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Left atrial appendage closure with the II generation Ultraseal device:An international registry. The LIGATE study.

Fecha de publicación: Fecha Ahead of Print:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Pivato, Carlo A.
  • Liccardo, Gaetano
  • Pelloni, Elisa
  • Pujdak, Krzysztof
  • Xuareb, Robert G.
  • Cruz-Gonzalez, Ignacio
  • Pisano, Francesco
  • Scotti, Andrea
  • Tarantini, Giuseppe
  • Cook, Stephane
  • Regazzoli, Damiano
  • Reimers, Bernhard
  • Condorelli, Gianluigi
  • Bragato, Renato Maria
  • Stefanini, Giulio G.
  • Pagnotta, Paolo

Grupos

Abstract

Objectives To assess feasibility and safety of second-generation left atrial appendage closure (LAAC) Ultraseal device in patients with nonvalvular atrial fibrillation (NVAF). Background LAAC with first-generation Ultraseal device (Cardia, Eagan, Minnesota) has been shown to be a feasible therapeutic option in patients with NVAF. However, there is a paucity of data regarding the novel second-generation Ultraseal device. Methods All patients with NVAF undergoing second-generation Ultraseal device implantation between February 2018 and September 2020 were included in a multicenter international registry. Periprocedural and post-discharge events were collected through 6-month follow-up. Co-primary efficacy endpoints were device success and technical success while primary safety endpoint was in-hospital major adverse event (MAE) occurrence. Results A total of 52 patients were included: mean age 75 +/- 8, 30.8% women, mean HAS-BLED 3 +/- 1. The device was successfully implanted in all patients. Technical success was achieved in 50 patients (96.1%). In-hospital MAEs occurred in three patients (5.8%). The incidence of 6-month all-cause death and major bleeding was 11.6% and 2.1%, respectively. No strokes, transient ischemic attacks, systemic embolisms, or device embolization were reported after discharge. Conclusions Second-generation Ultraseal device implantation was associated with high success rates and a low incidence of peri-procedural complications. Larger studies with longer follow-up are warranted to further evaluate the safety and the efficacy of this device, especially at long-term follow-up.

© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.

Datos de la publicación

ISSN/ISSNe:
1522-1946, 1522-726X

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS  John Wiley & Sons Inc.

Tipo:
Article
Páginas:
620-627
Factor de Impacto:
1,088 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 6

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Keywords

  • bleeding; closure; left atrial appendage; stroke

Campos de estudio

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