Background: Despite its significant impact on quality of life and mortality, there are currently no curative therapies available for chronic bronchitis (CB). Bronchial rheoplasty (BR) with RheOx® is a new endoscopic approach to address persistent cough and hypersecretion by reducing airway goblet cell hyperplasia.
Methods: The RheOx® Registry Study was conducted in 8 centers in Austria and Germany. Highly symptomatic CB patients were treated in 2 bronchoscopic sessions with BR. The follow-up through 6 months included assessment of serious adverse events (SAE) and symptom burden by questionnaires (COPD Assessment test [CAT], St. George?s Respiratory Questionnaire [SGRQ]).
Results: BR was performed in 50 patients, 41 underwent the 6-month follow-up (mean age 67.2+8.7yrs, FEV1 58.9±25.9%, SGRQ 54.8±18.2, CAT 24.9±7.0). Respiratory SAEs (n=16, 10 in first 30 days), mainly COPD exacerbations (n=4), were reported in 10 patients. One event of thoracic pain was deemed related to the device. One patient died due to renal failure 193 days following BR, unrelated to the procedure. 73% of the patients reached or exceeded the minimally clinically important difference for CAT (mean improvement -5.3±7.5) and 63% for SGRQ (mean -9.8±17.9). CAT responders (n=30) had significantly less residual volume (153.6 vs. 197.3%, p=0.007), higher FEV1 (64.0 vs. 39.0%, p=0.014) and 6-minute-walk-distance (401.6 vs. 273.1m, p=0.006) at study entry compared with non-responders.
Conclusion: Real world clinical experience reveals BR as a relatively safe and promising treatment option for highly symptomatic patients with CB. Patients with more preserved lung function and exercise capacity appear to benefit more from BR.