Lesion Durability and Safety Outcomes of Pulsed Field Ablation in >100 Paroxysmal Atrial Fibrillation Patients Vivek Y Reddy, MD 1,2 , Pierre Jais, MD 3 , Ante Anic, MD 4 , Jan Petru, MD 2 , Moritoshi Funasako, MD 2 , Hubert Cochet, MD PhD 2 , Raju Viswanathan, PhD 5 , Christopher Schneider, MS 5 , Charles Eggert, BS 5 , Lucie Sediva, MD 2 , Milan Chovanec, MD 2 , Toni Breskovic, MD 4 , Ivan Sikiric, BS 4 , Jacob Koruth, MD 1 , Srinivas R. Dukkipati, MD 1 and Petr Neuzil, MD PhD 2 1 Icahn School of Medicine at Mount Sinai, New York, NY, USA 2 Homolka Hospital, Prague, Czech Republic, 3 Le CHU de Bordeaux, Bordeaux Univ. & L’Institut de Rythmologie et Modéllation Cardiaque (LIRYC) IHU LIRYC ANR-10-IAHU-04, Equipex MUSIC ANR-11-EQPX-0030 Bordeaux, France, 4 KBC Split, Split, Croatia, 5 FARAPULSE, Inc. KBC SPLIT Klinički bolnički centar Split INTRODUCTION • We previously reported on the acute and 3-month outcomes from a series of paroxysmal AF patients receiving pulsed field ablation (PFA) for pulmonary vein isolation (PVI) • Herein, we present an expanded dataset (>100 pts) with i) prospective invasive re-assessments to assess PVI durability, and ii) safety at one year of follow-up using this novel ablative energy modality RESULTS • 113 patients (age 5711 yrs, 73.4% male, LA dia 4.10.4 cm) were enrolled and treated by 5 operators in 3 centers • The 88 most recent procedures were performed without general anesthesia • All PVs (100%, 439 of 439) in all pts (100%, 113 of 113) were isolated successfully using only the PFA catheters, including 15 left common PVs • Procedures required 33.815.1 min of LA dwell time METHODS • Pts were enrolled to one of three multicenter clinical trials - IMPULSE, PEFCAT or PEFCAT II - to undergo PVI using PFA waveforms, either monophasic or biphasic, with a PFA basket/flower catheter (Farawave, Farapulse, Inc.) • All study protocols included invasive remapping at 75-90 days • Pts were monitored for the study duration of the 1 year • Various safety assessments were performed to characterize the effect of PFA on extracardiac structures • PFA is a novel modality that employs an electric field to selectively ablate myocardium while sparing collateral tissue PFA catheter & Electric field Follow up in this cohort, including 51 pts reaching the 1-year timepoint, identified no other unexpected safety issues. Esophageal Safety 38 pts: post-procedure EGD revealed no evidence of esophageal lesions 18 pts: LGE-MR imaging demonstrated esophageal sparing immediately adjacent to sites of atrial enhancement - ie, ablation • Primary safety event rate was 1.8% (1 pericardial tamponade, 1 groin hematoma) - other prospective safety assessments included: Brain Safety 13 pts: Cerebral MRI (including both FLAIR and DWI) revealed no post-procedure ischemia or lesions PV Safety 60 pts: Repeat CT or MRI at 10342 days revealed no PV stenosis Prospective Remap Procedures 92 pts underwent a protocol-specified, prospective remap procedure at 9230 days • PV isolation was durable in 98% (100 of 102) of PVs with the optimized waveform, translating to all veins durably isolated in 92.3% (24 of 26) of patients CONCLUSIONS In a large cohort of patients treated by multiple operators, PFA using this basket/flower catheter has demonstrated i) an excellent safety profile with no unexpected safety issues over a full year of follow-up, and ii) a very high rate of durable PV isolation. Spared esophagus (LGE MRI) Left common PVs isolated using the PFA catheter Disclosures: Farapulse: J.K., P.N., P.J., - Research Grants and Consultant. V.R. – Consultant/stock., A.A. - Consultant, C.E., R.V., C.S. - Employee. J.P., M.F., H.C., L.S., M.C., T.B., I.S., S.D. - none.