heart-assist devices

心脏辅助装置
  • 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
    本研究采用CFD方法研究叶轮几何形状对血流动力学特性的影响,泵性能,和血液损伤参数,在经皮微轴向机械循环支持(MCS)装置。数值模拟采用SSTk-ω湍流模型的稳态雷诺平均Navier-Stokes近似。以不同的轮毂转换角度(α=0○,3○和5○)。分析包括23种不同压头(Δp=60-80mmHg)和角速度(ω=30-52kRPM)的情况。在两种情况下比较获得的流量,以评估叶轮的设计和工作条件对泵性能的影响。使用沿流线计算的应力累积值的统计中值来估计剪切诱导的血小板活化的比较风险。使用高于阈值(τ>425Pa)的剪切应力的平均暴露时间来估计溶血风险。结果表明,叶轮轮毂的形状对其流型有很大的影响,性能,和血液受损的风险,以及角速度。使用直轮毂(α=0〇)实现了最高流量(Q=3.7L/min)和效率(η=11.3%)。同样,对于相同的流量和压力条件,直轮毂叶轮的血损风险参数最低。这项研究揭示了泵设计对性能和血液损伤风险的影响,指示轮毂形状和角速度作为主要参数的作用。
    This study uses CFD methods to investigate the effects of the impeller\'s geometry on the hemodynamic characteristics, pump performance, and blood damage parameters, in a percutaneous microaxial Mechanical Circulatory Support (MCS) device. The numerical simulations employ the steady state Reynolds-Averaged Navier-Stokes approximation using the SST k-ω turbulent model. Three different impeller models are examined with different hub conversion angles (α = 0○, 3○ and 5○). The analysis includes 23 cases for different pressure heads (Δp = 60-80 mmHg) and angular velocities (ω = 30-52 kRPM). The obtained flow rate is compared between the cases to assess the effect of the impeller\'s design and working conditions on the pump performance. The comparative risk of shear-induced platelet activation is estimated using the statistical median of the stress-accumulation values calculated along streamlines. The risk of hemolysis is estimated using the average exposure time to shear stress above a threshold (τ > 425 Pa). The results reveal that the shape of the impeller\'s hub has a great impact on the flow patterns, performance, and risk of blood damage, as well as the angular velocity. The highest flow rate (Q = 3.7 L/min) and efficiency (η = 11.3 %) were achieved using a straight hub (α = 0○). Similarly, for the same condition of flow and pressure, the straight hub impeller has the lowest blood damage risk parameters. This study shed light on the effect of pump design on the performance and risk of blood damage, indicating the roles of the hub shape and angular velocity as dominant parameters.
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  • 文章类型: Journal Article
    Objectives.临时机械循环支持(TMCS)已成为治疗心源性休克的治疗策略的组成部分,作为决策的桥梁。TMCS可以促进心肺功能的恢复,末端器官功能,并可能降低左心室辅助装置(LVAD)植入的手术风险。尽管改善了血液动力学和终末器官功能,这些高危患者的LVAD术后发病率可能会增加。该研究的目的是比较在HM3植入之前有和没有TMCS的患者植入Heartmate3(HM3)后的结果。方法。在这项对2015年11月至2021年10月期间所有HM3患者进行的回顾性队列研究中,比较了既往有和没有TMCS的患者。患者人口统计学,基线临床特征,实验室测试,术中变量,术后结果,从患者记录中收集不良事件.结果。在植入LVAD之前,TMCS组显示血流动力学的改善。中位TMCS持续时间为19.5(14-26)天。然而,TMCS组有更多的凝血障碍,有更多的伤口感染,神经系统并发症,与HM3植入前没有TMCS的患者相比,更多的患者接受透析。在TMCS(N=22)和非TMCS组(N=41)中,HM3植入后四年的生存率分别为80%和82%,分别。结论。接受TMCS的患者具有可接受的短期和长期生存率,并且与接受HM3而没有先前TMCS的患者相当。然而,他们有一个更复杂的术后过程。
    Objectives. Temporary mechanical circulatory support (TMCS) has become a component in the therapeutic strategy for treatment of cardiogenic shock as a bridge-to-decision. TMCS can facilitate recovery of cardiopulmonary function, end-organ function, and potentially reduce the surgical risk of left ventricular assist device (LVAD) implantation. Despite the improvements of hemodynamics and end-organ function, post-LVAD operative morbidity might be increased in these high-risk patients. The aim of the study was to compare outcomes after Heartmate 3 (HM3) implantation in patients with and without TMCS prior to HM3 implant. Methods. In this retrospective cohort study of all HM3 patients in the period between November 2015 and October 2021, patients with and without prior TMCS were compared. Patients\' demographics, baseline clinical characteristics, laboratory tests, intraoperative variables, postoperative outcomes, and adverse events were collected from patient records. Results. The TMCS group showed an improvement in hemodynamics prior to LVAD implantation. Median TMCS duration was 19.5 (14-26) days. However, the TMCS group were more coagulopathic, had more wound infections, neurological complications, and more patients were on dialysis compared with patient without TMCS prior to HM3 implantation. Survival four years after HM3 implantation was 80 and 82% in the TMCS (N = 22) and non-TMCS group (N = 41), respectively. Conclusion. Patients on TMCS had an acceptable short and long-term survival and comparable to patients receiving HM3 without prior TMCS. However, they had a more complicated postoperative course.
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  • 文章类型: Journal Article
    目的:心脏手术,心源性休克(PCCS),和临时机械循环支持(tMCS)引起实质性炎症。因此,我们调查了基于硒的,在CSX持续试验的事后分析中,抗炎策略将使接受tMCS治疗的PCCS患者受益.
    方法:在SustainCSX试验中对接受tMCS治疗PCCS的患者进行事后分析,研究了大剂量硒对心脏手术患者术后器官功能障碍的影响。
    方法:tMCS治疗的持续时间。
    结果:术后器官功能障碍和30天死亡率。
    结果:39例患者接受tMCS治疗PCCS。硒和安慰剂组之间tMCS的中位持续时间没有差异(3天[IQR:1-6]与2天[IQR:1-7],p=0.52)。硒组的透析持续时间中位数更长(1.5天[0-21.8]vs.0天[0-1.8],p=0.048)。30天死亡率没有差异(53%与41%,OR1.44,95%CI0.32-6.47,p=0.62)。
    结论:在这项探索性研究中,在接受tMCS的PCCS患者中,围手术期大剂量补硒未显示出对器官功能障碍和死亡率的有益影响.
    OBJECTIVE: Cardiac surgery, post-cardiotomy cardiogenic shock (PCCS), and temporary mechanical circulatory support (tMCS) provoke substantial inflammation. We therefore investigated whether a selenium-based, anti-inflammatory strategy would benefit PCCS patients treated with tMCS in a post-hoc analysis of the sustain CSX trial.
    METHODS: Post-hoc analysis of patients receiving tMCS for PCCS in the Sustain CSX trial, which investigated the effects of high-dose selenium on postoperative organ dysfunction in cardiac surgery patients.
    METHODS: duration of tMCS therapy.
    RESULTS: postoperative organ dysfunction and 30-day mortality.
    RESULTS: Thirty-nine patients were treated with tMCS for PCCS. There was no difference in the median duration of tMCS between the selenium and the placebo group (3 days [IQR: 1-6] vs. 2 days [IQR: 1-7], p = 0.52). Median dialysis duration was longer in the selenium group (1.5 days [0-21.8] vs. 0 days [0-1.8], p = 0.048). There was no difference in 30-day mortality (53% vs. 41%, OR 1.44, 95% CI 0.32-6.47, p = 0.62).
    CONCLUSIONS: In this explorative study, a perioperative high-dose selenium-supplementation did not show beneficial effects on organ dysfunctions and mortality rates in patients with PCCS receiving tMCS.
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  • 文章类型: English Abstract
    Red blood cells are destroyed when the shear stress in the blood pump exceeds a threshold, which in turn triggers hemolysis in the patient. The impeller design of centrifugal blood pumps significantly influences the hydraulic characteristics and hemolytic properties of these devices. Based on this premise, the present study employs a multiphase flow approach to numerically simulate centrifugal blood pumps, investigating the performance of pumps with varying numbers of blades and blade deflection angles. This analysis encompassed the examination of flow field characteristics, hydraulic performance, and hemolytic potential. Numerical results indicated that the concentration of red blood cells and elevated shear stresses primarily occurred at the impeller and volute tongue, which drastically increased the risk of hemolysis in these areas. It was found that increasing the number of blades within a certain range enhanced the hydraulic performance of the pump but also raised the potential for hemolysis. Moreover, augmenting the blade deflection angle could improve the hemolytic performance, particularly in pumps with a higher number of blades. The findings from this study can provide valuable insights for the structural improvement and performance enhancement of centrifugal blood pumps.
    血泵中剪切应力超过阈值时红细胞会被破坏,进而引发患者出现溶血。离心式血泵叶轮结构设计对血泵的水力特性及溶血特性有着显著影响。基于此,本文采用多相流方法对离心式血泵进行数值模拟,探究了具有不同叶片数量及偏转角叶轮形式血泵的性能,分析了血泵的流场特性、水力性能以及溶血性能。数值模拟结果表明:血泵主要在叶轮及隔舌处出现了红细胞集聚现象及较大的切应力,导致此处溶血急剧增加;在一定范围内增加叶片数会提升血泵水力性能,同时也会增加溶血风险;增加叶片偏转角有助于提升血泵溶血性能,在叶片数较多时更为明显。本文研究结果可为离心式血泵的结构改进及性能改善提供参考。.
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  • 文章类型: Journal Article
    背景:心源性休克(CS)患者的治疗包括几种健康技术,包括Impella泵和静脉动脉体外膜氧合(VA-ECMO)。然而,虽然它们在临床实践中被广泛使用,与这些设备相关的资源使用和生活质量(QoL)信息很少。本研究的目的是,因此,收集并比较评估Impella与VA-ECMO治疗严重CS患者的临床和社会经济数据,最终进行成本效益(CEA)和预算影响(BIA)分析。
    方法:这是一个前瞻性加回顾性研究,在SDABocconi管理学院健康与社会护理管理研究中心的科学协调下进行的多中心研究以及米兰CarattereScientific(IRCCS)SanRaffaeleScientificInstitute的临床协调。Impella网络是为了本研究的目的而建立的,包括从意大利北部到南部地区的17个意大利临床中心。意大利网络有资格成为国际Impella心脏外科手术注册的一个小组。使用Impella泵治疗的CS患者(CP,5.0或5.5)将被前瞻性招募,以及有关临床结果的信息,资源使用和QoL收集。经济数据将与接受VA-ECMO治疗的可比患者的数据进行回顾性匹配。CEA和BIA都将在意大利采用社会观点进行。这项研究将有助于产生新的社会经济证据,为未来的覆盖决策提供信息。
    背景:截至2024年5月,大多数临床中心向其伦理委员会提交了文件(N=13;76%),六个中心获得了伦理批准,两个中心开始登记患者。研究结果将在同行评审的出版物中发表,并通过会议演示文稿进行传播。
    BACKGROUND: The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses.
    METHODS: This is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions.
    BACKGROUND: As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.
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  • 文章类型: Journal Article
    上半胸骨切开术是微创左心室辅助装置植入中流出移植物与升主动脉吻合的常用方法。也可以使用右胸小切开术,但是机器人辅助的使用只有轶事的报道。我们研究的目的是确认机器人辅助缝合流出移植物吻合术的可行性,并评估机器人缝合部分的性能指标。该程序由两名外科医生在八具尸体研究中进行。辅助装置泵头通过左侧小切口插入,流出移植物通过心包流向右侧第二间隙小切口。在升主动脉上放置部分闭塞钳后,进行了纵向主动脉切开术,并通过机器人进行了流出移植到升主动脉的吻合。该程序在所有八次尝试中都是可行的。平均流出移植物吻合时间为20.1(SD6.8)分钟,平均外科医生完成吻合的信心和舒适度分别为8.3(SD2.4)和6.9(SD2.2),分别,十级李克特量表。在对吻合口进行开放式检查时,在所有情况下都有良好的缝线对齐。我们得出的结论是,在良好的外科医生舒适度下,将左心室辅助装置流出移植物缝合到人升主动脉是非常可行的。吻合时间是可接受的,并且可以在适当对齐的情况下进行缝线放置。
    Upper hemi-sternotomy is a common approach for outflow graft anastomosis to the ascending aorta in minimally invasive left-ventricular assist device implantation. Right mini-thoracotomy may also be used, but use of robotic assistance has been reported only anecdotally. The aim of our study was to confirm the feasibility of robotically assisted suturing of the outflow graft anastomosis and to assess performance metrics for the robotic suturing part of the procedure. The procedure was carried out in eight cadaver studies by two surgeons. The assist device pump head was inserted through a left-sided mini-thoracotomy and the outflow graft was passed toward a right-sided second interspace mini-thoracotomy through the pericardium. After placement of a partial occlusion clamp on the ascending aorta, a longitudinal aortotomy was performed and the outflow graft to ascending aorta anastomosis was carried out robotically. The procedure was feasible in all eight attempts. The mean outflow graft anastomotic time was 20.1 (SD 6.8) min and the mean surgeon confidence and comfort levels to complete the anastomoses were 8.3 (SD 2.4) and 6.9 (SD2.2), respectively, on a ten-grade Likert scale. On open inspection of the anastomoses, there was good suture alignment in all cases. We conclude that suturing of a left-ventricular assist device outflow graft to the human ascending aorta is very feasible with good surgeon comfort. Anastomotic times are acceptable and suture placement can be performed with appropriate alignment.
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  • 文章类型: Journal Article
    晚期心力衰竭患者的照顾者可能会在提供护理方面承受负担,但患者健康状况的变化是否与护理人员负担相关尚不清楚.
    这项观察性研究包括在美国13个地点接受高级外科心力衰竭治疗的老年患者(60-80岁)及其护理人员。使用12项堪萨斯城心肌病问卷(范围,0-100;分数越高越好)。使用Oberst照顾负担量表评估照顾者负担,它衡量任务时间(OCBS-time)和任务难度(OCBS-difficult;范围,1-5;分数越低越好)。在3个晚期心力衰竭队列中,在手术前和12个月后进行了测量:接受长期左心室辅助装置支持的患者;具有移植前左心室辅助装置支持的心脏移植;以及没有移植前左心室辅助装置支持的心脏移植。使用多变量线性回归来确定12个月时OCBS时间和OCBS难度变化的预测因子。
    在162名护理人员中,平均年龄为61.0±9.4岁,139(86%)为女性,140人(86%)是患者的配偶。12个月时,99名(61.1%)护理人员的OCBS时间有所改善,61人(37.7%)经历了改善的OCBS难度(与没有变化或更差的OCBS相比)。基线12项堪萨斯城心肌病问卷较高10点预测12个月OCBS时间较低(β=-0.09[95%CI,-0.14至-0.03];P<0.001)和OCBS难度较低(β=-0.08[95%CI,-0.12至-0.05];P<0.001)。在12项堪萨斯城心肌病问卷中,每10点改善预测12个月OCBS时间(β=-0.07[95%CI,-0.12至-0.03];P=0.002)和OCBS难度(β=-0.09[95%CI,-0.12至-0.06];P<0.001)。
    在12个月的幸存者中,基线和患者健康状况的变化与随后的照顾者的任务时间和任务难度相关,在接受晚期心力衰竭手术治疗的二重组中,强调了连续12项堪萨斯城心肌病问卷评估的潜力,以确定有负担增加风险的护理人员。
    URL:https://www。clinicaltrials.gov;唯一标识符:NCT02568930。
    UNASSIGNED: Caregivers of patients with advanced heart failure may experience burden in providing care, but whether changes in patient health status are associated with caregiver burden is unknown.
    UNASSIGNED: This observational study included older patients (60-80 years old) receiving advanced surgical heart failure therapies and their caregivers at 13 US sites. Patient health status was assessed using the 12-item Kansas City Cardiomyopathy Questionnaire (range, 0-100; higher scores are better). Caregiver burden was assessed using the Oberst Caregiving Burden Scale, which measures time on task (OCBS-time) and task difficulty (OCBS-difficulty; range, 1-5; lower scores are better). Measurements occurred before surgery and 12 months after in 3 advanced heart failure cohorts: patients receiving long-term left ventricular assist device support; heart transplantation with pretransplant left ventricular assist device support; and heart transplantation without pretransplant left ventricular assist device support. Multivariable linear regression was used to identify predictors of change in OCBS-time and OCBS-difficulty at 12 months.
    UNASSIGNED: Of 162 caregivers, the mean age was 61.0±9.4 years, 139 (86%) were female, and 140 (86%) were the patient\'s spouse. At 12 months, 99 (61.1%) caregivers experienced improved OCBS-time, and 61 (37.7%) experienced improved OCBS-difficulty (versus no change or worse OCBS). A 10-point higher baseline 12-item Kansas City Cardiomyopathy Questionnaire predicted lower 12-month OCBS-time (β=-0.09 [95% CI, -0.14 to -0.03]; P<0.001) and OCBS-difficulty (β=-0.08 [95% CI, -0.12 to -0.05]; P<0.001). Each 10-point improvement in the 12-item Kansas City Cardiomyopathy Questionnaire predicted lower 12-month OCBS-time (β=-0.07 [95% CI, -0.12 to -0.03]; P=0.002) and OCBS-difficulty (β=-0.09 [95% CI, -0.12 to -0.06]; P<0.001).
    UNASSIGNED: Among survivors at 12 months, baseline and change in patient health status were associated with subsequent caregiver time on task and task difficulty in dyads receiving advanced heart failure surgical therapies, highlighting the potential for serial 12-item Kansas City Cardiomyopathy Questionnaire assessments to identify caregivers at risk of increased burden.
    UNASSIGNED: URL: https://www.clinicaltrials.gov; unique identifier: NCT02568930.
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