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The pilot prospective randomized trial is designed to determine the safety and feasibility of enrolling patients to surgically correct residual Mitral Regurgitation (MR) following Percutaneous Coronary Intervention (PCI) for Myocardial Infarction (MI) verses ongoing medical management of MR. The investigators hypothesize that correcting the MR in this patient subset would result in improved outcomes as measured by decreased number of major adverse cardiac events, including death, congestive heart failure requiring hospitalization, atrial fibrillation, deterioration of New York Heart Association (NYHA) functional status and improved quality of life.
The proposed study poses the fundamental question: is mitral valve repair associated with a survival benefit for patients with moderate mitral regurgitation after percutaneous coronary intervention for acute myocardial infarction? We hypothesize that correcting the mitral regurgitation in this patient subset would result in improved outcomes as measured by decreased number of major adverse cardiac events, including death, congestive heart failure requiring hospitalization, atrial fibrillation, deterioration of New York Heart Association (NYHA) functional status and quality of life. Our current proposal is a pilot prospective randomized trial of medical versus surgical management of patients with moderate MR after PCI for acute MI, specifically designed to test the safely and feasibility of the proposed strategy with the following three specific aims:
1. Identify potential obstacles to reimbursement of the surgical procedure proposed. Medicare guidelines do not exclude payment for surgery to repair moderate MR. The procedure is considered billable based on the surgeon's determination of medical need. The AHA/ACC guidelines acknowledge that revascularization alone does not abolish MR in many patients and that mitral valve annuloplasty is an effective treatment for MR in these circumstances. Third party payer insurance typically follows Medicare guidelines for reimbursement. Many surgeons are already performing mitral valve repair in the setting of CABG. Surgery for moderate MR should be a reimbursable procedure based on AHA/ACC guidelines. We will be, in this feasibility study, identifying any potential obstacles to reimbursement.
2. Establish feasibility and identify obstacles for enrolling patients in the trial. The invasive nature of the open cardiac surgery operation with its associated morbidity and mortality risks in the face of little patient symptomatology may be a strong deterrent to patient enrollment. Therefore, to address this potential problem, we have included plans for education of patients and referring physicians regarding the poor long term prognosis these patients face with an average mortality of 50% at 5 years (comparable to some cancers). This strategy would be instrumental for study recruitment. The availability of an effective treatment modality to correct MR makes the study possible from a technical standpoint. The literature from the 1970s on the subject of patient randomization to medical versus surgical management of stable and unstable coronary artery disease reports adequate patient recruitment for the proposed objectives and offers valuable insight regarding the feasibility of our proposal with respect to patient recruitment.
3. Establish the safety of mitral valve repair in the study population by documenting routine intraoperative variables and postoperative outcomes. In addition, we have developed a stopping rule for the trial if early (in-hospital) mortality for the surgical arm exceeds our pre-specified cut-off of 5% based on the method proposed by Kramar and Bascoul-Mollevi. A data and safety monitoring board (DSMB) that includes five independent investigators and a statistician has been established to ensure the safety of all participants involved in the study. The committee will evaluate the progress of the trial including participant recruitment, data quality, and risk versus benefit. They will also consider any interval developments that could have an impact of the ethics of the study.
Results of this study could lead to a radical change in the treatment paradigm for patients with ischemic MR following PCI for acute MI. In addition, insight gained from this study could advance our understanding of the interrelationship between LV remodeling and MR and shed some light into the mechanism of ventricular function deterioration following MI. Moreover, it may provide a framework for the development of further recommendations with respect to the indications for surgical intervention in this patient population.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
surgical mitral valve repair w/ mitral valve annuloplasty
Southern Illinois University School of Medicine
Not yet recruiting
Southern Illinois University
Published on BioPortfolio: 2014-08-27T03:12:25-0400
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