Major abdominal surgery (MAS) carries a high risk of 30-day mortality (\>5%). Perioperative myocardial injury (PMI) and myocardial injury after noncardiac surgery (MINS) frequently develop asymptomatically due to surgical analgesia. The 2022 European Society of Cardiology (ESC) Guidelines recommend routine surveillance with high-sensitivity cardiac troponin (hs-cTn) before and after surgery in high-risk patients, defining PMI by an absolute increase in hs-cTnT \>= 14 ng/L or a peak \> 5x ULN (\> 70 ng/L). However, validation in Asian populations and major abdominal visceral resections is scarce.
This prospective observational cohort study (TROP-MAS) recruits \>= 650 consecutive high-cardiovascular-risk patients undergoing major abdominal surgery at Bach Mai Hospital (Hanoi, Vietnam). The study systematically evaluates the incidence and prognostic significance of hs-cTnT kinetics (T0 baseline, T1 24h, T2 48h postoperative) regarding 30-day all-cause mortality, major adverse cardiovascular events (MACE), and severe noncardiac complications (acute kidney injury, sepsis, anastomotic leak, bowel ischemia). Furthermore, it derives and validates population-specific optimal prognostic cut-off values using ROC curve analysis and multivariable Cox modeling.
Scheduled for or undergoing elective, urgent, or emergency major abdominal surgery (pancreatectomy, liver resection, gastrectomy, colorectal surgery, or emergency laparotomy) with expected duration >= 2 hours or major visceral resection.
Age >= 65 years; OR
Age 45 to 64 years with at least one documented cardiovascular risk factor or comorbidity: documented coronary artery disease, congestive heart failure, prior ischemic stroke or TIA, peripheral arterial disease (resting ABI <= 0.90), diabetes mellitus requiring treatment, arterial hypertension, dyslipidemia/hypercholesterolemia, active cigarette smoking, overweight/obesity (BMI >= 25 kg/m²), family history of premature cardiovascular disease, unexplained cardiac signs/symptoms, chronic obstructive pulmonary disease (COPD), baseline chronic renal impairment (eGFR < 60 mL/min/1.73m² or serum creatinine > 177 umol/L), or Revised Cardiac Risk Index (RCRI) >= 2 points.
Signed Informed Consent Form permitting electronic medical record (EMR) data extraction and participation in a 30-day follow-up telephone interview.
Active acute myocardial infarction or acute coronary syndrome within 30 days prior to the index surgical procedure.
End-stage renal disease (ESRD) on maintenance hemodialysis or peritoneal dialysis.
Intraoperative mortality or death within the first 24 hours postoperatively due to acute massive surgical exsanguination.
Incomplete postoperative troponin testing protocol (missing both 24h and 48h postoperative blood samples).
Adult surgical patients with established or potential cardiovascular risk scheduled for or undergoing major abdominal surgery under general anesthesia at Bach Mai Hospital.
Cohort
Prospective
High-sensitivity cardiac troponin T (hs-cTnT) surveillance
Diagnostic testSerial blood sampling for high-sensitivity cardiac troponin T (hs-cTnT) measurement using the Roche Cobas Elecsys STAT assay: preoperatively within 24 hours before incision (T0), at 24 hours (± 6h) postoperatively (T1), and at 48 hours (± 6h) postoperatively (T2). Additional samples are obtained if ischemic symptoms or signs occur.
Incidence of Perioperative Myocardial Injury (PMI)
Occurrence of Perioperative Myocardial Injury (PMI) defined according to the 2022 ESC Guidelines as an absolute delta increase in high-sensitivity cardiac troponin T (Delta hs-cTnT \>= 14 ng/L) from preoperative baseline to postoperative 24h or 48h (or between postoperative 24h and 48h), OR any postoperative peak hs-cTnT concentration \>= 70 ng/L (\> 5x ULN, Roche Cobas Elecsys STAT assay).
All-Cause Mortality
Cumulative incidence of all-cause death occurring within 30 days after index major abdominal surgery, verified through hospital records, Electronic Medical Records (EMR), and structured Day 30 telephone interview.
Major Adverse Cardiovascular Events (MACE)
Composite of nonfatal cardiac arrest, nonfatal clinical AMI (Fourth Universal Definition), acute decompensated heart failure, malignant ventricular arrhythmia, and new ischemic/hemorrhagic stroke confirmed by neuroimaging.
Severe Sepsis and Septic Shock
Incidence of severe sepsis and septic shock defined by Sepsis-3 Consensus Criteria (infection with acute SOFA increase \>= 2 points; septic shock requiring vasopressors for MAP \>= 65 mmHg with lactate \> 2 mmol/L).
Major Surgical Complications
Incidence of Clavien-Dindo Grade \>= III complications (anastomotic leak, acute bowel ischemia, secondary peritonitis, intra-abdominal hemorrhage, and unplanned reoperation).
Prognostic Accuracy of hs-cTnT Kinetics for 30-Day Composite Major Complications and Mortality
Discriminative performance measured by Area Under the Receiver Operating Characteristic Curve (AUC / C-statistic) and derivation of optimal population-specific prognostic cut-off thresholds for Peak hs-cTnT and absolute Delta hs-cTnT to predict a 30-day composite major adverse outcome. The composite endpoint encompasses: 1. 30-day all-cause mortality; 2. Major adverse cardiovascular events (MACE: nonfatal cardiac arrest, acute myocardial infarction, acute heart failure, life-threatening arrhythmias, and stroke); 3. Major surgical and intra-abdominal complications (Clavien-Dindo Grade \>= III: gastrointestinal anastomotic leak/dehiscence, acute mesenteric/intestinal ischemia or gangrene, secondary peritonitis, intra-abdominal hemorrhage, and unplanned reoperation); 4. Severe non-cardiac complications (severe sepsis, septic shock by Sepsis-3 criteria, and acute kidney injury KDIGO Stage 2-3).
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Bach Mai Hospital
Lead sponsor
Hanoi Medical University
Collaborator
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