Denali和Octoparms下腔静脉滤器安全性与有效性对比的倾向性评分匹配分析  

Propensity score matching analysis of the safety and efficacy of Denali vs.Octoparms inferior vena cava filters

作　　者：王雪青 单硕 张福先[2] 罗小云[2] 厉祥涛 WANG Xueqing;SHAN Shuo;ZHANG Fuxian;LUO Xiaoyun;LI Xiangtao(Department of Surgery,Beijing Nuclear Industry Hospital,Beijing100045,China;Department of Vascular Surgery,Capital Medical University Affiliated Beijing Shijitan Hospital,Beijing 100038,China)

机构地区：[1]北京核工业医院外科,北京100045 [2]首都医科大学附属北京世纪坛医院血管外科,北京100038

出　　处：《中国普通外科杂志》2024年第12期1995-2002,共8页China Journal of General Surgery

摘　　要：背景与目的:Octoparms滤器是新上市的国产伞状可取出下腔静脉(IVC)滤器,经多中心、平行对照试验验证显示,其非劣效于Celect滤器。本研究将Octoparms滤器与Denali滤器放置和取出病例的临床指标进行比较,进一步评估其安全性和有效性。方法:2021年5月—2024年5月,首都医科大学附属北京世纪坛医院放置并尝试取出了289枚Denali滤器(Denali组)和78枚Octoparms滤器(Octoparms组)。将两组患者的一般资料进行倾向性评分匹配(PSM)后,比较两种滤器倾斜、贴壁、穿透静脉壁等发生率、滤器取出率及其他相关指标。结果:PSM后,Denali组和Octoparms组各纳入77例患者,除Octoparms组的放置费用明显低于Denali组外(P<0.05),两组患者的其他资料(性别、年龄、手术指征、滤器置入入路、IVC直径与角度等)差异均无统计学意义(均P>0.05)。Denali组的平均滤器留置时间长于Octoparms组(58 d vs.47 d,P=0.004);Denali组与Octoparms组的平均滤器倾斜度差异无统计学意义(4.4°vs.4.8°,P=0.71);滤器头端贴壁或明显倾斜在Octoparms组中更常见,但两组之间差异无统计学意义(P>0.05);两组滤器回收技术成功率均为100.0%,滤器回收过程中均无滤器断裂、血管破裂等并发症;两组其他回收方面的指标(手术入路、回收时长、回收技术及费用)差异均无统计学意义(均P>0.05)。结论:Octoparms作为新上市的国产滤器,与Denali滤器有相似的稳定性、取出率,是一种安全、可靠的滤器选择。Background and Aims:The Octoparms filter is a newly introduced domestically manufactured umbrella-shaped retrievable inferior vena cava(IVC)filter.A multicenter,parallel-controlled trial demonstrated its non-inferiority to the Celect filter.This study was performed to compare the clinical outcomes of the placement and retrieval of the Octoparms filter with those of the Denali filter to assess its safetyandefficacyfurther.Methods:From May 2021 to May 2024,289 Denali filters(Denali group)and 78 Octoparms filters(Octoparms group)were placed and attempted to be retrieved at Beijing Shijitan Hospital,affiliated with Capital Medical University.After propensity score matching(PSM)of baseline characteristics,the incidence of filter tilt,wall apposition,vein wall penetration,retrieval success rates,and other relevant variables were compared between the two groups.Results:After PSM,77 patients were included in each group.Following matching,except for the significantly lower placement cost in the Octoparms group(P<0.05),all baseline characteristics(e.g.,gender,age,surgical indications,filter insertion route,IVC diameter,and angle)showed no statistically significant differences between the two groups(all P>0.05).The average indwelling time of the filter was longer in the Denali group compared to the Octoparms group(58 d vs.47 d,P=0.004).There was no significant difference in the average filter tilt angle between the two groups(4.4 vs.4.8°,P-0.71).While wall apposition or significant tilt was more frequent in the Octoparms group,the difference was not statistically significant(P>0.05).Both groups achieved a 100.0%technical success rate for filter retrieval,with no complications such as filter fracture or vascular rupture during retrieval.Other retrieval-related variables(surgical approach,retrieval duration,retrieval techniques,and costs)also showed no significant differences between the two groups(all P>0.05).Conclusion:As a newly launched domestic filter,the Octoparms filter demonstrates comparable stability and retrieval

关 键 词：静脉血栓形成 下肢 肺栓塞 腔静脉滤器 倾向性评分 

分 类 号：R654.3[医药卫生—外科学]