Pump Device Found to Extend Lives of Heart Patients

The study appeared in the November 15, 2001, issue of The New England Journal of Medicine.

The study involved 129 patients with chronic ESHF, averaging 68 years old, who had not responded to medical treatment and were ineligible for heart transplantation. Of these, 68 patients had a LVAD, called HeartMate, implanted next to their natural heart to take over the pumping function of the left ventricle. The device employs a blood pump driven by an internal electric motor, which is connected to an external battery pack worn on a belt or shoulder pack. A control group of patients, averaging 66 years old, received angiotensin converting enzyme (ACE) inhibitors.

The patients with the HeartMate had a 52% chance of surviving one year, compared to 25% for patients in the control group. Quality of life was consistently higher in the
LVAD group at 12 months. The probability of device infection within three months was 28%. After two years, the device failed 35% of the time. The LVAD has been cleared by the U.S. Food and Drug Administration in 1994 as a bridge-to-transplant device. The study was administered through a cooperative research agreement among Columbia University (NY, New York, USA), the U.S. National Heart, Lung, and Blood Institute (NHLBI), and the developer of the LVAD, Thoratec Corp. (Pleasanton, CA, USA).

"This compelling study shows that even with a high rate of complications, a left ventricular device can provide a significantly longer and better quality of life in extremely ill heart failure patients,” said Dr. Claude Lenfant, NHLBI director.




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