Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement

Samir R. Kapadia, Susheel Kodali, Raj Makkar, Roxana Mehran, Ronald M. Lazar, Robert Zivadinov, Michael G. Dwyer, Hasan Jilaihawi, Renu Virmani, Saif Anwaruddin, Vinod H. Thourani, Tamim Nazif, Norman Mangner, Felix Woitek, Amar Krishnaswamy, Stephanie Mick, Tarun Chakravarty, Mamoo Nakamura, James M. McCabe, Lowell Satler & 60 others Alan Zajarias, Wilson Y. Szeto, Lars Svensson, Maria C. Alu, Roseann M. White, Carlye Kraemer, Azin Parhizgar, Martin B. Leon, Axel Linke, Raj Makkar, Hasanian Al-Jilaihawi, Samir Kapadia, Amar Krishnaswamy, E. Murat Tuzcu, Stephanie Mick, Susheel Kodali, Tamin Nazif, Vinod Thourani, Vasilis Babaliaros, Chandan Devireddy, Kreton Mavromatis, Ron Waksman, Lowell Satler, Augusto Pichard, Wilson Szeto, Saif Anwaruddin, Prashanth Vallabhajosyula, Jay Giri, Howard Herrmann, Evelio Rodriguez, John Lasala, Adam Greenbaum, William O'Neill, Marvin Eng, Joshua Rovin, Lang Lin, Douglas Spriggs, Shing Chiu Wong, Geoffrey Bergman, Arash Salemi, Richard Smalling, Biswajit Kar, Pranav Loyalka, D. Scott Lim, Michael Ragosta, Mark Reisman, James McCabe, Creighton Don, Samin Sharma, Annapoorna Kini, George Dangas, Paul Mahoney, Andrew Morse, Mark Stankewicz, Evelio Rodriguez, Axel Linke, Norman Mangner, Felix Woitek, Christian Frerker, David Cohen

    Research output: Contribution to journalArticle

    108 Citations (Scopus)

    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%, 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. 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)

    Original languageEnglish (US)
    Pages (from-to)367-377
    Number of pages11
    JournalJournal of the American College of Cardiology
    Volume69
    Issue number4
    DOIs
    StatePublished - Jan 31 2017

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    Intracranial Embolism
    Equipment and Supplies
    Safety
    Transcatheter Aortic Valve Replacement
    Thrombosis
    Magnetic Resonance Spectroscopy
    Arteries
    Stroke
    Magnetic Resonance Imaging
    Control Groups
    Brain

    All Science Journal Classification (ASJC) codes

    • Cardiology and Cardiovascular Medicine

    Cite this

    Kapadia, S. R., Kodali, S., Makkar, R., Mehran, R., Lazar, R. M., Zivadinov, R., ... Cohen, D. (2017). Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. Journal of the American College of Cardiology, 69(4), 367-377. https://doi.org/10.1016/j.jacc.2016.10.023

    Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. / 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; Makkar, Raj; Al-Jilaihawi, Hasanian; Kapadia, Samir; Krishnaswamy, Amar; Tuzcu, E. Murat; Mick, Stephanie; Kodali, Susheel; Nazif, Tamin; Thourani, Vinod; Babaliaros, Vasilis; Devireddy, Chandan; Mavromatis, Kreton; Waksman, Ron; Satler, Lowell; Pichard, Augusto; Szeto, Wilson; Anwaruddin, Saif; Vallabhajosyula, Prashanth; Giri, Jay; Herrmann, Howard; Rodriguez, Evelio; Lasala, John; Greenbaum, Adam; O'Neill, William; Eng, Marvin; Rovin, Joshua; Lin, Lang; Spriggs, Douglas; Wong, Shing Chiu; Bergman, Geoffrey; Salemi, Arash; Smalling, Richard; Kar, Biswajit; Loyalka, Pranav; Lim, D. Scott; Ragosta, Michael; Reisman, Mark; McCabe, James; Don, Creighton; Sharma, Samin; Kini, Annapoorna; Dangas, George; Mahoney, Paul; Morse, Andrew; Stankewicz, Mark; Rodriguez, Evelio; Linke, Axel; Mangner, Norman; Woitek, Felix; Frerker, Christian; Cohen, David.

    In: Journal of the American College of Cardiology, Vol. 69, No. 4, 31.01.2017, p. 367-377.

    Research output: Contribution to journalArticle

    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, Makkar, R, Al-Jilaihawi, H, Kapadia, S, Krishnaswamy, A, Tuzcu, EM, Mick, S, Kodali, S, Nazif, T, Thourani, V, Babaliaros, V, Devireddy, C, Mavromatis, K, Waksman, R, Satler, L, Pichard, A, Szeto, W, Anwaruddin, S, Vallabhajosyula, P, Giri, J, Herrmann, H, Rodriguez, E, Lasala, J, Greenbaum, A, O'Neill, W, Eng, M, Rovin, J, Lin, L, Spriggs, D, Wong, SC, Bergman, G, Salemi, A, Smalling, R, Kar, B, Loyalka, P, Lim, DS, Ragosta, M, Reisman, M, McCabe, J, Don, C, Sharma, S, Kini, A, Dangas, G, Mahoney, P, Morse, A, Stankewicz, M, Rodriguez, E, Linke, A, Mangner, N, Woitek, F, Frerker, C & Cohen, D 2017, 'Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement', Journal of the American College of Cardiology, vol. 69, no. 4, pp. 367-377. https://doi.org/10.1016/j.jacc.2016.10.023
    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 ; Makkar, Raj ; Al-Jilaihawi, Hasanian ; Kapadia, Samir ; Krishnaswamy, Amar ; Tuzcu, E. Murat ; Mick, Stephanie ; Kodali, Susheel ; Nazif, Tamin ; Thourani, Vinod ; Babaliaros, Vasilis ; Devireddy, Chandan ; Mavromatis, Kreton ; Waksman, Ron ; Satler, Lowell ; Pichard, Augusto ; Szeto, Wilson ; Anwaruddin, Saif ; Vallabhajosyula, Prashanth ; Giri, Jay ; Herrmann, Howard ; Rodriguez, Evelio ; Lasala, John ; Greenbaum, Adam ; O'Neill, William ; Eng, Marvin ; Rovin, Joshua ; Lin, Lang ; Spriggs, Douglas ; Wong, Shing Chiu ; Bergman, Geoffrey ; Salemi, Arash ; Smalling, Richard ; Kar, Biswajit ; Loyalka, Pranav ; Lim, D. Scott ; Ragosta, Michael ; Reisman, Mark ; McCabe, James ; Don, Creighton ; Sharma, Samin ; Kini, Annapoorna ; Dangas, George ; Mahoney, Paul ; Morse, Andrew ; Stankewicz, Mark ; Rodriguez, Evelio ; Linke, Axel ; Mangner, Norman ; Woitek, Felix ; Frerker, Christian ; Cohen, David. / Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. In: Journal of the American College of Cardiology. 2017 ; Vol. 69, No. 4. pp. 367-377.
    @article{c8ed7820638c4709b3bad384051ab778,
    title = "Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement",
    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{\%}, 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. 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 = "Kapadia, {Samir R.} and Susheel Kodali and Raj Makkar and Roxana Mehran and Lazar, {Ronald M.} and Robert Zivadinov and Dwyer, {Michael G.} and Hasan Jilaihawi and Renu Virmani and Saif Anwaruddin and Thourani, {Vinod H.} and Tamim Nazif and Norman Mangner and Felix Woitek and Amar Krishnaswamy and Stephanie Mick and Tarun Chakravarty and Mamoo Nakamura and McCabe, {James M.} and Lowell Satler and Alan Zajarias and Szeto, {Wilson Y.} and Lars Svensson and Alu, {Maria C.} and White, {Roseann M.} and Carlye Kraemer and Azin Parhizgar and Leon, {Martin B.} and Axel Linke and Raj Makkar and Hasanian Al-Jilaihawi and Samir Kapadia and Amar Krishnaswamy and Tuzcu, {E. Murat} and Stephanie Mick and Susheel Kodali and Tamin Nazif and Vinod Thourani and Vasilis Babaliaros and Chandan Devireddy and Kreton Mavromatis and Ron Waksman and Lowell Satler and Augusto Pichard and Wilson Szeto and Saif Anwaruddin and Prashanth Vallabhajosyula and Jay Giri and Howard Herrmann and Evelio Rodriguez and John Lasala and Adam Greenbaum and William O'Neill and Marvin Eng and Joshua Rovin and Lang Lin and Douglas Spriggs and Wong, {Shing Chiu} and Geoffrey Bergman and Arash Salemi and Richard Smalling and Biswajit Kar and Pranav Loyalka and Lim, {D. Scott} and Michael Ragosta and Mark Reisman and James McCabe and Creighton Don and Samin Sharma and Annapoorna Kini and George Dangas and Paul Mahoney and Andrew Morse and Mark Stankewicz and Evelio Rodriguez and Axel Linke and Norman Mangner and Felix Woitek and Christian Frerker and David Cohen",
    year = "2017",
    month = "1",
    day = "31",
    doi = "10.1016/j.jacc.2016.10.023",
    language = "English (US)",
    volume = "69",
    pages = "367--377",
    journal = "Journal of the American College of Cardiology",
    issn = "0735-1097",
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    number = "4",

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    TY - JOUR

    T1 - Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement

    AU - Kapadia, Samir R.

    AU - Kodali, Susheel

    AU - Makkar, Raj

    AU - Mehran, Roxana

    AU - Lazar, Ronald M.

    AU - Zivadinov, Robert

    AU - Dwyer, Michael G.

    AU - Jilaihawi, Hasan

    AU - Virmani, Renu

    AU - Anwaruddin, Saif

    AU - Thourani, Vinod H.

    AU - Nazif, Tamim

    AU - Mangner, Norman

    AU - Woitek, Felix

    AU - Krishnaswamy, Amar

    AU - Mick, Stephanie

    AU - Chakravarty, Tarun

    AU - Nakamura, Mamoo

    AU - McCabe, James M.

    AU - Satler, Lowell

    AU - Zajarias, Alan

    AU - Szeto, Wilson Y.

    AU - Svensson, Lars

    AU - Alu, Maria C.

    AU - White, Roseann M.

    AU - Kraemer, Carlye

    AU - Parhizgar, Azin

    AU - Leon, Martin B.

    AU - Linke, Axel

    AU - Makkar, Raj

    AU - Al-Jilaihawi, Hasanian

    AU - Kapadia, Samir

    AU - Krishnaswamy, Amar

    AU - Tuzcu, E. Murat

    AU - Mick, Stephanie

    AU - Kodali, Susheel

    AU - Nazif, Tamin

    AU - Thourani, Vinod

    AU - Babaliaros, Vasilis

    AU - Devireddy, Chandan

    AU - Mavromatis, Kreton

    AU - Waksman, Ron

    AU - Satler, Lowell

    AU - Pichard, Augusto

    AU - Szeto, Wilson

    AU - Anwaruddin, Saif

    AU - Vallabhajosyula, Prashanth

    AU - Giri, Jay

    AU - Herrmann, Howard

    AU - Rodriguez, Evelio

    AU - Lasala, John

    AU - Greenbaum, Adam

    AU - O'Neill, William

    AU - Eng, Marvin

    AU - Rovin, Joshua

    AU - Lin, Lang

    AU - Spriggs, Douglas

    AU - Wong, Shing Chiu

    AU - Bergman, Geoffrey

    AU - Salemi, Arash

    AU - Smalling, Richard

    AU - Kar, Biswajit

    AU - Loyalka, Pranav

    AU - Lim, D. Scott

    AU - Ragosta, Michael

    AU - Reisman, Mark

    AU - McCabe, James

    AU - Don, Creighton

    AU - Sharma, Samin

    AU - Kini, Annapoorna

    AU - Dangas, George

    AU - Mahoney, Paul

    AU - Morse, Andrew

    AU - Stankewicz, Mark

    AU - Rodriguez, Evelio

    AU - Linke, Axel

    AU - Mangner, Norman

    AU - Woitek, Felix

    AU - Frerker, Christian

    AU - Cohen, David

    PY - 2017/1/31

    Y1 - 2017/1/31

    N2 - 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%, 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. 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)

    AB - 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%, 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. 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)

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    JO - Journal of the American College of Cardiology

    JF - Journal of the American College of Cardiology

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