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Published on: June 3, 2018
Impact of TriGUARD 3 on cerebral protection in Chinese patients undergoing transcatheter aortic valve replacement
Yanbin Li1,2, Bin Wang1, Shichen Zhou1
1The State Key Laboratory of Frigid Zone Cardiovascular Diseases, Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China.
Insights
Cerebral embolic protection devices (CEPD) did not significantly reduce overall stroke lesions during TAVR. However, the TriGUARD 3 CEPD showed potential benefits in reducing lesions for patients with bicuspid aortic valve stenosis.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Medical Devices
Background:
- Severe aortic stenosis necessitates transcatheter aortic valve replacement (TAVR).
- Cerebral embolic protection devices (CEPD) aim to reduce stroke risk during TAVR.
- Limited data exists on CEPD use in China for TAVR procedures.
Purpose of the Study:
- To evaluate the performance of the TriGUARD 3 (TG3) cerebral embolic protection device (CEPD).
- To assess the impact of TG3 CEPD on cerebral ischemic lesion volume in patients undergoing TAVR in China.
Main Methods:
- Pooled data from a multicenter TG3 trial and a single-center registry.
- Comparison of CEPD group (n=62) with a control group (n=56).
- Pre- and postoperative diffusion-weighted magnetic resonance imaging (DW-MRI) to quantify total cerebral ischemic lesion volume.
Main Results:
- No significant difference in total lesion volume between the CEPD and control groups (p=0.456).
- In the bicuspid aortic valve (BAV) subgroup, TG3 CEPD use was associated with significantly lower total, average, and maximum single-lesion volumes (p<0.05).
- Median regression confirmed CEPD use was independently associated with reduced lesion volumes in the BAV subgroup.
Conclusions:
- TG3 CEPD did not significantly reduce total cerebral lesion volume in the overall TAVR cohort.
- An exploratory finding suggests TG3 CEPD may reduce cerebral lesions in patients with BAV stenosis.
- Further large-scale randomized studies are warranted to confirm these findings.
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.
