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  • 文章类型: Journal Article
    连续血糖监测仪(CGMs)是糖尿病患者使用的越来越普遍的电子医疗设备,与“手指棒”相比,提供了几个优点。因此,在放射肿瘤科诊所中看到的CGM患者有所增加。制造商规定,CGM不应暴露于辐射(诊断和治疗),由于设备损坏的风险,为患者和提供者带来挑战。我们提出了放射肿瘤患者CGM管理的工作流程,从提供者和工作人员的系统筛查开始。我们提出了CGM管理选项以及设备开药者,包括移除CGM或用定期的手指棒将其保持在适当的位置以确认准确性,并为放射肿瘤学提供者和工作人员提供指导。
    Continuous glucose monitors (CGMs) are an increasingly prevalent electronic medical device utilized by patients with diabetes, offering several advantages over \"finger sticks\". There is a resulting rise in patients with CGMs seen in radiation oncology clinics. Manufacturers specify that CGMs should not be exposed to radiation (both diagnostic and therapeutic), due to risk of device damage, creating challenges for patients and providers. We present a workflow for management of CGMs in radiation oncology patients, beginning with systematic screening by providers and staff. We propose options for CGM management together with the device prescriber, including removal of the CGM or keeping it in place with periodic finger sticks to confirm accuracy, and offer guidance to radiation oncology providers and staff.
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  • 文章类型: Journal Article
    背景:心力衰竭(HF)是一项重大的全球临床和公共卫生挑战,影响全球6430万人。为了解决捐赠器官的稀缺问题,左心室辅助装置(LVAD)植入已成为治疗终末期HF的关键干预措施,作为心脏移植的桥梁或作为目的地治疗。基于网络的健康论坛,如MyLVAD.com,作为HF症状患者及其护理人员的可靠信息来源,起着至关重要的作用。
    目的:我们的目标是发现用户在MyLVAD.com网站上分享的帖子中潜在的主题。
    方法:使用潜在的Dirichlet分配算法和可视化工具,我们的目标是在MyLVAD.com网站上分享的帖子中发现潜在的主题。通过应用主题建模技术,我们分析了2015年至2023年LVAD接受者及其家庭成员撰写的459篇帖子.
    结果:这项研究揭示了LVAD患者及其家人关注的5个突出主题。这些主题包括家庭支持(39.5%的体重值),涵盖子主题,如家庭护理角色和情感或实际支持;服装(23.9%重量值),与舒适相关的子主题,正常状态,和功能;感染(18.2%体重值),涵盖传动系统感染,预防,和护理;功率(12%重量值),涉及与权力依赖相关的挑战;和自我护理维护,监测,和管理(6.3%重量值),其中包括血液测试等子主题,监测,警报,和设备管理。
    结论:这些发现有助于更好地了解植入LVAD患者的经历和需求,为医疗保健专业人员提供有价值的见解,以提供量身定制的支持和护理。通过使用潜在的Dirichlet分配来分析来自MyLVAD.com论坛的帖子,这项研究揭示了用户讨论的关键主题,促进改善患者护理和加强患者与提供者的沟通。
    BACKGROUND: Heart failure (HF) is a significant global clinical and public health challenge, impacting 64.3 million individuals worldwide. To address the scarcity of donor organs, left ventricular assist device (LVAD) implantation has become a crucial intervention for managing end-stage HF, serving as a bridge to heart transplantation or as a destination therapy. Web-based health forums, such as MyLVAD.com, play a vital role as trusted sources of information for individuals with HF symptoms and their caregivers.
    OBJECTIVE: We aim to uncover the latent topics within the posts shared by users on the MyLVAD.com website.
    METHODS: Using the latent Dirichlet allocation algorithm and a visualization tool, our objective was to uncover latent topics within the posts shared on the MyLVAD.com website. Through the application of topic modeling techniques, we analyzed 459 posts authored by recipients of LVAD and their family members from 2015 to 2023.
    RESULTS: This study unveiled 5 prominent themes of concern among patients with LVAD and their family members. These themes included family support (39.5% weight value), encompassing subthemes such as family caregiving roles and emotional or practical support; clothing (23.9% weight value), with subthemes related to comfort, normalcy, and functionality; infection (18.2% weight value), covering driveline infections, prevention, and care; power (12% weight value), involving challenges associated with power dependency; and self-care maintenance, monitoring, and management (6.3% weight value), which included subthemes such as blood tests, monitoring, alarms, and device management.
    CONCLUSIONS: These findings contribute to a better understanding of the experiences and needs of patients implanted with LVAD, providing valuable insights for health care professionals to offer tailored support and care. By using latent Dirichlet allocation to analyze posts from the MyLVAD.com forum, this study sheds light on key topics discussed by users, facilitating improved patient care and enhanced patient-provider communication.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    心力衰竭(HF)继续影响全球人群,患病率不断增加。虽然HF的病理生理学非常复杂,自主神经系统的失调,就像交感神经活动增强一样,作为新疗法和HF的有吸引力的病理生理目标。已经发现神经激素激活的程度与症状的严重程度相关,功能能力下降,和死亡率。自主神经系统的神经调节旨在恢复交感神经系统和副交感神经系统之间的平衡。鉴于自主神经失调在HF的发展和进展中起主要作用,恢复这种平衡可能会对核心病理生理机制和各种HF综合征产生影响。自主调节已被提出作为旨在减少全身性炎症的潜在治疗策略。这种疗法,以药物和器械为基础的补充疗法可改善患者预后并降低疾病负担.目前,大多数专业协会都没有提供关于在HF中使用神经调节技术的明确建议。这些包括直接和间接的迷走神经刺激,脊髓刺激,压力反射激活疗法,颈动脉窦刺激,主动脉弓刺激,内脏神经调制,心肺神经刺激,去肾交感神经。在这次审查中,我们提供了HF神经调节的全面概述。
    Heart failure (HF) continues to impact the population globally with increasing prevalence. While the pathophysiology of HF is quite complex, the dysregulation of the autonomic nervous system, as evident in heightened sympathetic activity, serves as an attractive pathophysiological target for newer therapies and HF. The degree of neurohormonal activation has been found to correlate to the severity of symptoms, decline in functional capacity, and mortality. Neuromodulation of the autonomic nervous system aims to restore the balance between sympathetic nervous system and the parasympathetic nervous system. Given that autonomic dysregulation plays a major role in the development and progression of HF, restoring this balance may potentially have an impact on the core pathophysiological mechanisms and various HF syndromes. Autonomic modulation has been proposed as a potential therapeutic strategy aimed at reduction of systemic inflammation. Such therapies, complementary to drug and device-based therapies may lead to improved patient outcomes and reduce disease burden. Most professional societies currently do not provide a clear recommendation on the use of neuromodulation techniques in HF. These include direct and indirect vagal nerve stimulation, spinal cord stimulation, baroreflex activation therapy, carotid sinus stimulation, aortic arch stimulation, splanchnic nerve modulation, cardiopulmonary nerve stimulation, and renal sympathetic nerve denervation. In this review, we provide a comprehensive overview of neuromodulation in HF.
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  • 文章类型: Editorial
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  • 文章类型: Journal Article
    心房流量调节器(AFR;Occlutech)可用于在各种病理生理设置中创建具有预定直径的心房连通。在儿科人群中,经验仅限于少数病例报告。我们旨在报告先天性和后天性心脏病患儿AFR植入的初始单中心经验。
    从2021年12月到2023年6月,我们招募了10名患者(年龄6个月-16岁)。治疗适应症为:左心室收缩功能障碍(n=6),限制性心肌病伴肺动脉高压(n=2),一名12岁儿童(n=1)的原发性法洛四联症手术修复后右心室功能障碍,和失败Fontan(n=1)。所有患者均成功进行了AFR植入。8例需要进行房间隔穿刺;在其他2例中,使用先前存在的卵圆孔未闭和有孔的房间隔缺损。9例进行了球囊预扩张。在所有情况下植入8mm装置。手术的平均时间是50分钟,中位透视时间为17分钟,中位辐射暴露剂量为2.3Gy×cm2。
    术中无并发症报告。3例患者在随访期间死亡:1例由于败血症(手术后16天),1由于疾病进展(8个月后),1是由于心房通气后7天ECMO拔管失败。在剩下的病人中,LA扩张的减少,毛细血管后肺动脉高压,观察心力衰竭症状。
    AFR在儿童和危重环境中是安全可行的,允许右/左腔卸载和改善血流动力学和症状。
    UNASSIGNED: The Atrial Flow Regulator (AFR; Occlutech) can be used to create interatrial communication with a predetermined diameter in various pathophysiological settings. In the pediatric population, the experience is limited to a few case reports. We aim to report the initial single-center experience of AFR implantation in children with congenital and acquired heart disease.
    UNASSIGNED: From December 2021 to June 2023, we enrolled 10 patients (aged 6 months-16 years). Indications to treatment were: left ventricular systolic dysfunction (n = 6), restrictive cardiomyopathy with pulmonary hypertension (n = 2), postoperative right ventricle dysfunction after surgical repair of a native Tetralogy of Fallot in a 12-year-old child (n = 1), and failure Fontan (n = 1). AFR implantation was successfully performed in all patients. Transseptal puncture was needed in 8 cases; in the other 2 cases, preexisting patent foramen ovale and fenestrated atrial septal defect were used. Balloon predilation was performed in 9 cases. An 8 mm device was implanted in all cases. The mean time of the procedure was 50 minutes, the median fluoroscopy time was 17 minutes, and median radiation exposure dose was 2.3 Gy × cm2.
    UNASSIGNED: No complications were reported during the procedure. Three patients died during the follow-up: 1 due to sepsis (16 days after the procedure), 1 due to disease progression (8 months after), and 1 due to failure of ECMO decannulation 7 days after the atrial venting. In the remaining patients, a reduction of LA dilation, postcapillary pulmonary hypertension, and heart failure symptoms were observed.
    UNASSIGNED: AFR is safe and feasible in children and critical settings, allowing right/left cavities unloading and improvement of hemodynamics and symptoms.
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  • 文章类型: Journal Article
    人们早就知道,对冷诱导损伤的敏感性在不同细胞类型之间会有很大差异,据报道,犬骨细胞的致死温度范围为-2°C,乳腺腺癌的温度为-70°C。这表明,对于某些应用,可能存在“治疗窗口”,其中可以控制冷冻手术温度以专门针对更冷敏感的细胞类型,同时保留不太敏感的细胞。然而,这种潜在的选择性尚未发展成为实际的临床治疗方法,部分原因是缺乏可以提供一致的调查工具,在所需的温度范围内可重复冷却。在这里,我们描述了一种实验性的冷冻手术工具,它允许用户控制三个关键的冷冻手术参数-温度,压力,和持续时间。该工具由廉价的组件组成,通常在大多数实验室环境中都可以使用,并且可以成为开发和优化新型局部冷冻手术方法的实用研究工具。
    It has long been known that sensitivity to cold-induced damage can vary greatly between different cell types, with lethal temperatures reportedly ranging from -2°C for canine osteocytes, to -70°C for mammary adenocarcinomas. This suggests that, for certain applications, \"therapeutic windows\" may exist wherein the cryosurgery temperature could be controlled to specifically target more cold-sensitive cell types, while sparing less sensitive cells. However, this potential selectivity has not been developed into practical clinical treatments, in part because of a lack of available investigative tools that can provide consistent, reproducible cooling within the desired temperature range. Here we describe an experimental cryosurgery tool that allows user control over the three key cryosurgery parameters - temperature, pressure, and duration. The tool is composed of inexpensive components that are generally accessible in most laboratory settings, and could be a practical investigative tool for developing and optimizing novel topical cryosurgery approaches.
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  • 文章类型: Journal Article
    背景:建议使用WovenEndoBridge(WEB)装置密封动脉瘤颈部,以破坏动脉瘤内部的血流。本研究调查了WEB颈部并置与动脉瘤闭塞率之间的关系。
    方法:纳入了2017年3月至2022年5月在单个中心接受WEB治疗的动脉瘤。在分离后高分辨率锥束CT图像上评估了Web颈部并置(差/好)和Web突出(是/否)。用Bicettre闭塞量表评分(BOSS)评估血管造影闭塞。单变量和多变量分析检验了颈部并置与闭塞率之间的关联。
    结果:该研究包括141例患者的159例动脉瘤(平均年龄55.8±11.2岁;64.2%为女性)。123例(77.4%)和30例(18.9%)颈部并置和突出良好,分别。评分者之间的协议对颈部并置(κ=0.75)和突出(κ=0.78)都很好。在104例(65%)和130例(82%)中实现了完全和充分的闭塞,分别(中位随访18个月)。良好的颈部并置是充分(校正OR(aOR)=5.9,95%CI2.4至14.9;P<0.001)和完全闭塞(aOR=7.1,95%CI3.0至18.1;P<0.001)的重要独立预测因素。与动脉瘤复发组相比,充分闭塞组突出更频繁,但无统计学意义(P=0.06)。但与更多的血栓栓塞并发症相关(9/30(30%)vs12/129(9%);P<0.01)。在不良并置情况下,WEB形状修饰明显更大(P=0.03)。
    结论:在随访期间实现良好的颈部并置强烈预测动脉瘤闭塞。由于血栓栓塞风险增加,对动脉瘤闭塞的影响有限,因此应最大程度地减少WEB突出。
    BACKGROUND: Sealing of the aneurysm neck with a Woven EndoBridge (WEB) device is recommended for disrupting the blood flow inside the aneurysm. This study investigates the relationship between WEB neck apposition and aneurysm occlusion rates.
    METHODS: Aneurysms treated with a WEB from March 2017 to May 2022 at a single center were included. WEB neck apposition (poor/good) and WEB protrusion (yes/no) were evaluated on post-detachment high resolution cone beam CT images. Angiographic occlusion was assessed with the Bicêtre Occlusion Scale score (BOSS). Univariate and multivariable analysis tested the association between neck apposition and occlusion rates.
    RESULTS: The study included 159 aneurysms in 141 patients (mean age 55.8±11.2 years; 64.2% women). Good neck apposition and protrusion were noted in 123 (77.4%) and 30 (18.9%) cases, respectively. Inter-rater agreements were good for neck apposition (κ=0.75) and protrusion (κ=0.78). Complete and adequate occlusion was achieved in 104 (65%) and 130 (82%) cases, respectively (median follow-up 18 months). Good neck apposition was a strong independent predictor for both adequate (adjusted OR (aOR)=5.9, 95% CI 2.4 to 14.9; P<0.001) and complete occlusion (aOR=7.1, 95% CI 3.0 to 18.1; P<0.001). Protrusion was more frequent in the adequate occlusion group versus the aneurysm recurrence group without reaching statistical significance (P=0.06), but was associated with more thromboembolic complications (9/30 (30%) vs 12/129 (9%); P<0.01). WEB shape modification was significantly greater in poor apposition cases (P=0.03).
    CONCLUSIONS: Achieving good neck apposition of the WEB strongly predicts aneurysm occlusion during follow-up. WEB protrusion should be minimized due to the increase in thromboembolic risk with limited impact on aneurysm occlusion.
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  • 文章类型: Journal Article
    将来自各种可穿戴设备的健康和活动数据集成到研究中,提出了技术和操作挑战。真棒数据采集方法(ADAM)是一种通用的,基于Web的系统,旨在集成来自各种来源的数据并管理大规模的多阶段研究研究。作为一个数据收集系统,ADAM允许通过设备的应用程序可编程接口和移动应用程序的自适应实时问卷从可穿戴设备收集实时数据。作为临床试验管理系统,ADAM集成了临床试验管理流程,并有效地支持招聘,筛选,随机化,数据跟踪,数据报告,和整个研究过程中的数据分析。我们使用行为减肥干预研究(SMARTER试验)作为测试案例来评估ADAM系统。SMARTER是一项随机对照试验,筛选了1741名参与者,招募了502名成年人。因此,ADAM系统被有效且成功地部署,以组织和管理SMARTER试验.此外,凭借其通用的集成能力,当COVID-19大流行停止面对面接触时,ADAM系统进行了必要的切换,以无缝,及时地进行完全远程评估和跟踪。ADAM系统提供的远程原生功能将COVID-19锁定对SMARTER试验的影响降至最低。SMARTER的成功证明了ADAM系统的全面性和高效性。此外,ADAM被设计为可推广和可扩展的,以适应其他研究,只需最少的编辑,再开发,和定制。ADAM系统可以使各种行为干预和不同人群受益。
    UNASSIGNED: The integration of health and activity data from various wearable devices into research studies presents technical and operational challenges. The Awesome Data Acquisition Method (ADAM) is a versatile, web-based system that was designed for integrating data from various sources and managing a large-scale multiphase research study. As a data collecting system, ADAM allows real-time data collection from wearable devices through the device\'s application programmable interface and the mobile app\'s adaptive real-time questionnaires. As a clinical trial management system, ADAM integrates clinical trial management processes and efficiently supports recruitment, screening, randomization, data tracking, data reporting, and data analysis during the entire research study process. We used a behavioral weight-loss intervention study (SMARTER trial) as a test case to evaluate the ADAM system. SMARTER was a randomized controlled trial that screened 1741 participants and enrolled 502 adults. As a result, the ADAM system was efficiently and successfully deployed to organize and manage the SMARTER trial. Moreover, with its versatile integration capability, the ADAM system made the necessary switch to fully remote assessments and tracking that are performed seamlessly and promptly when the COVID-19 pandemic ceased in-person contact. The remote-native features afforded by the ADAM system minimized the effects of the COVID-19 lockdown on the SMARTER trial. The success of SMARTER proved the comprehensiveness and efficiency of the ADAM system. Moreover, ADAM was designed to be generalizable and scalable to fit other studies with minimal editing, redevelopment, and customization. The ADAM system can benefit various behavioral interventions and different populations.
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  • 文章类型: Journal Article
    背景:降低心血管疾病的巨大发病率和死亡率负担的关键是帮助人们将血压(BP)保持在安全水平。这需要更多的高血压患者被识别,诊断,并提供降低BP的工具。血压监测对高血压的诊断和管理至关重要。然而,传统BP监测仪(示波袖带血压计)的特点阻碍了高血压的快速有效诊断和管理.免校准,在无处不在的移动设备上运行的纯软件BP监控器可以实现按需BP监控,克服了传统BP监测仪的硬件障碍。
    目的:本研究旨在研究非接触式BP监测软件应用程序的准确性,用于将所有临床相关BP分类为高血压或非高血压,并评估其测量脉搏率的准确性(PR)和与1期高血压相关的BP患者的BP。
    方法:软件应用程序,商业上被称为Lifelight,根据国际标准化组织(ISO)81060-2:2018/AMD1:2020中概述的数据收集和数据分析方法进行了研究。“非侵入性血压计-第2部分:自动测量类型的临床研究。“这项验证研究是由独立实验室ElementMaterialsTechnologyBoulder(以前的Clinimark)进行的。该研究从85名年龄在18-85岁之间的人中收集了数据,这些人的BP分布广泛,在ISO81060-2:2018/AMD1:2020中。至少需要20%的Fitzpatrick音阶肤色为5或6(即,深色肤色)。通过将其BP测量值与使用ISO81060-2:2018/AMD1:2020中指定的同臂顺序方法通过双观察者手动听诊进行的测量值进行比较来评估应用程序的BP测量值的准确性。通过将其测量值与并发脑电图得出的心率值进行比较来评估应用的PR测量值的准确性。
    结果:该应用程序以每分钟1.3次搏动的精度均方根和每分钟1.1(SD0.8)次搏动的平均绝对误差测量PR。确定BPs超过临床收缩压阈值诊断高血压的敏感性和特异性分别为70.1%和71.7%。分别。这些比率与美国国家健康与护理卓越研究所的文献综述中报道的常规BP监测仪的比率一致。在正常血压和1期高血压范围内测量BP的应用程序平均误差(即,65/85,76%的参与者)收缩压为6.5(SD12.9)mmHg,舒张压为0.4(SD10.6)mmHg。平均绝对误差为11.3(SD10.0)mmHg和8.6(SD6.8)mmHg,分别。
    结论:无需校准,纯软件医疗设备根据ISO81060-2:2018/AMD1:2020进行了独立测试。这项研究中证明的安全性和性能表明,该技术可能是快速,可扩展的高血压筛查和管理的潜在解决方案。
    BACKGROUND: The key to reducing the immense morbidity and mortality burdens of cardiovascular diseases is to help people keep their blood pressure (BP) at safe levels. This requires that more people with hypertension be identified, diagnosed, and given tools to lower their BP. BP monitors are critical to hypertension diagnosis and management. However, there are characteristics of conventional BP monitors (oscillometric cuff sphygmomanometers) that hinder rapid and effective hypertension diagnosis and management. Calibration-free, software-only BP monitors that operate on ubiquitous mobile devices can enable on-demand BP monitoring, overcoming the hardware barriers of conventional BP monitors.
    OBJECTIVE: This study aims to investigate the accuracy of a contactless BP monitor software app for classifying the full range of clinically relevant BPs as hypertensive or nonhypertensive and to evaluate its accuracy for measuring the pulse rate (PR) and BP of people with BPs relevant to stage-1 hypertension.
    METHODS: The software app, known commercially as Lifelight, was investigated following the data collection and data analysis methodology outlined in International Organization for Standardization (ISO) 81060-2:2018/AMD 1:2020 \"Non-invasive Sphygmomanometers-Part 2: Clinical investigation of automated measurement type.\" This validation study was conducted by the independent laboratory Element Materials Technology Boulder (formerly Clinimark). The study generated data from 85 people aged 18-85 years with a wide-ranging distribution of BPs specified in ISO 81060-2:2018/AMD 1:2020. At least 20% were required to have Fitzpatrick scale skin tones of 5 or 6 (ie, dark skin tones). The accuracy of the app\'s BP measurements was assessed by comparing its BP measurements with measurements made by dual-observer manual auscultation using the same-arm sequential method specified in ISO 81060-2:2018/AMD 1:2020. The accuracy of the app\'s PR measurements was assessed by comparing its measurements with concurrent electroencephalography-derived heart rate values.
    RESULTS: The app measured PR with an accuracy root-mean-square of 1.3 beats per minute and mean absolute error of 1.1 (SD 0.8) beats per minute. The sensitivity and specificity with which it determined that BPs exceeded the in-clinic systolic threshold for hypertension diagnosis were 70.1% and 71.7%, respectively. These rates are consistent with those reported for conventional BP monitors in a literature review by The National Institute for Health and Care Excellence. The app\'s mean error for measuring BP in the range of normotension and stage-1 hypertension (ie, 65/85, 76% of participants) was 6.5 (SD 12.9) mm Hg for systolic BP and 0.4 (SD 10.6) mm Hg for diastolic BP. Mean absolute error was 11.3 (SD 10.0) mm Hg and 8.6 (SD 6.8) mm Hg, respectively.
    CONCLUSIONS: A calibration-free, software-only medical device was independently tested against ISO 81060-2:2018/AMD 1:2020. The safety and performance demonstrated in this study suggest that this technique could be a potential solution for rapid and scalable screening and management of hypertension.
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