Service Hospitalier Universitaire Pneumologie Physiologie, Pôle Thorax et Vaisseaux, CHU Grenoble Alpes, CS10217, 38043, Grenoble Cedex 9, France.
Université Grenoble Alpes, Grenoble, France.
Respir Res. 2021 Feb 19;22(1):62. doi: 10.1186/s12931-021-01664-5.
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.
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.
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, 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.
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.
靶向肺去神经支配（TLD）是一种新型的支气管镜治疗方法，它破坏了肺的副交感神经传入，减少了胆碱能活性亢进的临床后果。AIRFLOW-1 研究评估了 TLD 在中重度、有症状的 COPD 患者中的安全性和 TLD 剂量。本分析评估了 TLD 对 COPD 加重、肺功能和 3 年随访期间生活质量的长期影响。
TLD 是在一项前瞻性、能量水平随机（29 W 与 32 W 功率）、多中心研究（NCT02058459）中进行的。在程序修改后，为了确认胃肠道安全性的改善，还招募了更多的患者参加开放标签确认阶段。在治疗后 1、2 和 3 年评估 TLD 的持久性，并通过分析 COPD 加重、肺功能和生活质量来评估。
73.9%的患者（n=34）可获得 3 年的随访数据。在研究期间，中重度 COPD 加重的年化率保持稳定。肺功能（FEV、FVC、RV 和 TLC）和生活质量（SGRQ-C 和 CAT）在 3 年的随访中保持稳定。未观察到新的胃肠道不良事件和意外的严重不良事件。
COPD 患者的 TLD 显示出 3 年的积极安全性，没有与去神经治疗相关的迟发性严重不良事件。在 3 年的随访中，TLD 治疗患者的肺功能、生活质量和加重情况稳定。
