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Cardiology: ACC, STS Issue Guidance in Advance of Transcatheter Valve Therapy Approval

By Robert Fay

The American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS) issued a position statement to outline potential clinical issues and offer guidance regarding transcatheter valve therapy (TVT), the approval of which is anticipated later this year. The document is intended to “frame the discussion of key issues and questions for consideration as this new technology unfolds.”

Published on June 27, 2011 on both the Journal of the American College of Cardiology and Annals of Thoracic Surgery websites, the statement was authored by David R. Holmes, Jr., MD, president of the ACC Foundation, and Michael J. Mack, MD, president of the STS. It addition, it underwent a 26-member expert panel review.

Only patients with two types of valvular disease (aortic stenosis and mitral regurgitation) have participated in randomized trials of TVT devices, the PARTNER study of Edwards Lifesciences’ Sapien aortic valve replacement and the EVEREST II study of Abbott Laboratories' MitraClip. A U.S. Food and Drug Administration committee is slated to review a premarket approval application for Sapien aortic valve replacement July 20 and 21, and should have a final decision by October. Abbott is also expected to submit a premarket approval application for the MitraClip during 2011. The authors caution that widespread adoption of the minimally invasive techniques beyond those two study populations is inappropriate, and they recommend further study in other patient groups. To meet the challenges to “responsible diffusion” of TVT, the authors urge a cooperative effort by professional societies, industry, payers, and regulatory agencies. They offer the following recommendations:

  • Establish regional centers of excellence for heart valve diseases. Experts should develop criteria for centers that perform these procedures. In addition, limit device availability and reimbursement to centers that meet established criteria.
  • Form multidisciplinary heart teams, led by primary cardiologists, cardiac surgeons, and interventional cardiologists, which touch all aspects of care.
  • Establish a national registry of valvular heart disease for post-market surveillance, long-term outcome measurement, and comparative effectiveness research.
  • Develop training and credentialing criteria for practitioners in this field as well as for fellowship programs and postgraduate training.
  • Create expert consensus documents and appropriate use criteria based on interpretation of the current evidence.

Source: Holmes DR Jr., Mack MJ. 2011. Transcatheter valve therapy: a professional society overview from the American College of Cardiology and the Society for Thoracic Surgeons. Published on June 27, 2011 on the Journal of the American College of Cardiology website.