Back in the early 1990s, the nation's nearly 2 million emphysema sufferers began hearing about a seemingly miraculous operation that might give them back their lives.
Called lung volume reduction surgery (LVRS), it involves removing parts of the lungs that have lost elasticity and grown floppy and oversized as the walls between the tiny air sacs in the lungs became damaged, making it difficult for air to move in and out.
Emphysema sufferers are left gasping for breath and are desperate for a magic bullet. The disease, which has been linked to smoking, kills nearly 17,000 people a year. There is no cure.
The idea for LVRS dates to the late 1950s, when a surgeon named Otto Brantigan at the University of Maryland School of Medicine in Baltimore noticed that emphysema sufferers' lungs had expanded so much that the lungs had little room in the chest cavity to function." He hypothesized that taking out some of the most diseased part of the lung would improve breathing by freeing up room for the remaining healthier lung tissue.
Brantigan began operating, taking out 20 percent to 30 percent of the diseased lungs. In a 1959 report, he claimed that 75 percent of his patients improved, but he failed to provide any objective measurement. He also reported that 16 percent of his patients died shortly after surgery. Concerned with the mortality rate and criticism in newspaper editorials at the time, Brantigan eventually halted the operations and no other surgeon attempted the procedures, though many remained intrigued by its possibilities.
A New Look at the Old Procedure
In the early 1990s, a Canadian surgeon brought Brantigan's provocative research to the attention of Dr. Joel Cooper, a surgeon at Barnes-Jewish Hospital and a professor at Washington University School of Medicine, both in St. Louis.
Cooper became famous in 1985 when he performed the world's first successful lung transplant. During subsequent transplants, Cooper, like Brantigan, noticed that the chests of transplant patients who had emphysema were huge as a result of the distended lungs.
With patients having such big chests, Cooper found himself unsure of what size lungs to put in during transplants. He tended to want larger lungs than were available.
"What we found was that we'd put new lungs in, get rid of the huge distended lungs, and in the recovery room, the X-ray would show that the shape of the chest was much more normal already. [We found] that the distended chest had the capability of springing back. Suddenly Brantigan's notion makes a little more sense," Cooper told the Saturday Evening Post in 1994.
So in 1992, using medical and technical advances of the intervening decades, Cooper began doing LVRS on emphysema patients who were too sick or old to qualify for lung transplants. They had no other choices and so were willing to take some risks.
Soon, 20 patients had undergone the surgery, having 20 percent to 30 percent of each lung removed.
In 1994, Cooper presented his data on those patients at a meeting of the American Association for Thoracic Surgery. Its members are doctors who specialize in the thorax, or chest cavity, which contains the lungs and heart.
The news seemed electrifying. After six months, none of Cooper's patients had died, and the mean improvement rate in breathing was 82 percent, Cooper reported. When the mainstream press latched onto this success story, Cooper received more than 2,000 calls from desperate patients. Soon, other doctors began doing LVRS.
Because the procedure was so new and untested, the surgery was sometimes performed on patients who were already frail and sick with other ailments. Some doctors reported mortality rates of 20 percent.
Doctors decline to specify what they consider an acceptable mortality rate for such surgery, although some say that with a 5 percent to 10 percent mortality rate, the operation is considered somewhat risky.
But Cooper pointed out that patients with advanced emphysema have a 40 percent to 50 percent chance of dying within three years. By contrast, his office reports a 90 percent survival rate at two years for LVRS patients.
Since the surgery costs $25,000 to $50,000, most people couldn't afford it on their own and about 80 percent of the surgeries were paid for by Medicare. Because LVRS wasn't specifically overed, doctors billed the federal agency using codes for other lung-surgery procedures.
Medicare Balks, Calls for More Research
As news of Cooper's success spread, requests for Medicare reimbursement mushroomed. The Health Care Financing Administration, which administers Medicare, received about 200 such claims in 1993. In 1995 the agency received 2,000 claims. That year, tipped off by the sudden spike in lung surgeries, Medicare investigators
learned what doctors had been doing and cut off funding for LVRS, saying that not enough was known about the survival rates to justify the surgery. The issue is important because many insurance companies fall in line behind Medicare, paying for treatments that the agency covers and denying those it doesn't.
"This was a surgery that was very invasive for very sick individuals, and there was no information at the time as to whether the risks would be greater than any benefits," says an HCFA spokesman.
Many of those who urged caution likened the LVRS debate to that which swirled around bone marrow transplants, which for many years also sparked controversy and were not covered by managed care. Further research has since shown that bone marrrow transplants are not more effective than less invasive therapies.
Around this time, HCFA conducted its own study, tracking the Social Security numbers of 711 people who had undergone LVRS under Medicare before 1995.
HCFA then reviewed how many death certificates corresponded with those Social Security numbers. Around this time, HCFA conducted its own study, tracking 711 people who had the surgery under Medicare before 1995. The federal agency found that LVRS patients had a 25 percent mortality rate after 12 months and a 30 percent mortality rate 18 months after the surgery.
Critics attacked the agency's conclusions, saying the HCFA study didn't take into account whether the patients died because of the surgery or other reasons. Other studies since then have found higher success rates for the surgery and much lower mortality.
Cooper, for instance, analyzed 150 LVRS operations performed at his hospital and concluded that the mortality rate after 90 days was 4 percent. Six months after the operation, 70 percent of patients rated their health as "much better," 28 percent said they were "somewhat better," and 2 percent said they were no better or worse, Cooper reported.
Nonetheless, "It was our view and the view of many scientific agencies that we were badly in need of further research," the HCFA spokesman says. Agencies that concurred, he said, were the National Heart, Lung and Blood Institute, an agency of the National Institutes of Health; the Blue Cross Blue Shield Association Technology Evaluation Center, a non-profit group that does research and policy work for the insurance company and the American Thoracic Society.
Ditto for the federal Agency for Healthcare Policy and Research, which conducted an assessment of LVRS in 1996. It concluded that that the surgery showed some promise but that a comprehensive study was needed before Medicare would pay for it.
LVRS Study Begins
And so was born the National Emphysema Treatment Trial (NETT), a long-term, comprehensive study of LVRS, which would be carried out at 19 medical centers in the U.S. and supported by HCFA, the Agency for Healthcare Policy and Research and the National Heart, Lung and Blood Institute.
Originally, the goal of the researchers was to study 5,000 emphysema patients over a five-year period, or until 2001. Under the parameters of the study, half the patients would receive LVRS and the other half would receive non-surgical medical treatments.
"The objective is to collect information so that doctors and patients can make informed decisions," says Dr. Gail Weinmann of the NHLBI, who oversees the study as its program officer. "If there are beneficial effects of the procedure, how long do they last?" Determining that is one of the study's goals," says Weinmann, who says there is some concern that the surgery may work only temporarily.
But from the beginning, NETT had difficulty recruiting patients, and its rigorous entry requirements meant that two out of every three applicants were turned down. As a result, the study sample has been halved to about 2,500 patients, and recruitment is expected to continue until July 2002 unless an independent medical ethics committee decides it has sufficient data to prove that the surgery is either valuable or too dangerous to continue.
Ethical Questions Dog Study
The decision to withhold surgery from half the NETT patients has sparked a huge ethical controversy.Cooper, the surgeon who re-introduced LVRS in 1993, has said there is enough evidence that the operation works and that he will not withhold surgery from any patient who needs it and has insurance or private funds to pay for it. As a result, Cooper and Barnes-Jewish Hospital in St. Louis, where he works, have withdrawn from the study.
"They felt it was unethical to have a non-surgical group," confirms the HCFA spokesman. "Dr. Cooper has a lot of experience. He developed the modern version of this surgery, but I believe his reading of the scientific evidence is quite different than the general evaluation of the rest of the scientific community."
Other doctors have also quit, saying that compassion requires them to offer every available option to those struggling for breath. Because the average life expectancy after diagnosis for patients with advanced emphysema is about three years, which means that many of those in the Medicare study control group -- those who will not get the surgery -- will likely be dead by the time a conclusion is reached.
HCFA officials acknowledge that the terms of the study are difficult for emphysema patients desperate for any option that could buy them some time. They also acknowledge that the selection of patients and the medical techniques used during surgery have improved much since 1995, when it halted Medicare payments for LVRS.
"Subsequent to that decision, much more information became available," the HCFA spokesman says. "Today there are hundreds of published articles about lung-reduction surgery."
But HCFA still says that until the study is completed, it cannot make any decision about whether to pay for LVRS.
More Support for LVRS
Cooper's study isn't the only one pointing to the success of LVRS. In 1996, two non-profit organizations reviewed the existing research and said that while LVRS isn't appropriate for all patients, 85 percent of those who undergo it experience improvement. The groups were ECRI, which has offices in the U.S. and around the world; and the Blue Cross Blue Shield Association in Chicago. The agencies reported a mortality rate is 5 percent for experienced doctors performing the surgery, which is considered good for patients in such frail condition. The review also found that those who received non-surgical care showed no improvement.
"The procedure has some risk to it," confirms Dr. Robert McKenna of Cedars-Sinai Medical Center in Los Angeles, one of the NETT sites, which has done 19 surgeries as part of the study.
At his hospital, "Everyone has improved following the operation, but for only for a period of time. You have to figure out where in a person's course of living with emphysema it would be best to give them this extra boost of improvement. You don't want to do it when they're so bad off and weakened that they're in a wheelchair. You need to get it before that."
Still, HCFA officials insist that any decision to pay for the procedure will have to await the conclusion of the study at the end of 2002.
As to why so many doctors seem to support LVRS, the HCFA spokesman responds: "Those who passionately believe it's a good idea tend to write more. Surgeons see data in a different way than scientific researchers do. When this NETT study is concluded, then patients will have all the information to make choices about this."
HCFA says it can't comment on certain aspects of the study because of pending litigation. It is facing lawsuits from emphysema patients for whom Medicare has declined to pay for surgery since 1995 or from their survivors.
Patients are also suing private insurance carriers that have refused to pay for the surgery.
Kim Drummond, a registered nurse from Murfreesboro, Tennessee, is battling HCFA and Medicare to try to get LVRS for her father. She has filed a civil rights complaint accusing HCFA of health-care discrimination and has written her senators and congressman, complaining about the inconsistencies she has encountered from the federal agencies.
Critics have also accused Medicare of trying to cut costs at the expense of lives. McKenna, of Cedars-Sinai in Los Angeles, says that HCFA "wasn't sure [the surgery] worked, but I think their biggest concern was the cost."
But HCFA maintains that its decisions are not motivated by financial reasons.
"What it costs us per patient for the operation has nothing to do with making a national coverage decision, and that's an important point," the HCFA spokesman says. "Cost is not a part of this decision."
Denise Hamilton is a Southern California-based writer whose work appears in publications including Apria.com, the Los Angeles Times' Health section and New Times Los Angeles. Her first book, "The Jasmine Trade," is published by Scribner.
