Saint Luke's Mid America Heart Institute only program in region with FDA-approved device therapy for advanced heart disease
KANSAS CITY, Mo. — Patients with advanced heart disease who do not qualify for transplantation now have more options for life-extending therapy available only at Saint Luke's Mid America Heart Institute.
The Thoratec HeartMate II® Left Ventricular Assist System (LVAS) recently was FDA approved for use as permanent or Destination Therapy for patients suffering from end-stage heart failure. It is the only continuous flow implantable left ventricular assist device to receive FDA approval for both Bridge to Transplantation and Destination Therapy.
Saint Luke's Mid America Heart Institute is among select cardiac centers in the nation and the only heart program in the Kansas City region to offer the state-of-the-art therapy to these advanced heart failure patients for whom there is a critical care need.
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 quality for transplant, due to age or other extenuating circumstances, long-term therapy with HeartMate II may be an option.
Expanded use of the ventricular assist device offers new hope according to A. Michael Borkon, M.D., director of cardiac transplantation at Saint Luke's. “We see many patients for whom transplant isn't an option. The ability to now offer a ventricular assist system as long-term destination therapy is a notable addition to the comprehensive package of advanced heart failure treatment options offered at Saint Luke's,” he said. “It's great news for patients with advanced disease who otherwise have few options – the device can offer them improved survival and improved quality of life.”
Saint Luke's has performed over 36 successful implantations of ventricular assist devices (VADs) since 1999. The heart institute offers a wide spectrum of the latest heart failure treatment options and is involved in several clinical research trials. These include advanced mechanical circulatory support therapies such as extracorporeal membrane oxygenation (ECMO), an extravascular aortic counterpulsation device, and cardiac gene therapy.
About the HeartMate II Clinical Trial for Destination Therapy
The Thoratec HeartMate II® Left Ventricular Assist System (LVAS) received FDA approval as a Destination Therapy or long-term treatment option for patients suffering from advanced-stage heart failure on Jan. 20, 2010. FDA approval followed a successful clinical trial of 200 patients enrolled at 38 centers.
The study was a prospective, randomized evaluation. 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 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.
A continuous flow device, the HeartMate II is an implantable LVAS powered by a rotary pumping mechanism. With only one moving part, the device 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.
About Heart Failure
The American Heart Association estimates that about 5 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.
About Saint Luke's Heart Failure and Transplantation Program
Saint Luke's Heart Failure and Transplant Program is an integrated program offering comprehensive services to patients with all stages of heart failure, including mechanical circulatory support and heart transplantation. Now celebrating the 25th year of its founding, the heart transplant program has grown to become one of the top 10 in the nation in volume of adult cardiac transplantation, surpassing national benchmarks for volumes and survival. The program has transplanted more than 462 patients since 1985.