FDA approves continuous-flow heart-assist device pioneered at Texas Heart Institute at SLEH

The federal Food and Drug Administration today approved a continuous-flow heart-assist device pioneered at the Texas Heart Institute (THI) at St. Luke’s Episcopal Hospital (SLEH) for use as a permanent treatment for advanced heart failure.

“This is a huge accomplishment, ushering in a new era of hope for thousands of people”

The approval of the pump device, the HeartMate II, follows several years of clinical trials and is seen as a major milestone for patients in the United States. In any given year there are some 250,000 people who suffer from advanced heart failure, while only about 2,000 heart transplants are performed annually in the U.S.

In addition to the need far outpacing the supply of donor hearts, many patients, due to a variety of circumstances such as age and medical complications, are simply not candidates for heart transplants.

The device was previously approved as a way to “bridge” patients until a donor heart could be found. Today’s approval of the device as a destination (meaning permanent) therapy means those patients awaiting transplants, or those ineligible for transplants, have a badly needed new treatment option.

Because the HeartMate II is relatively small, requires less invasive surgery, is highly portable and has fewer moving parts than other pumps, it is expected to significantly increase the quality of life for patients. In addition, because of the HeartMate II’s small size, it has greatly expanded the population of patients who can be helped by such devices. Studies also have shown that continuous-flow pumps have significant advantages over pulsing pumps, including that they last far longer and don’t require patients to undergo replacement procedures as often.

“This is a huge accomplishment, ushering in a new era of hope for thousands of people,” said Dr. O.H. Frazier, THI’s Chief of the Center for Cardiac Support and widely considered the leading pioneer in development of heart-assist pumps and the latest continuous-flow technology. “We performed the first implant of the newly designed HeartMate II device in the United States as a bridge to transplant in November 2003 in a young man dying of heart failure. To date we have successfully implanted 150 of the devices – more than any center in the world -- both as a bridge to transplant and as participants in the trial to study the device as a permanent solution.”

The patient who received the first implant subsequently received a heart transplant. Dr. Reynolds Delgado, his cardiologist and Medical Director of Mechanical Support Devices in Heart Failure at THI, said, “The concept of an artificial heart has been dreamed about since the 1960s, and finally a practical solution is available that can be used permanently in these desperate patients who have no other options. Most exciting is that some of these patients, after having the device for a few months, actually have healing of their natural heart and recovery of its function, so the device can be removed. This was something never thought possible prior to these devices.”

Source: Texas Heart Institute