Intermountain Press Release

Murray, Utah —Patients in Utah with advanced heart failure who might otherwise face death are among the first in the nation to benefit from a newly-approved treatment option studied extensively by heart researchers at Intermountain Medical Center.

Intermountain Medical Center is of only 44 centers in the country to participate in the Thoratec HeartMate II Clinical Trial, which tested the effectiveness of the HeartMate II Left Ventricular Assist System (LVAS) as a bridge-to-transplantation treatment option for patients suffering from advanced-stage heart failure.

Based on findings from the clinical trial, the U.S. Food and Drug Administration has approved the tiny mechanical device as a temporary bridge for patients dying from advanced heart failure who need a transplanted heart for long-term survival. The HeartMate II is the first continuous flow cardiac assist system to be approved by the FDA in the United States.

The Intermountain Medical Center program has performed 225 successful implantations of ventricular assist devices in recent years, including 33 HeartMate II implants since 2005 when the national HeartMate clinical trial began.

"This is a very significant development for these patients, since there really are no other viable options for them once their conditions get to the point where they require a transplant in order to survive. The bottom line is this will save many lives," says Bruce Reid, M.D., co-director of the Utah Artificial Heart Program at Intermountain Medical Center.

The HeartMate II LVAS is a mechanical circulatory support device 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. It is designed for easier implantation, and with only one moving part.

The HeartMate II's new design provides exceptional reliability and improved 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.

Results from the national clinical trial found the HeartMate II to be safe and effective, with improved quality of life and survival compared with historical norms for heart-failure patients. In addition, the device is designed to be quieter and more durable than other devices. The HeartMate is much smaller that the original Heartmate LVAD, about one-eighth the size of the original device. HeartMate II provides continuous blood flow through the circulatory system using only one moving part — a rotary pumping mechanism.

With around 2,200 donor hearts available annually, there are large numbers of patients with end-stage heart failure placed on heart transplant waiting lists. These patients would be candidates to receive the HeartMate II LVAS as a therapeutic option to sustain them until transplant.

FDA approval was based on one-year follow-up data from the first 194 HeartMate II patients enrolled in the trial at Intermountain Medical Center and other research centers across the nation. The majority of patients in the study demonstrated vast improvement progressing from severe heart failure symptoms even at rest to being able to resume normal activities with little or no limitations.

Other highlights included:

• Survival to cardiac transplantation, recovery or ongoing on HeartMate II support was 80 percent at six months and 77 percent at one year.


• Eighty-four percent of the patients survived to hospital discharge or transplantation.


• 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 bridge-to-transplantation study of the HeartMate VE LVAS (HeartMate II's predecessor).

Currently, researchers at Intermountain Medical Center are participating in a clinical trial of HeartMate II as a long-term therapy (also known as destination therapy) that could potentially also serve as a permanent support option for these patients.

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. 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.

HeartMate II is manufactured and marketed by Thoratec of Pleasanton, California.