A feasibility and safety study of bronchoscopic thermal vapor ablation: a novel emphysema therapy.

Purpose: This study reports the feasibility and safety of novel second-generation bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation.

Description: Eleven patients with severe heterogeneous emphysema underwent unilateral bronchoscopic application of vapor thermal energy (mean 4.9 cal/g alveolar tissue; range, 3 to 7.5) with bronchial thermal vapor ablation (BTVA) aiming to induce a controlled inflammatory airway and parenchymal response with resultant LVR.

Evaluation: Nine women and 2 men, with a mean age of 61 years, forced expiratory volume in 1 second (FEV(1)) of 0.77 +/- 0.17 L (32% predicted), residual volume (RV) of 4.1 +/- 0.9 L (219% predicted), and gas transfer of 7.8 +/- 2.2 (34% predicted), underwent unilateral upper lobe treatments. Serious adverse events in 5 included probable bacterial pneumonia and exacerbations of airways disease in 2. Although no important FEV(1) or RV changes occurred during 6 months of follow-up, gas transfer improved, 16% to 9.0% +/- 2.1% (38% predicted), the Medical Research Council Dyspnoea Score improved from 2.6 to 2.1, and the St. George Respiratory Questionnaire Total Score improved from 64.4 at baseline to 49.1.

Conclusions: These preliminary data on unilateral BTVA therapy confirm feasibility, an acceptable safety profile, and the potential for efficacy.