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The ISHLT Registry for Mechanically Assisted Circulatory Support (IMACS) has launched!


links image JAMES K KIRKLIN, MD
Chair of IMACS Registry Committee
Professor and Director of the Division of Cardiothoracic Surgery
University of Alabama at Birmingham
Birmingham, Alabama, USA
jkirklin@uab.edu



Great News! The International Society for Heart and Lung Transplantation Registry for Mechanically Assisted Circulatory Support (IMACS) launched on January 9, 2013! IMACS is an international registry that is enrolling and following patients who receive durable mechanically assisted circulatory support devices (MCSD) in all countries and hospitals around the world that wish to participate.

Purposes of the IMACS Registry
IMACS' primary objective is scientific research, specifically the analysis of a large ongoing combined experience focusing on outcomes after device implantation and identification of associated risks factors. In addition, other purposes are:

IMACS Website
In addition to the IMACS Registry being launched, the official IMACS Website went live in January. Interested collectives and hospitals can access this website and obtain a wealth of information such as IMACS data elements, policies and procedures, and enrollment information, which will be briefly be discussed in the next section. Below you will find links to essential to IMACS:

IMACS Registry Committee - http://www.ishlt.org/registries/executiveCommittee.asp
IMACS Protocol - http://www.ishlt.org/registries/protocol.asp
IMACS Users' Guide - http://www.ishlt.org/registries/usersGuide.asp
IMACS Patient Enrollment - http://www.ishlt.org/registries/patientEnrollment.asp (Note: Access to the patient web based data entry system will be granted after a hospital is officially enrolled.)

Enrollment in IMACS
IMACS currently has forty-one hospitals and three collectives that have expressed interest in participating and submitting data to the registry. Sixteen of these hospitals have moved forward with the enrollment process by initiating regulatory requirements and one hospital is actually enrolled!

Requirements for enrollment can be found on the IMACS website under the Site Enrollment section - http://www.ishlt.org/registries/siteEnrollment.asp. First, if a hospital or collective is interested in registration and enrollment in IMACS, they should complete an IMACS Registry Institutional Enrollment Form and submit it via email to IMACS@uab.edu. Next, an IMACS staff member will contact the interested site to continue the enrollment process. In order to be enrolled in IMACS, the following items or forms will be requested:

  1. IMACS Registry Institutional Enrollment Form
  2. International Society for Heart and Lung Transplantation Registry for Mechanically Assisted Circulatory Support (IMACS) Memorandum of Agreement
  3. Human Subjects Research certification (Ethics Board, Institutional Review Board, etc.)
  4. Completed Training - At least one IMACS staff member at the institution must complete the IMACS training process. A live web-based data entry training session will be scheduled with the designated staff member at each institution. This training will be conducted in English.

Each item or form will need to be completed satisfactorily before a hospital or collective is officially enrolled in IMACS. Once a hospital is enrolled, they will be sent a user name and password is sent to begin entering data into the IMACS Registry.

Friendly IMACS staff is available to answer all questions or inquiries regarding the registry. Please send an email to IMACS@uab.edu. We are looking forward to hearing from you!



Disclosure Statement: The author has no conflicts of interest to disclose.


References: Kirklin MD, James K, Naftel PhD, David C, et al. IMACS Protocol 2012; p. 5