Department of Radiology, Hospital Universitario Dr. José Eleuterio González, Monterrey, Mexico.
Adient Medical, 12234 Shadow Creek Parkway, Building 8, Pearland, TX 77584.
J Vasc Interv Radiol. 2020 Nov;31(11):1817-1824. doi: 10.1016/j.jvir.2020.07.021. Epub 2020 Sep 29.
To prospectively evaluate the initial human experience with an absorbable vena cava filter designed for transient protection from pulmonary embolism (PE).
This was a prospective, single-arm, first-in-human study of 8 patients with elevated risk of venous thromboembolism (VTE). Seven absorbable IVC filters (made of polydioxanone that breaks down into HO and CO in 6 mo) were placed prophylactically before orthopedic (n = 5) and gynecologic (n = 2) surgeries, and 1 was placed in a case of deep vein thrombosis. Subjects underwent CT cavography and abdominal radiography before and 5, 11, and 36 weeks after filter placement to assess filter migration, embolization, perforation, and caval thrombosis and/or stenosis. Potential PE was assessed immediately before and 5 weeks after filter placement by pulmonary CT angiography.
No symptomatic PE was reported throughout the study or detected at the planned 5-week follow-up. No filter migration was detected based on the fixed location of the radiopaque markers (attached to the stent section of the filter) relative to the vertebral bodies. No filter embolization or caval perforation was detected, and no caval stenosis was observed. Throughout the study, no filter-related adverse events were reported.
Implantation of an absorbable vena cava filter in a limited number of human subjects resulted in 100% clinical success. One planned deployment was aborted as a result of stenotic pelvic veins, resulting in 89% technical success. No PE or filter-related adverse events were observed.
前瞻性评估专为预防肺栓塞（PE）而设计的可吸收腔静脉滤器的初步人体应用经验。
这是一项前瞻性、单臂、首例人体研究，纳入 8 例静脉血栓栓塞（VTE）风险升高的患者。7 例可吸收 IVC 滤器（由聚二氧杂环已酮制成，在 6 个月内分解为 HO 和 CO）预防性地置于骨科（n=5）和妇科（n=2）手术前，1 例置于深静脉血栓形成患者。所有患者在放置滤器前、后 5、11 和 36 周行 CT 腔静脉造影和腹部 X 线摄影，以评估滤器迁移、栓塞、穿孔以及腔静脉血栓形成和/或狭窄。在放置滤器前和 5 周时通过肺 CT 血管造影评估潜在的 PE。
整个研究期间或计划的 5 周随访均未报告有症状性 PE，也未检测到。根据不透射线标记物（附着于滤器的支架部分）相对于椎体的固定位置，未检测到滤器迁移。未检测到滤器栓塞或腔静脉穿孔，也未观察到腔静脉狭窄。整个研究期间，未报告与滤器相关的不良事件。
在少数人体中植入可吸收腔静脉滤器实现了 100%的临床成功率。由于狭窄的骨盆静脉，一次计划的部署被放弃，导致技术成功率为 89%。未观察到 PE 或滤器相关的不良事件。
