Long-term safety of bilateral targeted lung denervation in patients with COPD in a single procedure

Abstract

Background: Targeted lung denervation (TLD) is a novel bronchoscopic therapy that ablates parasympathetic pulmonary nerves along the main bronchi. Bilateral (single procedure) TLD treatment has previously been reported as feasible ( Eur Resp J 2014 44: Suppl 58, P1775). Aim: Evaluate long-term safety of treating both lungs in a single TLD procedure. Methods: A prospective, multicenter, study of patients with COPD (FEV 1 /FVC 1 30-60% predicted) was performed (NCT01716598). Patients underwent bilateral TLD using a lung denervation system (Holaira, Inc., USA) in a single procedure in an outpatient setting. Long-term safety was determined by bronchoscopic inspection of the treatment sites at 1-year and registration of all AEs through 18 months. Results: Fifteen patients (47% male, age 63.2±4.0 yrs) underwent TLD at 15 watts. Bronchoscopic inspection at 1-year was completed in 14 patients with complete healing reported in all. 12 patients completed 18-month follow-up with no deaths or unexpected AEs. 8 serious AEs were observed; 3 COPD exacerbations, 1 arrhythmia, 1 BPH, 1 hemoptysis, 1 motorcycle accident and 1 urinary retention. Overall respiratory AE rates have remained low over longer-term follow up. Conclusion: TLD delivered to both lungs in a single procedure is safe with no bronchoscopic findings at 1-year and consistent low number of respiratory related adverse events reported through 18 months.