TABLE 1.
Probability of complications potentially associated with face transplantation as derived from the literature
| Reference | Organ transplanted | Patients (n) | Death n (%) | Graft loss* n (%) | Acute rejection n (%) | PTDM (%) | CMV infection n (%) | PTLD n | GI (diarrhea) n (%) | Hematological complications n (%) | HTN | Increased serum creatinine (defined as >106 μmol/L, but <221 μmol/L) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dean et al, 2004 (40) | Kidney | 59 | 6 (10) | 1 (1.7) | 7 (12.0)† | 1 | – | 1/8 | – | – | – | |
| Johnson et al, 2000 (41)‡ | Kidney | 72 | 5 (6.9) | 9 (12.5) | 12 (16.7) | 6/46 (13.0)§ | CMV tissue invasive disease: 3 (4.2); CMV viremia or syndrome: 7 (9.7) to 10 (13.9) | 1 | – | – | – | – |
| Vanrenterghem et al, 2005 (44) | Kidney | 277 | 6 (2.2) | 7 (2.5) | 47 (17.0) | 12/235 (5.1) | 18 (6.5) | – | 33/277 (11.9) | Leukopenia, 23 (8.3); anemia, 72 (26.0) | – | – |
| Miller et al, 2000 (45) (MMF 1 g/day) | Kidney | 59 | 3 (5.1) | 0 | 19 (32.2) | 5/41 (12.2) | 4 (6.8) | 0 | 26/59 (44.1) | Anemia, 25 (42.4); leukopenia, 19 (32.2) | – | – |
| Miller et al, 2000 (45), (MMF 2 g/day) | Kidney | 58 | 3 (5.2) | 0 | 5 (8.6) | 2/43 (4.7) | 4 (6.9) | 0 | 37/58 (63.8) | Anemia, 26 (44.8); leukopenia, 21 (36.2) | – | – |
| Squifflet et al, 2001 (46)¶, (MMF 1 g/day) | Kidney | 79 | 2 (2.5) | 1 (1.3) | 12 (15.2) | 2/66 (3.0) | 7 (8.9) | – | 23/79 (29.1) | Leukopenia, 7 (8.9); anemia, | – | – |
| Squifflet et al, 2001 (46)¶, (MMF 2 g/day) | Kidney | 71 | 2 (2.8) | 1 (1.4) | 4 (5.6) | 4/64 (6.3) | Gastritis, 5 (7.0) | – | 30/71 (42.3) | Leukopenia, 13 (18.3); anemia, | – | – |
| Ciancio et al, 2004 (47,48) | Kidney | 50 | 4 (8.0) | 0 | 2 (4.0) | 5/37 (14.0) | Viremia 2 (4.0) to 1 (2.0); tissue invasive, 1 (2.0) | 0 | 1/50 | 0 | – | – |
| Ciancio et al, 2002 (49) | Kidney | 233 | 5 (2.1) | 2 (0.9) | 12 (5.1) | 14/233 (6.0) | CMV tissue invasive disease, 2 (0.8); CMV viremia or syndrome, 2 (0.8) to 4 (1.6) | 0 | 0 | 0 | – | – |
| Ahsan et al, 2002 (50) | Kidney | 100 | 1 (1) | 1 (1) | 11 | – | 6 | 1 | 0 | 0 | – | – |
| Mendez et al, 2005 (51)** | Kidney | 176 | 5 (2.8) | 5 (2.8) | 20 (11.4) | 9/117 (7.7) | CMV tissue invasive disease, 2.3; CMV viremia or syndrome, 5.1 to 7.4 (13) | 0 | 26/113 (23.0)†† | Leukopenia, 24.4% (43) anemia, 0.6% (1) | – | – |
| Miura et al, 2005 (53) | Kidney | 80 | 0 | 1 (1.3) | 21 | 3/80 | 22 | 2 | 0/80 | 0 | – | – |
| Goggins et al, 2003 (54) | Kidney | 58 | 0 | 0 | 6 | – | 3/58 (5.2) | 0 | – | – | – | – |
| Urbizu et al, 2002 (55) | Kidney | 50 | 1 (2.0) | 0 | 9 (18.0) | 9/50 (18.0) | 8 (16.0) | 0 | – | Leukopenia, 5 (10.0); anemia, 0 | – | – |
| Demibras et al, 2004 (56) | Kidney | 120 | 5 (4.2) | 1 (0.8) | 16 (13.3) | 13/120 (10.8) | 1 | 1 | 0/120 | 0 | – | – |
| Ciancio et al, 2005 (57)‡‡ | Kidney | 60 | 5 (8.3) | 1 (1.7) | 10 | 6/48§§ | 1 | 0 | – | Leukopenia, 0 | – | – |
| Rostaing et al, 2005 (58) | Kidney | 278 | 3 (1.1) | 2 (0.7) | 46 (16.5) | 14/259- (5.4)¶¶ | – | – | 39/278 (14.0) | Anemia, 58 (20.9); Leukopenia, 50 (18.0) | – | – |
| Hand transplants (1,4,5,7-9,11,12) | Hand | 10 | 0 | 1 | 8 | 6/9 | 5 | 0 | 0/10 | 6 - anemia | 2 | 6 |
| Probability | 0.03 | 0.02 | 0.14 | 0.08 | 0.07 | 0.004 | 0.18 | 0.11 - leukopenia; 0.13 - anemia | 0.77 | 0.22 | ||
| Taylor et al, 2005 (59)*** | Heart | 5668 | – | – | – | – | – | – | – | – | 76.8 (4353) | – |
| 5727 | 22.1 (1266) |
Where possible, graft loss secondary to rejection was included exclusively;
Clinical acute rejection;
Includes data from Ashan et al, 2001 (42), and Gonwa et al, 2003 (43) for 2- and 3-year follow-up data, respectively;
Plus, 2/46 (5.9) who required oral hypoglycemic agent;
Acute rejection as determined clinically – or biopsy proven;
Includes 6-month follow-up data from Gonwa et al, 2003;
Mycophenolate mofetil (MMF) discontinuation, 21.1 (4/19), and MMF dose adjustments, 23.3 (22/94);
Post-transplant diabetes mellitis (PTDM) was defined as insulin or oral hypoglycemic agent;
Three additional patients required oral hypoglycemic agents (total, 9/48);
Hyperglycemia reported in 44 (15.8) patients;
Cumulative prevalence of post-transplant morbidity in survivors within 1 year for transplants performed between January 2000 and June 2003. Results from the Registry of International Society for Heart and Lung Transplantation (59) was used as primary heart transplantation studies, which utilize tacrolimus, MMF and steroids as maintenance immunosuppressive therapy, either do not report on these parameters, withdraw steroids after an initial induction period, or outline the mean blood pressure and serum creatinine, and thus do not indicate the incidence of these complications. If only incidence or percentage of patients with given complications given as part of list of reasons for discontinuation of therapy, then that number is included/indicated. Where possible, graft loss secondary to chronic rejection reported only. CMV Cytomegalovirus; GI Gastrointestinal; HTN Hypertension; PTLD Post-transplant lymphoproliferative disease