Bronchial Rheoplasty For Treatment of Chronic Bronchitis: 12 Month Results from a Multi-Center Study. - 2020

Available online from MWHC library: July 1997 - present, Available in print through MWHC library: 1999 - present

CONCLUSIONS: This study provides the first clinical evidence of the feasibility, safety and initial outcomes of Bronchial Rheoplasty in symptomatic chronic bronchitis patients. MEASUREMENTS AND MAIN RESULTS: Bronchial Rheoplasty was performed in all 30 patients [63% male, mean age 67 (standard deviation 7.4), post-bronchodilator Forced Expiratory Volume in 1 second 65% (21%), COPD Assessment Test score 25.6 (7.1), and St. George's Respiratory Questionnaire score 59.6 (15.3)]. There were no device-related and 4 procedure-related serious adverse events through 6 months, and none thereafter through 12 months. The most frequent non-serious, device and/or procedure related event through 6 months was mild hemoptysis in 47% (14/30) patients. Histologically, mean goblet cell hyperplasia score was statistically significantly reduced (p<0.001). Significant changes from baseline to 6 months in COPD Assessment Test (mean -7.9; median -8.0; p=0.0002) and St. George's Respiratory Questionnaire (mean -14.6; median -7.2; p=0.0002) were observed, with similar observations through 12 months. METHODS: Pooled analysis of two separate studies enrolling 30 patients undergoing bilateral Bronchial Rheoplasty. Follow-up through 6 months (primary outcome) and 12 months included assessment of adverse events, airway histology and changes in symptoms using the COPD Assessment Test and St. George's Respiratory Questionnaire. OBJECTIVES: To evaluate the feasibility, safety and initial outcomes of Bronchial Rheoplasty in chronic bronchitis patients. RATIONALE: Chronic bronchitis is characterized by productive cough with excessive mucus production, resulting in quality of life impairment and increased exacerbation risk. Bronchial Rheoplasty uses an endobronchial catheter to apply non-thermal pulsed electric fields to the airways. Preclinical studies demonstrated epithelial ablation followed by regeneration of normalized epithelium.


English

1073-449X

10.1164/rccm.201908-1546OC [doi]


*Ablation Techniques/mt [Methods]
*Bronchi/su [Surgery]
*Bronchitis, Chronic/su [Surgery]
Aged
Bronchitis, Chronic/pp [Physiopathology]
Disease Progression
Female
Follow-Up Studies
Forced Expiratory Volume
Humans
Male
Prospective Studies
Quality of Life
Time Factors
Treatment Outcome


MedStar Franklin Square Medical Center


Angelos Center for Lung Disease


Journal Article