Pacemaker OK'd for heart failure

The FDA has approved this pacemaker for patients with heart failure.

By Rhonda Rowland
CNN Medical Unit

ROCKVILLE, Maryland (CNN) -- A pacemaker device that could help up to half of all heart failure patients live a more active life was approved for marketing by the U.S. Food and Drug Administration Tuesday. The device is Medtronic's InSync Biventricular Pacing System.

"The device was shown to markedly improve patient's quality of life and their functional capacity, and by functional capacity I mean that they were able to exercise longer and they were able to perform more of their activities of daily living," said Dr. William Abraham of the University of Kentucky, who conducted a major study of the device.

He presented his findings at a meeting of the American College of Cardiology in March.

Heart failure is the most rapidly growing form of heart disease in the United States. Some 5 million people have it and as many as 700,000 new cases are diagnosed each year.

When medications and surgeries and procedures like angioplasty no longer work, the only other course of action has been a heart transplant. Now patients have another treatment option.

The new pacemaker uses three wires, or leads, which are threaded into both sides of the heart to help it pump more efficiently. Researchers say it could help heart failure patients with a "conduction delay" -- in essence, a faulty electrical system in the heart.

In studies, heart failure patients who received the pacemaker saw improvement within a couple of weeks. Nurse Donna Lavai, for instance, was able to walk the hospital halls during her shift again after receiving her pacemaker. She had been so weak and out of breath before that she had to use a wheelchair some nights.

"These types of dramatic changes are absolutely typical for what we've seen," said Abraham. "It's literally like throwing a light switch."

Although there's no evidence the pacemaker helps patients live longer, doctors said some patients were able to come off the transplant waiting list and return to a fairly normal life. In addition, patients with a pacemaker spent fewer days in the hospital.

Other manufacturers are testing their pacemaker devices in heart failure patients, but none have FDA marketing approval yet.