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

MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Heart Failure Market to Surpass $16 Billion by 2026
News | Heart Failure| September 19, 2017
The heart failure space across the seven key markets of the U.S., France, Germany, Italy, Spain, the U.K. and Japan is...
Heart Failure Patients, Clinicians Have Differing Perceptions of Risk Level
News | Heart Failure| September 06, 2017
September 6, 2017 — Physicians identified a majority of patients with advanced...
Israeli Hospital Completes First Implant of CORolla Heart Failure Device
News | Heart Failure| September 05, 2017
Rambam Hospital in Haifa, Israel, recently became the first to use the CORolla device from Israeli start-up company...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD)| August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Sponsored Content | Videos | Cardiovascular Ultrasound| August 28, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
Registry Identifies Early Onset of Heart Failure and Lack of Defibrillators in Asia
News | Heart Failure| August 03, 2017
August 3, 2017 — The Asian Pacific Society of Cardiology (ASPC) held its first-ever late-breaking...
Left Atrial Pressure Monitor from Vectorious Medical Technologies Offers New Hope for Heart Failure Patients

On of the top stories in July was the introduction of a left atrial pressure monitor from Vectorious Medical Technologies to prevent heart failure patient hospitalizations or readmissions. Read the article"Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients."

Feature | August 01, 2017 | Dave Fornell
Aug.
Overlay Init