Arschang Valipour1, Pallav L Shah2, Christophe Pison3, Vincent Ninane4, Wim Janssens5, Thierry Perez6, Romain Kessler7, Gaetan Deslee8, Justin Garner2, Christine Abele1, Jorine E Hartman9, Dirk-Jan Slebos10. 1. Department of Respiratory and Critical Care Medicine, Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology, Otto-Wagner-Spital, Vienna, Austria. 2. Royal Brompton and Harefield NHS Trust, Chelsea and Westminster Hospital, and Imperial College, London, United Kingdom. 3. Service Hospitalier Universitaire Pneumologie Physiologie, Centre Hospitalier Universitaire Grenoble Alpes, InsermU1055, Université Grenoble Alpes, Grenoble, France. 4. CHU Saint-Pierre, Université libre de Bruxelles, Bruxelles, Belgium. 5. Department of Respiratory Diseases, KU Leuven, University Hospitals Leuven, Leuven, Belgium. 6. CHU Lille, Center for Infection and Immunity of Lille, INSERM U1019, CNRS UMR 8204 Univ Lille Nord de France, Lille, France. 7. Service de Pneumologie, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, France. 8. CHU de Reims, Hôpital Maison Blanche, INSERM UMRS 1250, Service de Pneumologie, Reims, France. 9. Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 10. Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands, d.j.slebos@umcg.nl.
Abstract
RATIONALE: Targeted lung denervation (TLD) is a novel bronchoscopic treatment for the disruption of parasympathetic innervation of the lungs. OBJECTIVES: To assess safety, feasibility, and dosing of TLD in patients with moderate to severe COPD using a novel device design. METHODS:Thirty patients with COPD (forced expiratory volume in 1 s 30-60%) were 1:1 randomized in a double-blinded fashion to receive TLD with either 29 or 32 W. Primary endpoint was the rate of TLD-associated adverse airway effects that required treatment through 3 months. Assessments of lung function, quality of life, dyspnea, and exercise capacity were performed at baseline and 1-year follow-up. An additional 16 patients were enrolled in an open-label confirmation phase study to confirm safety improvements after procedural enhancements following gastrointestinal adverse events during the randomized part of the trial. RESULTS:Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group, p = 0.6. Five patients early in the randomized phase experienced serious gastric events. The study was stopped and procedural changes made that reduced both gastrointestinal and airway events in the subsequent phase of the randomized trial and follow-up confirmation study. Improvements in lung function and quality of life were observed compared to baseline values for both doses but were not statistically different. CONCLUSIONS: The results demonstrate acceptable safety and feasibility of TLD in patients with COPD, with improvements in adverse event rates after procedural enhancements.
RCT Entities:
RATIONALE: Targeted lung denervation (TLD) is a novel bronchoscopic treatment for the disruption of parasympathetic innervation of the lungs. OBJECTIVES: To assess safety, feasibility, and dosing of TLD in patients with moderate to severe COPD using a novel device design. METHODS: Thirty patients with COPD (forced expiratory volume in 1 s 30-60%) were 1:1 randomized in a double-blinded fashion to receive TLD with either 29 or 32 W. Primary endpoint was the rate of TLD-associated adverse airway effects that required treatment through 3 months. Assessments of lung function, quality of life, dyspnea, and exercise capacity were performed at baseline and 1-year follow-up. An additional 16 patients were enrolled in an open-label confirmation phase study to confirm safety improvements after procedural enhancements following gastrointestinal adverse events during the randomized part of the trial. RESULTS: Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group, p = 0.6. Five patients early in the randomized phase experienced serious gastric events. The study was stopped and procedural changes made that reduced both gastrointestinal and airway events in the subsequent phase of the randomized trial and follow-up confirmation study. Improvements in lung function and quality of life were observed compared to baseline values for both doses but were not statistically different. CONCLUSIONS: The results demonstrate acceptable safety and feasibility of TLD in patients with COPD, with improvements in adverse event rates after procedural enhancements.
Authors: Samantha S C Kon; Jane L Canavan; Sarah E Jones; Claire M Nolan; Amy L Clark; Mandy J Dickson; Brigitte M Haselden; Michael I Polkey; William D-C Man Journal: Lancet Respir Med Date: 2014-02-04 Impact factor: 30.700
Authors: Jorine E Hartman; Karthi Srikanthan; Cielito Caneja; Nick H T Ten Hacken; Huib A M Kerstjens; Pallav L Shah; Dirk-Jan Slebos Journal: Respiration Date: 2021-09-01 Impact factor: 3.966
Authors: Arschang Valipour; Martin L Mayse; Alexander D Peterson; Philip J Johnson; Kristina T Rouw; Sherwin Asadi; James P Hummel Journal: Respiration Date: 2019-09-13 Impact factor: 3.580
Authors: Dirk-Jan Slebos; Bruno Degano; Arschang Valipour; Pallav L Shah; Gaetan Deslée; Frank C Sciurba Journal: BMC Pulm Med Date: 2020-02-13 Impact factor: 3.317
Authors: Dirk-Jan Slebos; Pallav L Shah; Felix J F Herth; Christophe Pison; Christian Schumann; Ralf-Harto Hübner; Peter I Bonta; Romain Kessler; Wolfgang Gesierich; Kaid Darwiche; Bernd Lamprecht; Thierry Perez; Dirk Skowasch; Gaetan Deslee; Armelle Marceau; Frank C Sciurba; Reinoud Gosens; Jorine E Hartman; Karthi Srikanthan; Marina Duller; Arschang Valipour Journal: Am J Respir Crit Care Med Date: 2019-12-15 Impact factor: 21.405