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HeartMate II ventricular assist device improves survival in heart failure

Posted Mar 16 2010 12:00am - Patients in severe heart failure who are too sick for transplantation have another lifesaving option these days surgery to implant a new compact, lightweight ventricular assist device (VAD) - the FDA-approved second generation VAD called HeartMate II. The procedure is available in San Antonio from Jay D. Pal, M.D., Ph.D., a cardiothoracic surgeon recruited in 2009 to The University of Texas Health Science Center at San Antonio.

Dr. Pal is a member of UT Medicine San Antonio, the multispecialty practice of physicians in the Health Science Center’s School of Medicine. Dr. Pal specializes in heart and lung transplantation, VAD implantation, surgery for heart failure, coronary revascularization and valve surgery. With his arrival, San Antonio now has a specialty-trained heart transplant surgeon with extensive experience with mechanical circulatory support.

Ventricular assist devices have come a long way since the first model gained U.S. Food & Drug Administration (FDA) approval in 1994. VADs now are available to a wider range of patients, not only those who need a short-term bridge to transplant but also those for whom a VAD will be the sole means to provide improved, long-term cardiac function. The VAD is called “destination therapy” for these patients.

In January 2010 the FDA gave the green light for HeartMate II, a second-generation VAD, to be used in this acutely ill population. HeartMate II is a continuous-flow, left ventricular assist system that is implanted just below the heart to provide mechanical circulatory support, according to an FDA press release. The system is powered by an electrical cable that passes through the skin to a controller worn around the waist.

The FDA action came after a multicenter study found that HeartMate II significantly improved survival and decreased complication rates when compared to earlier-generation devices.

“The FDA approval of HeartMate II is significant for multiple reasons,” Dr. Pal said. “First, it confirms the safety and efficacy of this device in the treatment of advanced heart failure for extended periods in patients who are not eligible for heart transplantation. Second, it provides a proven treatment option for many patients who have significant limitations in quality of life due to heart failure. The new approval allows us to provide this lifesaving treatment to a new population of patients who were previously not candidates for mechanical circulatory support.”

For more information about this FDA-approved therapy, including patient eligibility, please call the cardiothoracic surgery group of UT Medicine San Antonio at (210) 358-8001.

HeartMate II is a registered trademark of Thoratec Corp. of Pleasanton, CA.

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