Survey finds heart operation widely used outside guidelines

Many surgeons combine laser treatment, bypass, creating higher death risk


About three-quarters of the patients who receive an expensive, invasive and risky laser treatment for the chest pains of heart disease do not meet the medical criteria for which it was approved, researchers reported yesterday.

The Food and Drug Administration approved the treatment - TMR, for transmyocardial revascularization - only for patients with severe chest pains who could not have bypass surgery or angioplasty.

But the researchers found that large numbers of surgeons are performing it while patients are having bypasses.

Moreover, they reported, the procedure carries greater risks than bypass surgery. More than 1 in 16 who had TMR died, and 1 in 6 suffered serious medical consequences, including strokes, prolonged time on a ventilator and kidney failure.

These rates are 1 1/2 to two times those seen in patients with traditional bypass surgery.

TMR alone costs $24,340 per treatment, but additional payments to hospitals can nearly double that amount. It involves opening the chest and using a laser to drill holes in the beating heart in hope of relieving pain.

The FDA commissioned the study, published yesterday in The Journal of the American College of Cardiology, to find out how many patients were getting the procedure and what its risks were.

Medical experts say the findings offer a rare glimpse of what happens in the real world of medical practice, when doctors prescribe drugs or treatments "off label" - for patients who do not meet the criteria for which the drug agency approved them.

Off-label use is common with many drugs and devices, said Dr. Eric Peterson, a cardiologist at Duke University and lead author of the study, but "No one really knows" what the results of the practice are.

The study found that 3,136 patients had TMR from 1998 to 2001. But just 661, 21 percent, met the FDA criteria - severe chest pain and no other surgical options. The others had TMR along with bypass surgery.

"I was surprised by the volume and rapidity of off-label use," said Dr. Larry Kessler, the director of the FDA's office of science and technology in its Center for Devices and Radiological Health. "Within two years, anywhere from 67 to 83 percent of the use was off-label. That's really remarkable for a high-risk procedure."

Kessler said the patients were largely unaware that they were essentially subjects in a large, uncontrolled medical experiment. He called the off-label use of TMR "doing an experiment without informed consent."

The new study used the Society of Thoracic Surgeons' National Cardiac Database, which collects information from two-thirds of all hospitals in this country that do heart surgery.

The most dismal results were with patients who had worsening or changing angina - half of the patients in the database - and with those who had a heart attack within the previous three weeks, which was the case for one-quarter of the patients.

Those were conditions that the FDA had warned about, saying TMR was particularly risky then. The study found that mortality rates were at least double those of patients without those conditions. If doctors waited until the patients were more stable, that death rate might have been cut in half, Peterson said.

Some doctors defend combining TMR with bypass surgery.

"I agree that off-label use can become murky," said Dr. Keith Horvath, a surgeon at Northwestern University. But, "From a surgeon's point of view, we're combining two known therapies to give a more complete operation to maximize the blood flow to a patient's heart."

TMR was developed to help the most difficult of patients. "The patients literally feel like the walls are closing in on them," Horvath said. "There is very little they can do. One patient said he had a choice in the morning when he woke up between shaving, then sitting and resting, or not shaving and going to fix breakfast. Some said they wish they had their nitroglycerin in a Pez dispenser. That's how often they're taking it - 10, 15 times a day."

Horvath and others developed the procedure as a way to help such patients. They reasoned that holes drilled with lasers might relieve pain by allowing more blood to be delivered to the heart.

He and his colleagues obtained evidence, randomly assigning 192 patients with severe chest pain from heart disease and no other treatment options to have TMR or not. Their paper, published Sept. 19, 1999, in the New England Journal of Medicine, indicated that those who had TMR reported less chest pain.

Even then, some doctors were skeptical. The New England Journal paper was accompanied by an editorial by Dr. Richard A. Lange and Dr. L. David Hillis, cardiologists at the University of Texas Southwestern Medical Center at Dallas. They said there was no convincing explanation for why the method might work because the laser-drilled holes soon closed.

But once the food and drug agency approved TMR, the stage was set for its widespread use. The next question was whether Medicare would pay for it, and if so, for which patients. Medicare decided to cover not just the FDA's approved use, but other uses as well.

"It takes a lot of courage to publish a paper like this," said Dr. Scott Ramsey, an internist and health economist at the University of Washington. "It shows that TMR has gone from where the evidence is to where the money is."

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