IMACS® Frequently Asked Questions
The International Society for Heart and Lung Transplantation Registry for Mechanically Assisted Circulatory Support (IMACS®) is an international registry intended to enroll and follow patients who receive durable mechanically assisted circulatory support devices (MCSD) in all countries and hospitals that wish to participate.
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.
- 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
Any medical hospital outside the United States that has an active mechanical circulatory support device program is eligible to participate in IMACS®.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.
Participation in IMACS® is FREE. The registry is completely funded by ISHLT.Benefits to Centers
Benefits to ISHLT
- 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 MCS Community
- 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
- Improved outcomes from new techniques and devices
- Facilitate accelerated evaluation of new devices
- Development of international standards for MCS therapy
Yes, all participating hospitals will obtain regulatory approval before collecting registry data, as applicable per local regulations. Dated proof of regulatory agency approval will be sent to IMACS®. IMACS® will send annual reminders to the participating hospitals at least 30 days prior to expiration of regulatory approval. Lapse in providing regulatory approval to IMACS® will result in immediate suspension of data entry capability.
Enrollment requirements are available under the Site Enrollment/Regulatory
Yes, IMACS® WBDE training is provided. We utilize Cisco Web-Ex Online training services. Please contact Kathryn Hollifield at firstname.lastname@example.org
for more details.
All data entry questions and concerns can be emailed to Kathryn Hollifield, the IMACS® Clinical Affairs Director, at email@example.com