Aims Pulmonary vein isolation (PVI) either by balloon devices or radiofrequency forms the cornerstone of invasive atrial fibrillation (AF) treatment. Although equally effective cryoballoon (CB)-based PVI offers shorter procedure duration and a better safety profile. Beside the worldwide established Arctic Front Advance system, a novel CB device, POLARx, was recently introduced. This CB incorporates unique features, which may translate into improved efficacy and safety. However, multicentre assessment of periprocedural efficacy and safety is lacking up to date. Methods and results A total of 317 patients with paroxysmal or persistent AF were included and underwent POLARx CB-based PVI in 6 centres from Germany and Italy. Acute efficacy and safety were assessed in this prospective multicenter observational study. In 317 patients [mean age: 64 ± 12 years, 209 of 317 (66%) paroxysmal AF], a total of 1256 pulmonary veins (PVs) were identified and 1252 (99,7%) PVs were successfully isolated utilizing mainly the short tip POLARx CB (82%). The mean minimal CB temperature was −57.9 ± 7°C. Real-time PVI was registered in 72% of PVs. The rate of serious adverse events was 6.0% which was significantly reduced after a learning curve of 25 cases (9.3% vs. 3.0%, P = 0.018). The rate of recurrence-free survival after mean follow-up of 226 ± 115 days including a 90-day blanking period was 86.1%. Conclusion In this large multicentre assessment, the novel POLARx CB shows a promising efficacy and safety profile after a short learning curve.

Cryoballoon (CB)-guided pulmonary vein isolation (PVI) represents a cornerstone in the treatment of atrial fibrillation (AF). Recently, a novel balloon-guided single shot device (POLARx, Boston Scientific) was designed. Our study aimed to compare the efficacy, safety and characteristics of the novel CB system with the established one (Arctic Front Advance (Pro), AFA, Medtronic). A total number of 596 patients undergoing CB-guided ablation for AF were included. 65 patients (65.0 ± 11.6, 31% female) undergoing PVI with the POLARx were compared to a cohort of 531 consecutive patients (63.0 ± 27.9, 25% female) treated with AFA. Acute PVI was achieved in all patients (n = 596, 100%). Total procedure duration (POLARx 113.3 ± 23.2 min, AFA 100.9 ± 21.3 min; p < 0.001) and fluoroscopy time (POLARx 10.5 ± 5.9 min, AFA 4.8 ± 3.6 min; p < 0.001) were significantly longer in the POLARx group. The POLARx balloon achieved significantly lower nadir temperatures (POLARx −57.7 ± 0.9 °C, AFA −45.1 ± 2.6 °C; p < 0.001) and a significantly higher percentage of pulmonary veins successfully isolated with the first freeze (p = 0.027 *). One major complication occurred in the POLARx (2%) and three (1%) in the AFA group. Both ablation systems are comparably safe and effective. AF ablation utilizing the POLARx system is associated with longer procedure and fluoroscopy times as well as lower nadir temperatures.

Background Cryoballoon (CB)-guided pulmonary vein isolation (PVI) is an established treatment for atrial fibrillation (AF). This study aimed to evaluate ablation efficacy and freedom from arrhythmia recurrence using the novel POLARx compared to the Arctic Front Advance Pro (AFA) CB system including the analysis of individual PV characteristics. Methods A total of 687 patients underwent CB-guided ablation for AF. Arrhythmia recurrence was defined as an ECG documented episode of any AF/atrial tachycardia (AT) > 30 s. Anatomical characteristics were assessed using magnetic resonance imaging (MRI). For each PV, the cross-sectional orifice area (CSOA) was determined. Follow-up examinations were scheduled after 3, 6, and 12 months. Results Acute PVI was achieved in all patients. Twelve-month AF-free survival was similar between the groups (POLARx 43/86 (50%) vs. AFA 318/601 (53%), Log-rank (LR) p = 0.346). MRI found a comparable percentage of patients with normal PV anatomy (POLARx 71/86 (83%) vs. AFA 530/601 (85%), p = 0.162). Patients with variant PV characteristics presented with a significantly impaired 12-month AF-free survival (normal PVs 326/585 (56%) vs. variant PVs 27/102 (27%), LR p < 0.001) independent of the applied CB ablation system. PAF patients with AF recurrence presented with significantly larger CSOA of the left-sided PVs and the right superior PVs (LSPV: p < 0.001; LIPV: p < 0.001; RSPV: p < 0.001). In PERS AF, no association between CSOA and ablation outcome was observed. Multivariate analyses identified PERS AF (hazard ratio (HR) 2.504, confidence interval (CI), 1.900–3.299, p < 0.001) and variant PV anatomy (HR 2.124, CI 1.608–2.805, p < 0.001) as independent predictors for AF recurrence. Conclusions Both CB ablation systems are associated with comparable 12-month AF-free survival rates. Variant PV anatomy seems to be predictive for AF recurrence. An association between CSOA and the outcome after CB-guided PVI was demonstrated for PAF.

Aims Accessory pathway (AP) ablation is a standard procedure for the treatment of Wolff-Parkinson-White syndrome (WPW). Twelve-lead electrocardiogram (ECG)-based delta wave analysis is essential for predicting ablation sites. Previous algorithms have shown to be complex, time-consuming, and unprecise. We aimed to retrospectively develop and prospectively validate a new, simple ECG-based algorithm considering the patients’ heart axis allowing for exact localization of APs in patients undergoing ablation for WPW. Methods and results Our multicentre study included 211 patients undergoing ablation of a single manifest AP due to WPW between 2013 and 2021. The algorithm was developed retrospectively and validated prospectively by comparing its efficacy to two established ones (Pambrun and Arruda). All patients (32 ± 19 years old, 47% female) underwent successful pathway ablation. Prediction of AP-localization was correct in 197 patients (93%) (sensitivity 92%, specificity 99%, PPV 96%, and NPV 99%). Our algorithm was particularly useful in correctly localizing antero-septal/-lateral (sensitivity and specificity 100%) and posteroseptal (sensitivity 98%, specificity 92%) AP in proximity to the tricuspid valve. The accuracy of EASY-WPW was superior compared to the Pambrun (93% vs. 84%, P = 0.003*) and the Arruda algorithm (94% vs. 75%, P &lt; 0.001*). A subgroup analysis of children (n = 58, 12 ± 4 years old, 55% female) revealed superiority to the Arruda algorithm (P &lt; 0.001*). The reproducibility of our algorithm was excellent (ϰ&gt;0.8; P &lt; 0.001*). Conclusion The novel EASY-WPW algorithm provides reliable and accurate pre-interventional ablation site determination in WPW patients. Only two steps are necessary to locate left-sided AP, and three steps to determine right-sided AP.

Introduction Recently, a novel steerable sheath allowing its real‐time visualization within a 3D‐mapping system was introduced to facilitate atrial fibrillation (AF) ablation. Aim This study aimed to assess safety and efficacy of AF ablation using the visualized sheath and to compare its performance with a matched control group of patients who received ablation with conventional and non‐visualized sheaths. Methods The study included consecutive patients between 09/2019 and 02/2021 who underwent routine AF ablation using the visualized sheath. Patients were regularly followed‐up in our outpatient's clinic. Arrhythmia recurrence was defined as any atrial fibrillation (AF)/ atrial tachycardia (AT) episode lasting > 30 s after a blanking period of 3 months. Results A total number of 100 patients undergoing ablation using the visualized sheath were compared to a group of 99 matched patients. No major complications were observed. Total procedure duration (108 ± 22 min vs. 112 ± 12 min; p = 0.045), fluoroscopy time (7 ± 3 min vs. 10 ± 5 min; p < 0.001) and –dose (507 ± 501 cGy*cm2 vs. 783 ± 433 cGy*cm2; p < 0.001) were significantly lower using the visualized sheath. The benefit in terms of procedure duration was mainly driven by a shortened left atrial dwell time (73 ± 13 min vs. 79 ± 12 min; p = 0.001). During a mean follow‐up of 12 months, the overall procedural success was 85% in the visualized sheath group versus 83% in the control group (p = 0.948). Conclusion AF ablation using the novel visualized sheath is safe and effective and leads to a measurable decrease of procedure duration and radiation exposure. The integration of the novel sheath might help to further improve safety and efficacy of AF ablation.