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Center Volume Is Associated with Outcome After Pancreas

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Center Volume Is Associated with Outcome After Pancreas Original Clinical ScienceçGeneral Center Volume Is Associated With Outcome After Pancreas Transplantation Within the Eurotransplant Region Wouter Kopp, MD,1,2 Marieke van Meel, BSc,2 Hein Putter, PhD,3 Undine Samuel, MD,2 Helmut Arbogast, MD, PhD,4 Wolfgang Schareck, MD, PhD,5 Jan Ringers, MD,1 and Andries Braat, MD, PhD1 Background. Outcome after surgery depends on several factors, among these, the annual volume-outcome relationship. This might also be the case in a highly complex field as pancreas transplantation. No study has investigated this relationship in a European setting. Methods. All consecutive pancreas transplantations from January 2008 until December 2013 were included. Donor-, recipient-, and transplant-related factors were analyzed for their association with patient and graft survivals. Centers were classified in equally sized groups as being low volume (<5 transplantations on average each year in the 5 preceding years), medium volume (5-13/year), or high volume (≥13/year). Results. In the study period, 1276 pancreas transplantations were included. Un- adjusted 1-year patient survival was associated with center volume and was best in high volume centers, compared with medium and low volume: 96.5%, 94% and 92.3%, respectively (P = 0.017). Pancreas donor risk index (PDRI) was highest in high volume centers: 1.38 versus 1.21 in medium and 1.25 in low volume centers (P < 0.001). Pancreas graft survival at 1 year did not differ significantly between volume categories: 86%, 83.2%, and 81.6%, respectively (P = 0.114). After multivariate Cox-regression anal- ysis, higher PDRI (hazard ratio [HR], 1.60; P < 0.001), retransplantation (HR, 1.91; P = 0.002), and higher recipient body mass in- dex (HR, 1.04; P = 0.024) were risk factors for pancreas graft failure. High center volume was protective for graft failure (HR, 0.70; P = 0.037) compared with low center volume. Conclusion. Patient and graft survival after pancreas transplantation are superior in higher volume centers. High volume centers have good results, even though they transplant organs with the highest PDRI. (Transplantation 2017;101: 1247–1253) ancreas transplantation is the only definitive treatment transplant alone [PTA]) in case of life-threatening hypoglyce- Pfor patients with type 1 diabetes mellitus. This can be mic unawareness.1-3 Even though the number of patients on as a simultaneous pancreas kidney transplantation (SPK) the waiting list is relatively stable since 2009, optimal usage in case of end-stage renal disease (ESRD) or as a solitary pan- of scarce number of potential pancreas allografts is still creas transplant (pancreas after kidney [PAK], pancreas highly important.4 Apart from donor, recipient and trans- plant factors influencing outcome after transplantation,5,6 Received 6 January 2016. Revision received 19 April 2016. center factors may also play a significant role. Accepted 20 April 2016. The Dutch Institute for Clinical Auditing has been work- 1 Division of Transplantation, Department of Surgery, Leiden University Medical Cen- ing on valid outcome measures in 18 domains of healthcare, ter, Leiden, The Netherlands. most of them in oncological surgery. Eurotransplant is a non- 2 Eurotransplant International Foundation, Leiden, The Netherlands. profit organization that facilitates patient-oriented allocation 3 Department of Statistics, Leiden University Medical Center, Leiden, The Netherlands. and cross-border exchange of deceased donor organs. Active for transplant centers and their associated tissue typing labo- 4 Department of General, Visceral, Transplant, Vascular and Thoracic Surgery, Uni- versity of Munich-Grosshadern Medical Centre, Munich, Germany. ratories and donor hospitals in 8 countries, Eurotransplant en- 5 University Hospital Rostock, Rostock, Germany. sures an optimal use of donor organs. To be able to develop allocation policies based on state-of-the-art medical knowl- H.A., W.S., and J.R. represent the Eurotransplant Pancreas Advisory Committee. edge, Eurotransplant collects donor, recipient, and center data, W.H.K. and J.R. designed the study. M.M. and U.S. collected the data. H.P. and W.H.K. performed the statistical analysis. W.H.K., U.S., and A.E.B. wrote the as well as outcome data after transplantation. Information on article. All authors participated in critical appraisal and revision of the article. center-related outcome, provided that they represent valid and The authors declare no funding or conflicts of interest. useful outcome measures, should be publically available: to Correspondence: W.H. Kopp, MD, Division of Transplantation, Department of centers, to improve their results; to patients, to make a well- Surgery, Leiden University Medical Center, Albinusdreef 2 2333 ZA Leiden, The founded decision on a preferred center; and to politicians, to Netherlands. ([email protected]). design legitimate healthcare policies. This information can be Supplemental digital content (SDC) is available for this article. Direct URL citations derived from organizations, such as the Dutch Institute for Clin- appear in the printed text, and links to the digital files are provided in the HTML ical Auditing or Eurotransplant or from single-center reports. text of this article on the journal’s Web site (www.transplantjournal.com). With this information, efforts are being put into concen- Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. trating “high complex, low volume” care in The Netherlands.7 ISSN: 0041-1337/17/10106-1247 Especially oncology care is subject of this ongoing change. DOI: 10.1097/TP.0000000000001308 Transplantation has been the subject of concentration of care Transplantation ■ June 2017 ■ Volume 101 ■ Number 6 www.transplantjournal.com 1247 Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved. 1248 Transplantation ■ June 2017 ■ Volume 101 ■ Number 6 www.transplantjournal.com by the government longer and especially pancreas transplan- variables was done using Kaplan-Meier estimates and groups tation, with currently only 2 of 8 transplant centers with an were compared using Log-rank tests. Continuous variables active pancreas transplantation program. The question rises were analyzed using Cox proportional hazard models after whether this concentration is justified and if the volume out- testing of the proportional hazards assumption.12 P values come relationship also exists in the field of pancreas trans- less than 0.05 were considered statistically significant. All sig- plantation, as has been stated before.8,9 Recently, a German nificant factors from univariate survival analysis, as well as study advocated for an extensive analysis of volume-outcome factors that were different among volume groups were en- after transplantation.10 In 2014, within Eurotransplant there tered in multivariate Cox proportional hazards model. To ac- were 37 centers with an active pancreas transplant program, count for clustering of the data, robust sandwich estimates of performing a total of 199 vascularized pancreas transplants, the standard errors were used in multivariate analysis.13 Only thus averaging an annual number of pancreas transplanta- complete cases after multiple imputations were analyzed. 4 tions of a little over 5 each year. Missing Data Imputation The aim of this study is to investigate the effect of center volume on outcome after pancreas transplantation in the Recipient weight (6.2%), recipient height (6.2%), and Eurotransplant region. pancreas cold ischemia (25.4%) had missing values. Vari- ables that were included in the imputation model were: donor Design age, sex, weight, height, body mass index (BMI), cause of All consecutive vascularized pancreas transplantations that death, creatinine, DBD versus DCD, pancreas donor risk in- were performed in Eurotransplant centers from January 1, dex (PDRI), and donor country; recipient age, sex, weight, 2008, until December 31, 2013, were analyzed. Donor, pro- height, dialysis type, waiting time; pancreas cold ischemia curement, recipient, and transplant data that were derived time in minutes and hours, total pancreas cold ischemia time from the standard Eurotransplant database are shown in (hours), transplant type (SPK, PAK, PTA), center volume, warm Table 1. Follow-up data were collected through the Euro- ischemic period, transplant center, transplant year, organ transplant registry. The Eurotransplant registry data were quality, perfusion solution. Warm ischemic time, PDRI, cre- extracted at October 6, 2015. Graft survival was death cen- atinine, amylase, lipase, sodium, transplant center, donor sored. A frequently used definition of graft failure is that graft country, perfusion solution, and organ quality were used as failure has occurred, when the recipient had returned to ex- indicators only. Imputation method was automatically se- ogenous insulin therapy. This was the definition that the au- lected by SPSS (SPSS version 22, IBM, North Castle, NY) thors applied to all patients that were transplanted at the based on patterns of missing value analysis. To reduce sam- pling variability from the imputations, 20 imputation rounds Leiden University Medical Center. For all other centers, it 14 was unknown which definition was used, so the definition were performed. Results of multiple imputations are of pancreas graft failure was left up to the discretion of the shown in Table 2. Recipient BMI and PDRI were calculated transplant centers. When graft failure and death occurred basedontheimputedvalues. at the same day or a graft had not been
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