The goal of this observational study is to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term. The study aims to: 1. Evaluate the effectiveness and safety of TEER versus surgery in patients with DMR over long term. 2. Investigate the predictors of left ventricular dysfunction and clinical outcomes using advanced imaging techniques, such as cardiac MRI 3. Assess patient-reported recovery and quality of life outcomes using validated tools. The study focuses on improving care strategies for patients with DMR, particularly those at higher surgical risk, by identifying optimal treatment approaches and predictors of recovery.
This is an ambispective, (prospective and retrospective) cohort study collecting clinical, procedural, and follow-up data to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term.
Study Type
OBSERVATIONAL
Enrollment
60
Smidt Heart Institute, Cedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGComposite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Composite of all-cause mortality, heart failure hospitalization, and valve re-intervention
Time frame: From procedure to 3 years after procedure
Percentage of Participants With Residual Mitral Regurgitation Greater Than 2+ by Transthoracic Echocardiography
Percentage of participants with residual mitral regurgitation greater than 2+ assessed by transthoracic echocardiography after surgical mitral valve repair or transcatheter edge-to-edge repair.
Time frame: At 30 days, 6 months, and 1 year after procedure
Left Ventricular Ejection Fraction by Transthoracic Echocardiography
Left ventricular ejection fraction, measured as percentage by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
Time frame: At 30 days, 6 months, and 1 year after procedure
Mean Mitral Valve Gradient by Transthoracic Echocardiography
Mean transmitral valve gradient, measured in mm Hg by transthoracic echocardiography, after surgical mitral valve repair or transcatheter edge-to-edge repair.
Time frame: At 30 days, 6 months, and 1 year after procedure
Kansas City Cardiomyopathy Questionnaire Overall Summary Score
Kansas City Cardiomyopathy Questionnaire overall summary score, measured on a 0 to 100 scale, will be used to assess patient-reported health status after surgical mitral valve repair or transcatheter edge-to-edge repair. Higher scores indicate better health status.
Time frame: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
Six-Minute Walk Test Distance
Functional capacity will be assessed using the 6-minute walk test distance, measured in meters.
Time frame: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
SF-36 Physical Component Summary Score
The SF-36 Physical Component Summary score will be used to assess patient-reported physical health status. Scores are reported as scale scores, with higher scores indicating better physical health status.
Time frame: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
SF-36 Mental Component Summary Score
The SF-36 Mental Component Summary score will be used to assess patient-reported mental health status. Higher scores indicate better mental health status.
Time frame: At baseline and at 2 weeks, 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of Participants With All-Cause Mortality
Percentage of participants with all-cause mortality after surgical mitral valve repair or transcatheter edge-to-edge repair.
Time frame: At 30 days, 6 months, 1 year, and 5 years after procedure
Percentage of Participants With Heart Failure Hospitalization
Percentage of participants hospitalized for heart failure after surgical mitral valve repair or transcatheter edge-to-edge repair.
Time frame: At 30 days, 6 months, 1 year, and 5 years after procedure
Mitral Valve Reintervention
Percentage of participants requiring mitral valve reintervention after surgical mitral valve repair or transcatheter edge-to-edge repair.
Time frame: At 30 days, 6 months, 1 year, and 5 years after procedure
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