4D- Flow- MRI After Aortic Valve Surgery

Deutsches Herzzentrum Muenchen30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Valve Disease

Interventions

TriRecPROCEDURE

Trileaflet Reconstruction of the Aortic Valve

Aortic valve replacementPROCEDURE

Biological Prosthesis, Device: Edwards Perimount

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Deutsches Herzzentrum Muenchen, Department of Cardiovascular Surgery

Munich, Germany

RECRUITING

Outcomes

Primary Outcomes

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.