Background: Catheter cardiac ablation is a minimal interventional medical procedure intended to treat patients with abnormal heart rhythms such as atrial fibrillation. Ablation catheter creates lesions in the cardiac tissue that is responsible for the abnormal heart rhythms. Pulsed field ablation (PFA) is a novel source of energy that generates electrical field pulses to treat cardiac arrhythmias. There is limited real-world data describing neurovascular and acute myocardial infarction (MI) events among patients undergoing ablation with PFA systems.
Objectives: The aim of this study is to describe the timing and estimate the cumulative incidence and 95% confidence interval (CI) of neurovascular and MI events among patients undergoing PFA in a large U.S. hospital database.
Methods: Design and setting: An observational, retrospective cohort study was conducted using electronic healthcare data from the U.S. Premier Healthcare Database (PHD). Adult patients undergoing PFA with a billing charge for PulseSelect or FARAPULSE between January 1, 2024, and December 5, 2024, were included.
Exposure: PFA was identified via a charge description for either PulseSelect PFA System (manufactured by Medtronic) or FARAPULSE PFA System (manufactured by Boston Scientific) in the PHD.
Main outcome measure: Neurovascular [including Acute Ischemic Stroke/Transient Ischemic Attack] and acute myocardial infarction events were defined as the presence of a qualified ICD-10-CM diagnosis code during and within 30 days of the index procedure. No causality attribution between the study outcomes and a PFA device can be assessed from these data.
Statistical analysis: Patient characteristics and timing to event were summarized via descriptive analyses. Cumulative incidences and 95% CIs were calculated for neurovascular and MI events within 30-days by device.
Results: A total of 10,708 patients were identified; 9,305 treated with FARAWAVE and 1,403 treated with PulseSelect. Across both treatment groups, most patients were male (63%) and had a mean age of 68 (standard deviation: 10) years. Thirty-seven neurovascular events and 42 MI events were identified across both cohorts with 25 (67.5%) neurovascular events and 13 (31%) MI events diagnosed on the day of the PFA procedure. The cumulative incidences of neurovascular events were 0.3% (0.2%-0.5%) and 0.4% (0.2%-0.9%) for FARAWAVE and PulseSelect, respectively. The cumulative incidences of MI were 0.4% (0.3%-0.6%) and 0.3% (0.1%-0.7%) for FARAWAVE and PulseSelect, respectively.
Conclusions: Overall, the risks of neurovascular and MI events are less than 0.5% during and within 30-days of a PFA procedure in this US study population.
