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

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty; Cardiac Surgery; QALYs
• Intervention / Treatment: Other: Phone Calls

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.

• Study Type: Interventional
• Enrollment (Estimated): 265
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon CARRE, MD; Phone Number: +33 0556795679; Email: simon.carre@chu-bordeaux.fr

Study Locations

• France
  • France
    • Bordeaux, France, France, 33076
      • Recruiting
      • University Hospital, Bordeaux
      • Contact: Simon CARRE, MD; Phone Number: +33 0556795679; Email: simon.carre@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Frail group; Patients with Clinical Frailty Score CFS ≥ 4	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
Experimental: Non-frail group; Patients with Clinical Frailty Score CFS < 4	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Simon CARRE, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2025
• Primary Completion (Estimated): December 3, 2028
• Study Completion (Estimated): December 3, 2028

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Elderly; Cardiac Surgery; Frailty; Clinical Frailty Scale; QALYs; Cardio-pulmonary Bypass; EuroQol, postoperative
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty
• Other Study ID Numbers: CHUBX 2025/040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No