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31st Annual Meeting Abstracts: A Pilot Multi-Center Trial of the Intrabronchial Valve for Treatment of Severe Emphysema
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13. A Pilot Multi-Center Trial of the Intrabronchial Valve for Treatment of Severe Emphysema
D. E. Wood*1, R. J. McKenna*2, A. C. Mehta3, D. E. Ost4, D. H. Sterman5, X. Gonzalez6, S. C. Springmeyer6. 1University of Washington, Seattle, WA, 2Cedars-Sinai Medical Center, Los Angeles, CA, 3Cleveland Clinic, Cleveland, OH, 4North Shore University Hospital, Manhasset, NY, 5University of Pennsylvania, Philadelphia, PA, 6Spiration, Inc., Redmond, WA,
BACKGROUND: Lung Volume Reduction Surgery improves function and quality of life for selected patients with severe emphysema, but with significant morbidity and mortality. A minimally invasive therapy could provide palliation with less risk, and offer therapy to patients currently not considered for surgical therapy. The Intrabronchial Valve blocks distal airflow and is placed into bronchial segments leading to areas of severe emphysema with minimal perfusion.
METHODS: Thirty patients with severe emphysema underwent endoscopic placement of IBV’s into airways leading into both upper lobes. Follow-up bronchoscopy was done in all patients for observation and adjustments.
RESULTS: Five centers treated 30 patients. Patient follow-up ranged from 2 to 7 months. A mean of 6.5 valves were placed per patient were placed. Valves were easily positioned by flexible bronchoscopy in 98% of desired airways, and the procedure ranged from 15 to 120 minutes (mean 61). Discharge occurred within 2 days in 28 of 30 patients. Follow-up bronchoscopy resulted in additional valves or valve revision in 17 patients. All valves designated for removal were easily removed up to 3 months after original placement. There have been no deaths, device migration, device erosion, or significant bleeding. 80% of patients had no adverse events judged possibly or probably related to the device.
CONCLUSIONS: The IBV device is safe, easy to use, and the procedure complications are acceptable to proceed with further clinical studies. The IBV may be a minimally invasive alternative to surgical LVRS for patients with severe emphysema, with substantially less morbidity and mortality.
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