[经导管主动脉瓣置换术中使用脑栓塞保护装置的经验]
[Experience of the use of cerebral embolic protection device during transcatheter aortic valve replacement].
作者信息
Zhang Lan, Liu Xinmin, Xi Ziwei, Yuan Fei, Yao Jing, Jiang Zhengming, Yan Yunfeng, Song Guangyuan
机构信息
Center for Valvular Heart Disease Intervention, Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Beijing 100029, China.
Department of Cardiovascular Medicine, Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou 450007, China.
出版信息
Zhejiang Da Xue Xue Bao Yi Xue Ban. 2025 Jul 22;54(4):541-548. doi: 10.3724/zdxbyxb-2024-0532.
OBJECTIVES
To evaluate the feasibility, efficacy and safety of Sentinel cerebral embolic protection device (CEPD) during transcatheter aortic valve replacement (TAVR). This study is a subgroup analysis of the China Moderate to Severe Valvular Heart Disease Registry, which has been registered at the Chinese Clinical Trial Registry (ChiCTR2300075006).
METHODS
Patients undergoing TAVR with the Sentinel CEPD from October 2023 to September 2024 were retrospectively enrolled. A total of 80 patients were included, with a median age of 72 (68, 76) years, including 52 males (65.0%) and 28 females (35.0%); 62 patients (77.5%) with tricuspid valves, and 18 patients (22.5%) with bicuspid valves; 34 patients (42.5%) with type Ⅰ aortic arch, 24 patients (30.0%) with type Ⅱ aortic arch, 12 patients (15.0%) with type Ⅲ aortic arch, and 10 patients (12.5%) with bovine-type aortic arch. Clinical data of the patients were summarized and analyzed. The primary endpoints were success rate of Sentinel CEPD implantation, as well as all-cause death, symptomatic stroke, transient ischemic attack, and Sentinel CEPD access vessel complications during hospitalization and within 30 days postoperatively.
RESULTS
In the 80 patients, self-expanding valves were used in 68 cases (85.0%) and balloon-expandable valves in 12 cases (15.0%). Seventy-nine patients (98.8%) successfully underwent TAVR with Sentinel CEPD deployment. Macroscopically visible debris was captured in 92.5% (74/80) by filters of Sentinel CEPD. Although the procedure time for Sentinel CEPD placement was slightly longer in patients with bovine-type aortic arch, there was no statistically significant difference in deployment time among different aortic arch types (>0.05). During hospitalization and within 30 days postoperatively, only one case of transient ischemic attack occurred, and there was no all-cause mortality, symptomatic stroke, or access-site vascular complications related to the Sentinel CEPD observed.
CONCLUSIONS
The Sentinel CEPD demonstrates high feasibility across aortic arch types, potential efficacy in embolic capture, and excellent safety in TAVR.
目的
评估经导管主动脉瓣置换术（TAVR）期间使用Sentinel脑栓塞保护装置（CEPD）的可行性、有效性和安全性。本研究是中国中重度瓣膜性心脏病注册研究的亚组分析，该研究已在中国临床试验注册中心注册（注册号：ChiCTR2300075006）。
方法
回顾性纳入2023年10月至2024年9月期间接受使用Sentinel CEPD的TAVR患者。共纳入80例患者，中位年龄为72（68，76）岁，其中男性52例（65.0%），女性28例（35.0%）；62例（77.5%）为三尖瓣，18例（22.5%）为二尖瓣；34例（42.5%）为Ⅰ型主动脉弓，24例（30.0%）为Ⅱ型主动脉弓，12例（15.0%）为Ⅲ型主动脉弓及10例（12.5%）为牛型主动脉弓。总结并分析患者的临床资料。主要终点为Sentinel CEPD植入成功率，以及住院期间和术后30天内的全因死亡、症状性卒中、短暂性脑缺血发作和Sentinel CEPD入路血管并发症。
结果
80例患者中，68例（85.0%）使用了自膨胀瓣膜，12例（15.0%）使用了球囊扩张瓣膜。79例（98.8%）患者成功接受了使用Sentinel CEPD的TAVR。Sentinel CEPD过滤器在92.5%（74/80）的患者中捕获到肉眼可见的碎片。虽然牛型主动脉弓患者的Sentinel CEPD放置操作时间略长，但不同主动脉弓类型之间的放置时间差异无统计学意义（>0.05）。在住院期间和术后30天内，仅发生1例短暂性脑缺血发作，未观察到与Sentinel CEPD相关的全因死亡、症状性卒中和入路部位血管并发症。
结论
Sentinel CEPD在不同主动脉弓类型中均显示出高可行性、在栓塞捕获方面具有潜在有效性以及在TAVR中具有出色的安全性。
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