1. Clinical Outcome of Transcatheter Aortic Valve Replacement With TriGUARD 3™ Cerebral Embolic Protection Device.
- Author
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Daal SM, Jimenez-Rodriguez GMJ, Voskuil M, Kraaijeveld AO, Dessing TC, Ramjankhan FZ, Mokhles MM, and Stella PR
- Subjects
- Humans, Male, Aged, 80 and over, Female, Prospective Studies, Risk Factors, Treatment Outcome, Time Factors, Aortic Valve diagnostic imaging, Aortic Valve surgery, Transcatheter Aortic Valve Replacement, Ischemic Attack, Transient etiology, Ischemic Attack, Transient prevention & control, Aortic Valve Stenosis diagnostic imaging, Aortic Valve Stenosis surgery, Aortic Valve Stenosis complications, Intracranial Embolism diagnostic imaging, Intracranial Embolism etiology, Intracranial Embolism prevention & control, Stroke etiology, Stroke prevention & control, Stroke epidemiology, Embolic Protection Devices
- Abstract
Objective: Periprocedural stroke during transcatheter aortic valve replacement (TAVR) is a highly feared adverse event. The TriGUARD 3 cerebral embolic protection device (CEPD) may have the potential benefit of reduction of embolic events, but it still remains unclear whether it reduces the incidence of periprocedural stroke or transient ischemic attack (TIA). We aimed to investigate whether the latest TriGUARD 3 CEPD reduces the incidence of clinically overt stroke within 72 h or at discharge after TAVR., Methods: In this prospective single-center study 117 patients (mean age 80.3 years, 53.8 % male) were included from July 2020 to December 2021., Results: The primary efficacy endpoint of this study, periprocedural clinically overt stroke or TIA, within 72 h or at discharge after TAVR with the TriGUARD 3 CEPD occurred in 1/117 pts (0.8 %). Secondary endpoints (device related issues such as life-threatening or disabling bleeding, acute kidney injury, major vascular complications) were reported in 4/117 pts (3.4 %)., Conclusions: This study suggests that the use of the latest TriGUARD 3™ CEPD in transfemoral TAVR seems to be associated with a low rate of clinically overt stroke and a low rate of device related adverse events, reflecting "real world" TAVR practice. However these results should be hypothesis generating and confirmed in a large RCT., Competing Interests: Conflict of interest PS serves on advisory board Keystone Heart, AK received consultancy fees for Boston Scientific, all other authors declare no conflict of interest., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2023
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