TriGuard Device for Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement: A Multicenter Real-World Experience Masieh Abawi, Ermela.

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TriGuard Device for Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement: A Multicenter Real-World Experience Masieh Abawi, Ermela Yzeiraj; Adriaan Kraaijeveld,; Michiel Voskuil,; Pieter A. Doevendans; Joachim Schofer; Pieter R. Stella Consecutive patients with aortic stenosis scheduled for TAVR and suitable anatomy for TriGuard, were included in this prospective 2 center study Successful device performance was defined as I) Accessing the aortic arch with delivery catheter; II) Deployment of the TriGuard filter unit from the delivery catheter into the aortic arch; III) Positioning the TriGuard to cover the cerebral vessels (as verified by angiography) without obstruction of the blood flow and interference with TAVR procedure; IV) Retrieving and removing the TriGuard system intact

RESULTS TriGuard was implanted in 51 patients (80± 8 years, 51% male, logistic EuroSCORE 12.6±8.3) with either transfemoral (96%) or transapical (4%) approach. Pre-TAVR balloon dilatation was performed in 67%, post-TAVR dilatation in 18%. Successful device performance was 100% without interference with TAVR procedure. Disabling and all stroke rate was 0%

DW-MRI Results in Patients With and Without TriGuard Cerebral Embolic Protection During TAVI Ermela Yzeiraj, Klaudija Bijuklic, Timo Haselbach, Julian Witt, Korff Krause, Lorenz Hansen, Friedrich-Christian Riess, Joachim Schofer 10 patients received TAVI under cerebral embolic protection with the TriGuard device. Control patients from the same site where 150 patients who underwent TAVI without cerebral embolic protection. All patients were treated with a balloon expandable valve and underwent DW-MRI 3-5 days after the procedure. Cerebral DW-MRI were analysed by a blinded physician to assess incidence, number and volume of new CI.

Baseline Clinical Characteristics Variables No TG (n = 150) TG (n = 10) p Value Age, mean ± SD 83 ± 6 83.5 ± 5 0.738 Male sex, n (%) 69 (46) 8 (80) 0.050 Logistic EuroSCORE , mean ± SD 21.25± 13 23.8 ± 14.8 0.582 Hypertension, n (%) 127 (85) 10 (100) 0.360 Dyslipidemia, n (%) 78 (52) 6 (60) 0.751 Diabetes Mellitus, n (%) 33 (22) 0 (0) 0.123 Coronary artery disease, n (%) 91 (61) 0.322 Carotid artery disease, n (%) 30 (20) 0.005 Previous Stroke, n (%) 23 (15) 2 (20) 0.661 Atrial fibrillation, n (%) 48 (32) 0.506 COPD, n (%) 24 (16) 4 (40) 0.079 Chronic kidney disease, n (%) 63 (42) 0.194

% of patients with new lesions ~ RESULTS ~ TriGuard protected Variables No TG (n = 150) Median (IQR) Mean (SD) TG (n = 10) P value # of lesions 1 (0-3) 2.1 (0.2) 0 (0-0.75) 0.6 (0.4) 0.06 Total Lesion Volume (TLV) 119 (-298) 206 (23) 0 (0-31) 44 (32) 0.08 Single lesion volume (SLV) 63 (0-106) 74 (8) 0 (0-10) 15 (11) 0.05 Control unprotected P=0.004 68% 20% % of patients with new lesions

safe and effective TriGuard device is with a high performance success without interference with TAVR procedure and with 0% stroke rate