The TriGuard HDH device during TAVR achieved performance success in 64% of patients with no MACCE, and reduced mean cerebral lesion volume vs historical controls (13.8 vs 25.1; P=0.049).
Observational (n=14)
Does the TriGuard HDH embolic deflection device improve safety and reduce cerebral ischemic lesions in patients undergoing TAVR?
The TriGuard HDH embolic deflection device is feasible and safe during TAVR, and may reduce the volume of new cerebral ischemic lesions compared to unprotected TAVR.
OBJECTIVES: This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard™HDH in patients undergoing TAVR. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is associated with a high incidence of new cerebral ischemic lesions. The use of an embolic protection device may reduce the frequency of TAVR-related embolic events. METHODS: This prospective, single arm feasibility pilot study included 14 patients with severe symptomatic aortic stenosis scheduled for TAVR. Cerebral diffusion weighted magnetic resonance imaging (DWI) was planned in all patients one day before and at day 4 (±2) after the procedure. Major adverse cerebral and cardiac events (MACCEs) were recorded for all patients. Primary endpoints of this study were I) device performance success defined as coverage of the aortic arch takeoffs throughout the entire TAVR procedure and II) MACCE occurrence. Secondary endpoints included the number and the volume of new cerebral ischemic lesions on DWI. RESULTS: Thirteen patients underwent transfemoral TAVR and one patient a transapical procedure. Edwards SAPIEN valve prosthesis was implanted in 8 (57%) patients and Medtronic CoreValve prosthesis in the remaining 6 (43%). Predefined performance success of the TriGuard™HDH device was achieved in 9 (64%) patients. The composite endpoint MACCE occurred in none of the patients. Post-procedural DWI was performed in 11 patients. Comparing the DWI of these patients to a historical control group showed no reduction in number median 5.5 vs. 5.0, P = 0.857, however there was a significant reduction in mean lesion volume per patient median 13.8 vs. 25.1, P = 0.049. CONCLUSION: This study showed the feasibility and safety of using the TriGuard™HDH for cerebral protection during TAVR. This device did not decrease the number of post-procedural new cerebral DWI lesions, however its use showed decreased lesion volume as compared to unprotected TAVR. © 2016 Wiley Periodicals, Inc.
Samim et al. (Thu,) conducted a observational in severe symptomatic aortic stenosis (n=14). TriGuard HDH embolic deflection device vs. historical control group was evaluated on device performance success (coverage of aortic arch takeoffs) and MACCE occurrence. The TriGuard HDH device during TAVR achieved performance success in 64% of patients with no MACCE, and reduced mean cerebral lesion volume vs historical controls (13.8 vs 25.1; P=0.049).
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