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Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation.
Reddy, Vivek Y; Gerstenfeld, Edward P; Natale, Andrea; Whang, William; Cuoco, Frank A; Patel, Chinmay; Mountantonakis, Stavros E; Gibson, Douglas N; Harding, John D; Ellis, Christopher R; Ellenbogen, Kenneth A; DeLurgio, David B; Osorio, Jose; Achyutha, Anitha B; Schneider, Christopher W; Mugglin, Andrew S; Albrecht, Elizabeth M; Stein, Kenneth M; Lehmann, John W; Mansour, Moussa.
Affiliation
  • Reddy VY; 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 Dieg
  • Gerstenfeld EP; 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 Dieg
  • Natale A; 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 Dieg
  • Whang W; 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 Dieg
  • Cuoco FA; 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 Dieg
  • Patel C; 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 Dieg
  • Mountantonakis SE; 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 Dieg
  • Gibson DN; 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 Dieg
  • Harding JD; 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 Dieg
  • Ellis CR; 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 Dieg
  • Ellenbogen KA; 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 Dieg
  • DeLurgio DB; 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 Dieg
  • Osorio J; 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 Dieg
  • Achyutha AB; 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 Dieg
  • Schneider CW; 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 Dieg
  • Mugglin AS; 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 Dieg
  • Albrecht EM; 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 Dieg
  • Stein KM; 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 Dieg
  • Lehmann JW; 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 Dieg
  • Mansour M; 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 Dieg
N Engl J Med ; 389(18): 1660-1671, 2023 Nov 02.
Article in En | MEDLINE | ID: mdl-37634148
ABSTRACT

BACKGROUND:

Catheter-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.

METHODS:

In this randomized, single-blind, noninferiority trial, we assigned patients with drug-refractory paroxysmal atrial fibrillation in a 11 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.

RESULTS:

A 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).

CONCLUSIONS:

Among 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.).
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pulmonary Veins / Atrial Fibrillation / Catheter Ablation Type of study: Clinical_trials Limits: Humans Language: En Journal: N Engl J Med Year: 2023 Document type: Article
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Pulmonary Veins / Atrial Fibrillation / Catheter Ablation Type of study: Clinical_trials Limits: Humans Language: En Journal: N Engl J Med Year: 2023 Document type: Article