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 efficacy of Lava Liquid Embolic System (Lava LES), 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 one of two viscosities, administered by experienced physicians. Primary safety endpoint was freedom from 30-day major adverse events (MAE) defined as ischemia/infarction of target territory, non-target embolization, allergic reaction, and catheter breakage/entrapment. Primary efficacy 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 re-interventions. Secondary endpoints included serious adverse events and mortality.

Results: 113 patients (mean age 57.4 years [SD 18.0; range 18.0-93.0]; 63.7% male) with 148 lesions were enrolled at 19 US centers. Targeted areas included non-gastrointestinal (GI) visceral arteries (31.1%), kidneys (26.3%), upper GI (11.5%), lower GI (6.8%) and extremities (6.1%). Empiric embolization was performed for 20.9% of lesions. The primary efficacy endpoint was achieved in 94.3% of lesions (95.3% 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.