%0 Journal Article
%T Left atrial appendage closure with the II generation Ultraseal device: An international registry. The LIGATE study.
%A Pivato CA
%A Liccardo G
%A Sanz-Sanchez J
%A Pelloni E
%A Pujdak K
%A Xuareb RG
%A Cruz-Gonzalez I
%A Pisano F
%A Scotti A
%A Tarantini G
%A Cook S
%A Regazzoli D
%A Reimers B
%A Condorelli G
%A Bragato RM
%A Stefanini GG
%A Pagnotta P
%J Catheter Cardiovasc Interv
%V 100
%N 4
%D 10 2022
%M 35842775
%F 2.585
%R 10.1002/ccd.30336
%X To assess feasibility and safety of second-generation left atrial appendage closure (LAAC) Ultraseal device in patients with nonvalvular atrial fibrillation (NVAF).
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.
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.
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.
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.