This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 Biliary complications (leaks and strictures) were the most commonly reported complications following living-donor liver transplantation. This was true for both adult‑to‑child and adult‑to‑adult transplantation. In a review of literature assessing outcomes following adult‑to‑child transplantation, the incidence of biliary complications ranged from 5% to 14% (based on 4 studies). Higher rates of biliary complications were reported in 3 case series ranging from 14% (7/51) to 34% (14/41). Other complications reported included portal vein and hepatic artery thrombosis.
5.2 In a systematic review of adult recipient outcomes, the median reported biliary complication rate was 22.2% (based on 75 studies). Other common complications included infection, and hepatic and vascular complications, with median reported rates of 18.8%, 20.5%, and 7.1%, respectively. In a case series of 259 patients with long‑term follow‑up, cumulative 1-, 3- and 5‑year biliary complication rates were 12.9%, 18.2% and 20.2%, respectively. In this study the majority of patients had undergone right liver grafts.
5.3 Donor mortality was 0.2% (23/11,553) in a worldwide survey of living-donor liver transplant (LDLT) programmes (71 centres, 11,553 patients). Most deaths (15/23) occurred within 60 days and were related to the surgery. A systematic review of donor outcomes (214 studies) also reported that overall donor mortality was 0.2% (13/6000 procedures, 117 studies). Mortality for donation of a left lobe ranged from 0.05–0.21% and was lower than for right lobe donation (0.23–0.5%). In a matched case‑control study of 4111 donors, the risk of early death (within 90 days) among donors was estimated as 1.7 per 1000 donors (95% confidence interval [CI] 0.7 to 3.5) and did not vary with portion of liver donated (p=0.8).
5.4 Long‑term mortality of live liver donors was comparable to that of live kidney donors and National Health and Nutrition Examination Survey participants (1.2%, 1.2% and 1.4% at 11 years respectively, p=0.9) over a mean follow‑up of 7.6 years in the matched case‑control study of 4111 donors.
5.5 Donor morbidity of 26% (325/1262) at a median follow‑up of 36.5 months was reported in a retrospective case series of 1262 patients. Short‑term complications (within 4 weeks of surgery) occurred in 24% (308/1262) of donors. Medium- (4 weeks to 3 months) and long‑term (after 3 months) complications were rare and occurred in only 1.5% (17/1262) of donors. Complications were significantly more common in right lobe donors than in left lobe donors (44% compared with 19%, p<0.05). The severity of complications was worse in right lobe donors than in left lobe donors.
5.6 Severe life-threatening complications were reported in 0.06% (2/3565) of donors (1 had multi‑organ failure, 1 had lower body paralysis) in a survey of living donors in 38 Japanese LDLT centres.
5.7 The incidence of near‑miss events (defined as an event or events with potentially fatal consequences that are successfully managed with no lasting ill‑effects) in donors was 1% (126/11,553) in the worldwide survey of LDLT programmes: these events were more frequent at low (less than 50 LDLTs) and moderate volume (51–200 LDLTs) centres compared with high volume centres (more than 200 LDLTs, p<0.001).
5.8 Transplantation was needed in 0.04% of donors (5/11,553) after liver donation in the worldwide survey of LDLT programmes. Four donors needed liver transplantation because of hepatic failure related to hepatic vein thrombosis and 1 needed kidney transplantation because of nephropathy. Despite transplantation, 2 of these donors died.
5.9 Biliary complications were the most common complications reported in both right lobe and left lobe donors in the retrospective case series of 1262 patients at a median follow‑up of 36.5 months. The frequency of complications was significantly higher in right lobe donors than in left lobe donors (12% [61/500] versus 5% [38/762], p<0.05).
5.10 Infections occurred at a median rate of 6% (range 0–29%, based on 50 studies) in the systematic review of donor outcomes (214 studies). These were most commonly wound infections, urinary tract infections and pneumonia.
5.11 Liver dysfunction (needing admission to an intensive care unit) was reported in 0.08% (3/3565) of donors in the survey of living donors in 38 Japanese LDLT centres. Hyperbilirubinaemia was reported in 3% (43/1508) of right lobe liver donors in a multicentre survey of 1508 LDLT donors.
5.12 Gastric outlet obstruction was reported in 0.8% (27/3565) of donors in the survey of living donors in 38 Japanese LDLT centres. Small bowel obstruction was reported in 2% (28/1262) of donors (13 in right lobe donors and 15 in left lobe donors) in the retrospective case series of 1262 patients at a median follow-up of 36.5 months.
5.13 Intra-abdominal fluid collection was reported in 4% (53/1262) of donors and massive ascites was reported in 0.5% (6/1262) of donors in the retrospective case series of 1262 patients at a median follow-up of 36.5 months. The incidence was significantly higher in right lobe donors than in left lobe donors (fluid collection: 9.2% versus 0.9%, p<0.05; ascites: 1.0% versus 0.1%, p<0.05).
5.14 Massive intraoperative bleeding (secondary to clamp failure) and haemorrhage (needing surgical intervention) were reported in 0.4% of donors (39 and 5 out of 11,553 donors respectively) in the worldwide survey of LDLT programmes.
5.15 Intra-abdominal bleeding (n=3) and bleeding duodenal ulcers (n=3) were reported in 0.3% (6/1508) of right lobe liver donors, in the multicentre survey of 1508 LDLT donors.
5.16 Pancreatitis occurred in 0.2% (3/1508) of right lobe liver donors in the multicentre survey of 1508 LDLT donors. Hyperamylasaemia (more than 300 IU/litre) was reported in 0.4% (5/1262) of donors in the retrospective case series of 1262 patients at a median follow-up of 36.5 months. The incidence was significantly higher in right lobe donors than in left lobe donors (p<0.05).
5.17 Gastric complications (including gastric volvulus in 2 donors and perforated gastric ulcer in 1 donor) were reported in the worldwide survey of LDLT programmes. Gastric perforation occurred in 1 right lobe liver donor in the multicentre survey of 1508 LDLT donors.
5.18 Thrombotic events (including portal vein, inferior vena cava or hepatic vein thrombosis and pulmonary embolism) were reported in 0.2% (24/11,553) of donors in the worldwide survey of LDLT programmes.
5.19 Cardiac complications (including cardiac arrest and endocarditis in 1 donor each and myocardial infarction in 3 donors) were reported in the worldwide survey of LDLT programmes. Cardiac failure was reported in 1 donor in the survey of living donors (n=3565) in 38 Japanese LDLT centres.
5.20 Gastro-oesophageal reflux due to left liver hypertrophy was reported in 9% (7/83) of adult live liver donors who had right hepatectomy in a case series of 83 donors at a median follow‑up of 69 months.
5.21 Aborted hepatectomy was estimated to have occurred in 1% (136/11,553) of procedures on donors in the worldwide survey of LDLT programmes. Most of these aborted hepatectomies (72%, 98/136) occurred before bile duct transection. Aborted procedures were also reported after hepatic transection (n=12) and after anaesthesia but before the incision (n=8). The majority (78%, 106/136) of aborted hepatectomies were 'donor related' and the most common reasons were unexpected vascular or biliary anatomy (n=44), unexpected pathology (n=20), fatty liver (n=14) and haemodynamic instability (n=10). After aborted hepatectomy, 45% (61/136) of donors eventually donated at a second procedure. The incidence of aborted hepatectomy significantly decreased with centre experience (p<0.001).
5.22 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse events in donors: prolonged and intractable bile leakage in donors needing repeated interventions, unusual infections (gas gangrene of the stomach) and wound pain. They considered that the following were theoretical adverse events in donors: donor remnant liver insufficiency, medical or psychological problems and stress related to donation.