Predictors of Postoperative Delirium After Transcatheter Aortic Valve Implantation

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

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 Overview

• Status: Completed
• Conditions: Postoperative Delirium
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton Ticino
    • Lugano, Canton Ticino, Switzerland, 6900
      • Cardiocentro Ticino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients following TAVI

Other: Delirium assessment; 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); 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); Regional cerebral oxygen saturation monitoring during TAVI procedure; Other: CIRS (Cumulative Illness Rating Scale)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cardiocentro Ticino
• Investigators: Principal Investigator: Tiziano Cassina, MD, Cardiocentro Ticino

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimated): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Elderly; Delirium; Transcatheter Aortic Valve Implantation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: DELTAVI-CCT-ICU-2015