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.