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

Bulent Arslan; Mahmood K Razavi; Gary Siskin; Howard M Richard; Michael Katz; Robert Lookstein; Parag J Patel; Siobhan Flanagan; Matthew S Johnson; Nadine Abi-Jaoudeh; Ziv Haskal; LAVA investigators

doi:10.1016/j.jvir.2024.11.005

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

J Vasc Interv Radiol. 2024 Nov 12:S1051-0443(24)00701-2. doi: 10.1016/j.jvir.2024.11.005. Online ahead of print.

Authors

Collaborators

LAVA investigators:
Nadine Abi-Jaoudeh¹², Bulent Arslan¹³, Emily C Bendel¹⁴, Emil Cohen¹⁵, Clayton Commander¹⁶, Sabeen Dhand¹⁷, Siobhan Flanagan¹⁸, Ziv Haskal¹⁹, Hamed Jalaeian²⁰, Matthew Johnson²¹, Thor Johnson²², Sanjeeva Kalva²³, Michael Katz²⁴, Robert Lookstein²⁵, Maria Del Pilar Bayona Molano²⁶, Parag Patel²⁷, Andrew Picel²⁸, Howard M Richard²⁹, Gary Siskin³⁰, Gary Tse³¹

Affiliations

¹ Rush University Medical Center, Chicago, IL, USA.
² Saint Joseph Heart & Vascular Center, Orange, CA, USA. Electronic address: mrazavi@pacbell.net.
³ Albany Medical Center, Albany, NY, USA.
⁴ University of Maryland School of Medicine, Baltimore, MD, USA.
⁵ University of Southern California, Los Angeles, CA, USA.
⁶ Mount Sinai Medical Center, New York, NY, USA.
⁷ Froedtert & The Medical College of Wisconsin, Milwaukee, WI, USA.
⁸ University of Minnesota, Minneapolis, MN, USA.
⁹ Indiana University School of Medicine, Indianapolis, IN, USA.
¹⁰ University of California, Irvine, CA, USA.
¹¹ University of Virginia, Charlottesville, VA, USA.
¹² University of California, Irvine, California, USA.
¹³ Rush University Medical Center, Chicago, Illinois, USA.
¹⁴ Mayo Clinic, Rochester, Minnesota, USA.
¹⁵ Georgetown University Medical Center, Washington DC, Washington, USA.
¹⁶ University of North Carolina, Chapel Hill, North Carolina, USA.
¹⁷ PIH Health, Whittier, California, USA.
¹⁸ University of Minnesota, Minneapolis, Minnesota, USA.
¹⁹ University of Virginia, Charlottesville, Virginia, USA.
²⁰ Miller School of Medicine University of Miami, Miami, Florida, USA.
²¹ Indiana University, Indianapolis, Indiana, USA.
²² Medical University of South Carolina, Charleston, South Carolina, USA.
²³ Massachusetts General Hospital, Boston, Massachusetts, USA.
²⁴ University of Southern California, Los Angeles, California, USA.
²⁵ Icahn School of Medicine at Mount Sinai.
²⁶ University of Texas Southwestern, Dallas, Texas, USA.
²⁷ Froedtert & The Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
²⁸ Stanford University, Stanford, California, USA.
²⁹ University of Maryland, Baltimore, Maryland, USA.
³⁰ Albany University Medical Center, Albany, New York, USA.
³¹ University of California, Los Angeles, California, USA.

PMID: 39542208
DOI: 10.1016/j.jvir.2024.11.005

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.