Jan 21 2010
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
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