Experience of the use of Sentinel cerebral embolic protection device during transcatheter aortic valve replacement.

Abstract

Objectives: To evaluate the feasibility, efficacy and safety of the Sentinel Cerebral Embolic Protection Device (CEPD) during transcatheter aortic valve replacement (TAVR). This study is a subgroup analysis of the Chinese Registry of moderate to severe valvular heart disease (CREDIT), 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 (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. 98.8% (79/80) successful CEPD deployment. Macroscopically visible debris was captured in 93.8% (75/80) by filters of Sentinel CEPD. Although the procedure time for Sentinel CEPD placement was slightly longer in patients with bovine 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, 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.