5 Safety

5 Safety

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 Adverse events resulting in death were reported in 4% (5/121) of patients in a study of 121 patients (51 patients in a phase 2 study and 70 patients in a phase 3 randomised controlled trial). The causes of death were gastrointestinal haemorrhage due to a ruptured right hepatic artery, hepatic failure in a patient whose liver tissue was more than 90% tumour, gastric perforation, streptococcal sepsis and neutropenia. Death was reported in 2 patients in the case series of 46 patients: in both patients, hepatic arterial thrombosis occurred that was associated with infection caused by the catheter system. Death was reported in post-marketing surveillance in 1 patient out of 32 patients treated with this procedure. The patient died of a spontaneous retroperitoneal haemorrhage within 24 hours of the procedure.

5.2 Serious neutropenia was reported in 59% (71/121) of patients in the study of 121 patients. Complicated neutropenia (febrile neutropenia or neutropenic infection) was reported in 21% (25/121) of patients and was the underlying cause of death in 2 patients (described in section 5.1). Thrombocytopenia was reported in 80% (97/121) of patients, 27 of whom were readmitted, primarily for platelet transfusions. It caused bleeding events in 4 patients, including intracranial, retinal, vaginal and gastrointestinal haemorrhage.

5.3 Cardiovascular events classified as grade 3 or 4 were reported in 17% (21/121) of patients in the study of 121 patients; 13 of these occurred at the time of the procedure and 7 occurred within 30 days of the procedure.

5.4 Gastrointestinal events (including gastritis, ulceration, perforation, bleeding and gallbladder-related events) classified as grade 3 or 4 were reported in 11% (13/121) of patients in the study of 121 patients.

5.5 Haemorrhage occurred in 13% (16/121) of patients in whom 8 were classified as grade 3 or 4, in the study of 121 patients. Intracranial haemorrhage occurred in 2 patients with brain metastases; 1 of these patients died.

5.6 Hepatic events were reported in 44% (53/121) of patients in the study of 121 patients. Hepatic failure was the cause of death in 1 patient (described in section 5.1).

5.7 The specialist advisers listed anecdotal adverse events as hepatotoxicity, haemodynamic instability during the procedure, bleeding, and death from unexpected disseminated intravascular coagulation.

  • National Institute for Health and Care Excellence (NICE)