Clinical trial NCT03950440: Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Official title: Assessing the Incidence of Postoperative Delirium Following Aortic Valve Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Aortic Valve Stenosis
Keywords: Transaortic valve replacement
Surgical aortic valve replacement
TAVR
SAVR
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 250
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient presenting for the indicated surgery in a tertiary university hospital

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Postoperative Delirium
timeFrame: 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 outcomes:
measure: Onset Moment of Postoperative Delirium
timeFrame: During the first five postoperative days
measure: Duration of POD
timeFrame: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge
measure: Severity of POD
timeFrame: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge
measure: Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days
timeFrame: Until 30 days postoperatively
measure: Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months
timeFrame: 6 months
measure: Assessment of Instrumental Activities of Daily Living During 6-months Interview
timeFrame: 6 months postoperatively
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: Until 30 days postoperatively
measure: Hospital Length of Stay
timeFrame: Until 30 days postoperatively
measure: Count of Patients Discharged Directly Home
timeFrame: Until 30 days postoperatively
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Danny Hoogma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2023 Jul;166(1):156-166.e6. doi: 10.1016/j.jtcvs.2021.11.023. Epub 2021 Nov 17.