Udesen Nanna Louise Junker, Beske Rasmus Paulin, Hassager Christian, Jensen Lisette Okkels, Eiskjær Hans, Mangner Norman, Polzin Amin, Schulze P Christian, Skurk Carsten, Nordbeck Peter, Clemmensen Peter, Panoulas Vasileios, Zimmer Sebastian, Schäfer Andreas, Werner Nikos, Frydland Martin, Holmvang Lene, Kjærgaard Jesper, Engstøm Thomas, Schmidt Henrik, Junker Anders, Terkelsen Christian Juhl, Christensen Steffen, Linke Axel, Møller Jacob Eifer
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Department of Cardiology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
JAMA Cardiol. 2025 Jan 1;10(1):9-16. doi: 10.1001/jamacardio.2024.4197.
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.
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.
MAFP and standard of care or standard of care alone.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT01633502.
已证明使用微轴流泵（MAFP）进行机械循环支持可提高ST段抬高型心肌梗死所致心源性休克（STEMI-CS）患者的生存率。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。
确定与STEMI-CS的标准治疗相比，MAFP在不影响血流动力学的情况下是否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）休克试验的一项子研究，该试验是一项国际多中心、开放标签的随机临床试验。招募了来自丹麦、德国和英国14个心脏中心的患者。该试验的纳入标准为STEMI且收缩压低于100 mmHg或正在进行血管升压药治疗、左心室射血分数低于45%以及动脉血乳酸水平高于2.5 mmol/L。在纳入的患者中，排除在导管室死亡或入住重症监护病房（ICU）后立即死亡的患者后，其余患者进行了血流动力学、动脉血乳酸和血管活性药物使用情况的系列记录。心脏骤停后昏迷的患者以及有机械并发症或右心室衰竭的患者被排除。数据于2024年5月至9月进行分析。
MAFP与标准治疗或仅标准治疗。
心率和血压方面的血流动力学状态、动脉血乳酸浓度方面的代谢状态以及血管活性-正性肌力评分（VIS）。最初72小时内的临床事件包括：各种原因导致的死亡、机械循环支持的升级以及从ICU存活出院。
355名纳入患者中，324名（平均[四分位间距]年龄，68[58 - 75]岁；259名男性[80%]）接受了ICU治疗（MAFP组169名[52%]，标准治疗组155名[48%]）。基线特征均衡。两组心率无差异，两组平均动脉压均高于65 mmHg的治疗目标，但MAFP组通过较低的VIS达到该目标。随机分组时两组动脉血乳酸水平无差异，但到达ICU时，MAFP组动脉血乳酸水平显著低于标准治疗组（平均差值，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。MAFP组比标准治疗组提前12小时（95%置信区间，5 - 18小时）实现乳酸正常化（<2 mmol/L）。
使用MAFP可减少血管升压药和正性肌力药物的使用，同时维持STEMI-CS患者的血流动力学稳定性并更快实现乳酸水平正常化。
ClinicalTrials.gov标识符：NCT01633502。
