Galego Gilberto do Nascimento, Silveira Pierre Galvagni, Broering Júlia Jochen, Eli Eduardo da Silva, Corbellini Marcelo Peixer, de Oliveira Amir Antônio Martins
Universidade Federal de Santa Catarina - UFSC, Departamento de Cirurgia, Florianópolis, SC, Brazil.
Universidade Federal de Santa Catarina - UFSC, Departamento de Engenharia Mecânica, Florianópolis, SC, Brazil.
J Vasc Bras. 2016 Apr-Jun;15(2):99-105. doi: 10.1590/1677-5449.006915.
Pulmonary embolism is an important cause of cardiovascular death. Inferior vena cava filters have been shown to be effective for prevention of this condition.
To determine the safety, performance and efficacy of a new inferior vena cava filter in an ovine model.
BKone1 filters are self-centering with over-the-wire deployment, have three filtering regions and are made from nickel-titanium alloy. Eight of these filters were implanted in 8 sheep. The sheep were divided into 4 groups of two animals (A and B) and the number of clots injected differed by group. Two clots were injected in group 2, four in group 3, eight in group 4 and zero clots in group 1. A animals underwent euthanasia soon after the procedure and B animals were observed for 30 days and then euthanized after a control cavography. All inferior vena cavas were processed for histological examination. Clots were prepared in a metal mold, sectioned and then radiopaque markers were inserted. Clot capture was analyzed by identifying the radiopaque marker on fluoroscopy.
No clot migration was observed during follow-up. Control cavographies showed patent inferior vena cavas. Pathological examination indicated little inflammatory tissue response. All clots were captured in the condition with 2 clots, only one clot was missed in the group injected with 4 clots and in the condition of 8 clots, they were partly captured.
The filters were deployed safely. There was a reduction in efficacy as the number of blood clots increased.
肺栓塞是心血管死亡的重要原因。下腔静脉滤器已被证明对预防这种情况有效。
在绵羊模型中确定一种新型下腔静脉滤器的安全性、性能和有效性。
BKone1滤器为自定心且通过导丝展开，有三个过滤区域，由镍钛合金制成。将8个这种滤器植入8只绵羊体内。绵羊被分为4组，每组两只动物（A组和B组），每组注入的血栓数量不同。第1组注入0个血栓，第2组注入2个血栓，第3组注入4个血栓，第4组注入8个血栓。A组动物在手术后不久实施安乐死，B组动物观察30天，然后在对照腔静脉造影后实施安乐死。所有下腔静脉均进行组织学检查。血栓在金属模具中制备，切片后插入不透射线的标记物。通过在荧光透视下识别不透射线的标记物来分析血栓捕获情况。
随访期间未观察到血栓迁移。对照腔静脉造影显示下腔静脉通畅。病理检查表明炎症组织反应轻微。在注入2个血栓的情况下，所有血栓均被捕获；在注入4个血栓的组中，仅遗漏1个血栓；在注入8个血栓的情况下，血栓被部分捕获。
滤器安全植入。随着血栓数量增加，有效性降低。
