Photo Credit: Alfexe

Exploring the pros and cons of a micro axial flow pump for patients with ST-elevation myocardial infarction-related cardiogenic shock.

The use of a micro axial flow pump on top of standard care improved the survival of patients with ST-elevation myocardial infarction (STEMI)-related cardiogenic shock. However, this benefit is accompanied by more adverse events, as shown in the international DanGer Shock trial.

Cardiogenic shock is experienced by 1 in 10 patients with STEMI, and only 50% survive this event. Thus, Jacob Møller, PhD, from the Odense University Hospital in Denmark and his team explored in the DanGer Shock trial (NCT01633502) whether routine use of the micro axial flow pump Impella CP on top of standard care in patients with STEMI and cardiogenic shock results in lower mortality rates compared with standard therapy alone.

Eligible patients had STEMI, hypotension, hypoperfusion, and a left ventricular ejection fraction of less than 45%. The final analysis included 355 patients from 14 centers in Denmark, Germany, and the United Kingdom; 179 of them were in the intervention group and 176 in the standard care group.

At 6-months, death from any course occurred in 45.8% of participants in the micro axial flow pump group and 58.5% of participants in the standard care arm (HR 0.74; 95% CI 0.55–0.99; P =0.04). “This endpoint was reduced by absolute 13% by the actual flow pump with the number-needed-to-treat of 8,” Dr Møller commented.

A composite safety endpoint event (i.e. severe bleeding, limb ischemia, hemolysis, device failure, or worsening aortic regurgitation) occurred in 24% of participants in the micro axial flow pump group compared with only 6.2% in the standard care group (relative risk 4.74). In the intervention group, 21.8% of participants had moderate or severe bleeding (vs 11.9% in the control group), 5.6% had limb ischemia (vs 1.1% in the control arm), 3.9% had a stroke (vs 2.3% with standard care), and 11.7% sepsis (vs 4.5% in the control arm).  “To our surprise, we saw that more patients in the actual flow pump group ended up on renal replacement therapy (41.9% vs 26.7% with standard care), and we will look into whether this is device-related or related to survival bias,” Dr Møller explained.

Medical writing support was provided by Dr Susanne Kammerer
Copyright ©2024 Medicom Medical Publishers