The Lead Episode 29: A Discussion of Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation-New England Journal of Medicine

New England Journal of Medicine

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A study conducted by the ADVENT Investigators compared the efficacy and safety of pulsed field ablation with conventional thermal ablation for the treatment of paroxysmal atrial fibrillation. Pulsed field ablation delivers high-voltage electrical fields in microseconds, which may limit damage to tissues outside the heart. The randomized, single-blind, noninferiority trial included 305 patients assigned to pulsed field ablation and 302 patients assigned to thermal ablation. <br /><br />After one year, the primary efficacy endpoint of freedom from initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion, or repeat ablation was met in 73.3% of patients in the pulsed field ablation group and 71.3% of patients in the thermal ablation group. The difference between the two groups was 2.0 percentage points, with a 95% Bayesian credible interval of 5.2 to 9.2. The posterior probability of noninferiority was 0.999. <br /><br />Regarding safety, primary safety endpoint events occurred in 2.1% of patients in the pulsed field ablation group and 1.5% of patients in the thermal ablation group. The difference between the two groups was 0.6 percentage points, with a 95% Bayesian credible interval of 1.5 to 2.8. The posterior probability of noninferiority was 0.999. <br /><br />Based on these results, the study concluded that pulsed field ablation is noninferior to conventional thermal ablation for patients with paroxysmal atrial fibrillation in terms of freedom from adverse events and procedural failure after one year. The study was funded by Farapulse–Boston Scientific and is registered with ClinicalTrials.gov (NCT04612244).

Keywords

ADVENT Investigators

pulsed field ablation

conventional thermal ablation

paroxysmal atrial fibrillation

efficacy

safety

randomized trial

noninferiority

primary efficacy endpoint

primary safety endpoint