SUNDAY, Nov. 7, 2004 (HealthDayNews) --A mesh "sleeve" surgically wrapped around the heart has shown promise for helping people with heart failure.
Manufacturers of the new device, the Acorn CorCap Cardiac Support Device, will be filing for U.S. Food and Drug Administration approval in the first quarter of 2005, and the sleeve has been receiving quite a bit of comment at the annual meeting of the American Heart Association (AHA) in New Orleans.
"It's neither a drug nor electrical therapy," said Dr. Douglas Mann, a cardiologist at the Michael E. DeBakey Veterans Affairs Medical Center in Houston and lead author of a study presented Sunday at the AHA meeting. "It's a synthetic mesh wrap that's surgically implanted around ventricles and becomes part of the heart."
"This study was clearly rigorously conducted," added Dr. Raymond J. Gibbons, chairman of the AHA's committee on scientific sessions program.
About five million Americans have heart failure and, of those, up to 25 percent may be candidates for the device, Mann said.
The CapCor device addresses a significant aspect of heart failure: left ventricle dilation or remodeling -- enlargement of the heart. "When the heart gets very big, it gets overburdened and inefficient," Mann said.
The device seems to work by "encouraging" the heart to become more elliptical in shape and exerting gentle pressure on the organ to relieve stress, he explained.
"When you relieve stress on the failing heart, you allow it to rest," he added. "This allows it to regain more of a normal size and shape and therefore allows it to function more efficiently."
Currently, certain drugs and electrical therapies do help treat remodeling, but this would be the first implantable device.
The research involved 300 patients with heart failure. Gibbons said this was not a huge number for a clinical trial but was larger than for many other techniques that have been studied in the past.
Participants needing surgery for a leaky mitral valve were placed in a surgery group, then randomized for either surgery or surgery plus the CapCor. The rest of the patients were randomized to receive optimal medical therapy alone or optimal medical therapy plus the device. About two-thirds of the patients were in the surgery group.
Researchers assessed the participants on a "clinical composite" including death, a major cardiac procedure and a change in the severity of their disease. "We were looking to see if they were getting better, worse or the same," Mann explained.
In the end, people in the CapCor groups experienced a 70 percent overall improvement compared to those in the non-device groups (38 percent vs. 27 percent). In addition, fewer patients in the device group worsened compared to the non-device group (37 percent vs. 45 percent).
"There was also a significant decrease in the need for major cardiac procedures such as transplants, and there was an improvement in left ventricular structure -- big hearts became like small hearts," Mann said. "Quality of life also improved by two separate indices, and it was completely safe." The number of hospitalizations did not differ between the groups.
Mann envisioned the device to be "synergistic and additive" to existing therapies. "It would be on top of absolute first-rate medical therapy," he said.
CapCor is not for people with extremely advanced heart disease or mild coronary disease, he cautioned, but for those with moderate to severe disease. This generally means people who become short of breath walking up a flight of stairs, cooking or making the bed.
The device should reduce the number of transplants needed, although it would not prevent a person from getting a transplant if she needed one.
Asked about costs, Mann responded, "I can't even begin to imagine where the company will price the device. I'm just a humble cardiologist from Texas."
For more on heart failure, visit the American Heart Association Web site.