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 the exchange-related complications. An alternative option is performing the TSP through a steerable sheath and thus avoiding the exchange.

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

Methods: Patients undergoing CBA (with Arctic Front Advance Pro, Medtronic) at 3 centers in Poland were prospectively enrolled and assigned to the standard approach (N=62) or the no-exchange group (N=62). The TSP in the standard approach group was performed through a fixed-curve sheath that was exchanged for a 15F 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 (IQR) 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 (IQR) 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 has occurred in each group.

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