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    Safety summary

    Major complications

    In the meta-analysis of 9 studies including chyle leakage of a variety of aetiologies, the pooled major complication rate of TDE (based on 6 studies) was 2% (95% CI, 0.9 to 6.6%, p= 0.236; I2=26.4%). Bile leak was reported in 2 patients (Kim 2018).

    Access related complications

    Biliary peritonitis caused by needle penetration of the distended gallbladder was reported in 1 patient in the retrospective case series of 45 patients who had TDE for post-operative chylothorax. This was treated by emergency percutaneous cholangiography (Jun 2022).

    Biliary peritonitis (grade 4 according to CTCAE version 5) was observed after gallbladder puncture, needing cholecystectomy in 1 of 2 transbiliary punctures in a retrospective analysis of 35 procedures in patients with refractory chylous effusions (Schild 2020).

    Asymptomatic pulmonary embolism (as a result of glue migration during catheter pullback through the left renal vein) occurred in 1 patient in the retrospective analysis of 35 TDE procedures. Percutaneous removal of the embolus was unsuccessful and it was dislodged into a segmental pulmonary artery. Anticoagulation was given and the clinical course was uneventful in this patient (Schild 2020).

    Pancreatitis after pancreatic transgression (CTCAE grade 2) was observed in 1 patient in the retrospective analysis of 35 TDE procedures. This was treated with antibiotics and parenteral nutrition for 4 days (Schild 2020).

    Pulmonary embolism as a result of postoperative stress-induced cardiomyopathy (grade 5) 2 days after the procedure was reported in 1 patient who had embolisation in the thoracic duct and lymphatic networks in the case series of 52 patients (Gurevich 2022).

    Minor complications

    The systematic review of 7 studies reported that minor complications ranged from 4% to 6% and included further chyle leak (in 1 patient), leg and pedal oedema resulting in wound infections (in 2 patients), asymptomatic pulmonary embolisation (in 1 patient), and inconsequential coil misplacement in 1 patient (Power 2021).

    The meta-analysis of 9 studies reported minor complications in 4% (8/195) of patients who had TDE (based on 6 studies). These included non-target embolisation to lungs in 3 patients, non-target embolisation to the portal vein in 1 patient, guidewire fracture in 3 patients and perihepatic hematoma in 1 patient (Kim 2018).

    Asymptomatic free abdominal air after transgression of the colon (grade 1) was reported in 1 patient in the retrospective analysis of 35 TDE procedures (Schild 2020).

    A retrospective review of 106 patients who had TDE for symptomatic chylous effusions reported an overall 14% rate of 'probably-related' long-term complications after TDE. These included chronic leg swelling in 8% (4/46), abdominal swelling in 6% (3/46) and chronic diarrhoea in 12% (6/46) patients (Laslett 2012).

    The retrospective case series of 52 patients who had TDE and lymphatic embolisation reported minor (grade 1) complications such as hypotension, hypoxemia, fluid overload and grade 2 complications such as systemic inflammatory response syndrome and atrial fibrillation with rapid ventricular response and acute pulmonary oedema in 1 patient each (Gurevich 2022).

    Mortality

    The systematic review of 7 studies reported a mortality rate in 2 studies and ranged from 2% to 3% (1 patient in each study) (Power 2021).

    One patient (with clinical failure of TDE) died from the medical complication of persistent lymphatic leakage in the case series of 45 patients (Jun 2022).

    Anecdotal and theoretical adverse events

    In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events that they have heard about) and about theoretical adverse events (events that they think might possibly occur, even if they have never happened).

    For this procedure, professional experts listed no anecdotal adverse events. They considered that the following were theoretical adverse events: contrast allergy-either minor (self-limiting) or moderate (requiring drug treatment), and anaphylaxis.