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January 6, 2020

Multisociety Expert Systems of Care Document Addresses Transcatheter Mitral Valve Intervention

January 6, 2020—A report on transcatheter mitral valve intervention (TMVI) issued by the American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), Society for Cardiovascular Angiography and Interventions (SCAI), and Society of Thoracic Surgeons (STS) was recently accepted for publication. The preproof version of the report by Robert O. Bonow, MD, et al (“2019 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Mitral Valve Intervention”) is available online ahead of print in Journal of the American College of Cardiology.

On the ACC website, Sarah Gualano, MD, outlines the document’s 13 key points, which address the challenges of TMVI as a “rapidly evolving field with evolution in indications, equipment, technique, and clinical outcomes.”

First, Dr. Gualano noted the document’s purpose, stating, “[T]he primary goal of the updated 2019 recommendations is to promote optimal quality outcomes while balancing the need for access to innovative therapies for TMVIs. The structural measures of quality include the requirement that operators and institutions have the skills, experience, foundational surgical volume, and facilities that are fundamental to performing TMVI.”

Secondly, she summarizes the document’s stated scope: “This 2019 expert consensus focuses on the treatment(s) for a given patient rather than focusing on a particular type of intervention. Although the edge-to-edge clip repair device is the only FDA-approved device for transcatheter mitral valve repair, the authors acknowledge the introduction of transcatheter mitral valve replacement in the future. Adherence to these guidelines should maximize the likelihood of incorporating future therapies.”

Other summary points include the foundational importance of a multidisciplinary team for TMVI, the evolution of TMVI training (which should adhere to FDA approval requirements), and that sites incorporate methods and processes that promote patient-centered care with informed shared decision making.

Additionally, Dr. Gualano highlights the recommendation that the principal outcome measures for TMVI should mirror those for surgical mitral valve intervention. The document specifies experience requirements for new TMVI sites and existing transcatheter mitral valve repair programs, as well as the need for TMVI sites to document certain resources and ongoing percutaneous coronary intervention experience. Also, the recommendations call for institutions to have an active cardiac surgery program supported by at least two institutionally based cardiac surgeons and a full complement of diagnostic and therapeutic facilities.

In the report’s conclusions, Dr. Bonow and colleagues state, “Transcatheter interventions for patients with severe mitral regurgitation are expected to increase sharply in the years ahead. The prior 2014 multisociety document was published just 1 year after FDA approval of the edge-to-edge clip device for treatment of prohibitive surgical risk patients with severe primary mitral regurgitation and, thus, could not provide much granularity. The interim experience with the edge-to-edge clip device for mitral valve repair as reported to the STS/ACC TVT Registry and described in landmark randomized clinical trials (RCTs) allows for greater clarity regarding standard setting for this specific intervention. Additional perspectives on surgical mitral valve repair or replacement have been gained from registry analyses and RCTs.”

They continue, “Newer transcatheter systems for the treatment of severe mitral regurgitation are anticipated, and it is expected that the proposed requirements herein will need to evolve with further advances in equipment, techniques, and patient selection. Nevertheless, the guiding principles and foundational elements included in this and companion multisociety documents constitute an enduring commitment to optimizing patient outcomes.”

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