Portal de investigación
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
- Tipo:
- Article
- Páginas:
- 620-627
- DOI:
- 10.1002/ccd.30336
- PubMed:
- 35842775
- Factor de Impacto:
- 1,088 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS WILEY
Citas Recibidas en Web of Science: 8
Documentos
- No hay documentos
Filiaciones
Keywords
- bleeding; closure; left atrial appendage; stroke
Campos de Estudio
Cita
Pivato CA,Liccardo G,SANZ J,Pelloni E,Pujdak K,Xuareb RG,Cruz I,Pisano F,Scotti A,Tarantini G,Cook S,Regazzoli D,Reimers B,Condorelli G,Bragato RM,Stefanini GG,Pagnotta P. Left atrial appendage closure with the II generation Ultraseal device:An international registry. The LIGATE study. Catheter. Cardiovasc. Interv. 2022. 100. (4):p. 620-627. IF:2,300. (3).