High-risk Patients in Cardiac Surgery Procedures: HiriSCORE

Study Overview
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Brief Summary
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Over time there is a need to improve old and develop new risk models. Overall the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models. The use of improved risk models and increased accuracy in the technique of preparing these mathematical systems does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures. The aim of this study is: To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures Assessing the impact of pre-, intra- and postoperative period to the prognosis of morbidity and mortality in high-risk patients undergoing cardiac surgery procedures.

Detailed Description
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The risk predicts models are the mathematical tools for identification of the patients with complications risk after cardiac surgery procedures. Over time, however, due to technical progress (the development of hybrid surgery, new valves and prostheses), the development of new drugs, changes in the environment and social conditions in which do patients live, there is a need to improve old and develop new models. Based on the statement that high risk patients have similar characteristics (clinical and laboratory) regardless of the procedure to which they were submitted, creating a new risk score to this group of patients must be sought. Improving the model quality was achieved by using more accurate risk assessments. In general, the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models (EuroSCORE II, STS-score). However, the use of improved risk models and increased accuracy in the technique of preparing these mathematical systems, unfortunately, does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures. The aim of this study is: To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures (the investigators have proposed a high-risk evaluation criteria: EuroSCORE II> 5 or STS-score> 5); Assessing the impact of pre-, intra- and postoperative period to the prognosis of subsequent morbidity and mortality in high-risk patients who have passed cardiac surgery procedures. It was decided to conduct this research in two phases. The developmental phase is carried out for 30 months and includes an analysis of at least 2,000 patients who will pass cardiac surgery procedures in institutions and hospitals involved in the study. After this analysis, including outcomes, will be constructed the HiriSCORE, a new test-model for high-risk patients. In the validation phase of the study, which will involve a further 1,000 patients it is planned preparation and verification of effectiveness of the HiriSCORE model where it will be compared to the STS Score and the EuroSCORE II. The study will include the patients of 18 years old or older who have undergone cardiac surgery procedures, such as coronary artery bypass grafting (isolated or combined with any heart valve intervention), heart valve surgery, and surgery on the ascending aorta (only combined with operations on the aortic valve or CABG). Totally, it is proposed assessment of 170 variables (factors perceived risk) for each patient (preoperative, intraoperative, and up to 12 hours after surgery). The study of mortality and postoperative complications such as renal replacement therapy, stroke, reoperation for bleeding, respiratory failure, cardiogenic shock, will be carried out within 30 days after cardiac surgery procedures.

Official Title
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An International Multicenter Prospective Study for Identify High-risk Patients in Cardiac Surgery Procedures: HiriSCORE

Conditions
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C.Surgical Procedure; Cardiac

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing cardiac surgery procedures, such as coronary artery bypass grafting, heart valve surgeries, co-operations on aorta and valve or CABG and variations of this procedures, regardless of the operation or treatment outcomes Mortality risk with STS score>5 or EuroSCORE II>5 Exclusion Criteria: Isolated surgery on ascending aorta, aortic arch or descending aorta Heart transplantation Impossibility to include patient´s data in research

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Development / 2000 participants<br>Age >18 years; Patients undergoing cardiac surgery procedures (elective, urgent or emergency) for CABG; heart valve surgery; CABG + heart valve surgery; ascending aorta surgery + heart valve surgery or CABG, who have mortality risk with STS score>5 or EuroSCORE II>5. | |
| Validation / 1000 participants<br>Age >18 years; Patients undergoing cardiac surgery procedures (elective, urgent or emergency) for CABG; heart valve surgery; CABG + heart valve surgery; ascending aorta surgery + heart valve surgery or CABG, who have mortality risk with STS score>5 or EuroSCORE II>5. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality analysis | Patient´s mortality data collection following 30 days after the main procedure | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke with neurological consequences (pareses or plegia) | Stroke with neurological consequences (pareses or plegia) following 30 days after the main procedure | 30 days | 
| ST-elevation Myocardial infarction | ST- elevation Myocardial infarction following 30 days after the main procedure | 30 days | 
| Non- ST- elevation Myocardial infarction | Non- ST- elevation Myocardial infarction following 30 days after the main procedure | 30 days | 
| Deep sternal wound infection | Deep sternal wound infection following 30 days after the main procedure | 30 days | 
| Bleeding requiring reoperation | Bleeding requiring reoperation following 30 days after the main procedure | 30 days | 
| Sepsis | Sepsis following 30 days after the main procedure | 30 days | 
| Endocarditis | Endocarditis following 30 days after the main procedure | 30 days | 
| Respiratory failure | Respiratory failure following 30 days after the main procedure | 30 days | 
| Renal replacement therapy | Renal replacement therapy following 30 days after the main procedure | 30 days | 
| Hepatic failure | Hepatic failure following 30 days after the main procedure | 30 days | 
| Unplanned cardiac reoperation | Unplanned cardiac reoperation following 30 days after the main procedure | 30 days | 
| Unplanned cardiac percutaneous intervention | Unplanned cardiac percutaneous intervention following 30 days after the main procedure | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risk assessment, Mortality, Morbidity, Risk factor