Transplant Trial Watch

Intraoperative Tissue-Immunosuppressive Therapy Reduces Rejection Episodes in Heart Transplant Recipients.

Rabus, M. B., Cekmecelioglu, D. et al.

Experimental & Clinical Transplantation: Official Journal of the Middle East Society for Organ Transplantation, 2018; [record in progress].

To identify the effects of intraoperative antithymocyte globulin administration on donor hearts following cardiocirculatory death.

Patients were randomized to receive retrograde antithymocyte globulin infusion via coronary sinus intraoperatively and immediately after organ procurement or traditional antithymocyte globulin infusion after implantation.

30 patients with orthotropic heart transplants.

Allograft rejection and graft function.

30 days.

CET Conclusions
This small single-centre study investigated the role of intraoperative ATG injected directly to the coronary sinus during cardiac transplantation. Patients in both groups also received postoperative ATG infusion, to achieve the same total dose in both groups. The authors claim a significant reduction in the risk of acute rejection in the intraoperative ATG group, as well as a reduction in echocardiographic abnormalities and need of inotropic therapy. Whilst on the face of it, this sounds like a promising intervention, there are significant deficiencies in the methodology and reporting of this study. This study is described as randomised, but from the description in the manuscript it appears to be a sequential cohort study with all intraoperative ATG patients recruited at the end of the study. No power calculation is presented, and there is a real risk of type I error in the acute rejection results. I was unable to replicate the claim of a statistically significant increase in acute rejection – with 2/15 control and 0/15 study patients experiencing rejection, a Fisher exact test gives a p-value of 0.48, rather than the <0.05 reported in the manuscript. The claims of reduced inotrope use and improved echocardiographic function are not backed up with any data. In short, the data presented in the manuscript do not support the conclusion of the authors.

Jadad score

Data analysis
Per protocol analysis

Allocation concealment

Trial registration

Funding source
No funding received