January 20, 2010, ST. LOUIS – Physicians at Barnes-Jewish Hospital can expand use of a device targeted at helping heart failure patients survive long term, thanks to a decision today by the Food and Drug Administration (FDA).
The FDA approved the use of the HeartMate II device, a left ventricular assist device (VAD), for “destination therapy,” allowing an alternative to heart transplant for end stage heart failure patients.
“This is an opportunity to expand the use of mechanical assist devices in patients with advanced heart failure who are deemed not to be good heart transplant candidates,” says Greg Ewald, MD, medical director of the artificial heart program at Barnes-Jewish Hospital and Washington University School of Medicine. “These devices can serve as a long term mechanical therapy and many of these patients can return to a good quality of life with significantly diminished symptoms.”
VADs are devices that assist a failing heart in end stage heart failure pump oxygen rich blood through the body. They are surgically attached to the heart’s left ventricle and the device sits over the abdomen inside the skin and assists with heart function. External wires run from the device to a pack containing a power supply and the pump’s controller.
With the FDA approval, patients now can live long-term with the device in “destination therapy.” Previously, patients received HeartMate II as a destination therapy through a clinical trial at Washington University School of Medicine.
“We were one of the sites enrolling patients in destination therapy as part of a national trial,” says Dr. Ewald. “Results were recently presented at the American Heart Association meeting and that trial showed the HeartMate II is superior to the HeartMate XVE for long term heart failure and destination therapy."
“These devices give patients their lives back,” says Ann Petlin, RN, clinical nurse specialist in cardiac surgery at Barnes-Jewish Hospital. “Now, they’re able to get the circulation they need to survive.”
Barnes-Jewish Hospital has offered the HeartMate II to patients since 2002 as a “bridge to transplant,” allowing patients to live with the VAD until a donor heart became available through transplant. Use of such devices has expanded. In 2008, for the first time more devices (31) were implanted than donor hearts via transplant (24). In 2009 it was 52 VADS and 23 hearts.
That’s a considerable difference from the past few years, as on average the program’s surgeons implanted around 16 assist devices to around 25 hearts.
“Ventricular assist devices actually help us a lot in that a number of our patients get very ill while they’re waiting for transplant,” says Dr. Ewald. “In the past we would have put them on a cocktail of intravenous medicines and really hope that they got a donor call before they died of their heart failure.
“Now we can actually intervene in those patients, put in a device and support those patients until they can get safely transplanted, or they can live safely with the device at home long term,” says Dr. Ewald.
Barnes-Jewish’s has a 10 year track record of using VADs and is the only center in the region to implant them. In 2008, Barnes-Jewish Hospital’s ventricular assist device (VAD) destination therapy program earned the Gold Seal of Approval™ for health care quality by the Joint Commission, the nation's predominant standards setting and accrediting body in health care.