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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Aortic Valve Stenosis; Postoperative Delirium

Study type: Observational

Funder types: Other

Identifiers

NCT03950440

S61710

Details and patient eligibility

About

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).

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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)

Trial design