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

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.

A new frontier in left atrial appendage closure

“…One device-related perforation and one severe leak were noted, with total procedural success achieved in 94%. 4 These success rates compare favorably to the firstgeneration device reported by Asmarts et al, 3 as well as to other LAAC devices. In-hospital major adverse events (MAEs) occurred in 6%, including major bleeding in two patients and a minor stroke in one patient.…”

“…The sail covering polyester layer is now on the luminal surface of the device and the articulating joint has a lesser degree of movement to aid in deployment and retrieval. 4 According to this multicenter, retrospective, single-arm study, device and technical success was observed in 100% and 96% of patients, respectively. One device-related perforation and one severe leak were noted, with total procedural success achieved in 94%.…”

“…Notably, 43 of the 52 patients received echocardiographic follow-up, 9 of whom were | 929 evaluated with a TTE which makes it challenging to definitively exclude residual peri-device leaks or device-related thrombosis. 4 There was also no core lab involved, the procedures were reported voluntarily, and the events were not adjudicated by an independent committee. Finally, there was significant institutional variability among centers with regard to procedural characteristics and antithrombotic management.…”

“…3 In this issue of Catheterization and Cardiovascular Interventions, Pivato et al have analyzed the feasibility and safety of the second generation Ultraseal device in 52 consecutive patients with NVAF. 4 Compared to the first-generation device, the second-generation Ultraseal has updates including removal of the distal center port from the bulb, decrease in the overall length of the device, and modification of the sail covering. Removal of the distal center port from the bulb allows for more flexibility and a lower radial force, reducing the need for oversizing and providing for a safer deep implant.…”

Transcatheter Left Atrial Appendage Closure: Devices Available, Pitfalls, Advantages, and Future Directions

“…In a multicenter international registry including seven European centers and 52 patients undergoing second-generation Ultraseal device implantation, technical success was achieved in 96.1% patients. 7 The primary safety outcome of in-hospital major adverse events, defined as a composite of all-cause death, stroke or transient ischemic attack, systemic embolism, major bleeding, MI, major vascular complication, or device embolization, was found in 5.8% of patients. In the study, 34 patients underwent follow-up TEE at a median duration of 61 days; 2.9% patient had a peri-device leak >5 mm and no patients had a device-related thrombus (DRT).…”