Surgical lung volume reduction(LVR) has been shown to improve symptoms and lung function in patients with severe heterogeneous upper lobe emphysema. To avoid the inherent morbidity and mortality of surgical LVR, bronchoscopic techniques has been recently described. The current study reports the feasibility and safety of a novel BLVR technique using thermal vapour.
A pilot series of 20 patients with severe heterogenous emphysema received bronchoscopic application of thermal vapour energy to a single upper lobe target area. Bronchoscopic Thermal Vapor Ablation (BTVA, Uptake Medical Corp. Seattle) induces a controlled injury to airway and parenchyma leading to endogenous fibrosis of emphysematous regions resulting in gradual LVR. BTVA utilizes a Vapour Generator and disposable balloon vapor catheter, with target vapour dosing at 10 cal/g according to a prior CT based tissue-air algorithm. The primary endpoint was safety and secondary endpoint preliminary efficacy measures.
8 of 20 patients (2women/6 men, 0.79 L (28% predicted) FEV1 mean, 2.0 L (57% predicted) VC mean, 5,3 l (260% predicted) RV mean)underwent unilateral treatment. All had immediate mild Xray opacification in the target area indicative of thermal injury and localized inflammatory response. Adverse events (n = 4) were exacerbation of COPD and hemoptysis. Two patients with COPD exacerbations have had prolonged hospital stay due to the pneumiona. All patients have experienced LVR and have completed D30 followup with a mean improvement in FEV1 of 13.4% , VC of 6.3% and RV of 7.9% .
Early data on BTVA therapy confirms feasibility, an acceptable safety profile and the potential for efficacy. The efficacy results are anticipated to improve at the 3 and 6 month time points as healing and remodelling process have matured. Full 3 and 6 month follow-up data will be available for presentation in all subjects to confirm these preliminary findings, and define potential future variations to the vapour dosing algorithm.
BTVA holds the promise of a safe, simple and effective BLVR procedure despite the presence of collateral ventilation.
Ralf Eberhardt, No Financial Disclosure Information; No Product/Research Disclosure Information