Complications | Expected incidence (%) up to 30 days after liver transplantation |
SADEs | |
Device error* | 0 |
Deviation from the perfusion protocol† | 0 |
SAEs | |
Increased hepatic resistance‡ | 0–2 |
Post-reperfusion syndrome§ | 10–70 |
Primary non-function¶ | 4–8 |
Early allograft dysfunction** | 15–30 |
Vascular complications | |
Portal vein thrombosis†† | 1–4 |
Hepatic artery thrombosis‡‡ | 2–5 |
Massive biliary necrosis§§ | 1–5 |
*Any device error leading to termination of the perfusion (eg, motor pump failure).
†Any deviation from the perfusion protocol unable to be resolved within 30 min including: temperature >12°C, oxygenation <70kPa, pressure >5 mm Hg in the portal vein or >25 mm Hg in the hepatic artery to ensure adequate portal (50–150 mL/min) and arterial (20–80 mL/min) volumetric flow rates.
‡Increased vascular resistance after initiation of machine perfusion illustrated by a hepatic artery volumetric flow rate <20 mL/min or a portal venous flow rate <50 mL/min in the absence of technical or mechanical issues.
§Haemodynamic instability after reperfusion defined as postreperfusion syndrome with a decrease in mean arterial pressure >30% below baseline, lasting for ≥1 min, within 5 min after reperfusion (Aggarwal criteria40), or as vasoplegia with a fall in mean arterial pressure on reperfusion to <50 mm Hg either sustained >30 min and/or requiring >0.15 μg/kg/min norepinephrine, >2 U/hour vasopressin, or infusion of epinephrine (significant hypotension resistant to pressors).41
¶Non-life-sustaining graft function leading to graft loss or retransplantation within 7 days after liver transplantation.
**Presence of 1 or more of the following: bilirubin ≥10 mg/dL on postoperative day 7, INR ≥1.6 on postoperative day 7, lactate ≥2 mmol/L on postoperative day 7 in the absence of vascular complications (modified Olthoff criteria).42
††Radiologically or surgically proven thrombosis of the portal vein.
‡‡Radiologically or surgically proven thrombosis of the hepatic artery.
§§Radiological appearance of irregularities and beading dilatation of the intrahepatic bile ducts and/or the presence of cavitations and bile lakes leading to surgical or endoscopic intervention within 30 days.
SADE, serious adverse device event; SAE, serious adverse event.