Data Sheet 1_Impact of TriGUARD 3 on cerebral protection in Chinese patients undergoing transcatheter aortic valve replacement.docx

IntroductionIn 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.
MethodsData 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.
ResultsNo 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.
ConclusionIn 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.