美国食品药品监督管理局发出警告后时代下腔静脉滤器使用量的下降:2005年至2014年全国住院患者样本分析
Decreasing Utilization of Inferior Vena Cava Filters in Post-FDA Warning Era: Insights From 2005 to 2014 Nationwide Inpatient Sample.
作者信息
Wadhwa Vibhor, Trivedi Premal S, Chatterjee Kshitij, Tamrazi Anobel, Hong Kelvin, Lessne Mark L, Ryu Robert K
机构信息
Department of Radiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
Division of Interventional Radiology, University of Colorado Hospital, Aurora, Colorado.
出版信息
J Am Coll Radiol. 2017 Sep;14(9):1144-1150. doi: 10.1016/j.jacr.2017.04.022. Epub 2017 Jun 15.
BACKGROUND
To determine the impact, if any, of the 2010 FDA safety communication on the rate of inferior vena cava filter (IVCF) placement over time.
METHODS
The Nationwide Inpatient Sample was interrogated for the most recent years preceding and after the FDA safety communication-from 2005 to 2014. IVCF placements and associated diagnoses were identified using corresponding International Classification of Diseases, version nine codes. Trends in number of IVCF placement were evaluated in aggregate and by associated diagnoses, both of which were further stratified by hospital geographic cluster, hospital teaching status, and patient demographics. Generalized linear regression models were used to determine statistical significance of trends over time.
RESULTS
IVCF placements steadily increased between 2005 and 2010 (100,434 in 2005 versus 129,614 in 2010, growth rate 5.81%). Aggregate IVCF placements subsequently declined between 2010 and 2014 (96,005 in 2014, decline rate -6.48%). IVCF placements peaked in 2010, the year of the FDA advisory. The proportion of filter placements for therapeutic indication of venous thromboembolism increased significantly during the study period (69.8% in 2005 versus 80.4% in 2014, P < .001). Neither trend varied significantly by patient demographics or hospital characteristics.
CONCLUSIONS
IVCF placements have declined significantly since 2010, when the FDA advisory was released. The proportion of IVCFs placed in patients with venous thromboembolism, as opposed to prophylactic indications, is increasing.
背景
确定2010年美国食品药品监督管理局(FDA)安全通报对下腔静脉滤器(IVCF)随时间推移的植入率是否有影响(若有影响,则确定其影响程度)。
方法
对2005年至2014年期间,即FDA安全通报前后的最近几年的全国住院患者样本进行调查。使用相应的国际疾病分类第九版编码识别IVCF植入情况及相关诊断。对IVCF植入数量的趋势进行总体评估,并按相关诊断进行评估,二者均进一步按医院地理区域、医院教学状况和患者人口统计学特征进行分层。使用广义线性回归模型确定随时间变化趋势的统计学显著性。
结果
2005年至2010年期间IVCF植入量稳步增加(2005年为100,434例,2010年为129,614例,增长率为5.81%)。2010年至2014年期间IVCF植入总量随后下降(2014年为96,005例,下降率为-6.48%)。IVCF植入量在2010年达到峰值,即FDA发布咨询意见的那一年。在研究期间,用于静脉血栓栓塞治疗指征的滤器植入比例显著增加(2005年为69.8%,2014年为80.4%,P <.001)。这两种趋势在患者人口统计学特征或医院特征方面均无显著差异。
结论
自2010年FDA发布咨询意见以来,IVCF植入量显著下降。与预防性指征相比,植入静脉血栓栓塞患者的IVCF比例正在增加。