International Journal of COPD (Jul 2018)
Long-term safety of bilateral targeted lung denervation in patients with COPD
Abstract
Arschang Valipour,1 Sherwin Asadi,1 Christophe Pison,2 Marie Jondot,2 Romain Kessler,3 Khaled Benneddif,3 Gaetan Deslee,4 Margaux Verdier,4 Dirk-Jan Slebos,5 Martin Mayse6 1Department of Respiratory and Critical Care Medicine, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto-Wagner-Spital, Vienna, Austria; 2CHU Grenoble Alpes, Clinique Universitaire de Pneumologie, Université Grenoble Alpes, Grenoble, France; 3Service de Pneumologie, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, France; 4CHU de Reims, Hôpital Maison Blanche, Service de Pneumologie, INSERM UMRS903, Reims, France; 5Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; 6Nuvaira, Inc., Minneapolis, MN, USA Background: Targeted lung denervation (TLD) is a novel bronchoscopic therapy for COPD which ablates parasympathetic pulmonary nerves running along the outside of the two main bronchi with the intent of inducing permanent bronchodilation. The goal of this study was to evaluate the feasibility and long-term safety of bilateral TLD during a single procedure. Patients and methods: This prospective, multicenter study evaluated 15 patients with moderate-to-severe COPD (forced expiratory volume in 1 s [FEV1] 30%–60%) who underwent bilateral TLD treatment following baseline assessment without bronchodilators. The primary safety end point was freedom from documented and sustained worsening of COPD directly attributable to TLD up to 1 year. Secondary end points included technical feasibility, change in pulmonary function tests, exercise capacity, and health-related quality of life. Follow-up continued up to 3 years for subjects who reconsented for longer-term follow-up. Results: A total of 15 patients (47% male, age 63.2±4.0 years) underwent TLD with a total procedure time of 89±16 min, and the total fluoroscopy time was 2.5±2.7 min. Primary safety end point of freedom from worsening of COPD was 100%. There were no procedural complications reported. Results of lung function analysis and exercise capacity demonstrated similar beneficial effects of TLD without bronchodilators, when compared with long-acting anticholinergic therapy at 30 days, 180 days, 365 days, 2 years, and 3 years post-TLD. Five of the 12 serious adverse events that were reported through 3 years of follow-up were respiratory related with no events being related to TLD therapy. Conclusion: TLD delivered to both lungs in a single procedure is feasible and safe with few respiratory-related adverse events through 3 years. Keywords: COPD, bronchoscopy, radiofrequency ablation, denervation, device
