Introduction: Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multi-center, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF. Methods and Results: The study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of 1 or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow-up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean±SD or Median (IQR). PVI was performed with a 28mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [transient 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), Antiarrhythmic drugs (AAD) were continued or re-initiated in 26.8% of patients after the 3-month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved prior to discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%. Conclusions: This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomy present in patients with PAF. This cryoballoon system was safe and effective for treatment of patients with drug refractory or drug intolerant PAF.

Introduction: Percutaneous left atrial appendage closure (LAAC) is an alternative to oral anticoagulant (OAC) in patients with non-valvular atrial fibrillation (AF) and contraindication to long-term OAC. Combined strategy with percutaneous LAAC at the same time of other cardiac structural or electrophysiological procedure has emerged as an alternative to staged strategy. Aim: To describe our experience of combined LAAC procedures using Watchman™ devices. Method: All patients with combined LAAC procedure using Watchman™ (WN) devices performed from 2016-2021 were included. The primary safety endpoint was a composite of periprocedural complications and adverse events during follow-up. The primary efficacy endpoint included strokes, systemic embolisms, major bleeding, and cardiovascular death. Results: Since 2016, among the 157 patients who underwent LAAC using WN devices, 16 underwent a combined strategy: 6 TEMVR (37%), 6 typical atrial flutter ablation (37%), 2 LP implantation (13%) and 2 atrial fibrillation ablation (13%). The WN device was successfully implanted in 98% and 100% for single and combined LAAC respectively (p = 0.63). Median follow-up was 13 months (IQR 25/75 3/24) in the whole cohort. Device related complications occurred in 6 out of 141 patients (4%) who underwent single LAAC and in no (0/16) patient in the combined LAAC procedure (p=ns). The procedural related complications did not differ significantly between groups (5% vs 12%, respectively in the single and combined group, p=0.1). Conclusion: Combined procedure combining LAAC using the Watchman™ devices and one other structural or electrophysiological procedure is safe and effective. Larger series are needed to confirm these results.