Abstract

Abstract Introduction Pulmonary vein isolation (PVI) is the best and first strategies during ablation of atrial fibrillation (1-4). Short- and long-term effectivity as well as procedure time are important parameters during PVI-ablation. New efforts are made to find longer effectivity, low risk of the procedure and shorter procedure. Purpose The aim of our study is to compare the two "balloon - one shot" methods (radiofrequency balloon "RFB" and cryoballoon "CB") in terms of speed, efficacy and safety. Methods Prospective, randomized, pilot single-center trial including 74 consecutive patients with paroxysmal, persistent or long lasting persistent atrial fibrillation who undergo for the first time PVI-ablation between December 2022 and October 2023. Patient were randomized 1:1 according type of AF, Sex, Hypertension, left ventricular ejection fraction e left atrial volume in a multi-electrode radiofrequency balloon catheter Heliostar ablation or in cryoballoon system ablation. Both groups had comparable clinical characteristics. Results Median Age of the population was 64 year (iq range 57-70), 19 were female (25,7%), 31 patients (42%) had paroxysmal atrial fibrillation, median EF was 60% (iq range 55-65) and median left atrial volume 36 ml/mq (iq 28-40). 37 patients undergo cryoballoon PVI and 37 patients undergo RF balloon Ablation. Compared with the RFB group, the CB group showed a shorter procedure time [65 minutes (55-75) vs. 75 minutes (65-90) (P < 0.008)]. The DAP (dose area product) was lower in RFB Group [7 Gy*cm2 ( 5-10) vs CB Group 11 ( 7-18), p<0,001]. First-pass isolation was comparable. We had 5 complications in RFB group (1 pericardial effusion without pericardiocentesis, 3 transitory ST-elevation on ECG due to air embolism, 1 transient phrenic nerve palsy) and 3 complications in CB group (3 transient phrenic nerve palsy) P=ns. During the procedures in 3 cases of RF group and in 1 case of CB group (p=ns) we had to change the balloon due to technical issues. Conclusion The RFB appears to have a safety and efficacy profile similar to that of the CB for PVI. CB has shorter procedural times but with a higher X-Ray exposure.Figure 1Figure 2

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