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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Marius Butz, Phd, M.Sc.
- Número de teléfono: +49 6032 9965812
- Correo electrónico: m.butz@kerckhoff-klinik.de
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at discharge from acute hospital care
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative cognitive decline (POCD) assessed by a detailed neuropsychological test battery at 3 months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Matthias Renker, MD, Campus Kerckhoff, Justus-Liebig-Universität Gießen
- Investigador principal: Marius Butz, Phd, M.Sc., Campus Kerckhoff, Justus-Liebig-Universität Gießen
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedad de la válvula aórtica
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades cardiovasculares
- Desordenes mentales
- Complicaciones Postoperatorias
- Procesos Patológicos
- Enfermedades cardíacas
- Confusión
- Manifestaciones neuroconductuales
- Trastornos cognitivos
- Enfermedades de las válvulas cardíacas
- Obstrucción del flujo de salida ventricular
- Delirio
- Disfunción congnitiva
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Complicaciones cognitivas posoperatorias
- Delirio de emergencia
- Estenosis de la válvula aórtica
- Trastornos neurocognitivos
Otros números de identificación del estudio
- 185/25-HVU-NEURO
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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