SCAI Statement on MEDCAC Health Outcomes in Heart Failure Treatment Technology Studies Panel

March 23, 2017 -- The Centers for Medicare & Medicaid Services (CMS) convened a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The panel examined which health outcomes in studies of heart failure treatment technologies should be of interest to CMS and the growing challenges associated with the changing landscape of evidence generated prior to market authorizations of new and innovative technology. While MEDCAC panels do not make coverage determinations, CMS does benefit from their guidance.

The Society for Cardiovascular Angiography and Interventions (SCAI) joined with a coalition of leading medical organizations including the American Heart Association, American College of Cardiology, and the Heart Failure Society of America to develop a cohesive presentation to the panel that discussed additional outcomes that should be considered as meaningful primary health outcomes in research studies dealing specifically with heart failure.

Srihari S. Naidu, MD, FSCAI, from Westchester Medical Center, and a former SCAI Trustee, represented the Society during the discussion and applauded the panel for looking beyond mortality as a meaningful endpoint. Dr. Naidu expressed the importance of addressing the main clinical outcomes in heart failure (i.e. morbidity) and prioritizing quality of life that is consistent with palliative care principles, and both patient and physician expectations.

"This was a very important meeting which should serve to help justify therapies, including interventional devices, in the context of quality of life and functional status variables that more holistically represent the actual patient experience,” stated Dr. Naidu. “Going forward, we will have trials and evidence that will recognize those factors, above and beyond simple mortality, that are most, and at times more, meaningful to both patient and physician."

SCAI’s Interventional Heart Failure Working Group, currently chaired by Dr. Naidu, promotes a more thorough understanding of advanced forms of heart failure with an interventional cardiology focus, including the ability to perform a directed comprehensive invasive evaluation of complex pathophysiologic states, understand the clinical implications of the results, and implement advanced treatment strategies, be they pharmacologic or device-based.