Combination implant appears to
help more heart-failure patients
Reported September 02, 2009
The CRT-D, part automated defibrillator, part cardiac resynchronization
device, reduced hospitalizations in milder cases. But issues including cost
have some questioning how widely it should be used.
An implantable device that shocks an erratically beating heart and works to
keep both ventricles beating synchronously reduced hospitalizations for
heart failure by 41%, according to results reported Tuesday at the European
Society of Cardiology Congress in Barcelona, Spain.
The results, reported online in the New England Journal of Medicine, were
significantly better than preliminary results announced in June, when the
trial was halted prematurely because of its success.
"This is a real breakthrough" for patients with mild to moderate heart
disease, said Dr. Leslie Saxon, a cardiologist at USC's Keck School of
Medicine, one of the study sites.
"The results are very encouraging, but we need to take them with a grain of
salt," said Dr. Shephal K. Doshi, director of electrophysiology and pacing
at St. John's Health Center in Santa Monica. "No one receiving the devices
Because of the high price of the devices, he said, it is increasingly
important to identify which heart-failure patients are most likely to
benefit from them -- something that is not known.
The cellphone-sized combination device, called a CRT-D, incorporates an
automated defibrillator and a cardiac resynchronization device that shocks
both ventricles of the heart at the correct time to keep them beating
properly. The device has been approved by the Food and Drug Administration
for patients with severe heart disease, and about 60,000 are implanted each
year in such patients.
The new study is focused on patients with a milder form of heart failure
that accounts for about 70% of the 5.5 million U.S. heart failure patients.
More than a million such patients die every year.
Dr. Arthur J. Moss of the University of Rochester Medical Center and his
colleagues studied 1,820 patients at 110 medical centers in the United
States, Europe and Canada in the $38-million trial. About a third of the
patients received only an implanted defibrillator, and the rest got the
combination device. They were followed for an average of 2.7 years.
Overall, the risk of being hospitalized or dying from heart failure was
reduced by 41% in patients with the combination device -- from 25.3% in
patients with only a defibrillator to 17.2% in those with the CRT-D.
Women's risk dropped even more, about 63%. The risk of dying from heart
failure was the same in both groups, about 3% per year.
Adverse events were about the same in both groups. The primary drawback of
the CRT-D is its price, at least $30,000 -- compared with about $20,000 for
an implantable defibrillator. It costs about $10,000 to $15,000 for the
hospitalization and surgery to implant the CRT-D.
In an editorial accompanying the report in the New England Journal of
Medicine, Dr. Mariell Jessup of the University of Pennsylvania noted that it
would require 12 implants of the device to prevent one hospitalization for
heart failure, and asked: "Is this money that could be spent more wisely?"
Saxon, however, noted that hospitalization for heart failure was itself
expensive, and that 40% of those hospitalized were rehospitalized. The
incremental cost compared with a defibrillator can be easily justified, she
The study was funded by Boston Scientific, which manufactures the CRT-D.
Moss has received payments from the company in the past for presenting
Source : The Los Angeles Times