Bronchial rheoplasty for chronic bronchitis: real-world evidence of safety and performance

Background: Bronchial rheoplasty (BR) addresses mucosal inflammation and hypersecretion associated with chronic bronchitis (CB) by ablating goblet cell hyperplasia with nonthermal pulsed electric fields. This study assessed if BR continues to demonstrate a safe profile and symptom burden reduction in CB patients. Methods: This observational, post-market, single-arm registry was conducted at eight centres in Austria and Germany. Patients with CB and high symptom burden (COPD assessment test (CAT) score ≥7 points in the first two questions) were treated with two bronchoscopic BR procedures. The primary outcomes were safety and symptom burden at 12 months, evaluated by (serious) adverse events ((S)AEs) and questionnaire scores (CAT and St. George's Respiratory Questionnaire (SGRQ)). Subgroup analyses were performed to identify treatment responders. Results: ) 57.8±25.3% predicted, residual volume 166.2±39.6% predicted, CAT 24.8±6.8) with a follow-up time of up to 12 months (n=40). The procedure could be performed safely, with only two SAEs (thoracic pain) and 10 respiratory AEs (mainly COPD exacerbation) deemed to be related to the device or procedure over 12 months. Patients experienced statistically significant questionnaire score improvements in CAT (-5.5±8.0 at 6 months, -4.2±7.4 at 12 months) and SGRQ at 6 and 12 months. CAT responders (improvement ≥the minimal clinically important difference of 2 points) had more preserved lung function and better exercise capacity at baseline than CAT nonresponders. Conclusion: The real-world clinical experience demonstrates that BR is a relatively safe and promising treatment option for CB patients with significant symptom burden.