The LAVA Study: A Prospective, Multicenter, Single-Arm Study of a Liquid Embolic System for Treatment of Peripheral Arterial Hemorrhage

Abstract

Purpose: To present the results of the Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature (LAVA) study evaluating safety and effectiveness of Lava Liquid Embolic System, an ethylene vinyl alcohol (EVOH), for peripheral arterial hemorrhage (PAH).

Materials and methods: LAVA was a pivotal, prospective, multicenter, single-group, centrally adjudicated study of adults with active PAH. Patients received EVOH at 1 of 2 viscosities, administered by experienced physicians. The primary safety endpoint was freedom from 30-day major adverse events (MAEs) defined as ischemia/infarction of target territory, non-target embolization, allergic reaction, and catheter breakage/entrapment. The primary effectiveness endpoint was 30-day clinical success defined as absence of bleeding from target lesion after embolization without need for emergency surgery, re-embolization, or other target lesion reinterventions. The secondary endpoints included serious adverse events and mortality.

Results: A total of 113 patients (mean age, 57.4 years [SD ± 18.0; range, 18.0-93.0 years]; male, 63.7%) with 148 lesions were enrolled at 19 US centers. Targeted areas included the nongastrointestinal visceral arteries (31.1%), kidneys (26.3%), upper gastrointestinal (GI) (11.5%), lower GI (6.8%), and extremities (6.1%). Empiric embolization was performed for 20.9% of lesions. The primary effectiveness endpoint was achieved in 94.3% of lesions (95.3% of patients), exceeding the performance goal of 72%. Two target lesions treated with EVOH required subsequent re-embolization. No surgeries were performed for bleeding or ischemia. There were no MAEs reported per study definition. All-cause mortality rate at 30 days was 8.3%.

Conclusions: The LAVA study suggests that EVOH is effective and can be safely used as an embolic agent for treatment of PAH.