Aortic Valve Stenosis, Delirium - Postoperative, Neurocognitive Disorders, Postoperative Cognitive Dysfunction (POCD)
Conditions
Keywords
TAVI, HVU, Postoperative Cognitive Decline, Postoperative Delirium, Neuropsychology, Transcatheter Aortic Valve Implantation, Intensive Care Delirium Screening Checklist
Brief summary
Transcatheter aortic valve implantation (TAVI) is an established treatment for severe aortic stenosis. Despite improved procedural outcomes, neurocognitive complications such as postoperative delirium (POD) and postoperative cognitive decline (POCD) remain clinically relevant. Heart Valve Units (HVU) are specialized interdisciplinary care structures designed to improve treatment pathways and healthcare quality. However, their impact on neuropsychological outcomes has not been sufficiently investigated. HVU-NEURO is a prospective observational cohort study evaluating neuropsychological outcomes before and after implementation of an HVU. Approximately 500 patients undergoing transcatheter valve therapy will be included. Neurocognitive function will be assessed before intervention, at hospital discharge, and three months after intervention. POD will be assessed using the Intensive Care Delirium Screening Checklist (ICDSC). The primary objective is to evaluate the effect of HVU implementation on postoperative cognitive decline at discharge from acute hospital care.
Detailed description
HVU-NEURO is a prospective single-center observational cohort study conducted at the Kerckhoff-Klinik Bad Nauheim, Germany. The study investigates whether implementation of a structured Heart Valve Unit (HVU) influences neuropsychological outcomes in patients undergoing transcatheter valve therapy. Approximately 500 consecutive patients undergoing transcatheter valve therapy will be prospectively enrolled during two predefined 6-month observation periods before and after HVU implementation, separated by a 6-month run-in/blanking phase. Neuropsychological assessments will be performed preinterventionally, at discharge from acute hospital care, and three months after intervention. Postoperative delirium (POD) will be assessed during intensive care treatment using the Intensive Care Delirium Screening Checklist (ICDSC). The primary endpoint is postoperative cognitive decline (POCD) at discharge from acute hospital care. Secondary endpoints include POCD at three months, postoperative delirium, patient-reported postoperative neurocognitive symptoms, affective symptoms, posttraumatic stress symptoms, and instrumental activities of daily living. The study aims to improve understanding of neuropsychological outcomes and their integration into modern structured heart valve care pathways.
Interventions
None listed
Sponsors
Heart and Brain Research Group, Germany
University of Giessen
University Hospital Giessen and Marburg
Kerckhoff Klinik
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe aortic valve stenosis * Indication for transcatheter valve therapy according to current guideline recommendations and/or Heart-Team consensus * Sufficient German language proficiency, as study-related tests, questionnaires, and instructions are administered in German * Age ≥18 years * Willingness to participate voluntarily with written informed consent
Exclusion criteria
* Known pregnancy at the time of study inclusion * Life expectancy \<1 year due to non-cardiac disease * Pre-interventional psychiatric and neurological disorders (known and diagnosed dementia, depression, history of stroke or transient ischemic attack \[TIA\], migraine, epilepsy) with acute symptoms that may interfere with data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at discharge from acute hospital care | At discharge from acute hospital care (typically within 7 days after intervention) | Postoperative cognitive decline (POCD) will be assessed using repeated neuropsychological testing covering DSM-5-related cognitive domains and subdomains. POCD is defined as a decline of at least one standard deviation in at least 20% of assessed neurocognitive subdomains compared with baseline assessment. Learning and memory will be assessed using the Montreal Cognitive Assessment (MoCA) word list, including delayed free recall and the Memory Index Score (MIS). Complex attention will be assessed using the Trail Making Test A (TMT-A) for selective attention and the SKT-7 subtest of the Syndrom-Kurztest (SKT) for inhibitory control. Language will be assessed using the Regensburg Verbal Fluency Test (RWT), including semantic and phonemic verbal fluency. Perceptual-motor function will be assessed using the MoCA three-dimensional figure copy task. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at 3 months | 3 months after intervention | Postoperative cognitive decline (POCD) will be assessed using repeated neuropsychological testing covering DSM-5-related cognitive domains and subdomains. POCD is defined as a decline of at least one standard deviation in at least 20% of assessed neurocognitive subdomains compared with baseline assessment. Learning and memory will be assessed using the Montreal Cognitive Assessment (MoCA) word list, including delayed free recall and the Memory Index Score (MIS). Complex attention will be assessed using the Trail Making Test A (TMT-A) for selective attention and the SKT-7 subtest of the Syndrom-Kurztest (SKT) for inhibitory control. Language will be assessed using the Regensburg Verbal Fluency Test (RWT), including semantic and phonemic verbal fluency. Perceptual-motor function will be assessed using the MoCA three-dimensional figure copy task. |
| Postoperative Delirium | During intensive care stay (up to 2 days) | Incidence of postoperative delirium assessed during intensive care treatment using the Intensive Care Delirium Screening Checklist (ICDSC). |
| Patient-Reported Neurocognitive Symptoms | 3 months after intervention | Patient-reported postoperative neurocognitive symptoms assessed using the Postoperative Neurocognitive Disorder Questionnaire (PNCD-Q). |
| Postoperative Affective Symptoms | 3 months after intervention | Patient-reported affective symptoms assessed using the Postoperative Affective Disorder Questionnaire (PAD-Q). |
| Posttraumatic Stress Symptoms | 3 months after intervention | Posttraumatic stress symptoms assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). |
| Instrumental Activities of Daily Living | 3 months after intervention | Functional impairment assessed using Instrumental Activities of Daily Living (IADL). |
Contacts
CONTACTMarius Butz, Phd, M.Sc.
PRINCIPAL_INVESTIGATORMatthias Renker, MD
Campus Kerckhoff, Justus-Liebig-Universität Gießen
PRINCIPAL_INVESTIGATORMarius Butz, Phd, M.Sc.
Campus Kerckhoff, Justus-Liebig-Universität Gießen
Outcome results
None listed