Prognostic value of cerebral injury following transfemoral aortic valve implantation

Ghanem, Alexander; Müller, Andreas; Sinning, Jan‐Malte; Kocurek, Justine; Becker, B; Vogel, Marieke; Vasa‐Nicotera, Mariuca; Hammerstingl, Christoph; Schwab, Jörg O.; Nähle, C.; Thomas, Daniel; Wagner, Michael; Grube, Eberhard; Werner, Nikos; Nickenig, Georg

doi:10.4244/eijv8i11a198

Cited by 34 publications

(34 citation statements)

References 27 publications

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“…The widely used but possibly less sensitive mini-mental state examination of general cognitive function was administered to allow comparisons with other studies. We additionally assessed frailty, 19 quality of life, 20 instrumental activities of daily living, 21 and mood 22 using the following validated scores and questionnaires: The Edmonton frail scale scores of ≤3 and >7 indicate a lower (odds ratio, 0.3) and excessive risk (odds ratio, 5.0) of having a complication after surgery, respectively. 19 The health-related short form allows the assessment of mental and physical health-related status on a scale ranging from 0 to 100.…”

Section: Methodsmentioning

confidence: 99%

“…20 The Lawton instrumental activities of daily living score displays function in daily activities, with higher values reflecting better function; a value >52 has previously been used to determine independent lifestyle. 21 The geriatric depression score is a 30-item report, which displays patient mood on a scale ranging from 0 to 30, with a value <10 reflecting lack of depressive symptoms. 22 The occurrence of systemic inflammatory response syndrome (SIRS) was defined as fulfilling ≥2 of the following 4 criteria: body temperature <36.0°C or >38.0°C, heart rate >90 bpm, respiratory rate >20 breaths/min, or Paco 2 <32 mm Hg, leukocyte count >12 or <4 (10 9 /L) 1, 6, 24, 48, or 72 hours (E2) after TAVI.…”

Section: Methodsmentioning

confidence: 99%

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Cognitive Trajectory After Transcatheter Aortic Valve Implantation

Ghanem

Kocurek

Sinning

et al. 2013

Circ: Cardiovascular Interventions

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Background-Transcatheter aortic valve implantation (TAVI) is known to be associated with silent cerebral injury, which could contribute to cognitive impairment. Considering its increasing use, thorough longitudinal investigation of cognitive trajectory after TAVI is pivotal. Methods and Results-Repeatable battery for the assessment of neuropsychological status was performed before (E1), 3 days (E2), 3 months (E3), 1 (E4) year, and 2 years (E5) after TAVI. Baseline characteristics, procedural data, imaging parameters of brain injury (diffusion-weighted MRI), and the use of conceivable neuroprotective approaches were investigated for their effect on cognitive function. Cognitive performance was investigated in 111 patients (mean log EuroSCORE, 30±13%). Global cognitive function (repeatable battery for the assessment of neuropsychological status total score) increased transiently at E2 (P=0.02) and was comparable with baseline levels at E3, E4, and E5. Six patients (5.4%) demonstrated early cognitive decline. Persistence and late onset were seen infrequently (n=3, 2.7% and n=4, 3.6%, respectively). Hence, early cognitive decline was ruled out in 105 patients (94.6%), and a majority of patients (91%) demonstrated sustained cognitive performance throughout all investigated time points. Interestingly, only patient age (P=0.012), but not prior cerebrovascular events, cognitive status, direct TAVI, cerebral embolism in diffusion-weighted MRI, or the use of a cerebral embolic protection device was found to be independently associated with cognitive decline, linking higher age to cognitive impairment along the first 2 years after TAVI. Conclusions-Long-term cognitive performance was preserved in the great majority (91%) of patients throughout the first 2 years after TAVI, despite the high intrinsic risk for cognitive deterioration. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00883285.(Circ Cardiovasc Interv. 2013;6:615-624.)Key Words: cognition ◼ dementia ◼ injury ◼ intracranial embolism ◼ mild cognitive impairment ◼ stroke ◼ TAVR

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Cognitive Trajectory After Transcatheter Aortic Valve Implantation

Ghanem

Kocurek

Sinning

et al. 2013

Circ: Cardiovascular Interventions

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“…35 This is supported by midterm studies with follow-up of 1 year, which seem to suggest that silent cerebral embolism does not impact prognosis, in terms of either mortality, self-sufficiency, or HRQoL outcomes, although the latter may reflect the relative inattention paid to HRQoL measures until recent times. 59 Postulated longer-term implications including accelerated cognitive decline, dementia, and depression remain to be elucidated. 48,60,61 …”

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confidence: 99%

Characterization of Neurological Injury in Transcatheter Aortic Valve Implantation

et al. 2014

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“…Indeed, recent studies have implied that DW MRI lesions after TAVI are not related to self-sufficiency or mortality 1-year post procedure and that there may even be less cognitive decline post TAVI compared with surgery, despite a higher incidence of embolic lesions [37,38]. These studies are limited by small sample sizes but they suggest that there may limitations in utilizing DW MRI to evaluate TAVI outcomes.…”

Section: Discussionmentioning

confidence: 99%

Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit

Meller

Baumbach

Vörös

et al. 2013

BMC Med

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BackgroundNeurological events associated with transcatheter aortic valve implantation are major contributors to morbidity and mortality. Choosing an appropriate endpoint to determine neuroprotection device efficacy is a key difficulty inhibiting the translation of the innovation from the laboratory to the bedside. Cost and sample size limitations inhibit the feasibility of using the rate of clinical (such as stroke or other cerebral) events as the primary efficacy endpoint. This paper focuses on consensus opinions from the 2013 Yale-University College London (UCL) Device Innovation Summit.DiscussionNeuroimaging, specifically diffusion-weighted magnetic resonance imaging (DW MRI), may serve as a surrogate endpoint for clinical studies detecting cerebral events in which cost and sample-size limitations prohibit the use of clinical outcomes. A major limitation of using imaging to prove efficacy in cardiac device studies is that no standardized endpoint exists. Ongoing trials investigating cerebral protection devices for transcatheter aortic valve implantation are utilizing and reporting various qualitative and quantitative DW MRI values; however, single lesion volume, number of new lesions, and total lesion volume have been found to be the most reproducible and prognostically important imaging measures.SummaryDW MRI may be a useful surrogate endpoint for clinical studies detecting cerebral events to determine the device’s success in neurological protection. Consensus from the 2013 Yale-UCL Device Innovation Summit specifically recommends the reporting of mean single lesion volume, number of new lesions, and total volume, and encourages European Union (EU)-US regulatory consensus in the guidance of implementing this endpoint.

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Prognostic value of cerebral injury following transfemoral aortic valve implantation

Abstract: In this observational pilot study, "silent" cerebral injury is neither related to dependent lifestyle nor to mortality during the first year after TAVI. However, long-term follow-up is needed to elucidate fully the impact of silent stroke. Clinical trials number: NCT00883285.

Cited by 34 publications

References 27 publications

Cognitive Trajectory After Transcatheter Aortic Valve Implantation

Cognitive Trajectory After Transcatheter Aortic Valve Implantation

Characterization of Neurological Injury in Transcatheter Aortic Valve Implantation

Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit

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