Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement (IPOD-AV)

Assessing the Incidence of Postoperative Delirium Following Aortic Valve Surgery

Our primary aim in this observational study is to identify the incidence of POD in the first five postoperative days by using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) or nurse reports in patients undergoing different techniques of aortic valve replacement. Patients are followed 5 days postoperative with the 3D-CAM or until resolution of POD. Six months postoperatively, a follow-up by phone is planned for activity of daily living (ADL).

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Postoperative Delirium

Detailed Description

A significant and often underrecognized complication after surgery is postoperative delirium (POD) causing increased morbidity and mortality. This is especially true for the older cardiac surgical patient, in whom the incidence of POD is up to 70%. Surgical invasiveness and herewith related inflammation, a cholinergic load of medications, postoperative pain or use of opioids are examples of precipitating factors that can be altered to reduce the incidence of POD. Transaortic valve replacement (TAVR) is a revolutionary technique that has led to a dramatic decrease in surgical invasiveness and improved outcomes in high-risk surgical patients. However, only a few studies evaluated neurocognitive outcome after surgical aortic valve replacement (SAVR) compared to TAVR, suggesting a reduced incidence of POD with TAVR compared to SAVR. In contrast, other studies found almost no difference in POD in the aforementioned patient groups. Hence, it remains still unclear which technique best to use in patients at high risk for POD.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Any patient presenting for the indicated surgery in a tertiary university hospital

Description

Inclusion Criteria:

• Patients scheduled to undergo elective

  • TAVI
  • SAVR (with or without coronary artery bypass grafting (CABG) or pulmonary vein isolation (PVI))
• Patient able to read and understand the research materials

Exclusion Criteria:

• Inability to give informed consent
• Presence of delirium at baseline as screened with the 3-minute Diagnostic Confusion Assessment Method (3D-CAM)
• Combined surgical procedures (e.g. mitral valve surgery, aortic surgery or other)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Postoperative Delirium	Using the 3-minute Diagnostic confusion assessment method (3D-CAM), the derived version for intensive care unit (CAM-ICU) and nurse reports combined with interview with the caregivers and patient	Until the fifth postoperative day in hospital (an average of 5 days). In case of POD, followup was continued until resolution of POD or discharge (whichever comes first) up to 19 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of POD	Duration of delirium in days using the 3D-CAM or ICU-CAM	If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge
Onset Moment of Postoperative Delirium	Moment of onset of POD during the first five postoperative days or until discharge	During the first five postoperative days
Severity of POD	assessed with the delirium long severity measure-based confusion assessment method (CAM-S Long). Ten features are evaluated and scored. The first item is either 0 (not present) or 1 (yes). The other 9 features are scored as 0 (not present), 1 (present but mild) or 2 (present and marked). These subscores are than combined on a scale ranging from 0 (no delirium) to 19 (severe delirium).	If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge
Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days	Count of patient having an adverse event according to the composite endpoint "Early safety (at 30 days)" defined by the Valve Academic Research Consortium (VARC)-2. These include: all-cause mortality, all stroke, life threatening bleeding, acute kidney injury stage 2 or 3 and major vascular complications.	Until 30 days postoperatively
Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months	Count of patient having an adverse event according to the composite endpoint "Clinical efficacy (at 6 months)" defined by the Valve Academic Research Consortium (VARC)-2. These include: all-cause mortality, all stroke, rehospitalization, NYHA Classe 3 or 4 and valve dysfunction.	6 months
Assessment of Instrumental Activities of Daily Living During 6-months Interview	Assessment of Instrumental activities of daily living (IADL) divided over 7 items. Each item can be scored with either 0 (not capable), 1 (capable with aid) or 2 (without aid). These subscores are summed on a scale ranging from 0 (worse outcome) to 14 (best outcome).	6 months postoperatively
Intensive Care Unit (ICU) Length of Stay	Intensive care unit (ICU) length of stay following the procedure	Until 30 days postoperatively
Hospital Length of Stay	Amount of days hospitalized in the primary center	Until 30 days postoperatively
Count of Patients Discharged Directly Home	Discharge destination directly after discharge from the hospital back home	Until 30 days postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive care unit (ICU) length of stay	Intensive care unit (ICU) length of stay	30 days
Hospital length of stay	Amount of days hospitalized in the primary center	30 days
Discharge destination	Discharge destination defined as: home, nursing home, revalidation unit or other hospital.	30 days
6-months interview	Assessment of different questionnaires: self-administered instrumental activities of daily living, 5 dimensional quality of life (EQ-5D-5L), visual analoge scale for quality of life (EQ-VAS) and cognitive failure questionnaire.	6 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• Hoogma DF, Venmans E, Al Tmimi L, Tournoy J, Verbrugghe P, Jacobs S, Fieuws S, Milisen K, Adriaenssens T, Dubois C, Rex S. Postoperative delirium and quality of life after transcatheter and surgical aortic valve replacement: A prospective observational study. J Thorac Cardiovasc Surg. 2021 Nov 17:S0022-5223(21)01626-3. doi: 10.1016/j.jtcvs.2021.11.023. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2018
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): July 9, 2020

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: TAVR; Transaortic valve replacement; SAVR; Surgical aortic valve replacement
• Additional Relevant MeSH Terms: Mental Disorders; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Delirium; Aortic Valve Stenosis
• Other Study ID Numbers: S61710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No