Recommendations Published for Transcatheter Mitral Valve Therapy Programs

May 14, 2014—The Society for Cardiovascular Angiography and Interventions (SCAI) announced the publication of a multisociety consensus paper that outlines criteria for health care providers and institutions to offer consistent and appropriate care to patients in the field of transcatheter valve therapy. The document has been issued by the SCAI, the American Association for Thoracic Surgery, the American College of Cardiology, and the Society of Thoracic Surgeons.

“Operator & Institutional Requirements for Transcatheter Valve Repair and Replacement, Part II—Mitral Valve” has been published online in SCAI’s Catheterization and Cardiovascular Interventions, as well as the Journal of the American College of Cardiology, the Journal of Thoracic and Cardiovascular Surgery, and The Annals of Thoracic Surgery. Carl L. Tommaso, MD, served as chair of the writing committee.

According to SCAI, the document offers first-time guidance from the societies on developing and maintaining a transcatheter mitral valve therapy program, emphasizing collaboration between interventional cardiologists and cardiac surgeons. It is an important step toward achieving consistent, effective care, particularly as the Centers for Medicare & Medicaid Services prepare to issue a national coverage decision for transcatheter valve repair and replacement procedures. A committee comprised of cardiac surgeons and interventional cardiologists developed the recommendations in response to the changing landscape of treatment for valve disease.

SCAI stated that there was a need to establish core competencies and technical skills required for providers and institutions that offer transcatheter treatment options to patients. The paper emphasizes the need for a multidisciplinary team approach involving both surgeons and interventional cardiologists with extensive knowledge and diagnostic skills related to valvular disease.

The document also provides a roadmap for the clinical experience and provider skills necessary for successful transcatheter programs. It advises that operators, regardless of their specialty, should have a deep understanding of valvular heart disease, the ability to interpret echocardiographic and other radiographic images and to use 3D echocardiography, and expertise in the interpretation of computed tomography scans related to valve disease. Additionally, minimum requirements for individual providers should include an understanding of radiation safety needed for optimal imaging, exposure protection, and knowledge of the use of x-ray contrast agents.

On the institutional level, the recommendations focus on facility requirements and procedural volume for individual operators as well as new and existing programs. Each institution should have an active valvular heart disease surgical program with at least two institutionally based cardiac surgeons experienced in valvular surgery and should have available a full range of diagnostic imaging and therapeutic facilities.

The document stresses that long-term outcomes reporting and participation in data registries are mandatory for existing and new programs to ensure accurate data collection on survival and complications as well as determination of risk and long-term durability of devices.

In the SCAI announcement, Dr. Tommaso commented, “As these techniques continue to increase in use, we must promote consistent, best practices and standards of care for providers and institutions so that patients get the best possible care. These recommendations will help build and maintain programs centered on the best interests of patients.” Dr. Tommaso is Medical Director of the cardiac catheterization lab at NorthShore University HealthSystem/Skokie Hospital in Evanston, Illinois.

Dr. Tommaso added, “The institutional resources necessary to manage successful transcatheter programs are significant, on par with heart transplant and cardiac device assist programs, and should be performed in institutions that perform higher volumes of surgical valve operations with established track records. Likewise, interventional cardiology programs should have established and successful track records with structural heart disease.”