Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic MR

Study Overview
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Brief Summary
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Surgical treatment is the only approach with potentially defined clinical success for organic mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful MV repair is a clinical challenge in current practice. Especially when echo parameters at rest are within or near normal ranges and patients presenting disproportionately symptomatic in relation to the observed results. However, while MV regurgitation is a hemodynamic disease, currently used 2-dimensional (2D) transthoracic echocardiography (TTE) at rest lacks information about hemodynamic changes. Physical stress echocardiography is a promising technique to complement nowadays rest TTE in order to improve interpretation of hemodynamic changes. However, normal values for exercise echo are lacking in this postoperative patients cohort. A prospective, observational trial to determine normal values in stress echocardiographic parameters in asymptomatic patients after successful MV repair for organic MV regurgitation, is therefore highly needed. Purpose of the SEP- study is to determine normal values in stress echocardiographic parameters in asymptomatic patients at least 6 months after successful MV repair for organic MV regurgitation. These normal values for stress echo are of utmost importance to correctly and accurate interpret stress echo results during postoperative follow-up and to improve clinical decision making in patients post MV repair.

Official Title
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SEP-study; The Assessment of Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic Mitral Valve Regurgitation

Conditions
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Heart Valve Diseases, Mitral Valve Insufficiency, Heart; Dysfunction Postoperative, Cardiac Surgery, Heart; Disease, Mitral(Valve), Diseases of Mitral Valve

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years; Male or female from all ethnicities; At least 6 months post successful, isolated MV repair. S Asymptomatic Exclusion Criteria: Pulmonary hypertension >50 mmHg at rest; Atrial fibrillation (AF) at time of study related stress echo test; Known contraindication or incapability to perform peak exercise or inability to perform physical stress testing; LVEF <45%; NYHA class II and more. Other heart valve disease of more than mild severity; Concomitant surgery during MV repair, e.g. MAZE, TVP procedure; Prior heart valve surgery; Congenital heart disease; Disabling comorbidity, e.g. chronic obstructive pulmonary disease (COPD); Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic parameter: Peak mitral valve mean gradient (mmHg) | Echocardiographic measured mitral valve mean gradient at peak physical exercise | at least 6 months after successful MV repair | 
| Echocardiographic parameter: Peak systolic pulmonary artery pressure (sPAP, mmHg) | Echocardiographic measured sPAP at peak physical exercise | at least 6 months after successful MV repair | 
| Echocardiographic parameter: Increase in mitral valve regurgitation grade (grade 0-4, according to ESC guidelines) | Echocardiographic measured increase in mitral valve regurgitation at peak physical exercise during physical stress echo, compared to rest echo. Grading of mitral regurgitation will be performed according to the ESC guidelines. | at least 6 months after successful MV repair | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic parameter: Left ventricular function (LVF, quality description) | Echocardiographic measured LVF quality at rest and peak physical exercise | at least 6 months after successful MV repair | 
| Echocardiographic parameter: Mitral valve area (MVA, cm2) | Echocardiographic measured MVA at rest and peak physical exercise | at least 6 months after successful MV repair | 
| Echocardiographic parameter: Peak mitral valve peak gradient (mmHg) | Echocardiographic measured mitral valve peak gradient at peak physical exercise | at least 6 months after successful MV repair |