An implantable device that shocks an erratically beating heart back into normality and works to keep both ventricles of the heart beating in synchrony has reduced hospitalizations for heart failure by 41%, according to results reported today at the European Society of Cardiology Congress in Barcelona, Spain, and reported online in the New England Journal of Medicine. The results were significantly better than preliminary results announced in June when the trial was halted prematurely.
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 proper time to keep them beating properly. The device has been approved by the Food and Drug Administration for treating 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, which 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, called MADIT-CRT. About a third of the patients received only an implanted defibrillator, while the rest received 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 receiving the combination device. 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. The device was most effective in patients with an abnormality in their EKGs called a QRS duration of at least 150 milliseconds.
Adverse events were about the same in both groups. The primary drawback of the CRT-D is its price, estimated to be between $30,000 and $40,000 for the device plus an additional $10,000 to $15,000 for the hospital and surgeon to implant it, compared with about $20,000 for an implantable defibrillator.
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. "Is this money that could be spent more wisely?" she asked.
The study was funded by Boston Scientific, which manufactures the CRT-D. Moss has received payments from the company in the past for presenting lectures.
-- Thomas H. Maugh II