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Published on: June 3, 2018
[Experience of the use of cerebral embolic protection device during transcatheter aortic valve replacement]
Lan Zhang1,2, Xinmin Liu3, Ziwei Xi4
1Center for Valvular Heart Disease Intervention, Beijing Anzhen Hospital, Capital Medical University, National Clinical Research Center for Cardiovascular Diseases, Beijing 100029, China. zhanglan0621@sina.com.
Insights
The Sentinel cerebral embolic protection device (CEPD) is feasible and safe during transcatheter aortic valve replacement (TAVR), capturing debris in 92.5% of patients. This study confirms its effectiveness across various aortic arch types.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomedical Engineering
Context:
- Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for aortic stenosis.
- Cerebral embolic protection devices (CEPDs) aim to reduce stroke risk during TAVR.
- The Sentinel CEPD is designed to capture embolic debris during TAVR procedures.
Purpose:
- To evaluate the feasibility, efficacy, and safety of the Sentinel cerebral embolic protection device (CEPD) during transcatheter aortic valve replacement (TAVR).
- To assess Sentinel CEPD performance across different aortic arch anatomies.
- To analyze the rate of embolic debris capture and clinical outcomes associated with Sentinel CEPD use in TAVR.
Summary:
- Eighty patients undergoing TAVR with the Sentinel CEPD were analyzed.
- The Sentinel CEPD was successfully deployed in 98.8% of cases, capturing visible debris in 92.5%.
- No significant differences in deployment time were observed across aortic arch types, with low rates of stroke, transient ischemic attack, and vascular complications.
Impact:
- The Sentinel CEPD demonstrates high feasibility and safety in TAVR patients, regardless of aortic arch type.
- The device shows potential efficacy in capturing embolic material during TAVR.
- Findings support the routine use of Sentinel CEPD to mitigate neurological complications in TAVR.
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 (P>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.
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