University of Washington Medical Center is the only hospital in the Northwest selected to participate in a nationwide clinical trial of a new surgical technique that may offer better quality of life, and perhaps longer life, to people with advanced emphy sema.
In a new collaborative effort, the Health Care Financing Administration (administrator of Medicare) and the National Institutes of Health (through its National Heart, Lung and Blood Institute) will fund a clinical trial designed to determine the risks an d benefits of the operation, called lung volume reduction surgery (LVRS). Medicare will cover patient-care costs and NIH will fund the research. The study marks the first time that federal government agencies are collaborating to fund a trial of a surgica l procedure.
“We are very pleased that HCFA and NIH are collaborating to advance knowledge of this treatment,” said Dr. John Coombs, acting vice president for medical affairs and acting dean of the UW School of Medicine. “It’s a creative stroke. While the Food and Dr ug Administration has long evaluated new drugs and medical devices, the United States does not have a formal mechanism for evaluating new surgical procedures. We hope this study will set a precedent and become a model for the future. We need scientific ev idence on risks and benefits before new techniques become widely used.”
Of 18 medical centers across the nation selected to participate in the trial, UWMC is the only one west of Denver and north of Los Angeles. It is anticipated that UWMC will enroll patients from Washington, Oregon, northern California, Alaska, Idaho, Mont ana, Utah, Nevada and Wyoming in the trial.
LVRS has been performed at UWMC and other specialized medical centers for about two years. However, Medicare has denied insurance coverage for the last year, on the basis that the procedure is still experimental. Medicare will now cover the surgery for i ts beneficiaries who are enrolled in the trial.
UWMC was selected for the trial based on the large number of lung volume reduction surgeries it has already performed, the low rate of complications, the degree of improvement seen in patients treated, and the quality of the research produced.
“We find the average improvement in breathing and exercise capacity is about 40 percent,” said principal investigator Dr. Richard Albert, section head of pulmonary and critical care medicine at UWMC and professor of medicine. “While the data we have pert aining to quality of life are preliminary, they strongly suggest it is markedly improved.”
“These patients are the most grateful and satisfied patients we see,” said Dr. Douglas Wood, chief of general thoracic surgery and co-principal investigator for the new study. One of the surgeons most experienced in the new technique, Wood has performed all of the more than 100 lung volume reduction surgeries done at UWMC. He performed the Northwest’s first such surgery in September 1994.
A major goal of the study, which will last up to seven years, is to determine whether the surgery actually prolongs life.
“While HCFA and NIH are announcing the study now, we will not begin evaluating patients for the Medicare trial until late summer, and the first operations in the trial will not be performed until fall,” said Albert. “However, we will begin responding to inquiries immediately.”
UWMC expects to enroll at least 250 patients in the study. At present, only Medicare patients are eligible to participate, and they will be covered for the surgery only as participants in the trial
UWMC continues to perform lung volume reduction surgery for non-Medicare patients. Such patients are evaluated on an ongoing basis and can be seen at any time. About half of private insurers cover lung volume reduction surgery.
For more information, patients and physicians should call 1-800-826-1121.
Facts about emphysema and lung volume reduction surgery
In emphysema, the walls between the tiniest air sacs in the lungs break down, and those compartments become enlarged. Lung tissue loses elasticity and the lungs become distended and unable to expand and contract normally.
In lung volume reduction surgery, tissue that is most severely damaged–up to one-third of each lung–is removed, giving the remaining tissue more space to expand in the thoracic cage. The surgery typically requires hospitalization for about eight days.