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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transarterial aortic valve implantation | Experimental | Patients that are treated by trans arterial valve implantation (TAVI) |
|
| Surgical aortic valve replacement | Active Comparator | Patients that are treated by surgical aortic valve replacement (SAVR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transarterial aortic valve implantation - TAVI | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Fosse, MD PhD | Oslo University Hospital/University of Oslo | Principal Investigator |
| Karoline KH Fiane, Med Student | University of Oslo | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29233022 | Derived | Fiane KKH, Dahle G, Bendz B, Halvorsen PS, Abdelnoor M, Mollnes TE, Fosse E. Reduced inflammatory response by transcatheter, as compared to surgical aortic valve replacement. Scand Cardiovasc J. 2018 Feb;52(1):43-50. doi: 10.1080/14017431.2017.1416157. Epub 2017 Dec 12. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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A case Control study were patients undergoing two surgical Methods for aortic valve repair is compared
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| Surgical aortic valve replacement - SAVR | Procedure | 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. |
|
| 24 hrs |
| D014694 |
| Ventricular Outflow Obstruction |