Abstract
A multielectrode pentaspline basket/flower pulsed field ablation (PFA) catheter has demonstrated a high rate of PVI durability. Arrhythmia recurrence was also monitored in these studies. To investigate the relationship between PVI durability and clinical recurrence in a cohort of patients treated with the optimized PFA waveform. The PFA catheter (Farawave, Farapulse Inc, Menlo Park CA) was used to treat 121 PAF pts in 3 studies (IMPULSE NCT03700385; PEFCAT NCT03714178; PEFCAT2 NCT04170608) at 3 centers, of which a subset (n=49) received the optimized bipolar/biphasic waveform strategy (PFA-OW). After a 90-day blanking period including prospective remapping at 75-90 days, follow-up included weekly event monitor transmissions and 24h Holters at 6 and 12-months. All pts in the cohort (57±10 yr, 65%M, LA 40±5 mm) underwent successful PFA: 195 of 195 PVs (100%) isolated. Remapping yielded 96% (166 of 173 PVs) durable PVI at 81 days (69-98) in 44 of 49 pts. Atrial arrhythmia was documented in 7 pts (6 AF) at 186 days (159-265) but almost all (6 of 7) had isolated PVs at remap, which occurred prior to (129 days, 98-158; 5 pts) or after (16 days; 1 pt) recurrence. One pt had a single reconnected PV which was treated with RFA at 81 days: this pt had recurrent AF at 186 days. At median follow-up of 359 days (341-369), the 1-year K-M estimate for freedom from AF/AFL/AT was 85±5%. In PAF patients treated with the optimized PFA waveform, recurrent AF/AFL/AT was infrequent and appears to be largely related to non-PV triggers. It will be important to determine if the real-world outcomes with this (now commercially available) PFA catheter reflect the trial experience.
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