Prospective Neuropsychological Evaluation of the Implementation of a Heart Valve Unit (HVU-NEURO) (HVU-NEURO)
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.
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Marius Butz, Phd, M.Sc.
- Telefonnummer: +49 6032 9965812
- E-mail: m.butz@kerckhoff-klinik.de
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Non-HVU Cohort
Patients undergoing transcatheter valve therapy during the predefined 6-month observation period before implementation of the Heart Valve Unit (HVU).
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HVU Implementation Cohort
Patients undergoing transcatheter valve therapy during the 6-month HVU implementation and run-in phase.
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Post-HVU Cohort
Patients undergoing transcatheter valve therapy during the predefined 6-month observation period after implementation of the Heart Valve Unit (HVU).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at discharge from acute hospital care
Tidsramme: At discharge from acute hospital care (typically within 7 days after intervention)
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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. |
At discharge from acute hospital care (typically within 7 days after intervention)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at 3 months
Tidsramme: 3 months after intervention
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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. |
3 months after intervention
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Postoperative Delirium
Tidsramme: During intensive care stay (up to 2 days)
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Incidence of postoperative delirium assessed during intensive care treatment using the Intensive Care Delirium Screening Checklist (ICDSC).
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During intensive care stay (up to 2 days)
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Patient-Reported Neurocognitive Symptoms
Tidsramme: 3 months after intervention
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Patient-reported postoperative neurocognitive symptoms assessed using the Postoperative Neurocognitive Disorder Questionnaire (PNCD-Q).
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3 months after intervention
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Postoperative Affective Symptoms
Tidsramme: 3 months after intervention
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Patient-reported affective symptoms assessed using the Postoperative Affective Disorder Questionnaire (PAD-Q).
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3 months after intervention
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Posttraumatic Stress Symptoms
Tidsramme: 3 months after intervention
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Posttraumatic stress symptoms assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
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3 months after intervention
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Instrumental Activities of Daily Living
Tidsramme: 3 months after intervention
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Functional impairment assessed using Instrumental Activities of Daily Living (IADL).
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3 months after intervention
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Matthias Renker, MD, Campus Kerckhoff, Justus-Liebig-Universität Gießen
- Ledende efterforsker: Marius Butz, Phd, M.Sc., Campus Kerckhoff, Justus-Liebig-Universität Gießen
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Aortaklapsygdom
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Hjerte-kar-sygdomme
- Psykiske lidelser
- Postoperative komplikationer
- Patologiske processer
- Hjertesygdomme
- Forvirring
- Neuroadfærdsmæssige manifestationer
- Kognitionsforstyrrelser
- Hjerteklapsygdomme
- Ventrikulær udstrømningsobstruktion
- Delirium
- Kognitiv dysfunktion
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Postoperative kognitive komplikationer
- Emergence Delirium
- Aortaklapstenose
- Neurokognitive lidelser
Andre undersøgelses-id-numre
- 185/25-HVU-NEURO
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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