Abstract：
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.
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.
摘要：
探讨非瓣膜性心房颤动(NVAF)患者应用第二代左心耳封堵术(LAAC)超声封堵术的可行性和安全性。
带有第一代Ultraseal设备的LAAC（Cardia，伊根,明尼苏达州）已被证明是NVAF患者的可行治疗选择。然而,关于新型第二代Ultraseal设备的数据很少。
2018年2月至2020年9月期间接受第二代Ultraseal设备植入的所有NVAF患者均纳入多中心国际注册。通过6个月的随访收集围手术期和出院后事件。共同主要疗效终点是器械成功和技术成功，而主要安全终点是院内主要不良事件（MAE）发生。
共纳入52例患者：平均年龄75±8岁，30.8%为女性，平均HAS-BLED3±1。该装置已成功植入所有患者体内。50例患者（96.1％）获得了技术成功。3例患者发生院内MAEs（5.8%）。6个月全因死亡和大出血发生率分别为11.6%和2.1%,分别。没有中风，短暂性脑缺血发作,全身栓塞,出院后报告或装置栓塞。
第二代Ultraseal器械植入成功率高，围手术期并发症发生率低。需要更大的研究和更长时间的随访，以进一步评估该设备的安全性和有效性。尤其是长期随访。
带有第一代Ultraseal设备的LAAC（Cardia，伊根,明尼苏达州）已被证明是NVAF患者的可行治疗选择。然而,关于新型第二代Ultraseal设备的数据很少。
2018年2月至2020年9月期间接受第二代Ultraseal设备植入的所有NVAF患者均纳入多中心国际注册。通过6个月的随访收集围手术期和出院后事件。共同主要疗效终点是器械成功和技术成功，而主要安全终点是院内主要不良事件（MAE）发生。
共纳入52例患者：平均年龄75±8岁，30.8%为女性，平均HAS-BLED3±1。该装置已成功植入所有患者体内。50例患者（96.1％）获得了技术成功。3例患者发生院内MAEs（5.8%）。6个月全因死亡和大出血发生率分别为11.6%和2.1%,分别。没有中风，短暂性脑缺血发作,全身栓塞,出院后报告或装置栓塞。
第二代Ultraseal器械植入成功率高，围手术期并发症发生率低。需要更大的研究和更长时间的随访，以进一步评估该设备的安全性和有效性。尤其是长期随访。
