Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

It’s an incredible time to be in structural cardiology. Catheter based therapies are pushing our field forward and allowing our patients to live fuller lives without the morbidity of traditional treatment options.

Tricuspid valve surgery is morbid and carries a high mortality rate. Therefore, patients with this severe valve disorder have historically been undertreated with medical therapy, which is largely limited to diuretics. Clinical trial and registry data now has shown that transcatheter edge to edge repair (TEER) of the tricuspid valve is safe, efficacious and improves quality of life. To be able to offer a safe and effective, minimally invasive catheter based therapy is a BIG deal when we previously were limited to either open heart surgery or loop diuretics. This is the first time structural cardiology has actually developed a treatment that does not compete in a surgical space.

It is my hope that this technology be offered with the input and review of the currently developed Heart Team made up of CV subspecialists (cardiac surgery, heart failure, and especially imagers). However, I do think that requiring face to face evaluation is unnecessary and will limit the ability of this therapy to be offered to many patients who could benefit, particularly in underserved and rural areas.

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I am writing to express my strong support for the establishment of a national coverage decision for TriClip therapy.

This therapy is disruptive and offers hope to a large group of patients that currently have poor or no treatment options. Patients with symptomatic severe tricuspid regurgitation have traditionally been neglected by cardiologists and other specialists and left to have a poor quality of life due to the absence of meaningful treatment options aside from diuretics. These patients are generally very high surgical risk and are not offered surgery. TriClip therapy offers hope and meaningful improvements in the quality of life for these patients, that was not previously available.

The data supporting this therapy is very strong consisting of the randomized pivotal trial TRILUMINATE, which enrolled very quickly mostly during the COVID-19 era, speaking to the great unmet clinical need for these patients. The trial enrolled faster than almost any other trial of a new Structural Heart therapy in recent times. There are also numerous published registries both in the United States and outside the United States, supporting the efficacy of the therapy. Finally, this therapy has been approved in Europe since April 2020.

Since FDA commercial approval in April 2024, we have seen a great need for this therapy and there have been a large number of referrals to our center for this therapy, at times exceeding the number of referrals for transcatheter mitral repair with MitraClip.

In summary, it is critical that we have a national coverage decision for TriClip therapy which will allow for fair reimbursement, given the complexity of managing these patients and the particular advanced technical and imaging requirements of the procedure.

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TriClip represents the first of therapies available for treatment of patients with debilitating HF symptoms despite optimal medical therapy and severe tricuspid regurgitation. These patients suffer chronically and chores such as bending over and tying shoelaces and/or walking at the park with their grandchildren are prohibitive chores. In the eyes of insurance carriers and coverage determination these limitations are often overlooked, for more "harder" endpoints such as HF hospitalization and/or mortality. but for the patients we care for on a day in - day out basis, these limitations are far more tangible andan immediate threat to their quality of life. Having therapies such as T-TEER, which is safe, and effective in reducing these important patient-centered limitations is critical. The rigorous clinical data clearly supports the notion of patient centric symptom improvement and more recent contemporary data suggests that in carefully selected patients there may even be HF hospitalization reduction. The coverage determination should allow for
1. Rapid and equitable treatment of patients with severe TR as identified in the clinical trials
2. TR therapy should be provided after a thorough assessment of TR as the sole potential culprit and not a bystander (e.g. secondary to P-HTN).
3. A thorough assessment should consist of advanced imaging and hemodynamic studies
4. There is no role for surgical evaluation (i.e. "surgical sign off) in the treatment of T-TEER patients as isolated TV surgery is not a viable option and the mandate of a surgical evaluation will only service to delay care for these symptomatic patients.
5. Those patients undergoing isolated TV repair/replacement should first have a Heart Team evaluation and have been offered or declined from transcatheter therapies given the safety profile relative to surgery. This would be a missed opportunity not to prevent unnecessary isolated TV repair/replacement without a formal Heart Team evaluation
6. As it relates to treatment of TR, a Heart Team SDM is important and should include a member that has experience in the management of HF and valvular heart disease. A surgeons perspective is important, but not a mandate.
7. Implanting centers should have metrics monitored to ensure that appropriate patient selection and outcomes are being maintained. Centers not maintaining certain cadence and/or outcomes should be encouraged to refer to Heart Valve Centers capable of evaluating and providing higher quality outcomes. The coverage determination should emphasize not just the acute/short term treatment, but the treatment should be offered so long term durability is take into consideration - this is often best provided by centers/teams with considerable experience.

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T TEER has provided an opportunity to provide patients with tricuspid regurgitation a dramatic improvement in over all well being with very high success rate with a very low risk and complication rates. TR is a very insidious disease process that affects every part of the patient's life. Although no mortality benefit was noted the quality of life dramatically improved. I look at this similar to having a hip replacement. No morality benefit would be expected with having a hip replaced but the patient would feel better hip less pain, which would translate to better ambulation and quality of life

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As a practicing physician specializing in cardiology, I would like to express my support for the inclusion of tricuspid transcatheter edge-to-edge repair (TEER) in the National Coverage Decision. This innovative procedure represents a significant advancement in the management of patients with symptomatic tricuspid regurgitation, particularly those who are deemed high-risk for open-heart surgery and continue to have life limiting symptoms despite optimal medical treatment.

Recent clinical studies have demonstrated that TEER provides meaningful improvements in patient symptoms, functional capacity, and quality of life, with a favorable safety profile. Many of my patients suffer from heart failure symptoms due to tricuspid regurgitation, which can be debilitating and challenging to manage with conventional therapies alone. The ability to offer a less invasive option can lead to better outcomes for these individuals.

Moreover, expanding coverage for this procedure aligns with the goal of providing patient-centered care and ensuring that high-risk patients have access to potentially life-saving treatments. It is imperative that we recognize the evolving landscape of cardiovascular interventions and the need for timely access to new technologies.

I urge CMS to consider the evidence supporting the efficacy and safety of tricuspid TEER and to make this procedure widely available to patients in need.

Thank you for your attention to this important matter.

Sincerely,
Andrew Goodman, MD
Chair, Cardiovascular Medicine
Catheterization Laboratory Director
TriStar Centennial Medical Center
Nashville, TN
615-613-3462

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T TEER has provided significant symptom improvement to my patients, less lower extremity edema SOB and less hospitalizations with better quality of life.

Despite being FDA Approved, and the urge for better medical care to all our patients, we are struggling with compensation. Those are long procedures averaging 2-3 hrs. Amd sometimes longer. No work RVUs yet is identified to compensate for the physician time and effort. None of the cases we did so far is yet compensated as of this very moment. If this continues, This could be huge obstacle for us and patients.

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TR is a serious condition with significant clinical implications for our patients. For years, many individuals with symptomatic TR, especially those deemed high-risk for surgical valve repair or replacement, have had to endure a poor quality of life with only limited goal-directed medical therapy options. The adaptation of TEER for TR builds on the established success of this technology in treating mitral regurgitation, representing an important advancement in addressing this unmet medical need. Given the high morbidity associated with untreated TR, T-TEER holds the potential to provide substantial benefits to a patient population with few alternative therapies.

This NCA presents a timely opportunity to evaluate the clinical indications for T-TEER in Medicare beneficiaries. Evidence of improvements in patients' functional capacity and quality of life are critical to care pathways and cannot be undervalued. Continued research into whether T-TEER reduces mortality and decreases hospital admissions in the long term is essential.

An equally important aspect of this conversation around a minimally invasive, device-based therapy for TR is the demand for advanced imaging support, which is vital for this therapy and the broader structural heart space. Invasive echocardiography is necessary for the success of T-TEER, and the innovation and technical expertise of advanced imaging specialists (echocardiographers) play a crucial role in supporting this technology, optimizing outcomes, and shaping future therapies.

Furthermore, I urge CMS to consider health equity factors as part of this review. TR disproportionately impacts vulnerable populations, including those with limited access to care. Ensuring coverage for T-TEER could significantly improve outcomes in communities traditionally underserved in cardiovascular healthcare.

Thank you for the opportunity to contribute to this important discussion on expanding access to advanced technology and imaging support for TR management among Medicare beneficiaries.

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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 Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)

Thank you for the opportunity to comment on the National Coverage Analysis (NCA) for Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER).

Edwards Lifesciences (“Edwards”) supports the opening of this NCA. We support NCD with CED as the coverage pathway for breakthrough innovations, including T-TEER devices, which can enable timely and equitable patient access to critical therapeutic options while ensuring ongoing evidence generation.

The addition of T-TEER alongside Transcatheter Tricuspid Valve Replacement (TTVR) marks the beginning of a paradigm shift in the treatment of tricuspid regurgitation. In the United States, more than 1.5 million people suffer from significant TR (moderate and above).(1,2) Patients with severe TR suffer from significant and frequent symptoms affecting their everyday lives, including edema, ascites, shortness of breath, and chest pain which significantly impact their ability to care for themselves and to participate in everyday activities.

Policy considerations

Coverage to label

We encourage CMS to cover T-TEER for the treatment of TR when performed according to the FDA-approved indication. Incorporating language specific to currently approved indications could unintentionally exclude future labeled indications and future devices from coverage or require CMS to reopen the NCD prematurely, resulting in potential delays in patient access.

Non-FDA Approved Indications

Provision should include coverage for technologies within the context of additional clinical trials, providing a pathway for ongoing innovation. Additional clinical trials are necessary for deepening the evidence base for a technology, as well as for studying expanded indications in populations that would not meet the criteria for coverage.

Evidence supporting the benefits of T-TEER in the Treatment of TR

We would like to offer additional data sources in support of your analysis. PASCAL TR is currently being studied in the US for the treatment of severe tricuspid regurgitation. The CLASP II TR pivotal trial includes randomized and registry arms, as well as a roll-in cohort (https://clinicaltrials.gov/study/NCT04097145). There are also other completed, ongoing, and planned studies examining the performance of PASCAL TR as a treatment for severe tricuspid regurgitation, both in the United States and in Europe (3-10).

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

Citations

1. Cahill TJ, Prothero A, Wilson J, et al. Community prevalence, mechanisms and outcome of mitral or tricuspid regurgitation. Heart. 2021;doi:10.1136/heartjnl-2020-318482
2. U.S. Census Bureau (2021). American Community Survey 1-year Estimates.
3. Kodali S, et al. Feasibility study of the transcatheter valve repair system for severe tricuspid regurgitation. J Am Coll Cardiol. 2021;77:345-356.
4. Kodali S, et al. 1-Year Outcomes of Transcatheter Tricuspid Valve Repair. J Am Coll Cardiol. 2023;81(18):1766-1776.
5. Batchelor W, et al. CLASP TR EFS 1-Year Results: Coming of Age of Tricuspid Valve Edge-to-Edge Repair? J Am Coll Cardiol. 2023;81(18):1777-1779.
6. Baldus S, et al. Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results. Catheter Cardiovasc Interv. 2022;100:1291-1299.
7. Fam NP, et al. Transcatheter tricuspid valve repair with the PASCAL system. JACC Cardiovasc Interv. 2018;11:407-408.
8. Fam NP, et al. Compassionate use of the PASCAL transcatheter valve repair system for severe tricuspid regurgitation: A multicenter, observational, first-in-human experience. JACC Cardiovasc Interv. 2019;12:2488-2495.
9. Kitamura M, et al. 12-month outcomes of transcatheter tricuspid valve repair with the PASCAL system for severe tricuspid regurgitation. Catheter Cardiovasc Interv. 2021;97:1281-1289.
10. Gercek M, et al. Characterization of Screen Failures Among Patients Evaluated for Transcatheter Tricuspid Valve Repair (TriSelect-Study). JACC Cardiovasc Interv. 2023;16:1579-1589.

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The Tricuspid TEER NCD should be carefully thought out and avoid the pitfalls of the Mitral TEER NCD.

1. First, the tricuspid valve repair is an order of magnitude more difficult than mitral repair. It requires more time and is imaging intensive.
- we should not specify the qualifications and imaging requirements. In the mitral imaging it requires a cardiologist or separate anesthesiologist to perform the imaging. A technician can also be taught this skill and under supervision can provide adequate support. Not every institution is an academic center where imaging physicians can provide essentially free imaging without adequate compensation for time. Echo technicians (with supervision) can reduce this cost but are not allowed by the current mitral TEER NCD. This will make the procedure available to a larger geography.
- adequate compensation should be set for 4D ICE (intracardiac echocardiogram) or TEE imaging for physicians. If the primary operator uses ICE only then the physician should be compensated.

2. Due to the complexity of the procedure and time commitment, reimbursement for the procedure should depend on the number of clips required.

3. Due to the complexity of the procedure and time commitment, the procedure should be limited to sites that meet CMS requirements for Mitral TEER and can do an adequate number of procedures a year. Sites should have a minimum volume to maintain their status. Ideal should be at least 2 per month over an adequate period of time.

4. Again the procedure should have a heart team approach and have surgical consent as well.

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The treatment of Tricuspid valve disease lags far behind the treatments available for mitral and aortic valve disease. This is partly due to an erroneous belief that the tricuspid valve is un-important and partly because surgical interventions carries an unacceptably high mortality rate. Current published reports have placed surgical mortality at between 8% and 12%.

We are learning that right heart failure is a severely debilitating disease with very poor treatment options and high treatment mortality. The quality of life for individuals with right heart failure is poor and mortality is very high. One year mortality with severe in may be as high as 35%. Severe Tricuspid regurgitation is associated multiple problems that affects quality of life including Right heart failure with untreatable and life limiting symptoms including un-treatable edema, liver failure, reduced functional capacity and high re-admission rates.

TEER does improve quality of life and is a way to offer treatment to people with very limited other options because of high surgical and medical mortality and morbidity rates. Although mortality, was not substantially affected in recent Trials improved quality of life was. I believe the lack mortality benefit likely reflects the consequences of delayed intervention rather than the lack of efficacy from the procedure. Make no mistake, low risk ability to improve quality of life is a huge advancement in and of itself.

TEER of the tricuspid vale will change and improve lives with acceptable procedural risk and I believe will eventually show a mortality benefit when intervention is preformed early in the disease process.

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Dear Ms. Syrek Jensen,

Boston Scientific Corporation commends and supports CMS on the initiation of a national coverage analysis (NCA) for Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER). BSC is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We develop and supply medical devices in numerous clinical areas, including cardiology, which serve the needs of many patients, including Medicare beneficiaries. We offer the following comments in response to CMS’s request for public comment to the NCA for T-TEER.

T-TEER is used to treat patients with severe tricuspid regurgitation (TR), and its use can significantly impact patient outcomes, including improving quality of life and reducing tricuspid regurgitation. Among Medicare beneficiaries, severe TR is highly prevalent, affecting 10.1% of those aged 66–75 and increasing to 22.3% in those over the age of 75.

Historically, treatment options for the TR population have been limited to medical therapies, such as diuretics, digoxin, and angiotensin-converting enzyme inhibitors. Surgical interventions are rarely performed in these cases. T-TEER, which was recently approved by the US Food and Drug Administration (FDA), offers the opportunity to improve quality of life and functional status in patients with symptomatic severe tricuspid regurgitation.

BSC appreciates the opportunity to comment. Please reach out with any questions via email: liesl.hargens@bsci.com or phone: (612) 300-5829.

Sincerely,

Liesl Hargens
Vice President, Global Health Economics & Market Access
Boston Scientific

References:
1. Sorajja P, Whisenant B, Hamid N, Naik H, Makkar R, Tadros P, Price MJ, Singh G, Fam N, Kar S, Schwartz JG, Mehta S, Bae R, Sekaran N, Warner T, Makar M, Zorn G, Spinner EM, Trusty PM, Benza R, Jorde U, McCarthy P, Thourani V, Tang GHL, Hahn RT, Adams DH; TRILUMINATE Pivotal Investigators. Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. 2023;388(20):1833-1842.
2. Zheng J, Yu X, Zhou D, Fan M, Lin Z, Chen J. Prevalence and contributing factors associated with tricuspid regurgitation among patients underwent echocardiography assessment. BMC Cardiovasc Disord. 2024;24(1):552.
3. Mary C Mancini, MD, PhD, MMM. Tricuspid Regurgitation Medication. The heart.org Medscape. Updated Nov 05, 2021. Accessed November 1, 2024. https://emedicine.medscape.com/article/158484-medication?form=fpf.
4. Uncovering the Best Approaches for Isolated Tricuspid Valve Surgery. The Society of Thoracic Surgeons. January 22, 2023. Accessed November 1, 2024. https://www.sts.org/news/uncovering-best-approaches-isolated-tricuspid-valve-surgery#:~:text=From%20the%20Adult%20Cardiac%20Surgery,-Sinai%2C%20in%20this%20study.

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

RE: CAG-00468N Tricuspid Valve Transcatheter Edge-to-Edge Repair (T-TEER)

Dear Ms. Syrek Jensen:

Abbott welcomes the opportunity to comment on the National Coverage Analysis (NCA) for T-TEER, CAG-00468N.

Abbott believes establishing a national coverage policy for T-TEER with the TriClip™ TEER System will ensure predictable and consistent coverage for all Medicare beneficiaries to this FDA-designated Breakthrough Device. Abbott has worked collaboratively with CMS to best define the evidentiary requirements to support a National Coverage Determination (NCD) for T-TEER with the TriClip TEER System through the FDA-CMS Parallel Review Program and as a Transitional Coverage of Emerging Technology (TCET) pilot. This submission builds on the topics addressed in Abbott’s NCD request letter and includes recommendations to promote transparency in the coverage process and expedited access to FDA-approved breakthrough therapies. Specifically, Abbott requests that CMS consider:

1) Adopting an expedited timeline for publication of a Proposed NCD for T-TEER, and
2) Drafting the NCD with appropriate flexibility to account for continued advancement in this therapeutic area while promoting equitable patient access.

These recommendations are discussed below.

TriClip T-TEER System

Abbott’s TriClip TEER System received FDA approval on April 1, 2024, for the improvement of quality of life and functional status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce TR severity to moderate or less, as determined by a multidisciplinary heart team.

TriClip leverages the same clip-based technology as Abbott’s industry-leading MitraClip device, which in the past 20 years has treated more than 200,000 people with mitral regurgitation.

With more than 10,000 patients treated with the TriClip TEER System, the evidence shows that the therapy is safe, that TR reduction is effective and sustained, and that patients experience a significant improvement in quality of life [1,2,3,4,5]. This is substantiated by the TRILUMINATE Pivotal Trial [3] which demonstrated superiority over optimal medical therapy (OMT) alone, showed favorable safety and effectiveness outcomes, and met its primary endpoints in an elderly population (average age ~78 years) with significant frailties and co-morbidities. Key findings in the trials included marked reduction of TR, significant and sustained quality of life improvement, and a favorable balance between risk and benefit [3,5]. Notably, the device arm of the full randomized cohort from the TRILUMINATE Pivotal Trial had 0% in-hospital mortality, 0.4% cardiovascular mortality at 30 days, and 98.9% freedom from major adverse events [5]. In addition, published one-year results from the bRIGHT study support that the TriClip TEER System is safe and effective in a real-world population [6]. A summary of the clinical evidence for the TriClip TEER System can be found in the Summary of Safety and Effectiveness Data (SSED) on the FDA website.

Tricuspid Regurgitation

Tricuspid valve disease is a progressive condition with limited treatment options. Current standards of care are unable to meet the rising challenge of managing 1.6 million patients with moderate or greater TR in the United States [7,8].. Symptoms associated with TR, generally those of right-sided heart failure, include ascites, peripheral edema, hepatomegaly, decreased appetite, jugular vein enlargement, and/or abdominal fullness. For many patients, TR is not just associated with clinical symptoms, but it also translates into everything from movement difficulties to a lack of energy, negatively impacting their quality of life.

Current guideline-recommended treatments for tricuspid regurgitation involve medical therapy (focusing on improving TR symptoms [9]) or surgery - however, surgery for isolated TR is rarely performed. Although the ACC/AHA Guidelines list surgical intervention as a Class I recommendation if the patient has concomitant left-sided heart disease, it is not highly recommended to treat isolated TR due to high operative mortality risk [10]. In fact, in-hospital mortality nears 10% in the largest studies with patients ranging in age from 55 to 65 years, with high rates of cardiogenic shock (6.2% ? 19%), acute renal failure (5.3% ? 26.5%), and the need for new permanent pacemaker implantation (10.8% ? 26%) [11,12,13,14]. The most recent publication from the STS database reported case counts for isolated surgical intervention for TR has modestly decreased from 2,492 cases in 2018 to 2,035 cases in 2022 in a population whose average age was between 45 and 52 years [15]. Furthermore, the operative mortality for tricuspid valve repair and replacement for TR patients without endocarditis in this study remains elevated at 6.2% and 7.1%, respectively. As such, the low surgical volumes and high operative mortality in this young population indicate significant unmet clinical need, leaving many patients untreated. Medical therapy (diuretics) relieves systemic congestion and alleviates symptoms but is often inadequate in reducing TR [10].

The TriClip TEER System addresses an unmet need by offering a safe and effective minimally invasive option to treat TR.

Request for Expedited Timeline to Proposed NCD for T-TEER

Medicare patients, including those enrolled in Medicare Advantage plans, lack consistent access to the safe and effective TriClip TEER System because of the absence of an NCD. Abbott believes that an NCD outlining appropriate coverage standards for T-TEER would enable treating physicians, and multi-disciplinary heart teams, to offer the breakthrough TriClip TEER System based on the patient’s clinical profile and individual benefit-risk assessment regarding available treatment options.

Abbott has collaborated with CMS to define the evidence necessary to support an NCD for T-TEER with the TriClip TEER System through the FDA-CMS Parallel Review Program and as a TCET pilot. The TCET pilot process applied the principles that are outlined in the CMS guidance documents applicable to the TCET pathway, National Coverage Analysis Evidence Review, and Coverage with Evidence Development (CED). This process included the following major components:

Evidence Preview: A systematic literature review providing feedback on the strengths and weaknesses of the publicly available evidence.

Evidence Development Plan (EDP): Plan for conducting clinical and real-world evidence studies to meet the requirements for CED.

As the NCA process continues, Abbott requests that CMS leverage the time spent, and insights gained evaluating the TriClip TEER System clinical evidence through the Evidence Preview and EDP, to expedite a Proposed NCD and ultimately a Final NCD.

Prioritize Policy Flexibility to Ensure Equitable Patient Access

NCDs with CED are often in effect without change for many years. This reality makes it critical that CMS consider potential developments in the field and avoid unintended access restrictions or negative impact on clinical practice evolution due to overly specific coverage criteria.

Restrictive requirements imposed on hospitals as a condition of NCD CED coverage can reduce the availability of safe and medically necessary care and unintentionally hinder equitable patient access to innovative technologies. For example, the difficulty of traveling to an eligible hospital impacts not only the patient, but also their caregivers and families, often necessitating overnight stays and time off work. Likewise, highly specific procedure requirements may not adequately support evolving clinical practice.

In this spirit, Abbott believes that the following considerations will move us toward the shared goal of addressing a clinical unmet need and ensuring appropriate Medicare beneficiary access to this safe therapy:

Prioritize TEER infrastructure (multidisciplinary heart team, imaging training, and TEER experience) over surgical volumes for site requirements, given the relevance of M-TEER expertise (note that in the TRILUMINATE Pivotal trial, tricuspid valve surgical volume was not a requirement for trial sites).

Consider supporting more accessible care delivery, given the age, co-morbidities of this population, and the exceptional safety of TriClip therapy.

Embrace diverse and emerging modalities for intraprocedural imaging.

Permit, but do not require, co-implanters.

Advocate for patient management and care delivery specificity guided by the care team (e.g., anesthesia services restrictions) rather than prescriptive requirements.

Abbott thanks CMS for its focus on developing a coverage policy for T-TEER that will ensure Medicare beneficiaries can access the Breakthrough TriClip TEER System and benefit from this advancement in cardiac care.

Thank you for your consideration of our comments.

Sincerely,
Arthi Chandran
DVP Health Economics and Reimbursement
Abbott Medical Devices

References
(1) Lurz P, von Bardeleben RS, Weber M, Sitges M, Sorajja P, Hausleiter J, et al. Transcatheter Edge-to-Edge Repair for Treatment of Tricuspid Regurgitation. J Am Coll Cardiol. 2021;77(3):229-39.
(2) von Bardeleben RS, Lurz P, Sorajja P, et al. Two-Year Outcomes for Tricuspid Repair With a Transcatheter Edge-to-Edge Valve Repair From the Transatlantic TRILUMINATE Trial. Circulation. Cardiovascular interventions. 2023; 16(8), e012888.
(3) Sorajja P, Whisenant B, Hamid N, Naik H, Makkar R, Tadros P, et al., Transcatheter Repair for Patients with Tricuspid Regurgitation. New England Journal of Medicine. 2023; 388:1833-1842.
(4) 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.
(5) Tang G, Hahn R, Whisenant B, et al. Tricuspid transcatheter edge-to-edge repair for severe tricuspid regurgitation: 1-year outcomes from the TRILUMINATE randomized cohort. J Am Coll Cardiol. Oct 27, 2024; Epublished DOI: 10.1016/j.jacc.2024.10.086
(6) Lurz P, Rommel K, Schmitz T, et al. Real-World 1-Year Results of Tricuspid Edge-to-Edge Repair From the bRIGHT Study. . J Am Coll Cardiol. Volume 84, Issue 7; 2024, Pages 607-616
(7) Stuge et al. Emerging opportunities for cardiac surgeons within structural heart disease. J Thorac Cardiovasc Surg. 2006; 132 (6) p.1258-1261
(8) Leviner et al. Tricuspid Valve Replacement: The Effect of Gender on Operative Results. The Journal of Heart Valve Disease 2014; 23:209-215
(9) Rogers et al. The tricuspid valve. Circulation 2009; 119:2718-25
(10) Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol 2021; 77: 450-500.
(11) Zack CJ, Fender EA, Chandrashekar P, et al. National Trends and Outcomes in Isolated Tricuspid Valve Surgery. J Am Coll Cardiol. 2017;70(24):2953-2960. doi:10.1016/j.jacc.2017.10.039
(12) Hamandi M, Smith RL, Ryan WH, et al. Outcomes of Isolated Tricuspid Valve Surgery Have Improved in the Modern Era. Ann Thorac Surg. 2019;108(1):11-15. doi:10.1016/j.athoracsur.2019.03.004
(13) Dreyfus J, Flagiello M, Bazire B, et al. Isolated tricuspid valve surgery: impact of aetiology and clinical presentation on outcomes. Eur Heart J. 2020;41(45):4304-4317. doi:10.1093/eurheartj/ehaa643
(14) 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 (15) Thourani VH, Bonnell L, Wyler von Ballmoos MC, Mehaffey JH, Bowdish M, Kurlansky P, Jacobs JP, O'Brien S, Shahian DM, Badhwar V. Outcomes of Isolated Tricuspid Valve Surgery: A Society of Thoracic Surgeons Analysis and Risk Model. Ann Thorac Surg. 2024 Oct;118(4):873-881. doi: 10.1016/j.athoracsur.2024.04.014.

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To whom this may concern:

I have been performing transcatheter valve interventons for more than 30 years, startng with balloon mitral valvuloplasty in the 1990s and progressing to transcatheter aortc valve replacement (TAVR) and mitral transcatheter edge-to-edge repair (M-TEER) in the past decade and most recently to transcatheter tricuspid valve interventons. In additon to my clinical experience with these procedures, I have also been closely involved in research in catheter-based interventons for valvular heart disease—having designed and directed the quality of life substudies of many of the pivotal randomized trials in this space.

Based on both my clinical and research experience, I believe that tricuspid edge-to-edge repair (T-TEER) for treatment of tricuspid regurgitaton meets the “reasonable and necessary” criterion for Medicare coverage and am strongly in favor of a natonal coverage determinaton for T-TEER to ensure access to this procedure for Medicare beneficiaries.

There are many reasons why T-TEER should be covered for all Medicare beneficiaries:

1. Tricuspid regurgitaton is common, partcularly among older patents—frequently as a consequence of longstanding atrial fibrillaton, right ventricular dysfuncton, and increasingly due to structural valve damage from other cardiac implants such as pacemaker and defibrillator leads.
2. Severe tricuspid regurgitaton can lead to debilitatng symptoms including breathlessness, fatgue, and lower extremity and abdominal swelling—all of which can lead to functonal limitatons and poor quality of life.
3. Many older patents (including Medicare beneficiaries) place a high value on treatments that improve their quality of life and are less concerned with prolongaton of life.
4. Currently available medical therapy for severe tricuspid regurgitaton is limited to diuretcs, and surgical valve repair or replacement are performed infrequently—partcularly in older patents. Thus, patents with tricuspid regurgitaton have few therapeutc optons.
5. Based on the pivotal TRIUMINATE trial, treatment of severe tricuspid regurgitaton with T-TEER results in significant improvement in tricuspid regurgitaton and substantal improvement in symptoms, functonal status, and quality of life (QOL) compared with medical therapy alone. The magnitude of improvement across these domains is similar to what has been seen with other interventons for valvular heart disease such as TAVR and M-TEER.
6. Although the TRILUMINATE Pivotal Trial was not blinded, there are several lines of evidence that strongly suggest that the QOL benefits of T-TEER are biologically mediated beyond what might be expected from a placebo effect. Specifically, the magnitude of benefit and the durability of benefit are strongly suggestve of a true effect. Most importantly, we have found that the degree of QOL improvement with T-TEER is directly related to the degree of reducton in TR—a “dose-response” effect that is unlikely to occur with a placebo.

Based on all of these consideratons as well as my personal experience with treatng patents with severe TR, it is clear to me that T-TEER is both reasonable and necessary in order to improve the quality of life and functonal status of patents with severe TR. To ensure access to this therapy to all Medicare beneficiaries, it is critcal that Medicare cover T-TEER and provide appropriate reimbursement to both hospitals and to the physicians who perform these procedures (including the device implanter, structural imager, and cardiac anesthesiologist).

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Previously, tricuspid regurgitation was thought of as a disease that was unable to be treated with no clinical benefit of surgical intervention. Owing to the particularly ill patient population, there was both high morbidity and mortality associated with isolated tricuspid surgical treatment. Tricuspid transcatheter edge-to-edge repair (TEER) offers a treatment option to patients that is safe, effective, and reproducible. Importantly, morbidity associated with this therapy is quite low and patients have an option for true clinical and lifestyle benefits.

While current trials have not reflected mortality benefits, many would argue that outcomes such as mortality and heart failure hospitalizations need to be evaluated on a much longer term basis (ie more than 1 year followup in present studies). Importantly, patients in our center’s are experience have significant symptom improvement with a reduction in the need for “palliative therapies” such as diuretics. Furthermore, patient selection plays a key role and (when offered to patients early in the disease process) our center has witnessed remarkable clinical improvements in our patient population on a longer term basis.

Equally important is the nature of this technology. In operators with competence with mitral TEER, we find that tricuspid TEER is remarkably safe and particularly safe. There is very little “downside” to offering this therapy in patients that are likely to derive clinical benefit.

Overall, this therapy is safe, effective, and offers clinical benefits to a previously “untreatable” patient population.

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Tricuspid transcatheter edge-to-edge repair using the Abbott TriClip device represents a giant step forward in the ongoing fight against vascular heart disease. The tricuspid valve has long been overlooked as a therapeutic target for patient who suffer daily with dyspnea and fatigue. Surgical treatment as an isolated procedure outside the context of endocarditis has limited data and not widely accepted as a reasonable therapy. Furthermore, surgical Tricuspid valve replacement and repair is associated with high surgical risk as an isolated procedure.

t-TEER is an ideal therapy to be performed by interventional cardiologist for patient suffering from symptoms associated with severe tricuspid regurgitation. Surgeons, who have not been in a space from decades now, have no role in the Pre-procedural or intraprocedural portion Of these patients treatment. A heart failure cardiologist needs to be on the heart team regarding t-TEER.

This device is very expensive and needs to be reimbursed at rates exceeding those currently for m-TEER so that patients may have access to this procedure.

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I am writing in support for the coverage of tricuspid TEER, as a structural cardiologist, based on the current available literature. It has been called " forgotten valve" for years because of the challenging surgical options to address this condition. We finally have the ability to offer minimally invasive procedure with relatively low risk compared to surgery. Patients we treat on a daily basis inquired about quality of life more than anything else. Imaging is a big component and it would help to revisit the reimbursement part for the imaging cardiologist as they are the key for a successful T-TEER. I think patients with severe tricuspid regurgitation and evidence of Group 1 and possibly group 3 pulmonary hypertension need to be evaluated by pulmonary team to optimize their pulmonary condition prior to being offered T-TEER therapy.

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We appreciate the opportunity to comment on the request for coverage for tricuspid valve transcatheter edge-to-edge repair (T-TEER) for tricuspid regurgitation (TR) for Medicare beneficiaries. Based on the currently available evidence, we firmly believe that T-TEER has not been shown to provide any meaningful clinical benefit to Medicare beneficiaries and thus does not meet the “reasonable and necessary” criteria. Therefore we strongly recommend that T-TEER not receive Medicare coverage in the interests of protecting Medicare beneficiaries from the harms of this procedure with no clinical benefit.

Lack of Evidence of Benefit

T-TEER has not been shown to improve clinically meaningful outcomes, such as reduction of mortality, tricuspid valve surgeries, or hospitalizations for heart failure. The TRILUMINATE Pivotal trial, which served as the basis for FDA’s approval of TriClip, the only currently FDA-approved T-TEER device, found no difference in time to all-cause mortality or tricuspid valve surgery between the T-TEER and control groups at 12 months, and annualized rate of hospitalization for heart failure was numerically higher for the T-TEER group in the primary analysis population. A recently published updated analysis of TRILUMINATE Pivotal results that included a subsequently enrolled cohort also showed no difference in all-cause mortality and tricuspid valve surgery or heart failure hospitalizations between the T-TEER and control groups.

While there was a statistically significant increase in the mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score and improvement in 6-minute walk distance (6MWD) for the T-TEER group, the meaningfulness of these findings is nil as patients were not blinded to their treatment status, and therefore these findings actually measure a large placebo effect, which has been well-established for all medical procedures.

While the TRILUMINATE Pivotal study investigators argue that the association of TR grade reduction with improvement in KCCQ score and 6MWD provides evidence of functional improvement resulting from T-TEER, we do not agree. TR grade is subjective in the best of circumstances, and in this trial, TR grade suffers from bias as the TriClip device is clearly visible to those reading the echocardiograms. Additionally, KCCQ and 6MWD are similarly biased in an unblinded trial. The clinical benefits, if any of T-TEER, await a new blinded trial with a placebo arm or an RCT that is powered to objective endpoints, such as all-cause mortality. The underlying premise that T-TEER would lead to clinical improvement is not grounded in physiology, unfortunately. TR occurs due to right ventricular dilatation, which either occurs from right ventricular failure, which is the end stage of congestive heart failure of any cause, or from pulmonary hypertension. The underlying conditions of end stage heart failure with right ventricular failure or pulmonary hypertension are not addressed or improved by repair (or replacement) of the tricuspid valve. The reduction of TR grade in TRILUMINATE Pivotal is not meaningful to Medicare beneficiaries as it did not translate into mortality benefit or reduced heart failure hospitalizations. Thus, this procedure is unlikely to benefit Medicare beneficiaries with TR.

Evidence of Potential Harms

The safety data for T-TEER at 12 months from the TRILUMINATE Pivotal trial raises serious concerns. While there were no statistically significant differences, patients in the T-TEER group had numerically higher rates for multiple critical safety outcomes. In the full randomized cohort, patients receiving T-TEER had a numerically higher rate of cardiovascular death (5.8% v. 4.0%), including heart failure-related death (4.4% vs. 2.9%). All-cause mortality (8.6% vs. 8.0%) and hospitalizations (35.3% v. 34.2%) were also numerically higher in the T-TEER group. In the primary analysis population, there were higher rates of heart failure hospitalizations (14.9% v. 12.1%) and major bleeding (5.2% v. 1.1%) in the T-TEER group. Furthermore, patients receiving T-TEER in the primary analysis population had a higher rate of any serious adverse event at 12 months compared to those in the control group (48.0% v. 41.1%), including a higher rate of cardiac serious adverse events (26.9% v. 21.7%).

The TRILUMINATE Pivotal trial has also specified two 24-month outcomes—“Recurrent Heart Failure Hospitalizations at 24 Months” and “Freedom from All-Cause Mortality, Tricuspid Valve Surgery and Tricuspid Valve Intervention at 24 Months”—whose data were not available in its associated publications and are not currently available on its ClinicalTrials.gov webpage. Since T-TEER devices are permanently implanted, the results from these longer-terms outcomes, when available, should factor into the coverage decision. Coverage decisions should be based on clinically meaningful data, meaning all-cause mortality, the only objective endpoint in this unblinded trial. Alternatively, a second RCT should be done (2 RCTs should be the standard) which is blinded with a sham control, if the sponsor wishes to use a quality-of-life endpoint. QOL is certainly important, but highly subjective and must be measured only in high-quality, rigorously blinded trials.

Conclusion

T-TEER has not been shown to improve mortality or heart failure hospitalizations, and an improvement in a self-reported quality of life measure in an unblinded study is not a clinically meaningful benefit. The available evidence—including numerically higher rates of all-cause mortality, cardiovascular mortality, and hospitalizations—suggests that Medicare beneficiaries are more likely to be harmed by T-TEER coverage than reap any benefits. Consequently, coverage of T-TEER is not reasonable and necessary for Medicare beneficiaries, and we strongly recommend that CMS not cover T-TEER.

Sincerely,

Rita F. Redberg, MD MSc
Sarah Bitter, MA

References
i. www.doi.org/10.1056/NEJMoa2300525
ii. https://www.fda.gov/media/176091/download
iii. www.doi.org/10.1016/j.jacc.2024.10.089
iv. www.doi.org/10.1056/NEJMp1406388
v. www.doi.org/10.1016/j.jacc.2024.10.089

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Tricuspid transcatheter edge-to-edge repair (T-TEER) is currently FDA approved for treatment of symptomatic severe tricuspid regurgitation. This is a significant advancement in the management of these patients as there were no non-surgical options a year ago. The TRILUMINATE trial showed that T-TEER was associated with improvement in quality of life (KCCQ score) as compared to medical therapy alone. At the same time, the procedure was safe with a very low incidence of adverse events. Quality of life is very important for patients and sometimes matters more than hard outcomes – Adding quality rather than quantity. Some examples of verbiage from our patients after successful treatment of TR in clinical trials include: “Shockingly better in 1 month”, “Best I have felt in years”, “Thank you for helping me this as I can actually breathe now”, “I can now bend forward and go a flight of stairs”, etc. The majority of the treatments we offer to patients are to make them feel better, so they can enjoy life rather feel miserable. The data from TRILUMINATE and TRI-FR trials is convincing that T-TEER helps with improvement of symptoms and quality of life.

Another important part of T-TEER procedures is reimbursement. These procedures are more complex and take longer compared with mitral TEER (M-TEER). The patients treated with T-TEER also tend to be sicker and sometimes require inpatient intravenous diuresis to optimize them prior to the procedure. CMS should consider creating a new DRG and CPT for T-TEER, which reimburses hospitals and physicians at a higher rate than for M-TEER. There should be an additional RVU expense for interventional echocardiographer, who is an indispensable co-operator in this procedure.

There is a learning curve in understanding the tricuspid valve and performing the procedure effectively. Only one implanter is required for the procedure similar to M-TEER and it should not be a mandate to have 2 operators in each case. A critical part of T-TEER is an experienced interventional echocardiographer. We recommend having volume-based guidelines for T-TEER to make the procedure safe and effective.

The heart team should include an interventional cardiologist, a cardiac surgeon with tricuspid experience, echocardiographer, anesthesiologist and electrophysiologist.

Lastly, because of the safety of T-TEER and availability of M-TEER at >500 centers in the U.S., there is a possibility of expansion of this procedure to a non-urban centers reducing disparities in care. However, there needs to be monitoring of outcomes via the TVT registry to make sure that the outcomes are maintained with expansion to lower volume sites.

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

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

Colin M. Barker, MD
Section Chief, Interventional Cardiology
Vanderbilt University Medical Center

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Until now, there have been no approved therapies for the treatment of tricuspid regurgitation, resulting in it being considered the "forgotten valve." While the initial trial showed primarily a benefit with regards to symptom improvement, on review the length of follow up to this point was limited, and the intervention itself requires technical skill that continues to develop with time, and patient selection for those most likely to benefit continues to be fine tuned. The availability of T-TEER with the triclip system has been a boon to structural heart interventionalists for this space, where there were no options previously. While medical therapy is and should continue to be the mainstay, the availability of an option for those who continue to suffer, or have diminishing returns with diuretic therapy, is critical. Surgical therapy is known to be associated with a high morbidity and mortality to the point that it's essentially not an option for any but the most select cases, and even in that setting still comes with great risk.

Given that, as I noted above, utilization of the system requires a high level of experience and skill, even greater than that of M-TEER, it should be reserved for those interventionalists who are involved in a high yearly volume of M-TEER as a baseline, and have a dedicated team at an advanced center including highly trained structural heart imagers. Given the high level of experience and expertise required, and the significant procedural time involved (greater than that of TAVR or M-TEER on average), it is critical that appropriate reimbursement reflect this. As any physician in a successful TEER program can relate, the imager is as critical as the proceduralist for a successful program with high level outcomes, and towards that end should be included in reimbursement considerations.

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As a physician with four years of experience treating patients with T-TEER in Canada and now relocating to Illinois, I think it is important to remember the important impact such technology has oil patients and their quality of life. The majority of what we do as physicians is to make patients feel better from hip replacements to chemotherapy for terminal illness. Patients deserve this opportunity. Tricuspid regurgitation is a morbid condition that results in decreased quality of life ranging from terrible peripheral edema, ascites and overt right sided heart failure. Treatment with T-TEER is exceptionally safe and results in important improvement in symptoms that correlates with TR reduction and right ventricular remodelling. IN addition, recent data shows a trend towards decreased hospitalization. It is our moral imperative to do what we can to make patients feel better but there is also responsibility to identify those patients that will most benefit. Understanding which patients' quality of life is most affected and treating them is what will ultimately make a difference to this population. I hope you will seriously consider making this therapy available to those that can benefit.

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Transcatheter edge-to-edge repair with the Tri clip system has been shown in randomized control trials to improve quality of life. In her own experience we have a large number of patients who have advanced tricuspid valve disease either secondary to prior pacemaker implantation or due to other causes who have a very poor quality of life with very few options other than diuretics. They often tend to have difficulty lives with significant fatigue, shortness of breath and in many instances swelling in the legs, ascites and all the other sequelae of right sided volume overload.
The inability to alleviate the symptoms and improve the quality of life with this therapy has been extremely helpful and rewarding in our clinical experience. These patients are very grateful for the improved quality of life and feel like they have been given a new lease on life I believe it is imperative as a healthcare system that we continue to advance these therapies and continue to look for ways to gain additional information about the impact of these therapies and survival and long-term outcomes. I would hope that the Centers for Medicare services will look upon the results of the trials favorably and consider nationwide coverage of transcatheter edge-to-edge repair for the appropriate patients.

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November 1, 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 advocacy organizations, we appreciate the opportunity to respond to the CMS NCD Tracking Sheet regarding Tricuspid Valve Transcatheter Edge-to-Edge Repair (T-TEER), also known as the TriClip G4 System. Expanding Medicare coverage to include all FDA-approved minimally invasive transcatheter devices is essential for improving outcomes for patients suffering from symptomatic tricuspid regurgitation (TR).

Currently, over 1.6 million Americans live with moderate or severe TR. Those with TR face debilitating symptoms such as severe fatigue, breathlessness, and complications such as enlarged liver, kidney failure and fluid accumulation in the abdomen, legs, ankles, or feet. Traditional treatment options, which mainly consist of medical therapies and invasive open-heart surgery, often fail to significantly enhance long-term survival. The mortality risk associated with untreated moderate and severe TR is stark – with mortality rates rising by 17% and 34% respectively. This highlights the pressing need for safer and more effective treatment alternatives. Transcatheter therapies, such as the FDA-approved TriClip G4 System, offer a promising, less invasive option that can significantly improve a patient’s quality of life.

Medicare coverage policy for TR devices should reflect the advancements in medicine that continue to provide hope and options for patients. Importantly, evidence from recent clinical trials underscores the effectiveness of these technologies. For instance, 30 days after the TriClip procedure, 87% of patients experienced TR reduction to moderate or less, a stark contrast to the less than 5% of those treated with medication alone. Additionally, hospitalization rates decreased by 75% within three years post-procedure. Expanding Medicare coverage policies for these advanced technologies would not only enhance patient health outcomes but also reduce long-term healthcare costs associated with untreated TR.

We believe it is CMS’ intent to create a policy that applies broadly to T-TEER devices and isn’t limited to specific devices. Therefore, we urge CMS to adopt a "coverage to label" policy for FDA-approved devices. This approach will ensure that patients have continued access to new therapies as they become available. This flexibility is crucial, as future devices may have different indications. A broader coverage policy enables physicians to choose the best treatment options for their patients, particularly given the unique needs of those with TR.

We also want to emphasize the importance of T-TEER being included in the Transitional Coverage of Emerging Technology (TCET) Pilot. The concept of this pilot program could prove to be invaluable as it should allow patients timely access to innovative therapies while collecting essential data on their safety and effectiveness. By participating in the TCET Pilot, T-TEER could potentially help patients benefit from cutting-edge treatments, ultimately leading to better health outcomes and more informed coverage decisions in the future, but only if the process is as timely and efficient as intended.

Additionally, we must prioritize health equity in this coverage determination process. It is crucial to consider the unique challenges faced by underserved populations, especially those in rural and economically disadvantaged areas. Such communities often experience significant barriers to accessing advanced medical treatments, resulting in poorer health outcomes. This is where coverage requirements should allow for smaller and rural hospitals to participate from the beginning, without unnecessarily high procedural volume requirements. Ensuring equitable access to care must be a central focus of any new policy.

To achieve these goals, we hope that CMS streamlines pre-intervention evaluations to minimize burdens on patients. A single assessment by a qualified Heart Team member, whether conducted in-person or via telehealth, should suffice to determine procedural suitability. Additionally, we advocate that any hospital site requirements should take into account both patient outcomes and patient access.

In conclusion, we strongly advocate for a comprehensive and forward-thinking Medicare coverage policy that prioritizes patient access and patient centered care. By addressing health equity and recognizing the value of the TCET Pilot, we can help ensure that more patients potentially benefit from these minimally invasive treatments in an equitable and timely manner. We appreciate your attention to this critical issue and look forward to collaborating with CMS to develop policies that advance patient care.

Thank you for your consideration.

Sincerely,

The Heart Valve Disease Policy Task Force

Alliance for Patient Access
Association of Black Cardiologists
Caregiver Action Network
HealthyWomen
Heart Valve Voice US
Hypertrophic Cardiomyopathy Association
Men's Health Network
The Mended Hearts, Inc.
National Hispanic Health Foundation
National Minority Quality Forum
Partnership to Advance Cardiovascular Health
Preventive Cardiovascular Nurses Association
WomenHeart: The National Coalition for Women with Heart Disease

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November 1, 2024

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

RE: National Coverage Analysis for Tricuspid Transcatheter Edge-To-Edge Repair

Dear Ms. Syrek-Jensen:

The American Association for Thoracic Surgery (AATS), 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 tricuspid transcatheter edge-to-edge repair (T-TEER) and surgical tricuspid valve (TV) repair procedures. The societies are supportive of the development of a National Coverage Determination (NCD) for T-TEER and we appreciate the opportunity to comment on the National Coverage Analysis (NCA).

T-TEER 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. The TriClip device is currently the sole T-TEER device approved by the U.S. Food and Drug Administration (FDA). TriClip is indicated for use for the improvement of health status in patients with symptomatic severe TR despite being treated optimally with medical therapy, who are at intermediate or greater risk for surgery and for whom TV repair is deemed appropriate by a multi-disciplinary heart team (MDHT). The undersigned organizations recommend that CMS cover T-TEER 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
The universal adoption of 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., 2019; Nishimura et al., 2019; Bonow et al., 2020) 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 obligatory 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. 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 T-TEER in the Medicare Population
It is important for the MDHT to consider a number of factors when determining the appropriateness, possible benefits, and risks from T-TEER for any given patient. Clearly the primary goal is to choose the right therapy to treat TR without subjecting the patient to undue risk for the potential of an improved quality of life and possibly, morbidity and mortality benefit (Zahr et al, 2024). T-TEER is relatively safe (Madhavan et al, 2024) with 30 day mortality between 1-2%, re-intervention rate of 0-2%, major bleeding risk of 0-7%. Single leaflet device attachment is reported in 2.6-7.0% of patients which may then contribute to the efficacy of the device (residual TR >2+) of between 12-48% of patients. Recent studies have suggested that mortality increases with residual TR of >2+ (Stolz et al, 2024) or even mild-moderate TR (Dreyfus et al, 2024). Thus predicting the ideal patient for T-TEER requires a MDHT discussion which considers multiple factors:

Patient-specific risk factors: age, renal function, liver function, diuretic agent dosing, atrial fibrillation, long-term anticoagulation, left ventricular function, and pulmonary hypertension;

Right ventricular (RV) Anatomy and Physiology: RV size, depth, and function; papillary muscle location and height; and pacemaker or defibrillator leads;

Tricuspid valve morphologic characteristics determining procedural success: degree and location of TR, tricuspid leaflet morphology, scallop size, density of chordal structures, gap width, and imaging quality.

Assessment of Patient Risk: Age, RV size and function, pulmonary hypertension, end-organ dysfunction, bleeding risk, STS Risk Calculator for Isolated Tricuspid Valve Surgery (https://isolatedtvsurgcalc.research.sts.org/) and TRI-SCORE (https://www.tri-score.com).

Health Disparities and Equity
There are a number of health equity considerations specific to the patients with TR. First, clinically significant TR is 4 times more common in women than in men (Singh et al, 1999) with the prevalence increasing with age (Condello et al, 2021). Although the mean age of patients enrolled in the Triluminate Pivotal Trial was 78.0 ± 7.4 years, only 56% of these patients were female, suggesting an underrepresentation of women in the trial. Racial and ethnic differences have also been reported. In a single center study of 989 patients with severe TR, compared to non-Hispanic White patients (n = 169), non-Hispanic Black (n = 473) and Hispanic (n = 347) patients were younger with higher burden of comorbidities and worse functional class (Echarte-Morales et al, 2023). Ventricular functional TR was the predominant etiology in 82.9% of patients, with non-Hispanic Black and Hispanic being the most affected, and showed a trend of higher incidence of heart failure hospitalizations compared with non-Hispanic White patients (P = 0.05).

Although this single site study showed no difference in the rates of transcatheter device therapies by race/ethnicity, a study of the National Inpatient Sample database from 2016 to 2020 evaluating the access to tricuspid valve surgery (STV) found the utilization rate (number of surgeries/100,000 hospitalizations) was lower in Black and Hispanic patients compared with White patients for surgical tricuspid valve repair (STVr) (331 versus 493 versus 634, P< 0.01) and surgical tricuspid valve replacement (STVR) (312 versus 601 versus 728, P<0.01) (Ismayl et al, 2024). Similarly, the utilization rate was lower for women compared with men for STVr (1021 versus 1364, P<0.01) and STVR (930 versus 1,316, P<0.01). Whether similar access to care issues may exist for transcatheter device therapies, deserves further study.

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).

To support the MDHT consideration of risk of tricuspid valve intervention, predicted patient risk of mortality and major morbidity following isolated tricuspid surgery should be documented for all patients using the STS Isolated Tricuspid Valve Surgery Risk Calculator. This recently released tool is clinically relevant to this patient population and utilizes the most contemporary surgical data available (through 2023). Recent literature has demonstrated that surgical interventions for TR are now more common and carry lower risks than previously assumed (Thourani et al, 2024). This represents a significant shift from older studies, which reported much higher risks, and underscores contemporary advancements and improved safety. TRI-SCORE has been used in a small number of patients and may have validity going forward. It is encouraged as an alternative additive score to assist MDHT decision-making (Dreyfus et al, 2022).

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 T-TEER 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
T-TEER 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., 2019). Additionally, paralleling the recommendations for transcatheter mitral valve interventions (Bonow et al., 2020) 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 MDHT 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 T-TEER 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, deployment of septal closure devices, and advanced mechanical circulatory support to address right ventricle dysfunction, with outcomes that equal or exceed those established nationally for similar procedures, should offer transcatheter TV intervention.

Qualifications to begin a T-TEER program for facilities without T-TEER 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 T-TEER intervention programs. The current proposed case volumes for T-TEER pertain to the use of a transcatheter tricuspid valve repair device for the improvement of health status in patients with symptomatic, severe TR despite optimal medical therapy, for whom TV repair 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 T-TEER program to ensure adequate experience for the maintenance of a sustainable TV intervention program. Our goal with these recommendations is to enhance access to high quality care. We understand these criteria would encompass a certain number of sites at the outset. While the societies lack expertise on what number of sites are necessary to assure appropriate access, our focus was on identifying criteria that we believe offer the best approach to ensure patient safety and optimal outcomes for these complex procedures. Establishing high standards from the outset is crucial for achieving these objectives as facilities roll out new programs introducing Breakthrough technology. Sites could bolster their programs to meet the criteria, or experts on access could recommend adjustments to facility criteria through the NCD process in the coming months.

To initiate a T-TEER program in hospitals without prior T-TEER experience, the hospital program must meet the following qualifications:
a) =50 open heart surgeries in the previous year prior to the T-TEER program initiation, and;
b) =20 tricuspid valve surgeries in the 2 years prior to T-TEER 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
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 T-TEER 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 T-TEER 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/STS 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 T-TEER 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, equivalency, or certification in either interventional cardiology or cardiothoracic surgery

Certification of device-specific training.

To optimize outcomes at a new T-TEER 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 T-TEER
T-TEER should be performed by at least two physicians working as co-operators. An interventional echocardiographer must serve as a co-operator and provide imaging expertise during all aspects of the procedure; An interventional cardiologist or cardiac surgeon, as the other co-operator, must provide expertise in wire, catheter, and device manipulation and deployment. The interventional echocardiographer may not also provide anesthesiology care during the same procedure. At the MDHT’s discretion, if appropriate, an additional physician, either an interventional cardiologist or a cardiac surgeon, can be involved as a third operator in the procedure. All physicians who participate in the procedure must have device-specific training as required by the manufacture.

Qualifications to Maintain a T-TEER Program
To optimize outcomes at a T-TEER program, sites with T-TEER experience should maintain the following:
a) =20 tricuspid valve interventions (transcatheter or surgical) of which =10 are transcatheter over 1 year, or =40 tricuspid valve intervention (transcatheter or surgical) of which =20 are transcatheter 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 TriClip System by Abbott is the only FDA-approved device for the treatment of TR via T-TEER at this time, there is much research and development emerging in this space. One notable device in development is the PASCAL Transcatheter Repair System (Edwards).With emerging technologies on the horizon in the tricuspid valve repair 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 T-TEER. Additionally, we support a new NCD specific to TEER for the tricuspid valve, as this procedure requires expertise distinct from that needed for the mitral valve.

The societies support Medicare coverage for T-TEER 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

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) Zahr, F, Chadderdon, S. Predicting the Future in Tricuspid TEER: Numbers, Colors, or the Wide Space in Between. J Am Coll Cardiol Img. 2024 Jul, 17 (7) 743–745
7) Madhavan MV, Agarwal V, Hahn RT. Transcatheter Therapy for the Tricuspid Valve: A Focused Review of Edge-to-Edge Repair and Orthotopic Valve Replacement. Curr Cardiol Rep. 2024 Jun 17.
8) Stolz L, Kresoja KP, von Stein J, Fortmeier V, Koell B, Rottbauer W, Kassar M, Goebel B, Denti P, Achouh P, Rassaf T, Barreiro-Perez M, Boekstegers P, Rück A, Doldi PM, Novotny J, Zdanyte M, Adamo M, Vincent F, Schlegel P, von Bardeleben RS, Stocker TJ, Weckbach LT, Wild MG, Brunner S, Toggweiler S, Grapsa J, Patterson T, Thiele H, Kister T, Konstandin MH, Van Belle E, Metra M, Geisler T, Estévez-Loureiro R, Luedike P, Karam N, Maisano F, Lauten P, Praz F, Kessler M, Kalbacher D, Rudolph V, Iliadis C, Lurz P, Hausleiter J; On behalf of the EuroTR Investigators. Residual tricuspid regurgitation after tricuspid transcatheter edge-to-edge repair: Insights into the EuroTR registry. Eur J Heart Fail. 2024 May 29.
9) Dreyfus J, Taramasso M, Kresoja KP, Omran H, Iliadis C, Russo G, Weber M, Nombela-Franco L, Estevez Loureiro R, Hausleiter J, Latib A, Stolz L, Praz F, Windecker S, Zamorano JL, von Bardeleben RS, Tang GHL, Hahn R, Lubos E, Webb J, Schofer J, Fam N, Lauten A, Pedrazzini G, Rodés-Cabau J, Nejjari M, Badano L, Alessandrini H, Himbert D, Sievert H, Piayda K, Donal E, Modine T, Nickenig G, Pfister R, Rudolph V, Bernick J, Wells GA, Bax J, Lurz P, Enriquez-Sarano M, Maisano F, Messika-Zeitoun D; TRIGISTRY Investigators. Prognostic Implications of Residual Tricuspid Regurgitation Grading After Transcatheter Tricuspid Valve Repair. JACC Cardiovasc Interv. 2024 May 7:S1936-8798(24)00692-7.
10) The Society of Thoracic Surgeons. Risk Calculator – Isolated Tricuspid Valve Surgery. https://isolatedtvsurgcalc.research.sts.org/.
11) TRI-SCORE Calculator. https://www.tri-score.com
12) Singh JP, Evans JC, Levy D, et al. Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Cardiol. 1999;83(6):897-902.
13) Condello F, Gitto M, Stefanini GG. Etiology, epidemiology, pathophysiology and management of tricuspid regurgitation: an overview. Rev Cardiovasc Med. 2021;22(4):1115-1142.
14) Echarte-Morales, J, Bonnet, G, Torrado, J. et al. TCT-295 Race and Ethnicity in Patients With Severe Tricuspid Regurgitation: An Exploration of Disparities. JACC. 2023 Oct, 82 (17_Supplement) B117.https://doi.org/10.1016/j.jacc.2023.09.302.
15) Ismayl M, Ahmed H, Goldsweig AM, Alkhouli M, Guerrero M. Racial, ethnic, and sex disparities in the utilization and outcomes of tricuspid valve surgery. Ann Med Surg (Lond). 2024 Jun 19;86(8):4368-4376.
16) 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
17) Thourani VH, Bonnell L, Wyler von Ballmoos MC, Mehaffey JH, Bowdish M, Kurlansky P, Jacobs JP, O'Brien S, Shahian DM, Badhwar V. Outcomes of Isolated Tricuspid Valve Surgery: A Society of Thoracic Surgeons Analysis and Risk Model. Ann Thorac Surg. 2024 Oct;118(4):873-881. doi: 10.1016/j.athoracsur.2024.04.014.
18) Dreyfus J, Audureau E, Bohbot Y, Coisne A, Lavie-Badie Y, Bouchery M, Flagiello M, Bazire B, Eggenspieler F, Viau F, Riant E, Mbaki Y, Eyharts D, Senage T, Modine T, Nicol M, Doguet F, Nguyen V, Le Tourneau T, Tribouilloy C, Donal E, Tomasi J, Habib G, Selton-Suty C, Raffoul R, Iung B, Obadia JF, Messika-Zeitoun D. TRI-SCORE: a new risk score for in-hospital mortality prediction after isolated tricuspid valve surgery. Eur Heart J. 2022 Feb 12;43(7):654-662.
19) Zoghbi WA, Adams D, Bonow RO, et al. Recommendations 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.

20) 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. 21) 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.

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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 e?ective medical technologies that improve health outcomes.

We are pleased to submit these comments to the Centers for Medicare & Medicaid Services (CMS) regarding the National Coverage Analysis (NCA) for Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER). CMS states in the Tracking Sheet that this NCA follows the manufacturer’s participation in a pilot of the Transitional Coverage for Emerging Technology (TCET) program.(1) Although not specified, we presume that includes the development of an Evidence Preview (EP) by CMS and the submission of an Evidence Development Plan (EDP) by the manufacturer.

While we have received generally favorable reports from participants in the pilot regarding the EP and EDP processes, we are disappointed that the pilot raises questions about the likelihood that the TCET program will achieve its objective of providing access for Medicare beneficiaries to a new technology via a National Coverage Determination (NCD) finalized within six months of its approval or clearance by the Food and Drug Administration (FDA). In the case of T-TEER, the manufacturer submitted its formal NCD request on March 17, 2024, and the FDA granted premarket approval on April 2; however, CMS did not initiate this NCA until October 3, already six months after the FDA approval, and the expected completion date for the NCA listed on the Tracking Sheet is July 2, 2025, a full 15 months after FDA approval.(2)

MDMA urges CMS to take all possible action to make the coverage process under TCET as e?cient as possible and to shorten the expected timeframe for issuance of a final NCD providing Medicare beneficiary access to the innovative T-TEER procedure. This includes eliminating any procedural steps not required by statute. For example, in response to the public comment period for the TCET proposed guidance, MDMA recommended that when CMS has completed an EP and the agency, the Agency for Healthcare Research and Quality (AHRQ), and the manufacturer have reached agreement on an EDP, CMS should post the Tracking Sheet, Proposed Decision Memo, EP and EDP simultaneously.(3) In other words, CMS should eliminate the initial 30-day comment period that typically starts an NCA, which is not required by statute(4) and for which the purpose—to gather clinical evidence and other relevant information for CMS to consider in developing a proposed coverage decision—is obviated by the TCET process of developing the EP and proposed EDP. While that opportunity has passed with regard to T-TEER, MDMA urges CMS to act expeditiously to issue the Proposed Decision Memo for T-TEER following the close of this initial public comment period.

As innovators look to engage with CMS to potentially secure Medicare coverage for a new technology through the TCET coverage pathway, it is critical that CMS deliver on the timeliness of the final coverage policy. Transparent and predictable timelines and processes are essential. Most importantly, Medicare beneficiaries su?ering from life-threatening or debilitating medical conditions are relying on this new coverage pathway to access promising new technologies.

We appreciate the opportunity to comment on this important topic. If we can provide any additional information, please contact me at dwaldmann@medicaldevices.org or (202) 354-7171.

Sincerely,

Daniel Waldmann, JD
EVP, Health Policy & Reimbursement
Medical Device Manufacturers Association (MDMA)

Sources:
(1) Centers for Medicare & Medicaid Services, Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) Tracking Sheet, October 3, 2024, CAG-00468N. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=316&ncacaldoctype=NCA&status=Open&sortBy=status&bc=17.
(2) The experience has been similar for Transcatheter Tricuspid Valve Replacement (TTVR)—the only other new technology that has been identified as part of the TCET pilot and for which an NCA has been opened—with FDA approval issued on February 1, 2024, submission of a formal and complete NCD request on February 20, followed by a four-month delay before the initiation of the NCA on June 20 and an expected completion date of March 20, 2025 (thirteen months after FDA approval.)
(3) Letter from Mark Leahey, President and CEO, Medical Device Manufacturers Association, to Chiquita Brooks-LaSure, Administrator, Centers for Medicare & Medicaid Services, Aug. 28, 2023, at 13-14, https://www.regulations.gov/comment/CMS-2023-0107-0098.
(4) 42 U.S.C. §1395y(l)(3).

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To the CMS committee-
I would like to highlight the critical role of tricuspid clip technology amongst the other modalities of TTVI in advancing cardiac care for patients with tricuspid regurgitation (TR). With an estimated prevalence of TR affecting approximately 1.6 million adults in the United States, and its association with increased morbidity and mortality, innovative treatment options are essential for improving patient outcomes.

Recent clinical trials have demonstrated safety and efficacy in reducing moderate to severe TR and most importantly safely. Furthermore, these studies show that patients experience substantial improvements in functional capacity, with improvements of exercise tolerance and notable enhancements in quality of life measures, as evidenced by an improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores.

t-TEER offers a minimally invasive alternative to traditional surgical interventions, which can carry a surgical mortality risk of up to 6% and extended recovery periods.

As healthcare providers, we have a responsibility to provide access to the latest technologies that lead to improved clinical outcomes and patient satisfaction. The integration of tricuspid clip technology into standard treatment protocols aligns with our commitment to patient-centered care and aligns with evolving clinical guidelines.

We urge the CMS committee to recognize the value of this technology in the context of heart failure management and ensure its accessibility for those who would benefit most.

Thank you for considering this vital aspect of cardiac care.

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Surgical intervention for isolated TV regurgitation is rarely done and carries with it a potentially very high complication rate. This is a very under treated population who have few options, especially when oral diuretics stop working. This leaves these patients to have multiple hospitalizations for IV diuretics with eventual palliative care.
Triclip offers a tremendous advance for clinicians and patients. The ability to improve symptoms and potentially avoid hospital visits are critical points for consideration and make this device a vital tool in our treatment of severe symptomatic TR.

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Tricuspid valve disease is essentially an orphan. Current therapies commonly available to most patients are not curative. Treating symptoms for a condition doomed to deteriorate is helpful but not an end-goal, much as treating only the symptoms of cancer would be. Medical management is now the only available medical help for the vast majority of patients. Having both access to and payment for a true "fix" is the foundation of health care for tricuspid patients. Patients who are languishing and dying deserve nothing less.

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Transcatheter Tricuspid Edge to Edge Repair (T-TEER) has been shown to provide clinically relevant improvements in quality of life for patients with severe symptomatic tricuspid regurgitation. There is a large unmet clinical need for patients with severe symptomatic TR, a condition for which there is no established medical therapy. Surgery is infrequently performed and associated with high morbidity and mortality. Therefore, transcatheter therapies will likely be the dominant treatment modality for these patients, which are generally elderly with multiple comorbidities.
Making this therapy available to patients and recognizing the complexity required to execute these procedures, as it relates to invasive echocardiography and other advanced imaging modalities such as intracardiac echocardiography, is critically important. In addition to the interventional cardiologist performing these procedures the role of the interventional echocardiographer needs to be recognized and compensated adequately.

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Tricuspid regurgitation affects 1.6 million patients. Unfortunately, only .6% of these patients get treated. Medical management is suboptimal in relief of symptoms and surgery carries 10% mortality. Tricuspid TEER is a percutaneous option which has shows improvement in quality of life and more recently reduced HF admissions. The procedure is safe and requires short hospital stay. I strongly support a NCD for tricuspid TEER so we can treat these undertreated group of patients and give them a better quality of life.

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October 28, 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 organization dedicated to enhancing the lives of individuals affected by heart valve disease, I want to express our gratitude for the opportunity to comment on the NCA Tracking Sheet regarding Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER), also known as TriClip. As an organization deeply committed to patient-centered advocacy, HVV-US has a unique perspective to share regarding the lived experiences of patients with heart valve disease and the promise that breakthrough technologies hold. Recent advancements in transcatheter tricuspid therapies, such as TriClip, offer new possibilities for patients who might otherwise face more invasive treatment options. In light of this, HVV-US is hopeful that CMS will provide timely and adequate coverage for these innovative devices.

The lived experiences of our community members are paramount in our advocacy for these treatments. Before the FDA approval of TriClip, the field of tricuspid valve regurgitation had historically offered limited treatment options. A Tennessee patient named Gayle has a story that exemplifies the profound positive impact that the TriClip device has had on her quality of life and the potential benefits for many others living with heart valve disease.

In 2012, Gayle, a 68-year-old woman, began experiencing irregular heart rhythms and was diagnosed with AFib. During this process, her doctors discovered issues with her tricuspid valve and diagnosed her with tricuspid regurgitation. At that time, her only option was open-heart surgery to replace the valve—a path she was not ready to take. However, her symptoms continued to worsen. As an avid hiker, she could no longer keep pace with her husband; she experienced shortness of breath, and her AFib worsened despite medication. Even visiting her daughter and granddaughter in Santa Fe became a struggle, as her body could not tolerate the increased altitude.

Eventually, the exhaustion from her damaged tricuspid valve became unbearable. She returned to her cardiologist, who informed her about a clinical trial starting a few months later. In February 2020, Gayle became one of the first patients in Tennessee to participate in the clinical trial for TriClip. Despite the risks associated with being among the first patients to receive TriClip, the decision to undergo the procedure was almost instinctive for Gayle. She understood that the recovery and risks of open-heart surgery were far greater, leading her to opt for the smaller risks associated with the minimally invasive TriClip procedure.

After just one night in the hospital following the procedure, Gayle's life transformed. She immediately regained her energy and was able to cook breakfast for her family, who had come to town to care for her. Now, at 80, Gayle is back to hiking around the world and visiting her daughter and granddaughter in Santa Fe—activities she never imagined she would continue before the TriClip device.

Gayle's experience is just one of many illustrating how the TriClip device can significantly enhance patients' quality of life. She embodies the benefits TriClip offers to patients with tricuspid valve regurgitation: a renewed chance to enjoy daily activities without the complications, risks, and lengthy recovery associated with open-heart surgery.

A crucial element in the effective implementation of innovative treatments like TriClip is the healthcare team's role in guiding patient care through informed and shared decision-making. Heart Valve Voice US encourages CMS to adopt an evaluation process that leverages the expertise of specialized Heart Teams to provide comprehensive, patient-centered care, whether in-person or via telehealth. By streamlining these assessments, we can enhance care coordination and ensure equitable access to these breakthrough therapies for patients in diverse geographic areas.

Moreover, this approach will not only improve patient outcomes but also promote fairness in access to life-changing treatments. We urge CMS to consider the insights of patient advocates and medical experts when developing a regulatory framework that ensures equitable access based on geographic location while prioritizing safety in these procedures. Given that the needs of our community members vary significantly by location, CMS has a unique opportunity to uphold safety standards while addressing the diverse needs of patients nationwide.

We also want to emphasize the importance of including TriClip in the Transitional Coverage of Emerging Technology (TCET) Pilot. TriClip has proven to dramatically benefit patients across the country like Gayle, and participation in the TCET Pilot allows many more patients to experience these benefits, ultimately leading to better health outcomes and more informed future coverage decisions.

Heart Valve Voice US strongly recommends that CMS adopt a comprehensive coverage policy for TriClip that prioritizes patients' needs while reflecting advancements in tricuspid valve treatment. For patients like Gayle, the TriClip device represents a new chance to live life to its fullest. CMS has the opportunity to enable thousands more patients to access this life-changing treatment.

Thank you for considering our perspective on this important matter. We look forward to continued dialogue and collaboration on policies that improve outcomes for Medicare beneficiaries with tricuspid regurgitation.

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

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As an interventional cardiologist and structural heart specialist, I am writing to emphasize the urgent need of having NCA for TEER for treatment of tricuspid regurgitation. Tricuspid regurgitation is one of the most challenging valvular diseases we encounter in medical practice. Historically, the only available option for treatment is surgical, and historically, our cardiothoracic surgical colleagues often disfavored surgical interventions with tricuspid regurgitation, considering the increased risk of morbidity and mortality of operating on these patients, particularly as disease progression leads to pulmonary hypertension, right heart failure and secondary hepatic liver disease and multisystem involvement. Hence it is referred to as the forgotten valve, as patients are often not treated until too late, and the outcomes are poor.

Tricuspid regurgitation according to the largest currently available data of prevalence of valvular disease in population (data from Cardiocare) and I am a co-author of this article, was the most prevalent of any valvular disease accounting for 8% of patients above the age of 70, surpassing mitral and aortic disease.

TEER has evolved, as a very viable option for treating this complex population. Even years before the Triluminate trial, we have treated patient with the mitral clip applied in the tricuspid position when we were also treating mitral regurgitation. We have followed these patients, and they have done so much better symptomatically, and clinically, less likely to be admitted to the hospital with CHF, quality of life is better. Though the trial did not show mortality benefit, and heart failure hospitalization, we cannot under-estimate the impact on KCCQ as this is directly to quality of life. I suspect further on-going trials, and longer follow up, and further understanding of the timing of procedure will show better outcomes on hospitalization and possible mortality improvement. I suspect we will find the same difference between FR-MR trial and COAPT trial, when we have better understanding of when we treat these patients.

Having been involved with TEER of the tricuspid valve, it is important to highlight the safety of the procedure and the device, of the tri-clip, and efficiency of the procedure particularly with the advent of 3D ICE imaging which would improve the degree of treatment.

Furthermore, some of the data that is coming out of Trans-catheter tricuspid valve replacement TTVR, are showing high complication rates for the TTVR procedure and from experience demonstrates the superiority of TEER to TMVR as of currently.

There are more challenges we all need to understand about this specific disease and involvement of other pathologies. Regardless, the TEER offers this patient population, that is often left untreated a very viable option. The burden of cost of health care of CHF and CHF hospitalization is crippling to health care, and we need to start taking approaches where we can treat these patients earlier, with less invasive options and avoid deterioration of disease to a point of no options, and the cycle of in and out hospitalization with CHF, which is far more costly that aggressive earlier treatment of the disease.

Furthermore, historically, CMS requirement for TEER in the mitral position, mandated that centers needed to do certain amount of mitral repair vs replacement. The real-life experience in large spectrum of hospitals, academic, large health systems, small health systems, rural, that mitral repair is more demanding and many surgeons favoring cord sparing replacement of the valve, and the restriction is making it very difficult to deliver options of care of TEER to mitral patients because of this restriction. This restriction should NOT be applied to the tricuspid valve and should be removed from the mitral valve requirement as this will take away options of therapy for so many patients who simply are not able to travel to larger centers, and they are taxing the health care system more by recurrent CHF admission and morbidity.

I am writing in full support and urgent need for NCA for TEER for tricuspid valve disease.

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The recent FDA advent and approval of transcatheter edge to edge repair (T-TEER) represents a significant advance in the treatment of severe tricuspid valve regurgitation. Candidates for this therapy are often elderly and frail with multiple comorbidities that render them high risk for tricuspid valve surgery. There exist no truly effective medical therapies for this condition, other than diuretics which don't directly impact disease progression and only temporarily mask the symptoms. When referred to an interventional cardiologist, these patients are usually very symptomatic despite medical therapy and often desperate for treatment. I deem it imperative that we are able to offer a safe and effective therapy to improve health status in these complex patients who have historically been undertreated. Having participated in the TRILUMINATE Pivotal Trial and performed several hundreds of mitral TEER procedures, I have been reassured by the safety of TEER in general and the relative ease with which these procedures may be performed. In the proper hands (and team), this is a highly effective technique for reducing tricuspid regurgitation, and although there is still much to learn- including how to reduce recurrent heart failure hospitalizations and premature death in these patients, it is imperative that transcatheter tricuspid valve therapies such as T-TEER be made available to patients in need of treatment. In summary, I would strongly recommend that CMS provide coverage for TEER as a part of their commitment to ensure that patients have access to evidence-based quality care.

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T-TEER has been widely used globally to treat TR successfully and reduce symptoms of HF. CMS erred in creating regulations for TAVR by forcing inclusion of multiple physicians to complicate care for patients. Moreover, there are no standard therapies for TR (surgery is unproven and only performed concomittantly with other surgeries and there are no trials of medical therapy that improve outcomes in patients with TR).

Accordingly T-TEER should be approved for treatment of symptomatic TR patients (NYHA II or greater) with significant TR without need to be high risk for surgery nor without being performed by multiple operators. This is the best evidence based practice for our patients and will ensure access.

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My colleagues and I at Intermountain Medical Center are highly involved in the management of tricuspid valve regurgitation (TR). Since performing our first T-TEER procedure in 2017 we have treated nearly 200 patients with a variety of tricuspid valve devices, relying most heavily on the TriClip device. The emergence of transcatheter tricuspid interventions has allowed us to address the major unmet clinical needs of TR patients referred from throughout our multistate region and from our active heart failure and transplant program. Our multidisciplinary team includes a tremendous commitment from our imaging physicians, surgeons, heart failure physicians and cath lab among others. Together we have recognized how TR destroys the quality of life for many patients with impaired exercise capacity in its intermediate stage leading to ascites, cirrhosis, cachexia and death in later stages. We have similarly noted immediate and remarkable improvement in cardiac physiology and quality of life following successful interventions in our patients. While T-TEER procedures are among the most complex and difficult procedures we perform, demanding substantial expertise and commitment from multiple team members, the safety and clinical effectiveness of T-TEER make it a gratifying procedure which has become the foundation of our TV program.

Our T-TEER procedures usually require 2+ hours. Furthermore, the preprocedural evaluation of TR patients demands long and technically challenging transesophageal echos and CT scans. I am fortunate to enjoy the collaboration of advanced cardiac imagers who are willing to support this endeavor despite insufficient reimbursement. We also include 3D intracardiac echo in the majority of our procedures which was not available during the randomized trials but clearly enhances procedural outcomes. Reimbursement should reflect the significant time, effort and expertise of not only interventional cardiologists but also of cardiac imagers and procedures requiring expensive ancillary equipment.

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Tricuspid valve TEER is already here. T-TEER does what it promised to do, reduce TR. The Triclip device is FDA approved based on favorable safety and clear/durable improvement in symptoms and quality of life in carefully selected patients. Improving symptoms and quality of life are just as fundamental to our oath as physicians and health care providers as preventing death. Observations from selected T-TEER centers around the country confirm the impression that patients simply feel better after the procedure. CMS reimbursement is vital to optimizing and ensuring good procedural outcomes, enhancing innovation, and making this therapy available to all patients around the United States with severe TR and right sided heart failure for whom there is no durable medication option available.

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Thank you for taking my comment.

The development of trans-catheter therapies for valvular heart disease in the aortic and mitral spaces have changed how we care for valvular heart disease and represent a significant advancement in care for patients as part of a multi-disciplinary heart team approach.

Until now, the options for patients with severe TR have been very limited. TR is very common in the older population with at least 1.6 million suffering severe TR in the US. TR can be associated with mortality over years and is associated with substantial burden of morbidity with edema, ascites and cardiac cirrhosis, dyspnea and fatigue of low output state. TR substantially affects QOL and this is a significant unmet need.

Medical therapy is largely isolated to diuretics. Few patients undergo surgical therapy as an isolated procedure because most patients are comorbid and operative mortality is as high as 8% even in well selected patients. Fewer than 8000 TV isolated TV surgeries are performed in the US reflecting that surgery is not a viable solution for the overwhelming majority of patients with symptomatic TR. Given the lack of alternatives, most patients who do not respond to diuretics have been largely treated palliatively. We now have two approved catheter-based therapies: T-TEER with TriClip and TTVR with Evoque. Both technologies have a roll in treatment. It is important that T-TEER be part of the armamentarium for patient care. For patients with anatomy conducive to T-TEER, TriClip was proven safe and effective in the Triluminate study and in our own experience through clinical trials and commercially. Given that no oral anticoagulation is needed post procedure, there is no impact on the conduction system, and RV function is not impacted it is generally our first line therapy for severe non rheumatic symptomatic TR persistent despite OMT. TTVR also has a very important roll in management but the purpose of this comment is for T-TEER.

T-TEER with TriClip was shown in the Triluminate trial to substantially improve quality of life and this reflects the experience demonstrated in multiple registries in the US and Europe. That TriClip improves QOL for patients in a substantial, meaningful, and important way is not in doubt. Additionally, there are no alternative to transcatheter therapies for medical therapy refractory symptoms for the overwhelming majority of patients. Until now they just suffered and were palliated.

T-TEER is one of the most complex and expertise-based therapies of all endovascular therapies. For context, TAVR typically takes an hour of procedure time; M-TEER 90 min; and T-TEER 120 to 180 min or more. This procedure involves substantial expertise from multiple team members including the interventional cardiologist (or occasionally a surgeon) and an advanced imager as well as nurses and cath lab specialists as well as a cardiac anesthesia team. This is by far the most challenging imaging ask of any procedure with most systems limited by lack of imaging expertise in this area which limits access.

In order to bring this important therapy for an unmet need that is a burden to more than a million Americans, adequate reimbursement is needed to make this procedure viable for institutions and providers. Specifically, there is precedent for reimbursement for M-TEER both to hospital systems and providers (technical and professional). Reimbursement ideally would reflect the significant increase in time and effort and expertise for the TR population with longer length of stay, more expensive equipment requirements (most procedures benefit from not just TEE guidance but also 3D ICE concomitant guidance as they are synergistic for optimal procedural outcomes), higher degree of provider expertise, and substantially more time and effort from the providers with associated opportunity costs.

Reimbursement to providers should reflect the added procedural time and expertise for T-TEER over M-TEER precedents.

Importantly, this may be the time for CMS to act boldly and finally provide reimbursement to the imaging physician as an equal operator to the IC physician. T-TEER (like M-TEER) is a two-person procedure with the IC and Imager providing equally important roles. The imaging is not just providing pictures but truly is guiding the procedure. I cannot emphasize this enough. It is time for the imager to receive the same RVUs as the operator by designating this a two person procedure which includes an IC and Imager. The more completely CMS decides to cover T-TEER to reflect the significant time, cost, and expertise of the system and operators (including the imager), the more likely we will be able to offer this important procedure to patients with a significant and prevalent unmet need.

Thank you for taking my comments

Michael Rinaldi, MD FACC FASCI
Director, Structural Heart Program, Sanger Heart and Vascular Institute
Professor of Medicine, Wake Forest University
Carolinas Medical Center / Atrium Health

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I have been an investigator for Tricuspid TEER and Mitral TEER and have performed over 100 cases. For the appropriate patient, that is, patients with severe TR refractory to medical therapy who are high risk or inoperable surgically, Tricuspid TEER can alleviate symptoms in a one day, outpatient procedure with acceptable risk, even in patients with liver failure and high MELD scores.
I am in favor of rapid approval of Tricuspid TEER by CMS since the pivotal trials showed a benefit in this patient subset.
There is no alternative treatment except for Evoque Transcatheter Valve implantation, and there are numerous patients who cannot receive this valve because of anatomic limitations.

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I am writing in support of CMS approval of proposed NCD for transcatheter tricuspid valve edge-to-edge repair (T-TEER aka “TriClip”). The cardiology community for many years has cared for patients with symptomatic tricuspid regurgitation with limited medical or procedural options to offer that conveyed any sustained benefit. Randomized clinical trials (TRILUMINATE, TRISCEND) have now demonstrated significant, meaningful and sustained quality of life improvement for this patient population. Our center has been performing T-TEER to treat patients with symptomatic tricuspid regurgitation since recent FDA approval of TriClip. Locally, we have observed high procedural success with low complication rates and symptom/quality of life improvement that has surpassed that reported in randomized trials. We are eager to extend CMS coverage to this patient population with a long-awaited safe and effective therapy.

Thank you for your commitment to these patients.

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As a site implanter of the TRILUMINATE EFS and pivotal trials, I have been involved with TriClip studies since its inception. The TRILUMINATE pivotal trial demonstrates the excellent safety of the TriClip tricuspid transcatheter edge-to-edge repair (TEER) system and its efficacy in reduction in tricuspid regurgitation (TR) out to 1 year. We have seen many patients referred to our valve center very debilitated by their symptomatic severe to torrential TR, unable to carry on with their daily activities and very limited by their symptoms and with prior hospitalizations. After TriClip TEER, we have seen an improvement in their quality of life and functional status. A good % have even been able to pursue activities with their families and friends, that were not possible before. Although tricuspid TEER has the same Clip technology as mitral TEER, the imaging requirements and operator skill sets are different, and a true heart team approach involving general cardiologists, interventional cardiologists, cardiac surgeons, cardiac imagers, heart failure specialists and valve coordinators are key to success in treating these patients. I therefore fully endorse the need for a new NCD for this FDA-approved device and therapy of tricuspid TEER, separate from that of mitral TEER.

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As a valve disease cardiologist and structural heart interventionalist, I have taken care of TR patients without options for several years. There are no real surgical therapies and I have sent several patients to the OR knowing they were high risk but had no other options. Fortunately with the advent of transcatheter tricuspid therapies, I've now finally had the ability to take care of these very sick, desperate patients. We were involved in both TRISCEND and TRILUMINATE and found great clinical success with both, but found more clinical success commercially with T-TEER (Triclip), which has benefited over 20 patients at our institution since it's commercial approval in April. Every one of these patients has had clinical improvement and every one had no other options besides temporizing measures of diuretic adjustments. Unfortunately I've had to send far to many patients to hospice from cirrhosis and irreversible RV remodeling that won't allow for a Triclip or TTVR.

One of our first patients treated through TRILUMINATE was seen at her 3 year follow-up last month. She was hospitlized 4 times the year of her Triclip. She has not been hospitalized since, gardens (at 91 years old) and does 27 crunches everyday to "improve core strength". She is one of many examples we have clinically of success with this therapy.

I have more than 50 patients awaiting tricuspid therapies with no other options. This therapy is critical and necessary for our patients to not suffer and to have hope for the future both for longevity and quality of life.

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Previously, many have referred to the tricuspid valve as the "forgotten valve" as we focused on other pathologies for the aortic and mitral population. However, these patients are very sick and have decreased quality of life. In addition, we found that patients within severe tricuspid regurgitation had worsening outcomes with worsening tricuspid regurgitation leading to formation of massive and torrential categories of regurgitation. In addition, surgery is often higher risk for these patients, leading them to be managed often with medications alone. Diuretics can help in many cases of tricuspid regurgitation, yet many patients may go on to have renal dysfunction, liver dysfunction, and more.

However this valve is forgotten no more - with options now available to repair this valve without open heart surgery. The transcatheter revolution has led to significant advances in aortic and mitral disease and now it is the time for the tricuspid valve. We had the pleasure of enrolling in the TRILUMINATE trial. This landmark trial showed significant safety and efficacy of the Triclip system for tricuspid valve edge to edge repair. Multiple patients in my practice have had significant benefit and we believe this to be a great option for patients.

Transcatheter tricuspid valve therapy requires dedicated experience and a dedicated team. While there are learnings from other structural heart therapies this field has significant learning curve and close interaction between imager and implanter for best results. The technology is dedicated for the tricuspid valve allowing improved safety and maneuverability to treat both simple and complex pathology.

The future is bright with this therapy - and I strongly encourage the CMS to approve the NCD for this technology to allow patients across the US to have access to significant benefits from decreased tricuspid regurgitation. The quality of life improvement is a key metric that will allow these patients to live healthier and happier lives. We need an appropriate NCD with long-term, predictable, and consistent coverage for all Medicare beneficiaries. With this NCD, this valve will be forgotten no more - with the ability to increase access to care, improvement in outcomes, and dedicated research to continue the best that healthcare can offer.

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The medical literature and my 10 years of clinical practice devoted to heart valve disease tells us that severe, symptomatic TR - a disease that heavily impacts the female population - is a very morbid condition with few treatment options. Recent non-randomized as well as the randomized Triluminate trial Have demonstrated exquisite safety and meaningful clinical benefit for such patients when they undergo TV TEER. Having this treatment option available to us through FDA approval but with no payment makes the suffering are of our patients frustrating and I urge CMS to provide a payment for this Important intervention

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I am writing in support of the application for CMS coverage of tricuspid TEER therapy. For virtually all of my cardiology practice (21 years), we have rarely offered therapy for tricuspid regurgitation, despite abundant data showing a strong association between worsening TR, worsening RV size and function, and outcomes that all care about, such as mortality and heart failure (along with it's frequent requirement for hospitalization). TEER therapy now has a strong track record of safe and effective treatment of regurgitation, first in the mitral space, and now in the tricuspid space. It is granted that there is still much to learn about tricuspid valve intervention; but the ACC in partnership with the STS have created and harnessed the TVT database that will go a long way toward deepening our understanding of who should be treated, when they should be treated, and this will demonstrate profound benefits for patients.
Strong clinical trials to date have already demonstrated, in my mind, the safety of this procedure, and have already demonstrated significant, tangible benefits, which I fully expect will grow as time goes by. Based on the strong and favorable safety and outcomes data, I endorse approval of this technology for all Medicare recipients.

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Drink lots licorice root and rasberry bulb test with rose rub your body down with arnica oils an vitamins D, B, and K and vapor rub which will cause circulation to move through the issue lite movements and patience with your little one an your self. Maybe every a baby asprini and orange juice with beets juice mix in sanpellgrino or goood tasting $0.99 sparkling water like ICE or Clear Choice etc. with a few slices of citirus fruit light salads pre made from Walmart and Target with meats like chicken.

As Per Nature's Medicine Camille Campbell

Stage A: At risk. Risk factors for heart valve disease are present.
Stage B: Progressive. Valve disease is mild or moderate. There are no heart valve symptoms.
Stage C: Asymptomatic severe. There are no heart valve symptoms, but the valve disease is severe.
Stage D: Symptomatic severe. Heart valve disease is severe and is causing symptoms.

Cardiac catheterization. This test isn't often used to diagnose tricuspid valve disease. But it can be helpful if other tests haven't diagnosed the cause of the condition. A doctor guides a thin, flexible tube called a catheter through a blood vessel in the arm or groin. It's moved to an artery in the heart. Dye flows through the tube. This makes the heart arteries show up more clearly on X-rays taken during the test. Pressures in the heart also can be measured during this test.

Cardiac MRI. This test uses magnetic fields and radio waves to create detailed pictures of the heart. Cardiac MRI may help show the severity of tricuspid valve regurgitation. The test also gives details about the lower right heart chamber.

Electrocardiogram (ECG or EKG). This quick test records the electrical signals in the heart. It shows how the heart is beating. Sensors, called electrodes, stick to the chest and sometimes the legs. Wires connect the sensors to a computer, which displays or prints results.

Chest X-ray. A chest X-ray shows the condition of the heart and lungs.

Echocardiogram. This is the main test for diagnosing tricuspid valve regurgitation. It uses sound waves to create pictures of the beating heart. It shows how blood flows through the heart and the heart valves, including the tricuspid valve.

There are different types of echocardiograms. A standard echocardiogram is called a transthoracic echocardiogram (TTE). It creates pictures of the heart from outside the body. Sometimes, a more-detailed echocardiogram is needed to better see the tricuspid valve. This test is called a transesophageal echocardiogram (TEE). It creates pictures of the heart from inside the body. The type of echocardiogram you have depends on the reason for the test and your overall health.

Recent Reference of Acceptance of instruction
Mayo Clinic good review of information in full details.
11:38 AM 10/10/2024

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The recent development of structural interventions for treatment of valvular heart disease is one of the most significant advances in Medicine in the last 100 years. We finally can treat patients who otherwise often die of heart failure. The improvements in general health and cardiac outcomes provided by mitral TEER are impressive. Tricuspid TEER has similar potential for patients suffering from severe or greater tricuspid regurgitation. I heartily support Medicare coverage for this procedure to allow needy patients to benefit from this wonderful device.

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I am significantly in favor and strongly advocate for CMS approval for tricuspid valve TEER. This procedure is safe and associated with significant reduction in TR severity. Having been involved in the care of these patients and completed over 30 tricuspid TEER procedures I have been a direct witness of the immediate and mid-term impact on patient's symptoms, quality of life and heart failure class. It is quite remarkable in the appropriate clinical and anatomical setting.

Visualization of the tricuspid valve leaflet makes the procedure most challenging and laborious when compared to mitral TEER. Not infrequently, operators require the simultaneous of dual imaging with 3D-TEE and 3D intracardiac ultrasound to enhance procedural outcomes and device safety. Adding 3D ICE capabilities at the time of the procedure results in additional procedural access, procedural time and a major added cost (average $3500 per catheter/per case) to the organization. With that in mind, and contrary to mitral TEER, I would strongly advocate for CMS to support the add-on payment of 3D ICE in cases of tricuspid TEER for both physicians (RVU) and the organization (DRG). It will otherwise continue to represent an important financial burden for this innovative solution, and a risk to those patients that would otherwise benefit from its use.

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In expert hands and after thorough efforts of optimized medical therapy and continued GDMT and OMT after the T-TEER procedure, TriClip has shown to improve quality of life in patients who don't have other alternatives. In an attempt to achieve similar value for the patients, it appears critical to ask for the same thoroughness and expertise going forward. This is not a popular topic but in order to provide best value for these patients, guardrails like documented optimization of medical therapy prior to the procedure, shared decision making (similar to LAAO) and procedural volume requirements could be considered (i.e., >= 40 M-TEERs / year for the institution, or provider specific requirements). Of course, this comes with the caveat of allowing reasonable access to this therapy.

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I'm a Board Certified Cardiologist and practitioner. I treat patients with valvular heart disease on a daily basis. I have participated in the T-TEER FDA trials.
Tricuspid Regurgitation is a condition with limited surgical availability because the patients often have liver failure from passive congestion which makes them surgically inoperable. Most if not all of these patients with severe TR which is not adequately managed medically, will have an improved clinical outcome with tricuspid TEER. CMS should approve this condition so that medicare patients will have open access to this technology now that it has been approved by the FDA.

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As an operator of transcatheter edge to edge repair for Tricuspid Regurgitation, I can personally attest to the dramatic symptom and quality of life improvement experienced by my patients. The TriClip device has given this undertreated severe TR patients an opportunity to live and breath again! This therapy should be made easily accessible and widely available at appropriate medical centers so that patients can be treated in the communities in which they live and treated by experts who can deliver the best possible results.

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