Results of the first major nationwide study of lung volume reduction surgery show that the procedure improves function and quality of life for carefully selected emphysema patients, a Saint Louis University surgeon announced today.

Results of the six-year, multi-center trial demonstrate that patients who undergo lung volume reduction surgery - a procedure in which 25 to 30 percent of the diseased lungs are removed - have a better chance for improved quality of life than patients who receive only traditional therapy. They also show a select subgroup of patients live longer after receiving the treatment, though there is no survival benefit for patients overall.

"This is a landmark study because, although many people have undergone lung volume reduction surgery, until now nobody knew for certain how well it really worked or who was a good candidate," said Dr. Keith Naunheim, chief of cardiothoracic surgery at Saint Louis University.

Dr. Naunheim, who is one of two surgeons on the publication committee for the trial, announced the survival results this morning at the American Thoracic Society 99th Annual International Conference in Seattle, Washington.

He said the findings confirmed some expectations surgeons had going into the trial, but refuted others.

"There are so many things we surgeons think are absolutely true that we discover later are flat out wrong," he said. "Going into this, there were seven factors we were almost certain were going to be predictors of success. Only one of them proved to be correct. That's why this kind of broad study is important."

Patients in the trial who benefited most from the procedure had emphysema predominantly in the upper lobes of their lung, and were able to do little exercise prior to surgery. This group showed increased function and improved survival rates after lung volume reduction surgery, Dr. Naunheim said. However, patients who did not have upper lobe distribution of emphysema and were able to do more exercise prior to the surgery showed decreased function and survival rates.

"Identifying the patients who won't benefit was as important as identifying those who will," Dr. Naunheim said. "In the past, some patients who weren't very good candidates received this surgery. Surgeons now have the information they need to make the best decisions on behalf of their patients."

The study began in 1996 as a cooperative effort between the National Heart, Lung, and Blood Institute (NHLBI) - a division of the National Institutes of Health (NIH) - and the Centers for Medicare & Medicaid Services (CMS). NHLBI funded and administered the study, and CMS supported participants' care costs; both are agencies of the U.S. Department of Health and Human Services (HHS).

Researchers at 17 clinical sites studied survival, exercise capacity, lung function, quality of life scores, dyspnea (shortness of breath), and illness and hospitalization rates of 1,218 patients with severe emphysema for an average follow up of 29 months. At the start of the study, all participants received 6 to 10 weeks of pulmonary rehabilitation, which included education, counseling, exercise training, and other techniques to help patients understand and manage their condition, as well as optimize their ability to perform activities of daily living. The participants were then randomly divided into two groups: 608 patients were selected to receive surgery in addition to medical therapy, and 610 continued receiving medical therapy only.

Results of the trial will be published in the May 22 print edition of New England Journal of Medicine. They are available online at www.nejm.org.

Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first M.D. degree west of the Mississippi River. Saint Louis University School of Medicine is a pioneer in geriatric medicine, organ transplantation, chronic disease prevention, cardiovascular disease, neurosciences and vaccine research, among others. The School of Medicine trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and international level.

MEDIA CONTACT
Register for reporter access to contact details
CITATIONS

NEJM, 22-May-2003 and Meeting: American Thoracic Society (22-May-2003)