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Comparing rates of clinically relevant epistaxis in patients taking warfarin versus direct oral anticoagulants. 比较服用华法林和直接口服抗凝剂患者的临床相关鼻衄发生率。
IF 3.4 3区 医学 Q2 HEMATOLOGY Pub Date : 2024-11-20 eCollection Date: 2024-11-01 DOI: 10.1016/j.rpth.2024.102630
Khristian S Burke, Xiaowen Kong, Brian Haymart, Debbie DeCamillo, Mona Ali, Geoff Barnes, Scott Kaatz
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引用次数: 0
Andexanet alfa: trials just leave us with more questions.
IF 3.4 3区 医学 Q2 HEMATOLOGY Pub Date : 2024-11-15 eCollection Date: 2025-01-01 DOI: 10.1016/j.rpth.2024.102628
Richard J Buka

Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor (ANNEXA-I), the first ever randomized controlled trial of a reversal agent for direct oral anticoagulants, was published in 2024. The trial, which randomized patients with intracranial hemorrhage to andexanet alfa or usual care, was mandated by the United States Food and Drug Administration as part of its conditional approval in 2018. This approval was originally based on the single-arm trial, The Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors (ANNEXA-4). ANNEXA-I was stopped early for benefit and showed a reduction in the number of patients with significant hematoma expansion. However, the study was not powered for clinical endpoints such as disability or death and showed no difference in these outcomes. It did, however, show an increased risk of thrombosis, predominantly stroke with andexanet alfa. In this perspective, I reflect on some of the key criticisms of the trial and the implications for its interpretation.

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引用次数: 0
Hemostatic conditions following autologous transfusion of fresh vs stored platelets in experimental endotoxemia: an open-label randomized controlled trial with healthy volunteers 实验性内毒素血症患者自体输注新鲜血小板与储存血小板后的止血条件:一项以健康志愿者为对象的开放标签随机对照试验
IF 3.4 3区 医学 Q2 HEMATOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.rpth.2024.102612
Stefan F. van Wonderen , Floor L.F. van Baarle , Anita M. Tuip-de Boer , Chantal A. Polet , Robin van Bruggen , Christie Vermeulen , Thomas R.L. Klei , Chi M. Hau , Rienk Nieuwland , Cornelis van ’t Veer , Anna L. Peters , Sanne de Bruin , Alexander P.J. Vlaar , Bart J. Biemond , Marcella C.A. Müller

Background

Platelet increment is reportedly lower for maximum stored platelet concentrates (PCs) and during pyrexia, and in vitro function differs between fresh and stored PCs. However, little is known about the function of fresh and stored platelets during inflammation.

Objectives

The aim was to study differences in hemostatic function after transfusion of fresh or stored PCs in a human model of experimental endotoxemia.

Methods

Thirty-six healthy male subjects received either 2 ng/kg lipopolysaccharide (LPS) or a control (physiological saline 0.9%) and were randomly assigned to subsequently receive an autologous transfusion of either fresh (2-days-old) or stored (7-days-old) platelets, or saline control. Extracellular vesicles (EVs) were determined using flow cytometry, thrombin–antithrombin complex (TATc) was assessed using enzyme-linked immunosorbent assay, and hemostatic function was assessed using rotational thromboelastometry (ROTEM).

Results

LPS infusion caused a marked increase in TATc, EVs and fibrinolysis. Thromboelastometry data revealed that following infusion of LPS, subjects exhibited in general a hypocoagulable state compared with those not receiving LPS. Platelet transfusions led to a reduced clotting time and an augmentation in clot strength, indicated by maximum clot firmness, solely among subjects undergoing endotoxemia. There were no significant differences in TATc or amount of EVs release after transfusion of fresh or stored platelets.

Conclusion

A significant increase in TATc and EVs as well as a difference in hemostatic function after endotoxemia were observed. During endotoxemia, platelet transfusion resulted in enhanced coagulation and hemostatic function; however, no substantial differences were observed between transfusion of fresh or stored PCs.
背景据报道,最大限度储存的血小板浓缩物(PCs)和热病期间的血小板增量较低,新鲜和储存的 PCs 的体外功能也不同。方法36名健康男性受试者接受2纳克/千克脂多糖(LPS)或对照组(生理盐水0.9%)的治疗,随后随机分配接受新鲜(2天)或储存(7天)血小板或生理盐水对照组的自体输血。使用流式细胞术测定细胞外小泡(EVs),使用酶联免疫吸附测定法评估凝血酶-抗凝血酶复合物(TATc),使用旋转血栓弹性测定法(ROTEM)评估止血功能。血栓弹性测定法数据显示,与未注射 LPS 的受试者相比,输注 LPS 后受试者总体上表现出低凝状态。血小板输注缩短了凝血时间,并增强了凝块强度(以最大凝块坚固度表示),而这仅在接受内毒素血症治疗的受试者中出现。结论 观察到内毒素血症后 TATc 和 EVs 显著增加,止血功能也有差异。在内毒素血症期间,输注血小板可增强凝血和止血功能;然而,输注新鲜或储存的血小板之间并无实质性差异。
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引用次数: 0
Utilizing artificial intelligence for the detection of hemarthrosis in hemophilia using point-of-care ultrasonography 利用人工智能通过护理点超声波成像检测血友病患者的血红蛋白症
IF 3.4 3区 医学 Q2 HEMATOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.rpth.2024.102602
Pascal N. Tyrrell , María Teresa Alvarez-Román , Nihal Bakeer , Brigitte Brand-Staufer , Victor Jiménez-Yuste , Susan Kras , Carlo Martinoli , Mauro Mendez , Azusa Nagao , Margareth Ozelo , Janaina B.S. Ricciardi , Marek Zak , Johannes Roth

Background

Recurrent hemarthrosis and resultant hemophilic arthropathy are significant causes of morbidity in persons with hemophilia, despite the marked evolution of hemophilia care. Prevention, timely diagnosis, and treatment of bleeding episodes are key. However, a physical examination or a patient’s assessment of musculoskeletal pain may not accurately identify a joint bleed. This difficulty is compounded as hemophilic arthropathy progresses.

Objectives

Our system aims to utilize artificial intelligence and ultrasonography (US; point-of-care and handheld) to enable providers, and ultimately patients, to detect joint bleeds at the bedside and at home. We aimed to develop and assess the reliability of artificial intelligence algorithms in detecting and segmenting synovial recess distension (SRD; an indicator of disease activity) on US images of adult and pediatric knee, elbow, and ankle joints.

Methods

A total of 12,145 joint exams, comprising 61,501 US images from 7 international healthcare centers, were collected. The dataset included healthy participants and adult and pediatric persons with hemophilia, with and without SRD. Images were manually labeled by 2 experts and used to train binary convolutional neural network classifiers and segmentation models. Metrics to evaluate performance included accuracy, sensitivity, specificity, and area under the curve.

Results

The algorithms exhibited high performance across all joints and all cohorts. Specifically, the knee model showed an accuracy of 97%, sensitivity of 96%, specificity of 97%, and an area under the curve of 0.97 in SRD. High Dice coefficients (80%-85%) were achieved in segmentation tasks across all joints.

Conclusion

This technology could assist with the early detection and management of hemarthrosis in hemophilia.
背景尽管血友病护理有了明显的发展,但复发性血栓形成和由此导致的血友病关节病仍是血友病患者发病的重要原因。预防、及时诊断和治疗出血是关键。然而,体格检查或患者对肌肉骨骼疼痛的评估可能无法准确识别关节出血。我们的系统旨在利用人工智能和超声波成像技术(US;护理点和手持式),使医疗服务提供者以及最终患者能够在床边和家中检测到关节出血。我们的目标是开发和评估人工智能算法在成人和儿童膝关节、肘关节和踝关节的 US 图像上检测和分割滑膜凹胀(SRD,疾病活动的指标)的可靠性。数据集包括健康参与者、成人和儿童血友病患者,以及有和没有 SRD 的患者。图像由两位专家手动标注,并用于训练二元卷积神经网络分类器和分割模型。评估性能的指标包括准确性、灵敏度、特异性和曲线下面积。具体来说,膝关节模型的准确率为 97%,灵敏度为 96%,特异性为 97%,SRD 的曲线下面积为 0.97。在所有关节的分割任务中都达到了较高的 Dice 系数(80%-85%)。
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引用次数: 0
Impact of self-reported race on Villalta Scale postthrombotic syndrome scores and correlation with venous disease-specific quality of life: an exploratory analysis of the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis Trial 自我报告的种族对 Villalta 量表血栓后综合征评分的影响以及与静脉疾病生活质量的相关性:急性静脉血栓形成:急性静脉血栓形成:辅助导管定向溶栓的血栓清除试验的探索性分析
IF 3.4 3区 医学 Q2 HEMATOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.rpth.2024.102609
James Shih MD , Chu-Shu Gu PhD , Suresh Vedantham MD , John Kaufman MD , Susan R. Kahn MD

Background

The Villalta Scale (VS) to diagnose postthrombotic syndrome (PTS) consists of 5 patient-reported leg symptoms and 6 clinician-rated leg signs. It is unknown how the scale performs across racial groups.

Objectives

Our study explored if there were differences in VS scores, particularly clinician-rated signs components, according to self-reported race.

Methods

Exploratory analysis of the ATTRACT trial, a randomized controlled trial conducted at 56 US sites that investigated pharmacomechanical catheter-directed thrombolysis to prevent PTS after proximal deep vein thrombosis (DVT). At the 6-month visit after randomization, we compared self-reported Black (n = 123) and White (n = 541) participants for mean total VS score, VS symptoms score, VS signs score, individual signs scores, and correlation coefficients between VS signs and VS symptoms scores and between VS signs and Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) scores (a self-reported venous disease-specific quality of life measure).

Results

Mean total VS score (4.67 vs. 4.12, P = .54),VS signs score (1.66 vs. 2.00, P = .07), and VS symptoms score (2.83 vs. 2.04, P = .10) were similar between Black and White participants. The mean score for one individual VS sign, venous ectasia, was lower in Black vs. White participants (0.24 vs. 0.63, P< .01). There was similar, modest correlation in Black and White participants between VS signs and VS symptoms scores (rblack = 0.19; rwhite = 0.23) and between VS signs and VEINES-QOL scores (rblack = −0.32; rwhite = −0.30). Results were adjusted for ATTRACT trial treatment group, age, sex, body mass index, DVT extent, hypertension, diabetes, dyslipidemia, and congestive heart failure.

Conclusion

The findings suggest that some differences in VS scores exist according to self-reported race. It is unclear whether these reflect clinicians’ underrating of some VS signs and/or differences in PTS severity. Further work is needed to understand how the VS performs across racial groups.
背景诊断血栓后综合征(PTS)的 Villalta 量表(VS)由患者报告的 5 个腿部症状和临床医生评定的 6 个腿部体征组成。方法对 ATTRACT 试验进行探索性分析,该试验是一项随机对照试验,在美国 56 个地点进行,研究了药物机械导管引导溶栓以预防近端深静脉血栓 (DVT) 后的 PTS。在随机化后 6 个月的回访中,我们比较了黑人(n = 123)和白人(n = 541)参与者自我报告的平均 VS 总分、VS 症状分、VS 体征分、单个体征分、VS 体征与 VS 症状分之间的相关系数以及 VS 体征与静脉功能不全流行病学和经济学生活质量研究 (VEINES-QOL) 分(一种自我报告的静脉疾病特异性生活质量测量指标)之间的相关系数。结果 黑人和白人参与者的平均 VS 总分(4.67 vs. 4.12,P = .54)、VS 体征得分(1.66 vs. 2.00,P = .07)和 VS 症状得分(2.83 vs. 2.04,P = .10)相似。黑人和白人参加者在静脉异位这一 VS 征兆上的平均得分较低(0.24 vs. 0.63,P< .01)。在黑人和白人参与者中,VS 征兆和 VS 症状评分之间(黑人 = 0.19;白人 = 0.23)以及 VS 征兆和 VEINES-QOL 评分之间(黑人 = -0.32;白人 = -0.30)存在类似的适度相关性。结果根据 ATTRACT 试验治疗组、年龄、性别、体重指数、深静脉血栓程度、高血压、糖尿病、血脂异常和充血性心力衰竭进行了调整。目前还不清楚这是否反映了临床医生对某些 VS 征兆的低估和/或 PTS 严重程度的差异。要了解 VS 在不同种族群体中的表现,还需要进一步的研究。
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引用次数: 0
Inhibitor development upon switching from plasma-derived to recombinant factor VIII in previously untreated patients with severe hemophilia A: the PUP-SWITCH study 先前未经治疗的重度 A 型血友病患者从血浆衍生因子 VIII 转换为重组因子 VIII 后抑制剂的发展:PUP-SWITCH 研究
IF 3.4 3区 医学 Q2 HEMATOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.rpth.2024.102595
Syna Miri , Frits R. Rosendaal , Kaan Kavakli , Peyman Eshghi , Soha Mohammadi Moghaddam , Sara Scardo , Behnaz Habibpanah , Mohsen Elalfy , Susan Halimeh , Gabriella Nicolò , Dilek Gökçebay , Namık Özbek , Tiraje Celkan , Ahmad Mohammadi , Mehran Karimi , Amin Shahsavani , Bariş Yılmaz , Canan Albayrak , Burcak Gunes , Zühre Kaya , Flora Peyvandi

Background

The SIPPET randomized clinical trial showed that in previously untreated patients (PUPs) with severe hemophilia A, treatment with plasma-derived factor (F)VIII (pdFVIII) within the first 50 exposure days (EDs) was associated with a lower cumulative incidence of inhibitors than with recombinant FVIII (rFVIII). Switching to rFVIII beyond 50 EDs with pdFVIII is a treatment often implemented by many centers. The question is whether or not this switch may induce a risk of inhibitor development.

Objectives

We investigated if in PUPs with severe hemophilia A switched after 50 EDs from pdFVIII to rFVIII, a novel inhibitor peak appears.

Methods

The PUP-SWITCH observational retrospective study was designed to investigate the cumulative incidence of novel inhibitors after switching PUPs to rFVIII after 50 and before 150 EDs. Hemophilia centers that routinely switched PUPs from pdFVIII to rFVIII within this exposure time frame were invited to participate. Patients were followed up for at least 50 EDs after the switch.

Results

Ninety-seven patients were evaluated, and 87 were included according to eligibility criteria between 2020 and 2022. Only one of them developed an inhibitor 20 EDs after switching, so the cumulative incidence was 1.15% (95% CI, 0.03%-6.24%).

Conclusion

PUP-SWITCH, a study focusing on PUPs undergoing a product class switch from pdFVIII to rFVIII after 50 EDs, showed that switching appears to be safe pertaining to the risk of development of new inhibitors.
背景SIPPET 随机临床试验显示,对于既往未经治疗的重度 A 型血友病患者 (PUP),在最初 50 个暴露日 (ED) 内使用血浆衍生因子 (F)VIII (pdFVIII)治疗与重组 FVIII (rFVIII) 相比,抑制剂的累积发生率更低。在使用 pdFVIII 超过 50 个暴露日后改用 rFVIII 是许多中心经常采用的一种治疗方法。我们调查了从 pdFVIII 治疗 50 次后转用 rFVIII 的重度 A 型血友病患者中是否会出现新型抑制剂高峰。方法 PUP-SWITCH 观察性回顾研究旨在调查 50 次后和 150 次前从 pdFVIII 治疗转用 rFVIII 的重度 A 型血友病患者中新型抑制剂的累积发生率。受邀参加研究的血友病中心都是在这一暴露时间范围内将 PUP 从 pdFVIII 常规转换为 rFVIII 的。结果对 97 名患者进行了评估,根据资格标准,在 2020 年至 2022 年期间纳入了 87 名患者。结论PUP-SWITCH 是一项针对 50 次 ED 后从 pdFVIII 转换到 rFVIII 的 PUP 患者的研究,结果表明,转换过程似乎是安全的,不会产生新的抑制剂。
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引用次数: 0
Stability of the thromboxane B2 biomarker of low-dose aspirin pharmacodynamics in human whole blood and in long-term stored serum samples 低剂量阿司匹林在人全血和长期保存血清中的药效学稳定性
IF 3.4 3区 医学 Q2 HEMATOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.rpth.2024.102623
Giovanna Petrucci , Alessandro Rizzi , Simone Bellavia , Francesco Dentali , Giovanni Frisullo , Dario Pitocco , Paola Ranalli , Pier Andrea Rizzo , Irene Scala , Mauro Silingardi , Elisa Zagarrì , Gualberto Gussoni , Bianca Rocca

Background

Serum thromboxane B2 (sTXB2) is a validated biomarker of low-dose aspirin pharmacodynamics. In the original method, nonanticoagulated blood samples must be incubated at 37 °C immediately after withdrawal, centrifuged and serum supernatant should be frozen until assayed. Timely completion of all preanalytical steps may affect the feasibility and quality of sTXB2 measurements. The storage duration of frozen serum can also affect sTXB2 stability.

Objectives

We assessed the stability of sTXB2 in clotted blood samples stored at 4 °C before further processing and in sera stored at −40 °C for over a decade.

Methods

Venous whole blood withdrawn from individuals on chronic low-dose aspirin was dispensed in different tubes and immediately incubated at 37 °C for 1 hour. The reference tube was promptly processed following the original protocol; the remaining tubes were stored at 4 °C for 12 to 72 hours before further processing. Sera stored at a controlled −40 °C temperature for <1 to 15 years were reassayed. Values within the interassay variation limits (±9%) vs baseline were considered acceptable.

Results

Baseline sTXB2 values (median, 5.4 ng/mL; IQR, 2.4-13.4 ng/mL; n = 40) were comparable with those in samples at 4 °C up to 48 hours (median, 97% [IQR, 86%-104%] of the reference; n = 26), but at 72 hours, the variability exceeded the interassay variation. Thromboxane B2 levels were stable in frozen sera for up to 10 years (median, 101% [IQR, 87%-108%] of the reference; n = 32) but decreased significantly afterward (median, 87% [IQR, 74%-109%] at 15 years; P = .005; n = 32).

Conclusion

Thromboxane B2 is stable in clotted blood samples stored at 4 °C for up to 48 hours before further processing and in serum samples stored at −40 °C over 10 years.
背景:血清血栓素B2 (sTXB2)是低剂量阿司匹林药效学的有效生物标志物。在原始方法中,非抗凝血样本必须在提取后立即在37°C下孵育,离心,血清上清应冷冻直至检测。及时完成所有分析前步骤可能会影响sTXB2测量的可行性和质量。冷冻血清的保存时间也会影响sTXB2的稳定性。目的:我们评估了sTXB2在进一步处理前4°C保存的凝血样品和在- 40°C保存超过十年的血清中的稳定性。方法取慢性小剂量阿司匹林患者静脉全血,分装于不同的管中,立即37℃孵育1 h。对照管按照原方案及时处理;剩余的试管在4°C下保存12至72小时,然后进行进一步处理。在- 40°C控制温度下保存1至15年的血清再次检测。与基线相比,在测定间变异范围内的值(±9%)被认为是可以接受的。结果基线sTXB2值(中位数,5.4 ng/mL;IQR, 2.4 ~ 13.4 ng/mL;n = 40)与在4°C下放置48小时的样品(中位数,97% [IQR, 86%-104%]的参考;N = 26),但在72小时时,变异性超过了测定间的变异性。冷冻血清中血栓素B2水平稳定长达10年(中位数为参考值的101% [IQR, 87%-108%];n = 32),但之后显著下降(15年时中位数为87% [IQR, 74%-109%];P = 0.005;N = 32)。结论血栓素B2在4°C保存48小时的凝血样品中稳定,在- 40°C保存10年以上的血清样品中稳定。
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引用次数: 0
Primary thromboprophylaxis in ambulatory symptomatic patients with COVID-19: a systematic review and meta-analysis of randomized controlled trials COVID-19门诊症状患者的初级血栓预防:随机对照试验的系统回顾和荟萃分析
IF 3.4 3区 医学 Q2 HEMATOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.rpth.2024.102613
Davide Di Vece , Marco Valgimigli , Elliot Barnathan , Jean M. Connors , Frank Cools , Ulrike Held , Ajay K. Kakkar , Gregory Piazza , David Spirk , Saverio Virdone , Nils Kucher , Stefano Barco

Background

The global impact of the COVID-19 pandemic has prompted the search for strategies to improve outcomes in affected individuals, including those initially managed in outpatient settings. Thromboembolic events have been reported as a concerning complication.

Objectives

The aim of this study was to evaluate efficacy and safety of primary thromboprophylaxis in outpatients with COVID-19. The study protocol was registered in PROSPERO (CRD42022362776).

Methods

The study adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and conducted a comprehensive search of PubMed/MEDLINE, ClinicalTrials.gov, and OVID/Embase and CENTRAL from Cochrane for studies up to December 11, 2023, without language restrictions. Randomized controlled trials comparing prophylactic-dose anticoagulation with placebo or standard of care in symptomatic outpatients with COVID-19 were included in this analysis. The primary outcome was the composite of all-cause hospitalization and death within 30 days. Secondary outcomes included venous thromboembolism, the composite of venous thromboembolism and major arterial cardiovascular events, and the individual components of the primary outcome.

Results

Seven randomized controlled trials and 3758 COVID-19 outpatients were included. When compared with placebo or standard of care, thromboprophylaxis was associated with similar rates of all-cause hospitalization or mortality (relative risk, 1.00; 95% CI, 0.77-1.31) and lower rates of venous thromboembolism (relative risk, 0.28; 95% CI, 0.08-0.94), corresponding to a 0.6% absolute risk reduction and number needed to treat of 174.

Conclusion

Thromboprophylaxis in symptomatic COVID-19 outpatients led to reduction in venous thromboembolism risk, with no impact on hospitalization or death. However, the overall low absolute risk reduction may not support its routine use.
COVID-19大流行的全球影响促使人们寻求改善受影响个体(包括最初在门诊环境中进行治疗的个体)预后的策略。血栓栓塞事件已被报道为一种令人担忧的并发症。目的评价新型冠状病毒肺炎(COVID-19)门诊患者初级血栓预防的有效性和安全性。该研究方案已在PROSPERO注册(CRD42022362776)。方法:本研究遵循系统评价和荟萃分析的首选报告项目指南,并从Cochrane全面检索PubMed/MEDLINE、ClinicalTrials.gov、OVID/Embase和CENTRAL,检索截至2023年12月11日的研究,无语言限制。在有症状的COVID-19门诊患者中,比较预防性剂量抗凝与安慰剂或标准护理的随机对照试验被纳入该分析。主要转归为全因住院和30天内死亡的综合转归。次要结局包括静脉血栓栓塞,静脉血栓栓塞和主要动脉心血管事件的复合,以及主要结局的各个组成部分。结果纳入7项随机对照试验和3758例COVID-19门诊患者。与安慰剂或标准治疗相比,血栓预防与相似的全因住院率或死亡率相关(相对风险,1.00;95% CI, 0.77-1.31)和较低的静脉血栓栓塞率(相对危险度,0.28;95% CI, 0.08-0.94),对应于0.6%的绝对风险降低,需要治疗的人数为174人。结论有症状的COVID-19门诊患者预防血栓可降低静脉血栓栓塞风险,对住院和死亡无影响。然而,总体上较低的绝对风险降低可能不支持常规使用。
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引用次数: 0
Outcomes of patients with acute pulmonary embolism managed in-house vs those transferred between hospitals: a retrospective observational study 急性肺栓塞住院治疗患者与转院患者的预后:一项回顾性观察性研究
IF 3.4 3区 医学 Q2 HEMATOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.rpth.2024.102606
Priyanka Sridhar , Hong Yu Wang , Agostina Velo , Destiny Nguyen , Avinash Singh , Abdul Rehman , Jason Filopei , Madeline Ehrlich , Robert Lookstein , David J. Steiger

Background

Interhospital transfer (IHT) for acute pulmonary embolism (PE) is increasingly performed to improve access to advanced reperfusion therapies. It is unclear if outcomes of patients undergoing IHT are comparable with those of patients presenting in-house to hospitals with PE Response Team (PERT) capabilities.

Objectives

To determine whether outcomes of patients with acute PE undergoing IHT differ from those of patients presenting in-house.

Methods

We retrospectively reviewed 386 patients with acute PE who were treated by PERT at 1 of 3 urban teaching hospitals in the Mount Sinai Health System in New York City from January 2021 to October 2023. Propensity score–weighted analysis was performed to compare the outcomes of patients managed in-house with those of patients undergoing IHT.

Results

Two hundred eighty-four patients presented in-house, while 102 were transferred from other hospitals. Median PE Severity Index score was 84, and 3 (0.8%), 80 (20.7%), 237 (61.4%), and 66 (17.1%) had low-risk, intermediate low–risk, intermediate high–risk, and high-risk PE. Odds of receiving systemic thrombolysis (odds ratio [OR], 1.06; P = .06) or advanced therapies (OR, 0.95; P = .003) were not significantly different between the 2 groups. Rates of 30-day mortality, major bleeding, and readmission were 6.9%, 2.9%, and 9.8% for the IHT group and 10.6%, 2.1%, and 13% for the in-house group, respectively. IHT patients had lower odds of 30-day mortality (OR, 0.88; P = .003) and higher odds of major bleeding (OR, 1.03; P = .04).

Conclusion

PERT-guided IHT for patients with acute PE was associated with reduced mortality but increased risk of bleeding compared with patients managed in-house at hospitals with PERT capabilities.
背景:急性肺栓塞(PE)的医院间转移(IHT)越来越多地用于改善高级再灌注治疗的可及性。目前尚不清楚接受IHT的患者的结果是否与那些在具有PE反应小组(PERT)能力的医院内部就诊的患者的结果相当。目的确定急性肺心病患者接受IHT治疗的结果是否与住院患者不同。方法回顾性分析了2021年1月至2023年10月在纽约市西奈山卫生系统3所城市教学医院中的1所接受PERT治疗的386例急性PE患者。采用倾向评分加权分析比较内部管理的患者和接受IHT治疗的患者的结果。结果本院住院284例,外院转诊102例。PE严重性指数中位数为84,低危、中危、中危和高危PE分别为3(0.8%)、80(20.7%)、237(61.4%)和66(17.1%)。接受全身溶栓治疗的几率(优势比[OR], 1.06;P = .06)或先进疗法(or, 0.95;P = 0.003),两组间差异无统计学意义。IHT组30天死亡率、大出血和再入院率分别为6.9%、2.9%和9.8%,住院组为10.6%、2.1%和13%。IHT患者30天死亡率较低(OR, 0.88;P = 0.003),大出血的几率更高(OR, 1.03;P = .04)。结论与有PERT能力的医院内部管理的患者相比,PERT引导下的急性PE患者的IHT与死亡率降低相关,但出血风险增加。
{"title":"Outcomes of patients with acute pulmonary embolism managed in-house vs those transferred between hospitals: a retrospective observational study","authors":"Priyanka Sridhar ,&nbsp;Hong Yu Wang ,&nbsp;Agostina Velo ,&nbsp;Destiny Nguyen ,&nbsp;Avinash Singh ,&nbsp;Abdul Rehman ,&nbsp;Jason Filopei ,&nbsp;Madeline Ehrlich ,&nbsp;Robert Lookstein ,&nbsp;David J. Steiger","doi":"10.1016/j.rpth.2024.102606","DOIUrl":"10.1016/j.rpth.2024.102606","url":null,"abstract":"<div><h3>Background</h3><div>Interhospital transfer (IHT) for acute pulmonary embolism (PE) is increasingly performed to improve access to advanced reperfusion therapies. It is unclear if outcomes of patients undergoing IHT are comparable with those of patients presenting in-house to hospitals with PE Response Team (PERT) capabilities.</div></div><div><h3>Objectives</h3><div>To determine whether outcomes of patients with acute PE undergoing IHT differ from those of patients presenting in-house.</div></div><div><h3>Methods</h3><div>We retrospectively reviewed 386 patients with acute PE who were treated by PERT at 1 of 3 urban teaching hospitals in the Mount Sinai Health System in New York City from January 2021 to October 2023. Propensity score–weighted analysis was performed to compare the outcomes of patients managed in-house with those of patients undergoing IHT.</div></div><div><h3>Results</h3><div>Two hundred eighty-four patients presented in-house, while 102 were transferred from other hospitals. Median PE Severity Index score was 84, and 3 (0.8%), 80 (20.7%), 237 (61.4%), and 66 (17.1%) had low-risk, intermediate low–risk, intermediate high–risk, and high-risk PE. Odds of receiving systemic thrombolysis (odds ratio [OR], 1.06; <em>P</em> = .06) or advanced therapies (OR, 0.95; <em>P</em> = .003) were not significantly different between the 2 groups. Rates of 30-day mortality, major bleeding, and readmission were 6.9%, 2.9%, and 9.8% for the IHT group and 10.6%, 2.1%, and 13% for the in-house group, respectively. IHT patients had lower odds of 30-day mortality (OR, 0.88; <em>P</em> = .003) and higher odds of major bleeding (OR, 1.03; <em>P</em> = .04).</div></div><div><h3>Conclusion</h3><div>PERT-guided IHT for patients with acute PE was associated with reduced mortality but increased risk of bleeding compared with patients managed in-house at hospitals with PERT capabilities.</div></div>","PeriodicalId":20893,"journal":{"name":"Research and Practice in Thrombosis and Haemostasis","volume":"8 8","pages":"Article 102606"},"PeriodicalIF":3.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142748723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nonneutralizing antibodies in Nordic persons with moderate hemophilia A and B (the MoHem study) 北欧中度 A 型和 B 型血友病患者体内的非中和抗体(MoHem 研究)
IF 3.4 3区 医学 Q2 HEMATOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.rpth.2024.102611
Ragnhild J. Måseide MD, PhD , Erik Berntorp MD, PhD , Jan Astermark MD, PhD , Anna Olsson MD, PhD , Maria Bruzelius MD, PhD , Tony Frisk MD, PhD , Vuokko Nummi MD, PhD , Riitta Lassila MD, PhD , Karin Strandberg MD, PhD , Geir E. Tjønnfjord MD, PhD , Pål A. Holme MD, PhD

Background

The impact of nonneutralizing antibodies (NNAs) in moderate hemophilia is elusive.

Objectives

To explore the presence of NNAs in Nordic persons with moderate hemophilia A (MHA) and B (MHB) in relation to treatment modality, clinical outcome, history of inhibitor, and the corresponding factor VIII (FVIII)/factor IX (FIX) gene mutation.

Methods

A cross-sectional multicenter study covering persons with MHA and MHB in Sweden, Finland, and Norway. Inhibitors were analyzed with the Bethesda assay, and NNAs were detected by enzyme-linked immunosorbent assay.

Results

Plasma samples from 137 MoHem study participants (median age 29 years; Q1-Q3, 15-54) were analyzed. NNAs were present in 11 of 82 (13%) of people with MHA and 7 of 55 (13%) of those with MHB irrespective of prophylactic or on-demand treatment, most frequently after 150 exposure days (EDs). Three NNA positive patients had a history of high-titer inhibitor, but current analyses were negative (<0.6 BU/mL). Baseline FVIII/FIX activity was similar among NNA positive and negative patients. Current bleeding rates were low, but patients with NNAs captured a higher Hemophilia Joint Health Score (7 [median]; Q1-Q3, 3-20 vs. 4; 1-9) (P = .02) and had more frequently undergone arthroplasty or arthrodesis (5 [33%] vs. 15 [13%]) (P = .03).

Conclusion

NNAs were detected in 13% of Nordic persons with MHA and MHB, most frequently after 150 EDs. Patients with NNAs had more severe hemophilic arthropathy than patients without NNAs. The relationship between NNAs and clinical outcome in hemophilia should be further explored in a large cohort including pharmacokinetics and longitudinal observations with repeated blood sampling.
背景非中性抗体(NNAs)对中度血友病的影响尚不明确。目的探讨北欧中度血友病 A(MHA)和 B(MHB)患者体内 NNAs 的存在与治疗方式、临床结果、抑制剂史以及相应的因子 VIII (FVIII)/ 因子 IX (FIX) 基因突变的关系。结果分析了 137 名 MoHem 研究参与者(中位年龄 29 岁;Q1-Q3,15-54 岁)的血浆样本。无论是否进行预防性治疗或按需治疗,82 名 MHA 患者中有 11 人(13%)和 55 名 MHB 患者中有 7 人(13%)存在 NNA,最常出现在暴露 150 天 (ED) 之后。三名 NNA 阳性患者曾出现高滴度抑制剂,但目前的分析结果为阴性(0.6 BU/mL)。NNA 阳性和阴性患者的基线 FVIII/FIX 活性相似。目前的出血率较低,但 NNA 患者的血友病关节健康评分较高(7 [中位数];Q1-Q3,3-20 vs. 4;1-9)(P = .02),且更常接受关节成形术或关节固定术(5 [33%] vs. 15 [13%])(P = .03)。与无 NNA 的患者相比,有 NNA 的患者血友病关节病更为严重。NNAs与血友病临床结果之间的关系应在大型队列中进一步探讨,包括药代动力学和重复采血的纵向观察。
{"title":"Nonneutralizing antibodies in Nordic persons with moderate hemophilia A and B (the MoHem study)","authors":"Ragnhild J. Måseide MD, PhD ,&nbsp;Erik Berntorp MD, PhD ,&nbsp;Jan Astermark MD, PhD ,&nbsp;Anna Olsson MD, PhD ,&nbsp;Maria Bruzelius MD, PhD ,&nbsp;Tony Frisk MD, PhD ,&nbsp;Vuokko Nummi MD, PhD ,&nbsp;Riitta Lassila MD, PhD ,&nbsp;Karin Strandberg MD, PhD ,&nbsp;Geir E. Tjønnfjord MD, PhD ,&nbsp;Pål A. Holme MD, PhD","doi":"10.1016/j.rpth.2024.102611","DOIUrl":"10.1016/j.rpth.2024.102611","url":null,"abstract":"<div><h3>Background</h3><div>The impact of nonneutralizing antibodies (NNAs) in moderate hemophilia is elusive.</div></div><div><h3>Objectives</h3><div>To explore the presence of NNAs in Nordic persons with moderate hemophilia A (MHA) and B (MHB) in relation to treatment modality, clinical outcome, history of inhibitor, and the corresponding factor VIII (FVIII)/factor IX (FIX) gene mutation.</div></div><div><h3>Methods</h3><div>A cross-sectional multicenter study covering persons with MHA and MHB in Sweden, Finland, and Norway. Inhibitors were analyzed with the Bethesda assay, and NNAs were detected by enzyme-linked immunosorbent assay.</div></div><div><h3>Results</h3><div>Plasma samples from 137 MoHem study participants (median age 29 years; Q1-Q3, 15-54) were analyzed. NNAs were present in 11 of 82 (13%) of people with MHA and 7 of 55 (13%) of those with MHB irrespective of prophylactic or on-demand treatment, most frequently after 150 exposure days (EDs). Three NNA positive patients had a history of high-titer inhibitor, but current analyses were negative (&lt;0.6 BU/mL). Baseline FVIII/FIX activity was similar among NNA positive and negative patients. Current bleeding rates were low, but patients with NNAs captured a higher Hemophilia Joint Health Score (7 [median]; Q1-Q3, 3-20 vs. 4; 1-9) (<em>P</em> = .02) and had more frequently undergone arthroplasty or arthrodesis (5 [33%] vs. 15 [13%]) (<em>P</em> = .03).</div></div><div><h3>Conclusion</h3><div>NNAs were detected in 13% of Nordic persons with MHA and MHB, most frequently after 150 EDs. Patients with NNAs had more severe hemophilic arthropathy than patients without NNAs. The relationship between NNAs and clinical outcome in hemophilia should be further explored in a large cohort including pharmacokinetics and longitudinal observations with repeated blood sampling.</div></div>","PeriodicalId":20893,"journal":{"name":"Research and Practice in Thrombosis and Haemostasis","volume":"8 8","pages":"Article 102611"},"PeriodicalIF":3.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142702285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Research and Practice in Thrombosis and Haemostasis
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