Aortic Valve Stenosis, Postoperative Delirium
Conditions
Keywords
Transaortic valve replacement, Surgical aortic valve replacement, TAVR, SAVR
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.
Interventions
None listed
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
| 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. |
| 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. |
| 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 |
| Intensive Care Unit (ICU) Length of Stay | Until 30 days postoperatively | Intensive care unit (ICU) length of stay following the procedure |
| Hospital Length of Stay | Until 30 days postoperatively | Amount of days hospitalized in the primary center |
| Count of Patients Discharged Directly Home | Until 30 days postoperatively | Discharge destination directly after discharge from the hospital back home |
| 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). |
Countries
Belgium
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| TAVI Patients (n=84) Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI | 84 |
| 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 | 82 |
| 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 | 84 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 8 | 2 | 1 |
Baseline characteristics
| Characteristic | TAVI Patients (n=84) | Mini-sternotomy (n=82) | Full-sternotomy (n=84) | Total |
|---|---|---|---|---|
| Age, Continuous | 83 years STANDARD_DEVIATION 5.9 | 78 years STANDARD_DEVIATION 5.3 | 78 years STANDARD_DEVIATION 5.3 | 80 years STANDARD_DEVIATION 5.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 84 Participants | 82 Participants | 84 Participants | 250 Participants |
| EuroSCORE II | 7.28 % STANDARD_DEVIATION 5.98 | 2.47 % STANDARD_DEVIATION 1.47 | 5.03 % STANDARD_DEVIATION 4.09 | 4.95 % STANDARD_DEVIATION 4.68 |
| Sex: Female, Male Female | 32 Participants | 37 Participants | 33 Participants | 102 Participants |
| Sex: Female, Male Male | 52 Participants | 45 Participants | 51 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 84 | 2 / 82 | 1 / 84 |
| other Total, other adverse events | 28 / 84 | 18 / 82 | 18 / 84 |
| serious Total, serious adverse events | 36 / 84 | 21 / 82 | 17 / 84 |
Outcome results
Primary
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.
Population: Propensity weighted analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAVI Patients (n=84) | Number of Participants With Postoperative Delirium | 13 Participants |
| Mini-sternotomy (n=82) | Number of Participants With Postoperative Delirium | 41 Participants |
| Full-sternotomy (n=84) | Number of Participants With Postoperative Delirium | 45 Participants |
Comparison: Frailty scores (Tilburg and essential) and Euroscore were specified in the protocol. Age was added during the meeting before start of the data-analysisp-value: <0.000195% CI: [0.16, 0.44]Poisson regression
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAVI Patients (n=84) | Assessment of Instrumental Activities of Daily Living During 6-months Interview | 8.3 score on a scale | Standard Deviation 3.5 |
| Mini-sternotomy (n=82) | Assessment of Instrumental Activities of Daily Living During 6-months Interview | 10.8 score on a scale | Standard Deviation 3.2 |
| Full-sternotomy (n=84) | Assessment of Instrumental Activities of Daily Living During 6-months Interview | 11.1 score on a scale | Standard Deviation 3.2 |
Secondary
Count of Patients Discharged Directly Home
Discharge destination directly after discharge from the hospital back home
Time frame: Until 30 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAVI Patients (n=84) | Count of Patients Discharged Directly Home | 71 Participants |
| Mini-sternotomy (n=82) | Count of Patients Discharged Directly Home | 47 Participants |
| Full-sternotomy (n=84) | Count of Patients Discharged Directly Home | 55 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAVI Patients (n=84) | Duration of POD | 4 days |
| Mini-sternotomy (n=82) | Duration of POD | 3 days |
| Full-sternotomy (n=84) | Duration of POD | 4 days |
Secondary
Hospital Length of Stay
Amount of days hospitalized in the primary center
Time frame: Until 30 days postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAVI Patients (n=84) | Hospital Length of Stay | 4 days |
| Mini-sternotomy (n=82) | Hospital Length of Stay | 8 days |
| Full-sternotomy (n=84) | Hospital Length of Stay | 10 days |
Secondary
Intensive Care Unit (ICU) Length of Stay
Intensive care unit (ICU) length of stay following the procedure
Time frame: Until 30 days postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAVI Patients (n=84) | Intensive Care Unit (ICU) Length of Stay | 29 hours |
| Mini-sternotomy (n=82) | Intensive Care Unit (ICU) Length of Stay | 47 hours |
| Full-sternotomy (n=84) | Intensive Care Unit (ICU) Length of Stay | 46 hours |
Secondary
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
Population: Propensity weighted analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAVI Patients (n=84) | Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months | 32 Participants |
| Mini-sternotomy (n=82) | Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months | 21 Participants |
| Full-sternotomy (n=84) | Number of Patients With Adverse Events According to the Composite Endpoint Clinical Efficacy According to VARC-2 at 6 Months | 18 Participants |
Secondary
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
Population: Propensity weighted analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAVI Patients (n=84) | Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days | 31 Participants |
| Mini-sternotomy (n=82) | Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days | 22 Participants |
| Full-sternotomy (n=84) | Number of Patients With Adverse Events According to the Composite Endpoint Early Safety According to VARC-2 at 30 Days | 20 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAVI Patients (n=84) | Onset Moment of Postoperative Delirium | 4 days |
| Mini-sternotomy (n=82) | Onset Moment of Postoperative Delirium | 3 days |
| Full-sternotomy (n=84) | Onset Moment of Postoperative Delirium | 4 days |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TAVI Patients (n=84) | Severity of POD | 6 score on a scale |
| Mini-sternotomy (n=82) | Severity of POD | 5 score on a scale |
| Full-sternotomy (n=84) | Severity of POD | 5 score on a scale |