Inflammatory Response to Aortic Valve Replacement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reduced Inflammatory Response Using Transcatheter Aortic Valve Replacement as Compared to Conventional Surgery

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: Transarterial aortic valve implantation - TAVI
* Procedure: Surgical aortic valve replacement - SAVR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients eligible for aortic valve replacement without need for concurrent surgery Exclusion Criteria: known inflammatory disease and anti-inflammatory treatment
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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A case Control study were patients undergoing two surgical Methods for aortic valve repair is compared
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transarterial aortic valve implantation<br>Patients that are treated by trans arterial valve implantation (TAVI) | Procedure: Transarterial aortic valve implantation - TAVI<br>* 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.<br>|
| Active Comparator: Surgical aortic valve replacement<br>Patients that are treated by surgical aortic valve replacement (SAVR) | Procedure: Surgical aortic valve replacement - SAVR<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generation of several inflammatory markers measured through repeated blood samples | The total generation of several inflammatory markers is compared between the groups | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | ml blood loss compared between the groups | 24 hrs | 
| Blood transfusion | Number of blood Products tranfused after the procedure | 24 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, TAVI