Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

Cardiocentro Ticino201 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

201

Conditions

Postoperative Delirium

Interventions

Delirium assessmentOTHER

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)

MMSE (Mini Mental State Examination)OTHER

Barthel indexOTHER

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Cardiocentro Ticino

Lugano, Canton Ticino, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: Day 1-5 after transcatheter aortic valve implantation

Secondary Outcomes

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

Time frame: Baseline, intra-operative and days 1-5 after transcatheter aortic valve implantation

Onset of delirium

Time frame: Day 1-5 after transcatheter aortic valve implantation

Complications of delirium

Complications delirium related

Time frame: Day 1-5 after transcatheter aortic valve implantation

Type of delirium

Delirium classification according to Delirium Motor Subtype Scale (DMSS-4)

Time frame: Day 1-5 after transcatheter aortic valve implantation

Trajectories of neurocognitive function

Data from ClinicalTrials.gov

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