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:
Since their initial development, VADs have extended and improved survival for thousands of advanced heart failure patients. However, recent findings have highlighted the risks involved in using these devices. For example, in November 2013, writing in the NEJM, investigators at the Cleveland Clinic reported an increase in the apparent rate of pump thrombosis. The INTERMACS investigators also published similar findings based on registry data in the Journal of Heart and Lung Transplantation (JHLT).
Since these reports were released, clinicians, researchers, regulatory agencies, and industry have closely monitored the incidence of pump thrombosis and had extensive discussions as to the cause and appropriate response to the apparent increase in pump thrombosis. In the spring of 2015, the NHLBI and FDA asked INTERMACS investigators to conduct an updated analysis of the pump thrombosis data. In response to this request, the University of Alabama at Birmingham, Cleveland Clinic, and the NHLBI, three organizations involved in INTERMACS, collaborated to conduct three independent analyses of INTERMACS data.
At the workshop, these three organizations presented the results of their analyses. In addition, others presented information on the following topics:
After these presentations, workshop participants discussed the following potential areas to mitigate pump thrombosis and associated events:
Based on the presentation and discussion, workshop participants identified a set of research and policy priorities that may improve the safe use and study of current and future devices. These priorities include the following:
In addition, workshop participants made suggestions concerning planned trials:
The INTERMACS analyses are slated for publication in the JHLT. A proceedings from this workshop is in development for publication in a peer-reviewed journal.
Marissa Miller, D.V.M., M.P.H.
Marissa.Miller@nih.gov Tel: 301 594 1542