Bronchoscopic lung volume reduction (BLVR) using bioactive agents to remodel damaged lung tissue has reduced lung volume in a sheep model of emphysema. This abstract reports preliminary findings using this approach to treat advanced heterogeneous emphysema in humans.
A two-stage study involving 6 subjects was conducted at 2 medical centers to assess safety. Stage 1 subjects received subtherapeutic treatment at 2 subsegmental sites in a single lung. Stage 2 subjects received treatment at 4 subsegmental sites in a single lung. Safety was assessed as the number of serious adverse events associated with treatment in Stage 1 and 2 subjects.
There were no serious adverse events associated with initial BLVR treatment in either stage of the study. All subjects were discharged from the hospital on post-treatment Day 1. Two-month follow-up in Stage 2 subjects demonstrated improvements in pre- and post-bronchodilator FEV1 (+11% & +6%) and FVC (+20% & +12%), a reduction in RV (10%), improvement in 6 MWD (+35%), and a reduction in MRC dyspnea (3.3 to 2). These trends did not reach statistical significance. Two of the Stage 1 subjects have had subsequent retreatment at 2 sites. There were no early adverse events after retreatment; studies of therapeutic response are pending.
BLVR using tissue remodeling appears to be safe in subjects with advanced emphysema. Suggestion of efficacy after treatment at 4 sites is apparent at 2-month follow-up.
Additional follow-up is needed to assess long-term safety and durability of response. These results warrant further cautious clinical trials.
George Richard Washko MD, None.