Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)
What Have We Learned and What Will We Learn?
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The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) is a North American national registry for mechanical circulatory support devices (MCSDs) that are used to treat advanced heart failure. Durable MCSDs that have been approved by the US Food and Drug Administration (FDA) are included in this registry; however, MCSDs that remain in FDA trials pending initial approval (ie, investigational device exemption [IDE] trials) and devices intended for short-term use (eg, Abiomed BVS 5000 ventricular assist device [Abiomed, Danvers, MA]) are not included. The purposes of this article are to present a developmental history of INTERMACS, to outline the collaboration of INTERMACS with various constituencies (eg, FDA, National Institutes of Health, Center for Medicare & Medicaid Services, industry, and physicians), to present a summary of information generated to date by INTERMACS, and to describe the future directions of INTERMACS.
Developmental History of MCSDs and INTERMACS
The concept of using mechanical circulatory assistance for more than a brief time after a cardiac operation dates to the early 1960s with the development of MCSDs that fit the definitions of counterpulsation devices (eg, the intra-aortic balloon pump), ventricular assist devices (VADs), and total artificial hearts.1–5 The development and initial clinical evaluation of these devices were regulated by individual academic medical center review groups that evolved into institutional review boards. The FDA entered this arena in 1976 with the advent of the FDA section for device regulation based on passage of the 1976 Medical Device Amendments.6 By 1991, groups including the Institute of Medicine foresaw the need for a detailed longitudinal database for patients receiving MCSDs, stating in an Institute of Medicine report that “patients should be followed through a registry for the remainder of their lives….”7 The committee further recommended that the National Heart, Lung, and Blood Institute support long-term follow-up studies.
Eventually, a …