Valve Implant Improves Quality of Life for Emphysema Patients, Sciurba-Led Study Finds

Frank C. Sciurba

Tiny one-way valves that block portions of emphysema-ravaged lungs improved lung function, exercise tolerance, and symptoms with only a modest increase in adverse events, according to a multicenter international study led by researchers in 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 and results 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 to medical treatment in patients with severe emphysema, said principal investigator Frank C. Sciurba, a professor of medicine and director of the Emphysema/COPD (Chronic Obstructive Pulmonary Disease) Research Center in the 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 participants enrolled in the study, 220 were randomized to receive endobronchial valves, which are designed to allow emptying but not reinflation of overinflated portions of the lung, making those portions 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—which included pneumonia, respiratory failure, coughing up blood, and air leaking from the treated lung—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 nonblocked 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, chief of the medical school’s Division of Pulmonary Allergy and Critical Medicine.

The study was supported by Emphasys Medical Inc. and Pulmonx Inc. Sciurba is supported by the National Institutes of Health through a Specialized Centers in Clinically Oriented Research in COPD grant.