Artificial Hearts

February 29, 2008

ABIOMED, INC., the manufacturer of the AbioCor, total replacement artificial heart, strongly supports the proposed decision by the Centers for Medicare & Medicaid to cover artificial hearts under Coverage with Evidence Development.

We agree that the evidence to date is promising for the use of the AbioCor in patients who are not eligible for heart transplantation, who suffer from bi-ventricular heart failure with no other viable medical or surgical treatment option. Approximately 80 percent of these patients will be Medicare beneficiaries based on age alone; therefore, Medicare coverage will be essential to the successful furtherance of this program. Coverage with Evidence Development (CED) as proposed would allow for coverage of Medicare beneficiaries who receive the AbioCor under a well designed clinical study as provided for by CMS. ABIOMED, INC. strongly supports, and welcomes, this approach.

ABIOMED, INC. received approval from the Food and Drug Administration (FDA) to market the AbioCor under a Humanitarian Device Exemption (HDE) status in September 2006 following an IDE clinical trial of the device from 2001 to 2004. Since FDA approval, four U.S. centers have been preparing for implants which will resume in early 2008. ABIOMED, INC. worked diligently and collaboratively with the FDA on the design of a post-market study that meets or exceeds the clinical study requirements outlined as part of CED under the proposed CMS coverage decision. All implanting centers are familiar with the post-market study and have agreed to participate in compliance with its requirements. ABIOMED, INC. understands that CED will allow for CMS to pay for items and services furnished in connection with this post-market study as conditioned upon the care being delivered in a setting that adheres to a pre-described set of study parameters. The FDA-approved post-market study meets these criteria and any revisions or additions to the study will be brought to the attention of CMS.

ABIOMED, INC. supports the approach that CMS has proposed to cover artificial hearts under Coverage with Evidence Development and welcomes their input and interest in this vital program. It is our hope that coverage will be available for these very sick patients when no other treatment is available.

Gwen Mayes, JD, MMSc
Director of Government Relations/Reimbursement

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I am a cardiothoracic surgeon, a practicing at St, Vincent''s Hospital in Indainapolis. I am writing in support of the proposed coverage decision by the Centers for Medicare & Medicaid Services to cover the AbioCor, Total Replacement Heart under Coverage with Evidence Development.

The AbioCor, artificial heart program, is an integral component of the full spectrum of care for patients with end-stage heart failure.

St. Vincent''s has been selected as one of the first centers to perform the AbioCor procedure. We anticipate approximately five patients to be identified each year who are not eligible for a heart transplant and who are in bi-ventricular failure with weeks or months to live. Finding a suitable mechanical device capable of support for this patient population is essential.

Coverage with Evidence Development, as I understand it, will enable Medicare beneficiaries to receive coverage under the in-patient payment system when the device is used in a clinical study with restrictions similar to those in the post-market study as approved by the Food and Drug Administration (FDA). We at St. Vincent''s are well versed in the post-market study protocol and are eager to work with FDA and CMS in compliance with this study in order for beneficiaries to be covered.

We anticipate that approximately 80 percent of the patients who will receive the AbioCor device are Medicare beneficiaries. Therefore, coverage under the Medicare program is vital to the success of this program. We recognize that other commercial carriers will look to Medicare for evidence of value in the technology.

On behalf of hundreds of patientsand families and future of advanced cardiac care, I urge you to adopt the proposed coverage decision and provide coverage for the AbioCor, total replacement heart, under the artificial heart program with Coverage with Evidence Development.

If you have questions, please contact me at 317-583-7600.

Sincerely yours,

Christopher T. Salerno
Surgical Director Heart Transplant Program
St. Vincent''s Hospital
Indinapolis, IN

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On behalf of myself and Texas Heart Institute’s patients and families, I urge you to adopt the proposed coverage decision and provide coverage for the AbioCor, total replacement heart, under the artificial heart program with Coverage with Evidence Development. Texas Heart Institute is committed to the artificial heart program and we understand the importance of providing a continuum of care for patients with advance heart failure. As you are aware, Texas Heart Institute has wide experience and expertise as a leader in cardiac care and transplantation and our resources and support that our program brings will ensure patients receive optimal care with the AbioCor.

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I am the Research Manager at CorVasc MDs and St. Vincent Hopsital in Indianapolis, IN. I am writing in support of the proposed coverage decision by the Centers for Medicare & Medicaid Services to cover the AbioCor, Total Replacement Heart under Coverage with Evidence Development.

The AbioCor, artificial heart program, is an integral component of the practice of CorVasc and St Vincent Hospital for patients with end-stage heart failure. St Vincent Hopsital has been selected as one of the first centers to perform the AbioCor procedure. We anticipate patients to be identified each year who are not eligible for a heart transplant and who are in bi-ventricular failure with weeks or months to live. Finding a suitable mechanical device capable of support for this patient population is essential.

Coverage with Evidence Development, as I understand it, will enable Medicare beneficiaries to receive coverage under the in-patient payment system when the device is used in a clinical study with restrictions similar to those in the post-market study as approved by the Food and Drug Administration (FDA). We at CorVasc and St Vincent Hospital are well versed in the post-market study protocol and are eager to work with FDA and CMS in compliance with this study in order for beneficiaries to be covered.

We anticipate that approximately 80 percent of the patients who will receive the AbioCor device are Medicare beneficiaries. Therefore, coverage under the Medicare program is vital to the success of this program. We recognize that other commercial carriers will look to Medicare for evidence of value in the technology.

On behalf of our patients and their families, I urge you to adopt the proposed coverage decision and provide coverage for the AbioCor, total replacement heart, under the artificial heart program with Coverage with Evidence Development.

If you have questions, please contact me at magfell@corvascmds.com

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I am one of the cardiac surgeons who are involved in mechanical assist device therapy. Treatment options for patients with biventricular failure is currently very limited. CardioWest Temporary Artificial Heart is the best available option for treatment of such patients since it supports both side of the heart. It would be very much beneficial to the society if cardiac surgeons in this country can provide the CardioWest device to our patients. I strongly urge the CMS to approve such service. Thank you.

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I am Robert D. Dowling, Professor of Surgery at University of Louisville and am a cardiothoracic surgeon practicing at Jewish Hospital in Louisville, KY. I am writing in support of the proposed coverage decision by the Centers for Medicare & Medicaid Services to cover the AbioCor, Total Replacement Heart under Coverage with Evidence Development.

Our group has extensive experience with mechanical circulatory support including the AbioCor Total Replacement Heart. The AbioCor, artificial heart program, is an integral component of the practice of cardiothoracic surgery for patients with end-stage heart failure. There clearly are a number of patients that need biventricular replacement. Furthermore, it has been shown that the majority of morbidity and mortality with left ventricular assist devices is due to problems with the native right heart. Continued clinical use of the AbioCor Total Artificial Heart System would be a major advance in the field of circulatory support.

Jewish Hospital has been selected as one of the first centers to perform the AbioCor procedure. We anticipate approximately 15 patients to be identified each year who are not eligible for a heart transplant and who are in bi-ventricular failure with weeks or months to live. Finding a suitable mechanical device capable of support for this patient population is essential.

Coverage with Evidence Development, as I understand it, will enable Medicare beneficiaries to receive coverage under the in-patient payment system when the device is used in a clinical study with restrictions similar to those in the post-market study as approved by the Food and Drug Administration (FDA). We at Jewish Hospital are well versed in the post-market study protocol and are eager to work with FDA and CMS in compliance with this study in order for beneficiaries to be covered.

I have been practicing heart surgery with an emphasis on cardiac replacement therapy for 14 years. We frequently see patients with biventricular failure who are not transplant patients or would not survive until a donor organ became available. The AbioCor Total Artificial Heart is the only device that can address these complications.

We anticipate that approximately 80 percent of the patients who will receive the AbioCor device are Medicare beneficiaries. Therefore, coverage under the Medicare program is vital to the success of this program. We recognize that other commercial carriers will look to Medicare for evidence of value in the technology.

I urge you to adopt the proposed coverage decision and provide coverage for the AbioCor, total replacement heart, under the artificial heart program with Coverage with Evidence Development.

If you have questions, please contact me at 502-561-2180.

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I have had the unique opportunity to be deeply involved with the translational research and clinical application of circulatory support devices for 3 decades. The real value of the CardioWest TAH is it fills an important void in the mechanical circulatory support spectrum of devvices: an implantable device that provides the optimal treatment for irreversible severe biventricular failure in the larger patient population. Simply stated there is not another device or combinations thereof that replace right and left ventricular function as safely and effectively. As such, this device is not only important to have available, but also reimbursable so it can actually be offered to patients. To utilize another less than an ideal device or combination thereof because the TAH is not reimbursed is more than tragic.

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I am a cardiothoracic surgeon at the Texas Heart Institute where I have been very active in mechanical circulatory support, both in the clinical application of available technology and in the development of new devices and procedures. I am writing in support of the proposed coverage decision by the Centers for Medicare & Medicaid Services to cover the AbioCor, Total Replacement Heart under Coverage with Evidence Development. It is clear to me that this device, and subsequent iterations of it, will play an increasingly important role in the management of patients with refractory heart failure.

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Dear Dr. Phurrough,

As a Medicare-approved heart transplant center, and high volume ventricular assist device center (for both bridge to transplant and destination therapy), we strongly support the proposed decision to cover artificial hearts under Coverage with Evidence Development (CED).

Our hospital currently serves an estimated 2,500 patients with a diagnosis of heart failure annually. We perform an average of twenty five heart transplants and fifty ventricular assist device implants each year. Given the national shortage of donor organs, we view the artificial heart as a viable option for both bridge to transplant and destination therapy patients. Specifically, we would like to begin to utilize an artificial heart device in patients who meet the FDA’s approved age criteria and who are not otherwise transplant candidates. We believe that this would assist approximately five patients at our center each year. These are patients who today have no other treatment options. We also believe that this number would increase over time as the artificial heart develops to become a standard of care.

In order for our artificial heart program to be viable, there must be a mechanism for coverage. Coverage under CED was designed specifically as a first step to coverage when a “reasonable and necessary” standard has not been met. This is a viable first step for the AbioCor Total Replacement Heart. Through coverage of the artificial heart, CMS will facilitate the on-going development of a treatment option that will improve outcomes and the quality of life for patients with heart failure.

In summary, Johns Hopkins supports the proposed decision to cover artificial hearts under CED when used in a clinical study. Based on the existing experience and data, we have full intention of utilizing the AbioCor device for appropriate candidates, and would like to be able to do this for Medicare beneficiaries. Lastly, we believe that the artificial heart requires the same specialized services as heart transplantation and ventricular assist devices, and therefore recommend that only centers approved for heart transplantation be considered for use of these devices.

Thank you for your consideration of this important initiative in the advancement in treatment of heart failure.

Sincerely yours,

John V. Conte, MD
Surgical Director, Heart Transplantation and VAD
The Johns Hopkins Hospital

Stuart Russell, MD
Medical Director, Heart Failure and Transplantation
The Johns Hopkins Hospital

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The CardioWest TAH is the only technology currently available for patients with severe biventricular failure. This device is significantly better than the alternative, which involves biventricular support with 2 separate VAD systems (BiVADs). This technology needs to be supported and be made available for our patient population. Although I believe the number of patients requiring this kind of support will be small, approval for reimbursement will allow its continued availability to patients. I would be glad to personally testify to the importance of this technology.

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We are writing in regard to your request for public comments on the proposed decision for coverage of artificial hearts. We wish to specifically address the CardioWest Temporary Total Artificial Heart (TAH). We believe TAH technology is backed by a full body of evidence with convincing results. The Utah Artificial Heart Program’s experience (formerly at LDS Hospital) is consistent with reported clinical trial reports. Specifically, 75% of our TAH patients achieved transplantation. Our decision to stop using the TAH related to difficulty with reimbursement and the large console requiring that the patient remain in the hospital. We believe the TAH provides optimal support for patients with bi-ventricular failure by rapidly restoring hemodynamic stability and end-organ function, with the least amount of side-effects. We would like to be able to provide TAH support to our patients with bi-ventricular failure, and respectfully request that the TAH be covered for bridge to transplant both in and out of clinical trials. Sincerely,
Bruce B. Reid, MD, Surgical Director, Utah Artificial Heart Program
Stephen E. Clayson, MD, Associate Surgical Director, Utah Artificial Heart Program

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February 25, 2008

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group Centers for Medicare and Medicaid Services
7500 Security Blvd., Mail Stop C1-09-06
Baltimore, MD 21244

RE: Proposed Decision Memo for Artificial Hearts(CAG-00322N)

Dear Dr. Phurrough:

Please consider this letter as my extremely strong endorsement for approval of the SynCardia biventricular replacement (TAH-t) by the Centers for Medicare and Medicaid Services. As the Director of the Advanced Heart Failure Program at Virginia Commonwealth University, it is my pleasure to serve as the Senior Cardiologist on both the Cardiac Transplant Program and our present SynCardia Program. It has been my personal pleasure to follow the development of the SynCardia Total Artificial Heart and then with FDA approval to have our group become one of the first trainees at the University of Arizona. We subsequently brought this technology to Virginia and have incorporated it as an intrical part of our Cardiac Transplantation Program.

The SynCardia Biventricular Replacement System represents, to my way of thinking, a quantum leap in technology and patient care for those patients with severe biventricular failure awaiting cardiac transplantation. The SynCardia Biventricular System delivers the highest cardiac output of any device system, and therefore permits rapid and significant improvement in our patients. For the placement of the total artificial heart, cardiac output is significantly increased and end organ involvement is significantly improved. Furthermore, the SynCardia Total Artificial Heart permits us to offer patients cardiac transplantation who otherwise would not be candidates due to the presence of right ventricular failure secondary to pulmonary hypertension.

Thus, the SynCardia Total Artificial Heart System represents a significant advance in the care of patients. Furthermore, the nature of the surgical procedure permits patient recovery at a far greater rate. The SynCardia Total Artificial Heart System requires only a median sternotomy, and there is no abdominal incision required. This again permits more rapid healing, permits an earlier return to nutritional support, and permits the patients to be up and about at a much earlier date. Our enthusiasm for the SynCardia Total Artificial Heart is documented by our results. We have taken eight patients with documented biventricular failure to the operating room and have placed this system in these eight patients, all of whom survived, were successfully rehabilitated, and at the appropriate times, taken back to the operating room and underwent cardiac transplantation. All eight patients were discharged from our hospital, having been successfully transplanted.

Thus, it is my firm opinion that the SynCardia Biventricular Replacement System is a significant advance in both our scientific technology and in patient care for patients with severe end stage heart failure. It is with my wholehearted recommendation that the SynCardia Total Artificial Heart be approved by Medicare and Medicaid for further dissemination to our patients that require this system who are obviously desperately ill.

Once again, I’d like to thank you and all your colleagues for the significant amount of work you have put into this project, and obviously if I can be of any further help to you in this matter or any other matter, please feel free to call.

Very truly yours,

Michael L. Hess, M.D.
Professor of Medicine
Richardson Scholar in Medicine
Director, Heart Failure/Transplantation

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Our institution was an early adopter of the Syncardia technology and it has provided an important adjunct to our management of end stage heart failure as a bridge to heart transplantation. The published results are known and are impressive and significant but first hand we have seen the benefits the Syncardia device provides for our patients. Today, patients are often managed effectively for much longer than in the past with current drug therapy. However, when patients finally fail, they are truly end stage with often biventricular failure, which is where the Syncardia device has significant benefits. A simple L-VAD is not able to correct the problems of right ventricular overload. As a consequence some of these patients do to survive or wind up with requiring two devices for the left and right ventricles respectively. The Total artificial heart provides biventricular support with one device which what has made it so important and successful in many late/end stage CHF patients needing mechanical support to stabilize and support patients waiting for transplant.

I remain confident that the Syncardia technology is important, successful and adds a real new dimension to bridging patients to transplantation.

Finally, an important point regarding Medicare support, at the present time we are unable to offer the best technology for all or our patients because of the lack of Medicare coverage. Hopefully a favorable decision to support the Syncardia device will be forthcoming so as not to continue to deny optimal therapy to all of the needing patients.

Thanks for your consideration.

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Over 5 million Americans suffer from congestive heart failure and increasing by the addition of nearly 500,000 new patients every year. Nearly 300,000 patients die annually and among them 15-25 percent die waiting for heart transplantation. Mechanical circulatory support devices by way of left ventricular and biventricular assist devices are currently used as bridge to heart transplantation with the native heart being left in-situ till the time of transplantation. However, in a select group of patients with intractable cardiac arrhythmias, clots in the heart chambers, post-infarction ventricular septal defects, and severe right heart failure, replacing the native heart with The Syncardia CardioWest Total artificial heart with its higher flows (>9 liters per minute) helps in faster reversal of end-organ dysfunction especially renal failure and hepatic congestion and provides an excellent bridge to heart transplantation (1). In our experience at Ohio State University Medical Center, we feel that Syncardia CardioWest Total artificial heart is an excellent choice of mechanical circulatory support in patients with biventricular failure awaiting heart transplantation. While the existing console is cumbersome, the availability of the portable driver would help in the convenient ambulation of the patient and even discharge from the hospital setting while waiting for transplantation. A current impediment to more widespread use of this important therapy has been Medicare’s policy of non coverage. This certainly limits institutions’ ability to offer this lifesaving therapy. The proposed CMS coverage of the total artificial heart will enable more patients to benefit from this lifesaving therapy and we wholeheartedly support this.

1. Copeland, JK, Smith, RG, Arabia, FA, et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. N Eng J Med 351(9):859-67, 2004

Chittoor B. Sai Sudhakar, MBBS, FRCS
Benjamin Sun, MD
Division of Cardio-thoracic Surgery
Ohio State University Medical Center
Columbus, OH 43210

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As the technology to provide Artificial Hearts to patients has reached maturity, as evidenced by the increased survival and quality of life, the priority should now be to ensure sustained reimbursement for the care of these patients. Persons living in the US have benefited from years of advances in cardiac care, but many also have survived to suffer with irreversible bi-ventricular heart failure. The ability to move swiftly to replace their failing hearts with Artificial Heart Technology will yield decreased costs to payors for years to come, by reducing chronic expensive costs such as dialysis and long-term ventilatory support. Current para-corporeal technology has limited these patients’s quality of life and has been fraught with the complications with long term support due to the scarce resource of donor hearts. Heart replacement technology will reduce these complications through internalization of components, increased reliability and portability of control and driver systems. At this institution we have been late to apply this technology because of the lack of reimbursement for these pumps and the patient care. However, the total cost of the patients care without the pump far exceeds the cost if we had been able to place the pump and return the patient to home, free of heart failure. At the University of Rochester we look forward to being able to return out patients to health with Artificial Heart Technology. However, without reimbursement, these severe bi-ventricular failure patients will continue to drain our communities’ resources as we provide them care as they still progress in the spiral of heart failure to their death.

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The recent decision by Centers for Medicare and Medicaid Services to consider approval of use of the artificial hearts or biventricular replacement devices is very important and must be applauded. The decision to support the development of this important technology as part of an ongoing clinical trial is visionary as it allows for payment for the use of this technology in lifesaving situations while supporting further innovation and development. Our own experience has been very promising in a very ill group of patients in whom use of biventricular assist devices in the past had a 50 % failure to survive as compared to biventricular replacement with the Cardiowest (Syncardia) device with 100% survival to transplant. It will important for the scientific community to work closely with industry, FDA and CMS to create studies that are well designed, valid and help to create excellent outcomes for patients.

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To Whom It May Concern:

The Abiocor Total Artificial Heart is the culmination of more than twenty years of research and development for effective implantable technology to replace the failing heart. This technology also allows a meaningful quality of life for patients not suitable for cardiac transplant or the use of other mechanical circulatory support. Indications for the use of this technology are uncommon and currently it should only be implanted at centers of experience and training suitable for its application. It is, however, of life-saving importance in selected cases.

The availability of this technology should not be denied to the small number of patients in whom this technology would be life saving and quite possibly their only option. Such cases would include, but not be limited to, amyloidosis, certain selected heart tumors and varieties of cases involving late transplant vasculopathy resulting in cardiac insufficiency in post heart transplant patients who are still candidates for long-term support and possible re-transplant. An example of such a case where this technology should be implemented, we currently have a woman we in our ICU in her 50’s who is dying with virtual destruction of her heart from a massive myocardial infarction. Such a patient can not be satisfactorily supported long-term by the current LVAD technology. In her case, total heart replacement would be necessary for her survival. It is difficult for me (or any physician) to tell her family nothing can be done when I know this technology was developed and designed for this purpose. She is still in the prime of her life.

In cases such as this we have the possibility for meaningful long-term survival yet currently we are unable to apply it. This is significant, life-saving therapy that remarkable durability and effectiveness for cardiovascular support. Its availability should be made to the small number of patients who would undoubtedly benefit from its application. If I can be of further assistance to you please feel free to contact me.

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February 20, 2008

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd, Mail Stop C1-09-06
Baltimore, MD 21244

Re: Proposed Decision Memo for Artificial Hearts” (CAG-00322N)

Dear Dr. Phurrough:

In response to your request for public comments on the proposed decision for coverage of artificial hearts, Virginia Commonwealth University Health System (VCUHS) strongly supports The Centers for Medicare and Medicaid Services (CMS) coverage decision proposal for the artificial heart as implanted according to CMS prescribed criteria including Coverage with Evidence Development. VCUHS has successfully implanted 8 Cardiowest Total Artificial Hearts (TAH) (Syncardia Systems, Tucson, Arizona) as a bridge to transplantation. As a leader in the utilization of this technology, VCUHS champions any activity leading to expanded coverage for this proven life-saving option for the critically ill advanced heart failure patient. Our own experiences and references to literature are highlighted below. We appreciate your consideration of these points in your final coverage decision..

Dr. Jack Copeland at the University of Arizona, Tucson reported a 79% survival rate for patients bridged to transplant with the Cardiowest TAH. The control group which did not receive a mechanical circulatory assist device had a 46% survival rate to transplantation. Comparable survival rates were seen post heart transplantation. Patients bridged with the Cardiowest TAH had an 86% vs. a 64 % one-year survival in the control group.

End stage heart failure patients face numerous clinical problems often leading to the need for a heart transplant. Unfortunately, there is a serious shortage of organ donors. To bridge the gap to transplantation numerous mechanical circulatory assist devices have been developed and are in routine clinical use throughout the world. Some of these devices are used as an alternative to transplant. Not all patients meet the criteria for device placement for a variety of reasons including patient size, technical or surgical reasons, intracardiac shunts or thrombi, structural damage to the heart, or congenital heart defects. The Cardiowest TAH offers a beneficial alternative in these cases (El-Banayosy et al, 2005).

Since April 2006, VCUHS has implanted the Cardiowest TAH in eight patients with biventricular failure. All eight patients have been successfully bridged to heart transplant. Of these eight patients, seven continued to do well and one died of conditions unrelated to the use of the artificial heart. The average time from implantation of the device to transplantation has been approximately 4 weeks. As candidates for heart transplantation are often seriously debilitated prior to receiving a replacement heart, the time on the device allows their physical condition to improve, which in turn contributes positively to transplantation outcomes. For example, VCUHS patients implanted with the Cardiowest TAH have improved to the point of being able to participate in exercise programs that include 30-45 minutes on the treadmill each day while awaiting their heart. This improvement in health status contributed to successful outcomes later in their journey.

Since 2000 VCUHS surgeons have implanted 30 left ventricular assist devices as a bridge to heart transplantation with a 70% success rate. For patients with left ventricular failure and sufficient right heart function, the left ventricular assist device works well. However, for those patients with biventricular failure the total artificial heart is a more effective option. The Cardiowest device replaces the diseased ventricles and allows patients to function with near normal physical activity while awaiting a donor heart. The Cardiowest TAH advantage over several other models of biventricular assist devices is the degree of mobility the patient is afforded.

VCUHS is committed to providing the best available technology and care to patients with severe heart failure, requiring bridge to transplantation. There have been 4 instances in the past year where patients were denied access to the use of the total artificial heart due to insurance related issues. Our facility has provided indigent care in two cases to ensure this life saving technology was available to those in need. Five cases were covered by commercial insurers and one was covered by the Veterans Administration. From our experiences, patients with biventricular failure have the best outcomes with the Cardiowest Total Artificial Heart as noted with our reported success. Medicare coverage for this device is vital to ensuring healthy futures of patients with severe heart failure.

Most sincerely,

_______________________
John F. Duval
Chief Executive Officer
Medical College of Virginia Hospitals
VCU Health System

References

1. Copeland JG, Smith RG, Arabia FA, et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. NEJM 2004; 351 (9): 859-867.

2. El-Banayosy, Aly, Arusoglu, L, et al. Cardiowest Total Artificial Heart: Bad Oeynhausen Experience, The Society of Thoracic Surgeons, 2005,(80): 548-552.

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I agree the TAH use is not ready to be covered by CMS if implanted outside a major Heart Transplant center with signifficant VAD experience.

In experienced hands TAH has had better results than BiVAD for treating patients with end-stage biventricular heart failure. Patient selection and expert care are most important.

At VCUHS (Richmond, VA) we have implanted 8 Syncardia TAH-t devices in 2 years. ALL of these patients have made a great recovery and ALL of them have received a heart transplant successfully!

These patients did better, recovered faster (= spent less healthcare money) than they would have with BiVADS.

I would argue that TAH should be seen as an improved version of VADs and covered by CMS.

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I am a Mechanical Circulatory Support Coordinator and work intimately with our patients on support at home. I''m writing today to comment on SynCardia''s new driver allowing patients to go home! I cannot impress on you enough the effect of going home has for patients: some sense of control of their healthcare, self-worth, and feeling alive! I''ve seen our patients who were stuck in the hospital almost waste away while waiting with a VAD versus the folks who go home and sleep in their own bed, interact with their family and friends, do activities with their family and/or friends, gain weight (appropriately), become happier, cope better, exercise and become part of the healthy world. Even when I tell patients they are required to come to clinic once/week they are okay with that because the rest of the week they are home! Discharging patients from the hospital environment changes the patients'' perspective. They see themselves as "healthy" or at least on the mend towards healthy. The psychological benefits go a long way towards healing of the patient.

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