European Registry for Patients with Mechanical Circulatory Support

  • 文章类型: Journal Article
    目的:本研究旨在探讨欧洲机械循环支持患者注册中心(EUROMACS)中先天性心脏病(CHD)患者的特征和临床结局。
    方法:这是一项对接受MCS作为移植桥梁的EUROMACS参与者的回顾性研究,可能的桥梁移植,或2011年至2023年的抢救治疗/康复桥梁(n=5,340)。分别对成人和儿科队列进行分析。主要结果是MCS的死亡率;次要结果包括恢复,移植和并发症,包括出血,脑血管事件,还有败血症.
    结果:在成年患者中,CHD队列1年死亡率为33.3%,非CHD队列为22.1%.与非冠心病患者相比,成人冠心病患者在MCS植入后第一年内的死亡率(HR1.9895%CI1.35-2.91,p<0.001)和出血事件(sdHR2.10,95%CI1.40-3.16,p<0.001)的风险更高。在考虑了多个调解员之后,这两个协会仍然很重要。在儿科患者中,冠心病队列1年死亡率为22.1%,非冠心病队列为17.3%(HR1.3995%CI0.83~2.32,p=0.213).
    结论:与非CHDMCS患者相比,服用MCS的成人和儿科CHD患者具有更高的不良事件风险,尽管儿童没有更大的死亡风险。随着需要高级心力衰竭管理的CHD患者数量的持续增长,这些发现可以增强明智的决策。
    OBJECTIVE: This study aims to explore characteristics and clinical outcomes of patients with congenital heart disease (CHD) in the European Registry for Patients with Mechanical Circulatory Support (EUROMACS).
    METHODS: This is a retrospective study of EUROMACS participants receiving MCS as bridge-to-transplant, possible bridge-to-transplant, or rescue therapy/bridge-to-recovery from 2011 to 2023 (n = 5340). Adult and paediatric cohorts were analysed separately. The primary outcome was mortality on MCS; secondary outcomes included recovery, transplant and complications including bleeding, cerebrovascular events, and sepsis.
    RESULTS: Among adult patients, mortality at 1-year was 33.3% among the CHD cohort vs 22.1% in the non-CHD cohort. Adult CHD patients had higher hazards of mortality within the first year after MCS implantation [hazard ratios 1.98, 95% confidence interval (CI) 1.35-2.91, P < 0.001] and bleeding events (subdistribution hazard ratios 2.10, 95% CI 1.40-3.16, P < 0.001) compared with non-CHD patients. Both associations remained significant after accounting for multiple mediators. Among paediatric patients, mortality at 1 year was 22.1% in the CHD cohort vs 17.3% in the non-CHD cohort (hazard ratios 1.39, 95% CI 0.83-2.32, P = 0.213).
    CONCLUSIONS: Adult and paediatric patients with CHD on MCS have higher adverse event risk compared with non-CHD MCS patients, though children did not have greater risk of mortality. As the number of CHD patients requiring advanced heart failure management continues to grow, these findings can enhance informed decision-making.
    BACKGROUND: Registry name: EUROMACS.
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  • 文章类型: Journal Article
    背景:左心室辅助装置(LVAD)治疗是一种用于晚期心力衰竭且射血分数降低的既定治疗方法。我们评估了在荷兰植入LVAD的患者的特征和临床结果。
    方法:分析包括2016年至2020年在荷兰植入LVAD的患者。输入到此注册表中的基线特征,以及临床结果(设备死亡,心脏移植)和主要不良事件(装置功能障碍,大出血,主要感染和脑血管事件),进行了评估。
    结果:共有430例患者植入LVAD,平均年龄55±13岁,27%为女性。最初的设备策略是50%的桥接移植(BTT),29%的目的地治疗(DT),其余21%的桥梁决策(BTD)。经过17个月的随访,97(23%)例患者在主动LVAD支持期间死亡。1年生存率为83%,2年为76%,5年为54%。与所有时间点的DT相比,植入LVAD作为BTT的患者具有更好的结果(1年86%vs72%,2年83%vs59%,5年58%vs33%)。经常观察到主要不良事件,最常见的是严重感染,大出血和脑血管事件(0.84、0.33和0.09/患者年风险,分别),并且在不同的设备策略中相似。使用HeartMate3支持的患者的主要不良事件发生率较低。
    结论:荷兰长期支持LVAD5年后的长期生存率超过50%。主要不良事件,尤其是感染和出血,仍然经常被观察到,但随着HeartMate3LVAD的当代使用而减少。
    BACKGROUND: Left ventricular assist device (LVAD) therapy is an established treatment for advanced heart failure with reduced ejection fraction. We evaluated the characteristics and clinical outcomes of patients implanted with an LVAD in the Netherlands.
    METHODS: Patients implanted with an LVAD in the Netherlands between 2016 and 2020 were included in the analysis. Baseline characteristics entered into this registry, as well as clinical outcomes (death on device, heart transplantation) and major adverse events (device dysfunction, major bleeding, major infection and cerebrovascular event), were evaluated.
    RESULTS: A total of 430 patients were implanted with an LVAD; mean age was 55 ± 13 years and 27% were female. The initial device strategy was bridge to transplant (BTT) in 50%, destination therapy (DT) in 29% and bridge to decision (BTD) in the remaining 21%. After a follow-up of 17 months, 97 (23%) patients had died during active LVAD support. Survival was 83% at 1 year, 76% at 2 years and 54% at 5 years. Patients implanted with an LVAD as a BTT had better outcomes compared with DT at all time points (1 year 86% vs 72%, 2 years 83% vs 59% and 5 years 58% vs 33%). Major adverse events were frequently observed, most often major infection, major bleeding and cerebrovascular events (0.84, 0.33 and 0.09 per patient-year at risk, respectively) and were similar across device strategies. Patients supported with HeartMate 3 had a lower incidence of major adverse events.
    CONCLUSIONS: Long-term survival on durable LVAD support in the Netherlands is over 50% after 5 years. Major adverse events, especially infection and bleeding, are still frequently observed, but decreasing with the contemporary use of HeartMate 3 LVAD.
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