HeAlth-data Register sTudies of Risk and Outcomes in Cardiac Surgery

Study Overview
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Brief Summary
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The overall project aim is to study risk and outcomes following cardiac surgery by cross-linking high-quality national Swedish health-data registers for population-based investigations of individual level clinically relevant patient data.

Detailed Description
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The purpose of this research project is to study risks and outcomes in patients who underwent cardiac surgery. We aim to establish a fundament for the conduct of nationwide population-based studies by linking patient-level data from the Swedish Heart Surgery Register (SWEDEHEART), the National Patient Register, the Cause of Death Register, the National Diabetes Register, the Swedish Renal Registry, the Prescribed Drug Register, and the 2nd version of the Swedish-Danish Scandinavian Donations and Transfusions database. Cross-linking patient-level data is possible through the Personal Identity Number assigned to every individual who has resided in Sweden on a permanent basis. The Swedish Personal Identity Number is the unique identifier in all national registers. Specifically, we aim: To assess the importance of chronic kidney disease for prognosis after CABG. To assess the consequences of acute kidney injury following CABG. To analyze the prognosis in patients with depression prior to CABG. To study risks and benefits of blood transfusions in cardiac surgery. To study the risks associated with diabetes mellitus in cardiac surgery with special reference to type of diabetes (type 1 and type 2) and glycaemic control and duration of disease. To investigate the long-term impact of different surgical strategies (e.g. use of multiple arterial grafts or non-use of cardio-pulmonary bypass) during CABG. To analyze prognosis in relevant sub-populations undergoing CABG (e.g. patients 50 years or younger, possible differences between men and women, and patients with heart failure with preserved vs. reduced ejection fraction). To investigate survival and morbidity in patients between 50 and 69 years undergoing aortic valve replacement with particular reference to prosthesis type (mechanical vs. biological). To analyze the association between socioeconomic factors and prognosis in patients undergoing cardiac surgery. To investigate factors related to durability of bioprosthetic aortic heart valves.

Official Title
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HeAlth-data Register sTudies of Risk and Outcomes in Cardiac Surgery (HARTROCS)

Conditions
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Kidney Diseases, Cardiovascular Diseases, Depression, Diabetes Mellitus

Intervention / Treatment
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* Procedure: Coronary artery bypass surgery
* Procedure: Heart valve surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients who underwent cardiac surgery in Sweden during the study period Exclusion Criteria: -

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

| Intervention/Treatment |
| --- |
|Procedure: Coronary artery bypass surgery|Primary isolated coronary artery bypass surgery with or without use of cardio-pulmonary bypass|
|Procedure: Heart valve surgery|Heart valve surgery, aortic valve replacement or other heart valve procedures|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Infarction |  | 15 years | 
| Heart Failure |  | 15 years | 
| Stroke |  | 15 years | 
| End-Stage Renal Disease |  | 15 years | 
| Repeat Revascularization |  | 15 years | 
| Cardiovascular Death |  | 15 years | 
| Aortic valve reoperation |  | 15 years | 
| Composite | Combined end-point of death and other secondary end-points | 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery, Epidemiologic Methods, Blood Transfusions