Dutch-AMR Study: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Organic Mitral Regurgitation and Preserved Ejection Fraction: a Multicenter Registry Trial
Objective: To compare early MV repair versus watchful waiting in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function. Study design: Multicenter, registry trial. Study population: 250 Asymptomatic patients (18-75 years old) with severe organic MV regurgitation and preserved left ventricular function. The current European Society of Cardiology (ESC) guidelines on Valvular Heart Disease will be applied \[3\]. These guidelines are also used in the Netherlands. Accordingly, patients with an indication for MV surgery will not be included. Intervention: Intervention will be early MV repair compared to a watchful waiting strategy.
• 18-75 years.
• Asymptomatic patients. Asymptomatic is defined as absence of subjective limitations of exercise capacity or complaints expressed by the patient and confirmed by the treating cardiologist.
• Severe organic mitral valve regurgitation. Severe organic mitral valve regurgitation is defined as non-ischemic mitral valve regurgitation with an organic cause (intrinsic valve lesion) as determined by echocardiographic core-lab reading based on the criteria for definition of severe MR as issued by the ESC guidelines \[4\]. For practical reasons, referring cardiologists can use an ESC guidelines based index that was validated in the investigator's core-lab (Jansen et al, Practical echocardiographic semi-quantitative scoring system to determine severity of mitral regurgitation. Abstract presentation at ESC EUROECHO Congress 2011 and annual spring congress 2012 Netherlands Society of Cardiology).
• Preserved left ventricular function, Preserved left ventricular function is defined as left ventricular ejection fraction \>60% and left ventricular end-systolic dimension \<45 mm (no indexed value, measured by echocardiography).
• The likelihood of MV repair should be more than 90% determined by the local heart team with a cardiologist and cardiothoracic surgeon.