For years, endomyocardial biopsies have been the gold standard for monitoring potential cardiac rejection. But because rejection can be sporadic or patchy in its presentation, the biopsy can sometimes miss it, or pathologists can overdiagnose it or underdiagnose it.
DALLAS and NEW YORK – February 2021 – The Heart Valve Collaboratory (HVC) announced today that the U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) will participate in this “collaborative community”. A medical “collaboratory” is a forum in which multidisciplinary private and public sector members work together on medical device challenges to achieve aligned outcomes, solve shared problems, and leverage collective opportunities, in the interest of improving patient care.
About 90 percent of patients with advanced heart failure can be managed by a left ventricular assist device (LVAD). But for the 5 to 10 percent of patients with biventricular failure, an LVAD is not adequate. These patients have no option but a heart transplant or the current version of a total artificial heart.
With a 46 percent projected increase nationwide in patients living with heart failure between 2014 and 2030, the need to provide effective care for this patient population has taken on new urgency.
For critically ill patients with advanced heart or lung failure, extracorporeal membrane oxygenation (ECMO) is available at Baylor University Medical Center and three other Baylor Scott & White Health (BSWH) medical centers. A systemwide coordinated care initiative that aligned the services at these hospitals in North and Central Texas has improved ECMO outcomes across all sites, including a 32 percent reduction in overall mortality.
