Experimental lung surgery intended to help emphysema patients will be covered for Medicare recipients who take part in a clinical trial at the University of Maryland Medical Center and 17 other hospitals.
The nationwide trial, to begin next year, will evaluate the safety and effectiveness of volume-reduction surgery for patients in the late stage of emphysema.
In this procedure, surgeons remove about a third of the lung to increase its efficiency and relieve shortness of breath.
Not all volunteers, however, will have the operation. All participants will receive intensive treatment, including medication and physical therapy, but only half will get the surgery. Participants will be randomly assigned to one of the two groups.
Patients will be followed for seven years, after which their progress will be compared to see whether the surgery was helpful.
"We're trying to answer the question, is volume-reduction therapy more beneficial than rehabilitation?" said Dr. Mark J. Krasna, UM's director of thoracic surgery and principal investigator of the Baltimore arm of the study.
The UM Medical Center will enroll 150 to 250 patients. Pulmonary specialists from the Johns Hopkins University School of Medicine will help evaluate patients and deliver medical treatment, but all operations locally will be done at UM.
In addition, the Hopkins School of Hygiene and Public Health will collect and analyze data for all centers taking part in the study.
The procedure was pioneered in the 1950s by the late Dr. Otto Brantigan, a University of Maryland surgeon. Despite some remarkable successes, death rates at the time were unacceptably high. Three years ago, a St. Louis surgeon revived the operation, improving its safety by using modern techniques.
At the University of Maryland, Krasna and his colleagues have performed about 75 volume-reduction operations since 1994.
The approach has gained popularity around the country, but the federal Health Care Financing Administration withdrew Medicare coverage in January -- declaring that the surgery was spreading rapidly without proof of its merit.
Yesterday, HCFA and the National Heart, Lung and Blood Institute announced plans for the trial, in which 2,600 patients will be enrolled.
Dr. Claude Lenfant, director of the institute, said that although the operation "has been reported to improve lung function and quality of life in some cases, there still are many questions about its benefits and risks that should be answered before it is used widely."
While the government will not extend Medicare coverage of the surgery as a standard benefit, those in the clinical trial will be covered fully.
Lung volume-reduction surgery and the follow-up care can cost more than $30,000.
Emphysema, which afflicts about 2 million Americans, is a fatal disease that slowly robs people of their ability to breathe. Smoking is almost always the cause -- destroying lung tissue needed for the healthy exchange of oxygen and carbon dioxide.
Tiny air sacs break down and merge, forming larger ones that are less efficient at transferring oxygen to the bloodstream. The lung's narrow airways also become less elastic, causing air to become trapped inside the lung.
Patients feel short of breath and, in the advanced stages of the disease, cannot walk across a room without feeling winded. They compensate by taking shallow, rapid breaths -- a response that causes the lungs to expand to three times their normal size.
Volume-reduction surgery is based on the premise that the diseased lungs can be made more efficient if they are made smaller. Surgeons typically remove the upper third of the lungs.
The surgery is seen as a temporary measure that does not interrupt the underlying disease process.
Medicare's denial of coverage has become an emotional issue among emphysema patients. Many are elderly and have no other source of medical coverage.
People wanting more information about enrolling in the study should call Karen King, UM's nurse coordinator, at 328-2168.
Pub Date: 12/21/96