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 SatlerAlan Zajarias, Wilson Y. Szeto, Lars Svensson, Maria C. Alu, Roseann M. White, Carlye Kraemer, Azin Parhizgar, Martin B. Leon, Axel Linke, Hasanian Al-Jilaihawi, E. Murat Tuzcu, Vasilis Babaliaros, Chandan Devireddy, Kreton Mavromatis, Ron Waksman, Augusto Pichard, Prashanth Vallabhajosyula, Jay Giri, Howard Herrmann, 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, Creighton Don, Samin Sharma, Annapoorna Kini, George Dangas, Paul Mahoney, Andrew Morse, Mark Stankewicz, Evelio Rodriguez, Christian Frerker, David Cohen

Research output: Contribution to journalArticlepeer-review

185 Scopus 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%, 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

Keywords

  • cerebral embolic protection
  • neuroimaging
  • stroke
  • transcatheter aortic valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of 'Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement'. Together they form a unique fingerprint.

Cite this