Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement

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.

Inclusion criteria

• Heart team decision that both TAVI and SAVR are medically justified based on

• Degenerative aortic valve stenosis:

• Mean gradient > 40 mmHg or
• Jet velocity > 40 m/s or
• Surface of aortic valve < 1.0 cm²
• Patient shows symptoms of aortic stenosis

• NYHA functional class ≥ II or
• Angina pectoris or
• Syncope
• 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

• Congenital aortic valve defects
• Untreated clinically significant coronary artery disease or severe mitral or tricuspid insufficiency or mitral stenosis
• Previous heart surgery
• Percutaneous coronary intervention performed within one month prior to the study
• Hemodynamic instability requiring inotropic support or mechanical circulatory support
• Ischemic stroke or intracranial bleeding within the month before the start of the study
• Severe ventricular dysfunction with left ventricular ejection fraction < 20% as measured by echocardiogram
• Hypertrophic obstructive cardiomyopathy or severe basal septum hypertrophy
• Echocardiographic detection of intracardiac mass, thrombus, vegetation, or endocarditis
• Any other atherosclerotic disease that is considered as a contraindication for isolated aortic valve surgery
• Symptomatic carotid or vertebral artery disease
• Existing neurological or psychiatric disease (particularly cerebral infarction, cranio- cerebral trauma, manifest depression or dementia) that may interfere with neuropsychological testing.
• Contraindications for MRI examination (e.g. cardiac pacemaker, vena cava filter, claustrophobia)