Ci-452768-2 pulsed-field ablation in patients with permanent pacemaker or implantable cardioverter defibrillator: is it safe?

Pulse field ablation (PFA) is a novel catheter ablation technology with safety benefits due to its tissue selectivity. The risk of physical damage or electromagnetic interference (EMI) of PFA with cardiac implantable electronic devices (CIEDs) is unknown. The aim of our study was to assess the risk of PFA for CIEDs. PFA lesions (45 per CIED) were applied (Farapulse, Boston Scientific, MA, USA) to CIEDs (<5cm from the lead tip and <15cm from the generator). All devices were checked before and after PFA application for sensing and pacing parameters as well as integrity of shock circuits in ICDs using a heart simulator. Devices were interrogated for any spontaneous reprogramming, mode switching or other EMI effects. In total, 44 CIEDs were tested (16 pacemaker, 21 ICDs, 7 CRT-P/D) with 1,980 PFA applications. There was no change in device settings, functionality, electrical parameters and there was no visible damage to the CIEDs or leads. The risk on a device-based analysis is 0/44 (95% CI 0%-8%) and on a PFA pulse-based analysis is 0/1,980 (95% CI 0%-0.2%). Clinically relevant EMI appeared with oversensing and pacing inhibition, but not tachycardia detection. Bipolar PFA appears safe and does not result in damage to CIEDs or leads. Clinically relevant EMI does occur, but appropriate peri-procedural programming may mitigate this. In-vivo studies are needed to confirm our findings.