Updated Definitions of Adverse Events for Trials and Registries of Mechanical Circulatory Support: A consensus statement of the Mechanical Circulatory Support Academic Research Consortium

Abstract Durable and temporary mechanical circulatory support (MCS) device support provides life-saving benefit for patients with advanced heart failure but is associated with major adverse events. The accurate categorization and documentation of adverse events associated with MCS device therapy has long been recognized as an essential requirement to adequately assess patient outcomes, inform patient decision making, provide critical feedback to advance patient management practices, and improve device technology. Previous efforts in the field developed standardized adverse event definitions, however, the introduction of new technology, evolution in the understanding of the etiology of adverse events, and changes in patient care management practices have necessitated modifications to the criteria used to define adverse event definitions. The Mechanical Circulatory Support Academic Research Consortium (MCS-ARC) represents a multi-disciplinary collaborative effort to revise current adverse event definitions for durable and temporary MCS to improve patient management practices, promote a better understanding of current limitations of device technology, and promote global harmonization of adverse event definitions in the field of MCS.