Inflammatory Response in Aortic Valve Replacement

Study Overview
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Brief Summary
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The study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment (transcatheter aortic valve implantation using the transfemoral access route or the transapical access route).

Detailed Description
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Background Surgical and interventional therapy for aortic valve stenosis exposes the patients to a immune reaction, which is different depending on the type of the treatment. In this study, the investigators would like to better understand the inflammatory and antiinflammatory response in this patient population by monitoring the perioperative cytokine response (interleukins), the human leukocyte antigen expression (HLA-DR) and assessing soluble plasma factors (CD62L) involved in inflammatory processes. Objective Characterisation of inflammatory and antiinflammatory response in patients receiving aortic valve prosthesis selected for different treatment options. Methods Whole blood analysis at different time points (preoperatively, 4 / 24 /48 hours postoperatively) for different inflammatory and antiinflammatory markers: IL-6, IL-8, IL-10, CRP, TNF, soluble CD62L.

Official Title
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The Impact of Genetic Variability on Perioperative Morbidity and Mortality. Substudy: Inflammatory Response in Patients Undergoing Aortic Valve Replacement.

Conditions
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Inflammation, Systemic Inflammatory Response Syndrome, Thoracic Surgery, Aortic Valve Stenosis

Intervention / Treatment
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* Other: Whole blood analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Severe aortic valve stenosis Surgical aortic valve replacement Transcatheter aortic valve implantation No previous inflammatory condition Exclusion Criteria Missing informed consent Treatment with corticosteroids Treatment with antibiotics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Minimized extracorporeal circulation<br>Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the minimized extracorporeal circulation (MECC, group 1) | Other: Whole blood analysis<br>* In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.<br>|
| Conventional extracorporeal circulation<br>Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the conventional extracorporeal circulation (CECC, group 2) | Other: Whole blood analysis<br>* In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.<br>|
| Transcatheter aortic valve implantation, transfemoral access<br>Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transfemoral access route | Other: Whole blood analysis<br>* In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.<br>|
| Transcatheter aortic valve implantation, transapical access<br>Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transapical access route | Other: Whole blood analysis<br>* In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L) |  | Perioperative period ending after 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10) |  | Perioperative period ending after 48 hours postoperatively | 
| In-hospital mortality |  | In-hospital treatment until discharge (7-10 days) |