Patients Requiring Cardiac Surgery Clinical Trial
Official title:
Contribution of Preoperative Biological Data in Risk Assessment in Cardiac Surgery in Addition to the EuroSCORE
In cardiac surgery, the assessment of operative risk and quality of care is a major challenge
for both patient, and surgical team. It is also important for health care decisionmakers to
have predictive tools to compare alternative technics such as conventional cardiac surgery
and interventional cardiology. Since 1998, the European System for Cardiac Operative Risk
Evaluation (EuroSCORE), updated in 2012 (EuroSCORE II) is the most universally used system in
this purpose. Its success is the result of a good balance between predictive capability and
simplicity. It consists almost exclusively of clinical variables.
However, the objectivity and the predictive ability of some of those clinical items remain
controversial, particularly those addressing severity of illness for high-risk patients. For
instance, the degree of priority is submitted to the subjective assessment by the surgical
team at the time of surgery. Objective data describing the severity of patients arriving in
the operating room are still missing.
Many biomarkers are relevant in qualifying severity of syndromes: shock (PH, lactates, LDH),
heart disease (N-terminal pro b-type natriuretic peptide (NTproBNP), troponin T and I),
respiratory disorder (blood gaz analysis), liver insufficiency (TP, factor V), renal
impairment (serum creatinine, creatinine clearance), inflammatory condition (fibrinogen,
CRP), or the underlying medical condition such as diabetes (HbA1c, microalbuminuria) and
nutritional status (albumin).
In ICU, many scores use biological data to measure, on daily basis, the severity of the
patient status. Their routine use is simplified by applications available on smartphones.
They are drawn into hospital information systems.
In cardiac surgery, some studies seem to demonstrate the measurement of some preoperative
biological variables (eg NT Pro-BNP ...) in risk prediction. In terms of diabetes, HbA1c is
of particular interest because it detects underlying diabetes if unknown (emergent situation)
or reflects its poor control before surgery. This criterion could be more reliable than the
simple information of patient treated by insulin (EuroSCORE II criterion).
Finally, the reinforcement of existing scores with biological variables is recommended by the
group of recommendations in prognostic research strategy (PROGRESS 2014), rather than
creating new scores ex nihilo.
The hypothesis is that adding biological data collected at the time of arrival of the patient
in the operating room would better qualify the patients' severity condition and therefore
increase the risk prediction of early mortality and severe morbidity after cardiac surgery.
The purpose of this study is to test this hypothesis and especially test whether the
biological data would increase the EuroSCORE II performance, by improving the prediction for
high-risk patients.
Main objective: To improve the EuroSCORE II predictive power on the 90-day mortality and/or
severe hospital morbidity, incorporating immediate preoperative biological data.
Secondary objectives:
1. Analyze EuroSCORE II calibration by risk group (external validation).
2. Studying the improvement of the EuroSCORE II-bio predictive power by risk class,
especially high risk.
3. Refine selection and definition of discriminating criteria for diabetics for predicting
surgical risk in cardiac surgery (the HbA1c value, the existence of microalbuminuria,
the nature of treatment etc.).
4. Compare the risk profiles of operated patients in the French Overseas Departments to
those from different sites of Western Europe.
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