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Background: Rhythm control strategies for atrial fibrillation (AF), including catheter ablation, are substantially underused in racial/ethnic minorities in North America., Objectives: This study sought to describe outcomes in the CABANA trial as a function of race/ethnicity., Methods: CABANA randomized 2,204 symptomatic participants with AF to ablation or drug therapy including rate and/or rhythm control drugs. Only participants in North America were included in the present analysis, and participants were subgrouped as racial/ethnic minority or nonminority with the use of National Institutes of Health definitions. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest., Results: Of 1,280 participants enrolled in CABANA in North America, 127 (9.9%) were racial and ethnic minorities. Compared with nonminorities, racial and ethnic minorities were younger with median age 65.6 versus 68.5 years, respectively, and had more symptomatic heart failure (37.0% vs 22.0%), hypertension (92.1% vs 76.8%, respectively), and ejection fraction <40% (20.8% vs 7.1%). Racial/ethnic minorities treated with ablation had a 68% relative reduction in the primary endpoint (adjusted hazard ratio [aHR]: 0.32; 95% confidence interval [CI]: 0.13-0.78) and a 72% relative reduction in all-cause mortality (aHR: 0.28; 95% CI: 0.10-0.79). Primary event rates in racial/ethnic minority and nonminority participants were similar in the ablation arm (4-year Kaplan-Meier event rates 12.3% vs 9.9%); however, racial and ethnic minorities randomized to drug therapy had a much higher event rate than nonminority participants (27.4% vs. 9.4%)., Conclusion: Among racial or ethnic minorities enrolled in the North American CABANA cohort, catheter ablation significantly improved major clinical outcomes compared with drug therapy. These benefits, which were not seen in nonminority participants, appear to be due to worse outcomes with drug therapy. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508)., Competing Interests: Funding Support and Author Disclosures This work was supported by the National Institutes of Health (U01HL89709, U01HL089786, U01HL089907, and U01HL089645), St. Jude Medical Foundation and Corporation, Biosense Webster, Medtronic, and Boston Scientific Corporation. The content of this paper does not necessarily represent the views of the National Heart, Lung, and Blood Institute or the Department of Health and Human Services. Dr. Thomas has received grants from the National Heart, Lung, and Blood Institute (National Institutes of Health), Patient-Centered Outcomes Research Institute, and American Heart Association; and has received consulting fees from Sanofi, Boehringer Ingelheim, Janssen, Bristol Myers Squibb, and Medtronic during the conduct of the study. Dr. Al-Khalidi has received grants from the National Heart, Lung, and Blood Institute (National Institutes of Health) and the Mayo Clinic during the conduct of the study. Dr. Monahan has received grants from the National Heart, Lung, and Blood Institute (National Institutes of Health), St. Jude Foundation and Corporation, Biosense Webster, Medtronic, and Boston Scientific during the conduct of the study; has consulted without compensation from Biosense Webster; and has received personal fees from Thermedical outside the submitted work. Dr. Bahnson has received grants from the National Heart, Lung, and Blood Institute (National Institutes of Health) and the Mayo Clinic for conduct of the study; has received grants from Boston Scientific, St. Jude Medical Corporation, Biosense Webster, and Medtronic; and has received compensation for consulting from Cardiofocus and Ventrix during the conduct of the study but outside of the submitted work. Dr. Poole has received grants from ATriCure outside the submitted work. Dr. Mark has received grants from the National Heart, Lung, and Blood Institute (National Institutes of Health), the Mayo Clinic during the conduct of the study; and has received grants from Merck and HeartFlow outside the submitted work. Dr. Packer in the past 12 months has provided consulting services for Biosense Webster, Inc., Boston Scientific, CyberHeart, Medtronic, Inc., nContact, Sanofi, St. Jude Medical, and Toray Industries but has received no personal compensation for these consulting activities; has received grants from Abbott, Biosense Webster, Boston Scientific, CardioFocus, Medtronic, St. Jude Medical, CardioInsight, National Institutes of Health, Siemens, Thermedical, Endosense, Robertson Foundation, and Hansen Medical; has served on the advisory board without compensation for Abbott, Biosense Webster, Boston Scientific, CardioFocus, Medtronic, St. Jude Medical, Spectrum Dynamics, Siemens, Thermedical, Johnson & Johnson, and SigNum Preemptive Healthcare; has received speaking fees and honoraria from Biotronik and MediaSphere Medical; has received royalties from Wiley & Sons, Oxford, and St. Jude Medical; has joint equity with the Mayo Clinic in a privately held company, External Beam Ablation Medical Devices, outside the submitted work; and has received research funding from the NIH, Medtronic, Inc., Cryo Cath, Siemens AG, EP Limited, Minnesota Partnership for Biotechnology and Medical Genomics/University of Minnesota, Biosense Webster, Inc., and Boston Scientific. Mayo Clinic and Drs. Packer and Robb have a financial interest in mapping technology that may have been used at some of the 10 centers participating in this pilot research; in accordance with the Bayh-Dole Act, this technology has been licensed to St. Jude Medical, and Mayo Clinic and Drs. Packer and Robb received annual royalties >$10,000, the federal threshold for significant financial interest. Dr. Silverstein has reported that he has no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Early recurrence of atrial fibrillation (ERAF) is common after radiofrequency catheter ablation for AF. We sought to determine the incidence and prognostic significance of ERAF after cryoballoon ablation. Moreover, the benefit of early reablation for ERAF after cryoballoon ablation is undetermined., Methods and Results: The Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) trial randomized 245 patients with paroxysmal AF to medical therapy versus cryoballoon-based pulmonary vein ablation. Patients were followed for 12 months. ERAF was defined as any recurrence of AF >30 seconds during the first 3 months of follow-up. Late recurrence (LR) was defined as any recurrence of AF >30 seconds between 3 and 12 months. Of the 163 patients randomized to cryoablation, 84 patients experienced ERAF (51.5%). The only significant factor associated with ERAF was male sex (hazard ratio [HR], 2.18; 95% confidence interval [CI], 1.03-4.61; P=0.041). LR was observed in 41 patients (25.1%), and was significantly related to ERAF (55.6% LR with ERAF versus 12.7% without ERAF; P<0.001). Among patients with ERAF, only current tobacco use (HR, 3.84; 95% CI, 1.82-8.11; P<0.001) was associated with LR. Conversely, early reablation was associated with greater freedom from LR (3.3% LR with early reablation versus 55.6% without; HR, 0.04; 95% CI, 0.01-0.32; P=0.002)., Conclusions: ERAF after cryoballoon ablation occurs in ≈50% of patients and is strongly associated with LR. Early reablation for ERAF is associated with excellent long-term freedom from recurrent AF.

Objectives: This study sought to assess the safety and effectiveness of a novel cryoballoon ablation technology designed to achieve single-delivery pulmonary vein (PV) isolation., Background: Standard radiofrequency ablation is effective in eliminating atrial fibrillation (AF) but requires multiple lesion delivery at the risk of significant complications., Methods: Patients with documented symptomatic paroxysmal AF and previously failed therapy with ≥ 1 membrane active antiarrhythmic drug underwent 2:1 randomization to either cryoballoon ablation (n = 163) or drug therapy (n = 82). A 90-day blanking period allowed for optimization of antiarrhythmic drug therapy and reablation if necessary. Effectiveness of the cryoablation procedure versus drug therapy was determined at 12 months., Results: Patients had highly symptomatic AF (78% paroxysmal, 22% early persistent) and experienced failure of at least one antiarrhythmic drug. Cryoablation produced acute isolation of three or more PVs in 98.2% and all four PVs in 97.6% of patients. PVs isolation was achieved with the balloon catheter alone in 83%. At 12 months, treatment success was 69.9% (114 of 163) of cryoblation patients compared with 7.3% of antiarrhythmic drug patients (absolute difference, 62.6% [p < 0.001]). Sixty-five (79%) drug-treated patients crossed over to cryoablation during 12 months of study follow-up due to recurrent, symptomatic AF, constituting drug treatment failure. There were 7 of the resulting 228 cryoablated patients (3.1%) with a >75% reduction in PV area during 12 months of follow-up. Twenty-nine of 259 procedures (11.2%) were associated with phrenic nerve palsy as determined by radiographic screening; 25 of these had resolved by 12 months. Cryoablation patients had significantly improved symptoms at 12 months., Conclusions: The STOP AF trial demonstrated that cryoballoon ablation is a safe and effective alternative to antiarrhythmic medication for the treatment of patients with symptomatic paroxysmal AF, for whom at least one antiarrhythmic drug has failed, with risks within accepted standards for ablation therapy. (A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [Stop AF]; NCT00523978)., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)