Putting a Weakened Heart in Experimental Hands

COLUMBUS, Ohio — 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?"

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.

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.

"If it will help other people, that's what it's all about," Mr. Ray said. "If nobody ever did anything like this we wouldn't have angioplasty or anything. Somebody had to be an experiment somewhere, whether it's medicines or operations."

When Mr. Ray had his heart attack, he did not have high cholesterol or high blood pressure, did not smoke, was not overweight. His doctors, he said, called him "the enigma."

But he learned later that both of his grandfathers had died young from heart disease, one at 30 and the other at 50.

A few weeks after the heart attack, he suffered a stroke. He went back to work but lasted there less than three years. His wife got a job. His heart continued to decline. His three daughters, now 20, 26 and 30, say they grew up in hospitals, and the youngest says her earliest memory is of waving to the ambulance that took him away the morning of his heart attack. She never knew him when he was well.

During the last year he worsened noticeably, needing more and more sleep during the day and getting winded from the slightest exertion. By one important measure, he was in real trouble. In a healthy person, each heartbeat pumps out about 60 percent of the blood from the left ventricle. Mr. Ray's heart was pumping 18 percent.

In the operating room before his surgery on June 29, while he slept, doctors gathered around a monitor showing ultrasound images of his beating heart. Even to a layman's eye the beat seemed weak, and parts of the left ventricle did not move when they should have been pumping.

"It's amazing," one doctor said, tracing the edge of the ventricle on the monitor with a gloved finger. "Only this part is moving. This part is dead."

By 8:47 a.m., Mr. Ray was covered by blue surgical drapes, with only part of his torso exposed. A thick purple line had been drawn on his skin to mark the center of his chest. Wisps of smoke and the acrid odor of burned flesh rose from the operating table as Dr. Sai Sudhakar used an electrocautery scalpel to cut through skin and muscle. A shrill buzz filled the room as he sawed through the breastbone. Then he pushed a metal retractor into the incision, cranked open Mr. Ray's chest and peered down at his heart. It looked "pretty miserable," Dr. Sudhakar said.

By 9:30, Dr. Sudhakar had connected Mr. Ray's heart and aorta to the heart-lung machine that would oxygenate and pump his blood so that doctors could stop his heart to operate on it.

Now work on the heart itself could begin. At 9:57, Dr. Michler and Dr. Sudhakar injected a potassium chloride solution into Mr. Ray's heart, the same chemical used to execute prisoners by lethal injection. Within seconds, the heart stopped beating.

Dr. Michler reached into Mr. Ray's chest and grasped his heart, exploring it with his fingers.

"This is a terrible ventricle," he said. "His heart is scarred and has turned to calcium. About a third is calcified. It's literally as hard as a rock."

"This is bad for us," he went on. "It's technically challenging. This is a very high-risk patient."

Before working on the ventricle, the surgeons performed a bypass on a coronary artery at the back of the heart, using a vein that had been taken from Mr. Ray's leg. Using forceps to grip a fine curved needle no bigger than an eyelash, they sewed one end of the vein to the aorta, to pick up blood, and the other end to the coronary artery, below the blockage.

Then Dr. Michler cut open Mr. Ray's left ventricle and thrust his fingers inside. Its inner walls should have been the brownish hue of muscle, but instead were bone white.

"There's a tremendous amount of scarring here," Dr. Michler said. "All we're seeing right now is scar. All this white, this is very bad."

With scissors, he snipped out a bit of heart that was nothing but scar tissue. But not all the scar tissue could be cut away.

Next he began reshaping the ventricle. The idea was to sew a Dacron patch, an oval measuring an inch by an inch and a half, to the inner walls of the heart across the opening he had cut, and then to stitch the heart shut over the patch. In the process, the patch would become the new lining for part of the heart, the chamber would be reshaped and made smaller, and scar tissue would be sewn up in a way that excluded it from the working part of the ventricle.

The reshaping took about an hour. Then the surgeons did another bypass, this time on the anterior descending artery, the most important one in the heart.

Stepping away from the operating table, Dr. Michler looked at the before-and-after ultrasound images of Mr. Ray's heart. The ventricle was smaller and seemed to be contracting more forcefully.

"I hope we made the ventricle a little better," he said. "But we're far from being out of the woods." A few minutes later he spoke to Mr. Ray's wife, Monika, and their three daughters, Kim, Stephanie and Melanie. They sat huddled close together in a private waiting room and listened in silence as Dr. Michler said Mr. Ray was doing well, but warned that the next few days would be critical.

A week after the surgery, Mr. Ray's family said he was walking laps around the hospital corridors, and Dr. Michler said he was delighted to see such progress.

But it will be weeks or months before it is clear whether Mr. Ray's heart is working any better. It is not known how long any improvement might last. And it will take years to tell whether such surgery prolongs patients' lives.

In an e-mail message eight days after the operation, just before she brought her husband home, Monika Ray said that at first his recovery had been much harder than the family expected, even though his two older daughters are experienced nurses. He had severe pain and became uncharacteristically depressed, she said. But the problems passed.

"He looks like he has been run over by a train," she wrote. "But he looks GREAT to all of us."

In a telephone interview on July 9, Mr. Ray said he was tired but feeling better every day, able to climb stairs and walk up and down his long driveway, against his family's protests. He joked that in a few weeks he would be running short Olympic races.

Kevin Fitzsimons for The New York Times
Dr. Robert Michler, left, and Dr. Sai Sudhakar, center right, performing an experimental operation on Ric Ray. "We truly do not know" what treatment is best for heart patients like Mr. Ray, Dr. Michler said.

Last Resort

Good post neverdem. I know there are quite a few FReepers who suffer from various stages of heart failure. I'm going to ask my cardiologist about this during my next appointment.

A few years ago there was a Doctor in South America doing heart reduction by the bus load in primitive clinics and his patients were not only surviving but thriving. They brought him to the US to show them how to do it. I remember many leading surgeons panning him and his procedures.

BTW...I'm scheduled for bypass surgery next Tuesday at UCSF Med Center and because of a birth defect it is not routine.

I recall reading about the reduction surgery some time back. It does seem he had quite a good track record with it.

You've got mail.

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.