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This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement with biological prosthesis. The hypothesis is that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis.
Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) is a new treatment option for diseased aortic valves and offers benefits compared to conventional valve replacement. At the moment no prospective randomized trials evaluating the role of the TriRec procedure are available and factors contributing to long- term durability are unknown.
The investigators want to examine aortic flow patterns with 4D- Flow- Magnetic Resonance Imaging (MRI) in patients after the TriRec procedure or biological prosthetic valve replacement in a prospective randomized trial. Flow patterns in the ascending aorta, examined with 4D- Flow- MRI, show nearly laminar flow patterns and no outflow obstruction in healthy subjects with tricuspid aortic valves. In contrast, helical flow patterns, turbulences and increased flow velocities are observed in diseased valves and also after valve replacement with mechanical or biological prostheses. These helical flow patterns seem to influence aortic wall remodeling and may contribute to structural valve dysfunction of biological prosthesis.
The investigators hypothesize that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis. The results can contribute to understand mechanisms for long- term performance of this technique and determine the role of this novel technique for treatment of aortic valve disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TriRec | Experimental | Trileaflet Reconstruction of the Aortic Valve |
|
| Aortic valve replacement | Experimental | Biological prosthesis, Device: Edwards Perimount |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TriRec | Procedure | Trileaflet Reconstruction of the Aortic Valve |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Flow velocity in the ascending aorta (m/s) | Flow velocity in meters/ second in the ascending aorta in patients receiving either TriRec or biological prosthetic valve replacement measured by 4D- Flow- MRI. | Day 4-7 post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Flow vortices | Flow vortices: defined as rotating particles around a point within the vessel with the rotational direction diverting > 90° from the physiological flow direction. | Day 4-7 post surgery |
| Flow helicality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anatol Prinzing, MD | Contact | +49891218 | 2777 | prinzing@dhm.mhn.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Muenchen, Department of Cardiovascular Surgery | Recruiting | Munich | 80636 | Germany |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Aortic valve replacement |
| Procedure |
Biological Prosthesis, Device: Edwards Perimount |
|
Blood revolving around an axis parallel to the main blood flow generating a corkscrew like figure
| Day 4-7 post surgery |
| Systolic eccentricity | Localization of the main blood flow vector (central, little, severe eccentricity). | Day 4-7 post surgery |
| Flow patterns in the left ventricular outflow tract. | Flow patterns in the left ventricular outflow tract. | Day 4-7 post surgery |
| Effective orifice area (4D-Flow-MRI) | Effective orifice area (cm2) of the reconstructed or replaced valve (4D- Flow- MRI) | Day 4-7 post surgery |
| Effective orifice area (TTE) | Effective orifice area (cm2) of the reconstructed or replaced valve (transthoracic echocardiography (TTE) | Day 4-7 post surgery |
| Peak- and mean pressure gradients (mmHg, TTE) | Peak- and mean pressure gradients (mmHg, TTE) | Day 4-7 post surgery |
| Left- ventricular diameters (mm, TTE) | Left- ventricular diameters (mm, TTE) | Day 4-7 post surgery |
| Left- ventricular ejection fraction (%, TTE) | Left- ventricular ejection fraction (%, TTE) | Day 4-7 post surgery |
| Quantification of aortic regurgitation (MRI) | Quantification of aortic regurgitation (MRI) | Day 4-7 post surgery |
| Quantification of aortic regurgitation (TTE) | Quantification of aortic regurgitation (TTE) | Day 4-7 post surgery |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |