Center for Healthcare Outcomes and Policy and Department of Surgery, University of Michigan, Ann Arbor, Michigan 48109, USA.
J Hosp Med. 2013 Apr;8(4):173-7. doi: 10.1002/jhm.2013. Epub 2013 Feb 8.
The United States Food and Drug Administration recently issued a warning about adverse events in patients receiving inferior vena cava (IVC) filters.
To assess relationships between IVC filter insertion and complications while controlling for differences in baseline patient characteristics and medical venous thromboembolism prophylaxis.
Propensity-matched cohort study.
The prospective, statewide, clinical registry of the Michigan Bariatric Surgery Collaborative.
Bariatric surgery patients (n=35,477) from 32 hospitals during the years 2006 through 2012.
Prophylactic IVC filter insertion.
Outcomes included the occurrence of complications (pulmonary embolism, deep vein thrombosis, and overall combined rates of complications by severity) within 30 days of bariatric surgery.
There were no significant differences in baseline characteristics among the 1,077 patients with IVC filters and in 1,077 matched control patients. Patients receiving IVC filters had higher rates of pulmonary embolism (0.84% vs 0.46%; odds ratio [OR], 2.0; 95% confidence interval [CI], 0.6-6.5; P=0.232), deep vein thrombosis (1.2% vs 0.37%; OR, 3.3; 95% CI, 1.1-10.1; P=0.039), venous thromboembolism (1.9% vs 0.74%; OR, 2.7; 95% CI, 1.1-6.3, P=0.027), serious complications (5.8% vs 3.8%; OR, 1.6; 95% CI, 1.0-2.4; P=0.031), permanently disabling complications (1.2% vs 0.37%; OR, 4.3; 95% CI, 1.2-15.6; P=0.028), and death (0.7% vs 0.09%; OR, 7.0; 95% CI, 0.9-57.3; P=0.068). Of the 7 deaths among patients with IVC filters, 4 were attributable to pulmonary embolism and 2 to IVC thrombosis/occlusion.
We have identified no benefits and significant risks to the use of prophylactic IVC filters among bariatric surgery patients and believe that their use should be discouraged.
美国食品和药物管理局最近发布了关于接受下腔静脉(IVC)过滤器的患者发生不良事件的警告。
在控制基线患者特征和医学静脉血栓栓塞预防差异的情况下,评估 IVC 过滤器插入与并发症之间的关系。
倾向匹配队列研究。
密歇根州减肥手术协作的前瞻性、全州范围的临床登记处。
2006 年至 2012 年期间,来自 32 家医院的减肥手术患者(n=35477)。
预防性 IVC 过滤器插入。
30 天内与减肥手术相关的并发症(肺栓塞、深静脉血栓形成和严重程度的总体并发症发生率)的发生。
在接受 IVC 过滤器的 1077 名患者和 1077 名匹配对照患者中,基线特征无显著差异。接受 IVC 过滤器的患者肺栓塞发生率较高(0.84%比 0.46%;比值比[OR],2.0;95%置信区间[CI],0.6-6.5;P=0.232),深静脉血栓形成(1.2%比 0.37%;OR,3.3;95%CI,1.1-10.1;P=0.039),静脉血栓栓塞(1.9%比 0.74%;OR,2.7;95%CI,1.1-6.3,P=0.027),严重并发症(5.8%比 3.8%;OR,1.6;95%CI,1.0-2.4;P=0.031),永久性致残性并发症(1.2%比 0.37%;OR,4.3;95%CI,1.2-15.6;P=0.028)和死亡(0.7%比 0.09%;OR,7.0;95%CI,0.9-57.3;P=0.068)。在接受 IVC 过滤器的 7 例死亡患者中,4 例归因于肺栓塞,2 例归因于 IVC 血栓形成/闭塞。
我们没有发现减肥手术患者使用预防性 IVC 过滤器有任何益处,但存在显著风险,因此我们认为应劝阻使用。