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

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.