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

Purpose: 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). Methods: 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). Results: 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). Conclusions: 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.