Safety and Efficacy of Peripheral Embolization with EASYX Liquid Embolic Agent: A Multicenter Prospective Study.

PURPOSE: To evaluate the clinical safety and efficacy of EASYX, a new nonadhesive precipitating liquid embolic agent based on a polyvinyl alcohol ether polymer labeled with iodine molecules, for peripheral embolization. MATERIALS AND METHODS: This open-label prospective multicenter study was conducted on 50 consecutive patients treated with embolization using EASYX in 3 academic hospitals from April 2018 to July 2019. Indications for embolization were symptomatic varicocele (n = 15), type II endoleak (n = 8), acute hemorrhage (n = 16), portal vein embolization (PVE; n = 9), or angiomyolipoma (AML; n = 2). Patient characteristics, technical and clinical success rates, pain at injection, and satisfaction of the interventional radiologists were assessed. Follow-up imaging was performed using ultrasound for varicoceles (at 1 month) and computed tomography (CT) for the other indications (at 3 or 6 months). RESULTS: The immediate technical success rate was 98%. The clinical success rates were 100% for acute hemorrhage and type II endoleaks, 89% for PVE, 86% for varicoceles, and 50% for AMLs. Patients who underwent PVE showed significant hypertrophy of the future liver remnant at follow-up (P < .001), and 55.6% of patients proceeded to hepatectomy. The absence of artifacts on imaging allowed improved monitoring of the aneurysmal sac in patients with type II endoleaks. The satisfaction rate of the interventional radiologists was >90% for 5 of 7 items. CONCLUSIONS: EASYX as a novel copolymer liquid embolic agent was safe and efficient for peripheral embolization. The absence of tantalum allowed reduced CT artifacts on imaging follow-up, which was especially useful in patients with type II endoleaks.

Safety and efficacy of the VenaTech™ Retrievable inferior vena cava filter: a first-in-man single-center prospective study.

BACKGROUND: Venous thromboembolism (VTE) is a frequent condition worldwide, associated with significant morbidity and mortality. Though its primary treatment is anticoagulation, the placement of an inferior vena cava (IVC) filter is recommended in patients with some comorbidities. The objectives of this study were to evaluate the clinical safety and efficacy of the Venatech® retrievable IVC filter. This open-label prospective single-center study was conducted on 40 consecutive patients requiring temporary or permanent IVC filtration. Patient characteristics, technical success rates of filter placement and removal, and the occurrence of complications were assessed. Follow-up imaging was performed using CT-scan before retrieval or at 6 months in the permanent indication population. RESULTS: The filter was successfully implanted at the intended location in all the patients. Retrieval was attempted in 21 (52.5%) patients after a mean period of 50 days (range: 6-94 days), and the filter was successfully removed in 18 patients (85.7%). Reason for retrieval failure was filter with trapped thrombus (n = 2) and a > 15° tilt (n = 1). No complication was observed during the filter placement and retrieval. Follow-up imaging available in 30 patients (75%) demonstrated deep filter penetration (> 3 mm) in four patients (13.3%), severe filter tilt (> 15o) in five patients (16.7%), filter with trapped thrombus in three patients (10%), but no fracture or IVC thrombosis. CONCLUSION: This prospective study showed encouraging preliminary results of the safety and efficacy of the Venatech® retrievable IVC filter. The filter was easily delivered in the intended position and successfully removed in a high percentage of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02674672.