Combination device reduces heart failure deaths
A combination defibrillator and cardiac resynchronization device reduced deaths by nearly one-third in patients with mild heart failure in a study that was terminated early on Monday because of its success, the device’s manufacturer said Tuesday.
The combination device, called a CRT-D, had previously been shown effective in patients with severe heart failure, but this is the first study to investigate its use in those with milder forms of disease, who account for about 70% of the 5.5 million U.S. heart failure patients.
“This is a breakthrough finding,” said Dr. Albert Waldo, a cardiologist at University Hospitals Case Medical Center in Cleveland who was not involved in the study. “It shows for the first time that in a group of patients that have [mild] heart failure . . . you can decrease the death rate by 29%. . . . The data from the trial are very clear.”
Heart failure occurs when the muscles of the heart weaken and the ventricles fail to coordinate properly, or synchronize, reducing the ability of the organ to move blood through the body. In the most severe cases, patients can become so weak that they are bedridden, or suffer a variety of symptoms, such as shortness of breath, buildup of fluids in the lungs and other organs, confusion and fatigue. Patients with mild heart failure typically have few or no symptoms, but both groups have an equally high risk of atrial fibrillation (erratic heartbeats) or death.
Cardiac resynchronization therapy uses a cellphone-size device implanted in the chest to deliver a regular, small electric signal to the heart to trigger beating, increasing the ejection fraction. The device has leads going to both ventricles to make sure they are synchronized. (A conventional pacemaker has only one lead going to the right ventricle.)
The CRT-D device also contains a defibrillator to shock the heart back into normal rhythm if it begins to beat erratically.
In the study terminated Monday, Dr. Arthur J. Moss of the University of Rochester Medical Center and his colleagues studied more than 1,800 patients at 110 centers in the United States, Canada and Europe for as long as 4 1/2 years. Half received a defibrillator and half received the combination CRT-D device. The trial was sponsored by Boston Scientific Corp. of Natick, Mass., which manufactures the CRT-D and which released the preliminary results.
The trial was halted Monday when the executive committee overseeing it concluded that the study had achieved its primary goal, a significant reduction in deaths or surgical interventions with the CRT-D device. Similar devices are also made by St. Jude Medical Inc. of St. Paul, Minn., and Medtronic Inc. of Minneapolis.
The most important drawback of the devices is cost: about $25,000 to $30,000 for the device itself -- compared with $20,000 or less for a defibrillator alone -- and an additional $10,000 to $15,000 for the surgeon and the hospital.
Another complicating factor is that among patients with severe heart failure, for which the device has already been approved, “there are an awful lot of people who don’t get better” after the device is implanted, said Dr. Steven M. Schiff, chief of cardiology at Orange Coast Memorial Medical Center in Fountain Valley. The same is likely to be true for those with milder disease, he said. “There has been reams and reams of literature looking at other criteria to predict which people within the group will get better,” but so far, no one has found how to do this.
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