Recently approved heart device proven at Penn State Hershey

Based on the integral role Penn State Hershey Heart and Vascular Institute played in the landmark HeartMate II Destination Therapy Clinical Trial, Penn State Milton S. Hershey Medical Center announced today that the HeartMate II Left Ventricular Assist System (LVAS) has received FDA approval for Destination Therapy (DT), or long-term treatment option, for patients suffering from advanced stage heart failure who are not eligible for heart transplantation.

Now commercially available for all patients who qualify, the revolutionary device is the first continuous flow chronic LVAS to receive FDA approval for both bridge-to-transplantation and DT in the U.S.

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. For the 50,000-100,000 patients in the U.S. who do not qualify for transplant, due to age or other complications, such as cancer or other chronic medical problems, long-term therapy with HeartMate II may be an option. Penn State Hershey Medical Center remains among select cardiac centers in the nation to offer the state-of-the-art therapy to these advanced heart failure patients for whom there is a critical care need.

“We were able to participate and contribute to the study of the HeartMate II Trial, which demonstrated superiority of this new device over older technology,” said John P. Boehmer, program director of heart failure services at the Penn State Hershey Medical Center. “Our experience with this new device is similar to what was found in the study; patients do well and the device is very durable, allowing for long-term use with better quality of life. This is a breakthrough in offering long-term mechanical support now that people can live well for years on this device. We expect the demand for this type of treatment will increase, and we look forward to the opportunity to offer this treatment to more people in the Central Pennsylvania area.”

This year, the Medical Center has performed 53 successful implantations of mechanical circulatory support devices, including 26 left ventricular assist devices (LVADs) and 21 HeartMate II devices. The Medical Center has done 46 successful HeartMate II implants since 2006 when the organization joined the HeartMate II trial. Penn State Hershey Heart and Vascular Institute offers a wide range of the latest heart failure treatment options – including disease management services, pacing treatment to improve heart function, implantable defibrillators, high risk heart surgery, heart transplantation and clinical studies of new therapies for the management of heart failure. The doctors on the heart failure team are leaders in the field, including participation in the development of national guidelines and collaboration to advance knowledge of heart transplantation and mechanical circulatory support with devices such as the HeartMate II.

About the HeartMate II Clinical Trial for Destination Therapy (DT)

FDA approval of the HeartMate II for DT, followed a successful clinical trial of 200 patients enrolled at 38 centers.

The study was a prospective, randomized evaluation of the HeartMate II LVAS. Patients who did not qualify for heart transplantation were randomly assigned to treatment with the HeartMate® XVE LVAS (control group) or to treatment with the HeartMate II LVAS on a 2-1 basis, respectively.

The study concluded that treating patients with HeartMate II leads to dramatically improved survival (68 and 58 percent at one and two years), functional capacity (80 percent restored to and sustained at NYHA Class I or II through two years; doubling in six-minute walk test) and substantial improvement in quality of life unequaled by any other heart failure therapy.

Specific results included:

  • Dramatic improvements in functional capacity and quality life have been established in both Bridge-to-Transplantation and Destination Therapy.
  • At baseline, 96 percent of DT trial patients were NYHA Class IV/IIIB.
  • Seventy five percent improved to Class I or II at 3 months and 80 percent were Class I or II at 24 months

In addition, the study noted a significant reduction of adverse events, as HeartMate II is lower than the previous device in major categories (bleeding, infection, stroke, etc.).

The HeartMate II Destination Therapy trial demonstrated superior survival in this severely debilitated, high-risk advanced heart failure population with estimated survival of 68 and 58 percent at one and two years, comparing favorably to data on patients managed on medical management alone.

There also was a substantial and sustained improvement in the HM II patients’ 6-minute walk tests as the number of meters walked at two years more than doubled from baseline. At two years, HeartMate II patients achieved a median 6-minute walk of 372 meters, more than the distance of 4 American football fields. This improvement in 6-minute walk is a 3-fold improvement observed in Class IV patients during the COMPANION study.

About Heart Failure

The American Heart Association estimates that about five million Americans are affected by congestive heart failure, with 600,000 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.

HeartMate II LVAS (Left Ventricular Assist System) as an advanced heart failure treatment option

The HeartMate II LVAS was approved for Bridge-to-Transplantation in the U.S. in April 2008 and for Destination Therapy in 2009. A continuous flow device, the HeartMate II is an implantable LVAS powered by a rotary pumping mechanism. It is designed to have a much longer functional life than pulsatile devices and to operate more simply and quietly. The device, with only one moving part, 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. It also is smaller and easier to implant than a pulstatile device. Visit http://www.thoratec.com/ for more information.

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Last Updated February 10, 2010