Experts Find Dangers in Emphysema Surgery

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Aug. 15, 2001 -- After taking another look at an operation that has been becoming more common for emphysema patients, researchers have found the procedure can be dangerous and even deadly to some people with severe cases of the disease.

Emphysema is a disease largely associated with smoking and strikes about 2 million Americans each year. In recent years, doctors have been studying the effects of removing portions of the lung tissue to treat some of these patients.

When the National Institutes of Health began to follow up on what was happening to people who had this surgery, however, the investigators found 16% of those who had severe forms of the disease were dead within a month of the operation. Those who survived showed limited benefit from the procedure.

Researchers immediately halted more surgery on patients with the same characteristics of advanced illness. They are now confining their testing to more than 1,000 other emphysema patients because the surgery may still help them.

The investigators will publish the findings Oct. 11 in The New England Journal of Medicine but released them Tuesday to alert doctors and patients immediately.

Over the past few years, doctors had shown a lot of optimism with this surgery. In 1999, for example, the American College of Chest physicians assembled in Chicago and learned the procedure looked promising. Researchers had followed nearly 200 patients who received the surgery in St. Louis to treat their severe emphysema. The team found that 94% survived and 71% were still alive five years later.

The doctors had asked the patients to fill out a questionnaire on their quality of life before the procedure and again once a year. About 75% of the patients reported improved scores.

At the time, the surgery was being presented as a treatment, but not a cure, for the disease.

When the chest physicians met again the following fall, the results of the surgery still looked like it was helping patients. Some were able to improve their lung function and ability to exercise, even seeming to do better than those who received standard treatment for the disease.

One surgical team found only 4% of the patients died within six months after the surgery. The death rate among patients getting traditional treatment with medicine was 17%. And the benefits seemed to last for years after the procedure. Again, treatment was focusing around patients with severe emphysema.

But this week, other researchers have said that initial optimism probably went too far.

"There has been a prevailing view -- that I think unfortunately surgeons have contributed to -- that this operation may be a temporary cure for your disease, and it's clear that it's not for this subset of patients," said one of the researchers, Steven Piantadosi, MD, PhD, of Johns Hopkins University.

A pioneer in the surgery, Joel Cooper, MD, downplayed the findings. He said they were predictable because patients reported in the latest findings suffered from disease that was widely spread around their lungs. He said they were bad candidates for the surgery in the first place.

Cooper said his team dropped out of the five-year study in 1997 over this and other disagreements, including a condition that all participating surgeons stop doing the surgery outside the study.

He also said administrators at the federal Medicare program for the elderly, which is funding the study, are seeking justification to limit, delay, or deny coverage for the surgery, which typically costs from $25,000 to $40,000.

"Medicare has used the trial for its own purposes," said Cooper, a lung surgeon at Washington University in St. Louis.

An official at the Centers for Medicare and Medicaid Services said the agency didn't interfere with the scientific decision making. The official spoke on condition of anonymity, which is agency policy.

Gail Weinmann, MD, project officer for the study at the National Institutes of Health's Heart, Lung and Blood Institute, said surgeons agreed to forgo surgery outside the study because they saw a need for systematic research.

"There was a concern about the spread of the procedure so quickly, and that it could be doing harm," she said.

The surgery was first tried more than 30 years ago with disastrous results. Improvements in anesthesia, surgical methods and postoperative care revived it in the 1990s. It is based on the idea that smaller, but healthier lungs can work better after the operation.

The technique became so widespread in recent years, with around 8,000 operations now performed, that researchers had trouble finding patients for the study. They said some candidates feared they would be assigned to comparison groups taking normal treatment, which includes diet, exercise and drugs.

In the latest findings, though, none of the 70 patients in the normal treatment group died within a month. The surgery left 11 of 69 patients dead.

Over three years, surgery patients were four times more likely to die than the others. Also, surgery survivors gained only limited benefit in better breathing or quality of life.

Weinmann defended the decision to operate on patients included in the latest findings, saying they were an important group to study and there is little medicine can do for them.

Lung specialists outside the study said patients with broadly spread disease were suspected to be relatively poor candidates for the surgery. However, they said the findings are valuable because they underscore the potential danger for some patients who may be overly eager for the surgery.

"In these patients ... someone needs to have a serious talk with them," said Jeffrey Drazen, MD, a lung specialist who is also editor in chief of the journal.

"My guess is that most physicians will heed this warning," added Norman Edelman, MD, scientific consultant for the American Lung Association. -->

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