Attending Physician Rush University Medical Center Rush University Medical Center Chicago, Illinois, United States
Background: The Lava™ Liquid Embolic System (Lava LES; BlackSwan Vascular, Inc, Hayward, CA) is an injectable, EVOH-based, non-adhesive liquid embolic agent for the treatment of peripheral arterial hemorrhage.
Purpose/Objective: Prospective, single-arm, multicenter study, Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature (LAVA), to evaluate the safety and effectiveness of Lava LES.
Materials & Methods: Adult patients with active arterial hemorrhage in the peripheral vasculature were recruited at 20 centers in the USA. Patients received Lava LES at one of two viscosities via an interventional radiologist who had previously treated ≥5 patients with EVOH-based liquid embolics. Target lesion was defined as active hemorrhage or pseudoaneurysm on computed tomography angiography, endoscopy and/or conventional angiography. Primary safety endpoint: freedom from 30-day major adverse events (MAEs; ischemia or infarction of the target territory, non-target embolization, allergic reactions, catheter breakage or entrapment). Primary effectiveness endpoint: 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).
Results: 113 patients received Lava LES (mean age 57.4 years; 63.7% male; hypertension 58.4%; hyperlipidemia 31.9%; renal insufficiency 28.3%; diabetes 24.8%); Lava LES was administered to 141/148 target lesions. 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% (Figure). 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).
Conclusion: The LAVA study showed that Lava LES is a safe and effective embolic agent for treatment of peripheral arterial hemorrhage.
