Ventricular Assist Devices as Destination Therapy

Shortly, the Center for Medicare and Medicaid Services must decide the appropriate criteria for Ventricular Assist Device (VAD) teams. As proposed, the selection criteria will apply only to the use of VADs for destination therapy, VAD placement as a final therapy for congestive heart failure patients. Specifically, these are patients have who have end stage disease and who would be viable candidates for heart transplantation if not for one or more contraindications or other medically limiting barrier to transplant. Examples would be those with high levels of panel reactive antibodies, causing them to be at prohibitive risk for hyperacute rejection, or cancer patients with apparently curative resections but who have not survived long enough to be judged cured.

The REMATCH Trial, as published in the New England Journal of Medicine demonstrated a clear, but short lived, survival and quality of life advantage. The best results were obtained in patients who were inotrope dependent at the time of entry and those operated at certain centers with more experience and carefully followed, long term, post operative follow up protocols. Indeed, one of our patients was among the longest survivors on support until she was successfully transplanted this month at the University of Alabama, the REMATCH center which accepted our referral of this woman. We did not think that she was a good candidate for transplantation because of her morbid obesity. When transplanted, having corrected her obesity, she was living on her fourth, and failing, HeartMate device. The care of these patients will be expensive and require expert and careful management.

These details of the results of REMATCH militate for VAD use as destination therapy to be limited to centers who have demonstrated competence in the management of all aspects of the care of end stage heart failure patients including transplantation and the management of bridge-to-transplant VADs.

The question is, “What are appropriate criteria for center selection?” The Joint Commission on Accreditation of Health Care Organizations has proposed that only centers with demonstrated expertise with the VADs be eligible. CMS has proposed to modify that requirement so that only VADs that are FDA approved for bridge-to-transplant be considered. There are only three devices that enjoy that approval, Thoratec VAD and HeartMate XVE, now both manufactured by Thoratec Corporation of Pleasanton, CA, and Novacor (World Heart, Oakland, CA). I would like to suggest that this criterion is too limiting for at least two reasons.

First, some heart transplant centers have achieved excellent results with other devices. For example, at the Medical University of South Carolina we have used the ABIOMED AB5000 VAD (ABIOMED, Inc., Danvers, MA) with very acceptable survival. The AB5000 is approved for LVAD, RVAD, or BiVAD support of patients as bridge to recovery. Native heart recovery is the goal for the majority of ABIOMED’s products. AB5000 patients are placed on support with the hope that they can recover cardiac function. If recovery does not occur, the device can be use as bridge-to-transplant. Since we implanted the world’s first successful AB5000 in December 2003, we have experience with 14 patients, the majority implanted for profound cardiogenic shock, with ten survivors (71%). Five were successfully transplanted, four recovered good native heart function and one is currently being supported and is ambulatory. Three were placed on BVS5000 support at a referring hospital, transferred to MUSC and transitioned to the AB5000 anticipating a long recovery period.

At issue, however, is not MUSC’s VAD success, but rather the reasons we chose the AB5000 as our BiVAD system for emergency use. Over the years we have occasionally, and successfully, used the pneumatic HeartMate for less emergent patients and the ABIOMED BVS5000 for patients in cardiogenic shock. We reserved the HeartMate XVE for our more chronically deteriorating heart failure patients, expected to be on support indefinitely. When the AB5000 was introduced, we considered the Thoratec VAD system. However, we thought that the AB5000 offered a distinct advantage, so, unable to justify two systems, we chose the AB5000.

The advantage for us was quite clear. We are the only heart transplant program in South Carolina. Our referring hospitals with cardiac surgical programs all used the BVS5000 to rescue patients who presented to them in cardiogenic shock or who could not be weaned from cardiopulmonary bypass. If the patient was thought to have a recoverable heart or was a potential transplant candidate, the patient, once stable, was transferred to MUSC for further management. The BVS5000 is a good short term device, but is limited to a week to ten days before complications of the device become problematic. This is too short a recovery period for some hearts and often too little time to find a suitable donor. If we needed to convert the patient to a longer term device, the Thoratec would require yet another large operation and usually a cardiopulmonary bypass run, adding risk and morbidity to an already critically ill patient. In contrast, the BVS5000 can be replaced with the AB5000 for longer term support at the bedside without any operation at all. In our particular situation, and that of many other heart failure and transplant centers, if the currently proposed criteria are accepted, we will be denied the possibility of offering our patients VADs for destination therapy despite having excellent results with transplantation and with the AB5000. We will be unreasonably limited only because, in choosing a VAD system, we tried to support our referring hospitals and to protect our patients from additional and unnecessary operations.

Second, many centers are placing other VADs as part of clinical trials, such as the HeartMate II (Thoratec Corporation), Jarvik 2000 (Jarvik Heart, New York, NY) , and Micromed DeBakey VAD (Houston, TX) which are not yet FDA approved for bridge-to-transplant. The majority of their experience, even if excellent, will be with VADs that do not qualify under the proposed criteria.

Finally, I am concerned that regulatory and oversight agencies will eventually apply the criteria for destination therapy programs to all medium and long term support indications for VAD use. As the technology improves, becoming more reliable, durable, and safer, VADs may become more routinely used as a substitute for transplantation, freeing donors for those patients who are likely to have the best long term results for transplantation. As prices fall as a result of economies of scale, new generations of VADs may become appropriate for NYHA Class 3B or even 3A patients, improving not only survival but quality of life. The overly restrictive criteria for experience with specific VADs as proposed by CMS will severely limit the therapeutic options of all but the largest transplant centers and those who chose the Thoratec or Novacor VADs over other systems.

Thus, I encourage CMS as well as the Joint Commission to expand the list of qualifying VADs, but not the requirement for demonstrated experience and acceptable results. In this time of a woefully inadequate supply of cardiac donors, this will expand the armamentarium for those of us who struggle daily with the care of America’s growing population of heart failure patients.

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The Joint Commission believes that its Disease-Specific Care Certification for Ventricular Assist Device as Destination Therapy can contribute to the quality of care that Medicare beneficiaries receive. Certification by the Joint Commission means a facility is complying with the most state-of –the-art national standards for safety and quality of care. The Joint Commission standards focus on essential performance improvement strategies that help organizations continuously improve the safety and quality of care, thereby reducing the risk of error or low quality care. The Joint Commission believes that the CMS proposed-time limit (24 months post final decision date) for existing and new facilities to be certified by the Joint Commission is sufficient. The Joint Commission stands ready to enter into an effective partnership with the Medicare Program, and plans to have a program available by May 1, 2007.

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To Whom it Concerns:

ABIOMED welcomes the opportunity to provide the following comments on the Centers for Medicare and Medicaid Services (CMS) proposed decision memo on ventricular assist devices (VADs) as destination therapy (DT). Our comments refer to the proposed modified criteria for CMS eligibility criteria and the VAD DT Certification requirements adopted in October, 2006, by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (herein “JCAHO Recommendations”).

In summary, ABIOMED’s position and requests for clarification are as follows:

(1) Abiomed supports CMS’s proposal to reduce the volume eligibility of centers from 15 to 10 over a three-year time period; however, Abiomed does not support the proposal that surgical expertise be limited to one type of VAD (i.e., those for “long term use”). Surgical expertise and patient management for the high quality of care that CMS wishes to achieve can also be obtained with the use of a wide range of VADs, including those indicated for native heart recovery. Abiomed respectfully requests that CMS clarify the criteria for eligible VAD expertise by the implanting surgeon and whether those VADs approved for native heart recovery, but which happen to be needed to support a patient for longer periods of time (e.g., more than 30 days), will meet the eligibility criteria for implanting surgeons.
(2) Abiomed does not support CMS’s proposal to eliminate the requirement that a hospital must be a Medicare-approved heart transplant facility. Abiomed respectfully requests further clarification for the rationale to expand eligibility to non-transplant centers based upon the experience of one facility and the potential short and long term consequences to the Medicare heart transplantation program should non-transplant centers select and manage VAD patients who may ultimately require transplantation. To that end, Abiomed does not support the proposal to eliminate the opportunity for exception to the established standards and instead, recommends that it be retained.
(3) Abiomed does not support CMS’s proposal to require facilities to be approved under JCAHO certification to the extent that the JCAHO certification requirements are in conflict with Abiomed’s recommendations noted herein.
(4) Abiomed’s position is that the AbioCor, total replacement heart, provides support for non-transplant candidates similar to those selected for DT. Abiomed seeks clarification as to whether volume experience with the AbioCor, total replacement heart, qualifies for eligibility for VAD surgical experience.

ABIOMED, Inc. develops, manufactures and markets medical technology designed to restore, recover or replace the pumping function of the failing heart. Currently, ABIOMED manufactures and sells the AB5000™ Circulatory Support System and the BVS® 5000 Biventricular Support System for temporary support of patients with reversible acute heart failure. These two devices are the only FDA-approved devices for all potentially recoverable heart conditions. The FDA-approved labeling for the devices describes their “short term use”; however, this is not quantified in number of days. Clinical experience has shown in recent years that patients may require up to 95 days of support to recover native heart function.

Additionally, the company’s AbioCor® Implantable Replacement Heart received market approval as an HDE (“humanitarian device exemption”) by the FDA in September 2006. The device provides bi-ventricular support for patients ineligible for heart transplantation.

(1) Abiomed respectfully requests that CMS clarify the criteria for eligible VAD expertise by the implanting surgeon and whether those VADs approved for native heart recovery, but which happen to be needed to support a patient for longer periods of time (e.g., more than 30 days) will meet the eligibility criteria for implanting surgeons. As stated in CMS’s decision to reopen the existing coverage decision, there is the concern that “facilities are not maintaining the volume of VAD procedures that originally qualified them for approval.” CMS proposes to reduce the VAD implant volume standard from 15 to 10 over a 3-year period. However, the proposed decision, including reference to the JCAHO certification program, includes only experience with “long- term VADs” or those “approved for use for 30 days or more.”

Abiomed recommends that CMS consider including the use of all VADs – regardless of labeling – that demonstrate the desired standard of care. Further, Abiomed respectfully requests that CMS clarify whether its intent in establishing a minimum volume requirement of facilities is to further the use of a limited number of VADs or whether it is the ability for a facility and its surgeons to demonstrate a level of clinical expertise in surgical care, patient selection and high quality patient management. Abiomed respectfully argues that if CMS believes that there should be a minimum of 30 days of VAD support for each patient implanted to demonstrate surgical expertise, then the VAD in which that expertise is acquired should be immaterial. In other words, the original labeling by FDA or the common parlance of “short term” versus “long term” should be secondary to the demonstrated quality of care and length of care.

We respectfully request that CMS consider the follow points in support of our position.

(a) “Short term” devices may be needed for long term for better patient care. According to the Abiomed database, as of December 31, 2006, 501 AB5000 implants have been performed on patients with known outcomes. Of those, 95 (19 percent) required support for longer than 30 days. The vast majority of these patients were on support due to post- cardiotomy cardiogenic shock and acute myocardial infarction followed by shock. Clinical experience increasingly shows that patients may need up to 3-4 weeks to recover native heart function. (see Anderson, above). These very sick patients require the same level of surgical expertise and patient management for high quality care as those who received a VAD for “long term use.”

(b) “Long term” devices may be used for short periods of time. According to the United Network for Organ Sharing (UNOS), operating under contract with the U.S. Department of Health and Human Services as the Organ Procurement and Transplantation Network, between 2003 and 2005 (most recent data available), between 21 to 24 percent of the heart transplant candidates who were on a VAD at the time of transplant had been supported on the device 30 days or less. Under the proposed CMS decision, experience with these patients would meet the eligibility criteria for certification, although the duration of patient care and the use of the device were less than 30 days.

2003 2004 2005 Total heart Tx’s 2057 2015 2125 No VAD at time of transplant 1634 1599 1638 Yes, VAD 30 days or less 94 90 > 116 Yes, VAD greater than 30 days 329 326 > 371 Source: OPTN/UNOS Heart Transplant Candidate Waitlist

(c) “Short term” devices may be needed as a bridge-to-transplant. Although not promoted for this use, the AB5000 has been successfully used as a bridge-to-transplant device when the patient’s native heart did not show signs of recovery within a reasonable amount of time. As of July 2006, 52 patients had been supported on an AB5000 at the time the decision was made to place them on the national waiting list for a heart transplant. Ultimately, 36 (69%) of these patients were transplanted and required, on average, 40 days of support on the AB5000. Again, although not approved by FDA for this indication and not promoted for this use, it is a clinically-acceptable practice to continue the mechanical support of a patient who was originally thought to have a recoverable cardiac condition on the AB5000 until transplantation is possible. It is indeed desirable to not transition these patients to another BTT device, since such an added surgical procedure leads to poor outcome. For the small group of patients (n=3) that underwent this extra procedure, all died. Under the proposed approach, the AB5000 experience was comparable to other VADs with a “long term” use indication, should qualify for surgical experience for DT certification.

(d) CMS doesn’t approve heart transplant centers based upon the type of procedures performed, but rather the total number of transplants performed. Medicare approved transplant facilities must meet minimum volume and survival standards for coverage and reimbursement. This well-established standard does not differentiate volume based on the type of heart transplant performed (e.g., cadaver, domino), but rather counts all transplants as meeting the minimum volume standard.

(2) Abiomed respectfully requests further clarification for the rationale to expand eligibility for non-transplant centers based upon the experience of one facility and the potential short and long term consequences to the Medicare heart transplantation program in doing so. To that end, Abiomed recommends that CMS not eliminate the opportunity for facilities to gain approval under an exception to their standards. The CMS proposed decision is replete with solid arguments that DT procedures be limited to facilities “with sufficient expertise in complex cardiac procedures” due to the “technically demanding nature of this procedure.” Abiomed respectfully requests clarification for the CMS proposal to expand DT certification to non-transplant facilities that have – with one exception – traditionally not sought DT certification nor been considered to have experience with heart transplantation, the only procedure noted to require a commensurate skill and level of care. It is difficult for Abiomed to support a proposal that does not consider a transplant facility’s experience with VADs of “short term” use (although often used for weeks and months) to be commensurate with the expertise CMS seeks, yet would allow facilities unaccustomed to evaluating and treating transplant patients to seek DT certification.

(3) As stated above.

(4) Abiomed’s position is that the AbioCor, total replacement heart, provides support for non-transplant candidates similar to those selected for DT. Abiomed recommends that the AbioCor, total replacement heart, is included in the devices for VAD DT experience and that CMS clarify this point in their Final Decision Memo. The AbioCor, total replacement heart, is indicated for patients who are in Class IV heart failure, less than 75 years of age, on more than two inotropes, ineligible for a heart transplant and who have no other viable alternative treatment available. These patients are not dissimilar to the mix of patients eligible for DT. The AbioCor is a bi-ventricular, fully implantable device. During the clinical trial of the device (2001-2004) the average length of support was 5.2 months. Patients were also prepared for discharge from the hospital and long-term at- home management was an essential part of the AbioCor protocol. It is anticipated that 5-10 facilities will perform upwards of 25 procedures in the immediate future. Abiomed respectfully recommends that surgical experience with this device be included in the volume criteria and requests that CMS clarify this in the final decision.

In summary, we respect CMS’s decision to re- evaluate their coverage of DT and to attempt to bring alignment with the recently established JCAHO certification criteria. However, we are concerned that the approach proposed will provide an unwarranted incentive for physicians and surgeons to overlook the possibility of native heart recovery, (even with the growing clinical evidence that it may require weeks or months of support on the AB5000 for heart recovery) in order to meet the volume criteria for DT certification. There are legitimate and clinically-sound scenarios where a “short term” VAD has been needed for long term use to optimize a patient’s chances of survival and recovery and alternatively, there are many cases where a “long term” VAD has been implanted for very short periods of time. We urge CMS to consider including VADs commonly known for their “short term” use in the volume criteria for DT certification should their use be clinically warranted for longer lengths of time and the same clarification be made for the AbioCor, total replacement heart.

Gwen Mayes
Director of Government Relations and Reimbursement

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January 24, 2007

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Blvd., Mailstop: C1-09-06
Baltimore, MD 21244-8016

Attention: CAG 00119R

Dear Dr. Phurrough:

On behalf of the American Society of Transplant Surgeons (ASTS), we are delighted to have the opportunity to comment on the proposed facility criteria for Ventricular Assist Device (VAD) implantation as destination therapy. The ASTS is comprised of more than1000 transplant surgeons and physicians dedicated to excellence in transplantation surgery through education and research with respect to all aspects of organ donation and transplantation.

ASTS firmly supports the efforts of the Centers for Medicare and Medicaid Services (CMS) to make LVAD implantation as destination therapy more widely available to Medicare beneficiaries, and believe that the proposed revisions of the facility criteria will further this goal. However, ASTS cautions that care should be taken to ensure that appropriate patient selection criteria are used to identify those Medicare beneficiaries for whom this procedure is an appropriate clinical option and that patients are fully informed of all of the options available to them, including transplantation. We also believe that it is imperative that the facility criteria truly limit the performance of these complex procedures to fully qualified facilities.

In this regard, on behalf of ASTS, we would like to express concern about four specific aspects of the proposed criteria: patient selection, volume standards, BSA requirements, and JCAHO “deemed status.”

Patient selection

ASTS’ primary area of concern with respect to the proposed criteria is the lack of detail in the requirements pertaining to patient selection criteria. While the proposed facility criteria indicate that LVAD as destination therapy is to be performed only for those patients who are inappropriate for transplantation, the proposed criteria do not indicate how this determination is to be made. Since Medicare reimbursement for LVAD implantation as destination therapy is at the same rate as heart transplantation, LVAD facilities (especially those that are not transplant centers) may have a financial motivation to implant LVADs as destination therapy without a full and comprehensive examination of whether the patient(s) involved are appropriate transplant candidates. In fact, many patients who receive an LVAD as destination therapy ultimately become transplant patients with successful outcomes.

We believe that it is in the best interests of patients and in the best interests of the Medicare Program that safeguards be put in place to ensure that facilities approved to perform LVAD as destination therapy have clear patient selection criteria and that these criteria are enforced consistently. In this regard, we recommend that CMS consider the following options:

January 25, 2007

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Blvd.
Mailstop: C1-09-06
Baltimore, MD 21244-8016

Attention: CAG 00119R

Dear Dr. Phurrough:
On behalf of The Society of Thoracic Surgeons, representing the vast majority of board certified cardiac and thoracic surgeons nationally; we would like to comment on the proposed NCA for facility criteria for Ventricular Assist Device (VAD) implantation as destination therapy.

We applaud the initiative the department has taken and the balanced approach that is necessary to serve the dual goals of making these life prolonging technologies available to Medicare beneficiaries while safeguarding the quality and appropriateness of the care they receive.

We agree that the rapidly growing indication for VAD implantation coupled with the paucity of donor organs requires an appropriate expansion of ventricular assist devices as destination therapy in patients who are not transplant candidates. But we must stress that the way in which this policy is implemented will make major differences in the outcomes of patients. We believe the careful and successful implementation of safeguards in training, experience, certification, and patient selection will determine the success of this policy.

As the surgeons who treat these patients, we know the necessity of highly qualified facilities and highly skilled practitioners to meet the complex clinical needs of these beneficiaries. We believe that the training, skill and experience of both the facility and the surgical team are of importance to the success of a program.

While we generally are supportive of your proposed decision, we would like to comment on several areas of concern and make a few recommendations.

VAD implant volume standard

The reduction in volume requirements to 10 over a three year period is of concern to STS, not from absolute numbers not being adequate, but that some surgeons could acquire good and consistent results in a shorter period of time if properly trained. On the other hand, some surgeons may have poor patient outcomes, even with numbers that would qualify them for Medicare approval. While we agree that experience of the facility, the physicians, and the team is of great importance, a standard of fewer than four VADs per year, implanted either as destination therapy or as bridge to transplant is a poor metric for certification of a program.. A more desirable measurement would be clinical outcomes data. A minimum number of as few as 5 implants may be adequate if the center and surgeon have shown good clinical practices and performance leading to outcomes that are comparable to national standards over the period of a year. More important than a pure volume standard would be whether the procedure was done appropriately, successfully, and whether the patient was able to be discharged.

Data in regards to morbidity and outcome will be available from the INTERMACS registry. Current non-risk adjusted actuarial survival on LVAD’s in transplant centers is 76% at 6 months. Morbidity rates can be expressed as events per 100 patient days and rates 2 standard deviations beyond the averages as well as actuarial survival rates that are 2 standard deviations below normal should reflect unacceptable standards.

We agree that the facility volume standard is strengthened by the requirements for the individual physicians. The requirements for training and experience of the cardiologist and the cardiac surgeon must reflect experience gained in a center that has been approved to do cardiac transplantation in order that the team be appreciative of the other options for patients with severe CHF including advanced CHF surgery and cardiac transplantation.

We agree that a continuous period of 36 months to meet the volume standard is more appropriate than the previous static period, and ensures that approved facilities continue to maintain their program and personnel. It should be clarified as well whether the current volume recommendation is required both for the facility as well as the surgeon. It should be clear that although a center may have performed the minimum requirement of implants, this may no longer be true if the primary surgeon leaves without a new surgeon who has also met Medicare criteria.

Patient selection
One of the major determinants of the effectiveness of this policy will lie in the appropriate selection of patients for both transplant and for destination therapy. Destination Therapy patients must be evaluated for transplant by physicians trained in transplantation. The JCAHO requirements are appropriate if the Surgeon and Cardiologist trained in a center where CHF surgery and transplantation are offered. We recommend that physicians who have trained in non-transplant centers wishing to provide VAD implantation enter into a temporary agreement with a nearby transplant center during their first year to provide training in patient evaluation and selection, management of patients, device specific training, and other areas as necessary. We strongly recommend that prior to selection for VAD implantation as destination therapy, patients be offered a second opinion from a transplant center that also provides VAD implantation as destination therapy. Patients must be given full disclosure of appropriate options for therapy, including their options to be evaluated for transplantation.

Non-transplant center training and certification
As recommended in the area of patient selection; training on appropriateness criteria, device procedure and technique, and patient management is an essential component of ensuring the safe implantation of VADs in these very difficult patients. We recommend that part of the initial certification criteria include a formal arrangement with an experienced center that could serve as a safety net while a new non-transplant center becomes proficient in the many systems necessary for successful patient management and care. This could be accomplished within a year. This becomes even more crucial if an LVAD recipient who might later be considered transplantable develops a complication which precludes successful long-term survival as a Destination patient and could now be considered a transplant candidate. Currently, data from the INTERMACS registry reveals that about 20% of patients who had an LVAD implanted with the intention to treat as Destination therapy, eventually qualify for cardiac transplantation.

Board certification
The Society of Thoracic Surgeons represents highly skilled and well trained cardiothoracic surgeons not only in the USA, but around the world. We have observed that many countries have developed and maintained very high standards for training and certification of cardiothoracic surgeons, and thus we believe that “Board certification” should not be read as US Board certification only, but to apply to equivalent board certifications from countries that maintain similar standards.

BSA requirements
One of the CMS inclusion criteria is that the patients have a BSA greater than 1.5M2. We are concerned that this criterion unnecessarily excludes some smaller patients who would benefit from some existing devices or rotary pumps. We would suggest that be revised to reflect “a BSA appropriate to the indications for use of the specific LVAD.”

Registry reporting requirements
The ultimate measure of program or facility performance is evidenced by the results achieved for patients. Just as the STS national cardiac database can yield outcomes data for facilities and surgeons, we believe a similar approach is necessary as an ongoing monitor of results surveillance for approved facilities. The INTERMACS registry currently has 55 of 68 activated centers enrolling data into the registry. We believe that all approved facilities should be required to submit data on all patients to this registry as a requirement for certification. We would also recommend including IDE device data on an ongoing basis in this registry as well. Rather than the current annual reports, it would be prudent to have INTERMACS report to CMS on VAD centers more frequently to address any serious quality shortcomings on a more immediate basis.

JCAHO Standards
We are supportive of the JCAHO role in facility certification with the above mentioned improvements to the criteria for the training of the facility, experience of the cardiologist, and inclusion of transplant experience for the cardiac surgeon.

We believe the changes we have suggested including;
1. Both cardiologist and surgeon be required to have transplantation experience;
2. Establishment of a relationship between non-transplant DT centers and transplant centers for training and selection education, for those physicians whose training occurred in a non – transplant setting and;
3.Monitoring of outcomes through INTERMACS, will help assure quality clinical outcomes and address the concern that patients who would benefit from a transplant might be denied consideration of transplantation.

We must balance our concerns with the understanding that the shortage of donor organs requires that alternatives be available and that we ensure the safety of those alternatives without unduly retarding their availability.

We appreciate the opportunity to comment on this proposed NCA, and are available to you should you wish to discuss the proposal in more detail. To do so, please contact Michael Hogan in our Washington office at (202) 481-1026.

Sincerely yours,

Robert L. Kormos, MD
Frederick L. Grover, MD
Chairman
President
STS Workforce on Surgical Treatment of
Society of Thoracic Surgeons
End-Stage Cardiopulmonary Disease

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1. VAD implant volume should not be the only criteria. Survival (short and long-term), complications, crossover to transplant, QOL surveys, etc. should all be included. All centers should be required to join INTERMACS registry, for documentation, policing and outcomes. Programs that only do 10 patients with superior outcomes are much more preferable to 20 with poorly selected patients and worse outcomes.

2. All non-transplant centers should be required to have a formal, protocolized, affiliation with a transplant center. This should be structured so that the transplant center can be an overseer for patients, and be their advocate. If non-transplant centers are truly opting for the best outcome for their patients, they should allow the option of discussion, to their patients, with a trusted transplant team and program. By having particular affiliations between transplant centers and non-transplant centers, protocols and optimal resource utilization can be employed. Criteria for "bridge-to-decision" can be jointly agreed upon by both institutions. Hopefully this would answer the accusation of 'center-shopping' when patients have complications.

3. Transplant centers that perform larger numbers of transplants, generally have more support personnel, greater interdisciplinary factions, social support, ancillary care and research funding. Diffusing that by requiring every DT therapy center to do transplants as well would only harm patient selection and outcomes. Transplant centers should be maintained as centers-of-excellence for a scarce commodity. Non-transplant center should be able to have trained, experienced and committed DT programs as a reflection of committed transplant programs.

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Thoratec Corporation is pleased to submit comments on the proposed Left Ventricular Assist Device Certification Requirements recently proposed by the Joint Commission on Accreditation of HealthCare Organizations (“JCAHO”). Thoratec Corporation is a world leader in left ventricular devices to treat cardiovascular disease. Our Thoratec® VAD and HeartMate® have been implanted in more than 10,000 patients suffering from heart failure, and the HeartMate is the only left ventricular assist system approved by the FDA for use in both bridge-to-transplant and destination therapy. Thoratec works closely with the physician and hospital community implanting LVADs to advance health care standards in support of high quality LVAD services.In addition to manufacturing the above devices, Thoratec Corporation dedicates significant resources to supporting patients, healthcare professionals and the communities utilizing left ventricular assist device (“LVAD”) technology. We believe that through education, patients will achieve superior outcomes and experience the best possible quality of life. To that end, we offer a wide range of instructional programs and materials to LVAD centers and patients. For example, when a center purchases HeartMate or Thoratec VAD technology, key staff members attend a laboratory based training session to learn about the surgical and perioperative management issues related to the devices. This is a multidisciplinary program designed to address a wide variety of patient management issues. Attendees include surgeons, cardiologists, surgical staff, and other key staff who will be directly involved in the care of HeartMate or Thoratec VAD patients. Additionally, we have developed programs to meet the surgical training needs of new physician members of established programs. These sessions focus on the surgical and operational aspects of HeartMate and/or Thoratec VAD technology. Specifically, we concentrate on issues such as patient selection, pre, peri- and post- operative management, and device implant/explant. Finally, we have developed several in-service programs to educate key hospital staff members and the community support network about the safe and effective use of LVADs.Thoratec has contributed directly to Medicare coverage and payment policies, including implementation of Medicare hospital certification. We bring our experience with these programs over the past four years, and our on-going discussions with CMS to our comments on the JCAHO LVAD standards. We thank CMS for their openness in reviewing our concerns and comments.

Eligibility Requirements

In the proposed Decision memo, it was noted that, In the absence of prior experience with destination therapy, but understanding that it required commitment by a hospital in terms of providing experienced staff and adequate facilities to support the long term care of seriously ill cardiac patients as well as the ability to perform highly complex cardiac surgery, CMS’ interim facility approval criteria established 15 as the minimum number of procedures (destination therapy as part of the pivotal clinical trial or bridge-to-transplant) that must have been performed by a facility in the 33 month period between 01/01/01 and 09/30/03 to qualify for approval. Sixty-nine facilities were certified, including 13 that were granted an exception to stated criteria. As mentioned above, one facility was not a transplant facility, but had evidence of high volume and high quality complex cardiac surgeries, which CMS believed sufficed as a substitute for transplantation experience. Twelve facilities did not meet the required volume of 15 VAD procedures; however, close review of their applications demonstrated their long term commitment to their VAD programs; recently increased volumes; and being on track to reach 15 implants in the very near future. CMS determined at that time that it was reasonable and necessary for destination VADs to be implanted in facilities nearing the requisite 15 implants, even though they had not quite achieved that number by the cut-off date in October 2003

Many of those “exception hospitals” as noted above have provided Destination Therapy to end-stage heart failure patients with excellent results. Many rural areas with lower population may not have a specific number of implants, but rather a commitment to excellent care. Also, situations and events can not always be foreseen such as the impact of Hurricane Katrina on the VAD programs through out the New Orleans area. CMS earlier had the foresight to understand acknowledge exceptions. We would encourage CMS to allow JCAHO the same opportunity to recognize centers with “long-term commitment” where a hospital and surgeon’s clinical track record, location, clinical team, and patient population are all considered during the review process. Considering the “totality of the circumstances” will allow JCAHO and or CMS to simultaneously ensure patient access and patient safety. It will also allow the Joint Commission to recognize competency, and good outcomes.

Thoratec also underscores that best-practices and clinical guidelines for LVADs are continuing to be refined. We therefore urge JCAHO to review its standards yearly and as the clinical guidelines are refined for LVAD procedures and patient care, JCAHO’s standards will need to be updated. A regular review will prevent the standards from becoming stale and will ensure that they reflect current best practices.

Conclusion

Thoratec appreciates this opportunity to comment on JCAHO’s proposed accreditation standards and commends the joint commission on the important work it has done in this area. Our comments reflect JCAHO and Thoratec’s mutual goal of ensuring access to high quality care.

Please contact us if we can be of any further assistance.

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The members of our transplant and LVAD teams have discussed the proposed changes. The following reflects the consensus opinion of our team members:

1) Reducing the volume standard from 15 to 10 over a three-year period: We are neutral in regards to this change, but realize that the decrease in required numbers may limit the temptation of some centers to implant devices to meet the lower minimum numbers. However, we would like some clarification of the requirements regarding an individual surgeon's experience since this number is per surgeon, not per program. If two surgeons in a program implant 15 devices together (one as primary surgeon and the other as an assistant surgeon), can they both qualify for approval/certification by claiming 15 implantations each?

2) Changing the volume measurement period: We support this change since a program should be judged on recent performance and not historical data.

3) Eliminate the requirement for Medicare approval for heart transplantation: We strongly oppose this change. We feel that only a program that offers both transplantation and destination therapy can appropriately evaluate the relative merits of each therapy for a given patient. We are concerned that many patients may undergo implantation of destination devices at non-transplant centers who are otherwise good transplant candidates. We feel that this is most critical until that time that there are destination devices with long-term results that rival transplantation. At that point, it may be reasonable to expand the number of centers offering destination therapy. While there are a few non-transplant centers in this country that offer excellent care for LVAD patients, these centers could qualify for destination therapy status under the current opportunity to apply for an exception to the rules (which is one reason that we oppose the next proposed amendment). If non-transplant centers are allowed to implant destination devices, we would recommend that these centers be required to have a contractural relationship with a transplant center so that all destination patients can be formally evaulated for transplantion before implantation.

4) Eliminating the opportunity for exception: We oppose this amendment. We feel that the community will be best served with rules that are more strict and limit the number of destination therapy programs with the opportunity for a program to apply for an exemption. Rules that allow a center with less experience to qualify may lead to an undesireable drop in quality. However, an exemption should only be granted under exceptional circumstances, such as a low-volume program with good results that treats patients in an underserved area.

5) Requiring JCAHO certification for the VAD program: We strongly support this proposal since only those programs that meet the strictest criteria should be destination centers.

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I believe that a destination VAD center should be at least a trasnplant center. Destination therapy is more difficult than heart transplantation. I've been involved in heart transplantation since 1982 and involved with VADs since 1985. It requires a TEAM of dedicated VAD engineers and nurses and full commitment from the hospital. We are a Medicare approved VAD and heart transplant center in Spokane, WA and I have seen what happens when facilities that are not committed to this implant VADs - they end up on my service!!

The facility must commit to providing this service by hiring the right people and investing in the infrastructure. We have had transfers of patients on short and intermediate term VADs because their centers couldn't handle the patients after they were implanted. One Medicare approved heart transplant and VAD center (a university center) that has a poor program with only one half time nurse recently sent us their destination HeartMate II patient to manage. They shouldn't be in the business if they don't invest in the infrastructure and subsequently can't manage the patient. Current policies don't insure that centers will develope the team which is necessary to care for these most difficult patients. The new "relaxed" criteria are a disservice to the patients.

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