Effectiveness, Retrievability, and Safety of Celect vs. ALN Inferior Vena Cava Filters: A Randomized Prospective Multicenter Controlled Study

M. D. de Gregorio, J. Ciampi-Dopazo, J. Urbano, Román Bernal, Carolina Serrano-Casorrán, C. Bonastre, J. Abadal, S. Méndez, A. Fredes, Jose Rodríguez, Sergio Rodriguez, J. Guirola
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Abstract

The purpose of this study is to compare IVC Celect and ALN filters in regard to their efficacy, retrievability, and one-year follow-up after retrieval. Materials and Methods: This is a prospective randomized study, conducted in three centers between April 2020 and May 2021. A total of 115 participants were randomized, of which 15 participants were excluded for various reasons. Each group of 50 participants was finally assigned a type of filter (Celect n = 50 and ALN = 50). Tilt angles at placement and retrieval, rates of overall filter retrieval, complications, complex retrieval, and clinical follow-up at 12 months were compared. Results: One hundred participants (59 men and 41 women) were included. The mean age was 62.4 ± 13.3, with no significant differences between both groups (p 0.503). The mean of dwelling time was 44.7 ± 93 days. (p 0.520) Filter retrieval was successful in all participants (100%). The main complication in CT prior to removal was tilt >15° (31%) and filter tip embedment (16%). No significant differences were observed in the type of retrieval (standard or complex) between both filters (p 0.24); however, fluoroscopy time was significantly longer in the complex removal of the Celect filter: 29.1 ± 12 min vs. 17.5 ± 10.3 (p 0.005). After one year, no recurrent pulmonary embolism was observed in both types of filters. Conclusions: The ALN filter had a significantly lower rate of tip and filter tip embedding, with no differences in complexity or removal success rate. There were significant differences in the fluoroscopy time consumed for standard and complex retrievals between both filters, with less time for the ALN filter.
select与ALN下腔静脉过滤器的有效性、可回收性和安全性:一项随机、前瞻性、多中心对照研究
本研究的目的是比较IVC Celect和ALN过滤器的疗效、可检索性和检索后一年的随访。材料和方法:这是一项前瞻性随机研究,于2020年4月至2021年5月在三个中心进行。随机抽取115名参与者,其中15名参与者因各种原因被排除在外。每组50名参与者最终被分配一种过滤器类型(选择n = 50和ALN = 50)。比较放置和取出时的倾斜角度、整体滤镜取出率、并发症、复杂取出率和12个月的临床随访。结果:纳入100名参与者(男性59名,女性41名)。平均年龄为62.4±13.3岁,两组比较差异无统计学意义(p 0.503)。平均停留时间为44.7±93 d。(p 0.520)所有参与者的过滤器检索成功(100%)。切除前CT检查的主要并发症是倾斜>15°(31%)和滤嘴嵌入(16%)。两种过滤器在检索类型(标准或复杂)方面没有观察到显著差异(p 0.24);然而,在复杂去除select滤镜时,透视时间明显更长:29.1±12分钟vs. 17.5±10.3分钟(p 0.005)。一年后,两种滤过器均未观察到肺栓塞复发。结论:ALN过滤器的尖端嵌入率和尖端嵌入率均明显降低,但复杂性和去除成功率无显著差异。两种滤光器在标准和复杂检索所花费的透视时间上存在显著差异,ALN滤光器的时间更少。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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