Incidence and clinical outcomes of extended duration support in patients with Impella 5.5 - Analysis from the LOQI...

Impella 5.5 pumps are increasingly used in cardiogenic shock (CS) for extended hemodynamic support (>14 days). Rates of adverse events have not been well-characterized during longer durations of support. Therefore, we sought to define patient characteristics and adverse event rates in short versus extended duration of Impella 5.5 support (DOS).

Baseline demographics, clinical characteristics, and serious adverse events defined as death or serious deterioration of health (Serious Adverse Event (SAE): hemolysis, stroke, renal failure, and vascular complications) were analyzed. SAE exposure adjusted event rates were compared between patients supported ≤14 days (short DOS cohort) and >14 days (extended DOS cohort).

Among the 2262 patients enrolled across 31 sites in the LOQI (Long-Term Outcome and Quality Impella) registry, 443 patients were supported with the Impella 5.5. Compared to the extended duration cohort, the short duration cohort were older, had a greater proportion of women, and had a higher incidence of hypertension. Event adjusted exposure rate (EAER) was significantly lower in the extended versus short DOS cohort for cumulative SAEs, (EAER: 0.0776 vs. 0.0235 events/day; p<0.001) as well as each of the individual components: hemolysis (0.011 vs. 0.0029), stroke (0.0086 vs. 0.0024), renal failure (0.0177 vs. 0.005), vascular complications (0.0124 vs. 0.0053), and bleeding (0.0235 vs. 0.0061).

In a real-world setting, extended use of Impella 5.5 for >14 days did not increase the rate of serious adverse events and was able to provide hemodynamic support to a heterogenous group of patients presenting with cardiogenic shock with stable device performance.