Intermittent Pneumatic Compression Devices

  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    背景:神经外科围手术期静脉血栓栓塞(VTE)预防的管理差异很大,缺乏一般指南。争论的主要问题是药物预防VTE的剂量和开始时间,以平衡基于VTE的发病率和潜在危及生命的出血的风险。间歇性气动压缩(IPC)的机械VTE预防,然而,仅在几家神经外科医院建立,其功效尚未得到证实。本研究的目的是分析在择期神经外科手术中实施IPC装置前后的VTE风险。
    方法:2018年01月至2022年08月在我们神经外科进行的所有择期手术均对VTE的发生进行了调查。比较两组之间的VTE风险和相关死亡率:(1)仅化学预防(CHEMO;手术01/2018-04/2020)和(2)IPC和化学预防(IPC;手术04/2020-08/2022)。此外,对患者的一般情况和疾病特征以及住院时间进行评估,并与VTE风险进行比较.
    结果:在12.000例手术中,38例择期手术后发生了VTE。两组之间的VTE数量显着不同,CHEMO组的发生率为31/6663(0.47%),IPC组的发生率为7/6688(0.1%)。在这两组中,恶性脑肿瘤患者占患者比例最大,而良性肿瘤中的VTEs仅发生在CHEMO组。
    结论:使用机械和药物联合预防VTE可以显着降低神经外科手术后血栓栓塞的风险,因此,降低死亡率和发病率。
    BACKGROUND: The management of perioperative venous thrombembolism (VTE) prophylaxis is highly variable between neurosurgical departments and general guidelines are missing. The main issue in debate are the dose and initiation time of pharmacologic VTE prevention to balance the risk of VTE-based morbidity and potentially life-threatening bleeding. Mechanical VTE prophylaxis with intermittend pneumatic compression (IPC), however, is established in only a few neurosurgical hospitals, and its efficacy has not yet been demonstrated. The objective of the present study was to analyze the risk of VTE before and after the implementation of IPC devices during elective neurosurgical procedures.
    METHODS: All elective surgeries performed at our neurosurgical department between 01/2018-08/2022 were investigated regarding the occurrence of VTE. The VTE risk and associated mortality were compared between groups: (1) only chemoprophylaxis (CHEMO; surgeries 01/2018-04/2020) and (2) IPC and chemoprophylaxis (IPC; surgeries 04/2020-08/2022). Furthermore, general patient and disease characteristics as well as duration of hospitalization were evaluated and compared to the VTE risk.
    RESULTS: VTE occurred after 38 elective procedures among > 12.000 surgeries. The number of VTEs significantly differed between groups with an incidence of 31/6663 (0.47%) in the CHEMO group and 7/6688 (0.1%) events in the IPC group. In both groups, patients with malignant brain tumors represented the largest proportion of patients, while VTEs in benign tumors occurred only in the CHEMO group.
    CONCLUSIONS: The use of combined mechanical and pharmacologic VTE prophylaxis can significantly reduce the risk of postoperative thromboembolism after neurosurgical procedures and, therefore, reduce mortality and morbidity.
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  • 文章类型: Journal Article
    目的:这项前瞻性纵向研究描述了在家中使用专有的高级气动压缩装置(APCD)治疗下肢淋巴水肿(LED)患者。
    方法:在IRB批准后,4个参与的VA中心从2016年至2022年招募了LED患者。主要结局指标是健康相关生活质量(HR-QoL)问卷;(LYMQOL-leg)和基线时获得的通用SF-36v2™,12、24和52周。次要结果指标是肢体周长,蜂窝织炎事件,皮肤质量,以及对APCD和其他压缩疗法的依从性。
    结果:由于试验的一部分是在COVID期间进行的,179名患者接受了52周的随访,而143在所有时间点都有完整的测量结果。基线特征为平均年龄66.9±10.8岁,91%男性,平均BMI为33.8±6.9。LED为双侧92.2%。慢性静脉功能不全或静脉血栓水肿是LED最常见的病因(112例;62.6%),其次是创伤/手术(20例;11.2%)。4例患者(2.3%)的癌症治疗原因较低。患者被归类为国际淋巴学会(ISL)第一阶段(68.4%),两个(27.6%)和三个(4.1%)。
    方法:在所有LYMQOL腿功能域中观察到显着改善,外观,症状,情感,治疗12周后(p<0.0001)和随访52周后的总体评分。SF-36v2™在12周时在3个结构域中显示出显著的改善;在52周时在6个身体功能结构域中,身体疼痛,物理分量(p<0.0001),社会功能(p=0.0186),角色-物理(p<0.0006),心理健康(p<0.0333)。SF-36v2™评分<40表明与美国标准相比,LED患者的HR-QoL显著降低。52周时的次要结局指标:与基线相比,平均肢体周长减少1.4cm(p<.0001);在ISL第2/3期肢体中,平均肢体周长测量值的最大减少为1.9cm(6.0%)。先前发作的患者出现新的蜂窝织炎发作(21.4%vs6.1%,p=0.001)减少。基线时75%的皮肤色素沉着患者在52周时下降到40%(p<0.01)。52周时,合规,定义为使用5-7天/周,据报道,APCD占72%,弹性长袜占74%。
    结论:这项对患有LED的VA患者的纵向研究表明,在家庭使用APCD的情况下,通过52周,改善了通用和疾病特异性HR-QoL。四肢围长,蜂窝织炎发作和皮肤变色减少,同时保持良好的合规性。
    OBJECTIVE: This prospective, longitudinal, pragmatic study describes at home treatment with a proprietary advanced pneumatic compression device (APCD) for patients with lower extremity lymphedema (LED).
    METHODS: Following institutiona review board approval, four participating Veterans Affairs centers enrolled LED patients from 2016 to 2022. The primary outcome measures were health-related quality of life (HR-QoL) questionnaires (lymphedema quality of life-leg and the generic SF-36v2) obtained at baseline and 12, 24, and 52 weeks. The secondary outcome measures were limb circumference, cellulitis events, skin quality, and compliance with APCD and other compression therapies.
    RESULTS: Because a portion of the trial was conducted during the coronavirus disease 2019 pandemic, 179 patients had 52 weeks of follow-up, and 143 had complete measurements at all time points. The baseline characteristics were a mean age of 66.9 ± 10.8 years, 91% were men, and the mean body mass index was 33.8 ± 6.9 kg/m2. LED was bilateral in 92.2% of the patients. Chronic venous insufficiency or phlebolymphedema was the most common etiology of LED (112 patients; 62.6%), followed by trauma or surgery (20 patients; 11.2%). Cancer treatment as a cause was low (4 patients; 2.3%). Patients were classified as having International Society for Lymphology (ISL) stage I (68.4%), II (27.6%), or III (4.1%). Of the primary outcome measures, significant improvements were observed in all lymphedema quality of life-leg domains of function, appearance, symptoms, and emotion and the overall score after 12 weeks of treatment (P < .0001) and through 52 weeks of follow-up. The SF-36v2 demonstrated significant improvement in three domains at 12 weeks and in the six domains of physical function, bodily pain, physical component (P < .0001), social functioning (P = .0181), role-physical (P < .0005), and mental health (P < .0334) at 52 weeks. An SF-36v2 score <40 indicates a substantial reduction in HR-QoL in LED patients compared with U.S. norms. Regarding the secondary outcome measures at 52 weeks, compared with baseline, the mean limb girth decreased by 1.4 cm (P < .0001). The maximal reduction in mean limb girth was 1.9 cm (6.0%) at 12 weeks in ISL stage II and III limbs. New episodes of cellulitis in patients with previous episodes (21.4% vs 6.1%, P = .001) were reduced. The 75% of patients with skin hyperpigmentation at baseline decreased to 40% (P < .01) at 52 weeks. At 52 weeks, compliance, defined as use for 5 to 7 days per week, was reported for the APCD by 72% and for elastic stockings by 74%.
    CONCLUSIONS: This longitudinal study of Veterans Affairs patients with LED demonstrated improved generic and disease-specific HR-QoL through 52 weeks with at home use of an APCD. Limb girth, cellulitis episodes, and skin discoloration were reduced, with excellent compliance.
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    文章类型: Randomized Controlled Trial
    这项研究评估了与完全充血疗法(CDT)相比,与单独的CDT相比,高级间歇性气动压缩装置(IPC-LymphaPress®OptimalPlus)对淋巴水肿四肢体积减少的影响。目标是在准备显微外科手术时最大程度地减少水肿。计划进行多次淋巴静脉吻合术(MLVA)的50名受试者被随机(顺序)分配到实验组或对照组:实验IPC组25名(21名女性和4名男性),对照组25名(20名女性和5名男性)。两组年龄相似,性别分布,淋巴水肿的类型.结果表明,IPC组报告的体积损失大于对照组(p=0.00137),比较最终与初始肢体体积。添加IPC的平均水肿体积损失百分比(11.7%)是对照组(5.0%)的两倍。当考虑到治疗持续时间的差异时,与单独的保守治疗相比,IPC组实现了持续更大的比例体积损失(12.83%vs6.30%).在我们的试点研究中,添加到CDT的IPC导致更大的比例体积损失,并为MLVA手术提供更好的准备。
    This study assesses the impact of an advanced intermittent pneumatic compression device (IPC - Lympha Press® Optimal Plus) when added to Complete Decongestive Therapy (CDT) compared to CDT alone on volume reduction of limbs with lymphedema. The goal is to maximally reduce edema in preparation for microsurgery. Fifty subjects scheduled for Multiple Lymphatic-Venous Anastomosis (MLVA) were randomly (sequentially) assigned to experimental or control group: 25 (21 females and 4 males) in the experimental IPC group and 25 (20 females and 5 males) in the control group. The two groups were similar in age, sex distribution, and type of lymphedema. Results indicate the IPC group reported greater volume loss than the control group (p= 0.00137) comparing final vs. initial limb volume. The average percentage edema volume loss achieved with added IPC was two times greater (11.7%) than in the control group (5.0%). When differences in treatment duration were accounted for, the IPC group achieved consistently greater proportional volume loss (12.83% vs 6.30%) than conservative therapy alone. In our pilot study, IPC added to CDT resulted in greater proportional volume loss and provides better preparation for MLVA surgery.
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  • 文章类型: Journal Article
    背景:在静脉血栓栓塞中,肺血栓栓塞症(PTE)是术后最严重的并发症之一。深静脉血栓(DVT)是主要病因。考虑到日本心血管手术术后DVT和PTE的患病率未知,我们调查了连续接受心血管手术的患者的发病率.
    方法:共有225名在四家医院接受心血管手术的患者同意参与这项研究。我们在术前和术后使用下肢静脉超声评估DVT。排除了7例先前存在DVT的患者。术后抗血栓治疗由各机构的主治医师自行决定。术后间歇性充气加压治疗遵循每个机构的标准预防方案。将患者分为DVT和非DVT队列进行比较。连续变量表示为平均值±标准偏差,并通过t检验进行比较。
    结果:对下肢静脉超声图像的分析表明,在218例研究患者中,有16例发生了DVT(DVT,7.3%)。没有患者有PTE。手术相关数据显示总输血量明显较高(DVT组:61.2±49.9IUvs.非DVT组:DVT组27.7±30.2IU:p=0.018,效应大小=1.048)。基于术前的DVT的多变量logistic回归预测因子,术中,术后因素为输血(p=0.005,95%置信区间1.010-1.059,比值比1.034)。
    结论:本研究中术后发生DVT的发生率为7.3%。
    BACKGROUND: Among venous thromboembolism, pulmonary thromboembolism (PTE) is one of the most serious postoperative complications. Deep venous thrombosis (DVT) is the main cause. Considering the unknown prevalence of DVT and PTE in the postoperative period of cardiovascular surgery in Japan, we investigated the incidence in consecutive patients who underwent cardiovascular surgery.
    METHODS: A total of 225 patients who underwent cardiovascular surgery at four hospitals consented to participate in the study. We assessed DVT using lower extremity venous ultrasound preoperatively and postoperatively. Seven patients with preexisting DVT were excluded. Postoperative antithrombotic therapy was administered at the discretion of the attending physician at each institution. The postoperative intermittent pneumatic compression therapy followed the standard prophylaxis protocol at each institution. Patients were grouped into DVT and non-DVT cohorts for comparison. Continuous variables were expressed as means ± standard deviations and compared by the t-test.
    RESULTS: The analysis of lower extremity venous ultrasound images indicated that DVT developed in 16 of the 218 study patients (DVT, 7.3%). No patient had PTE. Procedure-related data revealed significantly higher total blood transfusion (DVT group: 61.2 ± 49.9 IU vs. non-DVT group: 27.7 ± 30.2 IU: p = 0.018, effect size = 1.048) in the DVT group. The multivariate logistic regression predictor of DVT based on preoperative, intraoperative, and postoperative factors was blood transfusion (p = 0.005, 95% confidence interval 1.010-1.059, odds ratio 1.034).
    CONCLUSIONS: The incidence of postoperatively developed DVT was 7.3% in this study.
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  • 文章类型: Journal Article
    背景:静脉血栓栓塞症(VTE)是住院创伤患者第四大可预防的医院获得性并发症。机械预防,使用顺序压缩或间歇气动压缩(IPC)装置,建议与药物预防一起预防VTE。然而,设备使用的依从性是降低机械预防有效性的障碍。
    目的:本研究旨在确定与IPC设备相比,使用运动和压缩(MAC)系统是否会影响创伤患者机械预防VTE的依从性。
    方法:本研究使用了在II级创伤中心进行的具有历史对照的前后设计,并对入住重症监护病房或急性护理层至少24小时的成年创伤患者进行了便利样本。我们于2022年11月和12月对MAC设备进行了为期2周的试验,并进行了前瞻性数据收集。历史对照组的数据收集是使用2022年8月和9月IPC设备依从性的时间点审核的患者进行的回顾性收集。
    结果:共有51例患者符合纳入标准,IPC组34例,MAC组17例。MAC组的平均(SD)预防时间为每天17.2h(4.0),IPC组为每天7.5h(8.8),具有统计学意义(p<.001)。
    结论:我们的研究结果表明,MAC设备可以提高机械预防的依从性。
    BACKGROUND: Venous thromboembolism (VTE) is the fourth most common preventable hospital-acquired complication for hospitalized trauma patients. Mechanical prophylaxis, using sequential compression or intermittent pneumatic compression (IPC) devices, is recommended alongside pharmacologic prophylaxis for VTE prevention. However, compliance with device use is a barrier that reduces the effectiveness of mechanical prophylaxis.
    OBJECTIVE: This study aimed to determine whether using the Movement and Compressions (MAC) system compared with an IPC device impacts compliance with mechanical VTE prophylaxis in trauma patients.
    METHODS: This study used a before-and-after design with historical control at a Level II trauma center with a convenience sample of adult trauma patients admitted to the intensive care unit or acute care floor for at least 24 h. We trialed the MAC device for 2 weeks in November and December 2022 with prospective data collection. Data collection for the historical control group occurred retrospectively using patients from a point-in-time audit of IPC device compliance from August and September of 2022.
    RESULTS: A total of 51 patients met inclusion criteria, with 34 patients in the IPC group and 17 patients in the MAC group. The mean (SD) prophylaxis time was 17.2 h per day (4.0) in the MAC group and 7.5 h per day (8.8) in the IPC group, which was statistically significant (p < .001).
    CONCLUSIONS: Our findings suggest that the MAC device can improve compliance with mechanical prophylaxis.
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  • 文章类型: Journal Article
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  • 文章类型: Clinical Trial Protocol
    背景:静脉血栓栓塞(VTE)是公认的术后风险。目前的预防方法涉及低分子量肝素(LMWH),渐变压缩长袜(GCS),和间歇性气动压缩装置(IPCDs)。澳大利亚指南,通常被外科医生采用,建议使用GCS和/或IPCD的LMWH。IPCDs构成临床风险,增加护理负担,耐受性差,是昂贵的一次性塑料制品。仅使用LMWH和GCS,如果没有IPCDs,可能更实际,对病人友好,并且具有成本效益,增加环境效益。
    方法:这是一个多中心,prospective,在新南威尔士州五家医院进行的双臂随机对照非劣效性试验,在澳大利亚。我们建议以1:1的比例在A组:LMWHGCSIPCD(n=2065)或B组:LMWHGCS(n=2065)之间随机分配4130名参与者。感兴趣的主要结果是在第30天电话随访(FU)时确定的症状性VTE(深静脉血栓形成/肺栓塞),通过超声或成像证实。解释下肢超声检查的放射科医生将对干预分配视而不见。次要结果是基线时的生活质量,第30天和第90天使用5级欧洲生活质量评分,IPCDs的合规性和不良事件,GCS,和LMWH,以及医疗保健费用(从患者和医院的角度来看),和全因死亡率。该试验具有90%的能力来检测2%的非劣效性,以检测从4%到2%的VTE减少率。
    背景:这项研究已获亨特新英格兰人类研究伦理委员会(2022/ETH02276)方案V.10,2023年7月13日批准。研究结果将在地方和国家会议以及科学研究期刊上发表。
    背景:ANZCTR12622001527752。
    BACKGROUND: Venous thromboembolism (VTE) is a recognised postsurgical risk. Current prevention methods involve low molecular weight heparin (LMWH), graduated compression stockings (GCS), and intermittent pneumatic compression devices (IPCDs). Australian guidelines, commonly adopted by surgeons, recommend LMWH with GCS and/or IPCDs. IPCDs pose clinical risks, increase care burden, are poorly tolerated, and are costly single-use plastic items. Utilising only LMWH and GCS, without IPCDs, could be more practical, patient-friendly, and cost-effective, with added environmental benefits.
    METHODS: This is a multicentre, prospective, two-arm randomised controlled non-inferiority trial at five New South Wales (NSW) hospitals, in Australia. We propose to randomise 4130 participants in a 1:1 ratio between arm A: LMWH+GCS+IPCDs (n=2065) or arm B: LMWH+GCS (n=2065). The primary outcome of interest is symptomatic VTE (deep vein thrombosis/pulmonary embolism) identified at the day 30 phone follow-up (FU), confirmed by ultrasound or imaging. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation. Secondary outcomes are quality of life at baseline, days 30 and 90 FU using the 5-level European Quality of Life Score, compliance and adverse events with IPCDs, GCS, and LMWH, as well as healthcare costs (from the perspective of the patient and the hospital), and all-cause mortality. The trial has 90% power to detect a 2% non-inferiority margin to detect a reduction rate of VTE from 4% to 2%.
    BACKGROUND: This study has been approved by the Hunter New England Human Research Ethics Committee (2022/ETH02276) protocol V.10, 13 July 2023. Study findings will be presented at local and national conferences and in scientific research journals.
    BACKGROUND: ANZCTR12622001527752.
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  • 文章类型: Meta-Analysis
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  • 文章类型: Journal Article
    静脉血栓栓塞症(VTE),其中包括深静脉血栓形成(DVT)和肺栓塞(PE),是泌尿外科手术后可能发生的严重并发症。它是手术患者中可预防的医院相关发病率和死亡率的主要原因[1]。在泌尿外科手术中,VTE仍然是严重的并发症和重大挑战[2],PE被认为是泌尿外科大手术患者术后死亡的最常见原因[3]。在泌尿外科手术中使用血栓预防的决定涉及权衡VTE风险的降低与围手术期出血的潜在增加[4]。然而,在泌尿外科手术中缺乏预防血栓的手术特异性证据。因此,我们回顾了泌尿外科手术中血栓预防的现有证据,并尝试在特定手术背景下总结这些证据.
    OBJECTIVE: Postoperative pulmonary embolism is a leading cause of mortality in patients undergoing major urologic surgeries, presenting a complex challenge in balancing the risks of venous thromboembolism (VTE) and perioperative bleeding. This study examines the current evidence on thromboprophylaxis in urological procedures, focusing on procedure-specific considerations.
    METHODS: Literature on thromboprophylaxis in urological procedures was reviewed during the past decade.
    RESULTS: Various mechanical thromboprophylaxis methods, such as compression stockings, pneumatic compression devices, foot pumps, mobilization, and exercises, are available preventive measures. Additionally, unfractionated heparin (UFH) and low molecular weight heparin (LMWH) are commonly used pharmacological agents for VTE prevention, with the choice between mechanical, pharmacological, or combined approaches tailored to individual patient characteristics and surgical requirements. Patient risk stratification into low, medium, and highrisk categories based on age, BMI, and VTE history guides the selection of thromboprophylaxis strategies. Surgical procedures are categorized as oncological or non-oncological, with uro-oncological surgeries posing a higher VTE risk than non-oncological procedures. Consequently, a combination of pharmacological and mechanical prophylaxis is typically recommended for uro-oncological patients, while pharmacological prophylaxis is reserved for high-risk individuals undergoing non-oncological surgeries. Mechanical prophylaxis is advised for high-risk patients undergoing procedures with elevated VTE risk.
    CONCLUSIONS: This study summarized an optimal thromboprophylaxis protocol taking into account patient risk factors and the specific urological procedure.
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