CHEST: Investigational Valve May Help In Emphysema

SALT LAKE CITY, Oct. 24 -- For patients with emphysema who might be candidates for lung volume reduction surgery, an umbrella-shaped valve could be a safe, effective, and non-invasive alternative, according to researchers here.

The investigational IBV Valve is implanted using flexible fiberoptic bronchoscopy and appears to have fewer complications and lead to shorter hospital stays than the surgical procedure, said Daniel Sterman, M.D., of the University of Pennsylvania in Philadelphia, at CHEST 2006, the meeting of the American College of Chest Physicians.

In a preliminary multi-center study, Dr. Sterman and colleagues implanted 520 valves over a 27-month period in 75 consecutive patients treated at nine medical institutions with severe upper-lobe emphysema.

On average, Dr. Sterman said, about seven of the valves were implanted in each patient to reduce ventilation in the diseased parts of the lungs and redirect the airflow to healthier regions.

Among the patients in a preliminary study, Dr. Sterman told reported, "overall, lung function did not improve, but their quality of life improved."

"Patients really care about what they can do on a daily basis -- can they brush their hair, can they brush their teeth, can they go to the store," he said, "and all those things seemed to improve."

On the other hand, in a subset of emphysema patients -- those who did not have treatment for the lingula -- lung function improved, mainly by increasing perfusion in the lower sections of the lungs, Dr. Sterman said.

It is for those patients, he said, that a planned randomized clinical trial of the experimental device is being planned.

The valve is similar in concept to lung volume reduction surgery in that it aims to make the lungs work more efficiently, thereby decreasing shortness of breath, Dr. Sterman said. He added that patients getting the valve usually spend one night in hospital for observation, versus a week or more for surgical patients.

The researchers measured the physical effects of the devices with CT and patient response with the St. George Respiratory Questionnaire.

About 60% of the patients -- dubbed Group A -- had reduced complications and good efficacy compared with the remaining Group B, Dr. Sterman said. They tended to be younger and to have fewer segments of the lungs involved, as well as not getting treatment in the lingula.

The serious complications within 90 days of implant were one bronchospasm and one COPD flare in Group A and two bronchospasms and one death with pneumothorax in Group B, the researchers found.

One of the conclusions of the study, Dr. Sterman said, is that "aggressive treatment" that involved placing valves in the lingula "was not in the patients' best interests" even if it had seemed like a god idea at the time.

"Although valve treatment is still investigational, it may offer an alternative treatment for patients with emphysema who are not good candidates" for surgery, said study coauthor Atul Mehta, M.D., of the Cleveland Clinic.

Mark Rosen, M.D, president of the American College of Chest Physicians, commented there is no cure for emphysema, and added "valve treatment may represent a valuable option for the palliative treatment of patients."

The valve treatment is not yet approved and was only available as part of a research trial sponsored by the developer of the device, Spiration, Inc., of Redmond, Wash.