Edition: U.S. / Global

Putting Weakened Heart in Experimental Hands

Published: July 19, 2004

Lying on the operating table, his thin arms outstretched to either side, Ric Ray spoke little as doctors and nurses in masks and scrubs descended on him with needles, scalpels and intravenous lines. It was 7:35 a.m.

Shaving Mr. Ray's chest with a few quick razor strokes, an anesthesiologist asked, ''When was your heart attack?''

''March 8, 1987,'' Mr. Ray replied.

''How old were you?''

''Thirty-five,'' Mr. Ray said softly.

The heart attack did so much damage that Mr. Ray's heart never recovered, but weakened steadily over the years. In 1990, when his daughters were 5, 12 and 15, he had to retire from his engineering career. By this year, his heart was pumping so little blood that he became short of breath just walking around the house, and his leg muscles, starved for oxygen, burned as if he were running a marathon. At 52, he had end-stage heart failure.

A few months ago, he began to think the time had come for a heart transplant, something he had tried to put off for as long as possible. A new heart might not buy him more than 10 years, he was told; he and his family hoped for more time.

A transplant surgeon suggested another possibility: a clinical trial, an experiment designed to find out whether medicines and certain types of heart surgery could help people with heart failure and blocked coronary arteries.

The experiment, at 90 centers around the world, is to include 2,800 patients who will be followed for seven years. Sponsored by the National Heart, Lung and Blood Institute, it is called Stich, for surgical treatments for ischemic heart failure. (The word ischemic refers to inadequate blood flow.)

Mr. Ray joined Stich and was assigned at random to undergo a risky operation at Ohio State University Medical Center, which would include bypass surgery to improve blood flow to his heart muscle as well as a more drastic procedure: cutting open his heart to reshape it, get rid of some scar tissue and help it pump more efficiently. For comparison purposes, others in the study will receive medicine alone, or medicine and bypass surgery.

Mr. Ray's surgeon, Dr. Robert E. Michler, chief of cardiothoracic surgery at Ohio State, said the study was being done because doctors did not know the best way to treat patients like Mr. Ray, with scarred, failing hearts and blockages in the arteries that feed blood to the heart muscle itself. Although there is a standard regimen of drugs, studies have not proved whether surgery can help. But some patients have surgery anyway.

''We truly do not know the answer as to which therapy is best for these patients,'' Dr. Michler said. ''I have a personal feeling that surgery will prove better, but that's completely explainable by the fact that I'm a surgeon and this is what I do. But I also believe in trying to do things scientifically, in an evidence-based way.''

In heart failure, the heart is weak and cannot pump enough blood to keep up with the body's needs. The major causes include damage from heart attacks, blocked or narrowed coronary arteries, diseased heart valves, high blood pressure and diabetes.

Five million Americans have heart failure. There are 550,000 new cases a year and 53,000 deaths. The condition contributes to another 200,000 deaths a year. Drugs and implantable defibrillators may prolong survival for some patients, but the disease still takes years off people's lives: 20 percent die within a year of the diagnosis, and 80 percent of men and 70 percent of women under 65 die within eight years. The number of cases has risen in recent years as the population has aged and more and more people survive heart attacks.

As heart failure progresses, the heart often enlarges and changes shape. As Dr. Michler explained, the left ventricle, the main pumping chamber, should be shaped like a football, but gradually dilates, becoming more like a basketball and losing its ability to contract properly. The surgery in the Stich trial is meant to reshape the ventricle and make it as much as 30 percent smaller.

The study could change medical practice, Dr. Michler said. Though many people with advanced heart failure would benefit from transplants, donor hearts are in short supply. Last year, only about 2,000 heart transplants were performed. Currently, more than 70 percent of patients with heart failure and blocked arteries are treated with medicine alone. If the Stich study finds that surgery works better, the pendulum could swing the other way.

''That kind of shift hasn't happened in cardiology in decades,'' Dr. Michler said.

For someone as sick as Mr. Ray, Dr. Michler estimated the chance of death from the operation at about 7 percent, a bit more than twice the average death rate in the United States from bypass surgery.

'I Have Nothing to Lose'

In an interview at his home the day before his surgery, Mr. Ray said, ''I have nothing to lose, or very little, when you compare it to the status quo, which isn't going to work very much longer.''

He was taking more than a dozen heart medicines, 20 to 30 pills a day. Though he could sit comfortably, standing for more than few minutes was difficult, and he tended to squat or lean forward from the waist to catch his breath.

At the very least, he said, he hoped the surgery might buy him some time before he needed a transplant. And he hoped doctors might learn something useful.