Faculty Collaboration Database

Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2017 Jan 31;69(4):367-377

Date

11/07/2016

Pubmed ID

27815101

DOI

10.1016/j.jacc.2016.10.023

Scopus ID

2-s2.0-85010433084 (requires institutional sign-in at Scopus site)   379 Citations

Abstract

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

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

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.

RESULTS: The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, p_noninferior < 0.001) and not statistically different from that of the control group (9.9%; p = 0.41). New lesion volume was 178.0 mm³ in control subjects and 102.8 mm³ 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.

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).

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

Author

Saif Anwaruddin MD Associate Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Aged
Aged, 80 and over
Aortic Valve
Cognition
Female
Humans
Intracranial Embolism
Magnetic Resonance Imaging
Male
Safety
Transcatheter Aortic Valve Replacement
Treatment Outcome