Bethesda, MD
Description
In collaboration with FDA’s Center for Devices and Radiologic Health, the NHLBI convened a workshop on the Current State of Thrombosis in Ventricular Assist Devices (VADs) on May 14, 2015, in Baltimore, Maryland. The workshop included cardiac surgeons, cardiologists, biostatisticians, bioengineers, and representatives from FDA, CMS, and the NHLBI to review available data on pump thrombosis, a major and potentially fatal complication of durable continuous-flow VADs, which are mechanical pumps that are used to support heart function and blood flow in people who have weakened hearts. Workshop members discussed possible approaches to mitigate pump thrombosis and other device-related serious adverse outcomes.
The workshop had the following specific goals:
- Review the available data on instances of pump thrombosis in currently marketed VADs by examining available evidence from clinical trials and relevant data from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), which includes a repository of clinical, demographic, and device-related information on patients who have VADs.
- Discuss device-associated risks and how best to mitigate them in clinical practice and research settings.
- Identify research needs and trial opportunities.
- Provide guidance on the conduct of interventional trials in advanced heart failure patients receiving VADs.