The Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) is a North American registry established in 2005 for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. Intermacs was established as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services, clinicians, scientists and industry representatives in conjunction with Dr. James K. Kirklin and the University of Alabama at Birmingham.
Intermacs collects clinical data relevant to mechanical circulatory support devices (MCSDs) from index hospitalization through follow-up evaluations. Post implant follow-up data is collected at 1 week, 1 month, 3 months, 6 months and every 6 months thereafter. Major outcomes after implant, e.g., death, explant, rehospitalization and adverse events, are entered within 30 days of occurrence and also as part of the defined follow-up scheduled intervals.
Intermacs provides contemporary data to demonstrate outcomes, with additional insight into appropriate risk stratification and patient selection. Death, transplant, and explant are the major discrete endpoints recorded. Complex endpoints include the patient’s level of function and quality of life, critical to the evaluation of current MCSD therapy these indices are becoming increasingly important as patient survival improves, and new devices will be compared for outcomes beyond survival.
Sponsored by The National Heart, Lung and Blood Institute (NHLBI) and housed at the University of Alabama at Birmingham, Intermacs launched in June 2006 with 15 participating hospitals within the United States. The registry has quickly grown to include the majority of MCSD centers in the U.S. Intermacs is recognized as the Joint Commission mandated registry for all U.S. centers implanting MCSDs for destination therapy and now has expanded to include all interested hospitals in the United States and Canada.
Over the last two decades, mechanical circulatory support devices (MCSDs) have been developed to augment or supplant failing myocardial performance. This therapy has been used successfully as a bridge to heart transplantation, a bridge to recovery, and as a permanent implantation or destination therapy for intractable heart failure. Although cardiac transplantation offers life-saving therapy for selected patients, its use is limited by a supply of donor organs which currently meets less than one-tenth of the need. As a consequence, the number of MCSDs implantations has increased in recent years. Despite favorable survival and quality of life outcomes, MCSDs have severe and sometimes life-threatening complications which include infections, thrombosis and device failure.
Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) is a registry for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives in conjunction with Dr. James K. Kirklin and the University of Alabama at Birmingham. Analysis of the data collected is expected to facilitate improved patient evaluation and management while aiding in better device development. Registry results are also expected to influence future research and facilitate appropriate regulation and reimbursement of MCSD implantations.