Early Postoperative Blood Glucose Variability and Outcome After TAVI

Study Overview
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Brief Summary
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Stress hyperglycaemia is a well-known risk factor of postoperative morbidity and mortality in cardiac surgery. Recently, several authors have reported that increased blood glucose (BG) variability could worsen the prognosis in this population.The transcatheter aortic valve implantation (TAVI) is a low invasive procedure proposed as an alternative technique to aortic valve replacement surgery in high-risk patients. The aim of this study is to describe the incidence of stress hyperglycaemia and assess whether BG variability could impact the outcome of patients undergoing TAVI.

Official Title
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Early Postoperative Blood Glucose Variability and Outcome After TAVI : a Retrospective Single-centre Study

Conditions
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Stress Hyperglycemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age>18 years old severe degenerative symptomatic aortic stenosis logistic Euroscore ≥ 20% or/and Society of Thoracic Surgeons score (STS) ≥ 10% recused for a conventional valve replacement by multidisciplinary team (surgeon, cardiologist) because of surgical contraindication or comorbidities related to the patient. written consent before the procedure concerning anonymous data processing. Exclusion Criteria: death per procedure postoperative admission in a critical care unit

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 |
| --- | --- |
| group M<br>patients who died or suffered from stroke, acute coronary syndrome, heart failure, complete atrioventricular block or life-threatening ventricular arrhythmias within 30 days after the procedure | |
| group T<br>other patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of stress hyperglycemia | Stress hyperglycemia is defined as a blood glucose value above 7.7 mmol/l requiring insulin infusion within the 48 first hours following the TAVI. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood glucose value | Mean blood glucose value is the mean of all the blood glucose values measured during the 48 first hours following the TAVI. | 48 hours | 
| Standard deviation of blood glucose value | Standard deviation of glucose value is the standard deviation of all the blood glucose values measured during the 48 first hours following the TAVI. | 48 hours | 
| Incidence of moderate hypoglycemia | Moderate hypoglycemia is defined as a blood glucose value under 3.3 mmol/l. | 48 hours | 
| Incidence of severe hypoglycemia | Severe hypoglycemia is defined as a blood glucose value under 2.2 mmol/l. | 48 hours | 
| Incidence of severe hyperglycemia | Severe hyperglycemia is defined as a blood glucose value above 11.0 mmol/l. | 48 hours | 
| Coefficient of variability of blood glucose | The coefficient of variability is the ratio of the standard deviation on the mean blood glucose value, expressed as a percentage. | 48 hours | 
| Mean daily variation of blood glucose | The mean daily variation of blood glucose is defined as the mean of the daily differences between the maximal and the minimal glucose value. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve replacement, percutaneous valve, blood glucose variability, TAVI