IBV™ Valve, an experimental intra-bronchial umbrella-like device for emphysema, shows promise in a large multicenter study, according to the American College of Chest Physicians:
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.