Aortic Valve Disease
Conditions
Keywords
aortic stenosis, aortic regurgitation, Trileaflet reconstruction of the aortic valve, Biological aortic valve prosthesis, aortic flow patterns, MRI
Brief summary
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
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.
Interventions
PROCEDURETriRec
Trileaflet Reconstruction of the Aortic Valve
PROCEDUREAortic valve replacement
Biological Prosthesis, Device: Edwards Perimount
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow velocity in the ascending aorta (m/s) | Day 4-7 post surgery | Flow velocity in meters/ second in the ascending aorta in patients receiving either TriRec or biological prosthetic valve replacement measured by 4D- Flow- MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flow helicality | Day 4-7 post surgery | Blood revolving around an axis parallel to the main blood flow generating a corkscrew like figure |
| Systolic eccentricity | Day 4-7 post surgery | Localization of the main blood flow vector (central, little, severe eccentricity). |
| Flow patterns in the left ventricular outflow tract. | Day 4-7 post surgery | Flow patterns in the left ventricular outflow tract. |
| Effective orifice area (4D-Flow-MRI) | Day 4-7 post surgery | Effective orifice area (cm2) of the reconstructed or replaced valve (4D- Flow- MRI) |
| Effective orifice area (TTE) | Day 4-7 post surgery | Effective orifice area (cm2) of the reconstructed or replaced valve (transthoracic echocardiography (TTE) |
| Flow vortices | Day 4-7 post surgery | Flow vortices: defined as rotating particles around a point within the vessel with the rotational direction diverting \> 90° from the physiological flow direction. |
| Left- ventricular diameters (mm, TTE) | Day 4-7 post surgery | Left- ventricular diameters (mm, TTE) |
| Left- ventricular ejection fraction (%, TTE) | Day 4-7 post surgery | Left- ventricular ejection fraction (%, TTE) |
| Quantification of aortic regurgitation (MRI) | Day 4-7 post surgery | Quantification of aortic regurgitation (MRI) |
| Quantification of aortic regurgitation (TTE) | Day 4-7 post surgery | Quantification of aortic regurgitation (TTE) |
| Peak- and mean pressure gradients (mmHg, TTE) | Day 4-7 post surgery | Peak- and mean pressure gradients (mmHg, TTE) |
Countries
Germany
Contacts
Primary ContactAnatol Prinzing, MD
Outcome results
None listed