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

UMC Utrecht

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT02371863

NL39865.041.14

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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