New Tube Procedure Helps 1st American Heart Patient

When Sharol Sperling jokes that her husband, Phillip, has a heart of steel, she is not insinuating that he is difficult or stingy.

Inside her husband’s coronary artery grafts are two stainless-steel cylinders--each like a thin, inch-long drinking straw. The stents, as they are called, serve as mechanical supports to prevent arterial closure.

“The stents are not actually within the heart’s chambers,” said Dr. Richard Gray, a cardiologist at Cedars-Sinai Medical Center familiar with the procedure, “but are in the coronary arteries, which lie over the surface of the heart and provide nutrition to the heart muscle.”

Sperling, 54, traveled to Switzerland last month to undergo the intravascular stent procedure, not yet approved in the United States by the Food and Drug Administration. He is believed to be the first American to receive coronary stents.

The nonsurgical technique is expected to be a useful adjunct to angioplasty--in which an inflatable balloon squeezes the blockage against the vessel’s wall--and may help some patients avoid emergency heart bypass surgery, say cardiologists.

A day after his return from Switzerland and just 10 days after undergoing the 2 1/2-hour procedure, Sperling sat in the den of his West Los Angeles home, looking healthy and relaxed.

“I haven’t felt this good since October,” said Sperling, consultant to a Los Angeles carpet mill he once owned. A few days after his return, he went for checkups by his cardiologist, Dr. Irwin Hoffman of Century City and consulting cardiologists Dr. Jeremy Swan, director of cardiology at Cedars-Sinai Medical Center and a professor of medicine at UCLA, and Dr. Neil Buchbinder, a Los Angeles cardiologist also on staff at Cedars-Sinai. All three doctors concurred that he’s doing fine, Sperling said.

Flying to Switzerland to undergo the procedure was a last resort for Sperling, who suffered his first heart attack at 39, his second at 45 and has undergone coronary artery bypass graft surgery twice. His current medical problems began in September, he said, about three years after his second bypass surgery. While on vacation, he began experiencing chest pains and on his return, he saw Hoffman who suggested angioplasty.

More Setbacks

But the technique failed repeatedly. “From October, 1986, until January, 1987, I had four angioplasties done on the same (coronary) artery,” Sperling said. “It just kept collapsing.

“After the third collapse, I asked my alternatives, in case it collapsed again (after the fourth angioplasty),” he said. His physicians told him that traveling to Switzerland--where the stent procedure is approved and is performed by cardiologist Dr. Ulrich Sigwart--would be one option.

Sigwart, an associate professor of cardiology at Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, and the University of Dusseldorf in Germany, first performed the stent procedure in March of 1986, after gaining the approval of his hospital’s ethics committee.

After Sperling’s third angioplasty, Swan sent his medical records to Sigwart, who evaluated Sperling as a good candidate.

Sperling said his fourth angioplasty, performed by Buchbinder in mid-January, at first seemed successful. But on April 13, Sperling recalled, he once again experienced chest pains, telltale clues of collapse. There was no debate about what to do next, he said. “I called the doctor (Hoffman) on Tuesday, and by Thursday we (Sperling and his wife) were flying to Switzerland.”

During the procedure on April 21, Sigwart inserted two stents in Sperling’s two coronary artery grafts. Awake during the procedure, Sperling said he talked with Sigwart and watched “instant replays” on a video screen. “He made me feel very much at ease,” Sperling said. At one point, Sperling said, he asked, “How’s it going?” and Sigwart answered, “This second one’s tough.”

Inserted after angioplasty, the tiny stents are introduced into coronary or peripheral arteries via a catheter. To date, Sigwart said from Switzerland, he has placed stents in 44 coronary arteries and 12 peripheral arteries. Two patients have died, both recipients of coronary stents. One patient died after bypass surgery for a “suspected but unfound occlusion,” according to Sigwart, and the cause of death in the other patient is unknown.

In a report published earlier this year in the New England Journal of Medicine, in which Sigwart reported on 34 stent procedures, the cardiologist said that no cases of restenosis, or renarrowing, had occurred during nine-week to nine-month follow-ups. Statistically, the likelihood of restenosis within the first six months is 30% or more, cardiac experts concur.

The procedure still needs long-term study, Sigwart said in the article. Infection and coronary spasm, he said, may be among the pitfalls.

Soon, patients like Sperling may not have to travel abroad to obtain the technique, researchers here said. Some human trials of the procedure are under way, according to an FDA spokesman, but the device has not been approved for marketing. Researchers in Georgia and Texas said they hope to gain FDA approval soon to study stents in humans.

Stents, proponents said, could be especially helpful when arteries narrow again after angioplasty or coronary artery bypass surgery.

Medical Projections

About 210,000 coronary angioplasties will be performed in the United States this year, according to projections from Biomedical Business International, a Tustin-based newsletter. Restenosis will occur at the time of angioplasty in about 5% of cases, experts estimate, and will occur within six months in another 30%.

In addition, about 205,000 coronary artery bypass graft surgeries will be performed this year, according to Biomedical Business International, with a restenosis rate, according to Sigwart, of about 50%.

The stents could also prove useful, cardiologists said, for failed peripheral artery angioplasties. About 60,000 peripheral angioplasties were performed last year, according to Biomedical Business International.

Animal studies of stents look promising, researchers claim. There’s no evidence of a foreign body reaction to the devices, said Dr. Gary Roubin, an assistant professor of medicine (cardiology) and director of research at the Andreas Gruentzig Cardiovascular Center at Emory University School of Medicine, one facility studying stents in animals. “It’s rapidly incorporated into the wall of the blood vessel.”

‘Body Can’t Reject It’

“It’s an inert metal, it has no antigens (substances to which the body reacts by production of antibodies) so the body can’t reject it,” said another investigator, Dr. Richard Schatz, a San Antonio cardiologist and clinical associate professor of medicine at the University of Texas Health Science Center at San Antonio who has been studying stents in animals for five years.

Sperling said he believes stents will prove successful over the long-term. “Sigwart said I would have no problems. He says I’m a new man and I feel like it. I really do.”

Following doctors’ orders, Sperling takes blood-thinning drugs, which Buchbinder said he’ll be on “quite a while.” He eats a low-cholesterol, low-sodium diet to keep his weight at 150 pounds, considered by his doctors ideal for his 5-foot-9 frame. “And I do a tremendous amount of walking, three to six miles a day, seven days a week. I roll out of bed at 7 in the morning. Keeping in shape is what has pulled me through all this.”

Sperling said he had no apprehension, either during the 12-hour flight to Switzerland or during the procedure, and has no second thoughts about being a pioneer.

His wife, Sharol, isn’t nearly as relaxed about it. “Of course, I had apprehension,” she said. “The last few months have been terribly stressful.”

But her husband’s optimism about his prognosis--and his refusal to worry about details like hospital bills--seems to carry them both through the rough times. Sperling gave the Swiss hospital a $3,000 deposit and estimates the final bill, which he hasn’t yet received, at $7,000.

His focus now is on recovery. “This has only put a temporary hold on our life, but never a stop,” he said. For the next three months or so, Sperling said he’ll stay close to home, visiting with his three children and eight grandchildren.