Validation of a variable loop circular pulsed field ablation catheter for assessment of pulmonary vein isolation by 3D mapping

Abstract Background In pulmonary vein isolation (PVI) procedures, acute effectiveness of ablation is usually assessed with dedicated mapping catheters with closely spaced and small electrodes. With catheter designs optimized for pulsed-field ablation (PFA), 3D mapping capabilities are limited due to limited mapping integration and fewer, larger and more widely spaced electrodes, all affecting EGM recordings. Purpose To validate the performance of a novel 3D mapping-enabled variable loop circular (VLC) PFA catheter for endpoint assessment of PVI compared to a dedicated octaspline high-density mapping catheter. Methods Patients undergoing a PVI procedure using the VLC PFA catheter were included. PVI was performed using the recommended ablation protocol of at least four applications per vein. Post-ablation maps of de novo procedures and pre- and post-ablation maps of repeat procedures were acquired twice, once with the VLC PFA catheter and once using a dedicated octaspline high-density mapping catheter. PV isolation status was assessed for each vein, as judged by the absence of localized EGM registered during 3D mapping within a wide-antral PV area. Additional PFA applications were delivered only after confirmation of residual PV connection by both catheters. Results In 30 patients (median age 73 years, IQR 56-78 years, 70% male, 19 de novo procedures, 11 repeat procedures), acute PVI was achieved in 100% with a median of 21 (IQR 18-24) PFA applications. 38 maps were available for both catheters, resulting in 148 PVs available for analysis (four veins were not mapped by both catheters). The accuracy of PV assessment with the VLCC was 98% (145/148 veins). In 2/158 (1.4%) PVs, the VLCC incorrectly indicated PV-isolation, with a mismatch close to the carina. In 1/158 (0.7%), the VLCC incorrectly indicated residual PV-conduction. In 12 cases, posterior wall ablation was performed using the PFA LVCC. Both catheters agreed in the assessment of the posterior wall in 11/12 (92%) of these cases. In the remaining case, the VLC PFA catheter did not record small fragmented signals on the posterior wall. Conclusion Despite fewer, larger and more widely spaced electrodes, endpoint assessment for PVI can be reliably performed with a novel 3D mapping-enabled VLC PFA catheter Hence, no additional dedicated mapping catheter is needed when performing PVI procedures.