Safety of denervation following targeted lung denervation therapy for COPD: AIRFLOW-1 3-year outcomes

• Main Authors: Pison Christophe, L. Shah Pallav, Slebos Dirk-Jan, Ninane Vincent, Janssens Wim, Perez Thierry, Kessler Romain, Deslee Gaetan, L. Garner Justin, E. Hartman Jorine, Degano Bruno, Mayr Anna, Mayse Martin, D. Peterson Alexander, Valipour Arschang
• Format: Article
• Language: English
• Published: BMC 2021-02-01
• Series: Respiratory Research
• Subjects: COPD; Nerves; Targeted lung denervation; Acetylcholine; Anticholinergic; Bronchoscopy
• Online Access: https://doi.org/10.1186/s12931-021-01664-5

Abstract Background Targeted lung denervation (TLD) is a novel bronchoscopic therapy that disrupts parasympathetic pulmonary nerve input to the lung reducing clinical consequences of cholinergic hyperactivity. The AIRFLOW-1 study assessed safety and TLD dose in patients with moderate-to-severe, symptomatic COPD. This analysis evaluated the long-term impact of TLD on COPD exacerbations, pulmonary function, and quality of life over 3 years of follow up. Methods TLD was performed in a prospective, energy-level randomized (29 W vs 32 W power), multicenter study (NCT02058459). Additional patients were enrolled in an open label confirmation phase to confirm improved gastrointestinal safety after procedural modifications. Durability of TLD was evaluated at 1, 2, and 3 years post-treatment and assessed through analysis of COPD exacerbations, pulmonary lung function, and quality of life. Results Three-year follow-up data were available for 73.9% of patients (n = 34). The annualized rate of moderate to severe COPD exacerbations remained stable over the duration of the study. Lung function (FEV1, FVC, RV, and TLC) and quality of life (SGRQ-C and CAT) remained stable over 3 years of follow-up. No new gastrointestinal adverse events and no unexpected serious adverse events were observed. Conclusion TLD in COPD patients demonstrated a positive safety profile out to 3 years, with no late-onset serious adverse events related to denervation therapy. Clinical stability in lung function, quality of life, and exacerbations were observed in TLD treated patients over 3 years of follow up.