heart-assist devices

心脏辅助装置
  • 文章类型: Letter
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  • 文章类型: Journal Article
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  • 文章类型: English Abstract
    To investigate the biomechanical effects of direct ventricular assistance and explore the optimal loading mode, this study established a left ventricular model of heart failure patients based on the finite element method. It proposed a loading mode that maintains peak pressure compression, and compared it with the traditional sinusoidal loading mode from both hemodynamic and biomechanical perspectives. The results showed that both modes significantly improved hemodynamic parameters, with ejection fraction increased from a baseline of 29.33% to 37.32% and 37.77%, respectively, while peak pressure, stroke volume, and stroke work parameters also increased. Additionally, both modes showed improvements in stress concentration and excessive fiber strain. Moreover, considering the phase error of the assist device\'s working cycle, the proposed assist mode in this study was less affected. Therefore, this research may provide theoretical support for the design and optimization of direct ventricular assist devices.
    为了研究直接心室辅助的生物力学影响以及探究最优的加载模式,本文基于有限元方法建立了心衰患者的左心室模型,并提出了一种维持压迫力峰值的加载模式,从血流动力学和生物力学两个方面与传统的正弦加载模式进行了对比。结果表明,两种模式都能显著提升血流动力学参数,射血分数分别从基线29.33%增加到37.32%与37.77%,峰值压力、每搏量和每搏功等参数都有所增加;且两种模式的应力集中、过度纤维应变等现象均有所改善。然而,当考虑到辅助装置工作周期的相位误差时,本文所提出的辅助模式受到的影响更小,故本文研究或可为直接心室辅助装置的设计和优化提供理论支持。.
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  • 文章类型: Journal Article
    左心室辅助装置(LVAD)上的患者由于人工泵表面与血液成分的永久接触而容易出现过多的止血障碍。我们旨在研究长期连续流动LVAD治疗患者的纤维蛋白凝块通透性是否改变,以及凝块通透性是否与临床特征和不良事件相关。我们调查了85名终末期心力衰竭患者(90.6%为男性,年龄48.6-63.8岁)根据当前临床适应症安排连续流动长期LVAD支持。定期对患者进行评估:LVAD植入前(T1),LVAD植入后3-6个月(T2),(T3)后6-12个月,然后每6个月。我们测试了前三个血液样本(T1-T3)和最后一个可用的血液样本(T4),但不超过LVAD植入后5年。我们评估了止血参数(活化部分凝血活酶时间(APTT)凝血酶原时间,活化部分凝血活酶时间,纤维蛋白原,D-二聚体,抗凝血酶,凝血酶时间,因子VIII,和vonWillebrand因子,阿司匹林诱导的血小板抑制,腺苷二磷酸试验)在研究期间的变化。使用压力系统评价纤维蛋白凝块渗透性并计算渗透性系数(Ks)。我们观察到在T1、T2、T3和T4时间段之间纤维蛋白凝块通透性(Ks)降低;对于每个比较,P<0.01。纤维蛋白凝块通透性与纤维蛋白原浓度呈负相关:r=-0.51,P<0.001,因子VIII活性r=-0.42,P<0.001。Ks与年龄没有关联,左心室射血分数(LVEF)和药物治疗P>0.001,但是阿司匹林患者的累积测量显示该组中Ks缩短P=0.0123。36.5%的患者发生主要不良心脑血管事件(MACCE),出血事件占25.9%,净不良临床事件(NACE)占62.4%;31.7%的患者死亡,17.6%接受移植。移植被认为是终点。在MACCE患者之间观察到Ks的差异,出血,NACE,和无不良事件的患者。Ks仅在无不良事件的患者中显示出恒定的正常化趋势(P<0.01)。晚期心力衰竭患者的凝块结构紊乱。在这组患者中,Ks值正常化的趋势与较少的血栓栓塞和出血并发症有关。
    Patients on left ventricular assist devices (LVAD) are prone to excessive hemostasis disturbances due to permanent contact of artificial pump surfaces with blood components. We aimed to investigate if fibrin clot permeability is altered in patients on long-term continuous-flow LVAD therapy and if the clot permeability is associated with clinical characteristics and adverse events. We investigated 85 end-stage heart failure patients (90.6% men, age 48.6-63.8 years) scheduled for continuous flow long-term LVAD support according to current clinical indications. The patients were assessed periodically: prior to LVAD implantation (T1), 3-6 months (T2) after LVAD implantation, 6-12 months after (T3) and then every 6 months. We tested the first three blood samples (T1-T3) and the last available blood sample (T4), but no longer than 5 years after LVAD implantation. We assessed hemostasis parameters (Activated Partial Thromboplastin Time (APTT) Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen, D-dimer, Antithrombin, Thrombin Time, Factor VIII, and von Willebrand Factor, aspirin-induced platelet inhibition, adenosine-diphosphate test) changes during the study period. Fibrin Clot Permeability was evaluated using a pressure system and Permeability Coefficient (Ks) was calculated. We observed a decrease in fibrin clot permeability (Ks) between T1, T2, T3 and T4 time periods; P < 0.01 for each comparison. Fibrin clot permeability was negatively correlated with fibrinogen concentration: r = - 0.51, P < 0.001, factor VIII activity r = - 0.42, P < 0.001. There was no association of Ks with age, Left Ventricular Ejection Fraction (LVEF) and medications P > 0.001, however cumulative measurements in patients on aspirin showed shortening of Ks in this group P = 0.0123. Major adverse cardiac and cerebrovascular events (MACCE) occurred in 36.5% patients, bleeding events in 25.9%, Net Adverse Clinical Events (NACE) in 62.4%; 31.7% patients died, and 17.6% underwent transplantation. The transplantation was considered as the endpoint. Discrepancies in Ks were observed between patients with MACCE, bleeding, and NACE, and patients without adverse events. Ks showed a constant trend towards normalization (P < 0.01) only in patients without adverse events. Patients with advanced heart failure have disturbed clot structure. A trend towards normalization of the Ks values is associated with fewer thromboembolic and bleeding complications in this group of patients.
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  • 文章类型: Case Reports
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  • 文章类型: Case Reports
    背景:本病例报告记录了SpectrumMedical在心脏移植手术中首次在全球范围内使用混合系统,注重其安全性和有效性。传统的体外循环系统通常使用开放式储液器,这增加了血液对空气的暴露,从而增加炎症反应和气体栓塞的风险。相比之下,混合系统旨在通过显着减少血液-空气界面来改善手术结果。该系统利用双腔心脏切开术-静脉储液器,带有可折叠的软袋,有效地减少与空气和异物的血液接触。然而,值得注意的是,目前没有证据支持这种方法在心脏移植中的应用.
    方法:一名41岁男性因扩张型心肌病使用左心室辅助装置进行心脏移植。围手术期和术后数据提供了系统有效性的证据。选择该患者是由于没有与他的主要心脏疾病无关的明显合并症。使他成为评估系统性能的理想人选。
    结论:该混合系统是安全有效的。在这种情况下的成功实施凸显了其优于传统心肺转流系统的优势,预示着心脏外科手术的前景.需要对常规心脏手术患者进行进一步研究以验证这些发现。
    BACKGROUND: This case report documents the first worldwide use of the Hybrid System from Spectrum Medical in a heart transplant procedure, focusing on its safety and efficacy. Traditional cardiopulmonary bypass systems often use an open reservoir, which increases the blood\'s exposure to air, thereby heightening the risk of an inflammatory response and gas embolism. In contrast, the Hybrid System is designed to improve surgical outcomes by significantly reducing the blood-air interface. This system utilizes a dual-chamber cardiotomy-venous reservoir with a collapsible soft bag, effectively minimizing blood contact with air and foreign materials. However, it is important to note that there is currently no evidence supporting the use of this methodology specifically in heart transplants.
    METHODS: A 41-year-old male managed with a left ventricular assist device because of dilated cardiomyopathy underwent a heart transplant using the Hybrid System. The perioperative and postoperative data provided evidence of the system\'s effectiveness. The selection of this patient was due to the absence of significant comorbidities unrelated to his primary cardiac condition, making him an ideal candidate to evaluate the system\'s performance.
    CONCLUSIONS: The Hybrid System is safe and efficient. The successful implementation in this case highlights its advantages over traditional cardiopulmonary bypass systems, suggesting a promising future in cardiac surgery. Further studies with routine cardiac surgery patients are required to validate these findings.
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  • 文章类型: Systematic Review
    选定的不符合心脏移植资格的晚期心力衰竭患者可以从左心室辅助装置治疗中受益,作为“目的地治疗”。有证据表明目的地治疗的疗效;然而,由于缺乏经济证据,目前尚未在英国国家卫生局内委托。
    对于不适合进行心脏移植(目的地治疗)的晚期心力衰竭患者,左心室辅助装置的临床和成本效益与医疗管理相比如何?
    对左心室辅助装置作为目的地治疗的临床和成本效益的证据进行了系统审查,包括:在可行的情况下,一项网络荟萃分析,以间接评估当前可用的左心室辅助设备与医疗管理相比的相对有效性.对于系统审查,搜索的数据源(截至2022年1月11日)是CochraneCENTRAL,MEDLINE和EMBASE通过Ovid进行初步研究,以及Epidemonikos和Cochrane系统评价数据库,用于相关系统评价。还搜索了试用登记簿,以及来自特定干预措施登记册的数据和报告。经济研究在EconLit中被确定,CEA注册表和NHS经济评估数据库(NHSEED)。通过检查纳入研究的参考列表来补充搜索。从英国国家卫生服务/个人社会服务的角度,开发了一种经济模型(马尔可夫)来估算左心室辅助设备与医疗管理相比的成本效益。进行确定性和概率敏感性分析以探索不确定性。在可能的情况下,所有分析都集中在目前唯一可用的左心室辅助装置(HeartMate3TM,雅培,芝加哥,IL,美国)在英国。
    临床有效性综述包括134项研究(240篇)。没有直接比较HeartMate3和医疗管理的研究(一项随机试验正在进行中)。当前可用的左心室辅助装置与早期装置相比并相对于医疗管理提高了患者存活率并降低了中风率和并发症。例如,使用HeartMate3装置24个月时的生存率为77%,而使用HeartMateII时的生存率为59%(MOMENTUM3试验)。间接比较表明,与医疗管理相比,死亡率降低[相对死亡风险0.25(95%置信区间0.13至0.47);24个月;本研究]。成本效益审查包括5项成本分析和14项经济评估,涵盖不同世代的设备,并具有不同的观点。与医疗管理相比,报告的每质量调整生命年的增量成本较后几代设备更低[低至46,207英镑(2019年价格;英国观点;时间期限至少5年)]。从英国国家卫生服务/个人社会服务的角度来看,与医疗管理相比,经济评估使用了不同的方法来获得当前左心室辅助设备的相对效果。所有这些都给出了类似的增量成本效益比,即每获得质量调整后的寿命年-寿命期53,496-58,244英镑。模型输出对与医疗管理相关的参数估计敏感。根据心力衰竭的严重程度,探索性亚组分析的结果没有实质性差异。
    没有直接证据将HeartMate3的临床有效性与医疗管理进行比较。间接比较是基于来自异质性研究的有限数据,这些研究涉及心力衰竭的严重程度(机构间登记机构间登记机构机械辅助循环支持评分分布)和可能的生存。此外,英国晚期心力衰竭的医疗管理成本尚不清楚.
    使用英国适用的成本效益标准,对于不符合心脏移植条件的晚期心力衰竭患者,左心室辅助装置与医疗管理相比可能不具成本效益.如果可用,持续评估HeartMate3与医疗管理相比的数据可用于更新成本效益估计值.需要对英国的医疗管理成本进行审计,以进一步减少经济评估中的不确定性。
    本研究注册为PROSPEROCRD42020158987。
    该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:NIHR128996)资助,并在《卫生技术评估》中全文发表。28号38.有关更多奖项信息,请参阅NIHR资助和奖励网站。
    由于年龄和合并症,大多数晚期心力衰竭患者不适合进行心脏移植,但选定的患者可以从左心室辅助装置中受益。用于此类患者的左心室辅助设备治疗被称为“目的地治疗”。这是一种长期疗法,涉及植入电池供电的泵来支持患者的心脏。该项目的目的是收集和评估左心室辅助装置用于目的地治疗时有效性的研究证据。并从英国国家卫生服务/个人社会服务的角度评估与医疗管理相比的物有所值。这项研究发现,目前可用的左心室辅助设备与早期设备相比,与医疗管理相比,可以提高患者的生存率,并减少中风率和并发症。然而,由于缺乏直接将当前设备与单独药物治疗进行比较的研究,因此证据存在不确定性.目前正在进行的临床试验正在对此进行评估。这也意味着对于左心室辅助设备是否可以提供目前为英国国家卫生局确定的物有所值的不确定性。
    UNASSIGNED: Selected patients with advanced heart failure ineligible for heart transplantation could benefit from left ventricular assist device therapy as \'destination therapy\'. There is evidence of the efficacy of destination therapy; however, it is not currently commissioned within the United Kingdom National Health Service due to the lack of economic evidence.
    UNASSIGNED: What is the clinical and cost-effectiveness of a left ventricular assist device compared to medical management for patients with advanced heart failure ineligible for heart transplantation (destination therapy)?
    UNASSIGNED: A systematic review of evidence on the clinical and cost-effectiveness of left ventricular assist devices as destination therapy was undertaken including, where feasible, a network meta-analysis to provide an indirect estimate of the relative effectiveness of currently available left ventricular assist devices compared to medical management. For the systematic reviews, data sources searched (up to 11 January 2022) were Cochrane CENTRAL, MEDLINE and EMBASE via Ovid for primary studies, and Epistemonikos and Cochrane Database of Systematic Reviews for relevant systematic reviews. Trial registers were also searched, along with data and reports from intervention-specific registries. Economic studies were identified in EconLit, CEA registry and the NHS Economic Evaluation Database (NHS EED). The searches were supplemented by checking reference lists of included studies. An economic model (Markov) was developed to estimate the cost-effectiveness of left ventricular assist devices compared to medical management from the United Kingdom National Health Service/personal social service perspective. Deterministic and probabilistic sensitivity analyses were conducted to explore uncertainties. Where possible, all analyses focused on the only currently available left ventricular assist device (HeartMate 3TM, Abbott, Chicago, IL, USA) in the United Kingdom.
    UNASSIGNED: The clinical effectiveness review included 134 studies (240 articles). There were no studies directly comparing HeartMate 3 and medical management (a randomised trial is ongoing). The currently available left ventricular assist device improves patient survival and reduces stroke rates and complications compared to earlier devices and relative to medical management. For example, survival at 24 months is 77% with the HeartMate 3 device compared to 59% with the HeartMate II (MOMENTUM 3 trial). An indirect comparison demonstrated a reduction in mortality compared to medical management [relative risk of death 0.25 (95% confidence interval 0.13 to 0.47); 24 months; this study]. The cost-effectiveness review included 5 cost analyses and 14 economic evaluations covering different generations of devices and with different perspectives. The reported incremental costs per quality-adjusted life-year gained compared to medical management were lower for later generations of devices [as low as £46,207 (2019 prices; United Kingdom perspective; time horizon at least 5 years)]. The economic evaluation used different approaches to obtain the relative effects of current left ventricular assist devices compared to medical management from the United Kingdom National Health Service/personal social service perspective. All gave similar incremental cost-effectiveness ratios of £53,496-58,244 per quality-adjusted life-year gained - lifetime horizon. Model outputs were sensitive to parameter estimates relating to medical management. The findings did not materially differ on exploratory subgroup analyses based on the severity of heart failure.
    UNASSIGNED: There was no direct evidence comparing the clinical effectiveness of HeartMate 3 to medical management. Indirect comparisons made were based on limited data from heterogeneous studies regarding the severity of heart failure (Interagency Registry for Mechanically Assisted Circulatory Support score distribution) and possible for survival only. Furthermore, the cost of medical management of advanced heart failure in the United Kingdom is not clear.
    UNASSIGNED: Using cost-effectiveness criteria applied in the United Kingdom, left ventricular assist devices compared to medical management for patients with advanced heart failure ineligible for heart transplant may not be cost-effective. When available, data from the ongoing evaluation of HeartMate 3 compared to medical management can be used to update cost-effectiveness estimates. An audit of the costs of medical management in the United Kingdom is required to further decrease uncertainty in the economic evaluation.
    UNASSIGNED: This study is registered as PROSPERO CRD42020158987.
    UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR128996) and is published in full in Health Technology Assessment; Vol. 28, No. 38. See the NIHR Funding and Awards website for further award information.
    The majority of patients with advanced heart failure would be unsuitable for heart transplantation due to their age and comorbidities but selected patients could benefit from a left ventricular assist device. Left ventricular assist device therapy for such patients is known as ‘destination therapy’. This is a long-term therapy that involves implanting a battery-powered pump to support the patient’s heart. The purpose of this project was to collect and assess the research evidence on the effectiveness of left ventricular assist devices when used for destination therapy, and to estimate value for money compared to medical management from the United Kingdom National Health Service/personal social service perspective. This research identified that the currently available left ventricular assist device improves patient survival as well as reducing stroke rates and complications compared to earlier devices and relative to medical management. However, there is uncertainty in the evidence due to the absence of studies directly comparing the current device to medical therapy alone. An ongoing clinical trial is currently assessing this. It also means there is uncertainty about whether left ventricular assist devices could provide value for money as determined currently for the United Kingdom National Health Service.
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  • 文章类型: Journal Article
    尽管在急性ST段抬高型心肌梗死的管理方面取得了显著进展,心力衰竭的患病率并未降低.以减少梗死面积为重点的新兴范例显示了在经历急性冠状动脉综合征后改善心力衰竭发生率的有希望的证据。在过去的几十年中,限制梗死面积一直是多项临床试验的重点,并导致左心室(LV)卸载作为潜在机制。用于LV卸载的微轴流装置的当代使用表明,急性心肌梗死并发心源性休克的死亡率有所改善。这篇综述的重点是证明梗死面积减少的临床数据,并强调正在进行的临床试验,这些临床试验为急性心肌梗死的管理提供了新的治疗方法。
    Despite significant advancements in managing acute ST-segment elevation myocardial infarctions, the prevalence of heart failure has not decreased. Emerging paradigms with a focus on reducing infarct size show promising evidence in the improvement of the incidence of heart failure after experiencing acute coronary syndromes. Limiting infarct size has been the focus of multiple clinical trials over the past decades and has led to left ventricular (LV) unloading as a potential mechanism. Contemporary use of microaxial flow devices for LV unloading has suggested improvement in mortality in acute myocardial infarction complicated by cardiogenic shock. This review focuses on clinical data demonstrating evidence of infarct size reduction and highlights ongoing clinical trials that provide a new therapeutic approach to the management of acute myocardial infarction.
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  • 文章类型: Case Reports
    暴发性心肌炎已被定义为心脏炎症的临床表现,伴有快速发作的心力衰竭和心源性休克。我们报告了一例17岁男孩因暴发性心肌炎而导致血液动力学紊乱和心脏骤停的病例。强化心肺复苏后约2小时,有13天的体外膜氧合支持,患者最终过渡到原位心脏移植。患者恢复顺利,移植后37天出院。移植的心脏显示所有四个心腔壁中弥漫性淋巴细胞浸润和心肌细胞坏死,证实了诊断并确定了暴发性心肌炎的根本原因。
    Fulminant myocarditis has been defined as the clinical manifestation of cardiac inflammation with rapid-onset heart failure and cardiogenic shock. We report on the case of a 17-year-old boy with hemodynamic derangement and cardiac arrest due to fulminant myocarditis. After about 2 h of intensive cardiopulmonary resuscitation, with 13 days of extracorporeal membrane oxygenation support, the patient finally bridged to orthotopic heart transplantation. The patient recovered uneventfully and was discharged 37 days after transplantation. The explanted heart revealed diffuse lymphocytic infiltration and myocyte necrosis in all four cardiac chamber walls confirming the diagnosis and identifying the underlying cause of fulminant myocarditis.
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  • 文章类型: Journal Article
    背景:ST段抬高型心肌梗死(STEMI)并发心源性休克(STEMI-CS)与高死亡率相关。病人在下班时间入院,特别是在周末和晚上,显示更高的死亡率,这称为“非工作时间效应”。机械循环支持治疗的STEMI-CS患者的非工作时间效应,尤其是Impella,尚未得到充分评估。
    目的:我们旨在调查非工作时间入院是否与该人群的高死亡率相关。
    方法:我们使用了2020年2月至2021年12月期间接受Impella治疗的连续患者的大规模日本注册数据,并比较了工作时间和非工作时间的入院情况。工作时间和非工作时间定义为工作日8:00至19:59之间的时间和剩余时间,分别。Cox比例风险模型用于计算30天死亡率的校正风险比(aHRs)。
    结果:在1,207例STEMI患者中,566(46.9%)患者(平均年龄:69岁;107名女性)接受Impella治疗的STEMI-CS患者。其中,300人(53.0%)在工作时间内入院。在随访期间(中位数22天[四分位距13-38天]),在非工作时间和工作时间内住院的患者中观察到112例(42.1%)和91例(30.3%)死亡,分别。非工作时间入院与30天死亡率的独立相关风险高于非工作时间入院(aHR1.60,95%置信区间:1.07-2.39;p=0.02)。
    结论:我们的研究结果表明,接受Impella治疗的STEMI-CS患者存在“非工作时间效应”。医疗保健专业人员应继续通过改善及时提供循证治疗和加强非工作时间医疗服务来解决心血管护理方面的差距。
    BACKGROUND: ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock (STEMI-CS) is associated with high mortality rates. Patients admitted during off-hours, specifically on weekends and at night, show higher mortality rates, which is called the \"off-hours effect\". The off-hours effect in patients with STEMI-CS treated with mechanical circulatory support, especially Impella, has not been fully evaluated.
    OBJECTIVE: We aimed to investigate whether off-hours admissions were associated with higher mortality rates in this population.
    METHODS: We used large-scale Japanese registry data for consecutive patients treated with Impella between February 2020 and December 2021 and compared on- and off-hours admissions. On- and off-hours were defined as the time between 8:00 and 19:59 on weekdays and the remaining time, respectively. The Cox proportional hazards model was used to calculate the adjusted hazard ratios (aHRs) for 30-day mortality.
    RESULTS: Of the 1,207 STEMI patients, 566 (46.9%) patients (mean age: 69 years; 107 females) with STEMI-CS treated with Impella were included. Of these, 300 (53.0%) were admitted during on-hours. During the follow-up period (median 22 days [interquartile range 13-38 days]), 112 (42.1%) and 91 (30.3%) deaths were observed among patients admitted during off- and on-hours, respectively. Off-hours admissions were independently associated with a higher risk of 30-day mortality than on-hours admissions (aHR 1.60, 95% confidence interval: 1.07-2.39; p=0.02).
    CONCLUSIONS: Our findings indicated the persistence of the \"off-hours effect\" in STEMI-CS patients treated with Impella. Healthcare professionals should continue to address the disparities in cardiovascular care by improving the timely provision of evidence-based treatments and enhancing off-hours medical services.
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