Evaluation of Zero-Exchange Transseptal Puncture Devices on Procedural Workflow and Consistency During Left Atrial Appendage Closure.

BACKGROUND

Reducing the number of device exchanges during a left atrial appendage (LAA) closure procedure can minimize the risk of injury, air embolism, and thrombus, and optimize procedural workflow. This study compared zero-exchange transseptal puncture (TSP) workflows facilitated by VersaCross Connect (VCC) that integrate directly into WATCHMAN (WM) therapy sheaths (FXD Curve Access [FXD] and TruSteer), with other TSP devices.

METHODS

Retrospective chart analysis was performed comparing a radiofrequency needle TSP device, requiring multiple exchanges (NRG, n = 30), requiring at least 1 exchange (VersaCross Large Access, n = 49), to a zero-exchange workflow with VCC paired with WM FXD (VCC-FXD, n = 215), or TruSteer Access (TS) (VCC-TS, n = 78) in terms of time to TSP from procedure start and time to initial WM deployment post-TSP in LAA.

RESULTS

One hundred percent TSP success was achieved in all attempts (n = 372). One reported in-hospital death occurred (1/372, 0.27%, reported as not related to TSP). TSP was similar in all groups. Time to initial WM deployment was significantly improved with zero-exchange devices, as was consistency between cases. Subanalysis of the 2 therapy sheaths integrated to VCC performed similarly in time to TSP time, and to initial WM deployment (VCC-FXD = 8.0 ± 4.0 minutes, VCC-TS = 8.1 ± 4.5; P > .999).

CONCLUSIONS

Use of VCC, providing a zero-exchange solution for LAA closure, resulted in an improved workflow and consistency of the first deployment of the WM device in LAA. Integration with FXD or TruSteer sheaths resulted in similar improvements overall.