Background: Encouraging results in several series of patients on refractory cardiogenic shock (CS) led to the consideration of including temporary mechanical circulatory support (TMCS) in the guidelines for CS management. Benefit on survival might be improved when TMCS devices are initiated early. This study assessed early TMCS for CS in the real-world condition of a cardiac assistance regional network. Methods: We examined the clinical features and outcomes of patients treated with TMCS, using data from a prospective cohort of patients admitted for CS in a cardiac assistance regional network. Patients were eligible when CS included systolic blood pressure (SBP) <90 mmHg despite adequate filling pressure or need of catecholamine to maintain SPB>90 mmHg, signs of congestion or tissue hypo-perfusion or blood lactate >2mmol/L. TMCS indication, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or percutaneous left ventricle assistance (Impella) was based on the initial severity of CS or if shock was refractory to medical treatment. To estimate the effect of early TMCS on mortality, we emulated a target trial of TMCS implantation versus no TMCS within 24 hours of ICU admission. Patients were followed until hospital discharge, death, or 180 days. Inverse probability of treatment weighting with propensity score was used to adjust for confounders. Results: Among 372 patients, 246 were included in the study: 121 treated by early TMCS (TMCS group) and 125 not treated by early TMCS (controls). Median age was 59.5 years, 71.9% were male, and the main etiologies were acute myocardial infraction (MI) (46.8%) and decompensated heart failure (27.2%). Crude in-hospital mortality was 38% (46/121) in the TMCS group and 22.4% (28/125) in the control group. After emulation, in-hospital mortality was not different between the TMCS group and the control group (HR=0.91, 95%CI:0.65-1.26). In sub-group analyses, in-hospital mortality was not different among patients with MI (HR=0.82, 95%CI:0.52-1.32), with other etiology than MI (HR=1.19, 95%CI:0.70-2.04), and with VA-ECMO only (HR=0.87, 95%CI:0.62-1.22). TMCS patients had two-fold longer hospital stays, and a higher rate of complications than controls. Conclusion: In this emulated target trial from real-world data, patients with CS treated with early TMCS had no improvement in survival compared to controls. Trial registration number: NCT03528291, registered trials May 18, 2017
Background The field of temporary mechanical circulatory support (TMCS) has advanced in last decade justifying that TMCS is increasingly used for treatment of refractory cardiogenic shock (CS). Nevertheless, the efficacy of TMCS (extracorporeal life support (ECLS) and Impella) in CS remains controversial due to the lack of high-quality evidence. The aim of this prospective multicenter observational study simulating a randomized trial was to assess the impact of TMCS on the hospital mortality in patients with CS. Methods This study (ClinicalTrials.gov ID: NCT03528291) was conducted at 3 TMCS centers organized in a cardiac assistance network, one as a level 1 TMCS center (expert center), and 2 as level 2 centers (hub centers). The study was designed and led by the heart team of the expert center with input from the hub centers. All patients admitted to an intensive care unit between July 2017 and May 2020 either directly at the TMCS centers or after transfer from a non-specialized hospital, were screened for TMCS indication provided they were admitted for CS. CS was defined according to the European Society of Cardiology criteria. Were excluded patients younger than 18 years, CS after cardiac surgery, or after cardiac arrest if it was refractory or with a no flow >3 min and/or out-of-hospital cardiac arrest with non-shockable rhythm, or CS in the context of myocardial infarction complications, massive pulmonary embolism, and if TMCS was contraindicated TMCS indication was decided after a multidisciplinary discussion carried out by the “heart team”. Implantation of TMCS resulted from an agreement of the heart team within the first 24 hours after admission mainly based on the initial severity of the CS, or if CS was refractory to the medical treatment. The primary outcome was in-hospital survival. A propensity score-weighted analysis was done for treatment-effect estimation. This method, which weights each patient according to their propensity score, includes all participants in the analysis. Results 246 patients with CS were included in the study: 121 in TMCS group (72% ECLS, 14% Impella, 14% both ECLS and Impella) and 125 in control group. After adjustment by a propensity score, hospital mortality was comparable in the two groups (32% TMCS group vs 27% control group; Odds ratio with TMCS, 1.28; 95% confidence interval, 0.87 to 1.88; p=0.21). Mortality at D180 was also similar in the two group (33% vs 30% respectively; p=0.51). Thromboembolic events were significantly higher in the TCMS group (14% vs 4%; p<0.01) as well as the transfusion rate ((median (IQR); 4.0 (0.0; 9.0) vs 0.0 (0.0; 0.0); p<0.01). Conclusion In our study, the use of TMCS does not seem to improve hospital survival in patients with cardiogenic shock. Thus, TMCS, which are iatrogenic side effects providers, should be reserved for the most severe patient and discussed by a multidisciplinary team. FUNDunding Acknowledgement Type of funding sources: None. Flow chart
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.