Pulsed Field Ablation Using Focal Contact Force-Sensing Catheters for Treatment of Atrial Fibrillation: 1-Year Outcomes of the ECLIPSE AF Study

Abstract

Background: Pulsed field ablation (PFA) is a promising treatment for atrial fibrillation. We report 1-year freedom from atrial arrhythmia outcomes using monopolar PFA delivered through 3 commercial, contact force-sensing focal catheters.

Methods: ECLIPSE AF (Safety & Clinical Performance Study of Catheter Ablation With the Centauri System for Patients With Atrial Fibrillation; NCT04523545) was a prospective, single-arm, multicenter study evaluating acute and chronic safety and performance using the CENTAURI system to deliver focal PFA with TactiCath SE, StablePoint, and ThermoCool ST. Patients with paroxysmal or persistent atrial fibrillation underwent pulmonary vein (PV) isolation under deep sedation or general anesthesia and returned for remapping at 90 days to evaluate chronic durability. Freedom from atrial arrhythmia was evaluated continuously through 12 months using standard rhythm monitoring for symptomatic episodes and 24-hour Holter at 6 and 12 months.

Results: Eighty-two patients (74% male, 51.2% paroxysmal, and 58.5% deep sedation) were treated. PV isolation was achieved in 100% of targeted veins (322/322) with first-pass isolation in 92.2% (297/322). There were 4 primary safety events in 4 patients (4.9%, 4/82); 1 nonembolic stroke due to exacerbated cardiac tamponade secondary to catheter perforation and 3 hemorrhagic vascular access complications. There were no incidences of adverse event fistula, diaphragmatic paralysis, myocardial infarction, pericarditis, thromboembolism, PV stenosis, transient ischemic attack, or death. Eighty patients (98%) underwent remapping. Optimized PFA cohorts 3, 4, and 5 showed per-patient isolation rates of 60%, 73%, and 81% and per-PV isolation rates of 84%, 90%, and 92%, respectively. One-year freedom from atrial arrhythmia was 80.2% (95% CI, 69.7%-87.4%) for the entire patient sample, including 41 patients who underwent repeat focal PFA with the CENTAURI system at remapping.

Conclusions: This study demonstrated that optimization of focal PFA with 3 contact force-sensing, solid-tip ablation catheters resulted in the progressive improvement of PV isolation durability at 3-month remapping and high freedom from atrial arrhythmia survival rates, providing a promising focal PFA treatment option integrated with current ablation workflows.

Keywords: atrial fibrillation; electrocardiography, ambulatory; fibrosis; incidence; pulmonary veins.

Figure 1.

Overlapping focal pulsed field ablation (PFA) lesions were applied along the circumference of the pulmonary veins to ensure adequate base lesion depth at each application. In addition, the treatment spacing between each focal lesion was taken into consideration to ensure adequate effective treatment depth between each focal PFA lesion.

Figure 2.

Treated patients were separated into 5 cohorts based on ablation settings, ablation catheter, and mapping system used during the index ablation procedure. LSPV indicates left superior pulmonary vein; PFA, pulsed field ablation; and RPSV, right superior pulmonary vein.

Figure 3.

Chronic pulsed field ablation (PFA) lesion durability was measured per-patient and per-pulmonary vein (PV), 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, 4, and 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 adverse events associated with the optimization in energy settings and clinical workflows.

Figure 4.

Kaplan-Meier curve estimates for freedom of atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) for all subjects treated in the study. Survival estimates were broken further down by cohort (A), single vs redo procedure (B), and patients with paroxysmal atrial fibrillation (PAF) vs persistent atrial fibrillation (PerAF) (C).