Lung Volume Reduction Surgery for patients with severe emphysema improves pulmonary function, exercise capacity and quality of life, but with significant morbidity and mortality. Minimally invasive therapy could provide palliation with less risk to patients not considered for surgical therapy. The Intrabronchial Valve (IBV, Spiration, Inc., Redmond, WA) blocks distal airflow when placed into bronchi leading to areas of severe emphysema, and is designed to allow passage of secretions and allow removal. We report 12 month results of the initial 30 patients in this pilot trial.
Thirty patients with severe upper-lobe predominant emphysema underwent endoscopic placement of multiple IBV into upper lobes via flexible bronchoscopy. Follow-up bronchoscopy was done in all patients after 1 month. Patients were followed at data collected at 1, 3, 6, and 12 month intervals.
Five centers treated 30 patients over a 6 month period between January and July 2004. Patient follow-up ranged from 6 to 12 months. A mean of 6.5 valves per patient were placed bilaterally in the desired segments without difficulty. The procedure ranged from 15 to 120 minutes (mean 61). Discharge occurred within 2 days of the procedure in 28 of 30 patients. Follow-up bronchoscopy at 1-2 months 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, no device migration, no device erosion, and no significant bleeding. Of the 30 patients, 24 or 80%, had no adverse events judged possibly or probably related to the device. Efficacy results are currently being collected and tabulated for the 12 month results.
The IBV device is safe, easy to use, and has acceptable procedural complications. Further clinical studies are planned to evaluate its clinical effectiveness for palliation of severe emphysema.
The IBV may be a minimally invasive alternative to surgical LVRS with substantially less morbidity and mortality.
Daniel Sterman, Consultant fee, speaker bureau, advisory committee, etc. Member (unpaid) of Scientific Advisory Board for Spiration, Inc.; Product/procedure echnique that is considered research and is NOT yet approved for any purpose. Spiration Intrabronchial Valve.