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, Alan Zajarias, Wilson Y Szeto, Lars Svensson, Maria C Alu, Roseann M White, Carlye Kraemer, Azin Parhizgar, Martin B Leon, Axel Linke, SENTINEL Trial Investigators, 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, Alan Zajarias, 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, 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, Alan Zajarias, Wilson Y Szeto, Lars Svensson, Maria C Alu, Roseann M White, Carlye Kraemer, Azin Parhizgar, Martin B Leon, Axel Linke, SENTINEL Trial Investigators, 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, Alan Zajarias, 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
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).
Keywords: cerebral embolic protection; neuroimaging; stroke; transcatheter aortic valve replacement.
Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed