Division of Cardiology, Columbia University Medical Center, New York, New York.
Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, Texas.
J Heart Lung Transplant. 2024 Sep;43(9):1478-1488. doi: 10.1016/j.healun.2024.05.015. Epub 2024 Jun 2.
The Impella 5.0 and 5.5 pumps (Abiomed, Danvers, MA) are large-bore transvalvular micro-axial assist devices used in cardiogenic shock (CS) for patients requiring high-capacity flow. Despite their increasing use, real-world data regarding indications, rates of utilization and clinical outcomes with this therapy are limited. The objective of our study was to examine clinical profiles and outcomes of patients in a contemporary, real-world CS registry of patients who received an Impella 5.0/5.5 alone or in combination with other temporary mechanical circulatory support (tMCS) devices.
The CS Working Group (CSWG) Registry includes patients from 34 US hospitals. For this analysis, data from patients who received an Impella 5.0/5.5 between 2020-2023 were analyzed. Use of Impella 5.0/5.5 with or without additional tMCS therapies, duration of support, adverse events and outcomes at hospital discharge were studied. Adverse events including stroke, limb ischemia, bleeding and hemolysis were not standardized by the registry but reported per individual CSWG Primary Investigator discretion. For those who survived, rates of native heart recovery (NHR) or heart replacement therapy (HRT) including heart transplant (HT), or durable ventricular assist device (VAD) were recorded. We also assessed outcomes based on shock etiology (acute myocardial infarction or MI-CS vs. heart failure-related CS or HF-CS).
Among 6,205 patients, 754 received an Impella 5.0/5.5 (12.1%), including 210 MI-CS (27.8%) and 484 HF-CS (64.1%) patients. Impella 5.0/5.5 was used as the sole tMCS device in 32% of patients, while 68% of patients received a combination of tMCS devices. Impella cannulation sites were available for 524/754 (69.4%) of patients, with 93.5% axillary configuration. Survival to hospital discharge for those supported with an Impella 5.0/5.5 was 67%, with 20.4% NHR and 45.5% HRT. Compared to HF-CS, patients with MI-CS supported on Impella 5.0/5.5 had higher in-hospital mortality (45.2% vs 26.2%, p < 0.001) and were less likely to receive HRT (22.4% vs 56.6%, p < 0.001. For patients receiving a combination of tMCS during hospitalization, this was associated with higher rates of limb ischemia (9% vs. 3%, p < 0.01), bleeding (52% vs 33%, p < 0.01), and mortality (38% vs 25%; p < 0.001) compared to Impella 5.0/5.5 alone. Among Impella 5.0/5.5 recipients, the median duration of pump support was 12.9 days (IQR: 6.8-22.9) and longer in patients bridged to HRT (14 days; IQR: 7.7-28.4).
In this multi-center cohort of patients with CS, use of Impella 5.0/5.5 was associated with an overall survival of 67.1% and high rates of HRT. Lower adverse event rates were observed when Impella 5.0/5.5 was the sole support device used. Further study is required to determine whether a strategy of early Impella 5.0/5.5 use for CS improves survival.
High capacity Impella heart pumps are capable of provide up to 5.5 liter/min of flow while upper body surgical placement allows for ambulation. Patients with advanced cardiogenic shock from acute myocardial infarction or heart failure requiring temporary mechanical circulatory support may benefit from upfront use of Impella 5.5 to improve overall survival, including native heart recovery or successful bridge to durable left ventricular assist device surgery or heart transplantation.
Impella 5.0 和 5.5 泵（Abiomed，马萨诸塞州丹弗斯）是用于心源性休克（CS）的大口径跨瓣微轴辅助装置，适用于需要高容量流量的患者。尽管它们的使用越来越多，但关于该治疗方法的适应症、使用率和临床结果的真实世界数据有限。我们的研究目的是检查接受 Impella 5.0/5.5 单独或与其他临时机械循环支持（tMCS）装置联合使用的 CS 注册患者的临床特征和结局。
CS 工作组（CSWG）注册中心包括来自 34 家美国医院的患者。在这项分析中，分析了 2020-2023 年期间接受 Impella 5.0/5.5 的患者的数据。研究了 Impella 5.0/5.5 的使用情况，包括与其他 tMCS 治疗方法联合使用或不联合使用、支持时间、出院时的不良事件和结局。不良事件包括卒中、肢体缺血、出血和溶血，但该注册中心没有标准化，而是根据每个 CSWG 主要研究者的判断报告。对于那些存活的患者，记录了原生心脏恢复（NHR）或心脏替代治疗（HRT）的比率，包括心脏移植（HT）或耐用心室辅助装置（VAD）。我们还根据休克病因（急性心肌梗死或 MI-CS 与心力衰竭相关的 CS 或 HF-CS）评估了结果。
在 6205 名患者中，有 754 名患者接受了 Impella 5.0/5.5（12.1%），其中 210 名 MI-CS（27.8%）和 484 名 HF-CS（64.1%）患者。Impella 5.0/5.5 作为唯一的 tMCS 装置在 32%的患者中使用，而 68%的患者接受了多种 tMCS 装置的联合治疗。Impella 插管部位可用于 524/754（69.4%）的患者，其中 93.5%为腋部配置。接受 Impella 5.0/5.5 支持的患者出院生存率为 67%，20.4%的患者实现了原生心脏恢复，45.5%的患者进行了心脏替代治疗。与 HF-CS 相比，接受 Impella 5.0/5.5 支持的 MI-CS 患者的院内死亡率更高（45.2% vs. 26.2%，p<0.001），接受心脏替代治疗的可能性更低（22.4% vs. 56.6%，p<0.001）。对于住院期间接受多种 tMCS 联合治疗的患者，与单独使用 Impella 5.0/5.5 相比，肢体缺血（9% vs. 3%，p<0.01）、出血（52% vs. 33%，p<0.01）和死亡率（38% vs. 25%，p<0.001）的发生率更高。在接受 Impella 5.0/5.5 的患者中，泵支持的中位时间为 12.9 天（IQR：6.8-22.9），桥接至心脏替代治疗的患者中位时间为 14 天（IQR：7.7-28.4）。
在这项多中心 CS 患者队列研究中，使用 Impella 5.0/5.5 的总生存率为 67.1%，心脏替代治疗的比率较高。当 Impella 5.0/5.5 是唯一的支持装置时，不良事件发生率较低。需要进一步研究以确定早期使用 Impella 5.0/5.5 治疗 CS 是否能提高生存率。
