Major Study Of Surgery For Severe Emphysema To Begin

December 23, 1996

The University of Maryland Medical Center is one of 18 sites chosen by federal health officials to perform lung volume reduction surgery for people with severe emphysema who are covered by Medicare. The surgeries will be part of a seven-year, national study to evaluate the safety and effectiveness of the procedure, which involves the removal of about 20 to 30 percent of a patient's over-inflated, diseased lungs.

Physicians at the University of Maryland Medical Center and the Johns Hopkins University will collaborate to form the Maryland Lung Volume Reduction Surgery Clinical Center. Patients in the study will undergo evaluation and receive medical therapy at either the University of Maryland Medical Center or the Johns Hopkins Hospital, and those selected for surgery will have it performed at the University of Maryland.

"This study will be important for us to evaluate definitively the role of lung volume reduction surgery and find out which patients would benefit the most," says Mark Krasna, M.D., director of General Thoracic Surgery at the University of Maryland Medical Center. Dr. Krasna, an associate professor of surgery who is the principal investigator of the study in Maryland, has performed volume reduction surgery on more than 75 patients since 1994.

Jonathan Orens, M.D., an assistant professor of medicine and pulmonologist at the University of Maryland and Henry Fessler, M.D., an assistant professor of medicine and pulmonologist at Johns Hopkins University School of Medicine, are working with Dr. Krasna on the study.

"While this operation has been performed on several thousand patients over the past two years, the duration of its benefit and its role in the comprehensive care of patients with emphysema can only be learned by direct comparison with the best available non-surgical care," says Dr. Fessler.

The surgery is offered to patients with severe emphysema, a chronic condition that is a major cause of death and disability in the United States. The disease, which affects about two million Americans, is usually caused by smoking. The damaged lung tissue becomes inflated with enlarged air sacs, preventing muscles involved in breathing to move normally. Lung volume reduction surgery has helped many patients to have improved lung function and better quality of life because their lungs are more able to expand and contract. However, the surgery is risky since patients have decreased lung function and are quite ill before the surgery because of their emphysema.

This will be the first large, prospective study of the surgical procedure. The study will be conducted by the National Heart, Lung, and Blood Institute (NHLBI) and funded by the Health Care Financing Administration (HCFA), which will cover patient care costs for the Medicare beneficiaries who are candidates in the study. It is the first time HCFA and NHLBI have collaborated on a study of this magnitude.

Nationwide, about 2600 patients will be enrolled. All will receive intensive medical therapy and pulmonary rehabilitation. Half of the patients will be randomly selected to undergo the volume reduction surgery. Throughout the study, all participants will be evaluated for exercise ability, lung function, quality of life, illness and survival. Both the University of Maryland and Johns Hopkins will evaluate and follow patients in the study and guide medical treatment.

The University of Maryland Medical Center is the only site in the Mid-Atlantic region where surgery will be performed as part of the study. In addition, it is one of only six centers in the U.S. where the surgery will be performed in two different ways. One method involves a standard chest incision. The other approach, a less-invasive technique called thoracoscopy, requires only a few small incisions and is guided by a video camera.

Medical therapy for emphysema includes medications to dilate constricted airways, reduce inflammation, and prevent infection. Exercise training and supplemental oxygen are also used.

Those interested in participating in the study should call Study Nurse Coordinator Karen King at 410-328-2168.

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University of Maryland Medical Center

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