作者
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
发表日期
2017/1/31
期刊
Journal of the American College of Cardiology
卷号
69
期号
4
页码范围
367-377
出版商
American College of Cardiology Foundation
简介
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 …
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SR Kapadia, S Kodali, R Makkar, R Mehran, RM Lazar… - Journal of the American College of Cardiology, 2017