Abstract No. 38 Pivotal, Prospective Multicenter US Study of Lava, a Liquid Embolic Agent Used to Treat Peripheral Arterial Hemorrhage

Abstract

The Lava Liquid Embolic System (Lava LES; BlackSwan Vascular, Inc, Hayward, CA) is an injectable, non-adhesive liquid embolic agent. A prospective, single-arm, multicenter study, Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature (LAVA), was designed to evaluate the safety and effectiveness of the Lava LES for peripheral arterial hemorrhage. Adult patients with active arterial bleeding in the peripheral vasculature were recruited at 20 centers in the USA. Of 160 screened patients, 113 patients received Lava LES (mean [SD] age, 57.4 [18.0] years; 63.7% male; most frequent morbidities hypertension 58.4%, hyperlipidemia 31.9%, renal insufficiency 28.3%, diabetes 24.8%) for 148 lesions. All patients received Lava LES at one of two viscosities (57.7% and 42.3% with lower and higher viscosity, respectively) with (33.1%) or without (66.9%) adjunctive coil and/or plug embolization. Target lesion was defined as active hemorrhage or pseudoaneurysm on computed tomography (CT) angiography, endoscopy and/or conventional angiography. The primary safety endpoint was freedom from 30-day major adverse events (MAEs; ischemia or infarction of the target territory, non-target embolization, allergic reactions to Lava LES, catheter breakage or entrapment). The primary effectiveness endpoint was clinical success (absence of bleeding from the target lesion after embolization, without the need for emergency surgery, re-embolization, or other target lesion re-interventions within 30 days). Targeted areas of bleeding included non-gastrointestinal (GI) visceral (36.3%; most frequently splenic or hepatic), renal (21.2%), upper GI (9.7%), lower GI (8.8%), extremity (7.1%), and other (16.8%). The mean (SD) volume of Lava LES delivered was 0.7 (0.7) mL. Clinical success at 30 days was 94.3% (133/141; 95% confidence interval: 89.1–97.5%). Technical success (absence of angiographic evidence of bleeding from the target lesion at the conclusion of the index procedure) was 97.3% (144/148). There were no reports of MAEs. All-cause mortality rate at 30 days was 8.3% (9/109; 4 patients exited the study without death before Day 30); two patients (1.9%) had bleeding-related mortality attributable to the target territory. Results from the LAVA study suggest that Lava LES is effective and can be safely used as an embolic agent for treatment of peripheral arterial hemorrhage.