71-year-old patient becomes first in country to receive device with new approval for ‘Destination Therapy’
MORRISTOWN, NJ FEBRUARY 5, 2010 – A 71-year-old Morristown Memorial Hospital patient became the first in the nation to receive the HeartMate II Left Ventricular Assist System as a Destination Therapy device in a non-transplant center. The device received FDA approval on Jan. 20 for Destination Therapy, which is a long-term treatment option for patients suffering from advanced-stage heart failure but who do not qualify for a heart transplant. HeartMate II is the first and only continuous flow chronic LVAS to receive FDA approval for both bridge-to-transplantation and Destination Therapy. Gagnon Cardiovascular Institute, located on the campus of Morristown Memorial, became the first commercial non-transplant center in the country to implant this device as Destination Therapy.
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 country who do not qualify for transplant, due to age or other extenuating circumstances, long-term therapy with HeartMate II is now an option.
“This device offers life-saving potential to patients who may not otherwise survive,” said Frank Smart, MD, chairman, cardiovascular services, Atlantic Health System, which owns and operates Morristown Memorial and Gagnon Cardiovascular Institute. “We expect patients who receive the HeartMate II to experience a significant boost to their functional capacity and quality of life.”
Gagnon’s Heart Success Program for patients with heart failure 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. Morristown Memorial’s ventricular assist device program has received the Gold Seal of Approval from The Joint Commission for Advanced Certification in Long-Term Ventricular Assist Device therapy, demonstrating that it is patient-centered, comprehensive, well developed and has met stringent standards of care.
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.