Abstract Background and Aims The DanGer shock trial showed a survival benefit of Impella in highly selected patients with ST-elevation myocardial infarction-related cardiogenic shock (STEMI-CS). In real-world settings, however, Impella is often used in broader populations not meeting trial criteria. This study aimed to assess the distribution and outcomes of DanGer shock-eligible and -ineligible acute myocardial infarction-related cardiogenic shock (AMI-CS) patients in a nationwide Japanese registry. Methods A total of 3975 AMI-CS patients treated with Impella between 2020 and 2023 were identified from the J-PVAD registry. Patients were stratified into five groups: eligible STEMI-CS, non-eligible STEMI-CS, out-of-hospital cardiac arrest (OHCA), mechanical complications (MCs), and non-STEMI-CS (NSTEMI-CS). Eligible STEMI-CS was defined as STEMI-CS fulfilling all of the following: lactate ≥ 2.5 mmol/L, systolic blood pressure 100 mmHg or catecholamine use, left ventricular ejection fraction 45%, and shock onset to first Impella support ≤24 h. Thirty-day mortality, associated risk factors, and complications were examined across the five groups. Results Eligible STEMI-CS accounted for 35.6% of all AMI-CS cases, with a 30-day mortality of 37.6%. Non-eligible STEMI-CS patients had lower mortality (27.6%), but it increased significantly with advanced age, renal dysfunction, veno-arterial extracorporeal membrane oxygenation use, ventricular arrhythmia, or sepsis. Thirty-day mortality was 51.3% in OHCA (63.4% without return of spontaneous circulation), 39.8% in MC, and 33.3% in NSTEMI-CS groups. Conclusions In this nationwide registry, one-third of AMI-CS patients treated with Impella met DanGer shock criteria. Outcomes in non-eligible subgroups were heterogeneous, highlighting the importance of individualized risk assessment in guiding Impella use in real-world practice.
“The J-PVAD (Japanese Registry for Percutaneous Ventricular Assist Devices) data show most real-world patients with Impella pumps fall outside the DanGer Shock criteria, reflecting the need for trial data outside of this carefully selected patient population.”
Arai et al. (2025) studied this question.