Impact of Bronchial Rheoplasty on exacerbations in chronic bronchitis: a US feasibility study

Abstract

Introduction: Chronic bronchitis (CB) is characterized by persistent cough and mucus hypersecretion and is associated with COPD exacerbations. Bronchial Rheoplasty (BR) using the RheOX system involves delivery of pulsed electric fields to ablate the airway epithelium and submucosa without thermal injury. Preliminary studies have demonstrated a reduction in airway goblet cell hyperplasia and improved symptoms following BR.

Objective: To assess the impact of BR on exacerbation frequency through 12 months.

Methods: This was a US multi-center, single-arm observational study including 21 patients with CB. Key entry criteria included sum of CAT Q1 and Q2 (cough and mucus score) ≥7 out of 10, FEV1/FVC< 0.7, FEV1 30-80% predicted. Patients were treated bilaterally (right lung first, left lung one month later) with BR from the carina to approximately all 5th order bronchi. 12 month follow-up was from the second procedure. Moderate (requiring medical treatment) and severe (requiring hospitalization) exacerbations were tabulated excluding the 30-day post-procedure recovery periods.

Results: Our cohort had a mean age 66±5.3 years, 57.1% male, and 52.4% GOLD II and 47.6% GOLD III. In the year prior to treatment, patients reported 22 moderate and 3 severe exacerbations (1.05±1.66 and 0.14±0.34 exacerbations/patient/year, respectively). Following BR, patients reported 7 moderate and 1 severe exacerbation, representing rates of 0.37±0.63 and 0.05±0.28 (relative reductions of 64.7% and 64.2%, respectively).

Conclusion: Bronchial Rheoplasty may reduce frequency of moderate and severe exacerbations in chronic bronchitis patients. Additional clinical research is underway to confirm these findings.