Division of Vascular and Interventional Radiology Stanford University School of Medicine Stanford CA.
J Am Heart Assoc. 2020 Dec 15;9(24):e017916. doi: 10.1161/JAHA.119.017916. Epub 2020 Nov 30.
Background Many patients are subject to potential risks and filter-related morbidity when standard retrieval methods fail. We evaluated the safety and efficacy of the laser sheath technique for removing embedded inferior vena cava filters. Methods and Results Over an 8.5-year period, 500 patients were prospectively enrolled in an institutional review board-approved study. There were 225 men and 275 women (mean age, 49 years; range, 15-90 years). Indications for retrieval included symptomatic acute inferior vena cava thrombosis, chronic inferior vena cava occlusion, and/or pain from filter penetration. Retrieval was also offered to prevent risks from prolonged implantation and potentially to eliminate need for lifelong anticoagulation. After retrieval failed using 3X standard retrieval force (6-7 lb via digital gauge), treatment escalation was attempted using laser sheath powered by 308-nm XeCl excimer laser system (CVX-300; Spectranetics). We hypothesized that the laser-assisted technique would allow retrieval of >95% of embedded filters with <5% risk of major complications and with lower force. Primary outcome was successful retrieval. Primary safety outcome was any major procedure-related complication. Laser-assisted retrieval was successful in 99.4% of cases (497/500) (95% CI, 98.3%-99.9%) and significantly >95% (<0.0001). The mean filter dwell time was 1528 days (range, 37-10 047; >27.5 years]), among retrievable-type (n=414) and permanent-type (n=86) filters. The average force during failed attempts without laser was 6.4 versus 3.6 lb during laser-assisted retrievals (<0.0001). The major complication rate was 2.0% (10/500) (95% CI, 1.0%-3.6%), significantly <5% (<0.0005), 0.6% (3/500) (95% CI, 0%-1.3%) from laser, and all were successfully treated. Successful retrieval allowed cessation of anticoagulation in 98.7% (77/78) (95% CI, 93.1%-100.0%) and alleviated filter-related morbidity in 98.5% (138/140) (95% CI, 96.5%-100.0%). Conclusions The excimer laser sheath technique is safe and effective for removing embedded inferior vena cava filters refractory to high-force retrieval. This technique may allow cessation of filter-related anticoagulation and can be used to prevent and alleviate filter-related morbidity. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01158482.
背景 当标准取回方法失败时,许多患者会面临潜在风险和与滤器相关的发病率。我们评估了激光鞘技术用于取出嵌入式下腔静脉滤器的安全性和有效性。
方法和结果 在 8.5 年的时间里,500 名患者前瞻性地参加了一项机构审查委员会批准的研究。其中 225 名男性和 275 名女性(平均年龄 49 岁;范围,15-90 岁)。取回的指征包括症状性急性下腔静脉血栓形成、慢性下腔静脉闭塞和/或滤器穿透引起的疼痛。取回还用于预防长期植入的风险,并可能消除终身抗凝的需要。在使用 3X 标准取回力(通过数字量表为 6-7 磅)后取回失败后,尝试使用 308nm XeCl 准分子激光系统(CVX-300;Spectranetics)驱动的激光鞘进行治疗升级。我们假设激光辅助技术可以以<5%的主要并发症风险和较低的力取回>95%的嵌入式滤器。主要结果是成功取回。主要安全性结果是任何与程序相关的主要并发症。激光辅助取回在 99.4%的病例(497/500)中成功(95%CI,98.3%-99.9%),明显>95%(<0.0001)。可回收型(n=414)和永久性(n=86)滤器的平均滤器滞留时间为 1528 天(范围,37-10047;>27.5 年)。在没有激光的情况下,平均力为 6.4 磅,而在激光辅助取回时为 3.6 磅(<0.0001)。主要并发症发生率为 2.0%(10/500)(95%CI,1.0%-3.6%),明显<5%(<0.0005),0.6%(3/500)(95%CI,0%-1.3%)来自激光,所有患者均成功治疗。成功取回允许 98.7%(77/78)(95%CI,93.1%-100.0%)停止抗凝,98.5%(138/140)(95%CI,96.5%-100.0%)缓解滤器相关发病率。
结论 准分子激光鞘技术用于取出对高力取回有抗性的嵌入式下腔静脉滤器是安全有效的。该技术可停止滤器相关抗凝,并可用于预防和缓解滤器相关发病率。