“Yes, we know that gelatin sponge works, but I believe that these are vital data to show that what we do is safe and effective, and to guide regulatory approval not only in Australia, but internationally,” said Warren Clements (Alfred Health, Melbourne, Australia), presenting preliminary efficacy results using EmboCube (Merit Medical) embolization gelatin to control haemorrhage.
Clements shared these results at The European Conference on Embolotherapy (ET) annual meeting (1–4 June, Vienna, Austria), ahead of a further data release at the Cardiovascular and Interventional Society of Europe (CIRSE) annual congress (14–18 September, Lisbon, Portugal).
“We know that uncontrolled bleeding is a leading cause of preventable death following trauma, and embolization has become an important facet of the management of haemorrhage in this space,” Clements stated. He described that, over the last 10 years, open surgery has been common in these patients, but now a “shift” toward endovascular techniques is taking place.
Charting the course of gelatin embolization, Clements highlighted that this technique was reportedly first used in 1967. “Why are we doing a study looking at gelatin when we know it works?” he asked the ET audience. In response, he explained that, often in interventional radiology (IR), clinicians adopt a technique that works and begin using it without gaining the “right data” to prove why.
“What happens is jurisdictional and regulatory bodies then step in,” Clements said. In Australia, Gelfoam sponge (Pfizer) is currently off-label for endovascular use following an embargo that was placed in May 2021, previously, Gelfoam was favoured for gelatin embolization procedures.
Clements et al, in the introduction to their study, note that this embargo did not reflect Australian IR user experience, which largely believed Gelfoam to be a “highly effective” live-saving tool. Providing evidence for their experience, Clements outlined their multicentre, prospective cohort study which enrolled 100 patients experiencing haemorrhage. Their primary endpoints were defined as safety—the absence of unanticipated serious adverse device-related effects within 24 hours, and effectiveness— technical success and clinical success, or the cessation of bleeding within 24 hours post-procedure.
In this patient population, the mean age was 56 years, and 48 patients were reported to be taking anticoagulants or antiplatelets. Clements stated that the vessels treated were significantly heterogenous, pointing out that the hepatic artery, uterine artery and pelvic artery were among the most commonly treated.
Technical success was achieved in all patients with no complications recorded with the use of gelatin. Clinical success was reported as 98% due to two patients requiring repeat intervention. Additionally, he noted a 7% rate of all-cause mortality, which, when considered in this patient population which experience multi- system trauma including neurological trauma, a 7% rate of mortality—a rate lower than general pelvic trauma management—is a “good rate”, Clements said.
Clements underlined that gelatin foam is safe and effective, despite this being somewhat known already. However, in collecting these “vital” data he hopes to guide regulatory approval in Australia to prevent future embargoes being placed which restrict clinicians access efficacious tools.
