Tiny Coils Improve Quality of Life for Patients with Severe Emphysema

Issue Date: 
May 30, 2016

The implantation of tiny coils into the lungs improves exercise ability, lung function, and quality of life for patients with severe emphysema, according to a large international trial presented by researchers at the University of Pittsburgh School of Medicine.

The findings, which have been published in the Journal of the American Medical Association, were presented earlier this month during the American Thoracic Society International Meeting in San Francisco.

“Some patients with advanced emphysema have few treatment options, and this trial significantly furthers our understanding of the potential role of minimally invasive lung volume reduction therapy as an option to improve symptoms,” said lead author Frank Sciurba, an associate professor in the Division of Pulmonology, Allergy and Critical Care Medicine, Pitt School of Medicine, and director of the UPMC Pulmonary Function and Exercise Physiology Laboratory.

Patients with emphysema, a form of chronic obstructive pulmonary disease, experience an over-inflation of the lungs that limits their ability to breathe deeply, resulting from the progressive destruction and collapse of their lungs’ air sacs and airways. The coils are intended to improve the elastic properties of the lungs to prevent collapse of the airways, allowing patients to exhale more completely, Sciurba explained.

The study included 315 patients recruited at 26 sites in the United States and Europe between December 2012 and November 2015. More than 75 percent of study participants were experiencing severe symptoms, yet their pattern of emphysema was such that they were not candidates for surgery or experimental valve treatment. These patients had few therapeutic options short of lung transplantation.

Participants were randomly assigned to either standard care, which included optimal inhaler medications and pulmonary rehabilitation, or to receive standard care plus bilateral coil insertion placed in the most severely affected lobe of each lung.

The researchers measured how far participants could walk in six minutes, both at baseline and after 12 months of treatment. Patients who received coils showed a modest improvement in walking distance at 12 months, while the usual care group declined in function over the same time period.

After one-year follow-up, the coil group overall was able to walk 15 meters (16 yards) farther than the usual care group in the allotted six minutes. Forty percent of the coil group was able to walk an additional 25 meters (27 yards) more, while only 27 percent of the non-coil group achieved those walking gains.

Forced expiration of air, the most common measure of lung function in emphysema patients, also improved more in those receiving coils than in those who didn’t receive them.

Patients receiving coils reported dramatic improvement in their quality of life, as measured by the emphysema-specific St. George’s Respiratory Questionnaire. Thirty-two percent more patients in the coil group achieved a meaningful level of self-reported improvement compared with those in the non-coil group.  

The benefits of the coils did come at a cost—initially, patients had a significantly higher rate of major complications, such as pneumonia and pneumothorax than those in the usual treatment group. However, the increased risk of serious adverse events appeared to be short lived. By nine months, there was no difference between the two groups. There also was no difference in the death rate measured at 12 months.   

The U.S. Food and Drug Administration, said Sciurba, will now determine whether the coils are ready for widespread use.