Unprecedented Collaboration Between the NIH and Medicare Columbia University Medical Center Only NYC-area Study Site
May 20, 2003
A major new government study shows that patients with severe emphysema who undergo bilateral lung volume reduction surgery (LVRS) on average do not face an increased risk of death, and are more likely to function better compared to those who receive only non-surgical treatment. The study also identified specific criteria to determine which patients will benefit from the procedure. The five-year randomized study, known as the National Emphysema Treatment Trial (NETT), represents an unprecedented collaboration between the National Institutes of Health (NIH) and Medicare, and was the combined effort of 17 clinical research sites, including NewYork-Presbyterian Hospital/Columbia Presbyterian Medical Center, the only greater New York City area site selected to participate.
The study's full results will be presented on May 20 at the American Thoracic Society 99th International Conference in Seattle and will appear in the May 22 edition of the New England Journal of Medicine.
The NETT study found that patients whose emphysema was mostly located in the upper lobes of the lung and whose exercise capacity was low after pulmonary rehabilitation but prior to surgery were more likely to survive longer and function better after LVRS compared to similar patients who solely received standard treatment. In contrast, in patients who did not have upper lobe distribution of emphysema and who had greater exercise capacity, LVRS decreased survival and failed to improve functional levels.
The NETT findings will help patients and their physicians make more informed decisions about whether lung volume reduction surgery is right for them, said Dr. Byron Thomashow, clinical professor of medicine at Columbia University College of Physicians Surgeons; medical director for the Jo-Ann LeBuhn Center for Chest Disease and Respiratory Failure at NewYork-Presbyterian Hospital/Columbia Presbyterian Medical Center; and co-principal investigator for the study site.LVRS represents the first major treatment advance for emphysema patients in almost 25 years.
The findings directly impact as many as 20 percent of emphysema patients — 400,000 Americans — who meet the requirements identified by the study, said Dr. Mark Ginsburg, assistant clinical professor of surgery at Columbia University College of Physicians Surgeons; associate director of general thoracic surgery and surgical director for the Jo-Ann LeBuhn Center for Chest Disease and Respiratory Failure; and co-principal investigator for the study site. Importantly, Medicare is currently reassessing its coverage of the procedure and will base a recommendation on data from the NETT study.
NETT represents a unique collaboration among three government agencies within the Department of Health and Human Services: the National Heart, Lung, and Blood Institute of the National Institutes of Health (NHLBI), the Centers for Medicare Medicaid Services (CMS), and the Agency for Healthcare Research and Quality (AHRQ). The study may represent a model approach for how to conduct and fund future studies of unproven treatments.
Emphysema is a progressive, chronic, and disabling lung condition that affects primarily individuals over age 50 who are current or former cigarette smokers. With emphysema, breathing becomes difficult as the fine architecture of the lung is destroyed, leading to large holes in the lung, obstructed airways, trapping of air, and difficulty exchanging oxygen because of reduced elasticity of the lungs. Emphysema costs more than $2.5 billion in annual health care expenses and causes or contributes to 100,000 deaths in the U.S. each year.
Current medical treatments include smoking cessation for those who still smoke, exercise rehabilitation, oxygen therapy for those with low blood oxygen levels, supportive and preventive measures such as flu shots and pneumonia vaccine, medications such as bronchodilators to help open airways, and prompt treatment of respiratory infections. In LVRS, 25 percent to 30 percent of the most damaged regions of each lung is surgically removed. Scientists believe that by surgically removing functionally useless tissue, air will move in and out of the remaining lung more readily, thereby easing symptoms associated with advanced emphysema and improving overall lung function. LVRS was widely performed from 1993 until 1995, at which time Medicare halted coverage of the procedure, citing concerns over risk for morbidity; many other insurance carriers followed suit.
A separate analysis of the cost effectiveness of LVRS (supported by AHRQ) has found that the direct monetary cost of lung volume reduction surgery is substantial over the short term, but over the long term, the procedure may be cost effective if the benefits observed in NETT are sustained.