微轴血流泵在心肌梗死所致心源性休克中的血流动力学和新陈代谢效应:DanGer 休克随机临床试验的一项子研究。

IF 14.8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS JAMA cardiology Pub Date : 2024-10-27 DOI:10.1001/jamacardio.2024.4197
Nanna Louise Junker Udesen, Rasmus Paulin Beske, Christian Hassager, Lisette Okkels Jensen, Hans Eiskjær, Norman Mangner, Amin Polzin, P Christian Schulze, Carsten Skurk, Peter Nordbeck, Peter Clemmensen, Vasileios Panoulas, Sebastian Zimmer, Andreas Schäfer, Nikos Werner, Martin Frydland, Lene Holmvang, Jesper Kjærgaard, Thomas Engstøm, Henrik Schmidt, Anders Junker, Christian Juhl Terkelsen, Steffen Christensen, Axel Linke, Jacob Eifer Møller
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引用次数: 0

摘要

重要性:使用微轴血流泵(MAFP)进行机械循环支持已被证明可提高ST段抬高心肌梗死诱发的心源性休克(STEMI-CS)患者的存活率。了解随着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 是否能在不影响血流动力学的情况下减少药物循环支持的需求:这是丹麦-德国(DanGer)休克试验的一项子研究,该试验是一项国际性、多中心、开放标签随机临床试验。来自丹麦、德国和英国 14 家心脏中心的患者参加了这项试验。试验的纳入标准为 STEMI 和收缩压低于 100 mm Hg 或正在接受血管加压治疗、左心室射血分数低于 45%、动脉乳酸水平高于 2.5 mmol/L。在登记的患者中,排除了在导管室死亡或在重症监护室(ICU)入院时立即死亡的患者,其余患者均连续记录了血液动力学、动脉乳酸和血管活性药物的使用情况。心脏骤停后处于昏迷状态的患者和患有机械并发症或右心室功能衰竭的患者被排除在外。数据分析时间为 2024 年 5 月至 9 月:主要结果和测量指标:以心率和血压表示的血流动力学状态、以动脉乳酸浓度表示的代谢状态以及血管活性-肌张力评分(VIS)。在最初 72 小时内发生的临床事件如下:各种原因导致的死亡、机械循环支持的升级以及从重症监护室出院:在355名登记患者中,324人(平均[IQR]年龄为68[58-75]岁;259人为男性[80%])接受了ICU治疗(MAFP组169人[52%],标准护理组155人[48%])。基线特征均衡。两组患者的心率无差异,平均动脉压均高于治疗目标值 65 mm Hg,但 MAFP 组患者的 VIS 值较低。随机分组时,两组的动脉乳酸水平没有差异,但在到达重症监护室时,MAFP 组的动脉乳酸水平明显低于标准护理组(平均差异为 1.3 mmol/L;95% CI,0.7-1.9 mmol/L),这种差异在最初 24 小时的观察中一直存在。MAFP组实现了乳酸正常化(结论和相关性:使用MAFP可减少血管加压药和肌力药物的使用,同时维持STEMI-CS患者的血流动力学稳定并更快地使乳酸水平恢复正常:试验注册:ClinicalTrials.gov Identifier:NCT01633502。
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Microaxial Flow Pump Hemodynamic and Metabolic Effects in Infarct-Related Cardiogenic Shock: A Substudy of the DanGer Shock Randomized Clinical Trial.

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.

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来源期刊
JAMA cardiology
JAMA cardiology Medicine-Cardiology and Cardiovascular Medicine
CiteScore
45.80
自引率
1.70%
发文量
264
期刊介绍: JAMA Cardiology, an international peer-reviewed journal, serves as the premier publication for clinical investigators, clinicians, and trainees in cardiovascular medicine worldwide. As a member of the JAMA Network, it aligns with a consortium of peer-reviewed general medical and specialty publications. Published online weekly, every Wednesday, and in 12 print/online issues annually, JAMA Cardiology attracts over 4.3 million annual article views and downloads. Research articles become freely accessible online 12 months post-publication without any author fees. Moreover, the online version is readily accessible to institutions in developing countries through the World Health Organization's HINARI program. Positioned at the intersection of clinical investigation, actionable clinical science, and clinical practice, JAMA Cardiology prioritizes traditional and evolving cardiovascular medicine, alongside evidence-based health policy. It places particular emphasis on health equity, especially when grounded in original science, as a top editorial priority.
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