Citing high patient mortality rates and saying more research was needed before lung volume reduction surgery could be reimbursed under Medicare, the federal government in late 1996 launched a comprehensive study of thecontroversial procedure that is likely to recruit patients until July 2002.
For thousands of emphysema sufferers who cannot pay for the $25,000 to $50,000 surgery and whose insurance does not cover it, the Medicare study offers the only hope of relief from the devastating disease that leaves patients gasping for their very lives.
But getting into this study is not a slam dunk. The screening process is so arduous and the surgery so specialized that only one in three applicants qualifies. And once enrolled, only half of patients will receive the surgery. The others will become part of a control group that receives medical treatment but no surgery so that scientists will have a basis of comparison.
Trial Delayed From the Beginning
Federal officials say the study took longer than expected to get off the ground because they had difficulty recruiting patients. Initially, they sought to gather data on up to 5,000 patients, but the study has since been scaled back to roughly half that.
Indeed, the first patient didn't enter the study until 1998 and since then, 900 have formally enrolled and half of those have undergone the surgery as part of the National Emphysema Treatment Trial (NETT), as the study is formally known.
Supported by the National Heart, Lung and Blood Institute, the Health Care Financing Administration and the Agency for Health Care Policy and Research, the study is being carried out at 17 sites across America.
Emphysema sufferers must go to one of the treatment centers for extensive evaluations, sometimes even before learning whether they will be accepted. This can be a problem for patients who live far from participating sites.
Dr. Gail Weinmann, who oversees NETT as its program officer at the National Institutes of Health's National Heart, Lung and Blood Institute, says that those who live far away should call the center closest to them and inquire about reimbursement for travel costs. "We provide expenses to the centers to be reimbursed for travel and lodging," she said.
Are You Eligible to Participate?
To be eligible, patients must have advanced emphysema and must have gone at least four months without smoking. The next step for patients is to ask their physician to send their medical history, a chest X-ray and results of spirometry and EKG tests to the participating center of their choice.
Those who are too frail and weak, too thin, who suffer from other serious diseases such as angina, have experienced a heart attack in the past six months and have various other medical problems are likely to be found ineligible, since the study seeks to eliminate those whose medical complications may to interfere with their survival, federal officials say.
Patients must have advanced emphysema that is concentrated in the upper lobes of their lungs, because the surgery removes that upper third of each lobe. The theory is that this will allow the remaining undiseased lungs to function more efficiently. This means patients with emphysema that is diffused throughout the lobes of their lungs are also ineligible.
These stringent criteria weed out two-thirds of applicants. Those who are accepted must then complete a six- to-10-week pulmonary-rehabilitation program before undergoing the surgery. The program includes daily exercise and various medications to bring the lungs up to their optimal operating capacity. Patients are also counseled by psychologists seeking to maximize their post-surgery success.
After completing this regimen, patients are randomly assigned to the control group or to the surgery group. Patients assigned to the control group are often bitter and disappointed, feeling that they are missing out on a chance at life. Some eventually drop out of the study and find ways to pay for the surgery themselves or sue their insurance providers in the hopes of forcing the carrier to pay.
Those selected for the surgery undergo the operation soon after their selection, either by an incision through the breast bone or the insertion of a tube through the chest wall.
Patients report being told that there is a 15 percent to 20 percent chance of complications that can include a collapsed lung, swelling or infection. NETT officials decline to release preliminary data from the federal study.
However, "Some patients spend time on ventilators. Some people die," a HCFA spokesman says bluntly.
What Happens After Surgery
The recovery process takes about six weeks. Patients then complete another rehabilitation program of physical exercise, breathing exercises and medication. Some report that they still use limited oxygen, but others say they have been off it completely after the surgery and feel fine.
How long this improvement lasts remains unknown, and that is a question the study seeks to answer. But five years after surgery, some people are still alive and able to get around, exercise and breathe without difficulty.
During the first two years after surgery, patients are evaluated every six months for exercise tolerance and pulmonary and cardiovascular function. They have laboratory and radiologic exams and psychosocial and quality-of-life assessments. After that, they are evaluated every year until NETT concludes.
Weinmann says results are being kept confidential until the study is completed. But she adds that the study is being monitored by an independent medical ethics panel that can stop the study at any time if data show that the surgery is either too dangerous or that enough research has been gathered to prove its effectiveness. The ethics panel reviews the study data each quarter.
Denise Hamilton is a Southern California-based journalist who writes a column for the Los Angeles Times' Health section. She also writes for Apria.com, New Times Los Angeles and other publications. Her book "The Jasmine Trade" will be published in July 2001.
