Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement.

MedStar author(s):
Citation: Journal of the American College of Cardiology. 69(4):367-377, 2017 Jan 31PMID: 27815101Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Aortic Valve/su [Surgery] | *Intracranial Embolism/pc [Prevention & Control] | *Transcatheter Aortic Valve Replacement/mt [Methods] | Aged | Aged, 80 and over | Cognition | Female | Humans | Magnetic Resonance Imaging | Male | SafetyYear: 2017Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007ISSN:
  • 0735-1097
Name of journal: Journal of the American College of CardiologyAbstract: BACKGROUND: Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP).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).Copyright � 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.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.OBJECTIVES: This study evaluated the safety and efficacy of TCEP during TAVR.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.All authors: Alu MC, Anwaruddin S, Chakravarty T, Dwyer MG, Jilaihawi H, Kapadia SR, Kodali S, Kraemer C, Krishnaswamy A, Lazar RM, Leon MB, Linke A, Makkar R, Mangner N, McCabe JM, Mehran R, Mick S, Nakamura M, Nazif T, Parhizgar A, Satler L, SENTINEL Trial Investigators, Svensson L, Szeto WY, Thourani VH, Virmani R, White RM, Woitek F, Zajarias A, Zivadinov RFiscal year: FY2017Digital Object Identifier: Date added to catalog: 2017-05-06
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 27815101 Available 27815101

Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007

BACKGROUND: Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP).

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).

Copyright � 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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.

OBJECTIVES: This study evaluated the safety and efficacy of TCEP during TAVR.

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.

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