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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients following TAVI | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delirium assessment | Other | 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) |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TAVI complications | Complications according to VARC-2 (Valve Academic Research Consortium -2) | Participants will be followed for the first 72-96 hours after TAVI |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiziano Cassina, MD | Cardiocentro Ticino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiocentro Ticino | Lugano | Canton Ticino | 6900 | Switzerland |
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| MMSE (Mini Mental State Examination) | Other |
|
| Barthel index | Other |
|
| HADS (Hospital Anxiety and Depression Scale) | Other |
|
| MNA-SF (Mini Nutritional Assessment - Short Form) | Other |
|
| NIRS (Near-Infrared Spectroscopy) | Device | Regional cerebral oxygen saturation monitoring during TAVI procedure |
|
| CIRS (Cumulative Illness Rating Scale) | Other |
|
| 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 |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| C018209 | 4-amino-4'-hydroxylaminodiphenylsulfone |
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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