Data Source

The study cohort was derived from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), a national, audited, US Food and Drug Administration (FDA)–approved registry for patients who receive mechanical circulatory support devices for treatment of advanced heart failure. The registry was created in June 2005 as a joint effort of the National Heart, Lung, and Blood Institute, the FDA, clinicians, scientists, and industry representatives. It is housed and managed at the University of Alabama at Birmingham. The Joint Commission requires that patients with a chronically implanted ventricular assist device have their health data entered into a national audited registry,⁶ and INTERMACS is the only registry that meets their requirements. Institutional review board approval is required at participating centers before data collection begins at the center. Centers transmit data using a Web-based system. The data are stored on a secure server provided by the United Network for Organ Sharing and are checked for completeness by the central collection facility. Data outliers are validated with the site of origin, but source documents are not checked against the submitted data. A medical events committee reviews major events, including cause of death, neurological dysfunction, bleeding, device malfunction, and infection.