1. The FOSTER Registry: Fontan Outcomes Study to improve Transplant Experience and Results

2. Background
Post-transplant outcomes in adult Fontan patients remain poorly defined.
Available studies limited to sub-groups within published registry data or single center studies.
Underpowered to detect significant differences
Lack sufficient detail to be clinically actionable
Significant, interrelated concerns regarding HT in this population:
1) When is the optimal time for HT referral?
2) Which patients benefit most from heart transplant?
3) What risk factors are associated with poor post- transplant outcomes?

3. Background
The FOSTER consortium is an international registry of adult Fontan patients referred for transplant.
Initial effort to address two primary aims

4. Aims
Aim #1: Determine the risk factors and mortality rate in adult Fontan patients referred for heart transplant. Three cohorts of patients who have undergone formal transplant evaluation will be included:
a) Patients listed and successfully transplanted
b) Patients listed but not transplanted
c) Patients not listed
Aim #2: Delineate the risk factors and mortality rate of adult patients with a Fontan who have successfully undergone transplant.

5. Patient Sample: Inclusion criteria:
History of Fontan completion;
End-stage, “failed” Fontan status;
Referral for heart transplantation;
Age ≥18 at time of transplant referral
Referral for formal transplant evaluation will define patients as “failed Fontans” and will serve as the time point from which clinical data will be extracted.
Endpoints of interest include transplant evaluation result (i.e. listed and transplanted, listed and not transplanted, and not listed) and alive-dead status at the time of the data collection.
Goal Enrollment: 240+ patients (Powered to detect a HR of 2 with an event probability of 0.3)

6. Project Management:
Columbia University Medical Center will serve as the data-coordinating center and will be responsible for:
Study Administration;
Quality control, Data security;
Statistical Analyses for Initial Projects;
A separate steering committee will be responsible for study oversight and will bear responsibility for scientific conduct and decision-making.

7. Data Collection Procedures:
Primary investigators will be identified at each study site to oversee study procedures at local participating centers.
Sites will be provided with study IDs corresponding to the number of patients at each site that meet inclusion criteria.
Study data will be abstracted from patient medical records and is designed to balance feasibility of completion with inclusion of key metrics.
Data entry will occur through a secure, HIPPA compliant server run by the data coordination center utilizing REDCap software.

8. Data Entry
REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing
An intuitive interface for validated data entry;
Audit trails for tracking data manipulation and export procedures;
Automated export procedures for data downloads to statistical software

10. Timeline Finalization of Data Entry System (Mid-April)
Study Center Recruitment (May)
Data Collection (July-November)
Database Completion (End of 2016)
Data Analysis (Early 2016)

11. Contacts Matthew Lewis ml3329@cumc.columbia.edu Marlon Rosenbaum