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

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). LAVA was a pivotal, prospective, multicenter...

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Veröffentlicht in:Journal of vascular and interventional radiology 2024-11
Hauptverfasser: Arslan, Bulent, Razavi, Mahmood K., Siskin, Gary, Richard, Howard M., Katz, Michael, Lookstein, Robert, Patel, Parag J., Flanagan, Siobhan, Johnson, Matthew S., Abi-Jaoudeh, Nadine, Haskal, Ziv, Bendel, Emily C., Cohen, Emil, Commander, Clayton, Dhand, Sabeen, Jalaeian, Hamed, Johnson, Matthew, Johnson, Thor, Kalva, Sanjeeva, Molano, Maria del Pilar Bayona, Patel, Parag, Picel, Andrew, Tse, Gary
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container_title Journal of vascular and interventional radiology
container_volume
creator Arslan, Bulent
Razavi, Mahmood K.
Siskin, Gary
Richard, Howard M.
Katz, Michael
Lookstein, Robert
Patel, Parag J.
Flanagan, Siobhan
Johnson, Matthew S.
Abi-Jaoudeh, Nadine
Haskal, Ziv
Abi-Jaoudeh, Nadine
Arslan, Bulent
Bendel, Emily C.
Cohen, Emil
Commander, Clayton
Dhand, Sabeen
Flanagan, Siobhan
Haskal, Ziv
Jalaeian, Hamed
Johnson, Matthew
Johnson, Thor
Kalva, Sanjeeva
Katz, Michael
Lookstein, Robert
Molano, Maria del Pilar Bayona
Patel, Parag
Picel, Andrew
Richard, Howard M.
Siskin, Gary
Tse, Gary
description 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). 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, nontarget 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. 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%. The LAVA study suggests that EVOH is effective and can be safely used as an embolic agent for treatment of PAH. [Display omitted]
doi_str_mv 10.1016/j.jvir.2024.11.005
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title The LAVA Study: A Prospective, Multicenter, Single-Arm Study of a Liquid Embolic System for Treatment of Peripheral Arterial Hemorrhage
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