PURPOSE: A safe and effective bronchoscopic treatment of emphysema could provide therapy to a large number of patients not considered for surgical therapy. The IBV™ Valve (Spiration, Inc., Redmond, WA) blocks airflow to areas of severe emphysema and was initially shown to improve health status with excellent safety. The trial was continued to evaluate other treatment algorithms and testing methods.
METHODS: A consecutive case series, 75 subjects with severe upper-lobe predominant emphysema. Valves were place into upper lobes via flexible bronchoscopy. Patients were evaluated and data collected at 1, 3, 6 month intervals.
RESULTS: 520 valves were implanted at 9 US centers over a 27 month period between January 2004 and April 2006. Patient follow-up ranges from 1 to 12 months. There has been no device migration and no device erosion. A subset of 46 subjects with reduced complications and retained efficacy (group A) is compared to 29 others (group B). The A group did not have lingular treatment (plus fewer segments, 5.7 vs. 7.0) and age less than 75 years. The 90 day serious complications were 1 bronchospasm and 1 COPD flare in the A group and 2 bronchospasm and 1 death with pneumothorax in group B. General (SF-36) and disease-specific (SGRQ) health status measures show significant improvement (e.g. SGRQ –11 ± 18 at 6 months, p<.01, group A). There are also significant improvements in oxygen use and DLCO.
CONCLUSION: The IBV valve has acceptable safety and efficacy results for proceeding with a randomized trial using criteria for group A.
CLINICAL IMPLICATIONS: The IBV valve will be evaluated in a multicenter randomized trial for severe upper-lobe emphysema.
DISCLOSURE: Daniel Sterman, Product/procedure/technique that is considered research and is NOT yet approved for any purpose, Spiration Intrabronchial Valve (IBV).