Lesion Durability and Safety Outcomes of Pulsed Field Ablation in >100 Paroxysmal Atrial Fibrillation Patients

Vivek Y Reddy, MD1,2, Pierre Jais, MD3, Ante Anic, MD4, Jan Petru, MD2, Moritoshi Funasako, MD2, Hubert Cochet, MD PhD2, Raju Viswanathan, PhD5,

Christopher Schneider, MS5, Charles Eggert, BS5, Lucie Sediva, MD2, Milan Chovanec, MD2, Toni Breskovic, MD4, Ivan Sikiric, BS4, Jacob Koruth, MD1,

Srinivas R. Dukkipati, MD1 and Petr Neuzil, MD PhD2

1Icahn School of Medicine at Mount Sinai, New York, NY, USA 2Homolka Hospital, Prague, Czech Republic, 3Le 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, 4KBC Split, Split, Croatia, 5FARAPULSE, 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 57�11 yrs, 73.4% male, LA dia 4.1�0.4 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 33.8�15.1 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 103�42 days

revealed no PV stenosis

Prospective Remap Procedures

92 pts underwent a protocol-specified, prospective remap

procedure at 92�30 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 multipleoperators, PFA using this basket/flower catheter hasdemonstrated i) an excellent safety profile with nounexpected 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.