Improvement in Outcomes of Clinical Islet Transplantation: 1999–2010
- Franca B. Barton, MS1⇓,
- Michael R. Rickels, MD2,
- Rodolfo Alejandro, MD3,
- Bernhard J. Hering, MD4,
- Stephen Wease, MPH1,
- Bashoo Naziruddin, PHD5,
- Jose Oberholzer, MD6,
- Jon S. Odorico, MD7,
- Marc R. Garfinkel, MD8,
- Marlon Levy, MD9,
- Francois Pattou, MD, PHD10,
- Thierry Berney, MD11,
- Antonio Secchi, MD12,
- Shari Messinger, PHD3,
- Peter A. Senior, PHD, MRCP13,
- Paola Maffi, MD, PHD12,
- Andrew Posselt, MD, PHD14,
- Peter G. Stock, MD, PHD14,
- Dixon B. Kaufman, MD, PHD7,
- Xunrong Luo, MD, PHD15,
- Fouad Kandeel, MD, PHD16,
- Enrico Cagliero, MD17,
- Nicole A. Turgeon, MD18,
- Piotr Witkowski, MD, PHD19,
- Ali Naji, MD, PHD2,
- Philip J. O’Connell, MD, PHD20,
- Carla Greenbaum, MD21,
- Yogish C. Kudva, MD22,
- Kenneth L. Brayman, MD, PHD23,
- Meredith J. Aull, PHARMD24,
- Christian Larsen, MD, PHD18,
- Tom W.H. Kay, MD, PHD25,
- Luis A. Fernandez, MD7,
- Marie-Christine Vantyghem, MD, PHD10,
- Melena Bellin, MD4 and
- A.M. James Shapiro, MD, PHD13
- 1The EMMES Corporation, Rockville, Maryland
- 2Department of Surgery, Division of Endocrinology, Diabetes and Metabolism, University of Pennsylvania, Philadelphia, Pennsylvania
- 3Department of Medicine, Division of Endocrinology/Diabetes/Metabolism, University of Miami, Miami, Florida
- 4Schultze Diabetes Institute and Department of Surgery, University of Minnesota, Minneapolis, Minnesota
- 5Islet Processing Laboratory, Institute of Biomedical Science, Baylor University Medical Center, Dallas, Texas
- 6Department of Surgery, Division of Transplant Surgery, University of Illinois at Chicago, Chicago, Illinois
- 7Department of Surgery, Division of Transplantation, University of Wisconsin, Madison, Wisconsin
- 8Department of Surgery, Division of General Surgery, Southern Illinois University, Springfield, Illinois
- 9Department of Transplant Services, University of Texas, Southwest Medical School, Dallas, Texas
- 10Department of General and Endocrine Surgery, Lille University, Lille, France
- 11Department of Surgery, Division of Transplantation and Visceral Surgery, Geneva University Hospital, Geneva, Switzerland
- 12Department of Internal Medicine, San Raffaele University, Milan, Italy
- 13Department of Medicine, Division of Endocrinology, University of Alberta, Edmonton, Alberta, Canada
- 14Department of Surgery, University of California, San Francisco, San Francisco, California
- 15Department of Medicine, Northwestern University, Chicago, Illinois
- 16Division of Diabetes, Endocrinology & Metabolism, City of Hope, Duarte, California
- 17 MGH Diabetes Center, Massachusetts General Hospital, Boston, Massachusetts
- 18Department of Surgery, Division of Transplantation Emory University, Atlanta, Georgia
- 19Department of Surgery, University of Chicago, Chicago, Illinois
- 20Centre for Transplant and Renal Research, Westmead Hospital, Westmead, New South Wales, Australia
- 21Diabetes Program, Benaroya Research Institute, Seattle, Washington
- 22Department of Endocrinology, Mayo Clinic, Rochester, Minnesota
- 23Department of Transplantation Surgery, University of Virginia, Charlottesville, Virginia
- 24Division of Transplantation Surgery, Weill-Cornell Medical College, New York, New York
- 25Department of Medicine, St. Vincent’s Institute, Fitzroy, Victoria, Australia
- Corresponding author: Franca B. Barton, fbarton{at}emmes.com.
Abstract
OBJECTIVE To describe trends of primary efficacy and safety outcomes of islet transplantation in type 1 diabetes recipients with severe hypoglycemia from the Collaborative Islet Transplant Registry (CITR) from 1999 to 2010.
RESEARCH DESIGN AND METHODS A total of 677 islet transplant-alone or islet-after-kidney recipients with type 1 diabetes in the CITR were analyzed for five primary efficacy outcomes and overall safety to identify any differences by early (1999–2002), mid (2003–2006), or recent (2007–2010) transplant era based on annual follow-up to 5 years.
RESULTS Insulin independence at 3 years after transplant improved from 27% in the early era (1999–2002, n = 214) to 37% in the mid (2003–2006, n = 255) and to 44% in the most recent era (2007–2010, n = 208; P = 0.006 for years-by-era; P = 0.01 for era alone). C-peptide ≥0.3 ng/mL, indicative of islet graft function, was retained longer in the most recent era (P < 0.001). Reduction of HbA1c and resolution of severe hypoglycemia exhibited enduring long-term effects. Fasting blood glucose stabilization also showed improvements in the most recent era. There were also modest reductions in the occurrence of adverse events. The islet reinfusion rate was lower: 48% by 1 year in 2007–2010 vs. 60–65% in 1999–2006 (P < 0.01). Recipients that ever achieved insulin-independence experienced longer duration of islet graft function (P < 0.001).
CONCLUSIONS The CITR shows improvement in primary efficacy and safety outcomes of islet transplantation in recipients who received transplants in 2007–2010 compared with those in 1999–2006, with fewer islet infusions and adverse events per recipient.
Footnotes
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A slide set summarizing this article is available online.
- Received January 10, 2012.
- Accepted April 26, 2012.
- © 2012 by the American Diabetes Association.
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