SAGE-Heart : Senior Assessment fraGility and Post-opErative QALYs 1 Year After Emergency HEART Surgery for Patients Aged 75 and Older
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Phone Calls.
- Who it may be relevant to
- Registry conditions: Frailty, Cardiac Surgery, QALYs. Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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 :
* Preoperative: During the anesthesia consultation: Calculation of the CFS (frailty assessment = CFS ≥ 4) EuroQoL 5D-5L (quality of life, with the index calculated with the French value set of the EuroQol), and routine care (renal function: urea, creatinine, albumin levels). * Postoperative (ICU and hospital): Collection of complication incidence, mortality (all causes and LATA-related). * Follow-up (by phone at 3, 6, and 12 months): CFS and EuroQoL scores, prevalence of chronic pain and analgesic use, dialysis dependency, accommodation status, readmission rates, and death date if applicable.
Interventions
- Other Phone Calls
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
Primary outcome measures
- Quality-Adjusted Life Years (QALYs) according to preoperative frailty status [Time frame: Month 12]
Secondary outcome measures (11)
- Postoperative complications [Time frame: From surgery through,Day 28]
- All-cause mortality [Time frame: Through Month 12]
- EQ-5D-5L Utility Index [Time frame: Baseline, Month 3, Month 6, and Month 12]
- Dialysis dependence [Time frame: Month 3, Month 6, and Month 12]
- Length of intensive care unit stay [Time frame: From ICU admission to ICU discharge (assessed up to Day 28)]
- Length of hospital stay [Time frame: From surgery to hospital discharge]
- Hospital readmissions [Time frame: Month 3, Month 6, and Month 12]
- Chronic postoperative pain [Time frame: Month 3, Month 6, and Month 12]
- Analgesic consumption [Time frame: Month 3, Month 6, and Month 12]
- Living situation [Time frame: Month 3, Month 6, and Month 12]
- EQ-5D-5L visual analogue scale (EQ VAS) [Time frame: Baseline, Month 3, Month 6, and Month 12]
Eligibility criteria
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) :
- Immediate emergency surgery: intervention performed before the start of the next working day following the decision to operate,
- Urgent (relative) emergency surgery: patients not admitted electively for surgery but requiring an intervention during the current hospital stay for medical reasons, and who cannot be discharged without undergoing a definitive procedure
Exclusion criteria
- Patients requiring preoperative cardiopulmonary resuscitation
- Scheduled (elective) surgery
- Lack of informed consent
- Impaired consciousness at the time of inclusion (defined by a Glasgow Coma Scale score < 15)
- Individuals under legal guardianship or judicial protection
- Individuals participating in another interventional research protocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- University Hospital, Bordeaux — Bordeaux
Identifiers
NCT: NCT07677319 · CHUBX 2025/040