Pivotal, Prospective Multicenter US Study of Lava, a Liquid Embolic Agent Used to Treat Peripheral Arterial Hemorrhage

Sunday, March 5, 2023

3:36 PM – 3:45 PM

Location: Phoenix Convention Center, 222C

Presenting Author(s)

MR

Mahmood K. Razavi, MD, FSIR

Interventional Radiologist
Vascular and Interventional Specialists of Orange County, Inc

Disclosure(s): No financial relationships to disclose

Author/Co-author(s)

Bulent Arslan, MD FSIR

Professor and Chair, Vascular and Interventional Service Line
Rush University Medical Center
Gary P. Siskin, MD

Professor and Chairman, Department of Radiology
Albany Medical Center
HR

Howard Richard, MD

Interventional Radiologist
University of Maryland Medical Center
MK

Michael Katz, MD

Interventional Radiologist
Keck School of Medicine of USC
Robert A. Lookstein, MD

Executive Vice Chair; Diagnostic, Molecular, and Interventional Radiology
Icahn School of Medicine at Mount Sinai
Nadine Abi-Jaoudeh, MD, FSIR

Professor of Radiology
University of California
Ziv J. Haskal, MD (he/him/his)

Professor
Univ of Virginia

Disclosure(s):

Mahmood K. Razavi, MD, FSIR: No financial relationships to disclose

Bulent Arslan, MD FSIR: Angiodynamics Inc: Advisory Committee or Review Panel Member (Ongoing), Consultant (Ongoing); BD Bard: Consultant (Ongoing), Speaking and Teaching (Ongoing); Blackswan Vascular Inc: Consultant (Ongoing), Ownership Interest (Ongoing), Speaking and Teaching (Ongoing); Cook Inc: Consultant (Ongoing), Speaking and Teaching (Ongoing); Medtronic Inc: Consultant (Ongoing), Speaking and Teaching (Ongoing); Penumbra: Speaking and Teaching (Ongoing)

Robert A. Lookstein, MD: No relevant disclosure to display

Nadine Abi-Jaoudeh, MD, FSIR: Angiodynamics Inc: Contracted Research (Ongoing); AstraZeneca: Consultant (Ongoing); BlackSwan Vascular Inc: Contracted Research (Terminated, November 7, 2022); Bruin Biosciences Inc.: Ownership Interest (Ongoing); Eisai Co., Ltd: Advisory Committee or Review Panel Member (Terminated, April 15, 2021); Genentech F. Hoffmann-La Roche Ltd: Consultant (Ongoing); Guerbet SA: Research Grant Recipient (Ongoing); Histosonics Inc.: Data safety Monitoring Board (Ongoing); Innova Vascular Inc: Advisory Committee or Review Panel Member (Ongoing); Instylla HES Inc: Contracted Research (Ongoing); Johnson and Johnson: Consultant (Ongoing); Lynx Group LLC: Advisory Committee or Review Panel Member (Terminated, January 27, 2022); Medtronic Inc: Advisory Committee or Review Panel Member (Terminated, April 30, 2021); Pfizer Inc: Advisory Committee or Review Panel Member (Terminated, October 15, 2021); Philips Medical Systems Inc Koninklijke NV: Research Grant Recipient (Ongoing); QED Therapeutics Inc: Advisory Committee or Review Panel Member (Terminated, February 1, 2021); Sirtex Medical Ltd: Contracted Research (Ongoing); Teclison Limited (PI): Research Grant Recipient (Ongoing)

Purpose: 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.

Materials and Methods: 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%).

Results: 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.

Conclusion: 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.