4D- Flow- MRI After Aortic Valve Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Changes of Aortic Flow Patterns Detected by 4D- Flow- MRI After Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium Compared to Prosthetic Valve Replacement With Biological Prosthesis

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Procedure: TriRec
* Procedure: Aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 50 years Documented symptomatic moderate or greater aortic stenosis or severe aortic insufficiency Aortic annulus > 19 mm Written informed consent of the patients. Exclusion Criteria: Concomitant intervention of the aortic root, ascending aorta or aortic arch Concomitant valve surgery Emergency surgery for any reason Neurological events (i.e. stroke, TIA) within the previous 6 months Coagulation disorders (including thrombocytopenia < 100.000/ml) Porcelain aorta/severe calcification of the ascending aorta Active endocarditis or other active systemic infections Participating in another trial that may influence the outcome of this trial Pregnancy Dual antiplatelet therapy Previous cardiac surgery (excluding percutaneous procedures) Contraindication for MRI- examinations

Ages Eligible for Study
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Minimum Age: 50 Years

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TriRec<br>Trileaflet Reconstruction of the Aortic Valve | Procedure: TriRec<br>* Trileaflet Reconstruction of the Aortic Valve<br>|
| Experimental: Aortic valve replacement<br>Biological prosthesis, Device: Edwards Perimount | Procedure: Aortic valve replacement<br>* Biological Prosthesis, Device: Edwards Perimount<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic stenosis, aortic regurgitation, Trileaflet reconstruction of the aortic valve, Biological aortic valve prosthesis, aortic flow patterns, MRI