Catheter Ablation -> Atrial Fibrillation & Atrial Flutter: -> Clinical Trials / Outcomes D-PO01 - Featured Poster Session (ID 11) Poster

D-PO01-136 - One Year Clinical Outcomes Following Pulsed Field Ablation For Paroxysmal Af (ID 932)

Abstract

Background: Pulsed field ablation (PFA) preferentially ablates myocytes. Using a novel PFA catheter, this safety margin, coupled with fast ablation times (<5 sec), afforded us the therapeutic flexibility to achieve high rates of PVI durability as assessed by ~3-mo remapping. While early outcomes were favorable, the long-term efficacy is unknown.
Objective: To describe 1-year clinical outcomes of PVI using PFA in paroxysmal AF.
Methods: PAF pts who failed at least 1 AAD were enrolled in either IMPULSEor PEFCAT(NCT03714178, NCT03700385) to undergo biphasic PFA of the PVs using a basket/flower catheter (Farawave, Farapulse Inc). Prospective remapping was performed between 2 and 3 mo, and pts were followed for 1 year. After a 90-day blanking window, monitoring included weekly event monitor transmissions (compliance was 89.5% on a weekly basis) and 24-hr Holters at 6 and 12 mo.
Results: In 2 centers, 103 patients (age 58±10 yrs, 76% male, LA dia 4.1±0.4 cm) were treated by 4 operators, with the 88 most recent pts not under general anesthesia. All PVs (100%, 401 of 401) in all pts (100%, 103 of 103) were isolated successfully, with procedures requiring 35±17 min of LA dwell time. The primary safety rate was 1.9% (1 tamponade, 1 hematoma). The optimized PFA waveform had been used in 26 pts that then underwent remapping: PVI was durable in 98% (100 of 102) of PVs, translating to all veins durably isolated in 92.3% (24 of 26 pts). At 307±70 days follow-up, 1-yr freedom from AF and from all atrial arrhythmias (AF/AFL/SVT) in 96 eligible pts was 87.5±3.6% and 78.5±4.5%, respectively. Among the 51 subjects who reached or exceeded the 1 yr timepoint, 90.1% (46 of 51 pts) were free from AF. Among subjects receiving the optimized PFA waveform, 93.3% (14 of 15 pts) remained free from AF through 1 yr. Interestingly, a pt with AF recurrence after verified lesion durability (63d F/U) underwent a second remap (213d F/U) in which all PVs remained isolated.
Conclusion: These long-term data of patients treated with this basket/flower PFA catheter revealed few safety events and excellent PVI durability. Importantly, this translated to a low rate of clinical atrial arrhythmia recurrence. These data help allay concern that the novel ablative mechanism of this modality may mask undiscovered compromises.

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