Aims The aim of this study was to compare procedural efficacy and safety, including 1-year freedom from AF recurrence, between the novel cryoballoon system PolarX (Boston Scientific) and the Arctic Front Advance Pro (AFA-Pro) (Medtronic), in patients with paroxysmal AF undergoing PVI. Methods and results This multicentre prospective observational study included 267 consecutive patients undergoing a first cryoablation procedure for paroxysmal AF (137 PolarX, 130 AFA-Pro). KM curves with the log-rank test was used to compare the 1-year freedom from AF recurrence between both groups. Multivariate Cox model was performed to evaluate whether the type of procedure (PolarX vs. AFA-Pro) had an impact on the occurrence of AF recurrences after adjustment on potentially confounding factors. The PolarX reaches lower temperatures than the AFA-Pro (LSPV 52 ± 5, vs. 59 ± 6; LIPV 49 ± 6 vs. 56 ± 6; right superior pulmonary vein: 49 ± 6 vs. 57 ± 7; right inferior pulmonary vein: 52 ± 6 vs. 59 ± 6; P < 0.0001). A higher rate of transient phrenic nerve palsy was found in patients treated with the PolarX system (15% vs. 7%, P = 0.05). After a mean follow-up of 15 ± 5 months, 20 patients (15%) had recurrences in AFA-Pro group and 27 patients (19%) in PolarX group (P = 0.35). Based on survival analysis, no significant difference was observed between both groups with a 12-month free of recurrence survival of 91.2% (85.1–95.4%) vs. 83.7% (76.0%–89.1%) (log-rank test P = 0.11). In multivariate Cox model hazard ratio of recurrence for PolarX vs. AFA-Pro was not significant [HR = 1.6 (0.9–2.8), P = 0.12]. Conclusion PolarX and AFA-Pro have comparable efficacy and safety profiles for pulmonary veins isolation in paroxysmal atrial fibrillation.
Aims There is an increasing trend evaluating the role of non-pulmonary vein (PV) triggers to improve ablation outcomes in persistent atrial fibrillation (AF) as pulmonary vein isolation (PVI) strategy alone has modest outcomes. We investigated the long-term safety and efficacy of left atrial appendage isolation (LAAi) in addition to PVI using cryoballoon (CB) in persistent AF. Methods and results In this multicentre retrospective analysis, we included a total of 193 persistent AF patients (mean age: 60 ± 11 years, 50.3% females) who underwent PVI and LAAi using CB. Baseline and follow-up data including electrocardiography (ECG), 24 h Holter ECGs, and echocardiography were recorded for all patients. Atrial tachyarrhythmia (ATa) recurrence was defined as the detection of AF, atrial flutter, or atrial tachycardia (≥30 s) after a 3-month blanking period. At a median follow-up of 55 (36.5–60.0) months, 85 (67.9%) patients with PVI + LAAi were in sinus rhythm after the index procedure. Ischaemic stroke/transient ischemic attack occurred in 14 (7.2%) patients at a median of 24 (2–53) months following catheter ablation. Multivariate regression analysis revealed heart failure with preserved ejection fraction [hazard ratio (HR) 2.29, 95% confidence interval (CI) 1.04–5.02; P = 0.038], male gender (HR 0.53, 95% CI 0.29–0.96; P = 0.037), and LA area (HR 1.04, 95% CI 0.53–1.32; P = 0.023) as independent predictors of ATa recurrence. Conclusion Our findings demonstrated that the LAAi + PVI strategy using CB had acceptable long-term outcomes in patients with persistent AF. Systemic thrombo-embolic events are an important concern throughout the follow-up, which were mostly observed in case of non-adherence to anticoagulants.
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