Temporary mechanical circulatory support (tMCS) using extracorporeal life support (ECLS), has been widely implemented in patients with cardiogenic shock (CS), although evidence regarding its efficacy and safety remains unclear. This lack of clarity has recently raised concerns about the role of tMCS in CS management. Conducting randomized controlled trials (RCTs) in the context of CS poses significant challenges due to ethical considerations and logistical complexities. In response to these challenges, emulated trials (ETs) are emerging as a promising alternative. By incorporating design features from idealized RCTs, they use robust and rigorous methods to assess the efficacy and safety of health interventions in real-life settings, using observational data. In our manuscript, we highlight the complementary nature of RCT and ETs by evaluating tMCS for CS patients. While RCTs follow a rigorous experimental design and provide reliable evidence, ETs can swiftly estimate the risk-benefit ratio without encountering logistical barriers thereby offering clinicians' early reassurance about the potential benefits of routinely used interventions. Furthermore, ETs offer potential value in unethical situations (refractory cardiac arrest or « crash and burn » CS) where interventional therapies, such as tMCS, are used as a last resort.

中文翻译：

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模拟试验能否在心源性休克试验中发挥关键作用？


使用体外生命支持 （ECLS） 的临时机械循环支持 （tMCS） 已在心源性休克 （CS） 患者中广泛实施，但有关其疗效和安全性的证据尚不清楚。这种缺乏明确性最近引发了人们对 tMCS 在 CS 管理中的作用的担忧。由于伦理考虑和后勤复杂性，在 CS 背景下进行随机对照试验 （RCT） 带来了重大挑战。为了应对这些挑战，模拟试验 （ETs） 正在成为一种有前途的替代方案。通过结合理想化 RCT 的设计特征，他们使用稳健而严格的方法，使用观察数据来评估现实生活中健康干预措施的有效性和安全性。在我们的手稿中，我们通过评估 CS 患者的 tMCS 来强调 RCT 和 ETs 的互补性。虽然 RCT 遵循严格的实验设计并提供可靠的证据，但 ETs 可以在不遇到后勤障碍的情况下快速估计风险收益比，从而为临床医生提供对常规使用干预措施的潜在益处的早期保证。此外，ETs 在不道德的情况下（难治性心脏骤停或 “碰撞和烧伤 » CS”）具有潜在价值，在这些情况下，干预疗法（如 tMCS）被用作最后的手段。