Zero-exchange workflow for cryoballoon ablation in pulmonary vein isolation using a direct over-the-needle transseptal access with the FlexCath sheath: A multicenter observational study.

Background: Transseptal puncture (TSP) is a crucial step during cryoballoon ablation (CBA) allowing for left atrium access. During the procedure an over-the-wire sheath exchange is required, which brings concerns about exchange-related complications. An alternative option is to perform the TSP through a steerable sheath and thus avoid the exchange.

Aims: We aimed to evaluate the feasibility, efficacy, and safety of a simplified zero-exchange workflow for the CBA procedure.

Material and methods: Patients undergoing CBA (with Arctic Front Advance Pro, Medtronic) at 3 centers in Poland were prospectively enrolled and assigned to a standard-approach (n = 62) or a no-exchange group (n = 62). The TSP in the standard-approach group was performed through a fixed-curve sheath that was exchanged for a 15 F steerable sheath (FlexCath Advance, Medtronic). In the no-exchange group the puncture was performed through the steerable sheath.

Results: TSP was successfully performed in all patients. In the no-exchange group compared to the standard-approach group, the median (interquartile range) procedure time and left atrium dwell time were significantly shorter (75.0 [60.0-90.0] min vs. 80.5 [70.0-100.0] min; P = 0.02 and 47 [40.0-56.0] min vs. 51.5 [43.25-64.5] min; P = 0.04, respectively) with comparable median (interquartile range) fluoroscopy time (14.0 [8.5-20.4] min vs. 12.25 [10.0-17.6] min; P = 0.74). Only one potentially TSP-related complication occurred in each group.

Conclusion: A direct TSP with a FlexCath Advance sheath is a feasible, safe, and efficient alternative to the standard approach.