Clinical Utility of Tissue Proximity Indication With a Variable-Loop Circular Catheter for Pulmonary Vein Isolation

Area of Science:

• Electrophysiology
• Cardiac Ablation Technologies
• Medical Device Innovation

Background:

• The variable-loop circular catheter (VLCC, VARIPULSE) integrates a Tissue Proximity Indication (TPI) function to monitor catheter-tissue contact during pulsed-field ablation (PFA).
• Previous reports suggest TPI-negative sites may contribute to gaps in ablation lesions, but real-time TPI utility remains unevaluated.

Purpose of the Study:

• To assess the success rate of pulmonary vein isolation (PVI) using the VLCC with its activated TPI function as the primary guidance.
• To evaluate an activated TPI function-guided ablation approach for PVI.

Main Methods:

• Sixty patients underwent PFA using the VLCC with the TPI function activated from the start.
• Pulmonary vein geometry was created using CARTOSOUND FAM, followed by PVI with TPI guidance, adjusting catheter orientation to TPI-positive tags.
• Post-ablation voltage mapping identified residual potentials, comparing rates with the TPI-guided strategy.

Main Results:

• First-pass PVI was achieved in 90% of patients (54/60) and 97.1% of pulmonary veins (231/238) using the activated TPI function-guided PFA strategy.
• Residual antrum potentials were observed in a small percentage (3.8%, 9/238) of pulmonary veins, requiring additional PFA applications.

Conclusions:

• Activated TPI function-guided PFA is associated with a low incidence of residual potentials.
• This approach shows potential for enhancing lesion continuity and improving the overall efficacy of PVI procedures.