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国产ZQL型可回收腔静脉滤器的临床研究

Clinical study of domestic ZQL-type retrievable vena cava filter.

作者信息

Xu Ke, Zhou Yu-bin, Wang Ai-lin, Xiao Liang

机构信息

Department of Radiology, First Affiliated Hospital of China Medical University, Shenyang, Liaoning 110001, China.

出版信息

Chin Med J (Engl). 2009 Jan 20;122(2):140-4.

PMID:19187635
Abstract

BACKGROUND

Pulmonary thromboembolism (PTE) is a serious disease often leading to disability and death. Percutaneous placement of an inferior vena cava (IVC) filter is an effective method to prevent fatal PTE caused by lower extremity deep venous thrombosis (LEDVT). We developed the ZQL-type retrievable vena cava filter. The aim of this study was to evaluate the safety and effectiveness of the ZQL-type filter for prevention of fatal PTE.

METHODS

A total of 144 patients with indications for placement of an IVC filter received insertion of filters via a femoral (n = 37) or jugular (n = 107) vein approach. Abdominal X-ray and color Doppler ultrasonography of IVC were regularly performed to visualize the position and condition of the IVC filter following filter placement. If thrombi in the lower extremity deep veins were removed within 2 weeks, the filter retrieval procedure was performed after an abdominal radiograph, an inferior vena cavogram and a pulmonary angiography. Otherwise, the filter should be kept permanently in place with regular follow-up inspections.

RESULTS

One hundred and forty-four filters were implanted at the target sites with a success rate of 98.61% for one-time placement and 100% for two-time placement. Of the 137 patients followed up (follow-up rate, 95.14%), 43 patients had filters retrieved during a period of between 7 and 14 days (median, 12 days) following filter placement. The remaining 94 patients were followed for 7 days to 39 months (median follow-up period, 17 months). No filter migration or tilt, filter fracture or IVC perforation was observed. No obstruction of IVC occurred. No symptomatic PTE developed during the follow-up period.

CONCLUSION

The ZQL-type retrievable vena cava filter is a safe and effective device to prevent PTE. This filter possesses a distinctive stent-shape, stable design, high capture efficacy, and is easy to insert and retrieve and thus is suitable for clinical application.

摘要

背景

肺血栓栓塞症(PTE)是一种常导致残疾和死亡的严重疾病。经皮置入下腔静脉(IVC)滤器是预防下肢深静脉血栓形成(LEDVT)所致致命性PTE的有效方法。我们研发了ZQL型可回收腔静脉滤器。本研究的目的是评估ZQL型滤器预防致命性PTE的安全性和有效性。

方法

共有144例有IVC滤器置入指征的患者通过股静脉(n = 37)或颈静脉(n = 107)途径接受滤器置入。滤器置入后定期进行腹部X线检查和IVC彩色多普勒超声检查,以观察IVC滤器的位置和状况。如果下肢深静脉血栓在2周内清除,则在腹部X线片、下腔静脉造影和肺血管造影后进行滤器回收操作。否则,应将滤器永久留置,并定期进行随访检查。

结果

144枚滤器成功置入目标部位,一次性置入成功率为98.61%,二次置入成功率为100%。在137例接受随访的患者中(随访率为95.14%),43例患者在滤器置入后7至14天(中位时间为12天)内进行了滤器回收。其余94例患者随访7天至39个月(中位随访期为17个月)。未观察到滤器移位或倾斜、滤器断裂或IVC穿孔。未发生IVC梗阻。随访期间未发生有症状的PTE。

结论

ZQL型可回收腔静脉滤器是预防PTE的一种安全有效的装置。该滤器具有独特的支架形状、稳定的设计、较高的捕获效率,且易于置入和回收,因此适合临床应用。

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