Aortic Valve Stenosis
Conditions
Keywords
Cardiac surgery, TAVI
Brief summary
A controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. As a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal TAVI.
Detailed description
18 patients admitted successively for conventional surgical aortic valve replacement and 18 patients admitted for transcatheter aortic valve implantation (TAVI) (9 transfemoral and 9 transaortic) are included. A plasma sample is obtained at defined timepoints before, during and after surgery. At each time points the following biomarkers are analyzed:Concentrations of the complement activation products C3bc and the terminal C5b-9 complement complex (TCC), the neutrophil release product myeloperoxidase (MPO), the cytokines IL-6, eotaxin, MCP-1 and MIP-1β (12). As marker of a myocardial cellular injury troponin T levels will be analyzed. The following clinical outcomes will also be monitored: Death (in hospital, 30 day and one year), blood transfusion, stroke, myocardial infarction. A dedicated registry will be established at the hospital according to the hospital's standard for storage of patient data. The registry will be deleted after completion of the study.
Interventions
PROCEDURETransarterial aortic valve implantation - TAVI
After insertion of a guidewire, either through the femoral artery or through the ascending aorta, the aortic ostium is dilated by a balloon and the valve is introduced through a catheter and expanded in the ostium.
PROCEDURESurgical aortic valve replacement - SAVR
The patient is operated through a sternotomy and coupled to a heart lung machine. The aorta is opened and the native valve excised. Then a biological artificial heart valve is sutured in place.
Sponsors
University of Oslo
Oslo University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A case Control study were patients undergoing two surgical Methods for aortic valve repair is compared
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients eligible for aortic valve replacement without need for concurrent surgery
Exclusion criteria
* known inflammatory disease and anti-inflammatory treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generation of several inflammatory markers measured through repeated blood samples | 24 hours | The total generation of several inflammatory markers is compared between the groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | 24 hrs | ml blood loss compared between the groups |
| Blood transfusion | 24 hrs | Number of blood Products tranfused after the procedure |
Outcome results
None listed