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

University Hospital, Bordeaux265 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Conditions

Frailty Cardiac Surgery QALYs

Interventions

Phone CallsOTHER

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

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital, Bordeaux

Bordeaux, France, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Month 12

Secondary Outcomes

Postoperative complications

Incidence of postoperative cardiac, respiratory, renal, infectious, and neurological complications during the first 28 postoperative days.

Time frame: From surgery through,Day 28

All-cause mortality

All-cause mortality assessed during ICU stay, hospital stay, and at Month 3, Month 6, and Month 12.

Time frame: 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

Time frame: Baseline, Month 3, Month 6, and Month 12

Dialysis dependence

Dialysis dependence among participants not receiving chronic dialysis before surgery.

Time frame: Month 3, Month 6, and Month 12

Length of intensive care unit stay

Duration of postoperative ICU stay.

Time frame: From ICU admission to ICU discharge (assessed up to Day 28)

Length of hospital stay

Total postoperative hospital length of stay.

Central Contacts

Simon CARRE, MD

CONTACT

0556795679 simon.carre@chu-bordeaux.fr

Data from ClinicalTrials.gov

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