Llagostera-Martín Marc, Cubero-Gallego Hector, Mas-Stachurska Aleksandra, Salvatella Neus, Sánchez-Carpintero Andrea, Tizon-Marcos Helena, Garcia-Guimaraes Marcos, Calvo-Fernandez Alicia, Molina Luis, Vaquerizo Beatriz
Interventional Cardiology Unit, Cardiology Department, Hospital del Mar, 08003 Barcelona, Spain.
Heart Diseases Biomedical Research Group (GREC), Hospital del Mar Medical Investigation Institute-IMIM, 08003 Barcelona, Spain.
J Clin Med. 2021 Apr 1;10(7):1421. doi: 10.3390/jcm10071421.
The LAmbre device is a novel system designed for left atrial appendage closure (LAAC). First registries showed a high rate of device implantation success. However, few mid-term results are available. We present our 1- and 12-month follow-up results for this device. This prospective, single-center registry included consecutive patients with nonvalvular atrial fibrillation who underwent LAAC with the LAmbre device. Transesophageal echocardiography (TEE) was performed at 1-month follow-up. In total, 55 patients were included. The population was elderly (75 ± 9.4 years), with a high proportion of comorbidities. The mean CHADS-VASc and HAS-BLED scores were 4.6 ± 1.6 and 3.9 ± 1.0, respectively. Previous history of a major bleeding event was present in 37 patients (67.3%). Procedural success was achieved in 54 patients (98.2%). Device success was achieved in 100% of patients in whom device implantation was attempted (54 patients). Major in-hospital device-related complications included mortality of one patient (1.8%) and pericardial tamponade in two patients (3.6%); the incidence of stroke was 0%. No thrombus or significant leaks (≥5 mm) were observed on 1-month TEE. At 12 months, adverse events were overall death (1.8%), transient ischemic attack/ischemic stroke (1.8%), and major bleeding events (Bleeding Academic Research Consortium (BARC) 3a and 3c; 11%). In this high-risk population, the LAmbre device seems to be a safe and effective option for LAAC with a remarkable mid-term performance.
LAmbre装置是一种专为左心耳封堵（LAAC）设计的新型系统。首批注册研究显示该装置植入成功率很高。然而，中期结果较少。我们展示了该装置1个月和12个月的随访结果。这项前瞻性单中心注册研究纳入了连续接受LAmbre装置LAAC治疗的非瓣膜性房颤患者。在1个月随访时进行经食管超声心动图（TEE）检查。总共纳入了55例患者。患者群体年龄较大（75±9.4岁），合并症比例较高。CHADS-VASc和HAS-BLED评分的平均值分别为4.6±1.6和3.9±1.0。37例患者（67.3%）有重大出血事件既往史。54例患者（98.2%）手术成功。在尝试植入装置的患者（54例）中，装置成功率达到100%。主要的院内装置相关并发症包括1例患者死亡（1.8%）和2例患者发生心包填塞（3.6%）；卒中发生率为0%。1个月TEE检查未观察到血栓或显著渗漏（≥5mm）。在12个月时，不良事件包括全因死亡（1.8%）、短暂性脑缺血发作/缺血性卒中（1.8%）和重大出血事件（出血学术研究联盟（BARC）3a和3c级；11%）。在这个高危人群中，LAmbre装置似乎是LAAC的一种安全有效的选择，中期表现出色。
