ABSTRACT
Background: The 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. Methods: The 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. Results: 157/157 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 11.0â s (Q1 = 8.0â s; Q3 = 13.8â s). Median procedure time was 62.5â min (Q1 = 50.0â min; Q3 = 70.5â min). LA-dwell time was 28.5â min (Q1 = 23.3â min; Q3 = 36.5â min). Median fluoroscopy duration was 11.6â min (Q1 = 10.1â min; Q3 = 13.7â 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. Conclusion: Rapid 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 Registration: ClinicalTrials.gov; Identifier NCT0560361.