Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement

Completed

Conditions: Aortic Valve Stenosis
Postoperative Delirium

Registration Number: NCT03950440

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary: 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 250

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Delirium	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.	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

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days	Until 30 days postoperatively	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.
Intensive Care Unit (ICU) Length of Stay	Until 30 days postoperatively	Intensive care unit (ICU) length of stay following the procedure
Duration of POD	If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge	Duration of delirium in days using the 3D-CAM or ICU-CAM
Assessment of Instrumental Activities of Daily Living During 6-months Interview	6 months postoperatively	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).
Hospital Length of Stay	Until 30 days postoperatively	Amount of days hospitalized in the primary center
Onset Moment of Postoperative Delirium	During the first five postoperative days	Moment of onset of POD during the first five postoperative days or until discharge
Severity of POD	If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge	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).
Count of Patients Discharged Directly Home	Until 30 days postoperatively	Discharge destination directly after discharge from the hospital back home
Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months	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.