What is the clinical evidence from this study?

Study design: Observational. Population: Symptomatic paroxysmal or persistent atrial fibrillation (n=138). Intervention: Pulsed-field ablation (Farawave catheter). Primary outcome: Electrical pulmonary vein isolation (PVI).

September 22, 2022Open Access

Pulsed-field ablation-based pulmonary vein isolation: acute safety, efficacy and short-term follow-up in a multi-center real world scenario

Key Result

Pulsed-field ablation achieved 100% acute electrical pulmonary vein isolation in patients with atrial fibrillation, with a 0.7% major complication rate.

Study Design

Type

Observational (n=138)

Multicenter

Yes

Structured PICO

Does pulsed-field ablation achieve effective and safe pulmonary vein isolation in patients with symptomatic paroxysmal or persistent atrial fibrillation?

Population

138 consecutive patients with symptomatic paroxysmal (38%) or persistent (62%) atrial fibrillation undergoing first pulmonary vein isolation. Mean age 67 ± 12 years, 66% male, treated at two German high-volume centers. Exclusion criteria: prior PVI or LA ablation, LA diameter > 60 mm, severe valvular heart disease, or contraindications to post-interventional oral anticoagulation.

Intervention

Pulsed-field ablation (PFA) using the Farawave catheter in conjunction with 3D mapping, applying 8 PFA applications in each pulmonary vein.

Outcome

Electrical pulmonary vein isolation (defined as elimination of all PV signals and confirmed by entrance block)surrogate

Pulsed-field ablation for pulmonary vein isolation is highly effective acutely and demonstrates a favorable safety profile with low recurrence rates in a real-world setting.

Limitations

Observational, non-randomized design
Limited number of patients
Conducted in only two high-volume centers

Abstract

Abstract Purpose Pulsed-field ablation (PFA) is a new energy source to achieve pulmonary vein isolation (PVI) by targeted electroporation of cardiomyocytes. Experimental and controlled clinical trial data suggest good efficacy of PFA-based PVI. We aimed to assess efficacy, safety and follow-up of PFA-based PVI in an early adopter routine care setting. Methods Consecutive patients with symptomatic paroxysmal or persistent atrial fibrillation (AF) underwent PVI using the Farawave® PFA ablation catheter in conjunction with three-dimensional mapping at two German high-volume ablation centers. PVI was achieved by applying 8 PFA applications in each PV. Results A total of 138 patients undergoing a first PVI (67 ± 12 years, 66% male, 62% persistent AF) were treated. PVI was achieved in all patients by deploying 4563 applications in 546 PVs (8.4 ± 1.0/PV). Disappearance of PV signals after the first application was demonstrated in 544/546 PVs (99.6%). More than eight PFA applications were performed in 29/546 PVs (6%) following adapted catheter positioning or due to reconnection as assessed during remapping. Mean procedure time was 78 ± 22 min including pre- and post PVI high-density voltage mapping. PFA catheter LA dwell-time was 23 ± 9 min. Total fluoroscopy time and dose area product were 16 ± 7 min and 505 275;747 cGy*cm 2 . One pericardial tamponade (0.7%), one transient ST-elevation (0.7%) and three groin complications (2.2%) occurred. 1-year follow-up showed freedom of arrhythmia in 90% in patients with paroxysmal AF ( n = 47) and 60% in patients with persistent AF ( n = 82, p = 0.015). Conclusions PFA-based PVI is acutely highly effective and associated with a beneficial safety and low recurrence rate. Graphical abstract

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