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This study reports on the performance of a leadless ventricular pacemaker with automated, enhanced accelerometer-based algorithms that provide atrioventricular (AV) synchronous pacing.

Background:Cryoablation is superior to antiarrhythmic drugs (AAD) for the prevention of arrhythmia recurrence in drug naïve (first-line) patients with paroxysmal atrial fibrillation (AF). The adoption and outcomes of first-line cryoablation in a real-world setting are unknown.Purpose:To describe global usage, safety, efficacy, and healthcare utilization outcomes in patients treated with cryoablation for first-line management of AF.Methods:Cryo Global Registry (NCT02752737) is an ongoing, prospective, multicenter registry. AF patients with an index cryoballoon ablation performed according to local standards of care at 58 centers in 26 global countries were included. Subjects undergoing first-line cryoablation were compared to patients with prior failed AAD usage and/or taking AADs at baseline. Serious procedure-related complication rates, 12-month freedom from a ≥30sec AF/atrial flutter (AFL)/atrial tachycardia (AT) recurrence after a 90-day blanking period, and healthcare utilization were compared.Results:Of 1,394 total patients, 433 (31.1%) were treated with first-line cryoablation. The proportion of first-line enrollments varied widely by world region and country. AAD-refractory patients failed a mean of 1.2 ± 0.5 AADs prior to cryoablation. Freedom from AF/AFL/AT after cryoablation in first-line and AAD-refractory was 90.0% (95% CI: 86.4-92.7%) vs 84.4% (95% CI: 81.5-86.8%) in paroxysmal AF and 72.9% (95% CI: 58.6-83.0%) vs 70.2% (95% CI: 62.9-76.4%) in persistent AF (overall p=0.02), respectively. Serious adverse event rates were not statistically different between first-line and AAD-refractory patients (2.3% vs 3.4%; p=0.32), with highest rates being groin-site complications (0.7% vs 0.5%), respectively. Freedom from repeat ablations in first-line vs AAD-refractory was 95.5% (95% CI: 92.7 - 97.2%) vs 93.1% (95% CI: 91.0 - 94.7%) in paroxysmal AF and 84.7% (95% CI: 71.8 - 92.1%) vs 88.2% (95% CI: 82.5 - 92.2%) in persistent AF (overall p=0.35), respectively.Conclusion:The current data support cryoablation as an early intervention strategy for treatment of patients with AF.