CLOSE protocol versus lower ablation index value for paroxysmal atrial fibrillation: A randomized noninferior clinical trial.

INTRODUCTION: The optimized ablation index (AI) value for catheter ablation of atrial fibrillation (AF) remains to be defined. We aimed to compare the efficacy and safety of CLOSE protocol and lower AI protocol in paroxysmal AF. METHODS AND RESULTS: Patients with symptomatic, drug-resistant paroxysmal AF for first ablation were prospectively enrolled from September 2020 to January 2022. The patients were randomly divided into CLOSE group (AI ≥ 550 for anterior/roof segments and ≥400 for posterior/inferior segments) and lower AI group (AI ≥ 450 for anterior/roof segments and ≥350 for posterior/inferior segments). First-pass isolation, acute pulmonary vein (PV) reconnections, 1-year arrhythmia recurrence, and major complications were assessed. Of the 270 enrolled patients, 238 completed 1-year follow-up (118 in CLOSE group and 120 in lower AI group). First-pass isolation in left PVs was higher in CLOSE group (71.2% vs. 53.3%, p = .005). Acute PV reconnections were comparable between groups (9.3% vs. 14.2%, p = .246). At 1 year, 86.4% in CLOSE group versus 81.7% in lower AI group were free from atrial arrhythmia (log rank p = .334). The proportion difference was -4.8% (95% CI: -14.1% to 4.6%), and p = .475 for noninferiority. Stroke occurred in four patients of lower AI group, and no cardiac tamponade, atrioesophageal fistula, major bleeding or death occurred post procedure. CONCLUSION: For patients with paroxysmal AF and treated by AI-guided PV ablation, lower AI is not noninferior to CLOSE protocol.

First-Line Catheter Ablation of Monomorphic Ventricular Tachycardia in Cardiomyopathy Concurrent With Defibrillator Implantation: The PAUSE-SCD Randomized Trial.

BACKGROUND: Catheter ablation as first-line therapy for ventricular tachycardia (VT) at the time of implantable cardioverter defibrillator (ICD) implantation has not been adopted into clinical guidelines. Also, there is an unmet clinical need to prospectively examine the role of VT ablation in patients with nonischemic cardiomyopathy, an increasingly prevalent population that is referred for advanced therapies globally. METHODS: We conducted an international, multicenter, randomized controlled trial enrolling 180 patients with cardiomyopathy and monomorphic VT with an indication for ICD implantation to assess the role of early, first-line ablation therapy. A total of 121 patients were randomly assigned (1:1) to ablation plus an ICD versus conventional medical therapy plus an ICD. Patients who refused ICD (n=47) were followed in a prospective registry after stand-alone ablation treatment. The primary outcome was a composite end point of VT recurrence, cardiovascular hospitalization, or death. RESULTS: Randomly assigned patients had a mean age of 55 years (interquartile range, 46-64) and left ventricular ejection fraction of 40% (interquartile range, 30%-49%); 81% were male. The underlying heart disease was ischemic cardiomyopathy in 35%, nonischemic cardiomyopathy in 30%, and arrhythmogenic cardiomyopathy in 35%. Ablation was performed a median of 2 days before ICD implantation (interquartile range, 5 days before to 14 days after). At 31 months, the primary outcome occurred in 49.3% of the ablation group and 65.5% in the control group (hazard ratio, 0.58 [95% CI, 0.35-0.96]; P=0.04). The observed difference was driven by a reduction in VT recurrence in the ablation arm (hazard ratio, 0.51 [95%CI, 0.29-0.90]; P=0.02). A statistically significant reduction in both ICD shocks (10.0% versus 24.6%; P=0.03) and antitachycardia pacing (16.2% versus 32.8%; P=0.04) was observed in patients who underwent ablation compared with control. No differences in cardiovascular hospitalization (32.0% versus. 33.7%; hazard ratio, 0.82 [95% CI, 0.43-1.56]; P=0.55) or mortality (8.9% versus 8.8%; hazard ratio, 1.40 [95% CI, 0.38-5.22]; P=0.62]) were observed. Ablation-related complications occurred in 8.3% of patients. CONCLUSIONS: Among patients with cardiomyopathy of varied causes, early catheter ablation performed at the time of ICD implantation significantly reduced the composite primary outcome of VT recurrence, cardiovascular hospitalization, or death. These findings were driven by a reduction in ICD therapies. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02848781.

Efficacy and safety of catheter ablation combined with left atrial appendage occlusion for nonvalvular atrial fibrillation: A systematic review and meta-analysis.

Atrial fibrillation (AF) is currently the most prevalent arrhythmia in clinical practice, with stroke being one of its major complications. Combining catheter ablation and percutaneous left atrial appendage occlusion (LAAO) into a "one-stop" intervention could reduce stroke incidence in selected high-risk patients and, at the same time, relieve AF symptoms in a single procedure. This meta-analysis analyzed the efficacy and safety of catheter ablation combined with LAAO for nonvalvular AF. PubMed, EMBASE, and the Cochrane Library were searched from inception to April 2019 to identify relevant citations. Efficacy indexes were procedural success, AF recurrence, stroke/transient ischemic attacks (TIA), and device-related thrombus (DRT). Safety indexes were all-cause death, major hemorrhagic complications, and pericardial effusion/cardiac tamponade. The incidence rate of events (ratio of events to patients) and 95% confidence interval (CI) were calculated as summary results. A forest plot was constructed to present pooled rates. Eighteen studies (two randomized controlled trials and 16 observational studies) were included. The results showed that one-stop intervention has significant efficacy and safety, with procedural success of .98 (95% CI, .97-1.00), AF recurrence of .24 (95% CI, .15-.35), stroke/TIA of .01 (95% CI, .00-.01), DRT of .00 (95% CI, .00-.01), all-cause mortality of .00 (95% CI, .00-.00), cardiac/neurological mortality of .00 (95% CI, .00-.00), major hemorrhagic complications of .01 (95% CI, .00-.02), and pericardial effusion/cardiac tamponade of .01 (95% CI, .00-.01). A single procedure with catheter ablation and LAAO in AF is a feasible strategy with significant efficacy and safety.

Safety and efficacy analysis of one-stop intervention for treating nonvalvular atrial fibrillation.

BACKGROUND: Nonvalvular atrial fibrillation (AF) is a common arrhythmia. The treatment strategy for AF mainly includes controlling symptoms and decreasing the rate of complications. Our study aimed to evaluate the safety and efficacy of combination treatment of catheter ablation and left atrial appendage (LAA) closure (one-stop intervention) in patients with nonvalvular AF. METHODS AND RESULTS: Thirty-four patients with symptomatic AF (mean CHA2 DS2 -VASc score 4.1 ± 1.3, mean HAS-BLED score 3.8 ± 1.2) were included. Patients first received radiofrequency-based left atrial ablation, and then the Watchman device (Boston Scientific, Natick, MA, USA) or AMPLATZER Cardiac Plug (ACP) (St. Jude Medical, Inc., St. Paul, MN, USA) was implanted for LAA closure. Follow-up was performed at 45 days and 3 months after LAA closure to assess for recurrence of AF and prevent stroke. Radiofrequency ablation and LAA closure were successful in 100% of patients without evidence of residual flow at the final transesophageal echocardiography evaluation. A Watchman device was implanted in 29 (85.3%) patients, and an ACP was implanted in five (14.7%) patients. No device-related thrombus formation or embolization was identified at the 45-day or 3-month follow-up. Serious complications, including death, transient ischemic attack, ischemic or hemorrhagic stroke, or major bleeding, were also not identified during the follow-ups. CONCLUSION: For symptomatic patients with nonvalvular AF and a high risk of stroke, the one-stop intervention is feasible, safe, and efficacious.