Device-Related Adverse Events and Outcomes in Patients With Temporary Mechanical Circulatory Support Placed at...

Temporary mechanical support (tMCS) devices are often placed for cardiogenic shock (CS) at regional referral centers (RRCs) before transfer to CS hub centers (HCs). We sought to assess for differences in device-related adverse events (DRAEs) and outcomes between patients with tMCS placement for CS at an RRC before transfer to an HC compared with initial tMCS device placement at an HC.

All patients with tMCS for CS from August 2021 to August 2024 at a single center were stratified by location of initial tMCS device placement. Baseline characteristics, adjudicated DRAEs, mortality, and unfavorable outcomes (death before discharge, heart transplant, or durable left ventricular assist device) were compared. DRAE rates were calculated as events/patient-week on tMCS. Multivariable logistic regression was performed to account for baseline differences. Kaplan-Meier and Cox regression were performed to compare mortality.

A total of 398 patients (77% HC-implanted, 23% RRC-implanted) were identified. RRC-implanted patients more commonly experienced cardiac arrest and had more advanced CS. DRAE prevalence was higher in RRC-implanted patients (any DRAE in 64% versus 33%), including bleeding (29% versus 12%), hemolysis (30% versus 18%), and vascular injury (22% versus 5%); P<0.05 for all. The overall DRAE rate was 0.33 events/patient-week and was numerically higher among RRC-implanted than HC-implanted patients (0.65 versus 0.24 events/patient-week). RRC-implanted patients had higher unadjusted in-hospital mortality (odds ratio, 2.52 [95% CI, 1.52-4.18]; P<0.001) and unfavorable outcomes (odds ratio, 2.55 [95% CI, 1.52-4.27]; P<0.001). This finding was significant after adjustment for baseline differences, but not after adjustment for CS severity and cardiac arrest (in-hospital mortality odds ratio, 1.72 [95% CI, 0.95-3.12]; P=0.07; unfavorable outcome odds ratio, 1.60 [95% CI, 0.87-2.92]; P=0.13).

Initial tMCS placement for CS at an RRC with transfer to an HC is associated with a higher DRAE prevalence and worse outcomes than initial tMCS placement at a CS HC. The higher mortality in RRC-implanted patients may be due to greater CS severity.