Incidence and Risk Factors of Acute Postoperative Confusion State After Trans-catheter Aortic Valve Implantation (TAVI)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Delirium
- Sponsor
- Cardiocentro Ticino
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Incidence of delirium
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Tiziano Cassina
Tiziano Cassina, MD
Cardiocentro Ticino
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of delirium
Time Frame: Day 1-5 after transcatheter aortic valve implantation
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.
Secondary Outcomes
- Mortality(30-days, 3-months and 1 year)
- Type of delirium(Day 1-5 after transcatheter aortic valve implantation)
- Risk factors for postoperative delirium(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(Day 1-5 after transcatheter aortic valve implantation)
- Trajectories of functional abilities(Changes from baseline up to 5 day and 3-months)
- Trajectories of neurocognitive function(Changes from baseline up to 5 day and 3-months)