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About IMACS®IMACS logo


MISSION

The specific mission of IMACS® is the promotion of scientific investigations and publications based on analyses of this multinational database, providing the opportunity for an international array of authors to collaborate in Registry investigations, presentations, and publications.


PURPOSES/GOALS
  • To capture worldwide data relating to the implantation and outcome of patients receiving cardiac assist devices designed for and capable of use for 30 or more days
  • To identify risk factors for complications
  • To improve patient selection and management before and after device implantation
  • To generate predictive models of outcome for given patient profiles
  • To generate statistical analyses of the data that can be used as the underlying evidence/ justification for government agency funded studies and clinical trials
  • To identify overall and best practices with the aim of improving current practices

GOVERNANCE

Ownership: The IMACS® Registry is owned by the ISHLT. The actual governance of IMACS® is by the IMACS® Board which is appointed by the ISHLT Leadership. The ownership of the data remains with the submitting hospital or collective.

Board: The IMACS® Board will provide oversight of the registry and all standard operating procedures will be approved by this board.  For a current list of the board members, go to the ISHLT website Boards & Committees - IMACS® Registry.

Committees: With the approval of the IMACS® Board, several committees will be established to oversee specific components of IMACS®. For example, a data access, analysis and publications committee will be formed and whose purpose will be to solicit, evaluate and manage specific requests for research.  A hospital standards committee will produce and implement policies for assessing data compliance from individual hospitals and collectives.


ELIGIBILITY

Any medical hospital outside the United States that has an active mechanical circulatory support device program is eligible to participate in IMACS®.

IMACS® enrollment can be completed by contacting IMACS® at imacs@uabmc.edu. Detailed information and steps to enrolling the facility and personnel in IMACS® can be found in the Site Enrollment/Regulatory section.

Inclusion Criteria

Patients who receive a MCSD after the hospital is activated (i.e., has received local regulatory approval and has gained access to the IMACS® database).

Exclusion Criteria

Patients who receive a non-durable mechanically circulatory support device (MCSD).There is no exclusion for age, gender, race, ethnicity, or any other demographic limit.


COST

Participation in IMACS® is FREE. The registry is completely funded by ISHLT.


DATA STRUCTURE AND ELEMENTS
  • Pre-implant form
  • Implant form
  • Discharge form
  • Follow-up (every 6 months) Form
Major Events
  • Death
  • Transplant
  • Recovery
  • Device Exchange
Adverse Events

Adverse Events will be captured in the discharge form and the follow-up forms.
  • Device Malfunction
  • Infection
  • Bleeding
  • Neurological Dysfunction
  • Respiratory Failure
  • Right Heart Failure
  • Arterial Non-CNS Thromboembolism

WHY PARTICIPATE IN IMACS®?

Benefits to Centers
  • Statistical summaries of hospital experience
  • Benchmarks for comparison against the international experience
  • Description of performance standards for units and practitioners
  • Determine resources (personnel, skills, training) needed to meet performance standards
  • Participate in device research
  • Generate volume and trend data to facilitate short and long term financial planning
Benefits to ISHLT
  • Own and direct an international high quality MCSD registry
  • Complement the ISHLT transplant registry as ISHLT emphasizes its role in MCSD research
  • Provides Statistical Reports and Research Analyses to ISHLT Researchers
Benefits to MCS Community
  • Improved outcomes from new techniques and devices
  • Facilitate accelerated evaluation of new devices
  • Development of international standards for MCS therapy

REFERENCES

ISHLT Mechanically Assisted Circulatory Support Registry Protocol. (2012). Birmingham, AL

IMACS® Brochure. (2011). Birmingham, AL

IMACS® Policies and Standard Operating Procedures: Appendix A. (2012). Birmingham, AL

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