The LAVA Study: A Prospective, Multicenter, Single-Arm Study of a Liquid Embolic System for Treatment of Peripheral Arterial Hemorrhage
Year: 2024
Type: article
Study design: Clinical Trial
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.
Authors: 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, Nadine Abi-Jaoudeh, Bulent Arslan, Emily C. Bendel, Emil Cohen, Clayton Commander, Sabeen Dhand, Siobhan Flanagan, Ziv Haskal, Hamed Jalaeian, Matthew Johnson, Thor Johnson, Sanjeeva Kalva, Michael Katz, Robert Lookstein, Maria del Pilar Bayona Molano, Parag Patel, Andrew Picel, Howard M. Richard, Gary Siskin, Gary Tse
Institutions: Rush University Medical Center, St. Joseph Hospital, Albany Medical Center Hospital, University of Maryland, Baltimore, University of Southern California, Mount Sinai Health System, Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, Froedtert Hospital, Medical College of Wisconsin, University of Minnesota, Indiana University Indianapolis, Indiana University School of Medicine, University of California, Irvine, University of Virginia, Mayo Clinic, Georgetown University Medical Center, University of North Carolina at Chapel Hill, PIH Health, University of Miami, Medical University of South Carolina, Massachusetts General Hospital, The University of Texas Southwestern Medical Center, Stanford University, University of California, Los Angeles
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,200
Funder: Sirtex Medical
OpenAlex ID: W4404303013