TriGuard™HDH embolic deflection device for cerebral protection during transcatheter aortic valve replacement.
OBJECTIVE
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].


CONCLUSIONS
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.
Department of Cardiology, University Medical Centre Utrecht, the Netherlands.
Mariam
M
Samim
Department of Neurology, University Medical Centre Utrecht, the Netherlands.
Bart
B
van der Worp
Department of Cardiology, University Medical Centre Utrecht, the Netherlands.
Pierfrancesco
P
Agostoni
Department of Radiology, University Medical Centre Utrecht, the Netherlands.
Jeroen
J
Hendrikse
Department of Radiology, Erasmus University Medical Centre, Rotterdam, the Netherlands.
Ricardo P J
RP
Budde
Department of Cardiology, University Medical Centre Utrecht, the Netherlands.
Freek
F
Nijhoff
Department of Thoracic Surgery, University Medical Centre Utrecht, the Netherlands.
Faiz
F
Ramjankhan
Department of Cardiology, University Medical Centre Utrecht, the Netherlands.
Pieter A
PA
Doevendans
Department of Cardiology, University Medical Centre Utrecht, the Netherlands.
Pieter R
PR
Stella
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D038524:Diffusion Magnetic Resonance Imaging; D057505:Embolic Protection Devices; D005240:Feasibility Studies; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D065386:Historically Controlled Study; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D009426:Netherlands; D010865:Pilot Projects; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
TriGuard embolic deflector system; aortic valve stenosis; cerebral embolic protection device; cerebral ischemic injury; intracranial embolism; transcatheter aortic valve replacement