Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions

Study Overview
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Brief Summary
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Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) may alter neurocognitive functions. We aim to differentiate the changes in cognitive functions after a TAVI.

Detailed Description
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Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) is the treatment of choice for patients with symptomatic aortic valve stenosis >75 years with comorbidities. The reduction in complications and also in mortality after TAVI is due, among other things, to the constant further development of TAVI devices but also to improved implantation technologies. Nevertheless, neurological complications are rare but of relevant impact. These are a.e. due to the passage of the TAVI system into an aorta that is often burdened with atheromatous plaques or the necessity to predilate the calcified aortic valve. Studies using cerebral magnetic resonance imaging (MRI) show that the vast majority of patients after TAVI had lesions in the brain that correspond to at least minimal cerebral infarction. Even if these are asymptomatic, various studies have shown that initially asymptomatic infarcts may be associated with an increased incidence of dementia and cognitive impairment, as well as being predictors of later symptomatic infarctions. Changes in hemodynamics after removal of the aortic stenosis could, on the other hand, improve neurocognitive function. Interestingly, the standard methods primarily investigate motor deficits, while neurocognitive function were currently not tested. The influence of a TAVI on the latter functions is therefore unknown. In this study, we aim to differentiate the changes in cognitive functions after a TAVI immediately after the procedure and after 6 months.

Official Title
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Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions

Conditions
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Cognition Disorder

Intervention / Treatment
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* Device: Transcatheter Aortic Valve Implantation (TAVI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: planned TAVI implantation Age ≥ 60 Intelligence quotient > 80 Sufficient knowledge of German Normal or corrected vision and hearing Exclusion Criteria: Serious neurological or psychiatric diseases that make participation in the trial procedure impossible Oncological disease with a life expectancy < 12 months pregnancy

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transcatheter Aortic Valve Implantation<br>Patients are assessed for cognitive function pre and post transcatheter aortic valve implantation. | Device: Transcatheter Aortic Valve Implantation (TAVI)<br>* Guideline/ FDA approved implantation of a Transcatheter Aortic Valve Implantation (TAVI)<br>|
| Control matched population<br>Control matched population are assessed for cognitive function at day 0 and at 6 month | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurocognitive performance for depression | Becks Depression Inventory (BDI) | 6 month post TAVI | 
| neurocognitive performance for health status | Questionnaire on health status (SF 36) | 6 month post TAVI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter Aortic Valve Implantation (TAVI), Cognitive Function, Aortic stenosis, Stroke, Frailty