National Coverage Analysis (NCA) View Public Comments

Artificial Hearts

Public Comments

Commenter Comment Information
Mayes, Gwen Title: Director, Government Relations
Organization: ABiom
Date: 03/01/2008
Comment:

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

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Salerno, MD, Christopher Date: 02/29/2008
Comment:

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

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Kar, Biswajit Organization: Texas Heart Institute
Date: 02/29/2008
Comment:

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

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Gfell, Mary Anne Title: Clinical Research Manager
Organization: CorVasc MDs
Date: 02/29/2008
Comment:

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

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Kohmoto, Takushi Date: 02/29/2008
Comment:

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.

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Dowling, Robert D. Title: M.D./Professor of Surgery
Organization: University Cardiothoracic Surgical Associates/University of Louisville
Date: 02/29/2008
Comment:

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

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Pae, Walter Title: William S Pierce Professor and Chief of CT Surg
Date: 02/29/2008
Comment:

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

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Cohn, William Title: Director Of Minimally Invasive Surgical Technology
Organization: Heart Failure and Transplant Service
Date: 02/29/2008
Comment:

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

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Banister, Nicole Title: Administrative Manager
Organization: Johns Hopkins Hospital
Date: 02/28/2008
Comment:

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

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Moazami, Nader Title: Associate Professor of Surgery
Organization: Washington University School of Medicine, St Louis
Date: 02/26/2008
Comment:

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

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Reid, Bruce Title: Surgical Director, Utah Artificial Heart Program
Organization: Intermountain Medical Center
Date: 02/25/2008
Comment:

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

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HESS, MICHAEL Title: PROFESSOR OF MEDICINE
Organization: VCU PAULEY HEART CENTER
Date: 02/25/2008
Comment:

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

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Vetrovec, George Title: Chairman of Cardiology
Organization: VCU Medical Center
Date: 02/25/2008
Comment:

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

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Sai Sudhakar, Chittoor Title: Assistant Professor
Organization: Ohio State University Medical Center
Date: 02/25/2008
Comment:

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

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massey, h todd Date: 02/25/2008
Comment:

current biventricular support is insufficient for longterm clinical applicationexisting artificial heart technology is superior to current paracorporeal optionscurrent reimbursement to hospitals has prevented wider application and advancement of this technology

Hallinan, William Title: Clinical Director
Organization: University of Rochester Medical Center
Date: 02/25/2008
Comment:

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

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Kasirajan, Vigneshwar Date: 02/22/2008
Comment:

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

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Haft, Jonathan Title: Assistant Professor of Cardiac Surgery
Organization: University of Michigan
Date: 02/22/2008
Comment:

The Cardiowest TAH-t is the best option for patients with end stage heart failure and severe biventricular failure as a bridge to heart transplant.

Frazier, M.D., O. H. Title: Chief, Transplant Services
Organization: St. Luke’s Episcopal Hospital
Date: 02/21/2008
Comment:

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

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Duval, John Title: Chief Executive Officer
Organization: VCUHealth Systems, MCV Campus
Date: 02/21/2008
Comment:

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

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Katlaps, Gundars Title: Cardiothoracic Surgeon
Organization: VCUHS
Date: 02/20/2008
Comment:

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

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Andrus, Shauna Title: RN, Mechanical Circulatory Support Coordinator
Organization: University of Washington Medical Center
Date: 02/10/2008
Comment:

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

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