Table1_Implementation of the multielectrode radiofrequency-balloon in real-world clinical practice—operator learning curve and procedural outcome at a high-volume center.docx

BackgroundThe novel multielectrode radiofrequency (RF) balloon catheter (HELIOSTAR™. Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF), combining RF-ablation and 3D-mapping visualization with the concept of a “single-shot”-ablation device. This study evaluates the operator learning curve und procedural outcome during implementation of the multielectrode RF-balloon at a high-volume center.MethodsThe first 40 patients undergoing PVI by multielectrode RF-balloon catheter at Heidelberg University Hospital were included in this prospective study. Procedural outcome was analyzed over the course of increasing experience with the device.Results157/157 pulmonary veins (PVs) were successfully isolated with the RF-balloon catheter, in 73.2% by a single RF-application. Median time to isolation (TTI) was 11.0 s (Q1 = 8.0 s; Q3 = 13.8 s). Median procedure time was 62.5 min (Q1 = 50.0 min; Q3 = 70.5 min). LA-dwell time was 28.5 min (Q1 = 23.3 min; Q3 = 36.5 min). Median fluoroscopy duration was 11.6 min (Q1 = 10.1 min; Q3 = 13.7 min). No serious procedure-related complications were observed, apart from one case of unclear, post-procedural acute-on-chronic kidney injury. With increasing operator experience, an additional reduction in procedure duration was observed.ConclusionRapid implementation of a “single shot”-ablation device combining RF-ablation and 3D-mapping can be achieved with high acute procedural efficacy and safety at a high-volume center. Previous experience with “single-shot” ablation devices may be advantageous for time-efficient introduction of the novel RF-balloon catheter into clinical practice.Clinical trial registrationhttps://clinicaltrials.gov, identifier NCT05603611.

背景：新型多电极射频（RF）球囊导管（HELIOSTAR™，Biosense Webster）是一种用于房颤（AF）肺静脉隔离（PVI）的新技术，该技术将射频消融与三维映射可视化相结合，并引入了‘单次消融’设备的概念。本研究旨在评估在高容量中心实施多电极射频球囊导管时的操作者学习曲线及手术结果。方法：将海德堡大学医院接受多电极射频球囊导管进行PVI手术的前40名患者纳入本研究。分析随着对该设备操作经验的增加，手术结果的变化。结果：157/157个肺静脉（PVs）成功实现了射频球囊导管的隔离，其中73.2%通过单次射频应用实现。隔离时间中位数（TTI）为11.0秒（Q1=8.0秒；Q3=13.8秒）。手术时间中位数为62.5分钟（Q1=50.0分钟；Q3=70.5分钟）。左心房（LA）停留时间中位数为28.5分钟（Q1=23.3分钟；Q3=36.5分钟）。荧光屏时间中位数为11.6分钟（Q1=10.1分钟；Q3=13.7分钟）。除一例术后急慢性肾脏损伤不明病例外，未观察到严重的与手术相关的并发症。随着操作者经验的增加，手术时间进一步缩短。结论：在大型中心快速实施结合射频消融和三维映射的‘单次消融’设备，可实现高急性手术效能与安全性。既往‘单次消融’设备的操作经验可能有助于高效地将新型射频球囊导管引入临床实践。临床试验注册：https://clinicaltrials.gov，标识符NCT05603611。