Microaxial Flow Pump Hemodynamic and Metabolic Effects in Infarct-Related Cardiogenic Shock: A Substudy of the DanGer Shock Randomized Clinical Trial.

Understanding the impact on hemodynamic stability over time is crucial for optimizing patient treatment.

了解随时间对血流动力学稳定性的影响对于优化患者治疗至关重要。

Background

To determine if an MAFP reduces the need for pharmacological circulatory support without compromising hemodynamics compared with standard care in STEMI-CS.

确定MAFP是否能在不损害血流动力学的情况下减少STEMI-CS患者对药物循环支持的需求，与标准治疗相比。

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.

设计、环境和参与者：这是丹麦-德国（DanGer）休克试验的子研究，这是一个国际性的、多中心的、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。

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.

试验的纳入标准为ST段抬高型心肌梗死(STEMI)、收缩压小于100毫米汞柱或正在接受血管加压治疗、左心室射血分数小于45%以及动脉乳酸水平大于2.5毫摩尔/升。

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.

在纳入的患者中，经过排除在导管室死亡或在重症监护室(ICU)立即入院后，剩余患者进行了血流动力学、动脉乳酸和血管活性药物使用的连续记录。

Patients who were in comas after cardiac arrest and patients with mechanical complications or right ventricular failure were excluded.

在心脏骤停后，处于昏迷状态的患者以及那些有机械并发症或右心室衰竭的患者被排除在外。

Data were analyzed from May to September 2024.

数据的分析是从2024年5月到9月进行的。

Methods

MAFP and standard of care or standard of care alone.

MAFP和标准治疗或仅标准治疗。

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).

心率和血压的心血管状态，动脉乳酸浓度的代谢状态，以及血管活性-正性肌力评分（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.

在最初的72小时内，临床事件如下：所有原因导致的死亡，机械循环支持的升级，以及从ICU活生生地出院。

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).

在355名入组患者中，有324名（平均年龄[四分位数间距]为68[58-75]岁；259名男性[80%]）接受了ICU治疗（169名[52%]在MAFP组，155名[48%]在标准护理组）。

Baseline characteristics were balanced.

基线特征是均衡的。

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.

两组之间的心率没有差异，平均动脉压在两组中都高于治疗目标的65毫米汞柱，但在MAFP组中，使用较低的VIS（血管活性药物评分）就达到了这一目标。

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.

在随机分组时，两组之间的动脉乳酸水平没有差异，但在到达ICU时，MAFP组的动脉乳酸水平显著低于标准护理组（平均差异，1.3 mmol/L；95%置信区间，0.7-1.9 mmol/L），这一差异在观察的前24小时内持续存在。

The MAFP group achieved lactate normalization (<2 mmol/L) 12 hours (95% CI, 5-18 hours) before the standard-care group.

MAFP组在标准护理组之前12小时（95%置信区间，5-18小时）实现了乳酸正常化（<2 mmol/L）。

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.

在STEMI-CS患者中使用MAFP可以减少血管加压药和正性肌力药物的使用，同时保持血流动力学稳定，并实现更快的乳酸水平正常化。

trial_registration

ClinicalTrials.gov Identifier: NCT01633502.

ClinicalTrials.gov注册号：NCT01633502。