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Postmarketing Surveillance of Inferior Vena Cava Filters Among US Medicare Beneficiaries: The SAFE-IVC Study. 美国医疗保险受益人下腔静脉滤器上市后监测:SAFE-IVC 研究。
Q1 Medicine Pub Date : 2024-11-06 DOI: 10.1001/jama.2024.19553
Enrico G Ferro, Julie B Mackel, Renee D Kramer, Rebecca Torguson, Eleni M Whatley, Gregory O'Connell, Brian Pullin, Nathan W Watson, Siling Li, Yang Song, Anna K Krawisz, Brett J Carroll, Marc L Schermerhorn, Jeffrey L Weinstein, Andrew Farb, Bram Zuckerman, Robert W Yeh, Eric A Secemsky

Importance: Inferior vena cava filters (IVCFs) are commonly used to prevent pulmonary embolism in selected clinical scenarios, despite limited evidence to support their use. Current recommendations from professional societies and the US Food and Drug Administration endorse timely IVCF retrieval when clinically feasible. Current IVCF treatment patterns and outcomes remain poorly described.

Objectives: To evaluate temporal trends and practice patterns in IVCF insertion and retrieval among older US patients and report the incidence of periprocedural and long-term safety events of indwelling and retrieved IVCFs.

Design, setting, and participants: Prespecified, retrospective, observational cohort of Medicare Fee-for-Service (FFS) beneficiaries, leveraging 100% of samples of inpatient and outpatient claims data from January 1, 2013, to December 31, 2021.

Exposure: First-time IVCF insertion while insured by Medicare FFS.

Main outcomes and measures: The primary safety outcome was the composite of all-cause death, filter-related complications (eg, fracture, embolization), operating room visits following filter-related procedures, or new diagnosis of deep vein thrombosis (DVT). Events were considered periprocedural if they occurred within 30 days of IVCF insertion or retrieval and long-term if they occurred more than 30 days after.

Results: Among 270 866 patients with IVCFs placed during the study period (mean age, 75.1 years; 52.8% female), 64.9% were inserted for first-time venous thromboembolism (VTE), 26.3% for recurrent VTE, and 8.8% for VTE prophylaxis. Of these patients, 63.3% had major bleeds or trauma within 30 days of IVCF insertion. The volume of insertions decreased from 44 680 per year in 2013 to 19 501 per year in 2021. The cumulative incidence of retrieval was 15.3% at a median of 1.2 years and 16.8% at maximum follow-up of 9.0 years. Older age, more comorbidities, and Black race were associated with a decreased likelihood of retrieval, whereas placement at a large teaching hospital was associated with an increased likelihood of retrieval. The incidence of caval thrombosis and DVT among patients with nonretrieved IVCFs was 2.2% (95% CI, 2.1%-2.3%) and 9.2% (95% CI, 9.0%-9.3%), respectively. The majority (93.5%) of retrieval attempts were successful, with low incidence of 30-day complications (mortality, 0.7% [95% CI, 0.6%-0.8%]; filter-related complications, 1.4% [95% CI, 1.2%-1.5%]).

Conclusions and relevance: In this large, US real-world analysis, IVCF insertion declined, yet retrievals remained low. Strategies to increase timely retrieval are needed, as nonretrieved IVCFs may have long-term complications.

重要性:尽管支持使用下腔静脉滤器(IVCF)的证据有限,但下腔静脉滤器通常在特定临床情况下用于预防肺栓塞。目前,专业协会和美国食品药品管理局建议在临床可行的情况下及时取出下腔静脉滤器。目前对 IVCF 治疗模式和结果的描述仍然很少:评估美国老年患者 IVCF 插入和取出的时间趋势和实践模式,并报告留置和取出 IVCF 的围手术期和长期安全事件的发生率:利用 2013 年 1 月 1 日至 2021 年 12 月 31 日期间住院病人和门诊病人报销数据的 100% 样本,对医疗保险付费服务 (FFS) 受益人进行预设、回顾性、观察性队列研究:主要结果和测量指标:主要安全性结果是全因死亡、过滤器相关并发症(如骨折、栓塞)、过滤器相关手术后的手术室就诊或新诊断的深静脉血栓(DVT)的综合结果。如果事件发生在IVCF插入或取出后30天内,则被视为围手术期事件;如果事件发生在IVCF插入或取出后30天以上,则被视为长期事件:在研究期间置入IVCF的270 866名患者中(平均年龄75.1岁;52.8%为女性),64.9%是首次置入静脉血栓栓塞症(VTE),26.3%是复发性VTE,8.8%是预防VTE。在这些患者中,63.3%的患者在植入 IVCF 后 30 天内出现大出血或外伤。插入量从 2013 年的每年 44 680 例降至 2021 年的每年 19 501 例。在1.2年的中位随访中,取回IVCF的累积发生率为15.3%,在最长9.0年的随访中,取回IVCF的累积发生率为16.8%。年龄越大、合并症越多、黑人种族越多,取栓的可能性就越小,而在大型教学医院就医则取栓的可能性越大。在未取出 IVCF 的患者中,腔隙血栓和深静脉血栓的发生率分别为 2.2% (95% CI, 2.1%-2.3%) 和 9.2% (95% CI, 9.0%-9.3%) 。大多数(93.5%)取管尝试成功,30天并发症发生率较低(死亡率为0.7% [95% CI, 0.6%-0.8%]; 过滤器相关并发症为1.4% [95% CI, 1.2%-1.5%]):在这项大型美国真实世界分析中,IVCF插入率有所下降,但取回率仍然很低。由于未取回的 IVCF 可能会产生长期并发症,因此需要制定策略以提高及时取回率。
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引用次数: 0
An Improved Alert System for Emerging Infectious Diseases. 改进的新发传染病警报系统。
Q1 Medicine Pub Date : 2024-11-06 DOI: 10.1001/jama.2024.22023
Nahid Bhadelia
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引用次数: 0
Associations of Internal Medicine Residency Ratings and Certification Examination Scores With Patient Outcomes-Reply. 内科住院医生评分和认证考试成绩与患者预后的关系--回复。
Q1 Medicine Pub Date : 2024-11-06 DOI: 10.1001/jama.2024.19945
Bradley M Gray, Bruce E Landon
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引用次数: 0
a fall. a fall.
Q1 Medicine Pub Date : 2024-11-06 DOI: 10.1001/jama.2024.15337
James M Wilkins
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引用次数: 0
Associations of Internal Medicine Residency Ratings and Certification Examination Scores With Patient Outcomes. 内科住院医师评级和认证考试成绩与患者预后的关系。
Q1 Medicine Pub Date : 2024-11-06 DOI: 10.1001/jama.2024.19942
James L Rudolph, Luci K Leykum
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引用次数: 0
A Young Woman With Headaches and Peripheral Vision Loss. 一位头痛并伴有周边视力丧失的年轻女性。
Q1 Medicine Pub Date : 2024-11-06 DOI: 10.1001/jama.2024.19493
Austin D Peer, M Aurel Nagy, Marc H Levin
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引用次数: 0
Associations of Internal Medicine Residency Ratings and Certification Examination Scores With Patient Outcomes. 内科住院医师评级和认证考试成绩与患者预后的关系。
Q1 Medicine Pub Date : 2024-11-06 DOI: 10.1001/jama.2024.19939
Andrei Brateanu, Moises Auron, Richard Wardrop
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引用次数: 0
Enhancing Medical Device Postmarketing Safety Surveillance-The Case of Inferior Vena Cava Filters. 加强医疗器械上市后安全监控--下腔静脉滤器案例。
Q1 Medicine Pub Date : 2024-11-06 DOI: 10.1001/jama.2024.19542
Behnood Bikdeli, Joseph S Ross
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引用次数: 0
More Than Half of US Adults With Uncontrolled Hypertension Don't Know They Have It. 超过一半的美国成人高血压患者不知道自己患有高血压。
Q1 Medicine Pub Date : 2024-11-05 DOI: 10.1001/jama.2024.20117
Samantha Anderer
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引用次数: 0
Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery: The SIRAKI02 Randomized Clinical Trial. 体外血液净化与心脏手术中的急性肾损伤:SIRAKI02 随机临床试验。
Q1 Medicine Pub Date : 2024-11-05 DOI: 10.1001/jama.2024.20630
Xosé Pérez-Fernández, Arnau Ulsamer, María Cámara-Rosell, Fabrizio Sbraga, Enric Boza-Hernández, Enrique Moret-Ruíz, Erika Plata-Menchaca, Doménech Santiago-Bautista, Patricia Boronat-García, Víctor Gumucio-Sanguino, Judith Peñafiel-Muñoz, Mercedes Camacho-Pérez, Antoni Betbesé-Roig, Lui Forni, Ana Campos-Gómez, Joan Sabater-Riera

Importance: Cardiac surgery-associated acute kidney injury (CSA-AKI) remains a significant problem following cardiopulmonary bypass (CPB). Various strategies are proposed to attenuate CSA-AKI, including extracorporeal blood purification (EBP), but little is known about the effect of EBP through an acrylonitrile-sodium methallylsulfonate/polyethyleneimine membrane during CPB.

Objective: To determine whether the use of an EBP device in a nonemergent cardiac surgery population reduces CSA-AKI after CPB.

Design, setting, and participants: This double-blind, randomized clinical trial was conducted in 2 tertiary hospitals in Spain. Patients 18 years or older undergoing nonemergent cardiac surgery who were at high risk for CSA-AKI were enrolled from June 15, 2016, through November 5, 2021, with follow-up data through February 5, 2022. Of 1156 patients assessed, 343 patients were randomized (1:1) to either receive EBP or standard care.

Intervention: Nonselective EBP device connected to the CPB circuit.

Main outcomes and measures: The primary outcome was the rate of CSA-AKI in the 7 days after randomization.

Results: Among 343 patients randomized (169 to receive EBP and 174 to receive usual care), the mean (SD) age was 69 (9) years and 119 were females. The rate of CSA-AKI was 28.4% (95% CI, 21.7%-35.8%) in the EBP group vs 39.7% (95% CI, 32.3%-47.3%) in the standard care group (P = .03), with an adjusted difference of 10.4% (95% CI, 2.3%-18.5%) using a log-binomial model (P = .01). No significant differences (P > .05) were observed in most of the predefined clinical secondary end points or post hoc exploratory end points. In a sensitivity analysis, EBP was found to be more effective in terms of CSA-AKI reduction in patients with chronic kidney disease, diabetes, hypertension, low left ventricular ejection fraction (<40%), and lower body mass index (<30). No differences were observed between the groups in adverse events tracking.

Conclusions and relevance: The use of a nonselective EBP device connected to the CPB circuit in a nonemergent population of patients undergoing cardiac surgery was associated with a significant reduction of CSA-AKI in the first 7 days after surgery.

Trial registration: ClinicalTrials.gov Identifier: NCT02518087.

重要性:心脏手术相关急性肾损伤(CSA-AKI)仍然是心肺旁路(CPB)术后的一个重要问题。人们提出了包括体外血液净化(EBP)在内的各种减轻 CSA-AKI 的策略,但对 CPB 期间通过丙烯腈-甲基烯丙基磺酸钠/聚乙烯亚胺膜进行 EBP 的效果却知之甚少:目的:确定在非急诊心脏手术人群中使用 EBP 装置是否可减少 CPB 后的 CSA-AKI:这项双盲随机临床试验在西班牙的两家三级医院进行。从 2016 年 6 月 15 日到 2021 年 11 月 5 日,接受非紧急心脏手术的 18 岁或以上 CSA-AKI 高风险患者被纳入试验,随访数据截止到 2022 年 2 月 5 日。在接受评估的 1156 名患者中,343 名患者被随机分配(1:1)接受 EBP 或标准护理:主要结果和测量指标:主要结果和测量:主要结果是随机化后 7 天内 CSA-AKI 的发生率:在343名随机患者中(169名接受EBP治疗,174名接受常规治疗),平均(标清)年龄为69(9)岁,119名为女性。EBP 组 CSA-AKI 发生率为 28.4%(95% CI,21.7%-35.8%),标准护理组为 39.7%(95% CI,32.3%-47.3%)(P = .03),使用对数二叉模型调整后的差异为 10.4%(95% CI,2.3%-18.5%)(P = .01)。在大多数预定义的临床次要终点或事后探索性终点中均未观察到明显差异(P > .05)。在一项敏感性分析中发现,EBP 在降低慢性肾病、糖尿病、高血压、左室射血分数低的患者 CSA-AKI 方面更为有效:在接受心脏手术的非急诊患者中使用连接到 CPB 电路的非选择性 EBP 设备与术后头 7 天 CSA-AKI 的显著降低有关:试验注册:ClinicalTrials.gov Identifier:试验注册:ClinicalTrials.gov Identifier:NCT02518087。
{"title":"Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery: The SIRAKI02 Randomized Clinical Trial.","authors":"Xosé Pérez-Fernández, Arnau Ulsamer, María Cámara-Rosell, Fabrizio Sbraga, Enric Boza-Hernández, Enrique Moret-Ruíz, Erika Plata-Menchaca, Doménech Santiago-Bautista, Patricia Boronat-García, Víctor Gumucio-Sanguino, Judith Peñafiel-Muñoz, Mercedes Camacho-Pérez, Antoni Betbesé-Roig, Lui Forni, Ana Campos-Gómez, Joan Sabater-Riera","doi":"10.1001/jama.2024.20630","DOIUrl":"10.1001/jama.2024.20630","url":null,"abstract":"<p><strong>Importance: </strong>Cardiac surgery-associated acute kidney injury (CSA-AKI) remains a significant problem following cardiopulmonary bypass (CPB). Various strategies are proposed to attenuate CSA-AKI, including extracorporeal blood purification (EBP), but little is known about the effect of EBP through an acrylonitrile-sodium methallylsulfonate/polyethyleneimine membrane during CPB.</p><p><strong>Objective: </strong>To determine whether the use of an EBP device in a nonemergent cardiac surgery population reduces CSA-AKI after CPB.</p><p><strong>Design, setting, and participants: </strong>This double-blind, randomized clinical trial was conducted in 2 tertiary hospitals in Spain. Patients 18 years or older undergoing nonemergent cardiac surgery who were at high risk for CSA-AKI were enrolled from June 15, 2016, through November 5, 2021, with follow-up data through February 5, 2022. Of 1156 patients assessed, 343 patients were randomized (1:1) to either receive EBP or standard care.</p><p><strong>Intervention: </strong>Nonselective EBP device connected to the CPB circuit.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was the rate of CSA-AKI in the 7 days after randomization.</p><p><strong>Results: </strong>Among 343 patients randomized (169 to receive EBP and 174 to receive usual care), the mean (SD) age was 69 (9) years and 119 were females. The rate of CSA-AKI was 28.4% (95% CI, 21.7%-35.8%) in the EBP group vs 39.7% (95% CI, 32.3%-47.3%) in the standard care group (P = .03), with an adjusted difference of 10.4% (95% CI, 2.3%-18.5%) using a log-binomial model (P = .01). No significant differences (P > .05) were observed in most of the predefined clinical secondary end points or post hoc exploratory end points. In a sensitivity analysis, EBP was found to be more effective in terms of CSA-AKI reduction in patients with chronic kidney disease, diabetes, hypertension, low left ventricular ejection fraction (<40%), and lower body mass index (<30). No differences were observed between the groups in adverse events tracking.</p><p><strong>Conclusions and relevance: </strong>The use of a nonselective EBP device connected to the CPB circuit in a nonemergent population of patients undergoing cardiac surgery was associated with a significant reduction of CSA-AKI in the first 7 days after surgery.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02518087.</p>","PeriodicalId":17196,"journal":{"name":"Journal of the American Medical Association","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11539008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142391479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Journal of the American Medical Association
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