Randomized trials of an experimental cardiac support device for patients with severe congestive heart failure have begun in North America. A total of 144 patients have been enrolled so far at the 28 U.S. and Canadian centers involved in evaluation of the mesh jacket. Physicians at Cedars-Sinai Medical Center in Los Angeles, California reported that they have successfully implanted their first device in an elderly woman with progressive heart failure.

The CorCap? jacket is an investigational device that can be implanted in patients ranging in age from 18 to 80 years of age who have been diagnosed with dilated cardiomyopathy or Class III or early Class IV heart failure. Developers hope the device will slow, arrest, or reverse the progression of heart failure, thereby preventing the need for end-stage alternatives or transplantation. They anticipate that by making this alternative available to heart failure patients earlier in the progression of their disease, outcomes will be improved and risks of surgical complications will be reduced.

In animal research and in initial limited human studies, the device prevented cardiac enlargement, decreased or eliminated mitral valve leakage, preserved or improved heart function, and promoted myocardial recovery by giving cells an opportunity to relax. The device consists of a patented fiber mesh designed to stretch in the direction that encourages the heart to revert to its natural shape without interfering with normal pumping action. The manufacturer, Acorn Company, says the specially engineered polyester fiber -- each filament approximately one-fifth the thickness of a human hair -- is highly biocompatible with human tissue and offers very little risk of rejection.

The 73-year-old woman (identified as Evelyn) who was the first patient at Cedars-Sinai to be implanted with the experimental device was able to go home one week after implantation.

"Based on the progress Evelyn is making, we hope that she'll be able to resume her routine activities over the coming weeks," said Kathy E. Magliato, M.D., cardiothoracic surgeon and one of two principal investigators at the center.

Because Evelyn was in the advanced stages of heart failure and was not a good candidate for a heart transplant, she had very few options remaining, said Dr. Magliato. "For her and many other patients like her, the experimental Acorn device may help extend and improve quality of life."