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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve geometry and hypo-atrenuated leaflet thickening. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac CT imaging | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-dimensional volume-rendered computed tomography | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regional expansion of valve prosthesis | Regional expansion measured using the angle formed by the border of each prosthetic leaflet and the centre point of the valve | At CT performed once no less than 30 days and up to 10 years after aortic valve replacement |
| Overall expansion of valve prosthesis | Overall expansion of the implanted prosthesis calculated as the ratio between the ex vivo cross-sectional area and the in vitro cross-sectional area of the implanted valve | At CT performed once no less than 30 days and up to 10 years after aortic valve replacement |
| Measure | Description | Time Frame |
|---|---|---|
| Eccentricity of valve prosthesis | Eccentricity of the implanted prosthesis calculated as ([max diameter-min diameter]/max diameter)Ă—100 | At CT performed once no less than 30 days and up to 10 years after aortic valve replacement |
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Inclusion Criteria:
Exclusion Criteria:
•Contraindication for CT with intravenous contrast injection
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Dalén, MD PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31950251 | Derived | Themudo R, Kastengren M, Bacsovics Brolin E, Cederlund K, Svensson A, Dalen M. Leaflet thickening and stent geometry in sutureless bioprosthetic aortic valves. Heart Vessels. 2020 Jun;35(6):868-875. doi: 10.1007/s00380-020-01553-9. Epub 2020 Jan 16. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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