Real-world applicability of DanGer Shock trial criteria in a cardiac intensive care unit
M Duarte Almeida, G R M Ferreira, J G Fiuza, F R Santos, L A Santos, O C Kungel, N CraveiroAbstract
Introduction
The DanGer Shock trial was the first to demonstrate a survival benefit with microaxial flow pumps (Impella CP) in patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock. However, the trial's stringent inclusion criteria—designed to exclude patients with either too low risk or a futile prognosis—raise questions about the generalizability of these findings to unselected "real-world" populations.
Purpose
To evaluate the eligibility for DanGer Shock criteria among patients admitted with acute myocardial infarction-related cardiogenic shock (AMI-CS) to a non-high-volume centre and to assess the potential impact on clinical decision-making.
Methods
We retrospectively analysed all patients admitted for AMI-CS to the Cardiac Intensive Care Unit between January 2023 and December 2024. Clinical, hemodynamic, and echocardiographic data were collected. DanGer Shock inclusion criteria (STEMI, lactate >2.5 mmol/L, LVEF <45%) and exclusion criteria (mechanical complications, isolated RV failure, or severe valvular disease) were systematically applied to assess patient eligibility.
Results
A total of 51 patients were included (47.1% female; mean age 73.8 ± 13.1 years), with an overall mortality rate of 51% (n=26). Eligibility was assessed through a stratified sequential exclusion process: starting with the total cohort (n=51), 6 patients were excluded for non-STEMI presentation, leaving 45 potential candidates; from these, 21 were excluded due to biochemical criteria (11 with lactate <2.5 mmol/L and 10 with unavailable lactate levels), leaving 24 patients; application of the systolic function criterion (LVEF <45%) led to the exclusion of 10 additional patients (LVEF ≥45%), leaving 14 patients; finally, after applying specific exclusion criteria (1 mechanical complication, 3 predominant RV dysfunction, and 1 severe valvular disease), only 9 patients (17.6%) remained eligible for inclusion according to the DanGer Shock trial criteria. Only 17.6% (n=9) of the initial population met all criteria for DanGer Shock eligibility. In this eligible subgroup, mortality was 44.4% (n=4). Notably, 5 patients (55.6%) survived with standard care alone, avoiding potential device-related complications.
Conclusion
Applying DanGer Shock criteria in our canter identified only 4-5 eligible patients per year. This low volume raises significant questions regarding the cost-effectiveness and proficiency of maintaining a local mechanical circulatory support program versus a "hub-and-spoke" referral model to high-volume centres. Furthermore, the survival of over half of the eligible patients without such support highlights the need for careful patient selection.