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The hypothesis is that the preoperative Clinical Frailty Score (CFS) is a predictive factor for a loss in quality-adjusted life years (QALYs) one year after emergency cardiac surgery under cardiopulmonary bypass (CPB) in patients aged 75 years and older.
The advancement of structural cardiology, particularly with percutaneous valve interventions, offers new treatment options without the need for cardiopulmonary bypass (CPB). Despite an increase in the use of these techniques, some studies highlight a notable rise in CPB usage in patients aged 80 and over, from 13.8% in 2013 to 20.5% in 2022. In France, the population aged 85 and above is expected to triple by 2050, meaning more elderly patients will be eligible for CPB cardiac surgery. Several global studies have examined the outcomes of older individuals undergoing CPB cardiac surgery. While EuroSCORE II and STS scores are effective in predicting short-term mortality, they lack accuracy in predicting long-term mortality, particularly in frail patients, and do not assess quality of life. New tools to evaluate frailty, such as the Clinical Frailty Scale (CFS), are now used in preoperative assessments for planned cardiac interventions. Identifying frail elderly patients early is crucial for improving patient and family information on care plans, especially in high-risk surgeries. Even in emergencies, patients must remain involved in their health decisions, and multidisciplinary collaboration is vital for improving postoperative recovery and quality of life.
Data will be collected :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frail group | Experimental | Patients with Clinical Frailty Score CFS ≥ 4 |
|
| Non-frail group | Experimental | Patients with Clinical Frailty Score CFS < 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phone Calls | Other | Phone calls will be made at 3, 6, and 12 months to report quality of life scores (EuroQol EQ 5D-5L) and other postoperative data |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality-Adjusted Life Years (QALYs) according to preoperative frailty status | QALYs over the 12-month follow-up will be estimated from EQ-5D-5L utility scores collected at baseline, Month 3, Month 6, and Month 12 together with survival data, and compared between participants with preoperative frailty (Clinical Frailty Scale ≥4) and those without frailty (Clinical Frailty Scale <4), with adjustment for EuroSCORE II. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Incidence of postoperative cardiac, respiratory, renal, infectious, and neurological complications during the first 28 postoperative days. | From surgery through,Day 28 |
| All-cause mortality |
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Inclusion Criteria:
Patients aged ≥ 75 years who are affiliated with or beneficiaries of a social security scheme and undergoing emergency cardiac surgery under cardiopulmonary bypass, either immediate or urgent (relative) :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simon CARRE, MD | Contact | 0556795679 | +33 | simon.carre@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Simon CARRE, MD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Bordeaux | Recruiting | Bordeaux | France | 33076 | France |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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All-cause mortality assessed during ICU stay, hospital stay, and at Month 3, Month 6, and Month 12.
| Through Month 12 |
| EQ-5D-5L Utility Index | Health-related quality of life assessed using the EQ-5D-5L utility index derived from the French value set | Baseline, Month 3, Month 6, and Month 12 |
| Dialysis dependence | Dialysis dependence among participants not receiving chronic dialysis before surgery. | Month 3, Month 6, and Month 12 |
| Length of intensive care unit stay | Duration of postoperative ICU stay. | From ICU admission to ICU discharge (assessed up to Day 28) |
| Length of hospital stay | Total postoperative hospital length of stay. | From surgery to hospital discharge |
| Hospital readmissions | Number of hospital readmissions since discharge, assessed at each follow-up visit. | Month 3, Month 6, and Month 12 |
| Chronic postoperative pain | Presence of chronic pain related to cardiac surgery. | Month 3, Month 6, and Month 12 |
| Analgesic consumption | Type of analgesic medication and frequency of use since the previous follow-up assessment. | Month 3, Month 6, and Month 12 |
| Living situation | Living at home versus institutionalization during follow-up. | Month 3, Month 6, and Month 12 |
| EQ-5D-5L visual analogue scale (EQ VAS) | Self-rated health status assessed using the EQ-5D-5L visual analogue scale (0-100). | Baseline, Month 3, Month 6, and Month 12 |