Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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Patients undergoing transcatheter aortic valve implantation (TAVI) have distinctive characteristics: they are old, frail, with several co-morbidities and take multiple medications. Hemodynamic instability, cerebral embolism, sedation, general anesthesia and hospitalization in intensive care expose those patients to postprocedural delirium. Acute neurocognitive dysfunctions are associated with adverse outcomes in these population. The objective of this study is to determine the incidence of delirium and neurocognitive disorders in elderly patients after TAVI.

Official Title
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Incidence and Risk Factors of Acute Postoperative Confusion State After Trans-catheter Aortic Valve Implantation (TAVI)

Conditions
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Postoperative Delirium

Intervention / Treatment
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* Other: Delirium assessment
* Other: MMSE (Mini Mental State Examination)
* Other: Barthel index
* Other: HADS (Hospital Anxiety and Depression Scale)
* Other: MNA-SF (Mini Nutritional Assessment - Short Form)
* Device: NIRS (Near-Infrared Spectroscopy)
* Other: CIRS (Cumulative Illness Rating Scale)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65>years Patients undergoing transcatheter aortic valve implantation Patients have given informed consent for participation at the study Exclusion Criteria: Patient suffering from delirium (CAM diagnosis) at recruitment Inability to understand the national languages Emergency procedures

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients following TAVI<br> | Other: Delirium assessment<br>* During the first post-procedural five days all patients will be evaluated on a daily basis for delirium occurrence by the CAM (Confusion Assessment Method) or CAM - ICU (Confusion Assessment Method - Intensive Care Unit)<br>Other: MMSE (Mini Mental State Examination)<br> <br> Other: Barthel index<br> <br> Other: HADS (Hospital Anxiety and Depression Scale)<br> <br> Other: MNA-SF (Mini Nutritional Assessment - Short Form)<br> <br> Device: NIRS (Near-Infrared Spectroscopy)<br>* Regional cerebral oxygen saturation monitoring during TAVI procedure<br>Other: CIRS (Cumulative Illness Rating Scale)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium | The primary outcome is incidence of delirium. Delirium screening will be carry out using the CAM or CAM-ICU in accordance with local hospital clinical delirium-screening guidelines. The assessment of presence of Delirium will be perform by clinician with CAM in agreement with Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV). CAM is standardized method to enable non-psychiatrically trained clinicians to identify delirium and assesses nine features of delirium: (1) acute onset, (2) inattention, (3) disorganized thinking, (4) altered level of consciousness, (5) disorientation, (6) memory impairment, (7) perceptual disturbances, (8) psychomotor agitation or retardation and (9) altered sleep-wake cycle. Delirium is diagnosed when feature 1 and 2 are present and either 3 or 4 are displayed. | Day 1-5 after transcatheter aortic valve implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for postoperative delirium | Association between incidence of delirium and patient vulnerabilities, exposure to noxious or precipitating factors. The risk factors will be divided in pre-procedural, intra-procedural and post-procedural | Baseline, intra-operative and days 1-5 after transcatheter aortic valve implantation | 
| Onset of delirium |  | Day 1-5 after transcatheter aortic valve implantation | 
| Complications of delirium | Complications delirium related | Day 1-5 after transcatheter aortic valve implantation | 
| Type of delirium | Delirium classification according to Delirium Motor Subtype Scale (DMSS-4) | Day 1-5 after transcatheter aortic valve implantation | 
| Trajectories of neurocognitive function | Change of Mini-Mental State Examination (MMSE) | Changes from baseline up to 5 day and 3-months | 
| Trajectories of functional abilities | Change of Barthel Index (for Activities of Daily Living, ADL) | Changes from baseline up to 5 day and 3-months | 
| Mortality | Postoperative survival | 30-days, 3-months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Transcatheter Aortic Valve Implantation, Elderly