| Autor: |
Valipour A; Karl Landsteiner Institute for Lung Research and Pulmonary Oncology, Vienna, Austria., Fernandez-Bussy S; Division of Pulmonary Medicine, German Clinic of Santiago, Chile.; Department of Pulmonary Medicine, Mayo Clinic, Jacksonville, Florida., Ing AJ; MQ Health, Macquarie University Hospital, Sydney, New South Wales, Australia., Steinfort DP; Department of Medicine, University of Melbourne, Parkville, Victoria, Australia.; Department of Respiratory Medicine, Royal Melbourne Hospital, Parkville, Victoria, Australia., Snell GI; Department of Respiratory Medicine, Alfred Hospital, Melbourne, Australia., Williamson JP; MQ Health, Macquarie University Hospital, Sydney, New South Wales, Australia., Saghaie T; MQ Health, Macquarie University Hospital, Sydney, New South Wales, Australia., Irving LB; Department of Medicine, University of Melbourne, Parkville, Victoria, Australia.; Department of Respiratory Medicine, Royal Melbourne Hospital, Parkville, Victoria, Australia., Dabscheck EJ; Department of Respiratory Medicine, Alfred Hospital, Melbourne, Australia., Krimsky WS; Medstar Franklin Square Medical Center, Baltimore, Maryland; and.; Gala Therapeutics, Menlo Park, California., Waldstreicher J; Gala Therapeutics, Menlo Park, California. |
| Abstrakt: |
Rationale: Chronic bronchitis (CB) 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 nonthermal pulsed electrical fields to the airways. Preclinical studies have demonstrated epithelial ablation followed by regeneration of normalized epithelium. Objectives: To evaluate the feasibility, safety, and initial outcomes of bronchial rheoplasty in patients with CB. Methods: Pooled analysis of two separate studies enrolling 30 patients undergoing bilateral bronchial rheoplasty was conducted. Follow-up through 6 months (primary outcome) and 12 months included assessment of adverse events, airway histology, and changes in symptoms using the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test and St. George's Respiratory Questionnaire (SGRQ). Measurements and Main Results: Bronchial rheoplasty was performed in all 30 patients (63% male; mean [SD] age, 67 [7.4]; mean [SD] postbronchodilator FEV 1 , 65% [21%]; mean [SD] COPD Assessment Test score 25.6 [7.1]; mean [SD] SGRQ score, 59.6 [15.3]). There were no device-related and four procedure-related serious adverse events through 6 months, and there were none thereafter through 12 months. The most frequent nonserious, device- and/or procedure-related event through 6 months was mild hemoptysis in 47% (14 of 30) patients. Histologically, the mean goblet cell hyperplasia score was reduced by a statistically significant amount ( P < 0.001). Significant changes from baseline to 6 months in COPD Assessment Test (mean, -7.9; median, -8.0; P = 0.0002) and SGRQ (mean, -14.6; median, -7.2; P = 0.0002) scores were observed, with similar observations through 12 months. Conclusions: This study provides the first clinical evidence of the feasibility, safety, and initial outcomes of bronchial rheoplasty in symptomatic patients with CB.Clinical trial registered with www.anzctr.org.au (ACTRN 12617000330347) and clinicaltrials.gov (NCT03107494). |
