Safety and clinical outcomes of micro-axial intravascular flow pump compared to intra-aortic balloon pump in cardiogenic shock.

BACKGROUND

The micro-axial intravascular flow pump (mAFP) may potentially improve the prognosis of cardiogenic shock (CS). Despite its advanced hemodynamic profile, efficacy remains undetermined. Safety and mid-term outcomes were compared between the mAFP and intra-aortic balloon pump (IABP).

METHODS

This single-center, cross-sectional study retrospectively evaluated 205 consecutive patients treated using the IABP or mAFP at Osaka Medical and Pharmaceutical University from January 2017 to June 2023. After exclusion of those with CS who were treated with only extracorporeal membrane oxygenation (ECMO), patients who required IABP or mAFP were enrolled in the current study. The primary outcome was 180-day mortality. Secondary outcomes were major [major bleeding (Bleeding Academic Research Consortium criteria 3-5), limb ischemia and stroke] and other complications (hemolysis, thrombocytopenia, acute kidney impairment and requirement of renal replacement therapy). Those outcomes were compared between IABP and mAFP.

RESULTS

Of all patients, 62 (30.2%) received the mAFP and 143 (69.8%) the IABP. There were no significant differences in 180-day mortality between the devices (P=0.86). Further investigation according to the Society for Cardiovascular Angiography and Intervention (SCAI) shock stage classification demonstrated that the mortality rate for SCAI C was significantly lower in the mAFP group (P=0.02), while mortality was not significantly different for SCAI D/E (P=0.71). The major and other complications were more frequent in the mAFP group (61.3% vs. 46.0%, P=0.02 and 90.3% vs. 68.8%, P<0.001, respectively). In multivariate analysis, age ≥75 years [hazard ratio (HR): 2.37, 95% confidence interval (CI): 1.42-3.97], out-of-hospital cardiopulmonary arrest (OHCPA) (HR: 2.05, 95% CI: 1.04-4.08), ECMO use (HR: 5.05, 95% CI: 2.85-8.95) and major complications (HR: 2.11, 95% CI: 1.07-4.17) were independently associated with mortality. Moreover, age ≥75 years (HR: 2.06, 95% CI: 1.08-3.92) and ECMO use (HR: 6.67, 95% CI: 3.32-13.42) were independent predictors of major complications, whereas mAFP (vs. IABP) (HR: 5.27, 95% CI: 1.71-16.30), age ≥75 years (HR: 2.80, 95% CI: 1.28-6.11) and ECMO use (HR: 8.34, 95% CI: 2.33-29.9) were independent predictors of other complications.

CONCLUSIONS

Classical CS attained benefit from the mAFP, whereas it is still challenging for patients with severe CS, particularly OHCPA and requirement for ECMO. The use of mAFP was associated with more complications and its true impact on clinical outcomes remains to be determined.