Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study.

Fecha de publicación: Fecha Ahead of Print:

Autores de IDIVAL

Autores ajenos al IDIVAL

  • Ekanem E
  • Neuzil P
  • Reichlin T
  • Kautzner J
  • van der Voort P
  • Jais P
  • Chierchia GB
  • Bulava A
  • Blaauw Y
  • Skala T
  • Fiala M
  • Duytschaever M
  • Szeplaki G
  • Schmidt B
  • Massoullie G
  • Neven K
  • Thomas O
  • Vijgen J
  • Gandjbakhch E
  • Scherr D
  • Johannessen A
  • Keane D
  • Boveda S
  • Maury P
  • García-Bolao I
  • Anic A
  • Hansen PS
  • Raczka F
  • Lepillier A
  • Guyomar Y
  • Gupta D
  • Van Opstal J
  • Defaye P
  • Sticherling C
  • Sommer P
  • Kucera P
  • Osca J
  • Tabrizi F
  • Roux A
  • Gramlich M
  • Bianchi S
  • Adragão P
  • Solimene F
  • Tondo C
  • Russo AD
  • Schreieck J
  • Luik A
  • Rana O
  • Frommeyer G
  • Anselme F
  • Kreis I
  • Rosso R
  • Metzner A
  • Geller L
  • Baldinger SH
  • Ferrero A
  • Willems S
  • Goette A
  • Mellor G
  • Mathew S
  • Szumowski L
  • Tilz R
  • Iacopino S
  • Jacobsen PK
  • George A
  • Osmancik P
  • Spitzer S
  • Balasubramaniam R
  • Parwani AS
  • Deneke T
  • Glowniak A
  • Rossillo A
  • Pürerfellner H
  • Duncker D
  • Reil P
  • Arentz T
  • Steven D
  • de Jong JSSG
  • Wakili R
  • Abbey S
  • Timo G
  • Asso A
  • Wong T
  • Pierre B
  • Ewertsen NC
  • Bergau L
  • Lozano-Granero C
  • Rivero M
  • Breitenstein A
  • Inkovaara J
  • Fareh S
  • Latcu DG
  • Linz D
  • Müller P
  • Ramos-Maqueda J
  • Beiert T
  • Themistoclakis S
  • Meininghaus DG
  • Stix G
  • Tzeis S
  • Baran J
  • Almroth H
  • Munoz DR
  • de Sousa J
  • Efremidis M
  • Balsam P
  • Petru J
  • Küffer T
  • Peichl P
  • Dekker L
  • Della Rocca DG
  • Moravec O
  • Funasako M
  • Knecht S
  • Jauvert G
  • Chun J
  • Eschalier R
  • Füting A
  • Zhao A
  • Koopman P
  • Laredo M
  • Manninger M
  • Hansen J
  • O'Hare D
  • Rollin A
  • Jurisic Z
  • Fink T
  • Chaumont C
  • Rillig A
  • Gunawerdene M
  • Martin C
  • Kirstein B
  • Nentwich K
  • Lehrmann H
  • Sultan A
  • Bohnen J
  • Turagam MK
  • Reddy VY

Abstract

Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

© 2024. The Author(s).

Datos de la publicación

ISSN/ISSNe:
1078-8956, 1546-170X

NATURE MEDICINE  NATURE PUBLISHING GROUP

Tipo:
Article
Páginas:
2020-2029
PubMed:
38977913

Citas Recibidas en Web of Science: 2

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