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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thomas.maugh@latimes.com
