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Bronchial Rheoplasty for Chronic Bronchitis: Results from a Canadian Feasibility Study with RheOx®.

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Bronchial Rheoplasty (BR) is a safe and feasible treatment for chronic bronchitis (CB), significantly improving cough and mucus symptoms. This innovative therapy shows promise for enhancing the quality of life for COPD patients.

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Area of Science:

  • Pulmonology
  • Medical Devices
  • Respiratory Medicine

Background:

  • Chronic bronchitis (CB) is a phenotype of chronic obstructive pulmonary disease (COPD) characterized by persistent mucus hypersecretion and cough.
  • CB significantly impairs quality of life, increases exacerbations, and leads to lung function decline.
  • Bronchial Rheoplasty (BR) utilizes non-thermal pulsed electric fields to treat airway epithelium and submucosa, with prior studies indicating reduced goblet cell hyperplasia and symptom relief.

Purpose of the Study:

  • To evaluate the safety and clinical feasibility of Bronchial Rheoplasty (BR) in patients diagnosed with chronic bronchitis (CB).

Main Methods:

  • A 3-center, single-arm study enrolled Canadian patients with CB meeting specific criteria (CAT score ≥ 7 for cough/mucus, FEV1 ≥ 30% predicted).
  • Patients underwent BR treatment sequentially on the right and left airways, with a 1-month interval.
  • Safety was assessed via Serious Adverse Events (SAEs) over 12 months, while clinical outcomes were measured using the St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT).

Main Results:

  • Ten CB patients (mean age 69 years) completed the 12-month follow-up, with successful BR procedures in all.
  • One device-related SAE (COPD exacerbation) occurred within 13 days post-procedure; no other SAEs were reported.
  • At 3 and 6 months, 90% of patients were CAT responders (≥ 2-point improvement), with similar positive trends observed in SGRQ scores.

Conclusions:

  • Bronchial Rheoplasty (BR) demonstrated a favorable safety profile and was well-tolerated by patients with chronic bronchitis.
  • Meaningful and sustained symptom improvement was observed up to 12 months post-treatment.
  • BR presents a potentially viable and effective therapeutic option for managing chronic bronchitis symptoms.