REFLECT is a prospective, multi-center, single-arm, global study designed to demonstrate the safety and effectiveness of the TriGuard™ HDH (Phase I) & TriGUARD 3™ (Phase II) Cerebral Embolic Protection Devices during Transcatheter Aortic Valve Replacement (TAVR). To learn more, visit the study information page at www.ClinicalTrials.gov.
The REFLECT Trial Phase II is a multicentre, prospective, Randomized, clinical study designed to assess the safety and Efficacy of cerebral protection from emboli released during Transcatheter Aortic valve Replacement Procedures with the TriGUARD 3™ Cerebral Embolic Protection Device.
Data presented at ACC (March 2015) and EuroPCR (May 2015) demonstrate benefits of Keystone Heart’s TriGuard™ HDH Cerebral Embolic Protection Device during TAVR. Based upon results from the DEFLECT III trial, the CE marked TriGuard™ HDH Cerebral Embolic Protection Device has improved in-hospital safety outcomes and cognitive scores at discharge during Transcatheter Aortic Valve Replacement (TAVR). Based on changes in NIH Stroke Scale, patients protected with the TriGuard™ HDH Cerebral Embolic Protection Device had 10% absolute reduction in stroke (4.9% vs. 14.3%). Minor strokes were under detected without detailed NIHSS assessment.
This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard™ HDH Cerebral Embolic Protection Device in patients undergoing TAVR.
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.
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.
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 Cerebral Embolic Protection 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].
This study showed the feasibility and safety of using the TriGuard™ HDH Cerebral Embolic Protection Device 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.
DEFLECT I clinical data presented at PCR 2013 demonstrated a significant reduction of over 60% of new brain lesion volume during protected TAVR procedures using the TriGuard™ Embolic Deflection Device (EDD), compared with historical data on unprotected TAVR procedures.