Let us settle the controversy—gelfoam is a safe intravascular embolic agent

Abstract

Objectives A 2021 safety alert restricted endovascular gelfoam use in Australia and resulted in an embargo on gelfoam sales to IR departments. This study aimed to show that gelfoam is safe in a population of trauma patients with pelvic injury, and discuss the basis of the recent controversies. Methods Retrospective cohort study between 1 January 2010 and 21 May 2021 of patients who underwent gelfoam embolisation for pelvic arterial haemorrhage. Primary outcome was the rate of adverse events related to intravascular gelfoam administration. Results Inclusion criteria met in 50 patients, comprising 58% males median age 59.9 years, and median injury severity score 31. There were 0 complications related to gelfoam use and 100% technical success. 35 patients (70%) received a non-targeted embolisation approach. All-cause mortality was observed in 5 patients (10%), unrelated to gelfoam. Conclusions Gelfoam is a safe and effective embolic agent in pelvic trauma. Patients are in urgent need of universal on-label registration of endovascular gelfoam products, as it is life-saving in major haemorrhage after trauma. Advances in knowledge Endovascular gelfoam is mandatory for a high-quality trauma service, and this study shows that it is safe to use intentionally in the endovascular space. Companies should work with interventional radiologists, sharing and collaborating to ensure positive outcomes for patients.