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