P1026Second-generation visually guided laser balloon ablation system for pulmonary vein isolation: Learning curve, safety and efficacy: The MERLIN registry

Abstract Funding Acknowledgements Cardiofocus Background Radiofrequency (RF) based pulmonary vein isolation (PVI) results in favourable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems, have been developed to possibly solve these limitations. The second-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. Purpose We determined safety, efficacy and learning curve of the LB2 for PVI. Method A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided in three groups (T1, T2, T3) of n = 15 patients per group. All patients underwent PVI using the LB2 by two operators. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. Results A total 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T 1–3, respectively (P = 0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 until T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P = 0.045. Adverse events occurred in 6.7% with a trend towards a lower complication rate with increasing experience. Conclusion The LB2 was safe and effective for PVI even for operators without any previous experience in laser balloon based PVI. Procedure time LA dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.