CLINICAL AND TRANSLATIONAL RESEARCH Long-Term (5 Years) Efficacy and Safety of Pancreas Transplantation Alone in Type 1 Diabetic Patients Ugo Boggi, 1,6 Fabio Vistoli, 1 Gabriella Amorese, 1 Rosa Giannarelli, 2 Alberto Coppelli, 2 Rita Mariotti, 3 Lorenzo Rondinini, 3 Massimiliamo Barsotti, 1 Stefano Signori, 1 Nelide De Lio, 1 Margherita Occhipinti, 2 Emanuela Mangione, 2 Diego Cantarovich, 1 Stefano Del Prato, 2 Franco Mosca, 4 and Piero Marchetti 2,5 Background. Although combined pancreas and kidney transplantation is an established procedure for the treatment of type 1 diabetes (T1D) in patients with end-stage renal disease, the role of pancreas transplant alone (PTA) in the therapy of T1D subjects with preserved kidney function is still matter of debate. Methods. We report our single-center experience of PTA in 71 consecutive T1D patients all with a posttransplant follow-up of 5 years. Patient and pancreas (normoglycemia in the absence of any antidiabetic therapy) survivals were determined, and several clinical parameters (including risk factors for cardiovascular diseases) were assessed. Cardiac evaluation and Doppler echocardiographic examination were also performed, and renal function and proteinuria were evaluated. Results. Actual patient and pancreas survivals at 5 years were 98.6% and 73.2%, respectively. Relaparotomy was needed in 18.3% of cases. Restoration of endogenous insulin secretion was accompanied by sustained normalization of fasting plasma glucose concentrations and HbA1c levels as well as significant improvement of total cholesterol, low-density lipoprotein-cholesterol, and blood pressure. An improvement of left ventricular ejection fraction was also observed. Proteinuria (24 hours) decreased significantly after transplantation. One patient developed end-stage renal disease. In the 51 patients with sustained pancreas graft function, kidney function (serum creatinine and glomerular filtration rate) decreased over time with a slower decline in recipients with pretransplant glomerular filtration rate less than 90 mL/min. Conclusions. PTA was an effective and reasonably safe procedure in this single-center cohort of T1D patients. Keywords: Pancreas transplantation, Type 1 diabetes, Cardiovascular risk factors. (Transplantation 2012;93: 842–846) P ancreas transplantation is a clinical option in the treat- ment of patients with type 1 diabetes (T1D) (1–3). This procedure may be considered as a group of three separate, clinical entities: simultaneous pancreas and kidney transplant (SPK), pancreas after kidney, and pancreas transplant alone (PTA) (1–3). It has been shown that SPK, by restoring both endogenous insulin secretion and renal function, has benefi- cial effects on diabetes complications and prolongs life expec- tancy (1–9). The usefulness of PTA in type 1 diabetic patients without advanced nephropathy is more debated (1–3, 5–7). It is generally accepted that patients are eligible for a PTA when they have a history of frequent, acute, and severe metabolic complications (hypoglycemia, hyperglycemia, and ketoaci- dosis) requiring medical attention; clinical and emotional problems with exogenous insulin therapy that are so severe as to be incapacitating; and consistent failure of insulin-based management to prevent acute complications (10). PTA may be also considered for T1D patients who have or are at high risk of secondary complications of diabetes (nephropathy, retinopathy, and neuropathy) as proposed by a few authors and scientific diabetes societies (1–3, 11). Recent studies re- ported that after PTA the 5-year patient survival is 90% (12) and that pancreas graft half-life is 9 years (13). Although it is not clear whether PTA impacts life expectancy in comparison with patients on the waiting list (5–7), the procedure is nev- ertheless associated with significant improvements in some microvascular diabetic complications (1–3, 9, 14, 15). On the other hand, probably because of the toxic effect of immuno- suppressants, significant decline of glomerular filtration rate The authors declare no funding or conflicts of interest. 1 Division of General and Transplant Surgery in Uremic and Diabetic Pa- tients, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy. 2 Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy. 3 Division of Cardiology, Cardiac and Thoracic Department, University of Pisa, Pisa, Italy. 4 Department of Oncology, Transplants and Advanced Technologies in Medicine, University of Pisa, Pisa, Italy. 5 Unit of Endocrinology and Metabolism of Transplantation, Azienda Os- pedaliero Universitaria Pisana, Pisa, Italy. 6 Address correspondence to: Ugo Boggi, M.D., Division of General and Trans- plant Surgery in Uremic and Diabetic Patients, Azienda Ospedaliera Univer- sitaria Pisana, Cisanello Hospital, via Paradisa 2, 56124 Pisa, Italy. E-mail: u.boggi@med.unipi.it U.B. and P.M. participated in research design, performance of the study, and writing the manuscript; F.V., G.A., R.G., A.C., R.M., L.R., M.B., S.S., N.D.L., M.O., E.M., D.C., S.D.P. and F.M. participated in the perfor- mance of the research. Received 14 July 2011. Revision requested 9 August 2011. Accepted 20 December 2011. Copyright © 2012 by Lippincott Williams & Wilkins ISSN 0041-1337/12/9308-842 DOI: 10.1097/TP.0b013e318247a782 842 | www.transplantjournal.com Transplantation • Volume 93, Number 8, April 27, 2012