Guidance Document Issued on Transcatheter Therapies for Mitral Regurgitation


November 25, 2013—An overview of transcatheter therapies for mitral regurgitation (MR) was jointly issued by the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS).

“Transcatheter Therapies for Mitral Regurgitation" is available on the websites of the ACC (www.cardiosource.org), AATS (www.aats.org), SCAI (www.scai.org) and STS (www.sts.org). It will also be published in future print issues of The Journal of the American College of Cardiology, AATS’s Journal of Thoracic and Cardiovascular Surgery, SCAI’s Catheterization and Cardiovascular Interventions, and STS’s The Annals of Thoracic Surgery.

According to an announcement from the ACC, the document is intended to help frame subsequent discussions among the various stakeholders. It highlights critical issues that should be considered as the technologies are integrated into clinical practice and examines the responsible dissemination of these transcatheter therapies. Specifically, the overview discusses critical components of the technologies, operator training, protocols for care, and assessment of outcomes.

John H. Calhoon, MD, and Patrick O’Gara, MD, are cochairs of the overview. Dr. Calhoon is Professor and Chair of Cardiothoracic Surgery at The University of Texas Health Science Center at San Antonio. Dr. O’Gara is Director of Clinical Cardiology at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School in Cambridge, Massachusetts.

In the ACC press release, Dr. Calhoon commented, “The authors and societies envision this document serving as a broad guideline for the responsible deployment of these new therapies for our patients and teams. With this overview as a foundation, our societies will plan future documents to address appropriate data collection and use, best practices, team composition, and further definition of patient characteristics.”

The ACC noted that the US Food and Drug Administration recently approved the use of the MitraClip (Abbott Vascular, Santa Clara, CA) for the treatment of highly selected patients with severe, degenerative MR who are considered to be at prohibitive risk for open surgery by an experienced heart team. Additionally, several other technologies to reduce MR, including annuloplasty devices and neochordal implants, are in various stages of development. The societies note that these therapies will likely have a significant impact on the care of selected patients with MR, just as transcatheter aortic valve replacement (TAVR) has for patients with aortic stenosis.

In the press release, Dr. O’Gara noted, “Both TAVR and transcatheter MR therapies represent transformative technologies that can extend care to select populations of patients considered prohibitive risk for open surgery. The lessons learned from the dissemination of TAVR will help guide a similar process for the integration of these transcatheter therapies for severe MR into clinical practice.”

As summarized by the ACC, the societal overview examines both the talent and technology necessary for successful transcatheter MR therapies. Citing the landmark SYNTAX trial, the overview states that the heart team is crucial. This team-based approach to cardiac care involves many practitioners, including primary cardiologists, interventional cardiologists, cardiac surgeons, imaging specialists, and nurses, among others. The overview also advises that transcatheter MR therapies should be performed only at regional heart centers that have a high volume of heart valve procedures. Because patient outcomes vary inversely with operator volume, the societies suggested that new transcatheter MR devices should only be available to high-volume centers that have met national criteria.

Regarding care protocols, the overview states that specific protocols for pre-, intra-, and postprocedural patient assessment and care should be put in place, as well as strategies to manage complications. Evaluation should include assessment of mitral valve anatomy and function, cardiac chamber sizes, biventricular function, pulmonary artery pressures, and any concomitant aortic or tricuspid valve pathology. Care protocols should include clear delineation of the various roles of the Heart Team members. In addition, patients should be transferred to a specialized cardiac/surgical intensive care unit after a procedure, where the team can provide optimal and coordinated care.

The overview stresses that the professional societies must set minimal performance standards with the adoption of transcatheter MR therapies, and they should be developing the training curriculum, establishing metrics for evaluation, and certifying completion of the training module.

Furthermore, the authors advocated careful data collection, analysis, and reporting through the new STS/ACC Transcatheter Valve Therapy (TVT) Registry, which was created in December 2011 to benchmark quality, enable cost analysis, and support comparative effectiveness research. As these data are interpreted and reported, the authors noted that indications and appropriate use criteria should be developed.

“Our societies embrace a process of integrating these new therapies into practice in a way that will ensure high-quality, patient-centric care provided by an experienced heart team with participation in a national registry to inform best practices,” concluded Dr. O’Gara in the ACC announcement.