What is Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support)?
Intermacs 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.
Who sponsors Intermacs?
This project has been funded in whole or in part with federal funds from the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), and the Department of Health and Human Services (HHS) under Contract Number HHSN268201100025C.
The University of Alabama at Birmingham (UAB) is the Data and Clinical Coordinating Center (DCC) responsible for maintaining the database.
Why is Intermacs important?
The objectives of Intermacs include, but are not limited to, the following:
- To facilitate the refinement of patient selection for maximizing outcomes with current and new device options.
- To improve and expedite new device clinical trials by providing historical control data reliable enough to serve as Objective Performance Criteria (OPC) standards for FDA.
- To develop consensus "best practice" guidelines to improve clinical management by reducing short and long term complications of MCSD therapy.
- To improve economic outcomes by identifying and optimizing factors affecting cost-effective therapy for cardiac failure patients.
- To use Intermacs data to guide improvements in technology, particularly as next generation devices evolve.
- To promote research into the underlying pathophysiologic substrate of advanced heart failure by defining and promoting the conditions necessary for myocardial recovery.
Who is eligible to participate in Intermacs?
Any medical center in the United States and Canada that has an active ventricular assist device therapy program is eligible to contribute to Intermacs. Your medical center must be certified to participate in Intermacs. To be certified, you must have at least one staff member trained on all aspects of Intermacs. Additionally, you must identify a Principal Investigator from your facility and we strongly encourage your PI to attend a training session. Medical centers must have qualified personnel in place at the time of application to the registry, to fill the following roles:
- Principal Investigator (PI), responsible for oversight of data submissions and registry compliance
- Site Administrator to act as "point person" for data related inquiries
What are the benefits of participating in Intermacs?
Participating in this registry will meet the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) reporting requirement that…"requires submission to a national audited registry of health data on all VAD destination therapy patients from the date of implantation throughout the remainder of their lives." Ongoing certification of MCSD programs and program staff require documentation of volume and outcomes which encompass both investigational and approved VADs. Intermacs is the only registry that meets the stringent data reporting requirement of Joint Commission, and will require inclusion of all patients implanted with devices designed for chronic implantation, regardless of initial intent. Intermacs is designed to simplify reporting of the essential outcome data and provide center-specific analyses for required quality improvement.
Are all medical centers implanting mechanical assist devices required to participate in Intermacs?
Participation in Intermacs is not mandatory. If you do choose to participate, you will be expected to adhere to the requirements for submission of patient data. Periodic audits will be conducted to assure that all MCSD patients are entered, data submissions are complete and submitted in a timely manner.
Is IRB approval required to participate in Intermacs?
Your hospital’s Institutional Review Board (IRB) or equivalent must review this registry before you will be permitted to submit patient data to Intermacs. If your IRB approves your application for participation in this registry, you must submit documentation of that decision to email@example.com. Your facility is responsible for obtaining and maintaining all patient consents and all IRB documentation. Your center will not be activated in Intermacs until IRB (or equivalent) approval has been submitted.
How do I enroll in Intermacs?
Enrollment formats are available under new site enrollment.
Will training be provided for my staff?
Yes, you are required to have at least one staff member trained on all aspects of Intermacs. The Coordinator Training will be held monthly. Additionally, you must identify a Principal Investigator from your facility and site administrator as the primary registry contact.