Table 9:
Safety of Islet Transplantation in Patients with Type 1 Diabetes Mellitus, from Observational Comparative Studies
| Immunosuppression Regimen | Adverse Outcome | |||
|---|---|---|---|---|
| Author, Year | Intervention | Control | Intervention | Control |
| Non-uremic patients | ||||
| Warnock et al, 2008 (49) | 31 ITA | 42 IIT |
Death: 0 Skin cancer: 1/31 (3%) Fatigue: 2/31 (6%) CMV: 1/31 (3%) |
Death: 0 Skin cancer: NR Fatigue: NR CMV: NR |
| Maffi et al, 2011 (52) | 33 ITA | 33 PTA |
Hospitalization: 16/33 (48%)a Transfusion: 2/33 (6%)a Re-laparotomy: 0/33 (0%)a Thrombosis: 3/33 (9%) Bleeding: 12/33 (36%) CMV reactivation: 2/33 (6%)a Other infection: 2/33 (6%) Worsening kidney function: 5/33 (15%) Other medical complication: 1/33 (3%) |
Hospitalization: 19/33 (58%)a Transfusion: 14/33 (42%)a Re-laparotomy: 18/33 (55%)a Thrombosis: 13/33 (39%) Bleeding: 5/33 (15%) CMV reactivation: 21/33 (64%)a Other infection: 5/33 (15%) Worsening kidney function: 4/33 (12%) Other medical complication: 2/33 (6%) |
| Uremic patients | ||||
| Gerber et al, 2008 (48) | 13 SIK | 25 SPK |
Death: 1 (not related) Intraperitoneal bleeding: 2/13 (15%) (no surgery) Laparotomy: 0a Infection: 0 Complications with islets: 3/13 (23%) |
Death: 0 Intraperitoneal bleeding: 2/25 (8%) (surgery required) Laparotomy: 10/25 (40%)a Infection: 2/25 (8%) Complications with pancreas: 12/25 (48%) |
| Mixed uremic and non-uremic patients | ||||
| Frank et al, 2004 (45) | 9 ITA 4 IAK |
25 SPK 5 PAK |
Death: 0 Hepatic steatosis: 3/13 (23%) (3 ITA, 0 IAK) Post-transplant surgery: 1/13 (8%) (0 ITA, 1 IAK) Mouth ulcer: 10/13 (77%)a (9 ITA, 1 IAK) Peripheral edema: 7/13 (54%) CMV: 0 Transfusion: 1/13 (8%)a (0 ITA, 1 IAK) Abscess drainage: 0 Malignancy: 1/13 (8%) (in situ squamous cell) |
Death: 1 (unknown cause) Hepatic steatosis: NR Post-transplant surgery: 7/30 (23%) (5 SPK, 2 PAK) Mouth ulcer: 0a Peripheral edema: NR CMV: 3/30 (10%) (3 SPK, 0 PAK) Transfusion: 13/30 (43%)a (10 SPK, 3 PAK) Abscess drainage: 3/30 (10%) (2 SPK, 1 PAK) Malignancy: NR |
| Vantyghem et al, 2009 (50) | 7 ITA 6 IAK |
17 IIT |
No. adverse events per patient Major: 18/13 Minor: 50/13 |
No. adverse events per patient Major: 13/17 Minor: 8/17 |
Abbreviations: CMV, cytomegalovirus; IAK, islet-after-kidney transplantation; IIT, intensive insulin therapy; ITA, islet transplantation alone; NR, not reported; PAK, pancreas-after-kidney transplantation; PTA, pancreas transplantation alone; SIK, simultaneous islet-kidney transplantation; SPK, simultaneous pancreas-kidney transplantation.
a
Denotes statistical significance.
Source: Adapted from Institute of Health Economics, 2013. (41)