Table 2

Serious adverse (device) events (SADEs)

ComplicationsExpected 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.