Novel streamlined technique for left atrial appendage closure using a radiofrequency wire-based large access system

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Transseptal puncture (TSP) for large sheath left atrial (LA) access is challenging in complex cardiac anatomies for left atrial appendage closure (LAAC).
• Existing methods for TSP can be time-consuming and radiation-intensive, particularly in patients with specific anatomical variations.

Purpose of the Study:

• To evaluate the procedural efficiency of the VersaCross large access (VLA) system for LAAC compared to the standard needle-based workflow.
• To assess the impact of the VLA system on key procedural metrics including time, fluoroscopy, and complication rates.

Main Methods:

• A retrospective analysis of 50 LAAC procedures using the WATCHMAN FLX device was conducted.
• Procedures were divided into two groups: VLA workflow (n=25) and standard needle workflow (n=25).
• Key endpoints included time to procedural efficiency, TSP time, LAAC success, fluoroscopy utilization, and complications.

Main Results:

• The VLA workflow demonstrated a statistically significant reduction in time to sheath insertion (27% faster) and device release (19% faster) post-TSP.
• Overall procedure time was reduced by 15% with the VLA system.
• Fluoroscopy time decreased by 25% and radiation dose by 60% using the VLA workflow, with greater consistency observed.

Conclusions:

• The VLA system effectively streamlines LAAC procedures, enhancing overall efficiency.
• This system reduces fluoroscopy time and radiation exposure, contributing to improved patient safety.
• The VLA system facilitates large-bore sheath delivery by enabling septal dilation, minimizing device exchanges and sheath manipulation.