Effectiveness and safety of the home-made umbrella-shaped Octoparms inferior vena cava filter in the prevention of pulmonary embolism / 中华放射学杂志

ABSTRACT

Objective:To evaluate the effectiveness and safety of the home-made umbrella-shaped Octoparms inferior vena cava filter in the prevention of pulmonary embolism.Methods:A multicenter, randomized, positive parallel controlled, non-inferiority clinical trial was conducted in ten hospitals in China from October 2017 to March 2019. A total of 188 subjects were enrolled according to the same inclusion and exclusion criteria in different institutes. The 188 subjects were randomly divided into the trial group or the control group according to 1∶1 by the central randomization system, with 94 cases in each group. Octoparms inferior vena cava filter was used in the trial group, and the Celect inferior vena cava filter in the control group. The primary effective index was clinical success rate,including the clinical success rate of filter placement and filter retrieval. The secondary index included the rate of manual success of the delivery sheath system,incidence of pulmonary embolism(within 6 months), incidence of filter fracture,migration (>20 mm),tilt(>15°) on insertion/retrieval,and the situation of inferior vena cava flow(within 6 months). Safety evaluation included the incidence of filter related complications and device-related adverse events immediately after surgery and during follow-up.Results:The success rate of implantation was 100% in 188 subjects. Filter retrieval was performed in 87 cases (92.55%) in the trial group and 91 cases (96.81%) in the control group. The clinical success rate of the trial group was 97.87%(92/94) and that of the control group 98.94%(93/94). There was no significant difference between the two groups (χ 2=0.77, P=0.380). The success rate of delivery sheath system was 96.81%(91/94) and 98.94%(93/94) in the trail group and the control group,respectively. There was no significant difference between the two groups( P=0.621). There was 1 case (1.22%) of new asymptomatic pulmonary embolism in the trial group after filter placement and 2 cases (2.44%) in the control group. There was no significant difference between the two groups ( P>0.05). No filter fracture or migration (>20 mm) occurred in either group. The tilting of filter (>15°) was found in 1 case (1.06%) in the test group and 1 case (1.06%) in the control group when the filter was placed. The tilting of filter (>15°) was found in 0 case in the test group and 2 cases (2.44%) in the control group when the filter was retrieved. There was no significant difference between the two groups ( P>0.05). Inferior vena cava thrombosis before filter retrieval was found in 5 cases (5.75%) in trial group and 3 cases (3.30%) in control group. There was no significant difference between the two groups ( P=0.489). There were no immediate serious complications during filter placement/removal in either group. No filter obstruction,migration,deformation,penetration and occlusion of inferior vena cava. The incidence of device-related adverse events was low in both group. There was no significant difference between the two groups ( P>0.05). Conclusion:The home-made umbrella-shaped Octoparms inferior vena cava filter is effective and safe in preventing pulmonary embolism, and is not worse than Celect filter.