The investigators also found that patients whose disease was concentrated in the upper lobes of the lungs and whose exercise capacity was low before surgery were more likely to survive longer and function better after surgery than those who received medical management alone. In contrast, patients who had more diffuse disease and greater exercise capacity were more likely to develop complications from the surgery.
"The findings provide crucial new information for weighing the benefits and risks of lung volume reduction surgery for the treatment of severe emphysema," said Steven Piantadosi, M.D., Ph.D., professor of oncology at Johns Hopkins and a lead investigator in the study.
Added Robert Wise, M.D., professor of medicine at Johns Hopkins and an author of the report, "They also tell us which patients will respond well to surgery and which ones are at risk of complications."
The researchers noted that although, on average, lung function and exercise capacity among surviving surgical patients improved significantly following LVRS, after two years these indicators returned to the same level as before surgery. In contrast, those who received medical therapy alone experienced losses in lung function to below baseline. Moreover, while the overall mortality rate was similar between the two groups throughout the study period, the risk of death during the first 90 days was significantly higher for patients who underwent surgery compared to those who received medical therapy alone (7.9 percent versus 1.3 percent).
The multicenter study, called the National Emphysema Treatment Trial (NETT), was designed to evaluate the effectiveness and safety of adding LVRS to medical management including pulmonary rehabilitation for advanced emphysema patients.
The findings are being presented May 20, 2003, at the American Thoracic Society 99th International Conference in Seattle, Wash., and posted simultaneously on the New England Journal of Medicine Web site (www.nejm.org). They will also appear in the May 22 print edition of the journal.
Johns Hopkins was the coordinating center for NETT researchers at the clinical sites that studied survival, exercise ability, lung function, quality of life, shortness of breath, and illness and hospitalization rates of 1,218 patients followed for an average of 29 months. At the start of the study, each patient underwent six to 10 weeks of pulmonary rehabilitation, which included education, counseling and exercise training, believed to help patients understand and manage their condition and make the most of their ability to perform activities of daily living. The participants were then randomly divided into one group of 608 patients who received surgery and ongoing medical management, and another group of 610 patients who got management but not surgery.
Emphysema is a progressive, chronic and disabling lung condition that affects an estimated 2 million Americans, 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 and trapping of air because of reduced elasticity of the lungs. According to the NIH, emphysema costs more than $2.5 billion in annual health care expenses and causes or contributes to 100,000 deaths in the United States each year.
Other Johns Hopkins researchers involved in the study are H. Fessler, J. Tonascia, P. Belt, K. Collins, B. Collison, J. Dodge, M. Donithan, V. Edmonds, J. Fuller, J. Harle, R. Jackson, H. Koppelman, S. Lee, C. Levine, H. Livingston, J. Meinert, J. Meyers, D. Nowakowski, K. Owens, S. Qi, M. Smith, B. Simon, P. Smith, A. Sternberg, M. Van Natta, and L. Wilson. The study was funded by the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services, and the Agency for Healthcare Research and Quality.
On the Web:
www.nejm.org
www.hopkinsmedicine.org
www.thoracic.org
www.nhlbi.nih.gov
Johns Hopkins Medical Institutions' news releases are available on an EMBARGOED basis on EurekAlert at http://www.eurekalert.org and from the Office of Communications and Public Affairs' direct e-mail news release service. To enroll, call 410-955-4288 or send e-mail to bsimpkins@jhmi.edu.
On a POST-EMBARGOED basis find them at http://www.hopkinsmedicine.org.
Journal
New England Journal of Medicine