Combination Heart Device Reduced Heart Failure
Maria Cheng, AP Medical Writer
While the device spared many patients from going to the hospital, it made no difference in saving lives, and some doctors say they won't rush to implant more patients with the pricey devices.
The study compared patients who got a defibrillator to correct abnormal heart rhythms with patients who got a device that added a heart resynchronization device, which helps the lower chambers of the heart pump at the same time.
The results were announced Tuesday at the European Society for Cardiology meeting in Barcelona and published online in the New England Journal of Medicine.
The defibrillator and resynchronization devices are commonly used in patients with serious heart failure, and doctors wondered if patients with mild illness might benefit.
"The answer is a clear, unequivocal yes," said Arthur Moss, of the University of Rochester Medical Center in New York, and the study's lead author.
Not everyone agreed. Douglas Zipes of the Indiana School of Medicine and a past president of the American College of Cardiology said too many patients were already getting the devices and that doctors needed to rethink who should get them.
Moss' study tracked more than 1,800 patients with mild heart disease in North America and Europe for more than four years. About half of the patients got a defibrillator, while the other half got a defibrillator plus a resynchronization device. The two implants are nearly identical, except the resynchronization device has an extra electrode that stimulates the left side of the heart.
Overall, patients who got the combined device had a 41 percent lower chance of developing heart failure, though women's chances dropped by 63 percent. The death rate in both device groups was about the same, around 3 percent.
The study was paid for by Boston Scientific Corp., which makes the devices.
In the U.S., about 60,000 patients with severe heart disease get the devices every year, out of more than 5 million people who have heart failure.
Some doctors thought the device's price — it sells for approximately $30,000 to $40,000, not including the cost of implantation — would be a major stumbling block to its acceptance. Patients with mild heart failure, who were not experiencing any painful symptoms, might also be reluctant to have surgery to get the device.
Clyde Yancy, president of the American Heart Association called it an "incremental (improvement), not a breakthrough." Yancy was not linked to the research.
Others agreed the study wouldn't immediately affect how heart failure patients are treated.
"Previous devices have shown us that it takes time to consider benefits for real-world populations," said Alfred Bove, president of the American College of Cardiology in a statement. "Even if costs were not a factor, we still do not have enough information to expand treatment right away."