{"title":"Could emulated trials play a key role in cardiogenic shock trials?","authors":"Aurore Ughetto, Nicolas Nagot, Clément Delmas","doi":"10.1016/j.healun.2024.10.025","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":15900,"journal":{"name":"Journal of Heart and Lung Transplantation","volume":" ","pages":""},"PeriodicalIF":6.4000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Heart and Lung Transplantation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.healun.2024.10.025","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍:
The Journal of Heart and Lung Transplantation, the official publication of the International Society for Heart and Lung Transplantation, brings readers essential scholarly and timely information in the field of cardio-pulmonary transplantation, mechanical and biological support of the failing heart, advanced lung disease (including pulmonary vascular disease) and cell replacement therapy. Importantly, the journal also serves as a medium of communication of pre-clinical sciences in all these rapidly expanding areas.