Inflammatory Response in Aortic Valve Replacement

Insel Gruppe AG, University Hospital Bern101 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

101

Conditions

Inflammation Systemic Inflammatory Response Syndrome Thoracic Surgery Aortic Valve Stenosis

Interventions

Whole blood analysisOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Dep. Anesthesiology and Pain Therapy

Bern, Switzerland

Outcomes

Primary Outcomes

Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L)

Time frame: Perioperative period ending after 48 hours postoperatively

Secondary Outcomes

Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10)

Time frame: Perioperative period ending after 48 hours postoperatively

In-hospital mortality

Time frame: In-hospital treatment until discharge (7-10 days)

Data from ClinicalTrials.gov

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