'Umbrella' valve provides a potential alternative to lung surgery

A new umbrella-like valve may help patients with emphysema breathe easier and may ultimately provide a noninvasive alternative to lung reduction surgery. In a new study presented at CHEST 2006, the 72nd annual international scientific assembly of the American College of Chest Physicians (ACCP), the IBVTM Valve, a nonsurgical, investigational device, was shown to be safe and effective for patients with emphysema.

Emphysema — a subtype of chronic obstructive pulmonary disease (COPD) — is a progressive and debilitating lung disorder, characterized by irreversible airflow obstruction. Current management for emphysema includes medication and/or supplemental oxygen, pulmonary rehabilitation, and, in rare cases, lung volume reduction surgery (LVRS) to remove the most diseased portions of the lung.

“The IBVTM Valve is similar in concept to LVRS in that it aims to make the lungs work more efficiently, thereby decreasing shortness of breath,” said the study's lead author Daniel H. Sterman, MD, FCCP, University of Pennsylvania Medical Center, Philadelphia, PA. “Unlike lung reduction surgery, valve treatment has fewer complications and a shorter hospital stay. For example, most valve-treated patients have a one-night observational hospital stay while surgical patients average a week or more in the hospital.” The one-way IBVTM Valve limits ventilation in diseased areas of the lungs and redirects ventilation to the remaining healthier portions of the lung while allowing for normal clearance of secretions.

In a multicenter preliminary pilot study, Dr. Sterman and researchers from the Cleveland Clinic Foundation, Cleveland, OH, University of Washington, Seattle, WA, and six additional US medical centers examined the safety and effectiveness of the IBVTM Valve on patients with severe upper-lobe emphysema. Over a 27-month period, 520 valves were implanted in 75 patients across the nine medical centers. The valves were implanted in the upper lobes of the lung using flexible bronchoscopy, with an average of 6 to 7 valves implanted per patient. Researchers used quantitative software and multidetector CT scans to measure the physical effects of the valves and the St. George Respiratory Questionnaire (SGRQ) to assess how patients felt after treatment.

Of the patients who received valve treatment, 46 patients (group A) had reduced complications and retained efficacy compared with the remaining patients (group B). In responding patients, valve treatment transferred an average of 20 percent ventilation and perfusion to healthier regions of the lung. Two thirds of patients in group A also had a 4-point or more SGRQ improvement at 6 months and showed significant improvements in oxygen use and DLCO. Compared with patients in group B, patients in group A were less than 75 years old, did not have lingular treatment, and had fewer lung segments treated. The 90-day serious complications were one bronchospasm and one COPD flare in the A group and two bronchospasm and one death with pneumothorax in group B.

“Patients responding to valve treatment may now be able to do simple, everyday activities, such as bathe or shower independently, walk around the house without stopping, talk without trouble breathing, and can go out for shopping or entertainment,” said study coauthor Atul C. Mehta, MD, FCCP, Cleveland Clinic Foundation. “Although valve treatment is still investigational, it may offer an alternative treatment for patients with emphysema who are not good candidates for LVRS.” Researchers stress that valve treatment is not yet approved by the US Food and Drug Administration and is only available as part of a research trial that is currently sponsored by the developer of the IBVTM Valve, Spiration, Inc.

“Although there is no cure for emphysema, proper treatment can improve a patient's exercise capacity, overall quality of life, and may result in longer survival,” said Mark J. Rosen, MD, FCCP, President of the American College of Chest Physicians. “Valve treatment may represent a valuable option for the palliative treatment of patients with emphysema.”