Cardiac specialists at BWH offer circulatory assist devices for cardiac conditions including advanced heart disease, acute myocardial infarction and cardiogenic shock, and complex coronary artery disease.
Cardiac specialists at Brigham and Women’s Hospital’s (BWH) Cardiovascular Center have been leaders in the clinical development of left ventricular assist devices (LVADs) and have participated in trials of LVADs intended as bridge to recovery, bridge to transplantation, and permanent therapy. In addition, according to Gregory S. Couper, MD, Surgical Director, Circulatory Assist Program, “The recent availability of percutaneous VADs has opened up a progression of therapies that can address heart failure from its most acute to chronic presentations.”
Michael M. Givertz, MD, Medical Director of the Heart Transplant and Circulatory Assist Program, concurs. “The VAD program is a multidisciplinary effort including cardiology, cardiovascular surgery, and dedicated nurse practitioner and nursing education participation. We work in partnership to offer the most appropriate and advanced therapeutic approach for every patient.”
HeartMate II
Currently, the Cardiovascular Center is a site for a national, multi-center pivotal trial of the HeartMate II as permanent therapy. The trial will compare the HeartMate II with the earlier-generation HeartMate XVE, which BWH surgeons have implanted both as bridge and as destination therapy for a number of years. Dr. Couper says, “The HeartMate II is a continuous flow VAD that we believe will improve patient care. It is quiet, portable, smaller and more durable than pulsatile devices.” The HeartMate II expands the benefits of VAD therapy for heart failure to smaller patients, including small women who had previously been excluded from VAD therapy.
In addition, the HeartMate II is simple, with only one moving part, and is less subject to mechanical stress. Therefore it is expected to last longer, potentially as long as three to five years, as compared with the HeartMate XVE which has an expected life of 15 to 24 months. Exciting data just presented at the American College of Cardiology national scientific meetings also shows that the HeartMate II has a much improved safety profile compared with the earlier generation device, with 3- to 10-fold lower rates of infection and stroke.
New percutaneous assist devices
Cardiovascular Center surgeons also work with cardiologists to provide percutaneous assist therapy for patients who are not candidates for surgical approaches. They have experience with the Impella 2.5 Recover and the TandemHeart devices. The Impella is currently being implanted under an investigational protocol to support patients during high-risk angioplasty.
It is intended for patients who are at ultra-high risk for major complications including heart attack and death during angioplasty, who are not surgical candidates, and who have only one remaining vessel supplying blood to the heart.
The TandemHeart is the only FDA-approved percutaneously placed (non-surgical) VAD option for high-risk angioplasty patients. It is used to support patients during high-risk angioplasty, and also to support patients with acute myocardial infarction and cardiogenic shock. The device may be left in place for up to fourteen days, serving as a bridge to recovery or to a permanent assist device. Frederic S. Resnic, MD, MSc, Director, Cardiac Catheterization Laboratory, says, “We are encouraged that percutaneous ventricular assist devices will afford an opportunity to stabilize emergent patients and identify the best permanent therapeutic approaches.”
Early referral
Dr. Couper recommends early referral for VAD therapy. “We can offer a broad range of therapeutic devices as well as multidisciplinary expertise and experience that allow us to design the most appropriate therapy for each patient. Higher levels of support earlier in the disease course or the hospitalization, before the onset of multisystem dysfunction that prevents or confounds treatment, may lead to better outcomes.”
To Refer a Patient for a VAD Trial
Patients with advanced or refractory heart failure who have failed optimal medical management, are inotrope or intraaortic balloon-pump dependent, and who are not eligible for heart transplant may be appropriate candidates to receive the HeartMate II. To inquire about the trial or to refer a patient, please contact Michael M. Givertz, MD, Transplant and Circulatory Assist Program at (617) 732-7347. To inquire about percutaneous VAD therapy trials, please contact Dr. Resnic at (617) 732-7133 or at fresnic@partners.org
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