Abstract

For patients with symptomatic atrial fibrillation (AF) pulmonary vein isolation (PVI) has evolved to the standard of care. For minimization of pulmonary vein reconnection, for reduction of complications and for improvement of PVI efficiency, also in a timely manner, many catheter technologies have been developed already. A new ablation modality in that regard is the radiofrequency balloon-catheter (RF-BC). However the evidence concerning this new technology is sparse. Evaluation of the procedural data, the safety profile and the clinical outcome using the new RF-BC in PVI. Since September 2021 patients with first-time PVI using the RF-BC (HELIOSTAR™, Biosense Webster) have been included in our ongoing monocentric register study. Esophageal temperature (ET) and phrenic nerve (PN) monitoring is performed during energy delivery. In case of ET exceedence above 42 degree Celsius an esophagogastroscopy (EGD) is conducted. Follow-up is scheduled for 3, 6, 12 and 24 months post ablation and in case of symptomatic recurrence. Until now 130 individuals (age [y]: 69 ± 9.8, female: 37.7%, paroxysmal AF 64.6%, CHA2DS2-VASc 4 ± 3, preserved ejection fraction 56.2%, left atrial diameter [mm] 45 ± 8.3) have been included in our study. Mean procedural duration (skin-to-skin) was 88 (± 35) minutes. Single-shot-isolation was possible in 80,2% of the 516 treated PVs. On average five energy deliveries per patient had been applied. Fortunately no pericardial tamponade, no stroke and no fatalities occurred. Nevertheless PN palsy was detected in one patient. Luckily it resolved completely within 48h. Due to ET exceedence in 6 of 20 patients esophageal lesions have been detected during EGD. All 6 lesions resolved spontaneously. Recurrence-free-survival after 6 months was 73.0% in the Kaplan-Meier analysis if no blanking period is applied, and 94.0% with a 90-day blanking period. Thanks to pulmonary vein isolation with only one energy-delivery in most cases, the RF-BC seems to be a very efficient ablation tool. But more importantly is seems to be also a safe one.

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