Ex-Vivo Perfusion of Human Donor Hearts Reduces Cold Ischemia Time

Abstract

Purpose Cold ischemia is an obligatory part of solid organ transplantation. Prolonged cold ischemia time (CIT) in heart transplantation can impact early allograft function and may be associated with chronic rejection. CIT beyond 6 hours is associated with increased recipient mortality based on ISHLT/UNOS database. Ex-vivo organ perfusion (Organ Care System (OCS)) maintains the donor hearts in a warm, beating state and reduces CIT. The purpose of this study is to compare CIT of donor hearts preserved on ice vs. on OCS. Methods and Materials PROCEED II is an FDA approved prospective, randomized, international multi-center study that is designed to compare OCS to cold static preservation of the donor hearts during transport. As of 10/01/12, 79 patients had been enrolled into this study. 40 patients were randomized to cold static preservation arm (control group); 39 patients were randomized to OCS (OCS group). Results Table 1 compares the cross clamp time and CIT for the OCS and Control groups.There is a statistically significant increase in possible cross clamp time (p Conclusions Ex vivo perfusion of donor hearts on OCS reduces CIT by nearly 40% when compared to the control group. Reduction in CIT may improve short and long term heart allograft function. Cross Clamp Vs. CIT for the OCS and Control Groups OCS Group - mean ± SD (range) Control Group - mean ± SD (range) Total Cross Clamp Time (min) 329 ± 79 (149-543) 180 ± 66 (36-312) OCS Group Explantation and Instrumentation Time (min) 29 ± 7 (16-50) N/A OCS Group Implantation Time (min) 80 ± 23 (43-142) N/A Total CIT (min) 109 ± 26 (62-169) 180 ± 66 (36-312)