Catheterization and Cardiovascular Interventions 84:885–896 (2014)

Cerebral Events and Protection During Transcatheter Aortic Valve Replacement Melanie Freeman, MBBS, Marco Barbanti, MD, David A. Wood, MD, Jian Ye, MD, and John G. Webb,* MD Stroke has emerged as one of the most concerning complications following transcatheter aortic valve replacement (TAVR), associated with high morbidity and mortality. We discuss the potential mechanisms of stroke following TAVR, as well as the newly developed embolic protection devices aimed to reduce the risk of stroke. VC 2014 Wiley Periodicals, Inc.

Key words: transcatheter aortic valve replacement; stroke; cerebral protection

INTRODUCTION

Transcatheter aortic valve replacement (TAVR) is an exciting technology with the potential to treat many patients with severe aortic stenosis, however, concern remains regarding potential serious adverse outcomes [1,2]. Stroke has emerged as one of the most concerning outcomes and is associated with significant morbidity and mortality. Although stroke has been reported in the range of 2–11% [3–6], this was prior to the development of standardized endpoint definitions (Table I) [7,8]. Regardless, much of the published data to date involved the use of early-generation high-profile TAVR devices, extremely high risk patients, and operators with limited case experience [9]. Within the randomized PARTNER trial comparing TAVR and surgical aortic valve replacement (SAVR) in high-risk patients, strokes and transient ischemic attacks were more frequent following TAVR at both 30 days (5.5% TAVR vs. 2.4% SAVR, P ¼ 0.04) and 1 year (8.3% TAVR vs. 4.3% SAVR, P ¼ 0.04) [1]. This early risk of stroke, however, was attenuated over time with no difference in stroke rates at 2 years (HR 1.22; 95% CI: 0.67–2.23; P ¼ 0.52) [2]. A pooled analysis by Eggebrecht et al. comprising more than 10,000 patients undergoing TAVR using both the Edwards SAPIENTM balloon expandable transcatheter heart valve (THV; Edwards Lifesciences, Irvine, CA) and the self expanding CoreValve ReValving SystemTM (Medtronic, Irvine, CA), showed an overall 30-day cerebrovascular event rate of 3.3 6 1.8%. Stroke was associated with a 3.5-fold increased mortality within the first 30 days [10]. Further concern relates to the finding of new ischemic lesions in as many as 84% of patients using diffusion-weighted magnetic resonance imaging (DWC 2014 Wiley Periodicals, Inc. V

MRI) [11]. In comparison, the incidence of silent embolic events following routine SAVR has been reported in up to 47% [12,13]. The clinical significance of these lesions following cardiac surgery remains unclear with conflicting evidence linking the appearance of new ischemic lesions with postoperative cognitive dysfunction and focal neurologic deficits [14]. Small studies in TAVR have failed to demonstrate an association between new ischemic lesions and cognitive decline [15,16], lifestyle, or 1-year mortality [17]. The pattern of new ischemic lesions detected on DW-MRI is multiple and distributed across both hemispheres, suggesting an embolic origin [11]. The distribution of cerebrovascular events tends to occur in two distinct phases, with an early peaking, followed by a constant late hazard phase. Of those events that occur early, the majority do so within the first two postoperative days suggesting a procedure-related mechanism [18]. We discuss the potential procedural and nonprocedural mechanisms of stroke following TAVR, as well as the newly developed embolic protection devices aimed to reduce the risk of stroke. St. Paul’s Hospital, University of British Columbia, Vancouver, Canada Conflict of interest: Drs. Wood, Webb, and Ye are consultants for Edwards Lifesciences. *Correspondence to: John G Webb MD, St. Paul’s Hospital, 1081 Burrard Street, Vancouver, BC, Canada V6Z 1Y6. E-mail: [email protected] Received 20 March 2013; Revision accepted 16 February 2014 DOI: 10.1002/ccd.25457 Published online 4 March 2014 in Wiley Online Library (wileyonlinelibrary.com)

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TABLE I. VARC-2 Criteria for Stroke and TIA Diagnostic criteria

Stroke classification

Stroke definitions

Acute episode of a focal or global neurological deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other neurological signs or symptoms consistent with stroke Stroke—Duration of a focal or global neurological deficit 24 h; OR

Cerebral events and protection during transcatheter aortic valve replacement.

Stroke has emerged as one of the most concerning complications following transcatheter aortic valve replacement (TAVR), associated with high morbidity...
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