SAGE-Heart : Senior Assessment fraGility and Post-opErative QALYs 1 Year After Emergency HEART Surgery for Patients Aged 75 and Older

University Hospital of Bordeaux

Status: Enrolling

Conditions: Cardiac Surgery; QALYs; Frailty

Treatments: Other: Phone Calls

Study type: Interventional

Funder types: Other

Identifiers

NCT07677319

CHUBX 2025/040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 265 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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265 participants in 2 patient groups

Frail group

Experimental group

Description:

Patients with Clinical Frailty Score CFS ≥ 4

Treatment:

Other: Phone Calls

Non-frail group

Experimental group

Description:

Patients with Clinical Frailty Score CFS \< 4

Treatment:

Other: Phone Calls