We appreciate the comments and thoughts Mensink et al1 have regarding our recently published Extended Pancreas Donor Program study2 on the extension of donor age for pancreas transplantation. We would like to respond to and clarify a few points.
Mensink et al suggested that very strict selection criteria were used in our study for the extended criteria organs, accounting for the low number of 61 standard organs and 18 extended donor criteria (EDC) organs after about 3 years. However, these low numbers are not a result of any special or strict selection criteria. The standard group was completed in March 2013 after reaching the planned number of patients; thereafter, only inclusion of patients that received an EDC (donor age, 50-60 years or body mass index [BMI], 30-34 kg/m2) organ was allowed. Unfortunately, Germany suffered from a marked decline in donor numbers from >1200 donors per year before 2012 to <900 in the following years. With this drastic reduction of donor and transplantation numbers, inclusion rate was substantially decreased mainly due to lack of organ supply. In our correspondence with the different transplant centers, we received feedback that surgeons used the same risk evaluation parameters as for regular organs and that the most important issue was the macroscopic appearance of the organ. Donor and recipient demographics shown in our article demonstrate that selection criteria were indeed equal for both groups.2
Also, in this regard, Mensink et al1 rightfully mentioned that it would be interesting to know how many EDC organs were accepted and then declined due to quality reasons and their criteria. Unfortunately, we have no possibility to provide those numbers. When designing the study, we did not incorporate a screening log for the offered organs. Only the transplanted organs and the recipients as study patients were recorded and monitored. In an effort to correct this omission, we tried to obtain relevant information through Eurotransplant. However, because there were transplants with EDC organs involving patients who did not want to take part in the study and also transplants at centers not participating in Extended Pancreas Donor Program, the screening information was simply not extractable via Eurotransplant.
Because it was the first publication of the study data, we aimed to stay true to the study design and published ITT data for the extended group using both BMI and donor age criteria. If we exclude the 1 high BMI patient, we reach a mean donor age of 52.4 years, ranging from 50 to 58 years in the extended age group. This is still a substantial extension of donor age compared to the previously allowed collective with a mean donor age of 31.7 years.2 With growing experience using EDC organs and our study data, we are in complete agreement with Mensink et al that this provides an opportunity to further increase pancreas transplantation numbers.
1. Mensink JW, de Boer JD, Kopp WH, et al. How far can we expand donor age criteria for pancreas transplantation? Transplantation
2. Proneth A, Schnitzbauer AA, Schenker P, et al. Extended pancreas donor program-the EXPAND study: a prospective multicenter trial testing the use of pancreas donors older than 50 years. Transplantation