Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement

Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). This study evaluated the safety and efficacy of TCEP during TAVR. Nineteen centers randomized 363 patients undergoing TAVR to a safety arm (n = 123), d...

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Published in:	Journal of the American College of Cardiology Vol. 69; no. 4; p. 367
Main Authors:	Kapadia, Samir R, Kodali, Susheel, Makkar, Raj, Mehran, Roxana, Lazar, Ronald M, Zivadinov, Robert, Dwyer, Michael G, Jilaihawi, Hasan, Virmani, Renu, Anwaruddin, Saif, Thourani, Vinod H, Nazif, Tamim, Mangner, Norman, Woitek, Felix, Krishnaswamy, Amar, Mick, Stephanie, Chakravarty, Tarun, Nakamura, Mamoo, McCabe, James M, Satler, Lowell, Zajarias, Alan, Szeto, Wilson Y, Svensson, Lars, Alu, Maria C, White, Roseann M, Kraemer, Carlye, Parhizgar, Azin, Leon, Martin B, Linke, Axel
Format:	Journal Article
Language:	English
Published:	United States 31.01.2017
Subjects:	Aged Aged, 80 and over Aortic Valve - surgery Cognition Female Humans Intracranial Embolism - prevention & control Magnetic Resonance Imaging Male Safety Transcatheter Aortic Valve Replacement - methods Treatment Outcome transcatheter aortic valve replacement stroke cerebral embolic protection neuroimaging
ISSN:	1558-3597, 1558-3597
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Abstract	Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). This study evaluated the safety and efficacy of TCEP during TAVR. 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. The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, p < 0.001) and not statistically different from that of the control group (9.9%; p = 0.41). New lesion volume was 178.0 mm in control subjects and 102.8 mm 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. 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).
AbstractList	Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP).BACKGROUNDNeurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP).This study evaluated the safety and efficacy of TCEP during TAVR.OBJECTIVESThis study evaluated the safety and efficacy of TCEP during TAVR.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.METHODSNineteen 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.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 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.RESULTSThe 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 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.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).CONCLUSIONSTCEP 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). Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). This study evaluated the safety and efficacy of TCEP during TAVR. 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. The rate of MACCE (7.3%) was noninferior to the performance goal (18.3%, p < 0.001) and not statistically different from that of the control group (9.9%; p = 0.41). New lesion volume was 178.0 mm in control subjects and 102.8 mm 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. 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	Nazif, Tamim Satler, Lowell Zajarias, Alan Svensson, Lars Virmani, Renu Woitek, Felix Kapadia, Samir R McCabe, James M Zivadinov, Robert Dwyer, Michael G Parhizgar, Azin Anwaruddin, Saif Thourani, Vinod H Szeto, Wilson Y Mick, Stephanie White, Roseann M Chakravarty, Tarun Krishnaswamy, Amar Kodali, Susheel Jilaihawi, Hasan Mangner, Norman Linke, Axel Nakamura, Mamoo Kraemer, Carlye Makkar, Raj Alu, Maria C Lazar, Ronald M Leon, Martin B Mehran, Roxana
Author_xml	– sequence: 1 givenname: Samir R surname: Kapadia fullname: Kapadia, Samir R email: kapadis@ccf.org organization: Cleveland Clinic, Cleveland, Ohio. Electronic address: kapadis@ccf.org – sequence: 2 givenname: Susheel surname: Kodali fullname: Kodali, Susheel organization: Columbia University Medical Center, New York, New York – sequence: 3 givenname: Raj surname: Makkar fullname: Makkar, Raj organization: Cedars-Sinai Medical Center, Los Angeles, California – sequence: 4 givenname: Roxana surname: Mehran fullname: Mehran, Roxana organization: Mount Sinai School of Medicine, New York, New York – sequence: 5 givenname: Ronald M surname: Lazar fullname: Lazar, Ronald M organization: Columbia University Medical Center, New York, New York – sequence: 6 givenname: Robert surname: Zivadinov fullname: Zivadinov, Robert organization: Buffalo Neuroimaging Analysis Center, Buffalo, New York – sequence: 7 givenname: Michael G surname: Dwyer fullname: Dwyer, Michael G organization: Buffalo Neuroimaging Analysis Center, Buffalo, New York – sequence: 8 givenname: Hasan surname: Jilaihawi fullname: Jilaihawi, Hasan organization: NYU Langone Medical Center, New York, New York – sequence: 9 givenname: Renu surname: Virmani fullname: Virmani, Renu organization: CV Path Institute, Gaithersburg, Maryland – sequence: 10 givenname: Saif surname: Anwaruddin fullname: Anwaruddin, Saif organization: University of Pennsylvania, Philadelphia, Pennsylvania – sequence: 11 givenname: Vinod H surname: Thourani fullname: Thourani, Vinod H organization: Emory University, Atlanta, Georgia – sequence: 12 givenname: Tamim surname: Nazif fullname: Nazif, Tamim organization: Columbia University Medical Center, New York, New York – sequence: 13 givenname: Norman surname: Mangner fullname: Mangner, Norman organization: Herzzentrum Leipzig GmbH-Universitätsklinik, Leipzig, Germany – sequence: 14 givenname: Felix surname: Woitek fullname: Woitek, Felix organization: Herzzentrum Leipzig GmbH-Universitätsklinik, Leipzig, Germany – sequence: 15 givenname: Amar surname: Krishnaswamy fullname: Krishnaswamy, Amar organization: Cleveland Clinic, Cleveland, Ohio – sequence: 16 givenname: Stephanie surname: Mick fullname: Mick, Stephanie organization: Cleveland Clinic, Cleveland, Ohio – sequence: 17 givenname: Tarun surname: Chakravarty fullname: Chakravarty, Tarun organization: Cedars-Sinai Medical Center, Los Angeles, California – sequence: 18 givenname: Mamoo surname: Nakamura fullname: Nakamura, Mamoo organization: Cedars-Sinai Medical Center, Los Angeles, California – sequence: 19 givenname: James M surname: McCabe fullname: McCabe, James M organization: University of Washington, Seattle, Washington – sequence: 20 givenname: Lowell surname: Satler fullname: Satler, Lowell organization: Medstar Washington Hospital Center, Washington, DC – sequence: 21 givenname: Alan surname: Zajarias fullname: Zajarias, Alan organization: Washington University School of Medicine, St. Louis, Missouri – sequence: 22 givenname: Wilson Y surname: Szeto fullname: Szeto, Wilson Y organization: University of Pennsylvania, Philadelphia, Pennsylvania – sequence: 23 givenname: Lars surname: Svensson fullname: Svensson, Lars organization: Cleveland Clinic, Cleveland, Ohio – sequence: 24 givenname: Maria C surname: Alu fullname: Alu, Maria C organization: Columbia University Medical Center, New York, New York – sequence: 25 givenname: Roseann M surname: White fullname: White, Roseann M organization: Duke Clinical Research Institute, Durham, North Carolina – sequence: 26 givenname: Carlye surname: Kraemer fullname: Kraemer, Carlye organization: NAMSA, Minneapolis, Minnesota – sequence: 27 givenname: Azin surname: Parhizgar fullname: Parhizgar, Azin organization: Claret Medical, Inc., Santa Rosa, California – sequence: 28 givenname: Martin B surname: Leon fullname: Leon, Martin B organization: Columbia University Medical Center, New York, New York – sequence: 29 givenname: Axel surname: Linke fullname: Linke, Axel organization: Herzzentrum Leipzig GmbH-Universitätsklinik, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/27815101$$D View this record in MEDLINE/PubMed
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Copyright	Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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Keywords	transcatheter aortic valve replacement stroke cerebral embolic protection neuroimaging
Language	English
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Snippet	Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). This study... Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection...
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SubjectTerms	Aged Aged, 80 and over Aortic Valve - surgery Cognition Female Humans Intracranial Embolism - prevention & control Magnetic Resonance Imaging Male Safety Transcatheter Aortic Valve Replacement - methods Treatment Outcome
Title	Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement
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