Long Term Follow Up for CTSN Mitral Valve Repair Studies
Long Term Follow Up for CTSN Mitral Valve Repair Studies
This study is a continuation of two previous studies --- the Severe Ischemic Mitral
 Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR)
 Trial (NCT00806988) --- to learn more about patients' health 5-10 years after their mitral
 valve surgeries. The investigators will collect long-term health information on SMR and MMR
 trial participants using electronic medical records, patient and/or family input, public
 records, and healthcare- and vital status-related databases.
This study is a continuation of two CTSN randomized trials --- the Severe Ischemic Mitral
 Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR)
 Trial (NCT00806988) --- for the purpose of assessing the long-term outcomes of the index
 surgical therapies. Key clinical outcomes will be collected utilizing electronic medical
 records, patient and/or family input, public records, and healthcare- and vital
 status-related databases. Extended follow-up data will be obtained on up to 199 SMR and 270
 MMR trial participants, who were alive at their 2-year follow-up evaluation. Patients will be
 followed for a minimum of 5 years and up to 10 years after randomization (the time of index
 surgical procedure). This follow-up data collection will be conducted by the Cardiothoracic
 Surgical Trials Network (CTSN) primarily utilizing the minimal PHI necessary to link data
 obtained from the MMR and SMR trials to other healthcare- and/or vital status-related
 databases.

 Because the design of surgical trials for ischemic mitral regurgitation that would use
 mortality as a primary endpoint requires the enrollment of thousands of patients, the
 selected primary endpoint for the CTSN SMR and MMR trials was an echocardiographic measure of
 left ventricular remodeling. Secondary endpoints included, among others, survival, adverse
 events, readmissions and costs over a 2-year period. The SMR trial showed no difference in
 left ventricular reverse remodeling, but the rate of moderate or severe mitral regurgitation
 recurrence was significantly higher with mitral valve repair, resulting in more heart
 failure-related adverse events and cardiovascular admissions. Longer-term follow-up will be
 critical to assess whether this observed trend amongst SMR patients will continue and whether
 a survival difference will manifest over time. In moderate ischemic mitral regurgitation,
 mitral valve repair provided a more durable correction of mitral regurgitation than coronary
 artery bypass grafting (CABG) alone, but repair did not improve survival or reduce overall
 adverse events or readmissions, and was associated with an early hazard of neurological and
 supraventricular arrhythmic events. Longer-term follow-up of MMR patients will provide
 insights into whether the higher degree of recurrent mitral regurgitation with CABG alone
 will be associated with differences in adverse events, readmissions and survival.
 Additionally, the benefits of alternative surgical treatments for ischemic mitral
 regurgitation, which have differential upfront risks and costs, will likely extend beyond 2
 years. Cost-effectiveness analysis will delineate the long-term cost-benefit trade-offs
 between mitral valve repair versus replacement for SMR, and of CABG with repair versus CABG
 alone for MMR, which should inform surgical decision making, and examine how differences in
 life expectancy and risk profiles of different patient groups affect cost-effectiveness over
 time. This extended follow-up should provide important clinical and health policy insights.
Inclusion Criteria:

 -  Randomized patients in the MMR and SMR trials who were still alive at 2 years after
 the index cardiac surgical intervention

 Exclusion Criteria:

 -  Patients participating in the MMR and SMR trials who withdrew consent prior to the
 2-year follow-up evaluation