美国食品和药物管理局发出安全警告后,按适应症分列的下腔静脉滤器最新使用趋势:从 2010 年到 2019 年的十年分析。

IF 1.7 2区 医学 Q3 PERIPHERAL VASCULAR DISEASE
Journal of Endovascular Therapy Pub Date : 2024-10-01 Epub Date: 2023-03-01 DOI:10.1177/15266028231156089
Titilope Olanipekun, Charles Ritchie, Temidayo Abe, Valery Effoe, Abimbola Chris-Olaiya, Isaac Biney, Young M Erben, Pramod Guru, Devang Sanghavi
{"title":"美国食品和药物管理局发出安全警告后,按适应症分列的下腔静脉滤器最新使用趋势:从 2010 年到 2019 年的十年分析。","authors":"Titilope Olanipekun, Charles Ritchie, Temidayo Abe, Valery Effoe, Abimbola Chris-Olaiya, Isaac Biney, Young M Erben, Pramod Guru, Devang Sanghavi","doi":"10.1177/15266028231156089","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Overall inferior vena cava filter (IVCF) utilization has decreased in the United States since the 2010 US Food and Drug Administration (FDA) safety communication. The FDA renewed this safety warning in 2014 with additional mandates on reporting IVCF-related adverse events. We evaluated the impact of the FDA recommendations on IVCF placements for different indications from 2010 to 2019 and further assessed utilization trends by region and hospital teaching status.</p><p><strong>Methods: </strong>Inferior vena cava filter placements between 2010 and 2019 were identified in the Nationwide Inpatient Sample database using the associated International Classification of Diseases, Ninth Revision, Clinical Modification, and Tenth Revision codes. Inferior vena cava filter placements were categorized by indication for venous thromboembolism (VTE) \"treatment\" in patients with VTE diagnosis and contraindication to anticoagulation and \"prophylaxis\" in patients without VTE. Generalized linear regression was used to analyze utilization trends.</p><p><strong>Results: </strong>A total of 823 717 IVCFs were placed over the study period, of which 644 663 (78.3%) were for VTE treatment and 179 054 (21.7%) were for prophylaxis indications. The median age for both categories of patients was 68 years. The total number of IVCFs placed for all indications decreased from 129 616 in 2010 to 58 465 in 2019, with an aggregate decline rate of -8.4%. The decline rate was higher between 2014 and 2019 than between 2010 and 2014 (-11.6% vs -7.2%). From 2010 to 2019, IVCF placement for VTE treatment and prophylaxis trended downward at rates of -7.9% and -10.2%, respectively. Urban nonteaching hospitals saw the highest decline for both VTE treatment (-17.2%) and prophylactic indications (-18.0%). Hospitals located in the Northeast region had the highest decline rates for VTE treatment (-10.3%) and prophylactic indications (-12.5%).</p><p><strong>Conclusion: </strong>The higher decline rate in IVCF placements between 2014 and 2019 compared with 2010 and 2014 suggests an additional impact of the renewed 2014 FDA safety indications on national IVCF utilization. Variations in IVCF use for VTE treatment and prophylactic indications existed across hospital teaching types, locations, and regions.</p><p><strong>Clinical impact: </strong>Inferior vena cava filters (IVCF) are associated with medical complications. The 2010 and 2014 FDA safety warnings appeared to have synergistically contributed to a significant decline in IVCF utilization rates from 2010 - 2019 in the US. IVC filter placements in patients without venous thromboembolism (VTE) declined at a higher rate than VTE. However, IVCF utilization varied across hospitals and geographical locations, likely due to the absence of universally accepted clinical guidelines on IVCF indications and use. Harmonization of IVCF placement guidelines is needed to standardize clinical practice, thereby reducing the observed regional and hospital variations and potential IVC filter overutilization.</p>","PeriodicalId":50210,"journal":{"name":"Journal of Endovascular Therapy","volume":null,"pages":null},"PeriodicalIF":1.7000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Updated Trends in Inferior Vena Cava Filter Use by Indication in the United States After Food and Drug Administration Safety Warnings: A Decade Analysis From 2010 to 2019.\",\"authors\":\"Titilope Olanipekun, Charles Ritchie, Temidayo Abe, Valery Effoe, Abimbola Chris-Olaiya, Isaac Biney, Young M Erben, Pramod Guru, Devang Sanghavi\",\"doi\":\"10.1177/15266028231156089\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Overall inferior vena cava filter (IVCF) utilization has decreased in the United States since the 2010 US Food and Drug Administration (FDA) safety communication. The FDA renewed this safety warning in 2014 with additional mandates on reporting IVCF-related adverse events. We evaluated the impact of the FDA recommendations on IVCF placements for different indications from 2010 to 2019 and further assessed utilization trends by region and hospital teaching status.</p><p><strong>Methods: </strong>Inferior vena cava filter placements between 2010 and 2019 were identified in the Nationwide Inpatient Sample database using the associated International Classification of Diseases, Ninth Revision, Clinical Modification, and Tenth Revision codes. Inferior vena cava filter placements were categorized by indication for venous thromboembolism (VTE) \\\"treatment\\\" in patients with VTE diagnosis and contraindication to anticoagulation and \\\"prophylaxis\\\" in patients without VTE. Generalized linear regression was used to analyze utilization trends.</p><p><strong>Results: </strong>A total of 823 717 IVCFs were placed over the study period, of which 644 663 (78.3%) were for VTE treatment and 179 054 (21.7%) were for prophylaxis indications. The median age for both categories of patients was 68 years. The total number of IVCFs placed for all indications decreased from 129 616 in 2010 to 58 465 in 2019, with an aggregate decline rate of -8.4%. The decline rate was higher between 2014 and 2019 than between 2010 and 2014 (-11.6% vs -7.2%). From 2010 to 2019, IVCF placement for VTE treatment and prophylaxis trended downward at rates of -7.9% and -10.2%, respectively. Urban nonteaching hospitals saw the highest decline for both VTE treatment (-17.2%) and prophylactic indications (-18.0%). Hospitals located in the Northeast region had the highest decline rates for VTE treatment (-10.3%) and prophylactic indications (-12.5%).</p><p><strong>Conclusion: </strong>The higher decline rate in IVCF placements between 2014 and 2019 compared with 2010 and 2014 suggests an additional impact of the renewed 2014 FDA safety indications on national IVCF utilization. Variations in IVCF use for VTE treatment and prophylactic indications existed across hospital teaching types, locations, and regions.</p><p><strong>Clinical impact: </strong>Inferior vena cava filters (IVCF) are associated with medical complications. The 2010 and 2014 FDA safety warnings appeared to have synergistically contributed to a significant decline in IVCF utilization rates from 2010 - 2019 in the US. IVC filter placements in patients without venous thromboembolism (VTE) declined at a higher rate than VTE. However, IVCF utilization varied across hospitals and geographical locations, likely due to the absence of universally accepted clinical guidelines on IVCF indications and use. Harmonization of IVCF placement guidelines is needed to standardize clinical practice, thereby reducing the observed regional and hospital variations and potential IVC filter overutilization.</p>\",\"PeriodicalId\":50210,\"journal\":{\"name\":\"Journal of Endovascular Therapy\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Endovascular Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/15266028231156089\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/3/1 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Endovascular Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/15266028231156089","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/3/1 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 0

摘要

背景:自2010年美国食品和药物管理局(FDA)发布安全通报以来,美国下腔静脉滤器(IVCF)的总体使用率有所下降。2014年,FDA更新了这一安全警告,并增加了报告IVCF相关不良事件的规定。我们评估了FDA的建议对2010年至2019年不同适应症下IVCF置入的影响,并进一步评估了不同地区和医院教学状况下的使用趋势:使用相关的《国际疾病分类》第九版、临床修订版和第十版代码,在全国住院病人抽样数据库中确定了 2010 年至 2019 年期间的下腔静脉滤器植入情况。根据静脉血栓栓塞(VTE)诊断和抗凝禁忌症患者的静脉血栓栓塞(VTE)"治疗 "指征和无静脉血栓栓塞患者的 "预防 "指征,对下腔静脉滤器置入情况进行分类。采用广义线性回归分析使用趋势:研究期间共放置了 823 717 个 IVCF,其中 644 663 个(78.3%)用于治疗 VTE,179 054 个(21.7%)用于预防。两类患者的年龄中位数均为 68 岁。用于所有适应症的 IVCF 总数从 2010 年的 129 616 例降至 2019 年的 58 465 例,总下降率为 -8.4%。2014年至2019年的下降率高于2010年至2014年(-11.6% vs -7.2%)。从 2010 年到 2019 年,用于治疗和预防 VTE 的 IVCF 置入率呈下降趋势,降幅分别为 -7.9% 和 -10.2%。城市非教学医院在 VTE 治疗(-17.2%)和预防适应症(-18.0%)方面的降幅最大。东北地区医院的 VTE 治疗(-10.3%)和预防性适应症(-12.5%)下降率最高:结论:与2010年和2014年相比,2014年至2019年期间IVCF置入量的下降率更高,这表明2014年FDA更新的安全适应症对全国IVCF的使用产生了额外影响。不同教学类型、地点和地区的医院在使用 IVCF 治疗 VTE 和预防适应症方面存在差异:临床影响:下腔静脉滤器(IVCF)与医疗并发症有关。2010年和2014年美国食品和药物管理局发布的安全警告似乎共同促成了2010-2019年美国IVCF使用率的显著下降。无静脉血栓栓塞症(VTE)患者的IVCF置入率降幅高于VTE。然而,不同医院和不同地区的 IVCF 使用情况各不相同,这可能是由于缺乏普遍接受的 IVCF 适应症和使用临床指南。有必要统一IVCF置入指南,以规范临床实践,从而减少观察到的地区和医院差异以及潜在的IVC过滤器过度使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Updated Trends in Inferior Vena Cava Filter Use by Indication in the United States After Food and Drug Administration Safety Warnings: A Decade Analysis From 2010 to 2019.

Background: Overall inferior vena cava filter (IVCF) utilization has decreased in the United States since the 2010 US Food and Drug Administration (FDA) safety communication. The FDA renewed this safety warning in 2014 with additional mandates on reporting IVCF-related adverse events. We evaluated the impact of the FDA recommendations on IVCF placements for different indications from 2010 to 2019 and further assessed utilization trends by region and hospital teaching status.

Methods: Inferior vena cava filter placements between 2010 and 2019 were identified in the Nationwide Inpatient Sample database using the associated International Classification of Diseases, Ninth Revision, Clinical Modification, and Tenth Revision codes. Inferior vena cava filter placements were categorized by indication for venous thromboembolism (VTE) "treatment" in patients with VTE diagnosis and contraindication to anticoagulation and "prophylaxis" in patients without VTE. Generalized linear regression was used to analyze utilization trends.

Results: A total of 823 717 IVCFs were placed over the study period, of which 644 663 (78.3%) were for VTE treatment and 179 054 (21.7%) were for prophylaxis indications. The median age for both categories of patients was 68 years. The total number of IVCFs placed for all indications decreased from 129 616 in 2010 to 58 465 in 2019, with an aggregate decline rate of -8.4%. The decline rate was higher between 2014 and 2019 than between 2010 and 2014 (-11.6% vs -7.2%). From 2010 to 2019, IVCF placement for VTE treatment and prophylaxis trended downward at rates of -7.9% and -10.2%, respectively. Urban nonteaching hospitals saw the highest decline for both VTE treatment (-17.2%) and prophylactic indications (-18.0%). Hospitals located in the Northeast region had the highest decline rates for VTE treatment (-10.3%) and prophylactic indications (-12.5%).

Conclusion: The higher decline rate in IVCF placements between 2014 and 2019 compared with 2010 and 2014 suggests an additional impact of the renewed 2014 FDA safety indications on national IVCF utilization. Variations in IVCF use for VTE treatment and prophylactic indications existed across hospital teaching types, locations, and regions.

Clinical impact: Inferior vena cava filters (IVCF) are associated with medical complications. The 2010 and 2014 FDA safety warnings appeared to have synergistically contributed to a significant decline in IVCF utilization rates from 2010 - 2019 in the US. IVC filter placements in patients without venous thromboembolism (VTE) declined at a higher rate than VTE. However, IVCF utilization varied across hospitals and geographical locations, likely due to the absence of universally accepted clinical guidelines on IVCF indications and use. Harmonization of IVCF placement guidelines is needed to standardize clinical practice, thereby reducing the observed regional and hospital variations and potential IVC filter overutilization.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
5.30
自引率
15.40%
发文量
203
审稿时长
6-12 weeks
期刊介绍: The Journal of Endovascular Therapy (formerly the Journal of Endovascular Surgery) was established in 1994 as a forum for all physicians, scientists, and allied healthcare professionals who are engaged or interested in peripheral endovascular techniques and technology. An official publication of the International Society of Endovascular Specialists (ISEVS), the Journal of Endovascular Therapy publishes peer-reviewed articles of interest to clinicians and researchers in the field of peripheral endovascular interventions.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信