The New England journal of medicine 2024 Apr 07
Microaxial Flow Pump or Standard Care in Infarct-Related Cardiogenic Shock.
Abstract
Background
The effects of temporary mechanical circulatory support with a microaxial flow pump on mortality among patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock remains unclear.
Methods
In an international, multicenter, randomized trial, we assigned patients with STEMI and cardiogenic shock to receive a microaxial flow pump (Impella CP) plus standard care or standard care alone. The primary end point was death from any cause at 180 days. A composite safety end point was severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation.
Results
A total of 360 patients underwent randomization, of whom 355 were included in the final analysis (179 in the microaxial-flow-pump group and 176 in the standard-care group). The median age of the patients was 67 years, and 79.2% were men. Death from any cause occurred in 82 of 179 patients (45.8%) in the microaxial-flow-pump group and in 103 of 176 patients (58.5%) in the standard-care group (hazard ratio, 0.74; 95% confidence interval [CI], 0.55 to 0.99; P = 0.04). A composite safety end-point event occurred in 43 patients (24.0%) in the microaxial-flow-pump group and in 11 (6.2%) in the standard-care group (relative risk, 4.74; 95% CI, 2.36 to 9.55). Renal-replacement therapy was administered to 75 patients (41.9%) in the microaxial-flow-pump group and to 47 patients (26.7%) in the standard-care group (relative risk, 1.98; 95% CI, 1.27 to 3.09).
Conclusions
The routine use of a microaxial flow pump with standard care in the treatment of patients with STEMI-related cardiogenic shock led to a lower risk of death from any cause at 180 days than standard care alone. The incidence of a composite of adverse events was higher with the use of the microaxial flow pump. (Funded by the Danish Heart Foundation and Abiomed; DanGer Shock ClinicalTrials.gov number, NCT01633502.).
Related Questions
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This is a great question for the interventional cardiology community. I have been very reserved in using prophylactic mechanical circulatory support in very high-risk PCI patients (particularly microaxial flow pump). It has been my observation that mechanical circulatory support is more and more wid...
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First and foremost, it is notable that DanGer Shock (Møller et al., PMID 38587239) was the first randomized trial to show a mortality benefit with the use of a microaxial flow pump in acute MI-associated cardiogenic shock - a practice that proliferated based upon promising outcomes in non-randomized...
What are your top takeaways from ACC 2024?
In the field of critical care cardiology, DanGer Shock stands out as a key trial presented at ACC 2024 and simultaneously published in NEJM (Møller et al., PMID 38587239). The “splash” of DanGer Shock comes as it is the first randomized controlled trial to demonstrate a mortality benefit from a temp...