Trial Outcomes & Findings for Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement (NCT NCT03950440)
NCT ID: NCT03950440
Last Updated: 2023-02-16
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
250 participants
Primary outcome 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.
Results posted on
2023-02-16
Participant Flow
Between September 2018 and January 2020, 250 patients were included: 84 patients in the TAVI group and 166 in the SAVR group. During the screening, 43 patients were non eligible (age \<70 years, additional valve surgery, already participated or were intubated) and 41 patients were excluded (did not speak Dutch, baseline delirium, declined to participated).
Participant milestones
| Measure |
TAVI Patients (n=84)
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Overall Study
STARTED
|
84
|
82
|
84
|
|
Overall Study
Primary Analysis
|
84
|
82
|
84
|
|
Overall Study
1 Month Follow-up
|
80
|
82
|
84
|
|
Overall Study
COMPLETED
|
76
|
80
|
83
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
1
|
Reasons for withdrawal
| Measure |
TAVI Patients (n=84)
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Overall Study
Death
|
8
|
2
|
1
|
Baseline Characteristics
Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Baseline characteristics by cohort
| Measure |
TAVI Patients (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
83 years
STANDARD_DEVIATION 5.9 • n=39 Participants
|
78 years
STANDARD_DEVIATION 5.3 • n=41 Participants
|
78 years
STANDARD_DEVIATION 5.3 • n=35 Participants
|
80 years
STANDARD_DEVIATION 5.7 • n=31 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=39 Participants
|
37 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
102 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=39 Participants
|
45 Participants
n=41 Participants
|
51 Participants
n=35 Participants
|
148 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
84 Participants
n=39 Participants
|
82 Participants
n=41 Participants
|
84 Participants
n=35 Participants
|
250 Participants
n=31 Participants
|
|
EuroSCORE II
|
7.28 %
STANDARD_DEVIATION 5.98 • n=39 Participants
|
2.47 %
STANDARD_DEVIATION 1.47 • n=41 Participants
|
5.03 %
STANDARD_DEVIATION 4.09 • n=35 Participants
|
4.95 %
STANDARD_DEVIATION 4.68 • n=31 Participants
|
PRIMARY outcome
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.Population: Propensity weighted analysis
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
Outcome measures
| Measure |
TAVI Patients (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Number of Participants With Postoperative Delirium
|
13 Participants
|
41 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: During the first five postoperative daysMoment of onset of POD during the first five postoperative days or until discharge
Outcome measures
| Measure |
TAVI Patients (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Onset Moment of Postoperative Delirium
|
4 days
Interval 2.5 to 4.5
|
3 days
Interval 2.5 to 5.0
|
4 days
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until dischargeDuration of delirium in days using the 3D-CAM or ICU-CAM
Outcome measures
| Measure |
TAVI Patients (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Duration of POD
|
4 days
Interval 2.5 to 8.0
|
3 days
Interval 2.5 to 5.0
|
4 days
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until dischargeassessed 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).
Outcome measures
| Measure |
TAVI Patients (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Severity of POD
|
6 score on a scale
Interval 4.0 to 12.0
|
5 score on a scale
Interval 3.0 to 7.0
|
5 score on a scale
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Until 30 days postoperativelyPopulation: Propensity weighted analysis
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.
Outcome measures
| Measure |
TAVI Patients (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days
|
31 Participants
|
22 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Propensity weighted analysis
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.
Outcome measures
| Measure |
TAVI Patients (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months
|
32 Participants
|
21 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 6 months postoperativelyAssessment 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).
Outcome measures
| Measure |
TAVI Patients (n=84)
n=63 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=70 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=66 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Assessment of Instrumental Activities of Daily Living During 6-months Interview
|
8.3 score on a scale
Standard Deviation 3.5
|
10.8 score on a scale
Standard Deviation 3.2
|
11.1 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Until 30 days postoperativelyIntensive care unit (ICU) length of stay following the procedure
Outcome measures
| Measure |
TAVI Patients (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Intensive Care Unit (ICU) Length of Stay
|
29 hours
Interval 25.0 to 68.0
|
47 hours
Interval 26.0 to 102.0
|
46 hours
Interval 27.0 to 76.0
|
SECONDARY outcome
Timeframe: Until 30 days postoperativelyAmount of days hospitalized in the primary center
Outcome measures
| Measure |
TAVI Patients (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Hospital Length of Stay
|
4 days
Interval 3.0 to 10.0
|
8 days
Interval 7.0 to 12.0
|
10 days
Interval 7.5 to 13.0
|
SECONDARY outcome
Timeframe: Until 30 days postoperativelyDischarge destination directly after discharge from the hospital back home
Outcome measures
| Measure |
TAVI Patients (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 Participants
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Count of Patients Discharged Directly Home
|
71 Participants
|
47 Participants
|
55 Participants
|
Adverse Events
TAVI Patients (n=84)
Serious events: 36 serious events
Other events: 28 other events
Deaths: 8 deaths
Mini-sternotomy (n=82)
Serious events: 21 serious events
Other events: 18 other events
Deaths: 2 deaths
Full-sternotomy (n=84)
Serious events: 17 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TAVI Patients (n=84)
n=84 participants at risk
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 participants at risk
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 participants at risk
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
Nervous system disorders
All stroke
|
10.7%
9/84 • Number of events 9 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
3.7%
3/82 • Number of events 3 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
3.6%
3/84 • Number of events 3 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
|
General disorders
Rehospitalization
|
10.7%
9/84 • Number of events 9 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
8.5%
7/82 • Number of events 7 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
11.9%
10/84 • Number of events 10 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
|
Cardiac disorders
NYHA 3/44
|
13.1%
11/84 • Number of events 11 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
9.8%
8/82 • Number of events 8 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
9.5%
8/84 • Number of events 8 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
|
Cardiac disorders
Valve dysfunction
|
15.5%
13/84 • Number of events 13 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
4.9%
4/82 • Number of events 4 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
2.4%
2/84 • Number of events 2 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
Other adverse events
| Measure |
TAVI Patients (n=84)
n=84 participants at risk
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI
|
Mini-sternotomy (n=82)
n=82 participants at risk
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
|
Full-sternotomy (n=84)
n=84 participants at risk
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR with or without concomitant revascularization and/or surgical ablation for atrial fibrillation thru full-sternotomy
|
|---|---|---|---|
|
General disorders
Early safety at 30 days
|
33.3%
28/84 • Number of events 28 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
22.0%
18/82 • Number of events 18 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
21.4%
18/84 • Number of events 18 • 6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place