1. Ex Vivo Lung Perfusion in Donation After Circulatory Death Lung Transplantation Increases Donor Utilization: Analysis of the NOVEL Extension Trial
Whitson B A, Shukrallah B, Mulligan M S, et al . J Heart Lung Transplant. Vol 37, Issue 4, Suppl, April 2018, Pages S147-S148.
Expansion of lung transplantation is limited by donor availability and donation after circulatory death (DCD) has attempted to address this shortage. Unfortunately, the uncontrolled recovery process does not result in a uniform donor allograft and the downsides of primary graft dysfunction (PGD) are large. Ex vivo lung perfusion (EVLP) affords the ability to evaluate and resuscitate lung donor allografts prior to transplantation. We sought to evaluate the efficacy and outcomes of EVLP and DCD lung donor allografts in a large, multicenter clinical trial (NOVEL Extension).
Methods: We reviewed the data from the 17 NOVEL Extension trial sites utilizing the XVIVO XPS™ platform and found 9 sites that had performed DCD recoveries with the XPS (median 2, range 1-5). We compared the outcomes of those recipients who received a DCD allograft with those who received a brain-dead donor (BDD) who had undergone EVLP as well as the control cohort in the trial registry. We compared the donor characteristics of those lungs which were transplanted and those that did not meet quality standards on EVLP and were not transplanted. For the recipients who received an EVLP allograft, we evaluated recipient characteristics. Standard statistical methods were utilized and PGD as well as overall survival were the primary endpoints.
Endpoints: From July 2011 through January 2017, there were 307 patients enrolled in the NOVEL Extension trial. Of those, we evaluated 99 control recipients and 95 who received an EVLP lung. There were 93 potential lung allografts which underwent EVLP which were not transplanted. Of the EVLP recipients, 71 received BDD and 24 DCD. The EVLP conversion rate for BDD was 55.5% and for DCD, 40.7%. There was no difference in laterality (71.8% v 85%, p=0.11) between BDD as compared to DCD. Similarly, donor age (33+/-13 v 33+/-10 years, p=0.4), donor gender (67%M v 67%M, p=.97) or highest PaO2 on EVLP (368+/-109 v 383+/-92, p=0.86) were not different between BDD and DCD. There were differences in donor cause of death with higher trauma in BDD (39% v 30%) and more “other” in DCD (18.5% v 33%), p=0.006. There were no differences in recipient disease: cystic fibrosis 5.6% v 4.2%, COPD 45.1% v 29.2%, fibrosis 39.4% v 45.8%, p=0.15) though there were for race (p=0.004). Recipient age (59+/-11 v 58.3+/-11 years, p=0.41), LAS (41+/-14 v 43+/-16, p=0.69), and EVLP run time (240+/-52 v 245+/-48, minutes p=0.67) were similar. There were no differences in rates of PGD at 24hr (p=0.07), 48hr (p=0.21), and 72hr (p=0.32) after transplant (Table). Overall, there was no difference in long-term survival between BDD, DCD, and control recipients (p=0.08).
DCD lung allografts successfully transplanted after EVLP evaluation have similar rates of PGD at 24hr, 48hr, and 72hr after transplant. The recovery rate for DCD was lower than for BDD under EVLP though the allograft quality was similar. Long-term survival between EVLP recovered BDD and DCD allografts was similar to non-EVLP controls. DCD recovery assessed via EVLP prior to transplantation is a viable option to expand the donor pool with good clinical outcomes.