Safety of denervation following targeted lung denervation therapy for COPD: AIRFLOW-1 3-year outcomes - Archive ouverte HAL Access content directly
Journal Articles Respiratory Research Year : 2021

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

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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 (FEV 1 , 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.
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Dates and versions

hal-03170571 , version 1 (16-03-2021)

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Attribution - CC BY 4.0

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Christophe Pison, Pallav L. Shah, Dirk-Jan Slebos, Vincent Ninane, Wim Janssens, et al.. Safety of denervation following targeted lung denervation therapy for COPD: AIRFLOW-1 3-year outcomes. Respiratory Research, 2021, 22, pp.62. ⟨10.1186/s12931-021-01664-5⟩. ⟨hal-03170571⟩
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