Matthew R Reynolds1,2, Qi Zheng3, Gheorghe Doros2,4. 1. Division of Cardiology, Lahey Hospital & Medical Center, Burlington, Massachusetts. 2. Baim Institute for Clinical Research, Boston, Massachusetts. 3. Division of Cardiology, Brigham & Women's Hospital, Boston, Massachusetts. 4. Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts.
Abstract
INTRODUCTION: The HeartLight laser balloon ablation system was US Food and Drug Administration approved in 2016 for the treatment of paroxysmal atrial fibrillation (AF), but there have been numerous single-center and multicenter studies published reporting its outcomes, in addition to a few randomized trials. We aimed to systematically review and synthesize currently published outcome data on AF ablation using the laser balloon ablation system. METHODS AND RESULTS: We performed a systematic review and meta-analysis of published studies of AF ablation performed using the laser balloon ablation system. Human studies reporting acute procedural results with a minimum of 6 months follow-up were included. Outcomes of interest included acute and 12-month procedural efficacy, safety, and procedure duration. Aggregated data were analyzed with random effects models, using a Bayesian hierarchical approach. We identified 17 published manuscripts comprising a sample of 1188 patients (mean age 61 years, 80% paroxysmal). At procedure end, 98.8% of targeted pulmonary veins were successfully isolated. The pooled estimate for 12-month freedom from atrial arrhythmia without use of antiarrhythmic drugs for patients with paroxysmal AF was 74.3% (95% confidence interval [CI], 59.9% to 86.4%), and for all AF types combined was 72.9% (65.3% to 79.9%). The most commonly reported procedural complication was phrenic nerve injury (pooled incidence 2.6%; 95% CI, 1.4% to 3.9%), which resolved during follow-up in most cases. CONCLUSION: Laser balloon ablation is highly effective at achieving pulmonary vein isolation. Although comparisons are mainly indirect, safety and 12-month efficacy compare favorably with those observed using other currently used AF ablation technologies.
INTRODUCTION: The HeartLight laser balloon ablation system was US Food and Drug Administration approved in 2016 for the treatment of paroxysmal atrial fibrillation (AF), but there have been numerous single-center and multicenter studies published reporting its outcomes, in addition to a few randomized trials. We aimed to systematically review and synthesize currently published outcome data on AF ablation using the laser balloon ablation system. METHODS AND RESULTS: We performed a systematic review and meta-analysis of published studies of AF ablation performed using the laser balloon ablation system. Human studies reporting acute procedural results with a minimum of 6 months follow-up were included. Outcomes of interest included acute and 12-month procedural efficacy, safety, and procedure duration. Aggregated data were analyzed with random effects models, using a Bayesian hierarchical approach. We identified 17 published manuscripts comprising a sample of 1188 patients (mean age 61 years, 80% paroxysmal). At procedure end, 98.8% of targeted pulmonary veins were successfully isolated. The pooled estimate for 12-month freedom from atrial arrhythmia without use of antiarrhythmic drugs for patients with paroxysmal AF was 74.3% (95% confidence interval [CI], 59.9% to 86.4%), and for all AF types combined was 72.9% (65.3% to 79.9%). The most commonly reported procedural complication was phrenic nerve injury (pooled incidence 2.6%; 95% CI, 1.4% to 3.9%), which resolved during follow-up in most cases. CONCLUSION: Laser balloon ablation is highly effective at achieving pulmonary vein isolation. Although comparisons are mainly indirect, safety and 12-month efficacy compare favorably with those observed using other currently used AF ablation technologies.