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It is imperative that professional societies, industry, payers, and regulatory agencies work collaboratively to promote needed research and ensure appropriate integration of transcatheter therapies for the treatment of patients with severe mitral regurgitation (MR), according to a new societal overview released by the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), the Society of Thoracic Surgeons (STS), and the Society for Cardiovascular Angiography and Interventions (SCAI) Foundation.

According to the societies, a number of transcatheter therapies for MR are expected to available for clinical use in selected patients in the coming years, and as such, a thoughtful process is needed to “ensure that such innovative treatments are introduced into medical practice in the United States with appropriate safeguards.” For example, the MitraClip device was approved by the U.S. Food and Drug Administration (FDA) this past October for the reduction of significant (≥3+), symptomatic, degenerative MR in highly anatomically selected patients, while other transcatheter approaches, including mitral annulus-based therapies, transapical neochordal implants, valve-in-valve and valve-in-annuloplasty ring therapies, and valve replacement therapies, are in development.

The societal overview, which is the first of what is expected to be several documents on this topic, contains several recommendations for appropriate integration. Among the highlights:

• Further research involving a wider spectrum of patients and devices.
• Continued development of regional heart valve referral centers of excellence that consist of a dedicated, multidisciplinary heart team and dedicated care pathways.
• Required participation of all centers in the ongoing TVT Registry, with limitation of new devices and reimbursement for their application to those centers that meet national criteria.
• Establishment of operator training and credentialing criteria for mitral valve procedures.
• Creation of guidelines, performance measures and appropriate use criteria for transcatheter MR interventions.

"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," the document states. The authors note that moving forward it is hoped that the document "will help frame subsequent discussions regarding such technology as it continues to evolve."

Keywords: Cooperative Behavior, Registries, Credentialing, United States Food and Drug Administration, Mitral Valve Insufficiency, Cardiology, Referral and Consultation, Thoracic Surgery

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