Impact of Procedure-Related Complications on Long-term Islet Transplantation Outcome.
BACKGROUND
Pancreatic islet transplantation offers a promising biotherapy for the treatment of type 1 diabetes, but this procedure has met significant challenges over the years. One such challenge is to address why primary graft function still remains inconsistent after islet transplantation. Several variables have been shown to affect graft function, but the impact of procedure-related complications on primary and long-term graft functions has not yet been explored.


METHODS
Twenty-six patients with established type 1 diabetes were included in this study. Each patient had two to three intraportal islet infusions to obtain 10,000 islet equivalent (IEQ)/kg in body weight, equaling a total of 68 islet infusions. Islet transplantation consisted of three sequential fresh islet infusions within 3 months. Islet infusions were performed surgically or under ultrasound guidance, depending on patient morphology, availability of the radiology suite, and patient medical history. Prospective assessment of adverse events was recorded and graded using "Common Terminology Criteria for adverse events in Trials of Adult Pancreatic Islet Transplantation."


RESULTS
There were no deaths or patients dropouts. Early complications occurred in nine of 68 procedures. β score 1 month after the last graft and optimal graft function (β score ≥7) rate were significantly lower in cases of procedure-related complications (P = 0.02, P = 0.03). Procedure-related complications negatively impacted graft function (P = 0.009) and was an independent predictive factor of long-term graft survival (P = 0.033) in multivariate analysis.


CONCLUSIONS
Complications occurring during radiologic or surgical intraportal islet transplantation significantly impair primary graft function and graft survival regardless of their severity.
1 French National Institute of Health and Medical Research-INSERM UMR 859, Diabetes Cell Therapy Lille, France. 2 General and Endocrine Surgery Department, Université Lille Nord de France, Lille University Hospital, Lille, France. 3 Endocrinology and Metabolism Department, Université Lille Nord de France, Lille University Hospital, Lille, France. 4 Université de Lille, Lille, France. 5 Radiology Department, Université Lille Nord de France, Lille University Hospital, Lille, France. 6 Nephrology Department, Université Lille Nord de France, Lille University Hospital, Lille, France.
Robert
R
Caiazzo
Marie-Christine
MC
Vantyghem
Violeta
V
Raverdi
Caroline
C
Bonner
Valery
V
Gmyr
Frederique
F
Defrance
Clara
C
Leroy
Geraldine
G
Sergent
Thomas
T
Hubert
Oliver
O
Ernst
Christian
C
Noel
Julie
J
Kerr-Conte
François
F
Pattou
D000293:Adolescent; D000328:Adult; D000368:Aged; D003922:Diabetes Mellitus, Type 1 / Q000628:therapy; D005260:Female; D006085:Graft Survival; D006801:Humans; D016381:Islets of Langerhans Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D016016:Proportional Hazards Models