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).
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
250
University Hospitals Leuven
Leuven, Belgium
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
Time frame: 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.
Onset Moment of Postoperative Delirium
Moment of onset of POD during the first five postoperative days or until discharge
Time frame: During the first five postoperative days
Duration of POD
Duration of delirium in days using the 3D-CAM or ICU-CAM
Time frame: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 6 months postoperatively
Intensive Care Unit (ICU) Length of Stay
Intensive care unit (ICU) length of stay following the procedure
Time frame: Until 30 days postoperatively
Hospital Length of Stay
Amount of days hospitalized in the primary center
Time frame: Until 30 days postoperatively
Count of Patients Discharged Directly Home
Discharge destination directly after discharge from the hospital back home
Time frame: Until 30 days postoperatively
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