Comparative Effectiveness of Percutaneous Microaxial Left Ventricular Assist Device vs Intra-Aortic Balloon Pump or No Mechanical Circulatory Support in Patients With Cardiogenic Shock.

Importance: Recent studies have produced inconsistent findings regarding the outcomes of the percutaneous microaxial left ventricular assist device (LVAD) during acute myocardial infarction with cardiogenic shock (AMICS).

Objective: To compare the percutaneous microaxial LVAD vs alternative treatments among patients presenting with AMICS using observational analyses of administrative data.

Design, Setting, And Participants: This comparative effectiveness research study used Medicare fee-for-service claims of patients admitted with AMICS undergoing percutaneous coronary intervention from October 1, 2015, through December 31, 2019. Treatment strategies were compared using (1) inverse probability of treatment weighting to estimate the effect of different baseline treatments in the overall population; (2) instrumental variable analysis to determine the effectiveness of the percutaneous microaxial LVAD among patients whose treatment was influenced by cross-sectional institutional practice patterns; (3) an instrumented difference-in-differences analysis to determine the effectiveness of treatment among patients whose treatment was influenced by longitudinal changes in institutional practice patterns; and (4) a grace period approach to determine the effectiveness of initiating the percutaneous microaxial LVAD within 2 days of percutaneous coronary intervention. Analysis took place between March 2021 and December 2022.

Interventions: Percutaneous microaxial LVAD vs alternative treatments (including medical therapy and intra-aortic balloon pump).

Main Outcomes And Measures: Thirty-day all-cause mortality and readmissions.

Results: Of 23 478 patients, 14 264 (60.8%) were male and the mean (SD) age was 73.9 (9.8) years. In the inverse probability of treatment weighting analysis and grace period approaches, treatment with percutaneous microaxial LVAD was associated with a higher risk-adjusted 30-day mortality (risk difference, 14.9%; 95% CI, 12.9%-17.0%). However, patients receiving the percutaneous microaxial LVAD had a higher frequency of factors associated with severe illness, suggesting possible confounding by measures of illness severity not available in the data. In the instrumental variable analysis, 30-day mortality was also higher with percutaneous microaxial LVAD, but patient and hospital characteristics differed across levels of the instrumental variable, suggesting possible confounding by unmeasured variables (risk difference, 13.5%; 95% CI, 3.9%-23.2%). In the instrumented difference-in-differences analysis, the association between the percutaneous microaxial LVAD and mortality was imprecise, and differences in trends in characteristics between hospitals with different percutaneous microaxial LVAD use suggested potential assumption violations.

Conclusions: In observational analyses comparing the percutaneous microaxial LVAD to alternative treatments among patients with AMICS, the percutaneous microaxial LVAD was associated with worse outcomes in some analyses, while in other analyses, the association was too imprecise to draw meaningful conclusions. However, the distribution of patient and institutional characteristics between treatment groups or groups defined by institutional differences in treatment use, including changes in use over time, combined with clinical knowledge of illness severity factors not captured in the data, suggested violations of key assumptions that are needed for valid causal inference with different observational analyses. Randomized clinical trials of mechanical support devices will allow valid comparisons across candidate treatment strategies and help resolve ongoing controversies.