Title :

Safety and Dose Study of Targeted Lung Denervation in Moderate/Severe COPD Patients

Author(s) :

Valipour, Arschang [Auteur]
Shah, Pallav l. [Auteur]
Imperial College London
Pison, Christophe [Auteur]
Centre Hospitalier Universitaire [CHU Grenoble] [CHUGA]
Laboratory of Fundamental and Applied Bioenergetics = Laboratoire de bioénergétique fondamentale et appliquée [LBFA]
Ninane, Vincent [Auteur]
Université libre de Bruxelles [ULB]
Janssens, Wim [Auteur]
Catholic University of Leuven = Katholieke Universiteit Leuven [KU Leuven]
Perez, Thierry [Auteur]
Centre d’Infection et d’Immunité de Lille - INSERM U 1019 - UMR 9017 - UMR 8204 [CIIL]
Kessler, Romain [Auteur]
Nouvel Hôpital Civil de Strasbourg
Deslée, Gaetan [Auteur]
Hôpital Maison Blanche
Garner, Justin [Auteur]
Imperial College London
Abele, Christine [Auteur]
Hartman, Jorine e. [Auteur]
University Medical Center Groningen [Groningen] [UMCG]
Slebos, Dirk-Jan [Auteur]
University Medical Center Groningen [Groningen] [UMCG]

Journal title :

Respiration

Pages :

329-339

Publisher :

Karger

Publication date :

2019-10-04

ISSN :

0025-7931

English keyword(s) :

Acetylcholine
Bronchoscopy
Lung disease obstructive
Parasympathectomy
Radiofrequency ablation

HAL domain(s) :

Sciences du Vivant [q-bio]/Médecine humaine et pathologie/Pneumologie et système respiratoire

English abstract : [en]

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 ...
Show more >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.Show less >

Language :

Anglais

Peer reviewed article :

Oui

Audience :

Internationale

Popular science :

Non

Collections :

• Centre d'Infection et d'Immunité de Lille (CIIL) - U1019 - UMR 9017

Source :

Harvested from HAL