… device (LVAD) trial for which data from the Interagency Registry for Mechanically Assisted
Circulatory Support (… These topics include the safety and effectiveness profile of the device as …

… to reach this goal is evident in the products and outcomes of an NHLBI-supported registry
for patients with mechanical circulatory support devices. This registry, which is described below…

… of MCS device implant … support with durable devices supporting both ventricles. This
configuration was represented by a Thoratec device on the left side and a planned Thoratec device …

… to the temporary device support include device turned off or explanted for recovery, alive
on device, bridge to durable or transplanted. Negative outcomes include death on device or …

… devices are currently limited to supporting our most challenging patients, those weighing less
than 20 kg and those with CHD. The introduction of new devices … by VAD support and will …

… supports the concept of mandated reporting of device outcomes to a national registry and
sets a model for other device therapies to ensure the highest level of safety for our patients. …

… registry, an ongoing national registry for patients implanted with a US Food and Drug
Administration–approved MCS device designed to support … In summary, the registry was launched …

… Kaplan-Meier survival estimates were calculated, censoring patients at the time of
transplantation or cessation of device support. Patients undergoing a device exchange were not …

… C) non-GI bleeding while on ventricular assist device support, stratified by device type. (Pedimacs,
Pediatric Interagency Registry for Mechanical Circulatory Support; tx, transplantation.) …

… Patients’ characteristics and outcomes of children supported with a temporary device (n =
41) were not analyzed in this report. The etiology of heart disease included 146 (73%) patients …