Sanghamitra Mohanty1, Prasant Mohanty1, Chintan Trivedi1, Carola Gianni1, Domenico G Della Rocca1, Luigi Di Biase1, Andrea Natale2. 1. From the Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin (S.M., P.M., C.T., C.G., D.G.D.R., L.D.B., A.N.); Dell Medical School, Austin, TX (S.M., A.N.); Electrophysiology and Arrhythmia Services, California Pacific Medical Center, San Francisco (A.N.); MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH (A.N.); and Division of Cardiology, Stanford University, CA (A.N.). 2. From the Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin (S.M., P.M., C.T., C.G., D.G.D.R., L.D.B., A.N.); Dell Medical School, Austin, TX (S.M., A.N.); Electrophysiology and Arrhythmia Services, California Pacific Medical Center, San Francisco (A.N.); MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH (A.N.); and Division of Cardiology, Stanford University, CA (A.N.). dr.natale@gmail.com.
Abstract
BACKGROUND: This meta-analysis systematically evaluated the outcome of pulmonary vein isolation (PVI) with and without focal impulse and rotor modulation (FIRM) ablation in patients with atrial fibrillation. METHODS AND RESULTS: Extensive literature search was performed for studies reporting outcomes of PVI alone and PVI+FIRM procedures. For PVI alone, only randomized trials conducted in the past 3 years reporting single-procedure off-antiarrhythmic drugs success rate at ≥12-month follow-up were included. In PVI+FIRM group, all published studies reporting single-procedure off-antiarrhythmic drugs success rate with at least 1-year follow-up were identified. Meta-analytic estimates were derived using DerSimonian and Laird random-effects models, and pooled estimates of success rate (95% confidence interval) were computed. Statistical heterogeneity was assessed using Cochran Q test and I2. Study quality was assessed using Newcastle-Ottawa Scale. Fifteen trials were included, 10 with PVI+FIRM (n=511, nonrandomized prospective design), and 5 with PVI-only trials (n=295, randomized trials). All patients in PVI-only trials had 100% nonparoxysmal atrial fibrillation, except 1 study, and no prior ablations. About 24% of PVI+FIRM population had paroxysmal atrial fibrillation. After 15.9±5.5 (median 12) months follow-up, the off-antiarrhythmic drugs pooled success rate was 50% in FIRM+PVI (95% confidence interval, 28%-72%) and 58% in PVI (95% confidence interval, 46%-71%). Difference in effect size between groups was not statistically significant (P=0.21). No significant heterogeneity (total or within group) was observed in this meta-analysis (negative I2 values considered equal to zero). CONCLUSIONS: The overall pooled estimate did not show any therapeutic benefit of PVI+FIRM approach over PVI alone, which suggests the need to reevaluate the clinical use of FIRM ablation in atrial fibrillation.
BACKGROUND: This meta-analysis systematically evaluated the outcome of pulmonary vein isolation (PVI) with and without focal impulse and rotor modulation (FIRM) ablation in patients with atrial fibrillation. METHODS AND RESULTS: Extensive literature search was performed for studies reporting outcomes of PVI alone and PVI+FIRM procedures. For PVI alone, only randomized trials conducted in the past 3 years reporting single-procedure off-antiarrhythmic drugs success rate at ≥12-month follow-up were included. In PVI+FIRM group, all published studies reporting single-procedure off-antiarrhythmic drugs success rate with at least 1-year follow-up were identified. Meta-analytic estimates were derived using DerSimonian and Laird random-effects models, and pooled estimates of success rate (95% confidence interval) were computed. Statistical heterogeneity was assessed using Cochran Q test and I2. Study quality was assessed using Newcastle-Ottawa Scale. Fifteen trials were included, 10 with PVI+FIRM (n=511, nonrandomized prospective design), and 5 with PVI-only trials (n=295, randomized trials). All patients in PVI-only trials had 100% nonparoxysmal atrial fibrillation, except 1 study, and no prior ablations. About 24% of PVI+FIRM population had paroxysmal atrial fibrillation. After 15.9±5.5 (median 12) months follow-up, the off-antiarrhythmic drugs pooled success rate was 50% in FIRM+PVI (95% confidence interval, 28%-72%) and 58% in PVI (95% confidence interval, 46%-71%). Difference in effect size between groups was not statistically significant (P=0.21). No significant heterogeneity (total or within group) was observed in this meta-analysis (negative I2 values considered equal to zero). CONCLUSIONS: The overall pooled estimate did not show any therapeutic benefit of PVI+FIRM approach over PVI alone, which suggests the need to reevaluate the clinical use of FIRM ablation in atrial fibrillation.
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