Large randomized trials assessing the efficacy of extracorporeal life support (ECLS) in patients with acute myocardial infarction (AMI) with cardiogenic shock in preventing all-cause mortality and neurologic outcomes are needed, according to a study published in Clinical Research in Cardiology.
In the Clinical Study of Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction trial (ClinicalTrials.gov Identifier: NCT02544594), 42 patients with cardiogenic shock complicating AMI were randomly assigned to receive ECLS (n=21; median age, 62 years; interquartile range [IQR], 50-68 years) or no ECLS (control group; n=21; median age, 70 years; IQR, 60-74 years). The study’s primary end point was left ventricular ejection fraction (LVEF) after 30 days, and secondary end points included mortality and neurologic outcomes assessed with the modified Rankin Scale after 12 months.
The 12-month all-cause mortality was 19% among patients receiving ECLS and 38% in the control group (P =.31). After the first 30 days, 1 patient in the control group died. During the follow-up, 3 patients had elective percutaneous coronary intervention (1 in the control group; 2 in the ECLS group). A favorable neurologic outcome (ie, modified Rankin Scale score ≤2) was observed in 61.9% of patients in the ECLS group and 57.1% in the control group (P =1).
Severe neurologic impairment (ie, modified Rankin Scale score, 3-5) was numerically more frequent in the ECLS vs control group (19.0% vs 4.8%, respectively).
“Our finding of an increased rate of severe neurologic disability among survivors requires particular attention,” the study authors commented. “One possible explanation could be a direct and harmful neurologic side effect of ECLS therapy.”
Study limitations include the lack of blinding, and the fact that the 2 groups had significant differences in baseline characteristics (age and incidence of multivessel disease), which may have had an impact on mortality.
“This pilot study showed that randomized studies with ECLS in [patients with] cardiogenic shock are feasible and safe,” the study authors commented. “Small numbers of included patients impede meaningful conclusions about mortality and neurologic outcome.”
Disclosures: LivaNova (Munich, Germany) supported the study.
Lackermair K, Brunner S, Orban M, et al. Outcome of patients treated with extracorporeal life support in cardiogenic shock complicating acute myocardial infarction: 1-year result from the ECLS-Shock study [published online November 12, 2020]. Clin Res Cardiol. doi: 10.1007/s00392-020-01778-8