Transcatheter Therapies for Mitral Regurgitation: A Professional Society Overview From the American College of Cardiology, American Association for Thoracic Surgery, Society for Cardiovascular Angiography and Interventions Foundation, and the Society of Thoracic Surgeons
The following are 10 points to remember about this overview on transcatheter therapies for mitral regurgitation (MR):
1. Transcatheter therapies hold promise for the management of carefully selected patients with severe MR using less invasive means whereby the experience of care may be improved.
2. Although registry experience in the United States and Europe has been encouraging, only a single randomized trial using a specific device in patients with MR has been reported, with recent Food and Drug Administration (FDA) approval for use of this device in eligible US patients with degenerative MR. Further research involving a wider spectrum of patients and devices is strongly encouraged.
3. The Heart Team approach is now an established paradigm for the care of patients with complex coronary or valvular heart disease. The key members of the Heart Team for transcatheter therapies for MR include primary (general) cardiologists, interventional cardiologists, cardiac surgeons, imaging specialists, valve and heart failure specialists, electrophysiologists, cardiac anesthesiologists, catheterization laboratory technologists, perfusionists, nurses, nurse practitioners, physician assistants, care coordinators, research coordinators, administrators, nutritionists, physical therapists, exercise physiologists, and social workers.
4. A cardiac catheterization laboratory with adequate space (~800 sq ft) to accommodate the operators, imagers, cardiac anesthesiologists, support staff, and their necessary equipment (including transesophageal echocardiography, anesthesia machines, intra-aortic balloon pumps) is mandatory. A hybrid operating suite is not strictly necessary for mitral procedures at this stage of development, but laminar air flow to provide operating room level sterility is mandatory.
5. There is need for continued development of regional heart valve referral centers of excellence. Criteria for the performance of transcatheter therapy for MR in such centers should be established and refined. Availability of new devices and reimbursement for their application should be limited to those centers that meet national criteria.
6. A heart valve referral center of excellence is defined in part by the competence and experience of the individual members of a dedicated, multidisciplinary heart team, each of whom has a clearly defined role and works collaboratively in the best interest of patients. Input is required from general cardiologists, heart valve and heart failure experts, advanced imagers, interventionalists, cardiac surgeons, and allied members of the heart team (e.g., anesthesia, geriatrics, neurology, nephrology, nursing, care coordination, pharmacy, physical therapy, social work). All aspects of patient evaluation and care must be addressed, including late follow-up. Lack of dedicated care pathways should disqualify a center from participation.
7. All centers are required to participate in the ongoing transcatheter valve therapy (TVT) registry to benchmark quality and enable outcomes and cost analysis, as well as comparative effectiveness research. Data quality, as well as productivity in publication of research projects from the registry, should be monitored.
8. Operator training and credentialing criteria for mitral valve procedures must be established, and are the subject of a joint professional competency document in development.
9. Guidelines for transcatheter mitral valve interventions should be substantiated and developed. Performance measures and appropriate use criteria would follow. Presently, the MitraClip is approved only for prohibitive surgical risk patients with degenerative MR who meet anatomic eligibility criteria. The COAPT trial will address the role of the MitraClip device in high surgical risk patients with functional MR.
10. It is imperative that professional societies, industry, payers, and regulatory agencies work collaboratively to promote needed research and ensure that this new technology is disseminated rationally and responsibly in the best interests of patients.
Keywords: Cooperative Behavior, Follow-Up Studies, Geriatrics, Mitral Valve Insufficiency, Cardiac Catheterization, Referral and Consultation, Nurse Practitioners, Comparative Effectiveness Research, Thoracic Surgery, Europe, Angioplasty, Balloon, Coronary, Registries, Bicarbonates, Coronary Angiography, Gases, Physical Therapists, Heart Failure, Cardiovascular Diseases, Heart Valve Diseases, Physician Assistants, United States, Echocardiography, Transesophageal
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