lesion durability and safety outcomes of pulsed field ... · basket/flower catheter (farawave,...
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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.