Citation: Journal of the American College of Cardiology. 69(4):367-377, 2017 Jan 31.Journal: Journal of the American College of Cardiology.Published: 2017ISSN: 0735-1097.Full author list: Kapadia SR; Kodali S; Makkar R; Mehran R; Lazar RM; Zivadinov R; Dwyer MG; Jilaihawi H; Virmani R; Anwaruddin S; Thourani VH; Nazif T; Mangner N; Woitek F; Krishnaswamy A; Mick S; Chakravarty T; Nakamura M; McCabe JM; Satler L; Zajarias A; Szeto WY; Svensson L; Alu MC; White RM; Kraemer C; Parhizgar A; Leon MB; Linke A; SENTINEL Trial Investigators.UI/PMID: 27815101.Subject(s): Aged | Aged, 80 and over | *Aortic Valve/su [Surgery] | Cognition | Female | Humans | *Intracranial Embolism/pc [Prevention & Control] | Magnetic Resonance Imaging | Male | Safety | *Transcatheter Aortic Valve Replacement/mt [Methods]Institution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access onlineDigital Object Identifier: https://dx.doi.org/10.1016/j.jacc.2016.10.023https://dx.doi.org/ 10.1016/j.saa.2016.11.024 (Click here) | (Click here)Abbreviated citation: J Am Coll Cardiol. 69(4):367-377, 2017 Jan 31.Local Holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007.Abstract: BACKGROUND: Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP).Abstract: OBJECTIVES: This study evaluated the safety and efficacy of TCEP during TAVR.Abstract: METHODS: Nineteen centers randomized 363 patients undergoing TAVR to a safety arm (n = 123), device imaging (n = 121), and control imaging (n = 119). The primary safety endpoint consisted of major adverse cardiac and cerebrovascular events (MACCE) at 30 days, and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on magnetic resonance imaging scans at 2 to 7 days. Patients underwent neurocognitive assessments, and the debris captured was analyzed.Abstract: RESULTS: The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, p<sub>noninferior</sub> < 0.001) and not statistically different from that of the control group (9.9%; p = 0.41). New lesion volume was 178.0 mm<sup>3</sup> in control subjects and 102.8 mm<sup>3</sup> in the device arm (p = 0.33). A post hoc multivariable analysis identified pre-existing lesion volume and valve type as predictors of new lesion volume. Strokes at 30 days were 9.1% in control subjects and 5.6% in patients with devices (p = 0.25) Neurocognitive function was similar in control subjects and patients with devices, but there was a correlation between lesion volume and neurocognitive decline (p = 0.0022). Debris found within filters in 99% of patients included thrombus, calcification, valve tissue, artery wall, and foreign material.Abstract: CONCLUSIONS: TCEP was safe, captured embolic debris in 99% of patients, and did not change neurocognitive function. Reduction in new lesion volume on magnetic resonance scans was not statistically significant. (Cerebral Protection in Transcatheter Aortic Valve Replacement [SENTINEL]; NCT02214277).Abstract: Copyright � 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.