Mitral Regurgitation
Conditions
Keywords
mitral regurgitation, echocardiography, MRI
Brief summary
Current American College of Cardiology/American Heart Association guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach.
Detailed description
Current ACC/AHA guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. There are those who advocate for performing early prophylactic mitral valve surgery while others advocate clinical follow-up until triggers emerge with echocardiography historically being the method used for longitudinal assessment of cardiac anatomy and function. Two studies showed that only \ 30% of asymptomatic severe mitral regurgitation made endpoints that triggered. However, these studies were limited and did not perform rigorous follow up assessment of regurgitant volume, left ventricular hemodynamics, exercise capacity, or quality of life assessment. In addition, in these studies mitral regurgitation and left ventricular size and function was assessed by echocardiography. Echocardiography has known limitations in assessing ventricular size and, as recent studies have shown, may not be the optimal modality to assess mitral regurgitant severity. MRI is the gold standard for non-invasive quantification of the left and right ventricles volumes and function and has emerged as a reference standard for quantifying mitral regurgitation. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach.
Interventions
None listed
Sponsors
Atlantic Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>=18 yrs 2. able to give informed consent 3. Diagnoses of moderate or severe degenerative mitral regurgitation (based on the integrated approach recommended by the American Society of Echocardiography)
Exclusion criteria
1. Left ventricular ejection fraction \<60% 2. Heart failure 3. Pulmonary hypertension (pulmonary artery systolic pressure \>40mmHg at rest or \>60mmHg with exercise as assessed by echocardiography) 4. Atrial fibrillation 5. Concomitant \> mild aortic or mitral stenosis, \>mild aortic or tricuspid or pulmonic regurgitation 6. Prior valvular heart disease surgery 7. Hypertrophic cardiomyopathy or an infiltrative cardiomyopathy 8. Unable to exercise on a treadmill 9. Symptomatic coronary artery disease 10. Comorbidities expected to impact functional capacity and confound symptom assessment (e.g COPD) 11. Expected lifespan of less than 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mitral regurgitant volume | Entry into study, 1 year, and 2 years | Change in mitral regurgitant volume quantified by MRI over follow-up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular end-diastolic volume | Entry into study, 1 year, and 2 years | Change in left ventricular end-diastolic volume quantified by MRI over follow-up period |
| Change in symptoms and quality | Entry into study, 1 year, and 2 years | Change in symptoms and quality of life as measured by EQ5DL questionnaires |
| Change in exercise capacity | Entry into study, 1 year, and 2 years | Change in exercise capacity measured by treadmill exercise test |
| Follow up events | 1 yea, and 2 years | Follow up events defined as death, need for surgery, heart failure symptoms, or valvular disease related hospitalizations |
| Change in degree of myocardial fibrosis | Entry into study, 1 year, and 2 years | Change in degree of myocardial fibrosis measured as the percentage left ventricular hyperenhancement and change in mean ECV |
Countries
United States
Contacts
Primary ContactSETH URETSKY, MD
Outcome results
None listed