Transcatheter therapies for mitral regurgitation: A professional society overview from the American College of Cardiology, the American Association for Thoracic Surgery, Society for Cardiovascular Angiography and Interventions Foundation, and the Society of Thoracic Surgeons

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. 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 FDA approval for use of this device in eligible U.S. patients with degenerative MR. Further research involving awider spectrum of patients and devices is strongly encouraged. It is recognized that the intricate structure and complex function of the mitral apparatus pose challenging technical hurdles. It is imperative that professional societies, industry, payers, and regulatory agencies work collaboratively to promote needed research and ensure that the technology is disseminated rationally and responsibly in the best interests of patients. The following recommendations for a path forward closely mirror those enunciated in a previous ACCF/STS Societal Overview. The leadership of our organizations proposes: 1. 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. 2. 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, and 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. 3. All centers are required to participate in an ongoing 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. 4. Operator training and credentialing criteria for mitral valve procedures must be established and are the subject of a joint professional competency document in development. 5. 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 (NCT01626079) will address the role of the MitraClip device in high surgical risk patients with functional MR. The ACC, AATS, SCAI, and STS are committed to the principle of working collaboratively together as professional societies and in partnership with the FDA, CMS, and industry partners to bring promising, innovative mitral valve technologies into clinical practice as validated by the evidence and in the best interests of patients.