medicare & Medicaid Services 
7500 Security Blvd. 
Baltimore, MD 21244

Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Ms. Syrek Jensen,

On behalf of the Stanford Byers Center for Biodesign Policy Program, I am pleased to submit comments to CMS on the Transcatheter Tricuspid Valve Replacement (TTVR) National Coverage Analysis (CAG-00467N). For over 24 years, our organization has focused on improving health outcomes and health equity through innovation education, translation and innovation policy. One of our most recent publications highlighted the challenges that many of America’s seniors and patients across the country face – all too often not getting access to critical medical technologies that have received FDA authorization but do not receive timely CMS coverage. 
 
Given the limited treatment options available to patients suffering with severe tricuspid regurgitation, the approval of the FDA Designated Breakthrough device (the EVOQUE Tricuspid Valve Replacement System), acceptance into the Parallel Review Program, and the now publicly disclosed engagement between CMS and the National Coverage Determination (NCD) requestor (Edwards Lifesciences) in a process similar to what has been proposed by the Agency in the Transitional Coverage of Emerging Technologies (TCET) guidance, we strongly urge CMS to act quickly and implement a TTVR NCD that affords Medicare beneficiaries timely and equitable access to TTVR. This coverage policy must balance the need for appropriate provider requirements without jeopardizing the ability for experienced transcatheter sites to offer this breakthrough technology.  
 
While we deeply appreciate CMS’s stated objectives to find ways to accelerate access, and their championing of TCET as an improvement upon existing CED programs, we are concerned that the intended effect of the Parallel Review Program in this situation – that “concurrent review by the Agencies of clinical evidence can reduce the time from FDA premarket approval or the granting of a de novo request to an NCD” – does not appear to have been met.  As noted specifically in the example cited by CMS and FDA in the Federal Register Notice, extending Parallel Review (81 FR 73113) was proposed to allow devices to receive Medicare coverage much faster (in that example less than 2 months) after receiving its premarket approval. This is unfortunately in contrast to the timelines published in the TTVR Tracking Sheet for this technology. EVOQUE was approved by the FDA on February 1, 2024 and the National Coverage Analysis (NCA) review was initiated on June 20, 2024, with a noted expected completion date of March 20, 2025. 
   
For the past three presidential administrations, CMS has examined creating a new dedicated accelerated coverage pathway for novel medical technologies that addresses unmet needs for America’s seniors. While we are eagerly awaiting the release of final guidance and hope that it is a meaningful and impactful policy that will accelerate patient access to critical medical technologies, we believe that efficiently finalizing a TTVR NCD in this case would set an important example that this new framework could be a viable pathway for those with similar worthy evidence, allowing, in this case, previously untreated Medicare patients with a diagnosis of tricuspid regurgitation to receive a safe and effective treatment with appropriate safeguards and continued data collection in place.  It’s our hope that success in this regard would demonstrate CMS’s commitment towards their stated goals, and encourage other innovators to pursue the pathway, enhancing innovation and access to breakthrough technologies for other Medicare populations in need in the future.
 
Thank you for the opportunity to comment on this NCA in the initial public comment period. If we can provide any additional information, please feel free to contact me at jmakower@stanford.edu

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July 19, 2024 

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group 
Centers for Medicare & Medicaid Services (CMS)
7500 Security Blvd 
Baltimore, MD 21244 

RE: National Coverage Analysis (NCA) for Transcatheter Tricuspid Valve Replacement (TTVR) (CAG-00467N) 

Dear Ms. Syrek Jensen:

On behalf of Medtronic, we appreciate the opportunity to respond to CMS’ request for public comment on the initiation of a national coverage analysis (NCA) on transcatheter tricuspid valve replacement (TTVR). 

Medtronic is the world’s leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. We are committed to the continual research and development necessary to produce high-quality products and to support innovative therapies that improve patients’ lives. 
Medtronic is the manufacturer of the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system. Medtronic received Breakthrough Device Designation and approval of an early feasibility study (EFS) by the FDA for the Intrepid TTVR System in September 2020. The Medtronic TTVR EFS (IDE G200199 / NCT 04433065) began enrolling patients with severe, symptomatic tricuspid regurgitation in October 2020 and received CMS IDE coverage in July 2021.

Tricuspid regurgitation affects more than 2 million patients in the United States and is a highly undertreated disease due to the unsuitability of many patients for surgical intervention and the high morbidity and mortality associated with surgical intervention. TTVR is an innovative procedure that provides an important treatment option for patients with severe, symptomatic tricuspid regurgitation. Given the limited treatment options for these patients, it is important to ensure that patients who are clinically suitable for this critical procedure have access to the therapy while ensuring optimal patient outcomes. 

In initiating the NCA, CMS has an opportunity to issue a coverage policy for TTVR that is evidence-based and ensures equitable patient access to TTVR through a transparent and publicly accountable process. As CMS develops national policy on TTVR, we offer the following points for consideration: 

     •     Medtronic is supportive of a TTVR national coverage determination (NCD) that covers all FDA approved TTVR devices and indications.  
     •     In considering whether ongoing evidence development will be necessary for TTVR, Medtronic believes that coverage with evidence development (CED), when carefully and appropriately 
            constructed, can serve as an effective tool to allow beneficiary access to critical advanced medical technologies and to gather ongoing, real-world evidence about a technology’s performance in 
            the Medicare population. Effective methodologies have been developed (and continue to evolve) to ensure wide patient access while enabling systematic evidence generation in the least 
            burdensome manner. We encourage CMS to consider such approaches, inclusive of existing and future TTVR technologies, if CED will be a component of the TTVR coverage policy. 
     •     Medtronic encourages CMS to seek input from clinical experts when defining TTVR site and operator procedural experience and volume requirements to ensure that requirements align with 
            patient clinical needs and the transcatheter valve procedure landscape. 

As always, Medtronic appreciates CMS’ consideration of these comments and we look forward to working with you on TTVR coverage policy that provides timely beneficiary access and the best possible outcomes for patients. 

Sincerely, 

Jeff Farkas
Vice President, Health Economics, Policy & Reimbursement 
Medtronic

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July 16, 2024

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Ms. Syrek Jensen,

As a practicing cardiac surgeon that has been involved in transcatheter valve procedures including early feasibility studies in the treatment of tricuspid valve disease, I can attest to the fact that tricuspid regurgitation (TR) is a major medical condition afflicting the Medicare population. This devastating disease has been underdiagnosed and undertreated historically. I have substantial clinical experience managing patients with TR by performing surgical tricuspid valve repair and replacement over the past 19 years. Most cardiac surgeons have extensive experience treating TR especially when it is associated with mitral regurgitation and other cardiac conditions necessitating heart surgery. Isolated TR surgery is less commonly performed but a significant surgical experience exists. Recently published contemporary data from The Society of Thoracic Surgeons’ National Database, shows that between 2017 and 2023, there were 13,587 isolated tricuspid valve operations performed in the US, the majority in the Medicare population, with an overall operative mortality of 5.5% for tricuspid valve repair and 5.7% for tricuspid valve replacement.

Surgery for TR was until recently the only option for treating patients with right ventricular heart failure and severe TR. Recently the US Food and Drug Administration (FDA) has approved the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR). As an additional less invasive option for treating these ill patients with severe TR, I am fully supportive of CMS coverage of the procedure under a National Coverage Determination with Coverage with Evidence Development (CED). However, due to the advanced medical condition of these patients as well as multiple options available for management, I strongly advocate for the management by a multi-disciplinary heart team (MDHT) approach for all options including surgery, TTVR, medical and/or palliative therapy and potentially tricuspid transcatheter edge to edge repair (T-TEER).

As the clinical experience with TTVR is quite limited at the current time as well as the fact that there are likely large numbers of patients with advanced disease presenting, an approach similar to the introduction of transcatheter aortic valve replacement (TAVR) is warranted. This includes comprehensive assessment for all treatment options by the MDHT including interventional cardiologist and cardiac surgeon, but importantly in addition, imaging specialists, heart failure experts, and electrophysiologists. All patients should undergo risk assessment using the just published STS tricuspid surgery risk algorithm. This new risk calculator is specifically calibrated to help assess the TTVR population. This tool provides the best available evidence for clinical decision-making, ensuring that patient selection and risk assessment are based on contemporary data. It is essential that the use of this risk calculator be integrated into the coverage determination to support informed clinical decisions by the heart team.
TTVR is a complex transcatheter procedure that requires multidisciplinary expertise. Surgeons bring a unique perspective and important view of tricuspid valve intervention. In addition to first hand knowledge of futile patients for tricuspid valve intervention, valve surgeons have in-depth three-dimensional knowledge of the tricuspid anatomy, its mechanistic function, as well as knowledge of the detailed anatomic relationship to the conduction system, and other cardiac structures, as well as the valve specific elements of clefts and chordal structures that all go into safe procedural device delivery.

Based on the experience with the TAVR NCD that included both a cardiac surgeon and an interventional cardiologist performing the procedure, the success and safety of this program should be the template for a TTVR NCD also. As TTVR has an evolving but as yet unclear safety profile, I feel that this inclusive aspect of intraprocedural participation as was utilized with TAVR, but not mandated for M-TEER, will ensure the safest rollout of this new technology to Medicare beneficiaries. As integral members of the heart team, surgeons should serve as co-operators in TTVR procedures, similar to how we participate in the very and safe successful model used for TAVR. Surgeons are uniquely qualified to mitigate risks and complications, which are essential for ensuring patient quality and safety. As a surgeon, I have been involved in TTVR procedures since early feasibility studies. I am firmly committed to enhancing patient access to these technologies and my practice and my specialty’s leadership remains focused that this safely occurs with TTVR.

Furthermore, I urge that all procedures should be collected in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage with evidence development.

I urge CMS to adopt a conservative approach in establishing coverage at this early stage in the clinical development of TTVR. While the initial clinical profile of TTVR is compelling, the FDA approval is based on data from fewer than 100 patients treated at experienced medical centers. This limited and under representative dataset is insufficient to draw broad conclusions on the safety of commercial implementation, particularly in less experienced centers. Therefore, I feel strongly that CMS take a cautious approach to ensure patient safety and optimal deployment of this device. While all providers are committed to enhancing open access, protecting public trust is paramount, and the rollout of this technology must be executed thoughtfully. I believe that a team-based approach to both pre-procedural and operator/procedural care is essential, and that cardiac surgeons must be required as co-operators in these procedures to ensure the highest quality patient care and safety possible.

In summary, while the TTVR technology is very promising, and I fully support its roll out, the initial approval was based on a very small patient cohort and may not be representative of the wider real-world patient population. CMS should proceed safely to provide the best outcomes for the Medicare population, treating this under-treated group with careful oversight. Ensuring that surgeons are part of the process from the pre-operative stage through the actual procedure to post procedure care is crucial for patient safety and quality outcomes. I feel that this multidisciplinary approach, mirroring the well planned and executed TAVR rollout, will be of great importance for the success of TTVR without in any way negatively impacting patient access.

Sincerely,

Gorav Ailawadi, MD, MBA
Helen & Marvin M Kirsh Professor
Chair, Department of Cardiac Surgery
University of Michigan

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The American Association for Thoracic Surgery (AATS), Association of Black Cardiologists (ABC), American College of Cardiology (ACC), American Society of Echocardiography (ASE), Heart Rhythm Society (HRS), Society for Cardiovascular Angiography and Interventions (SCAI) and Society of Thoracic Surgeons (STS) are the professional medical societies representing the physician and health care professionals who care for tricuspid regurgitation (TR) patients having transcatheter tricuspid valve replacement (TTVR) and surgical tricuspid valve (TV) replacement procedures. The societies are supportive of the development of a National Coverage Determination (NCD) for TTVR and we appreciate the opportunity to comment on the National Coverage Analysis (NCA). 

Transcatheter tricuspid valve replacement (TTVR) represents an emerging technology to treat severe TR. Candidates for this technology have tricuspid valve disease severe enough to cause symptoms despite optimal medical therapy and are at intermediate or greater risk for TV surgery. During a TTVR procedure, a bioprosthetic valve is implanted in the TV annulus using a catheter via a transfemoral venous approach. 

The EVOQUE tricuspid valve replacement system is currently the sole TTVR device approved by the U.S. Food and Drug Administration (FDA). The EVOQUE device is indicated for use for the improvement of health status in patients with symptomatic severe TR despite being treated optimally with medical therapy and for whom TV replacement is deemed appropriate by a Heart Team. The undersigned organizations recommend that CMS cover TTVR for the treatment of TR when performed according to the FDA-approved indication. Non-approved indications should only be performed within a clinical study.

The Multidisciplinary Heart Team (MDHT)
The universal adoption of multi-disciplinary heart teams (MDHT) in cardiovascular medicine and surgery derives from their established role in the care of patients undergoing cardiac transplantation and/or mechanical support, as well as from their demonstrated value in a pivotal trial of percutaneous coronary intervention versus coronary artery bypass grafting for patients with severe coronary artery disease (Serruys et al., 2009). The MDHT is a foundational element of the institutional requirements for the establishment of transcatheter programs for the treatment of patients with aortic stenosis  and mitral regurgitation (Bavaria et al., 2018; Nishimura et al., 2019; Bonow et al., 2019) The 2020 AHA/ACC guidelines for the management of patients with valvular heart disease (VHD) include a Class 1 recommendation for evaluation by a MDHT when intervention is considered (Otto et al., 2021). In addition, referral to a comprehensive heart valve center (Nishimura et al., 2019) is preferred when treatment options are being considered for asymptomatic patients with severe VHD, patients who may benefit from repair versus valve replacement, and for patients with multiple co-morbidities.

Given the high prevalence of secondary TR, patients with this disease often present with multiple co-morbidities which must be considered by the MDHT. For patients with TV disease, we recommend minimum requirements for MDHT membership (Table 1) include a general or valve cardiologist, heart failure specialist, multi-modality imaging specialists (echo, CT, MR), interventional echocardiographer, interventional cardiologist, electrophysiologist, cardiac surgeon, cardiac anesthesiologist, advanced practice providers, program navigator, structural heart coordinator, and data manager. Additional specialists, including geriatricians, stroke neurologists, nephrologists, hepatologists, hematologists, nutrition counselors, rehabilitation experts, and social workers may need to be included as part of the MDHT in specific circumstances.

Table 1. MDHT Requirements for Tricuspid Valve Intervention
General/valve cardiologist
Heart failure specialist
Multi-modality imaging specialists: Echocardiography, Computed Tomography, Magnetic Resonance
Interventional echocardiographer
Interventional cardiologist
Cardiac surgeon
Electrophysiologist 
Cardiac anesthesiologist
Advanced practice providers
Program navigator
Structural heart coordinator
Data manager
Other*
* The MDHT may require the inclusion of additional specialists such as geriatricians, stroke neurologist, nephrologist, hepatologist, hematologists, nutrition counselors, rehabilitation experts, and social workers. 

Evaluation by the MDHT is an obligate step in the patent’s journey, as mandated by best practices and regulatory authorities. The team should meet regularly (preferably weekly) to review case histories, imaging findings and other pertinent studies, determine procedural risk, achieve consensus on management recommendations, review outcomes, assess quality, and verify reporting. Patient’s individual needs and preferences should be emphasized. Ideally, the MDHT approach will leverage the combined experience and expertise of the group and lead to more standardized and evidence-based decision-making. The general/valve cardiologist is usually responsible for the initial referral to the MDHT and longer-term follow-up and communication. For patients being considered for the treatment of severe TR, it is particularly important to ensure optimization of heart failure management which may include interventions for both reduced and preserved ejection fraction phenotypes. Concomitant valvular heart disease is also common in these patients treatment of which may secondarily reduce the severity of TR. Patients with TR frequently develop atrial fibrillation or have prior cardiac implanted electronic device (CIED) leads thus obligating the MDHT to consider rhythm management and the specific challenges imposed by the presence of indwelling CIED leads or the need for a new CIED. Integration of imaging data across modalities is essential for procedural planning. A dedicated and trained intra-procedural echocardiographer must be a part of the MDHT since their integral role in guidance and selection cannot be overemphasized. As indicated by the Request for TTVR Medicare National Coverage Determination by Edwards Lifesciences (page 19), “In the context of the TRISCEND II trial, an interventional cardiologist and cardiac surgeon frequently performed the intra-operative components of the procedure, which was appropriate given the procedures were performed as a part of a clinical trial.” The physicians who are present during the performance of the procedure will demonstrate the knowledge and skill necessary to accomplish the technical aspects of transcatheter or surgical device deployment safely and effectively and participate in post-procedural patient management. Each physician directly participating in the procedure has the responsibility to ensure optimal patient outcomes. 

Risk-Benefit Analysis of TTVR 
It is important for the MDHT to consider a number of factors when determining the appropriateness, possible benefits, and risks from TTVR for any given patient. The FDA indication for use of the EVOQUE device is to improve health status in patients with symptomatic, severe TR despite optimal medical therapy (OMT), for whom TV replacement is deemed appropriate by a heart team. The first consideration is the definition of OMT. Although the TRISCEND II Trial showed a benefit in health status measures compared to OMT, such treatment was not prescriptive nor well-defined given the lack of Class I level of recommendations for medical management of TR (Otto et al, 2021). In addition, OMT continues to evolve as more is learned about the relationship between TR and the medical/device management of heart failure, as well as of atrial fibrillation (Adamo et al., 2024). TR reduction is observed following reduction of mitral regurgitation (Adamo et al, 2022), after cardiac resynchronization therapy (Stassen et al., 2022). TR is also reduced in many AF patients with rhythm control interventions (Soulat-Dufour et al, 2022). Given the relationship between heart failure with preserved ejection fraction and TR (Muraru et al., 2024; Hahn et al., 2024), the effectiveness of sodium glucose cotransporter-2 (SGLT2) inhibitors in reducing the progression of severity of TR is an area of active investigation. Studies suggest that this class of drugs improves right ventricular function and reduces peak TR velocities (Mustapic et al., 2022). Randomized control trials assessing the effect of SGLT2 inhibitors on TR are underway (NCT06027307 and NCT056866160). Clinicians should be aware of this changing medical landscape and consult with advanced heart failure experts prior to consideration of interventional therapy.

Second, device therapy is recommended for patients with severe, symptomatic TR. A recent study has shown that whereas TR progresses in approximately 20% of patients over 2 years, it may regress  in up to 38% of patients (Bolumburu et al., 2024), evidence of the protean and dynamic nature of this disease and the need for consistent follow-up prior to referral for interventional therapy. In addition, quantitation of TR is both challenging and nuanced. Adjudication required centralized core lab assessment within the TRISCEND II trial. Recent consensus documents have described current quantitative methods for assessing TR (Hahn et al., 2023) and studies show health benefits increase with each TR grade reduction following transcatheter repair with the greatest improvement seen in patients with low baseline health status (Arnold et al., 2024a; Arnold et al., 2024b). Thus it is likely that the greatest benefit will be seen in patients with severe or greater TR.  Assessment of both baseline health status and TR severity should be performed by the MDHT prior to consideration of advanced therapies. 

Third, the MDHT determination of the appropriateness of tricuspid valve replacement necessarily involves the consideration of isolated TV surgery, which is the only current guideline recommended intervention(Otto et al., 2021). Although current studies continue to show relatively high surgical mortality (~7%) and morbidity (~11% pacemaker rates) in the elderly and co-morbid patient population presenting for operation, these rates may be decreasing as awareness of the disease increases, patients are referred earlier in their disease process, and new surgical techniques are adopted (Shih et al., 2023; Russo et al., 2022; Yang et al., 2021; Thourani et al., 2024). A number of prior surgical risk scores have been published (Dreyfus et al., 2021; LaPar et al., 2018; Wang et al., 2022;) and a recent risk score and online risk calculator for isolated tricuspid surgery by the STS have been developed (Thourani et al., 2024), some of which may be predictive of outcomes for transcatheter repair technologies (Omran et al., 2022; Adamo et al., 2024) and thus may help with the shared decision-making process.

Finally, a risk-benefit assessment of TTVR must be performed by the MDHT.  In the as-treated population of patients undergoing TTVR, the 30 day composite major adverse events (MAEs) reported in the FDA Summary of Safety and Effectiveness Data (SSED) was 27.4% and included among other outcomes, a 3.2% cardiovascular mortality, 10.2% severe bleeding (defined as fatal, life-threatening, extensive or major bleeding), and a 14.7% rate of arrhythmia and conduction disorder requiring permanent pacemaker.  In addition to MAEs, 57 serious adverse events were also reported. These risks must be balanced against the main reported benefits of TTVR, namely, improvement in quality of life and symptom burden.

One additional co-morbidity seen in the symptomatic, severe TR population is worth mentioning.  Although the Request for TTVR Medicare NCD states that patients with pre-existing cardiac electronic devices (CIEDs) are appropriate candidates for this therapy, concerns have been raised about the safety of this practice.  In the as-treated population of patients undergoing TTVR, >35% of patients receiving the EVOQUE device had CIED leads across the tricuspid valve; these leads were “jailed” against the native annulus by the TTVR.  Given the likely inability to extract jailed leads if indicated (eg, in the setting of lead/pacer pocket infection or lead malfunction), the electrophysiologist on the heart team plays an essential role in determining risk of future complications, likelihood of successful/effective lead extraction, feasibility of alternative pacing methods, as well need for placement of new CIEDs (Hahn et al., 2024). The MDHT discussion should include consideration of transcatheter devices that may not jail the CIED lead. Follow-up of the patients with prior CIED and trans-tricuspid valve leads within the trial and during commercial use is critical and should require periodic interrogation of jailed leads to further identify risks of this procedure.

Patient Evaluation 
Each patient’s suitability for surgical tricuspid valve intervention, transcatheter intervention, or palliative therapy must be evaluated and documented collaboratively by the MDHT. This collaboration includes discussions among an interventional echocardiographer,  interventional cardiologist, and cardiac surgeon with experience in the care and treatment of TR and may also include a heart failure specialist, an electrophysiologist and other specialists as needed. The evaluation for TV surgical or transcatheter intervention must take place only after optimization of medical therapies. 

For accurate diagnosis, prognosis, and effective planning of TV therapy, it is essential to perform multimodality cardiac imaging that specifically targets the anatomy and function of the TV apparatus, right-side chambers, and adjacent structures (Cammalleri et al., 2021).

The interventional echocardiographer is expected to evaluate the mechanism and confirm severity of TR (Zoghbi et al., 2017; Hahn et al, 2023) to consider the anatomic and functional criteria which may determine the appropriateness of TTVR, to consider all possible therapies (medical, transcatheter, surgical, or palliative) and to discuss those anatomic and functional considerations in detail with the MDHT.

Facility Infrastructure Requirements
TTVR must be furnished in a hospital with the appropriate infrastructure. The institution must have an active cardiac surgical program supported by at least 2 institutionally based cardiac surgeons experienced in the treatment of patients with VHD and at least one physician with interventional cardiology privileges. This recommendation parallels the “2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacements for Transcatheter Aortic Valve Replacement” (Bavaria et al., 2020). Additionally, paralleling the recommendations for transcatheter mitral valve interventions (Bonow et al., 2019) institutions must have at least 1 interventional echocardiographer with level 3-training and National Board of Echocardiography certification, or a cardiac anesthesiologists with training and experience in the acquisition and quantitative interpretation of TTE, TEE, and 3D TEE studies in patients with TR.

The need for patient facilities sufficient to allow high-quality preprocedural/postprocedural care with personnel experienced in managing patients who have undergone open-heart procedures and MHDT consultation is self-evident. Implanting physicians must have prompt access to facilities with the necessary equipment, including a cardiac catheterization laboratory and an interventional/implantation suite. Appropriate office space for the medical, nursing, and technical personnel involved is also required, preferably in a central setting. Ancillary testing facilities (pulmonary function, echocardiography, vascular duplex scanning, clinical laboratory, CT) should be of high quality, ideally accredited by the appropriate certifying organization, and able to accommodate the patient load in a timely manner. Operators must have access to advanced imaging, including cine fluoroscopy and 2D/3D transesophageal echocardiography (TEE) throughout the TTVR procedure, and access to 2D/3D intracardiac echocardiography (ICE) is highly recommended. Facilities should have rapid access to a cardiac electrophysiologist with expertise in lead extraction, leadless pacemaker placement, and coronary sinus lead placement.
By their very nature, these complex procedures should only be undertaken in institutions that routinely perform surgical TV operations and participate in the STS Adult Cardiac Surgical Database with outcomes that equal or exceed those expected for their case mix relative to national benchmarks. Similarly, only institutions with interventional cardiology programs that have established programs in PCI, balloon valvuloplasty, TAVR, M-TEER, catheter closure of periprosthetic leaks, and deployment of septal closure devices, with outcomes that equal or exceed those established nationally for similar procedures, should offer transcatheter TV intervention.

Qualifications to begin a TTVR program for facilities without TTVR experience.
Important issues to consider in the establishment of a transcatheter TV intervention program are the size and spectrum of the clinical referral base needed to ensure an adequate number of patients to provide for the viability of the program. Below are the recommended requirements to start TTVR intervention programs. The current proposed case volumes for TTVR pertain to the use of the EVOQUE tricuspid valve replacement system for the improvement of health status in patients with symptomatic, severe TR despite optimal medical therapy, for whom TV replacement is deemed appropriate by a heart team. Intervention for TR is a rapidly evolving field and recommended case volumes for transcatheter TV repair and replacement systems that may become available in the future may differ. Introduction of this technology across communities must also take into account the well-recognized barriers faced by women, under-represented racial and ethnic groups, and persons living in rural areas to surgical and trans-catheter cardiac interventions. The case volumes reflect an expert consensus that strikes a balance across procedural quality, expected outcomes, and patient access. They are readily achievable for many sites and should not be considered exclusionary. Minimum case volume requirements reflect the process, infrastructure, and commitment needed for a successful, competent program but are not necessarily sufficient for expertise.  

The program case volumes recommended were obtained by querying the STS Adult Cardiac Surgery Database, the STS/ACC TVT Registry, reviewing the published experiences of other data sources, and soliciting expert opinion. The proposed requirements are constructed to: 1) ensure patient safety and promote quality; 2) demonstrate that there is commitment on the part of the institution to the structural heart disease program; and 3) use existing volume as surrogate for an established TTVR program to ensure adequate experience for the maintenance of a sustainable TV intervention program. 

To initiate a TTVR program in hospitals without prior TTVR experience, the hospital program must meet the following qualifications:
a) =50 open heart surgeries in the previous year prior to the TTVR program initiation, and;
b) =20 tricuspid valve surgeries in the 2 years prior to TTVR program initiation, and;
c) =2 physicians with cardiac surgery privileges, and; 
d) =1 physician with interventional cardiology privileges, and;
e) 1 board certified/board-eligible cardiac electrophysiologist available for pacemaker implantation or lead extraction when required, and; 
f) =100 TAVR and =20 TEER procedures per year or =200 TAVR and =40 TEER over the previous 2 years (STS/ACC TVT Registry Analysis)
g) =200 complete TEE performed per year or =400 complete TEE performed over the previous 2 years (Wiegers et al., 2019; Little et al., 2023)

Both the interventional cardiologist and surgeon will need to have appropriate training in order to establish a TTVR program. Following the establishment of a program all members of the multidisciplinary team will need to maintain minimal volume requirements for continued participation and will be monitored on an ongoing basis to ensure acceptable outcomes as defined by the Societies’ criteria.

Operator training is a crucial component for treating structural/valvular heart disease using a transcatheter approach. Construction of a training curriculum encompassing clinical, imaging, procedural and post-procedural elements is essential. Criteria for fellowship and postgraduate training will be established by the participating Societies in an expert consensus statement currently under development.

Defining minimum operator and institutional requirements for these therapies is an important first step to ensuring their optimal implementation. Several of the TTVR competencies recommended parallel those included in the “2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement,” (Bavaria et al., 2019) and the “2019 AATS/ACC/SCAI/STST Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Mitral Valve Intervention,” (Bonow et al. 2020) although many are specific to TV interventions.

Operator Requirements
To optimize outcomes at a new TTVR intervention program, the primary catheter operator (interventional cardiologist or surgeon) should document:
• =50 career structural valve procedures (Bass et al., 2023), of which =25 are TEER procedures 
• Board eligibility or certification in either interventional cardiology or cardiothoracic surgery
• Certification of device-specific training.

To optimize outcomes at a new TTVR intervention program, the interventional echocardiographer should document:
• =50 career structural valve disease procedures of which =25 are TEER procedures
• Level 3 or equivalent board eligibility or certification in echocardiography
• Certification of device-specific training

Requirements for the Intraoperative Technical Aspects of TTVR
At the initiation of a TTVR program, three physician operators will actively participate in the TTVR procedure: 
1. An interventional echocardiographer should be considered a co-operator for TTVR and must provide imaging expertise in patient and device selection as well as catheter position and device deployment. The interventional echocardiographer will not also provide anesthesia during the procedure.
2. An interventional cardiologist must provide expertise in vascular access, catheter management, wire manipulation, and device deployment.
3. A cardiac surgeon skilled in transcatheter valve procedures must provide additional expertise in catheter management, wire manipulation, and device deployment, as well as intra-procedural complication management. 
All physicians who participate in the procedure must be board certified or equivalent in their specialty and have received device-specific training as required by the device manufacturer. All TTVR institutions must submit complete data to the STS/ACC TVT Registry.

The joint 3 specialty physician composition of the intra-procedural team can be reconsidered by the institution after consistent demonstration of procedural safety with a 30-day major complication rate of <20% (composite of CV death, severe bleeding, non-elective TV re-intervention, and major access/vascular/cardiac structural complications) as documented in the STS/ACC TVT Registry following a minimum of 25 cases or 3-years of TTVR procedures. Upon meeting these safety and quality requirements, the composition of the team working as co-operators may be adjusted to an interventional echocardiographer (who must provide imaging expertise during all aspects of the procedure (and may not also provide anesthesia services)), and one other procedural co-operator skilled in transcatheter procedures with device-specific training, who may be an interventional cardiologists or cardiac surgeons with appropriate board certification. After achieving this initial minimal safety and quality threshold, TTVR institutions must demonstrate maintenance of this threshold of <20% complication rate as documented by the STS/ACC TVT Registry on an annual basis. Institutions not achieving this minimum annual threshold of safety and quality should revert to the original 3 operator composition until such time this quality threshold can be maintained for 3 consecutive years. 

Qualifications to Maintain a TTVR Program
To optimize outcomes at a TTVR program, sites with TTVR experience should maintain the following: 
a) =20 tricuspid valve interventions(transcatheter or surgical) of which =10 are transcatheter and of which =5 are TTVR in 1 year, or =40 tricuspid valve intervention (transcatheter or surgical) of which =20 are transcatheter and of which =10 are TTVR over 2 years, and;
b) The initial complement of specialty expertise must be maintained, and;
c) =50 transcatheter structural cases per year or =100 over the previous 2 years.

Registry/ CED Requirements
Coverage with Evidence Development (CED) is an extremely powerful mechanism offering significant value to payers, clinicians, and patients. CED has been demonstrated to be an ingenious technique allowing the diffusion of diverse innovative cardiovascular technologies and services into the marketplace while simultaneously promoting timely clinical safety and effectiveness evaluations. The societies support the use of CED to provide Medicare beneficiaries with prompt access to new technologies and services when early evidence suggests, but does not yet convincingly demonstrate, a net benefit for beneficiaries.

The success of the combined STS and ACC TVT registry is established. Mandatory reporting to the STS/ACC TVT registry under CED through a supplementary module will allow for post-market surveillance, long-term outcome measurement, and comparative effectiveness research. The registry module to supplement the existing TVT registry for TAVR and mitral valve TEER system will be developed by the STS and ACC in conjunction with input from specialty societies and other relevant stakeholders. The importance of obtaining completeness of one year outcomes data including patient reported outcomes must be emphasized.

Use of drug or device subject to FDA regulations and the status of current FDA regulatory review
While the EVOQUE system by Edwards’ is the only FDA-approved device for the treatment of TR via TTVR at this time, there is much research and development emerging in this space. Devices currently in development include Intrepid (Medtronic), LuX-Valve (Jenscare Biotechnology), GATE (Navigate Cardiac Structures, Inc.), Topaz (TriCares), VDYNE valve (VDYNE), and TRISOL Valve (Trisol Medical). With many emerging technologies on the horizon in the tricuspid valve replacement space, the societies recommend that the developed NCD extend to future devices that use similar technology and fall within the same device class. This approach ensures that the NCD remains relevant and applicable as new technologies receive FDA-approval, supporting ongoing advances in TR management using transcatheter tricuspid valve replacement. 

The societies support Medicare coverage for TTVR  along with recommended facility and operator requirements, including CED. We thank CMS for the opportunity to provide comment on the NCA. Please direct any questions or concerns to Amanda Stirling, Regulatory Affairs Associate, at 202-375-6553 or astirling@acc.org.

Sincerely,

David R. Jones, MD
President, American Association for Thoracic Surgery

Anthony Fletcher, MD, FACC, FSCAI
President, Association of Black Cardiologists

Cathleen Biga, MSN, FACC
President, American College of Cardiology 

Theodore Abraham, MD, FASE
President, American Society of Echocardiography 

Kenneth A. Ellenbogen, MD, FHRS
President, Heart Rhythm Society 

James B. Hermiller, MD, MSCAI
President, Society for Cardiovascular Angiography and Interventions 

Jennifer C. Romano, MD, MS
President, The Society of Thoracic Surgeons 

References
1) Serruys PW, Morice MC, Kappetein AP, et al. SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72.
2) Bavaria, J, Tommaso, C, Brindis, R. et al. 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement: A Joint Report of the American Association for Thoracic Surgery, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2019 Jan, 73 (3) 340–374.
3) Nishimura RA, O'Gara PT, Bavaria JE, et al. 2019 AATS/ACC/ASE/SCAI/STS Expert Consensus Systems of Care Document: A Proposal to Optimize Care for Patients With Valvular Heart Disease: A Joint Report of the American Association for Thoracic Surgery, American College of Cardiology, American Society of Echocardiography, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2019 May 28;73(20):2609-2635. doi: 10.1016/j.jacc.2018.10.007.
4) Bonow, R, O’Gara, P, Adams, D. et al. 2019 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Mitral Valve Intervention: A Joint Report of the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and The Society of Thoracic Surgeons. J Am Coll Cardiol. 2020 Jul, 76 (1) 96–117
5) Otto, C, Nishimura, R, Bonow, R. et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2021; 77(4): e25-e197.
6) Adamo M, Chioncel O, Pagnesi M, et al. Epidemiology, pathophysiology, diagnosis and management of chronic right-sided heart failure and tricuspid regurgitation. A clinical consensus statement of the Heart Failure Association (HFA) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the ESC. Eur J Heart Fail 2024; 26(1): 18-33.
7) Adamo M, Pagnesi M, Ghizzoni G, et al. Evolution of tricuspid regurgitation after transcatheter edge-to-edge mitral valve repair for secondary mitral regurgitation and its impact on mortality. Eur J Heart Fail 2022; 24(11): 2175-84.
8) Stassen J, Galloo X, Hirasawa K, et al. Tricuspid regurgitation after cardiac resynchronization therapy: evolution and prognostic significance. Europace 2022; 24(8): 1291-9.
9) Soulat-Dufour L, Lang S, Addetia K, et al. Restoring Sinus Rhythm Reverses Cardiac Remodeling and Reduces Valvular Regurgitation in Patients With Atrial Fibrillation. J Am Coll Cardiol 2022; 79(10): 951-61.
10) Muraru D, Badano LP, Hahn RT, et al. Atrial secondary tricuspid regurgitation: pathophysiology, definition, diagnosis, and treatment. European Heart Journal 2024.
11) Hahn RT, Lindenfeld J, Böhm M, et al. Tricuspid Regurgitation in Patients With Heart Failure and Preserved Ejection Fraction: JACC State-of-the-Art Review. J Am Coll Cardiol 2024; 84(2): 195-212
12) Mustapic I, Bakovic D, Susilovic Grabovac Z, Borovac JA. Impact of SGLT2 Inhibitor Therapy on Right Ventricular Function in Patients with Heart Failure and Reduced Ejection Fraction. Journal of clinical medicine 2022; 12(1).
13) Bolumburu AA, Ruiz JMM, Mahia P, et al. Determinants of Tricuspid Regurgitation Progression and Its Implications for Adequate Management. JACC: Cardiovascular Imaging 2024; 17(6): 579-91.
14) Hahn RT, Lawlor MK, Davidson CJ, et al. Tricuspid Valve Academic Research Consortium Definitions for Tricuspid Regurgitation and Trial Endpoints. J Am Coll Cardiol 2023; 82(17): 1711-35.
15) Arnold SV, Goates S, Sorajja P, et al. Health Status After Transcatheter Tricuspid-Valve Repair in Patients With Severe Tricuspid Regurgitation. J Am Coll Cardiol 2024; 83(1): 1-13.
16) Arnold SV, Spertus JA, Gosch K, et al. Validation of the Kansas City Cardiomyopathy Questionnaire in Patients with Tricuspid Regurgitation: The Tri-QOL Study. medRxiv 2024: 2024.02.07.24302462. 
17) Shih E, George TJ, DiMaio JM, et al. Contemporary Outcomes of Isolated Tricuspid Valve Surgery. J Surg Res 2023; 283: 1-8.
18) Russo M, Di Mauro M, Saitto G, et al. Beating Versus Arrested Heart Isolated Tricuspid Valve Surgery: Long-term Outcomes. Ann Thorac Surg 2022; 113(2): 585-92.
19) Yang L, Zhou K, Yang YC, et al. Outcomes of redo-isolated tricuspid valve surgery after left-sided valve surgery. Journal of cardiac surgery 2021; 36(9): 3060-9.
20) Thourani VH, Bonnell L, Wyler von Ballmoos MC, et al. Outcomes of Isolated Tricuspid Valve Surgery: A Society of Thoracic Surgeons Analysis and Risk Model. The Annals of Thoracic Surgery 2024.
21) Dreyfus J, Audureau E, Bohbot Y, et al. TRI-SCORE: a new risk score for in-hospital mortality prediction after isolated tricuspid valve surgery. Eur Heart J 2021.
22) LaPar DJ, Likosky DS, Zhang M, et al. Development of a Risk Prediction Model and Clinical Risk Score for Isolated Tricuspid Valve Surgery. Ann Thorac Surg 2018; 106(1): 129-36.
23) Wang TKM, Akyuz K, Kirincich J, et al. Comparison of risk scores for predicting outcomes after isolated tricuspid valve surgery. Journal of cardiac surgery 2022; 37(1): 126-34.
24) Omran H, Pfister R, Ehrenfels M-A, et al. Prognostic Performance of the Surgical TRI-SCORE Risk Score in Patients Undergoing Transcatheter Tricuspid Valve Treatment. JACC: Cardiovascular Interventions 2022; 15(19): 1996-8.
25) Adamo M, Russo G, Pagnesi M, et al. Prediction of Mortality and Heart Failure Hospitalization After Transcatheter Tricuspid Valve Interventions: Validation of TRISCORE. JACC Cardiovasc Interv 2024; 17(7): 859-70.
26) Hahn RT, Wilkoff BL, Kodali S, et al. Managing Implanted Cardiac Electronic Devices in Patients With Severe Tricuspid Regurgitation. J Am Coll Cardiol 2024; 83(20): 2002-14.
27) Cammalleri V, Carpenito M, Bono MC, Mega S, Ussia GP, Grigioni F. Transcatheter Tricuspid Valve Therapy: From Anatomy to Intervention. Front Cardiovasc Med. 2021 Nov 18;8:778445
28) Zoghbi WA, Adams D, Bonow RO, et al. Recomm,endations for noninvasive evaluation of native valvular regurgitation: a report from the American Society of Echocardiography developed in collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr 2017;30:303-71.
29) Analysis of STS/ACC TVT Registry 
30) Wiegers SE, Ryan T, Arrighi JA, et al. 2019 ACC/AHA/ASE Advanced Training Statement on Echocardiography (Revision of the 2003 ACC/AHA Clinical Competence Statement on Echocardiography): A Report of the ACC Competency Management Committee. J Am Coll Cardiol. 2019 Jul 23;74(3):377-402. 
31) Little SH, Rigolin VH, Garcia-Sayan E, et al. Recommendations for Special Competency in Echocardiographic Guidance of Structural Heart Disease Interventions: From the American Society of Echocardiography. J Am Soc Echocardiogr. 2023 Apr;36(4):350-365.
32) Bass TA, Abbott JD, Mahmud E, et al. 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions): A Report of the ACC Competency Management Committee. Circ Cardiovasc Interv. 2023 Apr;16(4).

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July 19, 2024

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Ms. Syrek Jensen,

On behalf of the Advanced Medical Technology Association (AdvaMed), we are pleased to submit comments to the Centers for Medicare & Medicaid Services (CMS) on the Transcatheter Tricuspid Valve Replacement (TTVR). AdvaMed appreciates CMS’s opening of a National Coverage Analysis (NCA) for a new Breakthrough-device designated technology. AdvaMed member companies produce the medical devices, diagnostic products, and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. We are committed to ensuring patient access to lifesaving and life-enhancing devices and other advanced medical technologies in the most appropriate settings.

AdvaMed and CMS share a common goal – the establishment of a clear and expeditious coverage process, based on scientifically sound clinical evidence with appropriate safeguards, for emerging technologies that will benefit Medicare-eligible patients, including the 54 percent of Medicare-eligible patients enrolled in Medicare Advantage organizations in 2023(1). These goals are evident in the intent of the proposed Transitional Coverage for Emerging Technology (TCET) pathway. We urge CMS to quickly finalize the TCET guidance to ensure Medicare beneficiaries have timely access to innovative technologies.

AdvaMed has long advocated for, and strongly supports, true engagement and dialogue between device companies and CMS. The NCA requestor, Edwards Lifesciences, notes in their detailed response to this public comment period key process milestones and deliverables related to TTVR coverage, including application and acceptance into the FDA-CMS Parallel Review program; development of an Evidence Preview (EP); and completion of an Evidence Development Plan (EDP). This process mirrors that of the TCET proposed guidance. The TTVR NCA Tracking Sheet lists the statutory due dates for completion of the NCA. While the TCET proposed guidance indicates that this is the intended process, nothing in the tracking sheet indicates to the public that CMS is implementing this ‘new process’ or intends to accelerate the timing of the coverage policy. AdvaMed recommends that CMS consider the precedent the agency is setting in how documents are published, such as the EP or EDP, and when information is made publicly available.

Additionally, we are perplexed as to why this initial 30-day comment period is necessary, especially given the TCET milestones of an EP and an EDP. Moreover, neither of the only two other National Coverage Determinations (NCDs) that were initialized via the parallel review process included this initial 30-day comment period(2,3), nor is it required by statute(4). Early engagement with CMS by the manufacturer provided both under parallel review and proposed in the TCET guidance may obviate the need for this initial comment period in many cases and could help achieve CMS’ objective of an expedited coverage process.

We encourage CMS to work quickly in issuing a Proposed Decision Memo, following the close of this comment period, and once again encourage CMS to finalize the TCET guidance and increase the transparency around coverage efforts for technologies such as the subject of this NCA. We look forward to continuing our work with the Agency. If you have questions regarding these comments or if you require additional information, please contact me at tburke@advamed.org.

Sincerely,
Tara Burke, PhD
Vice President, Payment and Healthcare Delivery Policy
AdvaMed

References:
1) “July 2024: A Data Book: Healthcare Spending and the Medicare Program.” Medicare Payment Advisory Committee (MedPAC), Chapter 9, 16 July 2024, www.medpac.gov/document-type/data-book/. Accessed 19 July 2024.
2) “Tracking Sheet for Screening DNA Stool Test for Colorectal Cancer.” CMS.Gov , www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=212. Accessed 19 July 2024.
3) “Tracking Sheet for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.” CMS.Gov, www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=290. Accessed 19 July 2024.
4) 42 U.S.C. §1395y(l)(3)

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Dear Ms. Syrek Jensen,

Tricuspid regurgitation (TR) is a significant valvular problem with limited current therapy. The National Inpatient Sample showed that roughly 4.7% of 2015 admissions included the diagnosis of TR. Until 2023, the only treatment for TR was surgical valve repair or replacement. Most of these procedures are performed in conjunction with left-sided valve disease. Isolated tricuspid surgeries are done far less frequently, and the updated Society of Thoracic Surgeons Adult Cardiac Surgery Database showed operative mortality of 7.3%, excluding patients with endocarditis.
Given the limited options for these sick patients, the results of transcatheter tricuspid therapies were met with enthusiasm. Specifically, Transcatheter tricuspid valve replacement (TTVR) has the potential to completely eliminate TR, a promising development. Surgeons have shown previously that any residual TR after surgery results in worse outcomes. Therefore, as a surgeon, I will completely support the National Coverage Decision for TTVR, which provides hopeful options for eliminating TR using transcatheter strategies.
The success of the heart team concept in transcatheter aortic valve replacement (TAVR) does not need explanation. The very similar NCD for TAVR mandated the involvement of both interventional cardiologists and cardiac surgeons in all TAVRs, which continues to this date. This allowed for the careful assessment of all patients undergoing TAVR and the 'rational dispersion' of the new technology. The TTVR evidence is still in its infancy. The data is limited to 6 months, and a thorough assessment of each patient will be needed to disseminate this technology. In my opinion, the surgeon's involvement will bring more safety to the heart team discussion since surgeons will bring their expertise to the table better if they are involved in the procedure. The new STS Tricuspid valve risk calculator will allow for an improved surgical risk assessment of TR patients. Given the high screen failure rate of roughly 50% in these trials, surgical options in these patients, and the use of the heart team and surgeons' involvement will be critical.

In summary, I fully support the approval of TTVR. However, given the current limited data, I firmly believe that surgeon involvement in these procedures is not just beneficial but essential to ensure the safety of these patients.

Tsuyoshi Kaneko MD
Chief, Cardiac Surgery Section
Division of Cardiothoracic Surgery
Washington University in St. Louis

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As the Health Research Group Director at Public Citizen and a former member (2010-2012) of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), I write to urge the Centers for Medicare & Medicaid Services (CMS) to convene MEDCAC as part of the National Coverage Analysis for the EVOQUE Triscuspid Valve Replacement System. Public Citizen's Health Research Group shares the significant concerns that have been raised about the evidence that is available for transcatheter tricuspid valve replacement. These concerns include the design of the TRICSEND II trial, which was unblinded and thus susceptible to bias and the placebo effect. The outcomes of the trial were evaluated at only 30 days and 6 months, with substantial missing data at 12 months. There was a high 30-day rate of major adverse events (27.4%) in the treatment group. Moreover, 12 out of 96 patients in the device group died by 12 months, as compared to 4 out of 54 patients in the control group.

MEDCAC is uniquely qualified to advise CMS about the available evidence to support the request for Medicare coverage of the EVOQUE System. We urge CMS to convene a MEDCAC meeting so that the evidence can be publicly presented and fully discussed before a coverage decision is made.

Thank you for the opportunity to comment.

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July 14, 2024

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Ms. Syrek Jensen,

I am a practicing cardiac surgeon, and based on my clinical experience as a heart valve specialist can affirm that tricuspid regurgitation (TR) significantly affects the Medicare population. With over 15 years of clinical experience in managing patients with TR through surgical tricuspid valve repair and replacement and through my participation in numerous clinical trials of transcatheter tricuspid valve repair and replacement therapies, I stand by the fact that cardiac surgeons have substantial expertise in evaluating and treating TR, especially when it is associated with mitral regurgitation and other cardiac conditions requiring heart surgery. Through my involvement in multiple clinical trials of transcatheter technologies for valvular heart disease, including technology for the tricuspid valve, I have also been a witness to the deep knowledge and expertise that surgeons bring to the heart team treating patients with valvular heart disease.

While isolated TR surgery is less common than other valve surgery, there exists significant surgical experience in this area. Recent data from The Society of Thoracic Surgeons’ National Database, published from 2017 to 2023, reveals that 13,587 isolated tricuspid valve operations were performed in the US, predominantly in the Medicare population, with an overall operative mortality of 5.5% for tricuspid valve repair and 5.7% for tricuspid valve replacement. Surgery has, until recently, been the sole option for treating patients with right ventricular heart failure and severe TR. With the approval of the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR) by the US Food and Drug Administration (FDA) we now have a less invasive option for treating severely ill patients with severe TR for the first time.

I wholeheartedly support CMS coverage of the procedure under a National Coverage Determination with Coverage with Evidence Development (CED) as an additional option to treat our patients with severe, symptomatic TR. Given the complex medical condition of these patients, the intricacies of the anatomy and pathophysiology that must be taken into consideration for successful treatment, as well as the numerous available management options, I strongly advocate for a multi-disciplinary heart team (MDHT) approach for all options, including surgery, TTVR, medical and/or palliative therapy, and potentially tricuspid transcatheter edge to edge repair (T-TEER). Due to the limited clinical experience with TTVR at present and the likelihood of many patients with advanced disease, a similar approach to the introduction of transcatheter aortic valve replacement (TAVR) is a sine qua non, in my opinion. This involves a comprehensive assessment of all treatment options by the MDHT, including an interventional cardiologist and cardiac surgeon, as well as imaging specialists, heart failure experts, and electrophysiologists. It is imperative for all patients to undergo a valid risk assessment, which is now available in the form of the recently published STS tricuspid surgery risk algorithm, specifically calibrated to help assess the TTVR population. Integrating the STS risk calculator for isolated tricuspid valve surgery into the coverage determination is essential to support truly informed clinical decisions by the heart team.

TTVR is a complex transcatheter procedure that requires multidisciplinary expertise. Surgeons have a unique understanding of the anatomy and provide a perspective that is vital for any tricuspid valve intervention. Specifically, surgeons possess in-depth three-dimensional knowledge of the tricuspid anatomy, its mechanistic function, as well as knowledge of the detailed anatomic relationship to the conduction system and other cardiac structures, along with the valve-specific elements of clefts and chordal structures, all of which are crucial for safe procedural device delivery. Furthermore, experience with transcatheter valve therapies is now a requirement for surgeon certification by the American Board of Thoracic Surgeons, ensuring a comprehensive understanding and skill set for valvular pathologies in the cardiac surgery community. Furthermore, many of us have been instrumental in developing and studying transcatheter valve therapies.

Drawing from the success and safety of the TAVR National Coverage Determination, which included both a cardiac surgeon and an interventional cardiologist performing the procedure, a similar model must be adopted for a TTVR National Coverage Determination. As the safety profile of TTVR is still evolving and remains unclear, inclusive intraprocedural participation, as used for TAVR, will ensure the safest rollout of this new technology to Medicare beneficiaries. Surgeons are integral members of the heart team and should, therefore, be involved in all aspects of TTVR procedures, similar to their participation in the very successful model used for TAVR. Surgeons are uniquely qualified to perform transcatheter valve interventions and mitigate risks and complications, which are essential for ensuring patient quality and safety.

As a surgeon, I am dedicated to improving patient access to these technologies, and my focus is on ensuring the safe implementation of TTVR. Additionally, I assert that all procedures should be included in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage while more evidence is being developed. I urge CMS to take a cautious approach to establishing coverage at this early stage in the clinical development of TTVR. While the initial clinical profile of TTVR is compelling, the FDA approval is based on data from fewer than 100 patients treated at experienced medical centers. The limited data available now is insufficient to draw broad conclusions on the safety of widespread commercial implementation, particularly in less experienced centers. Further, in the case of TAVR, we have learned from several studies that less stringent NCD criteria do not necessarily translate into better access for underserved communities, as was the hope, but rather in clustering of programs in areas and communities with existing access to the technology (Ashwin et al. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008260). For all these reasons, I strongly urge CMS to take a cautious approach to ensure patient safety and quality of care.

In summary, even though TTVR technology shows great promise, and I am fully in favor of its implementation, the initial approval was based on a very limited number of patients and may not accurately represent the broader real-world patient population. CMS should move forward cautiously, providing careful oversight for this undertreated group. It is essential to ensure that surgeons are involved in the entire process, from the pre-operative stage through the procedure itself to post-procedure care, in order to safeguard patient safety and ensure high-quality outcomes. I believe that this coordinated approach, resembling the well-planned and well-executed TAVR rollout, will be crucial for the success of TTVR without negatively impacting patient access in any way.

Respectfully submitted,

Moritz C. Wyler von Ballmoos, MD, PhD, MPH, FAHA, FACC
System Chair, Cardiovascular & Thoracic Surgery
Executive Chair, Heart & Vascular Service Line
Texas Health Resources & Texas Health Harris Methodist Hospital
1325 Pennsylvania Ave, Suite 550
Fort Worth, TX 76104

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Please accept my comments as a cardiac surgeon who has been in practice since 2001 and have been fortunate to work at leading institutions, including Case Western, Harvard and Stanford. A large scope of my career has been dedicated to the innovative space of structural heart disease and minimally invasive surgery. These advances have been remarkable, and have led to the improvement of so many lives. TAVR as an example has been perhaps the most amazing innovation in the field of cardiac disease in my career. What has made this procedure so successful has been the collaboration between cardiac surgery and interventional cardiology, and much of this was because of the CMS insistence on a heart team that would assess and treat these patients together. This new paradigm has been so successful, that it has now been applied to multiple other fields, including complex coronary artery disease, heart failure and atrial fibrillation. When physicians are mandated to work together, this results in stronger teams, better patient advocacy and better outcomes.

Tricuspid regurgitation can be a very complex disease to manage, and the options to treat these patients will increase significantly. There is a great need to improve therapeutic options for these patients, otherwise, many are left to suffer and die. As such, I welcome the recent approval of the FDA for the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR). I am fully supportive of CMS coverage of this procedure, and any other similarly established procedure, under a National Coverage Determination with Coverage with Evidence Development (CED).

I am concerned however, about potential rules that would allow single-operator procedures with this system. Whether it would be performed by a surgeon only or a cardiologist only, I feel this would be a wrong decision. This would be a tremendous step backwards in the comprehensive treatment of patients with severe tricuspid regurgitation. It is imperative that we maintain the well-established format of a multi-disciplinary heart team (MDHT) approach for all therapeutic options including surgery, TTVR, medical and/or palliative therapy and potentially tricuspid transcatheter edge to edge repair (T-TEER). We have seen in multiple areas that allowing individuals to act alone in both the decision-making process and the therapeutic process has the potential to lead to substandard care and to harm patients.

I feel strongly that TTVR procedures should be introduced in a manner similar to TAVR. This would include a comprehensive assessment of all treatment options by the heart team, which needs to involve several groups of physicians: cardiac surgeons, interventional cardiologists, cardiac imaging specialists, heart failure experts and occasionally electrophysiologists. All patients should undergo risk assessment using the just published STS tricuspid surgery risk algorithm. It is essential that the use of this risk calculator be integrated into the coverage determination to support informed clinical decisions by the heart team. Once a decision has been made to treat the patient with a system such as EVOQUE, the procedure needs to be performed by a group of 3 physicians: cardiac surgeons, interventional cardiologists and cardiac imaging specialists. TTVR is a complex transcatheter procedure that requires multidisciplinary expertise. Speaking as a surgeon, I believe we bring a unique and important perspective on the tricuspid valve that are essential to maximizing the beneficial results of one intervention versus another. Allowing single operators to perform this procedure will violate this principle that has been so crucial to the success of TAVR, in my opinion.

The successful experience with the TAVR NCD, which included both a cardiac surgeon and an interventional cardiologist performing the procedure, should be the gold standard. This same process should be applied for a TTVR NCD also. This process was not applied for mitral TEER and I believe this was a serious mistake. I believe that mitral TEER would be even more successful had the same standards been applied as with TAVR. I urge you not to make the same mistake again. Surgeons and cardiologists are both integral members of a good heart team and should therefore serve as co-operators in TTVR procedures, similar to how we participate in the very successful model used for TAVR. Surgeons are uniquely qualified to mitigate some of the risks and complications, which could include device detachment and migration, right atrial perforation, right ventricular perforation and significant bleeding. My only aim is to maximize patient safety, which is best accomplished when teams work together, not when individuals work alone.

Furthermore, I urge that all procedures be collected in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage with evidence development. This is the only safe mechanism by which we can obtain reliable data for all procedures, not just the ones that are reported as being successful in promotional materials or published case series highlighting good results.

Thank you for the opportunity to comment. I support the approval and roll out of this procedure, many patients stand to benefit tremendously. I have no issue or concern with that, although we need to proceed cautiously and to monitor results. However I feel equally strongly that there needs to be multidisciplinary collaboration in both the evaluation/decision making for these patients and in the technical procedural aspects as well.

Regards,
Marc Pelletier, MD, MSc, FRCSC
Chief, Division of Cardiac Surgery, University Hospitals
Professor, Case Western Reserve University
Cleveland, Ohio

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As a practicing cardiac surgeon who has been involved in transcatheter procedures since 2007, I can attest to the fact that tricuspid regurgitation (TR) is a significant medical condition afflicting the Medicare population. I have substantial clinical experience managing patients with TR by performing surgical tricuspid valve repair and replacement over the past 29 years. Most cardiac surgeons have extensive experience treating TR especially when it is associated with mitral regurgitation and other cardiac conditions necessitating heart surgery. Isolated TR surgery is less commonly performed but a significant surgical experience exists. Recently published contemporary data from The Society of Thoracic Surgeons’ National Database, shows that between 2017 and 2023, there were 13,587 isolated tricuspid valve operations performed in the US, the majority in the Medicare population, with an overall operative mortality of 5.5% for tricuspid valve repair and 5.7% for tricuspid valve replacement. This also highlights experience in patient selection and perioperative management of these patients as outcomes do not simply depend on technique.

Surgery for TR was until recently the only option for treating patients with right ventricular heart failure and severe TR. Recently the US Food and Drug Administration (FDA) has approved the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR). As an additional less invasive option for treating these ill patients with severe TR, I am fully supportive of CMS coverage of the procedure under a National Coverage Determination with Coverage with Evidence Development (CED). However, due to the advanced medical condition of these patients as well as multiple options available for management, I advocate strongly for the management by a multi-disciplinary heart team (MDHT) approach for all options including surgery, TTVR, medical and/or palliative therapy and potentially tricuspid transcatheter edge to edge repair (T-TEER).

As the clinical experience with TTVR is quite limited at the current time as well as the fact that there are likely large numbers of patients with advanced disease presenting, an approach similar to the introduction of transcatheter aortic valve replacement (TAVR) is warranted till we fully understand role of this therapy in treating these patients. This model has demonstrated how a new technology can be introduced safely in majority centers in US and right treatment is chosen for right patient i.e. SAVR or TAVR. To ensure this

1. Patient should be assessed for all treatment options by the MDHT including interventional cardiologist and cardiac surgeon, but importantly in addition, imaging specialists, heart failure experts, and electrophysiologists.

2. All patients should undergo risk assessment using the just published STS tricuspid surgery risk algorithm. This new risk calculator is specifically calibrated to help assess the TTVR population. It is essential that the use of this risk calculator be integrated into the coverage determination to support informed clinical decisions by the heart team.

3. Surgical involvement in the procedure be mandatory as valve surgeons have in-depth three-dimensional knowledge of the tricuspid anatomy, its mechanistic function, as well as knowledge of the detailed anatomic relationship to the conduction system, and other cardiac structures, as well as the valve specific elements of clefts and chordal structures that all go into safe procedural device delivery. Two experts from different specialties always bring balanced perspective during the procedure and this helps minimizing complications and poor outcome.

4. procedures should be collected in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage with evidence development.

I urge CMS to adopt a conservative approach and cautious approach in establishing coverage at this early stage in the clinical development of TTVR. While the initial clinical profile of TTVR is compelling, the FDA approval is based on data from fewer than 100 patients treated at experienced medical centers. This limited and under representative dataset is insufficient to draw broad conclusions on the safety of commercial implementation, particularly in less experienced centers. I believe that a team-based approach to both pre-procedural and operator/procedural care is essential, and that cardiac surgeons must be required as co-operators in these procedures to ensure the highest quality patient care and safety possible.

Respectfully submitted,
NAME: Vinayak Bapat
TITLE: Chief of Cardiac Surgery, Abbott Northwestern and United hospitals, Minneapolis

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July 16, 2024
Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Ms. Syrek Jensen,

As a practicing cardiac surgeon, I can attest to the fact that tricuspid regurgitation (TR) is a significant medical condition afflicting the Medicare population. I have substantial clinical experience managing patients with TR by performing surgical tricuspid valve repair and replacement almost every week. Furthermore, I have published extensively on the importance of patient selection for treatment strategy in transcatheter and surgical therapy for structural valve disease in both aortic and mitral valve disease. Tricuspid valves are even more important to have multidisciplinary real time decision making given the complex relationship between TR, right ventricular dysfunction and left sided valve disease. Most cardiac surgeons have extensive experience treating TR especially when it is associated with mitral regurgitation and other cardiac conditions necessitating heart surgery. Isolated TR surgery is less commonly performed but a significant surgical experience exists. Recently published contemporary data from The Society of Thoracic Surgeons’ National Database, shows that between 2017 and 2023, there were 13,587 isolated tricuspid valve operations performed in the US, the majority in the Medicare population, with an overall operative mortality of 5.5% for tricuspid valve repair and 5.7% for tricuspid valve replacement.

Surgery for TR was until recently the only option for treating patients with right ventricular heart failure and severe TR. Recently the US Food and Drug Administration (FDA) has approved the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR). As an additional less invasive option for treating these ill patients with severe TR, I am fully supportive of CMS coverage of the procedure under a National Coverage Determination with Coverage with Evidence Development (CED). However, due to the advanced medical condition of these patients as well as multiple options available for management, I advocate strongly for the management by a multi-disciplinary heart team (MDHT) approach for all options including surgery, TTVR, medical and/or palliative therapy and potentially tricuspid transcatheter edge to edge repair (T-TEER).

As the clinical experience with TTVR is quite limited at the current time as well as the fact that there are likely large numbers of patients with advanced disease presenting, an approach similar to the introduction of transcatheter aortic valve replacement (TAVR) is warranted. This includes comprehensive assessment for all treatment options by the MDHT including interventional cardiologist and cardiac surgeon, but importantly in addition, imaging specialists, heart failure experts, and electrophysiologists. All patients should undergo risk assessment using the just published STS tricuspid surgery risk algorithm. This new risk calculator is specifically calibrated to help assess the TTVR population. This tool provides the best available evidence for clinical decision-making, ensuring that patient selection and risk assessment are based on contemporary data. It is essential that the use of this risk calculator be integrated into the coverage determination to support informed clinical decisions by the heart team.

TTVR is a complex transcatheter procedure that requires multidisciplinary expertise. Surgeons bring a unique perspective and important view of tricuspid valve intervention. Valve surgeons have in-depth three-dimensional knowledge of the tricuspid anatomy, its mechanistic function, as well as knowledge of the detailed anatomic relationship to the conduction system, and other cardiac structures, as well as the valve specific elements of clefts and chordal structures that all go into safe procedural device delivery.

Based on the experience with the TAVR NCD that included both a cardiac surgeon and an interventional cardiologist performing the procedure, the success and safety of this program should be the template for a TTVR NCD also. As TTVR has an evolving but as yet unclear safety profile, I feel that this inclusive aspect of intraprocedural participation as was utilized with TAVR, but not mandated for M-TEER, will assure the safest rollout of this new technology to Medicare beneficiaries. Surgeons are integral members of the heart team and should therefore serve as co-operators in TTVR procedures, similar to how we participate in the very successful model used for TAVR. Surgeons are uniquely qualified to mitigate risks and complications, which are essential for ensuring patient quality and safety. As a surgeon, I remain committed to enhancing patient access to these technologies and my practice and my specialty’s leadership remains focused that this safely occurs with TTVR. Furthermore, I urge that all procedures should be collected in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage with evidence development.

I urge CMS to adopt a conservative approach in establishing coverage at this early stage in the clinical development of TTVR. While the initial clinical profile of TTVR is compelling, the FDA approval is based on data from fewer than 100 patients treated at experienced medical centers. This limited and under representative dataset is insufficient to draw broad conclusions on the safety of commercial implementation, particularly in less experienced centers. Therefore, I feel strongly that CMS take a cautious approach to ensure patient safety and optimal deployment of this device. While all providers are committed to enhancing open access, protecting public trust is paramount, and the rollout of this technology must be executed thoughtfully. I believe that a team-based approach to both pre-procedural and operator/procedural care is essential, and that cardiac surgeons must be required as co-operators in these procedures to ensure the highest quality patient care and safety possible.

In summary, while the TTVR technology is very promising, and I fully support its roll out, the initial approval was based on a very small patient cohort and may not be representative of the wider real-world patient population. CMS should proceed cautiously, treating this under-treated group with careful oversight. Ensuring that surgeons are part of the process from the pre-operative stage through the actual procedure to post procedure care is crucial for patient safety and quality outcomes. I feel that this multidisciplinary approach, mirroring the well planned and executed TAVR rollout, will be of great importance for the success of TTVR without in any way negatively impacting patient access.

Respectfully submitted,

J. Hunter Mehaffey MD MSc
Director of Cardiac Surgery Research
Department of Cardiovascular and Thoracic Surgery
West Virginia University
james.mehaffey@wvumedicine.org
828-779-3929

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Administrator Chiquita Brooks-LaSure
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Brooks-LaSure,
CMS should not provide coverage for Edwards’ EVOQUE tricuspid valve replacement system at this time given significant concerns with the TRISCEND II trial design. Firstly, fewer than half of the device and control groups were evaluated at a 12-month visit. With complete data from only 30 days and 6 months, the study is not complete and safety is not fully understood. Additionally, the trial was unblinded making the evidence equivocal given the resulting placebo and bias. On top of this, the data was not reviewed by an FDA panel before premarket approval. For these reasons, among others, CMS should not provide coverage for Edwards’ tricuspid valve replacement until the safety and efficacy of the product are further studied.

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We discussed at one of our noon conferences the existing data and feel it is premature to grant coverage for the procedure.

Points that concern us without further evaluation:
-The existing study was unblinded, making all subjective outcomes susceptible to placebo effect and bias
-Outcomes evaluated only at 30 days and 6 months
-Missing data – 12-month visit completed for less than half of the device and control groups
-High 30-day major adverse events (MAE) rate - 27.4%. The performance goal was 70% based on safety outcomes for isolated tricuspid valve replacement surgery however it would be more useful to compare to patients who are managed medically.
-22.6% of patients that did not already have pacemarkers/ICDs now require permanent pacemakers –
-10% had severe bleeding
-12 out of 96 patients in the device group died by 12 months, vs. 4 out of 54 in control —> this is not well explained.

In terms of primary outcome, while TRISCEND II reported improved TR grade, this is a surrogate measure and the more clinically meaningful outcomes to patients are NYHA functional class and KCCQ score. It is difficult to assess to what extent these improvements were driven by placebo effect since KCCQ score is self-reported and study personnel assessing NYHA functional class were not blinded to the individual’s treatment assignment

MEDCAC should be convened to review this evidence before any NCA is completed. A blinded larger trial would be warranted with more objective outcomes such as mortality or hospitalizations, etc.

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July XX, 2024
Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244
Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Ms. Syrek Jensen,

As a practicing cardiac surgeon, I can attest to the fact that tricuspid regurgitation (TR) is a significant medical condition afflicting the Medicare population. I have substantial clinical experience managing patients with TR by performing surgical tricuspid valve repair and replacement over the past 30 years. Most cardiac surgeons have extensive experience treating TR especially when it is associated with mitral regurgitation and other cardiac conditions necessitating heart surgery. Isolated TR surgery is less commonly performed but a significant surgical experience exists. Recently published contemporary data from The Society of Thoracic Surgeons’ National Database, shows that between 2017 and 2023, there were 13,587 isolated tricuspid valve operations performed in the US, the majority in the Medicare population, with an overall operative mortality of 5.5% for tricuspid valve repair and 5.7% for tricuspid valve replacement.

Surgery for TR was until recently the only option for treating patients with right ventricular heart failure and severe TR. Recently the US Food and Drug Administration (FDA) has approved the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR). As an additional less invasive option for treating these ill patients with severe TR, I am fully supportive of CMS coverage of the procedure under a National Coverage Determination with Coverage with Evidence Development (CED). However, due to the advanced medical condition of these patients as well as multiple options available for management, I advocate strongly for the management by a multi-disciplinary heart team (MDHT) approach for all options including surgery, TTVR, medical and/or palliative therapy and potentially tricuspid transcatheter edge to edge repair (T-TEER).

As the clinical experience with TTVR is quite limited at the current time as well as the fact that there are likely large numbers of patients with advanced disease presenting, an approach similar to the introduction of transcatheter aortic valve replacement (TAVR) is warranted. This includes comprehensive assessment for all treatment options by the MDHT including interventional cardiologist and cardiac surgeon, but importantly in addition, imaging specialists, heart failure experts, and electrophysiologists. All patients should undergo risk assessment using the just published STS tricuspid surgery risk algorithm. This new risk calculator is specifically calibrated to help assess the TTVR population. This tool provides the best available evidence for clinical decision-making, ensuring that patient selection and risk assessment are based on contemporary data. It is essential that the use of this risk calculator be integrated into the coverage determination to support informed clinical decisions by the heart team.

TTVR is a complex transcatheter procedure that requires multidisciplinary expertise. Surgeons bring a unique perspective and important view of tricuspid valve intervention. Valve surgeons have in-depth three-dimensional knowledge of the tricuspid anatomy, its mechanistic function, as well as knowledge of the detailed anatomic relationship to the conduction system, and other cardiac structures, as well as the valve specific elements of clefts and chordal structures that all go into safe procedural device delivery.

Based on the experience with the TAVR NCD that included both a cardiac surgeon and an interventional cardiologist performing the procedure, the success and safety of this program should be the template for a TTVR NCD also. As TTVR has an evolving but as yet unclear safety profile, I feel that this inclusive aspect of intraprocedural participation as was utilized with TAVR, but not mandated for M-TEER, will assure the safest rollout of this new technology to Medicare beneficiaries. Surgeons are integral members of the heart team and should therefore serve as co-operators in TTVR procedures, similar to how we participate in the very successful model used for TAVR. Surgeons are uniquely qualified to mitigate risks and complications, which are essential for ensuring patient quality and safety. As a surgeon, I remain committed to enhancing patient access to these technologies and my practice and my specialty’s leadership remains focused that this safely occurs with TTVR.

Furthermore, I urge that all procedures should be collected in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage with evidence development.

I urge CMS to adopt a conservative approach in establishing coverage at this early stage in the clinical development of TTVR. While the initial clinical profile of TTVR is compelling, the FDA approval is based on data from fewer than 100 patients treated at experienced medical centers. This limited and under representative dataset is insufficient to draw broad conclusions on the safety of commercial implementation, particularly in less experienced centers. Therefore, I feel strongly that CMS take a cautious approach to ensure patient safety and optimal deployment of this device. While all providers are committed to enhancing open access, protecting public trust is paramount, and the rollout of this technology must be executed thoughtfully. I believe that a team-based approach to both pre-procedural and operator/procedural care is essential, and that cardiac surgeons must be required as co-operators in these procedures to ensure the highest quality patient care and safety possible.

In summary, while the TTVR technology is very promising, and I fully support its roll out, the initial approval was based on a very small patient cohort and may not be representative of the wider real-world patient population. CMS should proceed cautiously, treating this under-treated group with careful oversight. Ensuring that surgeons are part of the process from the pre-operative stage through the actual procedure to post procedure care is crucial for patient safety and quality outcomes. I feel that this multidisciplinary approach, mirroring the well planned and executed TAVR rollout, will be of great importance for the success of TTVR without in any way negatively impacting patient access.

Respectfully submitted,

Gregory P. Fontana, MD, FACC, FACS
National Medical Director, Cardiovascular Research
HCA Healthcare Research Institute

National Physician Director, Cardiothoracic Surgery
HCA Healthcare

Director, CardioVascular Institute
Chairman, Cardiothoracic Surgery
Medical Director, Cardiovascular Service Line
Los Robles Regional Medical Center

O 805-852-9100 | F 844-442-4951
227 West Janss Road Suite 340 | Thousand Oaks CA 91360

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July 15, 2024

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244
Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Ms. Syrek Jensen,

As a practicing cardiac surgeon, I can attest that tricuspid regurgitation (TR) is a significant medical condition afflicting the Medicare population. I have substantial clinical experience managing patients with TR by performing more than 2000 surgical tricuspid valve repair and replacement over 40 years. Most cardiac surgeons have extensive experience treating TR especially when it is associated with mitral regurgitation and other cardiac conditions necessitating heart surgery. Isolated TR surgery is less commonly performed but a significant surgical experience exists. Recently published contemporary data from The Society of Thoracic Surgeons’ National Database, shows that between 2017 and 2023, there were 13,587 isolated tricuspid valve operations performed in the US, the majority in the Medicare population, with an overall operative mortality of 5.5% for tricuspid valve repair and 5.7% for tricuspid valve replacement.

Surgery for TR was until recently the only option for treating patients with right ventricular heart failure and severe TR. Recently the US Food and Drug Administration (FDA) has approved the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR). As an additional less invasive option for treating these ill patients with severe TR, I am fully supportive of CMS coverage of the procedure under a National Coverage Determination with Coverage with Evidence Development (CED). However, due to the advanced medical condition of these patients as well as multiple options available for management, I advocate strongly for the management by a multi-disciplinary heart team (MDHT) approach for all options including surgery, TTVR, medical and/or palliative therapy and potentially tricuspid transcatheter edge to edge repair (T-TEER).

As the clinical experience with TTVR is quite limited at the current time as well as the fact that there are likely large numbers of patients with advanced disease presenting, an approach similar to the introduction of transcatheter aortic valve replacement (TAVR) is warranted. This includes comprehensive assessment for all treatment options by the MDHT including interventional cardiologist and cardiac surgeon, but importantly in addition, imaging specialists, heart failure experts, and electrophysiologists. All patients should undergo risk assessment using the just published STS tricuspid surgery risk algorithm. This new risk calculator is specifically calibrated to help assess the TTVR population. This tool provides the best available evidence for clinical decision-making, ensuring that patient selection and risk assessment are based on contemporary data. It is essential that the use of this risk calculator be integrated into the coverage determination to support informed clinical decisions by the heart team.

TTVR is a complex transcatheter procedure that requires multidisciplinary expertise. Surgeons bring a unique perspective and important view of tricuspid valve intervention. Valve surgeons have in-depth three-dimensional knowledge of the tricuspid anatomy, its mechanistic function, as well as knowledge of the detailed anatomic relationship to the conduction system, and other cardiac structures, as well as the valve specific elements of clefts and chordal structures that all go into safe procedural device delivery.

Based on the experience with the TAVR NCD that included both a cardiac surgeon and an interventional cardiologist performing the procedure, the success and safety of this program should be the template for a TTVR NCD also. As TTVR has an evolving but as yet unclear safety profile, I feel that this inclusive aspect of intraprocedural participation as was utilized with TAVR, but not mandated for M-TEER, will assure the safest rollout of this new technology to Medicare beneficiaries. Surgeons are integral members of the heart team and should therefore serve as co-operators in TTVR procedures, similar to how we participate in the very successful model used for TAVR. Surgeons are uniquely qualified to mitigate risks and complications, which are essential for ensuring patient quality and safety. As a surgeon, I remain committed to enhancing patient access to these technologies and my practice and my specialty’s leadership remains focused that this safely occurs with TTVR.

Furthermore, we urge that all procedures should be collected in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage with evidence development.

We urge CMS to adopt a conservative approach in establishing coverage at this early stage in the clinical development of TTVR. While the initial clinical profile of TTVR is compelling, the FDA approval is based on data from fewer than 100 patients treated at experienced medical centers. This limited and under representative dataset is insufficient to draw broad conclusions on the safety of commercial implementation, particularly in less experienced centers. Therefore, we feel strongly that CMS take a cautious approach to ensure patient safety and optimal deployment of this device. While all providers are committed to enhancing open access, protecting public trust is paramount, and the rollout of this technology must be executed thoughtfully. We believe that a team-based approach to both pre-procedural and operator/procedural care is essential, and that cardiac surgeons must be required as co-operators in these procedures to ensure the highest quality patient care and safety possible.

At the University of Michigan, we have a unique experience with transcatheter tricuspid devices, in that we have enrolled in and utilized both the transcatheter tricuspid replacements trials, Evoque and Intrepid. We have also used both transcatheter tricuspid repair devices, Triclip and Pascal. Our transcatheter mitral and tricuspid program has been a fully MDHT involving, Cardiology, Interventional Cardiology, Heart failure, Cardiac Surgery and Cardiac Imaging since beginning more than 12 years ago. We feel that patients have benefitted from the interaction amongst providers. Furthermore, our outcome data supports this with the highest clinical. outcomes in terms of patient quality and safety. We feel this continuing approach of interaction between surgeons and cardiologists is uniquely important in the transcatheter tricuspid area. To further emphasize our support for this MDHT approach to transcatheter tricuspid, I have asked the chief of our structural heart program, an interventional cardiologist, to sign this letter together with me.

In summary, while TTVR technology is very promising, and we fully support its roll out, the initial approval was based on a very small patient cohort and may not be representative of the wider real-world patient population. CMS should proceed cautiously, treating this under-treated group with careful oversight. Ensuring that surgeons are part of the process from the pre-operative stage through the actual procedure to post procedure care is crucial for patient safety and quality outcomes. We feel that this multidisciplinary approach, mirroring the well planned and executed TAVR rollout, will be of great importance for the success of TTVR without in any way negatively impacting patient access.

Respectfully submitted,

Steven F Bolling, MD
Professor of Cardiac Surgery
Department of Cardiac Surgery

Stanley J. Chetcuti, MD
Professor
Eric J. Topol Professor of CVM
Director Cardiac Catheterization Laboratory
Co-Director Structural Heart Service
Division of Cardiovascular Medicine
Department of Internal Medicine

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July 17, 2024

Administrator Chiquita Brooks-LaSure
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Brooks-LaSure,

On behalf of Heart Valve Voice US, a national non-profit patient advocacy group dedicated to enhancing the lives of individuals affected by heart valve disease, we appreciate the opportunity to comment on the NCD Tracking Sheet regarding Transcatheter Tricuspid Valve Replacement (TTVR). As an organization deeply rooted in patient-centered advocacy, HVV-US has a unique perspective to share regarding patients’ lived experience with heart valve disease and the promise that breakthrough technologies provide. Recent advancements in transcatheter tricuspid therapies, such as the approval earlier this year of the breakthrough EVOQUE tricuspid replacement system, offer potential for patients who otherwise would not be able to address their valvular disease without more invasive options. With that in mind, HVV-US is hopeful that CMS will provide timely and adequate coverage for these new devices.

As you know, for patients grappling with tricuspid regurgitation, the availability of treatment options has historically been limited. In recent years, the landscape of transcatheter valve procedures has evolved significantly, with robust clinical experience and the establishment of multidisciplinary Heart Teams, necessitating policies that reflect these advancements. As Medicare considers a national coverage policy for TTVR, we believe it is imperative that CMS strike a balance between rigorous safeguards and expeditious patient access.

Drawing from past coverage policies, including those for TAVR and M-TEER, flexibility in coverage criteria is essential to prevent unintended barriers to care. Patients need inclusive coverage requirements that are sensitive to their diverse needs and that avoid unnecessary burdens and delays.

For HVV-US, the focus must include the lived patient experience with heart valve disease. One poignant example of the impact of timely intervention is the story of Mary, a member of our community who bravely navigated the challenges of tricuspid regurgitation.

In 2019, Mary was in hospice care, suffering from tricuspid regurgitation. Due to other health issues, she was unable to undergo open heart surgery to address her condition. She spent two years in and out of the hospital, knowing her tricuspid valve was failing. Her legs and feet were so swollen she couldn’t lift her feet to walk, and she could only move from her bed to the couch to the bathroom. She couldn’t comfortably lift her head, speak, or even breathe—her quality of life was severely diminished.

After two years of enduring tricuspid regurgitation, Mary felt she was reaching a breaking point and began preparing her critical documents and funeral plans; at her next follow-up appointment, she asked her cardiologist what it would feel like to die. Shortly thereafter, she received a call informing her that she had qualified for a clinical trial surgery for the TTVR. Mary says she immediately began to feel hopeful.

Two months later, on January 11th, Mary woke up from her surgery and remembers laughing for the first time in over two years—it no longer physically hurt her body. By that afternoon, she was able to pick up her feet as she walked through the hospital halls and wasn’t out of breath. She had a renewed sense of purpose and will to live.

Mary's journey illustrates the transformative potential of TTVR. Following the intervention with the EVOQUE system, she shared how her quality of life dramatically improved—a profound testament to the life-changing impact of innovative medical advancements.

Likewise, a critical component in the shared decision-making process of heart valve disease treatment is the clinician’s role in evaluating and guiding patient care. HVV-US urges CMS to consider a streamlined evaluation process that leverages the expertise of Heart Team members to ensure comprehensive and patient-centered assessments. This approach not only enhances care coordination but also promotes equitable access to TTVR across diverse geographic settings.

Finally, the experience of the sites and operators is paramount in achieving optimal outcomes for patients. Input from stakeholders, including patient advocates and medical experts, is essential in establishing criteria that prioritize safety while ensuring equitable access based on geographic location. We urge CMS to prioritize policies that acknowledge the expertise and perspectives of these stakeholders. By incorporating their insights into regulatory frameworks, CMS can foster a healthcare environment that not only meets rigorous safety standards but also addresses the diverse needs of patients across the country.

In closing, Heart Valve Voice US urges CMS to adopt a coverage policy for TTVR that prioritizes patient needs while reflecting advancements in transcatheter valve technology. By fostering collaboration and patient-centered care through the Heart Team model, we can ensure that individuals suffering from tricuspid regurgitation, like Mary, receive timely access to transformative treatments like the EVOQUE system.

Thank you for considering our perspective on this critical matter. We look forward to continuing our dialogue and collaborating towards policies that improve outcomes for Medicare beneficiaries with tricuspid regurgitation.

Sincerely,
Berkeley Barnett
Heart Valve Voice US
Director, Policy & Advocacy

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On behalf of the Medical Device Manufacturers Association (MDMA), I am pleased to submit comments to CMS on the Transcatheter Tricuspid Valve Replacement (TTVR).

MDMA is a national trade association that provides educational and advocacy assistance to hundreds of innovative companies in the field of medical technology. Our members, the majority of which are small to mid-sized medical device companies, have a strong record of delivering breakthrough therapies to treat chronic diseases and life-threatening conditions while lowering the cost of care. MDMA’s mission is to ensure that patients have timely access to the latest advancements of safe and effective medical technologies that improve health outcomes.

As outlined in public comment submitted in response to the Transcatheter Tricuspid Valve Replacement (TTVR) Tracking Sheet (1), Edwards Lifesciences (“Edwards”) has been participating in a coverage process similar to that outlined in the Transitional Coverage of Emerging Technologies (TCET) notice and proposed guidance. The manufacturer describes their experience, to-date, with CMS, including:

July 16, 2024
Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Re: CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Ms. Syrek Jensen,

Tricuspid regurgitation (TR) is a significant medical condition afflicting the Medicare population. I am a clinically active cardiac surgeon who evaluates and manages patients with severe tricuspid regurgitation in an academic medical center. I currently participate in multidisciplinary heart team evaluations of these patients.

Isolated TR surgery is less commonly performed but a significant surgical experience exists. Recently published contemporary data from The Society of Thoracic Surgeons’ National Database, shows that between 2017 and 2023, there were 13,587 isolated tricuspid valve operations performed in the US, the majority in the Medicare population, with an overall operative mortality of 5.5% for tricuspid valve repair and 5.7% for tricuspid valve replacement. To place these mortality numbers in perspective – the operative mortality for tricuspid valve surgery is approximately 10 – fold higher than for an elective coronary artery bypass grafting operation – which is now at 0.5%. The nuances and medical decision making necessary to ensure excellent outcomes for these patients undergoing therapy for TR requires multidisciplinary input to continue to lower this number from over 5%.

Surgery for TR was until recently the only option for treating patients with right ventricular heart failure and severe TR. Recently the US Food and Drug Administration (FDA) has approved the EVOQUE transcatheter valve for transcatheter tricuspid valve replacement (TTVR). As an additional less invasive option for treating these ill patients with severe TR, I am fully supportive of CMS coverage of the procedure under a National Coverage Determination with Coverage with Evidence Development (CED). However, due to the advanced medical condition of these patients as well as multiple options available for management, I advocate strongly for the management by a multi-disciplinary heart team (MDHT) approach for all options including surgery, TTVR, medical and/or palliative therapy and potentially tricuspid transcatheter edge to edge repair (T-TEER).

There remain several similarities with the roll -out of Transcatheter Aortic Valve Replacement (TAVR) and TTVR therapies. Both patient populations represent high-risk patients for whom open operations were either high (>8% calculated risk for mortality) or prohibitive risk. Both are disruptive technologies. As a practicing and engaged TAVR operator in a center which performs >150 TAVR procedures/year with outstanding outcomes, I understand my key involvement in ensuring successful outcomes for our TAVR patients. Similarly, in the TTVR space, my input as a cardiac surgeon into the anatomic nuances of tricuspid leaflets and clefts, right ventricular dysfunction with TR, and specific anatomic relationships of the chordal structures, conduction system, and the tricuspid annulus are essential to ensuring a complete understanding of how TTVR will impact patients. Furthermore, I urge that all procedures should be collected in the STS/ACC TVT Registry, which will further inform the community about the outcomes and quality of this breakthrough device under the provisions of coverage with evidence development.

In summary, while the TTVR technology is very promising, and I fully support its roll out, the initial approval was based on a very small patient cohort and may not be representative of the wider real-world patient population. CMS should proceed cautiously, treating this under-treated group with careful oversight. Ensuring that surgeons are part of the process from the pre-operative stage through the actual procedure to post procedure care is crucial for patient safety and quality outcomes. I feel that this multidisciplinary approach, mirroring the well planned and executed TAVR rollout, will be of great importance for the success of TTVR without in any way negatively impacting patient access.

Sincerely,

Joseph C. Cleveland, Jr., MD
Chief, Division of Cardiothoracic Surgery
Frederick and Carol Grover Professor of Surgery
Vice-Chair, Faculty Affairs, Department of Surgery
Surgical Director, Mechanical Circulatory Support
University of Colorado Anschutz Medical Center

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Dear CMS,

We appreciate the opportunity to emphasize the significance of a National Coverage Decision for Transcatheter Tricuspid Valve Repair (TTVR). The compelling data on TTVR highlights not only the clinical efficacy but also the profound impact on patients' lives. Studies have consistently shown that TTVR significantly improves symptoms and dramatically enhances the quality of life for individuals suffering from severe symptomatic tricuspid regurgitation. These improvements are not just statistical; they translate into tangible benefits for patients, allowing them to engage more fully in daily activities and reducing the burden on caregivers and the healthcare system. A positive coverage decision would ensure broader access to this life-changing treatment, aligning with CMS's mission to promote high-quality, effective healthcare for all beneficiaries.

Sincerely,
Carlos E Sanchez, MD

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CAG-00467N Transcatheter Tricuspid Valve Replacement (TTVR)

Dear Centers for Medicare and Medicaid Services,

The prevalence of significant tricuspid regurgitation is high and the morbidity and mortality stemming from it are substantial. Beyond diuretics, there is little to offer in the way of medical therapy and surgery is uncommonly performed for these patients given its high risk and frequent complications. In this context, the arrival of an effective minimally invasive, catheter-based procedure addresses a large unmet clinical need. While the data are incomplete and long-term outcomes unknown, early results are very promising and transcatheter tricuspid valve replacement (TTVR) is a welcome new treatment option.

In setting guidelines for evaluation of patients with tricuspid regurgitation and performance of TTVR, both clinical expertise and patient access must be considered and prioritized. Overly onerous requirements that don’t increase safety will only serve to drive up costs and unnecessarily slow evaluation/treatment times and limit access.

From a multidisciplinary team representing all key stakeholders in this decision, here are recommendations regarding the evaluation, treatment, and management of patients with TR being considered for and treated with TTVR:

Under care of a heart team: borrowing the words of the mitral TEER NCD: “The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multidisciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care.” The heart team must include the following members with experience and training as specified: (1) interventional cardiologist with expertise in the structural heart valve procedures; (2) cardiac surgeon with expertise in heart valve disease; and (3) interventional echocardiographer (cardiologist or anesthesiologist) with expertise in structural heart valve procedures. When needed, the team should also include an electrophysiologist and heart failure cardiologist experienced in treating patients with advanced heart failure.

Pre-procedure evaluation: Each patient's suitability for TTVR must be evaluated, documented, and made available to other heart team members. A face-to-face evaluation and examination by a TTVR implanter (cardiologist or surgeon) or TTVR interventional echocardiographer is required. The heart team should review and discuss patients considered for TTVR to form a multidisciplinary recommendation.

TTVR procedure requirements: A cardiac surgeon should NOT be specifically required to participate in the case. The TRISCEND trial did not require a cardiac surgeon to participate in the procedures and most/many sites did not have a cardiac surgeon participate in the procedure. The data from that trial are what form the basis for the FDA approval of the device, so there is no solid rationale for requiring a cardiac surgeon in the procedure when the trial did not. The following language (with minor modification) from the mitral TEER NCD would seem to be appropriate for TTVR:

- An interventional cardiologist OR cardiac surgeon from the heart team must perform the TTVR and an interventional echocardiographer from the heart team must perform transesophageal echocardiography during the procedure (unless the procedure can be done with intracardiac echocardiography). The interventional cardiologist and cardiac surgeon (or 2 interventional cardiologists or 2 cardiac surgeons) may jointly participate in the intra-procedural technical aspects of TTVR as appropriate. All physicians who participate in the procedure must have device-specific training as required by the manufacturer.

Thank you for considering these comments.

Sincerely,

Brian R. Lindman, MD, MSc
Medical Director, Structural Heart and Valve Center
Vanderbilt University Medical Center

Colin M. Barker, MD
Section Chief, Interventional Cardiology
Director, Cardiac Catheterization Laboratory
Vanderbilt University Medical Center

Kashish Goel, MD
Director, Transcatheter Heart Valve Interventions
Vanderbilt University Medical Center

Tarek Absi, MD
Surgical Director, Structural Heart and Valve Center
Vanderbilt University Medical Center

Frederick W. Lombard, MBChB
Division Chief, Cardiothoracic Anesthesia
Vanderbilt University Medical Center

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July 1, 2024

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Ms. Syrek Jensen,

Edwards Lifesciences (“Edwards”) is pleased with the opening of the National Coverage Analysis (NCA) for Transcatheter Tricuspid Valve Replacement (TTVR). Edwards believes that the posting of the Tracking Sheet is an important step towards securing timely and equitable patient access to life-changing medical innovation. Patients with tricuspid regurgitation (TR) suffer from debilitating symptoms and currently have limited or no therapeutic treatment options; patients and physicians are eagerly seeking use of this U.S. Food and Drug Administration (FDA)Designated Breakthrough device, which can be facilitated via the completion of a Medicare national coverage determination (NCD).

We appreciate the opportunity to submit comments on the TTVR NCA, which expands on topics covered in our NCD request letter and support transparency in the coverage process. Our comments focus on three areas:

• CMS/FDA Parallel Review of the Edwards EVOQUE System
• Principles for TTVR Medicare Coverage Policy
• Recommendations for TTVR Medicare Coverage Policy

In summary, Edwards believes that with the completion of the Evidence Preview, approval of the Evidence Development Plan, and the posting of the Tracking Sheet, CMS should move quickly to the next step of issuing the Proposed Decision Memo in alignment with the intent of the Parallel Review program. As CMS considers the coverage parameters for TTVR, we urge the Agency to consider four key principles:

• Enabling timely and equitable access for Medicare beneficiaries while minimizing patient burden;
• Balancing flexibilities for hospitals and clinicians while optimizing patient outcomes;
• Durability of coverage policy during evidence generation; and
• Commitment to ongoing evidence generation.

Edwards was accepted into the Parallel Review Program on May 21, 2020. Under the Parallel Review Program, there was concurrent review by CMS and the FDA of the Premarket Approval (PMA) submission for the Edwards EVOQUE tricuspid valve replacement system (EVOQUE system) with the goal of “prompt and efficient patient access” for Medicare beneficiaries.(1)

On February 1, 2024, the FDA completed its review of the PMA application and approved the EVOQUE system for the improvement of health status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by a Heart Team. As stated by the FDA in its press announcement on the EVOQUE system approval: “[t]his approval marks the first transcatheter replacement device indicated for use in the tricuspid position.”(2)

The results from the Breakthrough Pathway Cohort of the Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device (“TRISCEND II Pivotal Trial”) were the basis for the FDA approval of the EVOQUE system. Successful six-month results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in 2023. These results showed favorable safety and effectiveness outcomes, demonstrating superiority to optimal medical therapy (OMT) alone and meeting all primary endpoints. Key findings in the trial included significant reduction or elimination of tricuspid regurgitation and significant and sustained quality of life improvement, while demonstrating a favorable balance between risk and benefit. A summary of the clinical evidence for TTVR was provided in our NCD request, which is linked in the TTVR Tracking Sheet, and can also be found in the Summary of Safety and Effectiveness Data (SSED) on the FDA website.

The TTVR Tracking Sheet specifies that the NCA will analyze “the clinical evidence for characteristics or comorbidities that make patients more or less likely to benefit from the device and whether specific treatment conditions are necessary to achieve the outcomes demonstrated in clinical studies. Other outcomes of interest may include decreased mortality, decreased frequency of exacerbations requiring emergency room or hospital admission, improved function, and quality of life.”

Under Parallel Review, CMS assessed these topics outlined in the Tracking Sheet over the course of the last year. The process applied the principles and processes that are outlined in the Proposed Guidance documents that were released in June 2023 for the Transitional Coverage for Emerging Technologies (TCET) pathway, National Coverage Analysis Evidence Review, and Coverage with Evidence Development (CED). The process required the following:

• Evidence Preview – This CMS-generated document summarizes a systematic literature review that provides CMS’s feedback on the strengths and weaknesses of the publicly available evidence for the EVOQUE system at the time the review was conducted. In its review, CMS assessed the topics that have then been articulated in the TTVR Tracking Sheet, posted June 20, 2024. The Evidence Preview for EVOQUE was finalized by CMS in December 2023.

• Evidence Development Plan (EDP) – As defined in the TCET proposed guidance, the purpose of this sponsor-generated document is to articulate to CMS the planned body of evidence for a technology that will address the evidence needs under CED. The intent is to estimate the timepoint in the future at which there would be sufficient evidence for CMS to move from transitional coverage to “durable coverage” (i.e., coverage without the requirement for evidence development). The EDP for EVOQUE outlines Edwards’ plan for conducting and reporting on clinical and real-world evidence studies to fulfill the requirements for CED. The EDP for EVOQUE was approved by CMS and the Agency for Healthcare Research and Quality (AHRQ).

Edwards believes that with the completion of the Evidence Preview, approval of the Evidence Development Plan, and the posting of the Tracking Sheet, CMS should move quickly to the next step of issuing the Proposed Decision Memo in alignment with the intent of the Parallel Review program of “facilitating earlier access to innovative medical technologies for Medicare beneficiaries.”(1) To date, two technologies have completed the Parallel Review Program. In both instances, CMS issued the Tracking Sheet and the Proposed Decision Memo together. For the first technology to successfully complete the Parallel Review Program, Exact Sciences’ Cologuard, FDA approved the medical device on August 11, 2014. On the same day, CMS initiated its NCA. CMS published a final NCD establishing coverage on October 9, 2014, less than 2 months after the medical device received its premarket approval.1 Edwards recognizes the difference in timing of our Parallel Review technology, mainly that CMS required the completion of the Evidence Preview and EDP prior to issuing a Proposed Decision Memo. The TCET Proposed Guidance states CMS’ goal is to finalize an NCD for technologies accepted into and continuing in the TCET pathway within 6 months after FDA market authorization. That date for EVOQUE would be August 1, 2024.

Below is a summary of Edwards’ principles for developing a coverage policy and the recommendations for the TTVR coverage policy that we respectfully request CMS consider in the development of its draft coverage policy.

In the United States, more than 1.6 million people suffer from significant TR (moderate and above).(3,4) The prevalence of moderate or greater TR is more frequent in women than men, with approximately four times as many women with the disease.(5) The prevalence of TR increases with age and the incidence of TR is expected to increase with an aging population.(6)

In the absence of clinical guidelines recommending isolated tricuspid valve surgical replacement, most patients with TR are medically managed for their symptoms and are not treated for the underlying disease.(7,8) The EVOQUE system was the first FDA approved TTVR technology indicated for the improvement of health status in patients with symptomatic severe TR despite being treated optimally with medical therapy for whom tricuspid valve replacement is deemed appropriate by a Heart Team. As an FDA Designated Breakthrough device, the EVOQUE system creates new hope for patients for whom no other treatment options previously existed. Susheel Kodali, MD, director, Structural Heart and Valve Center at Columbia University Irving Medical Center/New York-Presbyterian Hospital and TRISCEND II Study Principal Investigator, states:

In our submission of the NCD request for TTVR under the Parallel Review program, Edwards considered the impact of the criteria for coverage of this innovative technology on the many Medicare beneficiaries without alternatives. As CMS considers the coverage parameters for TTVR, we urge the Agency to consider four key principles:

• Enabling timely and equitable access for Medicare beneficiaries while minimizing patient burden;
• Balancing flexibilities for hospitals and clinicians while optimizing patient outcomes;
• Durability of coverage policy during evidence generation; and
• Commitment to ongoing evidence generation.

The paramount goal for a national coverage policy is to achieve the balance of facilitating timely patient access to treatment while optimizing patient outcomes. Patients with TR suffer from significant and frequent symptoms affecting their everyday lives, including edema, ascites, shortness of breath, and chest pain. Patients with TR not only experience the significant burden from this disease, but frequently suffer from multiple comorbidities, including atrial arrhythmias, hyperlipidemia, ischemic heart disease, and diabetes.(8) The patient population with severe TR is highly symptomatic, unable to participate in everyday activities.

To better understand the goals of the patients with TR in seeking treatment, Edwards incorporated a patient preference survey into the TRISCEND II pivotal trial. For 53% of patients who were treated with EVOQUE, caring for themselves was the most important activity following treatment.(10) Patients also ranked visiting friends and family, walking one block, and climbing stairs as priority activities they were unable to do prior to treatment and were seeking to improve.

In developing coverage parameters, CMS can alleviate unnecessary burdens on this patient population and their families by ensuring each coverage requirement optimizes the care pathway to treatment. Below we present how coverage requirements such as defining the eligible patient population, hospital volume requirements, and the Heart Team and patient evaluation requirements may impact patient access.

Results from the TRISCEND II Pivotal Trial were the basis for the FDA approval of the EVOQUE system (a summary of the trial results can be accessed in the FDA Summary of Safety and Effectiveness). During the design of the pivotal trial, specific inclusion and exclusion criteria were critically evaluated. Notably, for participation in the study, patients were not required to be ineligible for tricuspid valve surgery. This decision was largely based on the absence of clinical guidelines recommending isolated surgical intervention and the need to treat the patient population most likely to benefit.

CMS must ensure that coverage for TTVR is consistent with the experience to date and the patient population meeting FDA labeling criteria. As such, Edwards recommends CMS cover TTVR according to the FDA-approved indication for the EVOQUE system. Without access to the EVOQUE system, an FDA Designated Breakthrough device, this patient population suffering from a debilitating disease will not have access to treatment options.

In the early stages of a novel technology, hospital volume requirements serve as a proxy for identifying the facilities that have the infrastructure and clinical expertise necessary to ensure positive patient outcomes, procedural safety, and clinical success. As CMS establishes the requirements for hospitals to be eligible to perform the procedure, there will be implications on where beneficiaries can seek out this care and how far they must travel.

The burden of the distance traveled to a hospital providing the needed treatment can significantly impact a patient’s access to care. As has been demonstrated in cancer treatment, as patients travel greater distances to receive care, the disease is more advanced at diagnosis and prognoses and quality of life worsen. The threshold for these poorer outcomes was more than 50 miles or over one hour of travel time.(11) The lack of public transportation and significant physical travel distances are even more acutely felt by a patient population burdened with severe symptoms. Patients participating in the clinical trial were not all located near the trial sites. Some patients reported driving several hours for each visit, having to manage through the physical challenges of lengthy travel. Restrictive hospital volume requirements in a coverage policy will directly correlate with beneficiaries’ ability to access care.

There are unintended consequences of overly restrictive hospital volume requirements on equitable patient access to innovative technologies. For example, research found that during the initial growth phase of transcatheter aortic valve replacement (TAVR) programs in the United States, hospitals serving wealthier patients were more likely to start programs.(12,13) This pattern of growth has led to inequities in the dispersion of TAVR, with lower rates in poorer communities, despite the treatment having been associated with lower mortality rates in patients for whom TAVR would be appropriate.(14) This may be a part of ongoing geographic and socioeconomic disparities in care.(15,16,17)

Distance to the hospital not only impacts the patient, but also the caregivers, family, and friends supporting the patient. Even prior to seeking treatment, caregiver strain increases as patient symptoms worsen. Increasing the distance required to travel for TR treatment further exacerbates this strain and may require overnight stays and time off from work by caregivers.

Edwards evaluated the potential impact of hospital volume requirements for TTVR, specifically to assess the impact on Medicare beneficiaries. Using the Transcatheter Edge-to-Edge Repair for Mitral Valve Regurgitation (M-TEER) hospital volume requirements as an example, we evaluated the impact of requiring hospitals to perform at least 20 M-TEER procedures per year to be eligible to perform TTVR. This requirement results in more than a quarter of Medicare beneficiaries without access (i.e., living in a zip code more than 50 miles from the nearest eligible TTVR hospital). Similarly, of all low-income zip codes, 89% would not have access to TTVR under these hospital volume requirements.

Edwards recommends CMS require hospitals to meet either of the volume requirements outlined in (A) or (B):

This proposed approach, as compared to = 20 M-TEER as a hospital volume requirement, balances the need for patient access with hospital characteristics we believe support positive patient outcomes. Under this proposal, more than 10 million more beneficiaries, a segment of which has TR, would be in geographic proximity to a hospital eligible to provide TTVR. Further, while this approach reduces the disparate impact on low-income beneficiaries by half, Edwards urges CMS to evaluate how other components of this policy can increase access to care for underserved populations.

Table 1. Impact of hospital volume requirements on Medicare beneficiary access

While the impact on patient access is critical to consider when establishing coverage parameters, hospital volume requirements must also appropriately identify hospitals with the experience and infrastructure necessary to successfully perform TTVR. Our recommended hospital volume requirements ensure hospitals performing TTVR have the following necessary experience:

• Transcatheter procedural experience;
• Transcatheter imaging experience; and
• Understanding of the tricuspid valve.

Both M-TEER and TAVR coverage policies require hospitals to have experience providing the corresponding surgical intervention. However, in both cases, surgical experience with each valve was necessary with the introduction of the procedures, as surgery was the only alternative treatment option for the given patient population. Isolated tricuspid valve surgery is rarely performed and is not guideline-directed for patients with TR. As such, we only propose to incorporate explicit tricuspid valve surgical experience into criteria (B), referenced above, and should not be required for a hospital to be eligible to perform TTVR.

Due to the nature of their disease and number of comorbidities, patients with severe TR who are referred by their cardiologists for treatment require intense and frequent healthcare. Based on an internal analysis of an administrative claims and electronic health records database, Edwards estimates that in the first year of being diagnosed with symptomatic, severe TR, a patient has approximately 12 physician office visits. Over the next two years, an untreated patient with symptomatic severe TR will likely at least maintain this same level of healthcare utilization. As such, to reduce the burden on a patient population suffering debilitating symptoms, evaluations for TTVR should be focused and targeted on determining suitability for TTVR.

In determining suitability for TTVR, it is important that either the interventional cardiologist OR the cardiac surgeon on the Heart Team evaluate the patient for anatomical considerations impacting procedural success, such as leaflet morphology, annular dilatation, or right ventricular function. Edwards recommends CMS take a targeted and thoughtful approach in requiring patient evaluation for TTVR. While patient evaluation is critical to ensure effective treatment of TR, overly burdensome evaluation requirements may deter patients from seeking care and may be unnecessary in an already overburdened healthcare system.

After conducting the patient evaluation, the interventional cardiologist or cardiac surgeon on the Heart Team will provide a treatment recommendation to the Heart Team. The Heart Team will guide the treatment of the patient who has been referred for TTVR, in coordination with subspecialists.

As per the 2019 AATS/ACC/ASE/SCAI/STS Expert Consensus Systems of Care Document: A Proposal to Optimize Care for Patients With Valvular Heart Disease, Heart Teams have emerged as the standard of care in managing patients with valvular heart disease and ensure a multi-disciplinary approach to managing structural heart patients pre-, peri-, and post-operatively.(19) The Heart Team approach combines the knowledge of multiple disciplines, such as interventional cardiology, cardiac surgery, and interventional imaging.

Once a patient is identified as a candidate for TTVR, the Heart Team assesses if other specialty consultations are needed, such as consultation with an electrophysiologist for a patient with a pre-existing pacemaker or with a nephrologist for a patient with chronic kidney disease. In current clinical practice and as recommended in the multi-society consensus for treatment of patients with valvular heart disease, Heart Teams regularly consult with specialists as needed.(19)

Edwards endorses the continued and evolving role of the Heart Team and encourages hospitals to consider how to alleviate burdens on both clinicians and patients, where possible. To support this effort, CMS should implement a coverage policy providing flexibilities, where clinically appropriate, in recognition of the relative maturity of Heart Teams.

As CMS considers the coverage policy options for TTVR, we urge the Agency to consider the evolution of clinical practice as it relates to transcatheter therapies. The first transcatheter NCD was implemented in 2012 for the coverage of TAVR. The introduction of this novel transcatheter technology, along with the NCD, drove hospital infrastructure to adapt to providing transcatheter technologies, and clinical practice to evolve to improve outcomes. This once novel procedure has since become a well-established treatment modality that improves the lives of approximately 100,000 patients each year in the United States.(20) Similarly, mitral valve transcatheter technologies and other transcatheter therapies have been incorporated into clinical practice and strengthened the infrastructure of transcatheter procedure offerings in hospitals across the country.

As noted above, hospitals experienced in transcatheter cardiac procedures have mature and well-defined Heart Teams that play a critical role in managing the pre-, peri-, and post-operative care of the patient.

Flexibility in the composition of the Heart Team ensures that finite hospital resources are used appropriately, and each patient receives the most appropriate care. Each patient with TR is unique, with different symptoms, comorbidities, and patient preferences in their treatment. As such, the Heart Team involvement must be calibrated for different patients. For example, the Heart Team caring for a patient with a pre-existing pacemaker or pre-existing conduction system disease may require consultation with an electrophysiologist. However, requiring an electrophysiologist be present for every TTVR case during Heart Team discussions will cause delays in access to treatment. Hospitals should maintain discretion to determine the members of the Heart Team clinically necessary to care for patients undergoing TTVR.

The greatest clinical experience with TTVR has been performed within the context of the TRISCEND II Pivotal Trial. The protocol for the trial did not require an interventional cardiologist and cardiac surgeon to jointly perform the intra-operative components of the TTVR, which has since been reflected in early commercial experience. As such, Edwards recommends CMS implement a coverage policy that requires either an interventional cardiologist or cardiac surgeon perform the intra-operative aspects of TTVR, permitting a second operator when appropriate.

This approach is currently incorporated into the M-TEER coverage policy, in which the policy allows but does not require two operators. The policy states that a second operator may jointly participate in the procedure, as appropriate. Accordingly, some hospitals mandate two physicians jointly perform the M-TEER procedure. This flexibility in coverage policy has ensured that hospitals do not spend redundant resources when not clinically appropriate to ensure patient safety and procedural success. It has also helped to reduce potential barriers due to logistical challenges (e.g., staffing or scheduling) for patients where delays in care may have clinical implications.

Requiring two operators to perform the intra-operative aspects of TTVR may negatively impact patient access to the procedure. Over time, as the procedure matures and procedural demand increases, concurrent shortages of cardiology physicians and thoracic surgeons may present a hurdle to access. The Health Resources & Services Administration (HRSA) anticipates a 15% and 24% shortfall of cardiology physicians and thoracic surgeons, respectively, by 2030, which will continue to worsen.(21) Additional requirements for two operators to participate in the intra-operative aspects of TTVR may delay care for patients seeking TTVR, as well as for patients requiring other care furnished by these specialists.

As both the interventional cardiologist and cardiac surgeon are core members of the Heart Team at every hospital, we believe the collaboration amongst specialists will be maintained in the absence of requiring both to perform the TTVR procedure, and that when patient or institutional needs are better served by two operators this option is preserved.

An NCD is expected to be in place for several years before it is reconsidered. Furthermore, the NCD will apply to beneficiaries insured under Medicare fee-for-service as well as under Medicare Advantage (MA); as of 2024, there are nearly 70 million Medicare beneficiaries in total. Thus, the NCD will be in place for a significant duration of time with relevance for a significant portion of the total US population.

Edwards believes the NCD for TTVR should be appropriate for the entire duration of the NCD. Coverage parameters should optimize patient outcomes and ensure prudent dispersion of the technology, while allowing adequate flexibility for the technology to grow and be adopted throughout the entire duration of the NCD. Edwards estimates that the NCD will be reconsidered in 7+ years, due to the current estimates for when the EVOQUE CED study could be completed, and at which point CMS may have the evidence necessary to establish durable coverage. Edwards believes the NCD should be appropriate for the entire 7+ year period.

One example of how to build flexibility into the NCD is to establish coverage for TTVR when furnished according to an FDA-approved indication instead of explicitly specifying the current indications for use within the policy itself, which is consistent with all previous transcatheter NCDs. This allows the policy to comprehend any changes in the indications without having to reopen the policy, a process that can be lengthy and resource-intensive for CMS and for all involved stakeholders.

Another example of how to build flexibility into the NCD is to establish hospital volume requirements that allow for the technology to be adopted by hospitals that serve broader patient populations than is currently available in the early days of adoption. We believe this NCD under CED should have the appropriate coverage parameters that allows for the continuation of good outcomes and broader adoption for the future. TTVR is currently offered in a limited number of hospitals as hospitals and clinicians gain experience and awareness of the therapy and as Edwards, as the manufacturer, provides the training and support necessary for performing the procedure. In five years, for instance, the maturity of transcatheter programs and awareness of the therapy will have grown, and a broader swath of hospitals will be ready to adopt the procedure. It is important that the coverage policy does not prohibit such adoption. The consequence of this constraint will be patients who are unable to receive treatment for their disease, and potentially inequitable diffusion of the technology, further exacerbating health disparities among underserved populations.

Experience under the NCDs for TAVR and M-TEER indicates that adjusting hospital volume requirements does not lead to rapid growth in the number of hospitals offering the technology; rather, for those technologies there was a steady addition of hospitals offering the therapies despite changes in hospital volume requirements. This is partly due to the rigorous training and experience requirements mandated by Edwards. Unnecessary coverage parameters should be avoided and limit patient access.

Edwards is committed to ongoing evidence generation for the EVOQUE system. In the coming years, Edwards plans to continue reporting follow-up data from the TRISCEND II Pivotal Trial, conducting planned studies using real-world data and executing a post-approval study. Edwards anticipates a broad body of evidence, both sponsored by Edwards and others, will be published over the next several years prior to a reconsideration for durable coverage by CMS. The Society for Thoracic Surgeon (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry has robust data collection that will support a broad body of evidence related to TTVR. In the first 5 years of the TAVR NCD with CED, there were 41 studies published using the TVT Registry data. As demonstrated by the TAVR experience, there is great interest and commitment among the cardiovascular community to grow the body of evidence for novel technologies. Since the Evidence Preview was completed in 2023, there have already been numerous publications related to TR and TTVR. In the last month alone, there have been two publications that provide important information about TR and therapies to treat TR.(22,23)

As a company dedicated to ongoing innovation and evidence generation, Edwards is aligned with CMS’ objectives of improving health outcomes while delivering greater value through an evidence-based coverage policy. Edwards supports an NCD with CED as the coverage pathway for EVOQUE, as timely access to this technology is critical for Medicare beneficiaries with TR. Coverage under the CED pathway is aligned with the principles of Breakthrough technologies, enabling patient access to critical therapeutic options while ensuring ongoing evidence generation.

Consistent with the process articulated in the Proposed Guidance documents for TCET and CED, CMS requires the manufacturer to develop a fit-for-purpose evidence plan for addressing research questions for CED. As such, Edwards submitted a protocol for a study that will use real-world data to fulfill the CED requirements. This study will provide critical insight on the real-world outcomes for TTVR, including outcomes for sub-populations such as sex and race. The completion of this study will serve as the primary basis for a reconsideration of the coverage policy.

Requiring CED studies to have written fully executable protocols aligned with CMS-identified technology-specific research questions creates additional transparency and accountability for evidence generation. We agree with the approach, as outlined in TCET, that all manufacturers with technologies covered under an NCD with CED should be actively participating in the ongoing evidence generation related to a procedure as outlined in the technology-specific EDP.

Further, we support that each technology have its own Evidence Preview conducted by CMS, from which CED research questions may be based. In preparation for coverage of TTVR, the Evidence Preview literature review was specific to publications related to EVOQUE, limiting its applicability to other TTVR technologies. Additionally, it was critical to have the completed Evidence Preview prior to developing the EVOQUE EDP.

Even within a class of similar medical devices, each technology is unique in its target patient population, mechanism of action, and potential adverse events. For example, the EVOQUE valve uses nine anchors to capture the native tricuspid valve leaflets for positioning and deployment. However, other TTVR technologies currently being investigated for the treatment of symptomatic severe tricuspid regurgitation have unique attributes and mechanisms of action.(24) While these technologies intend to treat a similar patient population, during a period of coverage under CED, real-world evidence generation should be required for each of these technologies, answering questions specific to each.

Coverage for technologies within the context of additional clinical trials provides a pathway for ongoing innovation, benefitting patients and clinical outcomes. Additional clinical study is critical for deepening the evidence base for a technology, potentially in expanded indications in populations that would not meet the criteria for coverage and would require findings in these studies to be publicly reported.

Edwards has developed recommendations for a coverage policy for TTVR, which are summarized in the table below. These recommendations were developed based on the principles of:

• Enabling timely and equitable access for Medicare beneficiaries while minimizing patient burden;
• Balancing flexibilities for hospitals and clinicians while optimizing patient outcomes;
• Durability of coverage policy during evidence generation; and
• Commitment to ongoing evidence generation.

As we have demonstrated in our long history of bringing innovative therapies to patients with Medicare coverage, Edwards is committed to the process CMS has defined for such technologies under the NCD with CED pathway. We are acutely aware of the unmet need for patients with TR and encourage CMS to move swiftly and carefully to the next step of establishing a national coverage policy for TTVR, enabling patients’ timely access to this innovation. Thank you for your consideration of our comments.

Sincerely,

/s/
Daveen Chopra
Corporate Vice President and General Manager, Transcatheter Mitral and Tricuspid Therapies (TMTT)
Edwards Lifesciences

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Dear Centers for Medicare & Medicaid Services,

I am writing to strongly advocate for the National Coverage Analysis (NCA) of the EVOQUE tricuspid valve replacement system. This revolutionary technology addresses a tremendous unmet need in the treatment of tricuspid regurgitation, a condition that has long challenged clinicians and significantly impacted patient quality of life.

The EVOQUE system represents a paradigm shift in tricuspid valve treatment. As an experienced operator who has performed over 100 research compassionate use cases using various transcatheter tricuspid therapies, including T-TEER, TTVR, and TricValve, I can attest to the transformative potential of this technology. Our results have been nothing short of amazing, demonstrating significant improvements in patient outcomes and quality of life.

It is crucial to emphasize that the success of this procedure relies heavily on the skill and experience of the operators. Proficiency in M-TEER (Mitral Transcatheter Edge-to-Edge Repair) is essential, as it provides the foundational skills necessary for tricuspid interventions. Furthermore, the procedure should be performed by a comprehensive heart team including a heart failure specialist, electrophysiologist, cardiac imager, and interventional surgeon. This multidisciplinary approach ensures optimal patient selection and procedural outcomes.

TTVR, in particular, has shown to be remarkably user-friendly and consistently delivers excellent results when patients are carefully selected. The reliability and reproducibility of these outcomes make it a game-changer in tricuspid valve treatment.

The available evidence, while still emerging, is extremely promising. Studies have shown significant reductions in tricuspid regurgitation, improvements in right ventricular function, and enhanced quality of life for patients. These results are particularly impressive given the historically poor outcomes and limited treatment options for tricuspid valve disease.

I strongly urge CMS to consider the following in their coverage determination:

The EVOQUE system and similar transcatheter tricuspid therapies represent a beacon of hope for patients who previously had few, if any, viable treatment options. By providing coverage for this technology, Medicare can play a crucial role in advancing cardiovascular care and improving the lives of countless beneficiaries.

Thank you for your consideration of this vitally important matter.

Sincerely,

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