News | Heart Failure | April 04, 2017

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

Society representative stresses importance of looking beyond mortality as a meaningful endpoint to quality of life

SCAI, MEDCAC panel, health outcomes, heart failure, treatment technologies

April 4, 2017 — This week the Centers for Medicare & Medicaid Services (CMS) convened a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to examine which health outcomes in studies of heart failure treatment technologies should be of interest to CMS. The panel also assessed 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, M.D., 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. 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 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 Naidu, promotes a more thorough understanding of advanced forms of heart failure with an interventional cardiology focus. This includes 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.

For more information: www.scai.org

Related Content

EMPRISE Study Shows Empagliflozin Reduces Heart Failure Hospitalization with new data presented at AHA 2018. #AHA18 #AHA2018
News | Heart Failure | November 07, 2018
November 6, 2018 – Initial results from the real-world EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) s
Acute Heart Failure Mortality, Rehospitalizations Reduced With Blood Volume Measurement
News | Heart Failure | November 02, 2018
In a new study, acute heart failure patients who received individualized treatment by blood volume measurement with the...
Daxor Corp. Collaborating With CHF Solutions on Heart Failure Fluid Overload Management

CHF Solutions' Aquadex FlexFlow System

News | Heart Failure | November 01, 2018
November 1, 2018 — Daxor Corp.
NHLBI Pauses CONCERT-HF Heart Failure Trial
News | Heart Failure | October 29, 2018
The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, is pausing the...
A patient who received the HeartMate III LVAD system showing off his external battery pack. He served as a patient ambassador in the Abbott booth at ACC 2018. The HeartMate III, with its magnetic levitated pump, showed a big reduction in clotting over previous LVADs in a key late-breaking trial at ACC earlier this year.

A patient who received the HeartMate III LVAD system showing off his external battery pack. He served as a patient ambassador in the Abbott booth at ACC 2018. The HeartMate III, with its magnetic levitated pump, showed a big reduction in clotting over previous LVADs in a key late-breaking trial at ACC earlier this year.

Feature | Heart Failure | October 19, 2018
October 19, 2018 — Abbott announced today that the HeartMate 3 Left Ventricular Assist Device (LVAD) has received U.S
Ohio State First in U.S. to Test Shunt Device for Heart Failure
News | Heart Failure | October 04, 2018
The Ohio State University Wexner Medical Center is first in the country to test a new medical device designed to help...
Mitral Regurgitation Volume Reduced at One Year in REDUCE FMR Trial
News | Heart Failure | September 28, 2018
Heart failure patients who received the Carillon Mitral Contour System in the REDUCE FMR clinical trial showed a...
Cardiac Dimensions Randomizes First Patient in CARILLON Trial of Mitral Contour System
News | Heart Failure | September 20, 2018
Cardiac Dimensions announced the company has randomized its first patient in the CARILLON Pivotal Trial.
Overlay Init