April 25, 2008

The Thoratec® HeartMate II Left Ventricular Assist Device received FDA approval this week as a bridge-to-transplantation treatment option for patients suffering from advanced heart failure.

The device is the first of a new generation of blood pumps to receive FDA approval in the United States. Unlike the first generation devices containing pulsing pumps and valves, these continuously flowing rotary pumps do not need such components so they are smaller, quieter and less prone to complications.

INTEGRIS Baptist Medical Center is one of only 44 centers in the country, and the only one in Oklahoma, participating in the landmark clinical trial of the HeartMate II LVAD.

“The HeartMate II trial is influencing the evolution of medical science,” says program director James Long, M.D., Ph.D. “This next-generation device provides life-saving potential for patients who may not otherwise survive without this important therapy. This gives us one more option for combating heart failure and improving quality of life.”

INTEGRIS Baptist Medical Center is the only facility in Oklahoma that offers a full spectrum of advanced cardiac care options with mechanical circulatory support devices, providing everything from temporary to permanent treatment options.

While the bridge-to-transplantation arm of this study is now complete, Dr. Long and his team at INTEGRIS will continue to participate in the “permanent” long-term therapy arm of the HeartMate II LVAD trial, exploring ways to better treat chronic heart failure.

Persons with advanced heart failure can call the INTEGRIS Advanced Cardiac Care office to learn more about their options at (405) 713-7040.

ADDITIONAL INFORMATION:

HeartMate II LVAS as a Treatment Option
The HeartMate II LVAS is a mechanical circulatory support system intended for a broad range of advanced-stage heart failure patients. A rotary, continuous-flow device, the HeartMate II is designed to provide long-term cardiac support. The device is implanted alongside a patient’s native heart and is designed to take over the pumping ability of the weakened heart’s left ventricle – it can pump up to 10 liters of blood per minute covering the full output of a healthy heart. The HeartMate II is designed for easier implantation and for improved reliability and patient quality of life. An external system controller regulates pump speed, and a power cable connects the device to a small monitor and power base unit. The device is designed to have a much longer functional life than the previous generation of devices and to operate more simply and quietly. It is also significantly smaller in size.

About the HeartMate II Clinical Trial
FDA approval of the HeartMate II for bridge-to-transplantation followed a successful clinical trial involving 44 centers in the United States and two in Canada with approximately 450 BTT patients. The approval was based on data from the first 194 patients enrolled in the trial. Clinical evidence supported improved survival rates and quality of life for a broad range of patients. Highlights of the data submitted to the FDA include:

• The median duration of support was 132 days, and the cumulative patient support in the trial was 109 years.
• Survival to cardiac transplantation, recovery or ongoing was 80 percent at six months and 77 percent at one year.
• Eighty four percent of the patients survived to hospital discharge or transplantation.
• Significant improvements were observed across all measures of functional status and quality of life as compared to baseline status.
• The incidence of major adverse events with comparable definitions – including infections, strokes and bleeding requiring surgery – was significantly lower than what was clinically observed in the previous BTT study of the first-generation HeartMate VE LVAS.
• The majority of patients demonstrated significant improvement, progressing from severe heart failure symptoms even at rest to being able to resume normal activities with little or no limitation, as noted by 85 percent improved to NYHA Class I or II and 15 percent improved to NYHA Class III.

About Heart Failure
The American Heart Association estimates that about five million Americans are affected by congestive heart failure, with 550,000 new cases diagnosed each year. The prognosis for patients with advanced heart failure is poor, with projected one-year mortality rates exceeding those of other terminal diseases such as AIDS, leukemia and lung cancer. According to the American Heart Association, cardiovascular disease remains the No. 1 cause of death in the United States. Though transplants offer hope for approximately 2,000 advanced heart failure patients each year, more than 250,000 patients have no viable treatment option and are considered at high risk for repeated hospitalizations, severely diminished quality of life and limited life expectancy.