Inflammatory Response in Aortic Valve Replacement

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Inflammation; Aortic Valve Stenosis; Systemic Inflammatory Response Syndrome; Thoracic Surgery

Treatments: Other: Whole blood analysis

Study type: Observational

Funder types: Other

Identifiers

NCT02324140

041/09_2

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

101 participants in 4 patient groups

Minimized extracorporeal circulation

Description:

Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the minimized extracorporeal circulation (MECC, group 1)

Treatment:

Other: Whole blood analysis

Conventional extracorporeal circulation

Description:

Patients with severe aortic valve stenosis undergoing surgical aortic valve replacement using the conventional extracorporeal circulation (CECC, group 2)

Treatment:

Other: Whole blood analysis

Transcatheter aortic valve implantation, transfemoral access

Description:

Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transfemoral access route

Treatment:

Other: Whole blood analysis

Transcatheter aortic valve implantation, transapical access

Description:

Patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation using the transapical access route

Treatment:

Other: Whole blood analysis