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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Onset Moment of Postoperative Delirium | Moment of onset of POD during the first five postoperative days or until discharge | During the first five postoperative days |
| Duration of POD | Duration of delirium in days using the 3D-CAM or ICU-CAM |
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Inclusion Criteria:
Patients scheduled to undergo elective
Patient able to read and understand the research materials
Exclusion Criteria:
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Any patient presenting for the indicated surgery in a tertiary university hospital
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| Name | Affiliation | Role |
|---|---|---|
| Danny Hoogma, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34876283 | Result | 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. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | TAVI Patients (n=84) | Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics without propensity weighting.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAVI Patients (n=84) | Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Propensity weighted analysis | Posted | Count of Participants | Participants | 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. |
|
6 months postoperatively patients were contacted by phone and by mail. Furthermore the general practitioner and/or treating cardiologist was contacted for relevant information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAVI Patients (n=84) | Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery by TAVI |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All stroke | Nervous system disorders | VARC-2 | Systematic Assessment | According to VARC-2 criteria |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Early safety at 30 days | General disorders | VARC-2 | Systematic Assessment | According to VARC-2 criteria |
We would like to refer to the published manuscript
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Danny Feike Hoogma | University Hospitals Leuven | 003216344270 | danny.hoogma@uzleuven.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 13, 2018 | May 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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presence of neural injury markers
| 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). | 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. | 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. | 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). | 6 months postoperatively |
| Intensive Care Unit (ICU) Length of Stay | Intensive care unit (ICU) length of stay following the procedure | Until 30 days postoperatively |
| Hospital Length of Stay | Amount of days hospitalized in the primary center | Until 30 days postoperatively |
| Count of Patients Discharged Directly Home | Discharge destination directly after discharge from the hospital back home | Until 30 days postoperatively |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| EuroSCORE II | Mean | Standard Deviation | % |
|
Patients aged ≥ 70 years and scheduled for aortic valve replacement surgery SAVR without concomitant revascularization or surgical ablation for atrial fibrillation thru mini-sternotomy
| OG002 | 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 |
|
|
|
| Secondary | Onset Moment of Postoperative Delirium | Moment of onset of POD during the first five postoperative days or until discharge | Posted | Median | Inter-Quartile Range | days | During the first five postoperative days |
|
|
|
| Secondary | Duration of POD | Duration of delirium in days using the 3D-CAM or ICU-CAM | Posted | Median | Inter-Quartile Range | days | If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge |
|
|
|
| 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). | Posted | Median | Inter-Quartile Range | score on a scale | If POD develops during the first 5 postoperative days, patient will be followed until POD has resolved or until discharge |
|
|
|
| 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. | Propensity weighted analysis | Posted | Count of Participants | Participants | Until 30 days postoperatively |
|
|
|
| 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. | Propensity weighted analysis | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 6 months postoperatively |
|
|
|
| Secondary | Intensive Care Unit (ICU) Length of Stay | Intensive care unit (ICU) length of stay following the procedure | Posted | Median | Inter-Quartile Range | hours | Until 30 days postoperatively |
|
|
|
| Secondary | Hospital Length of Stay | Amount of days hospitalized in the primary center | Posted | Median | Inter-Quartile Range | days | Until 30 days postoperatively |
|
|
|
| Secondary | Count of Patients Discharged Directly Home | Discharge destination directly after discharge from the hospital back home | Posted | Count of Participants | Participants | Until 30 days postoperatively |
|
|
|
| 8 |
| 84 |
| 36 |
| 84 |
| 28 |
| 84 |
| EG001 | 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 | 2 | 82 | 21 | 82 | 18 | 82 |
| EG002 | 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 | 1 | 84 | 17 | 84 | 18 | 84 |
|
| Rehospitalization | General disorders | VARC-2 | Systematic Assessment |
|
| NYHA 3/44 | Cardiac disorders | VARC-2 | Systematic Assessment | According to VARC-2 criteria |
|
| Valve dysfunction | Cardiac disorders | VARC-2 | Systematic Assessment | According to VARC-2 criteria |
|
|
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| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |