Pulsed field ablation using focal contact force-sensing catheters for treatment of atrial fibrillation: acute and 90-day invasive remapping results

Abstract

Aims: Pulsed field ablation (PFA) has emerged as a promising alternative to thermal ablation for treatment of atrial fibrillation (AF). We report performance and safety using the CENTAURI™ System (Galvanize Therapeutics) with three commercial, focal ablation catheters.

Methods and results: ECLIPSE AF (NCT04523545) was a prospective, single-arm, multi-centre study evaluating safety and acute and chronic pulmonary vein isolation (PVI) durability using the CENTAURI System in conjunction with the TactiCath SE, StablePoint, and ThermoCool ST ablation catheters. Patients with paroxysmal or persistent AF were treated at two centres. Patients were analysed in five cohorts based upon ablation settings, catheter, and mapping system. Pulsed field ablation was performed in 82 patients (74% male, 42 paroxysmal AF). Pulmonary vein isolation was achieved in 100% of pulmonary veins (322/322) with first-pass isolation in 92.2% (297/322). There were four serious adverse events of interest (three vascular access complications and one lacunar stroke). Eighty patients (98%) underwent invasive remapping. Pulsed field ablation development Cohorts 1 and 2 showed a per-patient isolation rate of 38% and 26% and a per-PV isolation rate of 47% and 53%, respectively. Optimized PFA Cohorts 3-5 showed a per-patient isolation rate of 60%, 73%, and 81% and a per-PV isolation rate of 84%, 90%, and 92%, respectively.

Conclusion: ECLIPSE AF demonstrated that optimized PFA using the CENTAURI System with three commercial, contact force-sensing, solid-tip focal ablation catheters resulted in transmural lesion formation and high proportion of durable PVI with a favourable safety profile, thus providing a viable treatment option for AF that integrates with contemporary focal ablation workflows.

Keywords: Atrial fibrillation; Focal catheter; Pulmonary vein isolation; Pulsed electric fields; Pulsed field ablation; Remapping.

Graphical abstract

Figure 1

Configuration of the CENTAURI System in a standard EP laboratory. ECG, electrocardiogram; EP, electrophysiology.

Figure 2

Cohorts were established based upon ablation settings, ablation catheter, and mapping system used during the index ablation procedure.

Figure 3

Acute PVI and 90-day chronic PVI durability were assessed using high-density remapping to verify entrance and/or exit block. Voltage maps correlated with placement of PEF applications, and 90-day remaps confirmed no degradation of the line of block created at the index procedure. PEF, pulsed electric field; PVI, pulmonary vein isolation.

Figure 4

Chronic PFA lesion durability, measured by per-patient and per-PV isolation rate at 90 days, for each cohort. Patients in the PFA workflow development Cohorts 1 and 2 showed a per-patient isolation rate of 38% and 26%, and a per-pulmonary vein isolation rate of 47% and 53%, respectively. Patients in the optimized PFA Cohorts 3–5 showed a per-patient isolation rate of 60%, 73%, and 81% and a per-PV isolation rate of 84%, 90%, and 92%, respectively. There were no AEs associated with the optimization in energy settings and clinical workflows. PFA, pulsed field ablation; PV, pulmonary vein.

Figure 5

Points of reconnection along the PVs were addressed by delivering focal touch-up PFA using the CENTAURI System. As depicted in these examples, PV reconnections typically required minimal focal touch-up applications (a) posterior left PV carina indicated by red ablation tags, (b) epicardial sleeve posterior right carina, and (c) posterior right carina indicated by dotted ablation tags to re-isolate the vein, emphasizing the overall chronic durability of the WACAs created at the index procedure. PV, pulmonary vein; WACA, wide antral circumferential ablation.