Safety, efficacy, and quality of life outcomes of pulsed field ablation in Japanese patients with atrial fibrillation: results from the PULSED AF trial.

BACKGROUND

Pulsed field ablation (PFA), a novel treatment for atrial fibrillation (AF), has yet to be evaluated in a Japanese cohort.

METHODS

In this sub-analysis of the PULSED AF trial, 12-month outcomes of paroxysmal AF (PAF) and persistent AF (PsAF) patients treated with PFA in four Japan centers were assessed. After a 90-day blanking period, primary efficacy was determined via freedom from a composite endpoint of acute procedural failure, arrhythmia recurrence, or antiarrhythmic drug escalation over 1 year. Patient improvement was evaluated via two quality of life (QoL) surveys (AFEQT and EQ-5D) at baseline and 12 months.

RESULTS

The analysis included 32 patients, 16 PAF and 16 PsAF, with PAF patients averaging 61.1 ± 10.6 years and PsAF patients averaging 62.8 ± 11.5 years of age. Females made up 31% of PAF and 25% of PsAF cohorts. Acute pulmonary vein isolation was achieved in 100% of both cohorts. The primary efficacy success rate at 12 months was 75.0% for PAF and 56.3% for PsAF patients. No primary safety events occurred. The mean AFEQT score significantly increased for both PAF (25.9 points, p < 0.0001) and PsAF (13.2 points, p = 0.0002) patients, while the EQ-5D-5L score improved significantly for PAF (0.12 points, p = 0.048) patients but not for PsAF (0.04 points, p = 0.08) patients.

CONCLUSIONS

Similar to outcomes in the global cohort, ablation with the PulseSelect™ PFA catheter was efficient, effective, and safe in a Japanese population, resulting in improved QoL for PAF and PsAF patients.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04198701.