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Ventricular Assist Device (VAD) Program

Ventricular Assist Device (VAD) Program at the Division of Cardiothoracic Surgery, SUNY Downstate Medical Center

There is a great need in the medically underserved area of Brooklyn in which SUNY Downstate Medical Center is located, for the treatment of advanced heart failure. In light of the shortage of donors for heart transplant, and the great number of patients with co-morbidities as contraindications to heart transplant in the patient population of Brooklyn, there is a great need for an alternative to heart transplant for this sizable population of patients with advanced heart failure.

Although laboratory and clinical research in this area has not been fruitful for more than three decades, the landscape has improved markedly in recent years for two reasons: improved technology and favorable reimbursement. The FDA has approved the use of implantable VAD for end-staged heart failure as “bridge to transplant “and “destination therapy”.

Currently, a number of miniature VADs are in clinical trials to this aim. One such device (Heart-Mate II) is approved as of February of 2008 as a “bridge to transplant” and its indication as “destination therapy” is expected within 2 years pending the results of an on-going trial. It is anticipated that a number of these miniature devices will be approved by the FDA in the near future.

The small sizes of these new devices have improved the safety profile of the surgery required for the implantation. Furthermore, they are less complex for long term use, significantly more durable, and associated with lower risks of infection and thromboembolism, which had been the major downsides of this technology.

The VAD program is expected to have significant pull-through effects and a positive impact on the volume of cardiac surgery and cardiology caseload. Phase I of the program will involve use of the VAD treatment as “bridge to transplant”. As such, the patients will need to be enlisted on the heart transplant list at a participating transplant program in advance. Once we have performed 10 such cases, we will be qualified to apply for a designation from CMS as a “Destination Therapy” program.

The regulatory requirements from CMS regarding the application process have been ascertained. In this phase II of the development, SUNY Downstate Medical Center will be allowed to treat patients with VAD therapy as their definitive treatment, to include those patients who are not candidates for transplant.

At this stage, we suspect there will be patients who will receive VADs as “bridge to recovery,” where the implantable VADs are used as temporary support until the hearts recover from the acute insult. They are expected to have their implantable VADs explanted electively. In phase III, our hope is that a heart transplant program will be a reality once the VAD program will mature.

To Contact Us:

Division of Cardiothoracic Surgery
450 Clarkson Avenue, Box 40
Brooklyn, New York 11203
Tel: 718-270-1981 | Fax: 718-270-3843