Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement.
BACKGROUND
Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP).


OBJECTIVE
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%, pnoninferior< 0.001) and not statistically different from that of the control group (9.9%; p = 0.41). New lesion volume was 178.0 mm3in control subjects and 102.8 mm3in 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).
Cleveland Clinic, Cleveland, Ohio. Electronic address: kapadis@ccf.org.
Samir R
SR
Kapadia
Columbia University Medical Center, New York, New York.
Susheel
S
Kodali
Cedars-Sinai Medical Center, Los Angeles, California.
Raj
R
Makkar
Mount Sinai School of Medicine, New York, New York.
Roxana
R
Mehran
Columbia University Medical Center, New York, New York.
Ronald M
RM
Lazar
Buffalo Neuroimaging Analysis Center, Buffalo, New York.
Robert
R
Zivadinov
Buffalo Neuroimaging Analysis Center, Buffalo, New York.
Michael G
MG
Dwyer
NYU Langone Medical Center, New York, New York.
Hasan
H
Jilaihawi
CV Path Institute, Gaithersburg, Maryland.
Renu
R
Virmani
University of Pennsylvania, Philadelphia, Pennsylvania.
Saif
S
Anwaruddin
Emory University, Atlanta, Georgia.
Vinod H
VH
Thourani
Columbia University Medical Center, New York, New York.
Tamim
T
Nazif
Herzzentrum Leipzig GmbH-Universitätsklinik, Leipzig, Germany.
Norman
N
Mangner
Herzzentrum Leipzig GmbH-Universitätsklinik, Leipzig, Germany.
Felix
F
Woitek
Cleveland Clinic, Cleveland, Ohio.
Amar
A
Krishnaswamy
Cleveland Clinic, Cleveland, Ohio.
Stephanie
S
Mick
Cedars-Sinai Medical Center, Los Angeles, California.
Tarun
T
Chakravarty
Cedars-Sinai Medical Center, Los Angeles, California.
Mamoo
M
Nakamura
University of Washington, Seattle, Washington.
James M
JM
McCabe
Medstar Washington Hospital Center, Washington, DC.
Lowell
L
Satler
Washington University School of Medicine, St. Louis, Missouri.
Alan
A
Zajarias
University of Pennsylvania, Philadelphia, Pennsylvania.
Wilson Y
WY
Szeto
Cleveland Clinic, Cleveland, Ohio.
Lars
L
Svensson
Columbia University Medical Center, New York, New York.
Maria C
MC
Alu
Duke Clinical Research Institute, Durham, North Carolina.
Roseann M
RM
White
NAMSA, Minneapolis, Minnesota.
Carlye
C
Kraemer
Claret Medical, Inc., Santa Rosa, California.
Azin
A
Parhizgar
Columbia University Medical Center, New York, New York.
Martin B
MB
Leon
Herzzentrum Leipzig GmbH-Universitätsklinik, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.
Axel
A
Linke
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D003071:Cognition; D005260:Female; D006801:Humans; D020766:Intracranial Embolism / Q000517:prevention & control*; D008279:Magnetic Resonance Imaging; D008297:Male; D012449:Safety; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome
cerebral embolic protection; neuroimaging; stroke; transcatheter aortic valve replacement