Controversial Lung Surgery on Hold for More Studies

Dr. Robert Kovan, a psychiatrist, was forced into retirement in 1994 because he could no longer talk to his patients. His lungs, scarred by a lifetime smoking habit of two packs a day, would not provide him enough breath to speak in complete sentences.

Kovan became permanently linked to an oxygen tank, his outside excursions limited to brief trips on an electric cart. “I was drained all the time from struggling to breathe,” Kovan said. “It’s like suffocating. You get a pain in your chest because you are struggling for breath. Your rib muscles get very sore and it is psychologically very stressful.”

But today, Kovan, 66, plays golf three times a week and is planning a vacation in Europe in June. His remarkable rehabilitation is the result of a controversial new procedure called lung volume reduction surgery, in which surgeons paradoxically attempt to improve breathing by cutting out part of the lungs.

In the three years since the most widely used version of the $30,000 procedure was perfected, surgeons around the country have performed it on more than 3,500 emphysema patients, with some groups claiming a success rate as high as 87%.

“This really offers patients with a disabling disease a genuine alternative that they have never had before,” said Dr. Scott Lerner of the University of Missouri at Kansas City Medical Center.

“We haven’t done this long enough to know that it is going to make people live longer,” added Dr. Daniel Miller of Jewish Hospital in Louisville, Ky., “but it produces an incredible improvement in their quality of life.”

But critics charge, and proponents concede, that the complex, labor-intensive surgery is spreading too rapidly to hospitals that are not equipped to handle it, endangering patients and driving up health costs. “It’s a very, very difficult operation,” Miller said. “Some centers had to close down because they had 100% mortality rates.”

Physicians do not yet know, furthermore, which patients are the best candidates for the surgery, whether the risk of death outweighs the potential benefits and what the long-term effects of the surgery will be, argues Dr. Barry J. Make of the National Jewish Center for Immunology in Denver. “Surgery for emphysema is not ready for prime time,” he said.

Troubled by these controversies, and perhaps alarmed by the prospect that the majority of the country’s estimated 2 million emphysema patients may demand the costly procedure, the Health Care Financing Administration--which oversees all Medicare payments--in January classified the surgery as experimental and stopped paying for it. Because the agency, via Medicare, covered an estimated 90% of all such surgeries before the ban, its action had the effect of imposing a de facto moratorium.

The agency recently agreed to sponsor a clinical trial of the procedure to be conducted by the National Institutes of Health. But proponents of the surgery argue that the trial will take too long to complete, permitting needless suffering and death among the emphysema patients who are not part of the experiment.

Some even fear that “control” patients in the trial who do not receive surgery will die as a result.

Kovan, from the patient’s perspective, believes that the ban is a mistake. “This surgery saved my life, as far as I am concerned,” he said. Medicare’s refusal to pay for the surgery “is an absolute crime. They are penny-wise and pound-foolish.”

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Lung volume reduction surgery is targeted at emphysema, the most prevalent form of chronic obstructive pulmonary disease. Although some cases are genetic in origin, more than 80% of emphysema cases are caused by excessive smoking. Chemicals, gases and tar in cigarette smoke cause the lung to literally dissolve.

Lungs are composed of 300 million tiny air sacs, called alveoli, made of thin, elastic tissue. Expansion and contraction of the alveoli, regulated primarily by the diaphragm, allows an individual to breathe in and out.

In emphysema, the tissue between alveoli breaks down, causing them to collapse into larger sacs that lose much of their elasticity. The lungs gradually expand until they fill the entire chest cavity, pressing down on the diaphragm so that it can no longer regulate breathing. Muscles in the rib cage and abdomen take over, but breathing with them is inefficient and tiring.

“To get a sense of what it is like, take a deep breath and hold it briefly,” said Dr. Robert McKenna of Good Samaritan Hospital in Los Angeles. “Then try to take in another breath on top of that. They are always breathing like that, near the capacity of their lungs.”

“These patients are miserable,” adds Dr. John Eugene of UC Irvine and Western Medical Center in Anaheim.

Conventional treatment includes antibiotics and vaccination to prevent respiratory infections and pneumonia, inhaled steroids to reduce lung inflammation, oxygen therapy, and breathing exercises and physical therapy to improve lung function.

But Lerner said, “The medicines that we have used over the years simply do not improve symptoms very much and have significant toxicities,” including high blood pressure and diabetes. “I’ve been in practice for 19 years, and there is nothing [short of surgery] that improves a patient with severe disabling emphysema.”

The treatment of last resort for the most severely disabled is a lung transplant, but the mortality rate for that $150,000 procedure is about 30% and donor organs are scarce. As a result, only about 700 lung transplants are conducted each year.

“One reason I got into lung volume reduction surgery was to save donor organs for those who [are in imminent danger of dying and] need them the most,” Lerner said.

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The goal of lung reduction surgery is to remove dead lung tissue, freeing room for the diaphragm to function once more and allowing lung tissues to flex naturally. Doctors achieve this either by shrinking diseased tissue with a laser or by surgically removing it.

In either case, the surgery is risky because the patients are extremely sick and restoring lung function is difficult after any kind of surgery, experts say.

Surgeons first tried lung volume reduction surgery 40 years ago, but the technique was too complicated and technically demanding for the era. It fell into disfavor until the late 1980s, when surgeons such as Eugene and Dr. Akio Wakabayashi of the Irvine Medical Center began using lasers to reduce the volume of emphysematic lungs.

Diseased tissue shrinks when exposed to a laser beam, Eugene said, while healthy tissue remains unaffected because it contains blood vessels that absorb the laser’s energy. “It’s almost a diagnostic procedure to tell which tissue is affected,” he said.

Although the laser procedure helped emphysema patients, virtually all agree, it is not as effective as the surgical approach to lung volume reduction pioneered by Dr. Joel Cooper of the Washington University School of Medicine in St. Louis. Cooper’s inspiration was to use cow pericardial (heart) tissue to protect the lung left in place.

Diseased lung tissue tears easily, like wet tissue paper. To prevent it from ripping, Cooper used a stapler sheathed in cow pericardium to trim the edges where tissue is cut away. The cow tissue acts like bias tape on the hem of clothing, reinforcing the tissue and sealing the holes created by stapling.

The “very, very difficult” surgery only takes an hour, but it is “extremely labor-intensive,” said Jewish Hospital’s Miller. Because patients are so ill, preparation for the surgery and follow-up requires a large team of specialists, including cardiologists, pulmonologists, nutritionists, physical therapists and in some cases, psychiatrists. Recovery in the hospital usually requires 10 to 21 days.

Lung volume reduction surgery “is only 20% of my practice, but it’s 80% of the work,” he added. That is why most practitioners believe that it should be performed only at large, regional centers where surgeons can become proficient at the procedure.

“The more you do, the better you get at it,” Miller said, noting that his team had lost nine patients in the first year they performed the surgery, but only one in the 10 months following. They have performed more than 150 surgeries to date.

The results can be spectacular. Miller said that 87% of his patients have been able to get off oxygen and 50% are off medication, for example. McKenna said 70% of his have been freed from their oxygen tether. Kansas City’s Lerner said his patients have a 45% to 50% improvement in breathing capacity.

Dr. Anne M. Kuzma and her colleagues at the Temple University School of Medicine reported this month at a meeting of the American Thoracic Society on a study of the quality of life of 10 patients who underwent the procedure. Using a widely recognized Sickness Impact Profile that measures illness-related impairment in 12 areas of behavior, the team found that eight of the 10 patients reported a 24% to 100% improvement.

“These are quite gratifying results,” Lerner said.

Improved breathing can take as long as three months to appear fully, but some patients report almost instantaneous benefits. “When I came out of the anesthesia [after the surgery], I said, I really think there is improvement already,” Kovan said. “My breathing was better than it had been for five or six years.”

Patients continue to improve for as long as nine months, surgeons agree, and then plateau, with the benefits remaining constant. So far, no one has observed any later loss of function in the patients, but no surgery patients have been followed for more than about 18 months.

Some laser surgery patients, however, have been followed for longer periods. In another report at the Thoracic Society meeting, Dr. Francois Petureau of the Centre Hospitalier Purpan in France reported on 18 patients undergoing laser reductions. Five years after the procedure, seven of the nine patients still alive were improved. At eight years, four of five were improved.

The procedure has an “interesting survival rate,” the team concluded, and should be considered a long-term efficient treatment for patients with severe emphysema.

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Professional groups have been cautious in endorsing the new procedure. Dr. Norman Edelman of the State University of New York at Stony Brook, speaking for the American Lung Assn., said his agency “has not taken an official position other than to note that the short-term effects appear to be positive.”

He added, however: “The results appear to be sufficiently encouraging to warrant funding by HCFA.”

The American Thoracic Society also weighed in at its annual meeting this month, contending that in an official statement that “the operation should not be considered experimental.” The group also recommended “that this operation be performed only at [large] centers where these procedures can be more completely studied.”

“We are calling for caution,” said the society’s president, Dr. Leonard D. Hudson of the University of Washington.

Surgeons have not been entirely sure how the procedure achieves its results. Clearly, taking pressure off the diaphragm makes breathing easier, but there is more to it than that, said Dr. Frank Sciurba of the University of Pittsburgh Medical Center.

In a recent paper in the New England Journal of Medicine, Sciurba and his colleagues reported that the surgery restores the elasticity of healthy lung tissue. When healthy tissue is freed from the stiff diseased tissue, he found, it can spring back like a collapsing balloon, forcing air out of the lungs when a patient exhales. McKenna and others have papers in preparation reporting similar results.

The biggest question remaining is who will most benefit from the surgery. Physicians agree that the vast majority of emphysema victims are not, and may never be, candidates for it.

“Somebody who used to go jogging, but now can only walk is not sick enough for the procedure,” Good Samaritan’s McKenna said. A patient has to be very sick to warrant undertaking the risks that are associated with a palliative, but not curative, surgery, he said. Patients must also have a pattern of disease in the lungs that permits removal of affected tissue. The lack of such a pattern “eliminates three out of every four” patients who are otherwise sick enough.

Miller agreed, noting that he had winnowed a field of 3,500 potential surgery patients down to only 170 who were accepted for the program.

“Realistically, maybe 15,000 to 20,000 Americans each year are candidates,” McKenna concluded.

But under the Health Care Financing Administration’s ban, most candidates for the surgery will have to wait until after the forthcoming six-year trial, which will not begin until next year. It will involve about 2,400 patients at several medical centers. All will get aggressive conventional treatment for their lung disease and half will be randomly assigned to undergo the surgery.

“That means that only 1,200 people will get Medicare-funded surgery over an eight-year period,” McKenna said. “It’s really disturbing that they are denying access to the surgery to the thousands and thousands of Americans who could benefit from it.”

Researchers also believe that it will be difficult to get patients to participate in the trial as controls. “Patients have been informed that there is a potential surgical treatment,” and are not going to want to be in the half of the study that does not receive it, Eugene said.

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Denver’s Make, who has reservations about the procedure, said the proposed NIH trial “has the potential to answer a lot of the questions we have about the surgery. I would counsel people to avoid the surgery until the outcome of the trial is clear.”

But Eugene is succinct in his reply. “The operation works, I can say that without hesitation. If I have any doubts, it is about the long-term results of the operation,” he said.

The scenario for lung volume reduction surgery is most likely going to be the same as that for heart bypass surgery, he concluded. “We know they will live as long with medical management as with surgical management. But, statistically speaking, they will always have an improved quality of life with surgery.”

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Room to Breathe

In emphysema, the diseased lung expands, filling the chest cavity, depressing the diaphragm and making breathing difficult. A recently developed surgical remedy has shown great promise.

1. Surgeons cut out the diseased tissue, using staples to seal the remaining portions of lung with cow heart tissue. The tissue acts like bias tape on the seam of a garment, preventing fragile lung tissue from tearing and stopping air from leaking through holes made by the staples.

2. The surgery eases pressure on the diaphragm, allowing normal breathing to be restored. Removing the diseased tissue also makes it easier for the lungs to expel trapped air.

Source: Stanford University