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Aortic valve stenosis is one of the most common types of heart disease in the aging Western population. While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted aortic valve implantation (TAVI) has developed as an alternative to open-heart surgery, especially for high-risk patients. Recently, increased surgeon experience and improved transcatheter valve systems have led to a global trend to use TAVI in patients with low or intermediate risk. Although cognitive impairment after cardiac surgery is well known, the effect of TAVI on cognitive function has not yet been adequately investigated. The aim of this study is to compare the occurrence and progression of delirium, postoperative cognitive decline (POCD), cerebral infarction, and health-related quality of life (QOL) in patients with intermediate risk for catheter-assisted (TAVI) and surgical (SAVR) aortic valve replacement.
Full description
The present project is a substudy of the DEDICATE Trial (ID: NCT03112980). It is a randomized intervention study taking place at the Kerckhoff-Klink Bad Nauheim Germany (Campus Justus Liebig University Giessen) involving 100 patients undergoing aortic valve replacement (TAVI vs. SAVR) with a focus on cognitive outcome. A detailed assessment of psychological and health-related functions will be performed before intervention, during hospitalization and 3 months after intervention. During hospitalization, the occurrence and progression of delirium will be assessed with the Intensive Care Delirium Screening Checklist (ICDSC). Other cognitive data will be collected before and 3 months after surgery with a selected and comprehensive neuropsychological test battery, including the evaluation of attention, word fluency, executive functions and various functional areas of memory. In addition, parameters of health-related QOL will be collected before and 3 months after the intervention using the SF-36, and information on anxiety and depression will be collected using the Hospital Anxiety and Depression Scale (HADS). A few days after the intervention, magnetic resonance images of the brain will be acquired to assess cerebral infarction.
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Inclusion criteria
Heart team decision that both TAVI and SAVR are medically justified based on
Degenerative aortic valve stenosis:
Patient shows symptoms of aortic stenosis
Low to intermediate surgical risk (STS: 2-6%)
A transfemoral or alternative access for TAVI can be implemented
Patient has agreed in writing to participate in the study
Patient is able to understand the patient information and sign it personally
Patient agrees to undergo SAVR if randomization into the control group occurs
Readiness for MRT examination and neuropsychological testing after 3 months
Patients aged 65 to 85 years.
Native German speaker (since a neuropsychological test is language dependent)
Exclusion criteria
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31 participants in 2 patient groups
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Central trial contact
Marius Butz, Dipl.-Psych.; Martin Jünemann, Dr.med.M.Sc.
Data sourced from clinicaltrials.gov
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