Importance Mechanical circulatory support with a microaxial flow pump (MAFP) has been shown to improve survival in ST-elevation myocardial infarction-induced cardiogenic shock (STEMI-CS). Understanding the impact on hemodynamic stability over time is crucial for optimizing patient treatment. Objective To determine if an MAFP reduces the need for pharmacological circulatory support without compromising hemodynamics compared with standard care in STEMI-CS. Design, Setting, and Participants This was a substudy of the Danish-German (DanGer) Shock trial, an international, multicenter, open-label randomized clinical trial. Patients from 14 heart centers across Denmark, Germany, and the UK were enrolled. Inclusion criteria for the trial were STEMI and systolic blood pressure less than 100 mm Hg or ongoing vasopressor treatment, left ventricular ejection fraction less than 45%, and arterial lactate level greater than 2.5 mmol/L. Of the enrolled patients, after exclusions from death in the catheterization laboratory or immediately on intensive care unit (ICU) admission, the remaining patients had serial recordings of hemodynamics, arterial lactate, and use of vasoactive drugs. Patients who were in comas after cardiac arrest and patients with mechanical complications or right ventricular failure were excluded. Data were analyzed from May to September 2024. Interventions MAFP and standard of care or standard of care alone. Main Outcomes and Measures Hemodynamic status in terms of heart rate and blood pressure, metabolic status in terms of arterial lactate concentration, and vasoactive-inotropic score (VIS). The clinical events during the first 72 hours were as follows: death from all causes, escalation of mechanical circulatory support, and discharge alive from the ICU. Results From 355 enrolled patients, 324 (mean [IQR] age, 68 [58-75] years; 259 male [80%]) underwent ICU treatment (169 [52%] in the MAFP group, 155 [48%] in the standard-care group). Baseline characteristics were balanced. There was no difference in heart rate between groups, and mean arterial pressure was above the treatment target of 65 mm Hg in both groups but was achieved with a lower VIS in the MAFP group. No difference in arterial lactate level was found between groups at randomization, but on arrival to the ICU, the MAFP group had significantly lower arterial lactate levels compared with the standard-care group (mean difference, 1.3 mmol/L; 95% CI, 0.7-1.9 mmol/L), a difference that persisted throughout the first 24 hours of observation. The MAFP group achieved lactate normalization (<2 mmol/L) 12 hours (95% CI, 5-18 hours) before the standard-care group. Conclusions and Relevance Use of a MAFP reduces the use of vasopressors and inotropic medication while maintaining hemodynamic stability and achieving faster normalization of lactate level in patients with STEMI-CS. Trial Registration ClinicalTrials.gov Identifier: NCT01633502.

中文翻译：

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微轴流泵血流动力学和代谢对梗死相关心源性休克的影响：DanGer 休克随机临床试验的子研究。


重要性 使用微轴流泵 （MAFP） 的机械循环支持已被证明可以提高 ST 段抬高型心肌梗死诱导的心源性休克 （STEMI-CS） 的生存率。了解随时间推移对血流动力学稳定性的影响对于优化患者治疗至关重要。目的 确定与 STEMI-CS 的标准护理相比，MAFP 是否在不影响血流动力学的情况下减少了对药物循环支持的需求。设计、设置和参与者 这是丹麦-德国 （DanGer） 休克试验的子研究，这是一项国际性、多中心、开放标签的随机临床试验。来自丹麦、德国和英国的 14 个心脏中心的患者被纳入。该试验的纳入标准是 STEMI 和收缩压低于 100 mm Hg 或正在进行的血管加压药治疗，左心室射血分数低于 45%，动脉乳酸水平高于 2.5 mmol/L。在入组患者中，在导管室或立即入住重症监护病房 （ICU） 时被排除死亡后，其余患者有血流动力学、动脉乳酸和血管活性药物使用的连续记录。排除心脏骤停后昏迷的患者和机械并发症或右心室衰竭患者。数据分析时间为 2024 年 5 月至 9 月。干预措施 MAFP 和护理标准或单独的护理标准。主要结果和测量 心率和血压方面的血流动力学状态，动脉乳酸浓度方面的代谢状态，以及血管活性物质-正性肌力评分 （VIS）。最初 72 小时内的临床事件如下：全因死亡、机械循环支持升级和 ICU 活着出院。 结果 在 355 例入组患者中，324 例 （平均 [IQR] 年龄，68 [58-75] 岁;259 例男性 [80%]）接受了 ICU 治疗 （MAFP 组 169 例 [52%]，标准护理组 155 例 [48%]）。基线特征是平衡的。两组心率无差异，两组平均动脉压均高于 65 mm Hg 的治疗目标，但 MAFP 组在较低的 VIS 下达到。随机分组时，两组之间的动脉乳酸水平没有差异，但在到达 ICU 时，MAFP 组的动脉乳酸水平与标准护理组相比显著降低 （平均差，1.3 mmol/L;95% CI，0.7-1.9 mmol/L），这种差异在观察的最初 24 小时内持续存在。MAFP 组在标准护理组前 12 小时 （95% CI，5-18 小时） 达到乳酸正常 （<2 mmol/L）。结论和相关性 MAFP 的使用减少了血管加压药和正性肌力药物的使用，同时保持了血流动力学稳定并加快了 STEMI-CS 患者的乳酸水平正常化。试验注册 ClinicalTrials.gov 标识符： NCT01633502.