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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimized extracorporeal circulation | Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the minimized extracorporeal circulation (MECC, group 1) |
| |
| Conventional extracorporeal circulation | Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the conventional extracorporeal circulation (CECC, group 2) |
| |
| Transcatheter aortic valve implantation, transfemoral access | Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transfemoral access route |
| |
| Transcatheter aortic valve implantation, transapical access | Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transapical access route |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole blood analysis | Other | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria
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Patients with severe aortic valve stenosis selected for surgical aortic valve replacement or transcatheter aortic valve implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Frank Stüber, MD, Prof. | Dep. Anesthesiology and pain Therapy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. Anesthesiology and Pain Therapy | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D018746 | Systemic Inflammatory Response Syndrome |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D000082862 | Aortic Valve Disease |
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whole blood analysis
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |