Martes 27 de Noviembre de 2001, Ip nš 8

Heart assist pump shows promise
Por Debra Goldschmidt

An implanted pump that gives a boost to failing hearts can extend lives and improve quality of life, according to a study presented Monday at the annual meeting of the American Heart Association.

The study's lead researcher says the data indicates that such heart pumps could be used as "destinations" or permanent therapy rather than as just temporary solutions for patients waiting for a transplant, which is all that is currently allowed.

"The field of device regulation changes with this data," lead researcher Dr. Eric Rose said Monday.

The pumps that were studied are known as LVADs -- left ventricular assist devices.

The trial study, known as REMATCH -- Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart failure -- found that terminally ill heart failure patients have a much better survival rate when treated with an LVAD than when treated with medication and medical monitoring.

The findings of the study were released on the New England Journal of Medicine's Web site Monday to coincide with the presentation of the research at the conference. The study will be published in the November 15 edition of the journal.

In an editorial that accompanies the publication of the study, Dr. Mariell Jessup cautions that "we now know that ventricular assist devices prolong life; we do not yet know for how long and at what cost."

HeartMate VE (vented electric) LVADs were used in the study, which was partially funded by the HeartMate's manufacturer, Thoratec Corp.

The patients in the study were all too sick and too old to qualify for a heart transplant and had a 75 percent chance of dying within one year.

Rose said patients who received the LVAD reduced their risk of death by 48 percent for one year.

He called that the equivalent of 270 lives saved for every 1,000 patients with end-stage heart failure a year compared with 70 deaths prevented for every 1,000 patients in those treated with medication, such as beta blockers.

Of the 129 patients in the study, 68 received the pump while the other 61 were treated with "medical management."

According to Columbia University, which coordinated the three-year, 22-site trial, the pump is the size of a compact disc player and is implanted into the upper part of the abdominal wall of the patient.

A tube that runs into the left ventricle drains blood into the device. The pump then sends the blood to the aorta, the artery that supplies the oxygen-rich blood to the brain and the rest of the body.

Another tube attached to the pump runs outside of the body and attaches to a battery pack about the size of a videotape. This battery pack is placed in a holster that the patient wears over the shoulder. The patient also wears a control system, the size of a beeper, on his or her belt.

Unlike an artificial heart, the pump leaves the heart in place, giving it a boost. Rose said there is hope that it may even enable the heart to repair itself enough that the pump could eventually be removed.

California-based Thoratec Corp. has filed an application with the U.S. Food and Drug Administration for its device to be used as treatment for patients with end-stage heart failure. Currently the FDA allows heart-assist devices only as a bridge -- temporary treatment for patients who are waiting for transplants.

Rose said the cost of the pump is in the range of that of a heart transplant, which he estimated to be approximately $160,000. He added that he is involved in discussions to allow Medicare and Medicaid coverage for such pumps.

Funding for the study was provided by the National Heart Lung and Blood Institute, Thoratec Corp., and the 22 centers participating in the trial. NHLBI, Thoratec, and Columbia University designed the study.


  12/11/2001. CNN.