• Vivek Y Reddy, Edward P Gerstenfeld, Andrea Natale, William Whang, Frank A Cuoco, Chinmay Patel, Stavros E Mountantonakis, Douglas N Gibson, John D Harding, Christopher R Ellis, Kenneth A Ellenbogen, David B DeLurgio, Jose Osorio, Anitha B Achyutha, Christopher W Schneider, Andrew S Mugglin, Elizabeth M Albrecht, Kenneth M Stein, John W Lehmann, Moussa Mansour, and ADVENT Investigators.
• From the Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai (V.Y.R., W.W.), and Lenox Hill Hospital, Northwell Health (S.E.M.) - both in New York; the University of California, San Francisco, San Francisco (E.P.G.), Scripps Clinic and Prebys Cardiovascular Institute, San Diego (D.N.G.), and Boston Scientific, Menlo Park (A.B.A., C.W.S.) - all in California; Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin (A.N.); Case Western Reserve University, Cleveland (A.N.); Trident Medical Center, Charleston, SC (F.A.C.); University of Pittsburgh Medical Center Pinnacle, Harrisburg (C.P.), and Doylestown Hospital, Doylestown (J.D.H.) - both in Pennsylvania; Vanderbilt University Medical Center, Nashville (C.R.E.); Virginia Commonwealth University, Richmond (K.A.E.); Emory University Hospital, Atlanta (D.B.D.); Grandview Medical Center, Birmingham, AL (J.O.); Paradigm Biostatistics, Anoka (A.S.M.), and Boston Scientific, St. Paul (E.M.A., K.M.S.) - both in Minnesota; Lehmann Consulting, Naples, FL (J.W.L.); and Massachusetts General Hospital, Boston (M.M.).
• N. Engl. J. Med. 2023 Nov 2; 389 (18): 166016711660-1671.

BackgroundCatheter-based pulmonary vein isolation is an effective treatment for paroxysmal atrial fibrillation. Pulsed field ablation, which delivers microsecond high-voltage electrical fields, may limit damage to tissues outside the myocardium. The efficacy and safety of pulsed field ablation as compared with conventional thermal ablation are not known.MethodsIn this randomized, single-blind, noninferiority trial, we assigned patients with drug-refractory paroxysmal atrial fibrillation in a 1:1 ratio to undergo pulsed field ablation or conventional radiofrequency or cryoballoon ablation. The primary efficacy end point was freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion, or repeat ablation. The primary safety end point included acute and chronic device- and procedure-related serious adverse events.ResultsA total of 305 patients were assigned to undergo pulsed field ablation, and 302 were assigned to undergo thermal ablation. At 1 year, the primary efficacy end point was met (i.e., no events occurred) in 204 patients (estimated probability, 73.3%) who underwent pulsed field ablation and 194 patients (estimated probability, 71.3%) who underwent thermal ablation (between-group difference, 2.0 percentage points; 95% Bayesian credible interval, -5.2 to 9.2; posterior probability of noninferiority, >0.999). Primary safety end-point events occurred in 6 patients (estimated incidence, 2.1%) who underwent pulsed field ablation and 4 patients (estimated incidence, 1.5%) who underwent thermal ablation (between-group difference, 0.6 percentage points; 95% Bayesian credible interval, -1.5 to 2.8; posterior probability of noninferiority, >0.999).ConclusionsAmong patients with paroxysmal atrial fibrillation receiving a catheter-based therapy, pulsed field ablation was noninferior to conventional thermal ablation with respect to freedom from a composite of initial procedural failure, documented atrial tachyarrhythmia after a 3-month blanking period, antiarrhythmic drug use, cardioversion, or repeat ablation and with respect to device- and procedure-related serious adverse events at 1 year. (Funded by Farapulse-Boston Scientific; ADVENT ClinicalTrials.gov number, NCT04612244.).Copyright © 2023 Massachusetts Medical Society.

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