Related Experiment Video
Updated: Jul 28, 2026
A Porcine Heterotopic Heart Transplantation Protocol for Delivery of Therapeutics to a Cardiac Allograft
Published on: February 14, 2022
A multicenter, randomized, controlled trial of Celsior for flush and hypothermic storage of cardiac allografts
J D Vega1, J L Ochsner, V Jeevanandam
1Emory University Hospital, Atlanta, Georgia, USA. david_vega@emory.org
Insights
Celsior preservation solution is as safe and effective as conventional methods for donor heart storage. This multicenter trial found comparable patient survival and adverse events, with fewer cardiac issues in the Celsior group.
Area of Science:
- Cardiology
- Transplantation Medicine
- Organ Preservation
Background:
- Donor heart preservation is critical for successful transplantation.
- Evaluating novel preservation solutions like Celsior is essential for improving outcomes.
Purpose of the Study:
- To assess the safety and efficacy of Celsior solution for flush and hypothermic storage of donor hearts.
- To compare Celsior against conventional preservation solutions in heart transplant recipients.
Main Methods:
- A multicenter, randomized, controlled, open-label trial.
- 131 heart transplant recipients were randomized to Celsior or conventional preservation solutions.
- Patients were followed for 30 days post-transplantation.
Main Results:
- Graft loss rates were numerically lower with Celsior (Day 7: 3% vs 9%; Day 30: 6% vs 13%), though not statistically significant.
- No significant differences in 7-day patient survival or overall adverse events were observed.
- Fewer cardiac-related serious adverse events occurred in the Celsior group (13% vs 25%).
Conclusions:
- Celsior demonstrates comparable safety and efficacy to conventional solutions for cardiac allograft preservation.
- Celsior may offer a potential benefit in reducing cardiac-related adverse events post-transplantation.
Background:
A multicenter, randomized, controlled, open-label trial was conducted to evaluate the safety and efficacy of Celsior when used for flush and hypothermic storage of donor hearts before transplantation.
Methods:
Heart transplant recipients were randomized to one of two treatment groups in which donor hearts were flushed and stored in either Celsior or conventional preservation solution(s) (control). Study subjects were followed for 30 days after transplantation.
Results:
A total of 131 heart transplant recipients were enrolled (Celsior, n = 64; control, n = 67). The treatment groups were evenly distributed in donor and recipient base line characteristics. Graft loss rate was lower in the Celsior group on day 7 (3% versus 9%) and on day 30 (6% versus 13%), but the difference was not statistically significant based on 95% confidence interval analysis. No significant difference was measured between the Celsior and control groups in 7-day patient survival (97% versus 94%) and the proportion of patients with one or more adverse events (Celsior, 88%; control 87%) or serious adverse events (Celsior, 38%; control, 46%). Significantly fewer patients in the Celsior group developed at least one cardiac-related serious adverse event (13% versus 25%).
Conclusions:
Celsior was demonstrated to be as safe and effective as conventional solutions for flush and cold storage of cardiac allografts before transplantation.
