Valve Implant Improves Quality of Life for Emphysema Patients
Pitt-Led International Study Published in New England Journal of Medicine
PITTSBURGH, Sept. 22, 2010 – Tiny one-way valves that block portions of emphysema-ravaged lungs improved lung function, exercise tolerance and symptoms at the cost of a modest increase in adverse events, according to a multicenter, international study led by researchers at the University of Pittsburgh School of Medicine. The findings are available in the Sept. 23 issue of the New England Journal of Medicine.
Emphysema, a leading cause of disability and death, is marked by progressive destruction of the air sacs in the lungs, which makes it difficult to expel air resulting in overinflation of the lungs. Over time, patients suffer with progressively labored breathing during exercise and at rest. Medical therapies offer limited improvement and surgical techniques, such as lung transplantation and lung volume reduction surgery, are costly and associated with significant adverse events.
The Endobronchial Valve for Emphysema Palliation Trial (VENT) compared the safety and efficacy of endobronchial valves (EBV) to medical treatment in patients with severe emphysema, explained principal investigator Frank C. Sciurba, M.D., associate professor of medicine, and director of the Emphysema/COPD Research Center (ECRC) in the division of pulmonary, allergy and critical care medicine, Pitt School of Medicine. “This study confirmed that a minimally invasive alternative to lung reduction surgery can result in significant improvements in well-selected patients. Lessons learned in this study will allow us to better select patients who are most likely to benefit from the procedure.”
Of the 321 enrolled in the study, 220 participants were randomized to receive EBV, which are designed to allow emptying but not reinflation of overinflated portions of the lung, making them shrink and allowing the healthier portions of the lung to function more normally. The valves are about the size of a pencil eraser and are inserted using a bronchoscope. They are being tested as a minimally invasive substitute for lung-reduction surgery, a procedure that involves removing selected areas of hyperinflated lungs.
Standard tests of lung function showed measurable improvements among participants who received the valves. At 12 months, there was no difference in survival rates, but valve patients reported feeling better. Adverse events included pneumonia, respiratory failure, coughing up blood and air leaking from the treated lung, and were mild relative to the possible complications of lung surgery.
While the valves currently are available clinically only in Europe, more clinical trials in the United States are anticipated. The next trials will utilize lessons learned in the VENT study, which revealed that patients with the most heterogeneous emphysema (differences in severity between lobes of the lung) and who had complete fissures between lobes (preventing the non-blocked lung from filling the blocked lung back up with air) have much better results.
“This trial used creative lung-imaging and exercise technologies to select patients who may truly benefit from valve placement and reflects the innovation at the University of Pittsburgh in the treatment of advanced lung disease,” said Mark Gladwin, M.D., chief, Division of Pulmonary Allergy and Critical Medicine.
The Universtiy of Pittsburgh Emphysema Research Center has ongoing programs testing novel treatments for emphysema and COPD. Patients interested in more information regarding research or clinical evaluation in the ECRC or Comprehensive Lung Center can call (866) 948-COPD.
The study was supported by Emphasys Medical Inc. and Pulmonx Inc. and Dr. Sciurba is supported by the National Institutes of Health through a Specialized Centers in Clinically Oriented Research in COPD grant.
University of Pittsburgh School of Medicine
As one of the nation’s leading academic centers for biomedical research, the University of Pittsburgh School of Medicine integrates advanced technology with basic science across a broad range of disciplines in a continuous quest to harness the power of new knowledge and improve the human condition. Driven mainly by the School of Medicine and its affiliates, Pitt has ranked among the top 10 recipients of funding from the National Institutes of Health since 1997 and now ranks fifth in the nation, according to NIH data for 2008 (the most recent year for which the data are final).
Likewise, the School of Medicine is equally committed to advancing the quality and strength of its medical and graduate education programs, for which it is recognized as an innovative leader, and to training highly skilled, compassionate clinicians and creative scientists well-equipped to engage in world-class research. The School of Medicine is the academic partner of UPMC, which has collaborated with the University to raise the standard of medical excellence in Pittsburgh and to position health care as a driving force behind the region’s economy. For more information about the School of Medicine, see www.medschool.pitt.edu.