ORIGINAL RESEARCH article
Front. Cardiovasc. Med.
Sec. Structural Interventional Cardiology
Impact of TriGUARD 3 on Cerebral Protection in Chinese Patients Undergoing Transcatheter Aortic Valve Replacement
Yanbin Li 1
Bin Wang 1
Shichen Zhou 1
Yujie Zhou 2
Mao Chen 3
Jianfang Luo 4
Jianan Wang 5
Jun Jin 6
Xiaoping Peng 7
Jianzeng Dong 8
Zening Jin 9
Yongjun Wang 9
Yaling Han 1
Kai Xu 1
1. Northern Theater Command General Hospital, Shenyang, China
2. Beijing Anzhen Hospital Affiliated to Capital Medical University, Beijing, China
3. West China Hospital of Sichuan University, Chengdu, China
4. Guangdong Provincial People's Hospital, Guangzhou, China
5. The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China
6. Army Medical University Xinqiao Hospital, Chongqing, China
7. The First Affiliated Hospital of Nanchang University, Nanchang, China
8. The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
9. Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, China
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Abstract
Introduction: In China, evidence regarding cerebral embolic protection device (CEPD) use during transcatheter aortic valve replacement (TAVR) for severe aortic stenosis treatment is limited. This study evaluated the TriGUARD 3 (TG3) CEPD performance in patients undergoing TAVR. Methods: Data from two studies were pooled: the CEPD group was derived from a multicenter TG3 trial in China, whereas the control group was obtained from a single-center registry. All participants underwent transfemoral TAVR and completed pre-and postoperative diffusion-weighted magnetic resonance imaging (DW-MRI). The primary outcome was total cerebral ischemic lesion volume on DW-MRI. Results: No significant difference was observed between groups in total lesion volume (CEPD [n =62] vs. control [n = 56]; 256.53 [interquartile range (IQR), 44.12–667.99] vs. 271.88 [IQR, 96.10–650.87]; p=0.456). Median regression analysis in the overall cohort showed no significant association between CEPD use and total lesion volume (p=0.181). Nonetheless, among patients with bicuspid aortic valve (BAV) stenosis, the CEPD group demonstrated significantly lower total lesion volume (165.43 [IQR, 32.96–311.13] vs. 309.38 [IQR, 96.10–788.49]; p=0.025), average lesion volume (61.3 [IQR, 23.44–89.65] vs. 93.75 [IQR, 51.73–137.07]; p=0.019), and maximum single-lesion volume (89.65 [IQR, 28.13–174.02] vs. 164.14 [IQR, 75.00–365.08]; p=0.019). Median regression revealed that CEPD use was significantly associated with reductions in total, average, and maximum single-lesion volumes (median differences: -406.1, -82.2, and -137.6; all p< 0.05), independent of age, sex, hypertension, diabetes, valve type, and pre-dilatation. Conclusion: In patients with severe aortic stenosis undergoing transfemoral TAVR, TG3 CEPD did not significantly reduce the total lesion volume on DW-MRI. In the BAV subgroup, an association was observed between device use and reductions in total, average, and maximum single-lesion volumes. This exploratory finding is hypothesis-generating and should be further elucidated in larger randomized studies.
Summary
Keywords
bicuspid stenosis, cerebral ischemia, Diffusion-weighted imaging, Embolic protection, Neuroprotection, Transcatheter valve replacement
Received
29 August 2025
Accepted
11 February 2026
Copyright
© 2026 Li, Wang, Zhou, Zhou, Chen, Luo, Wang, Jin, Peng, Dong, Jin, Wang, Han and Xu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
*Correspondence: Yaling Han; Kai Xu
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