The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support

Abstract

Background: Impella was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in Impella use, clinical outcomes, and costs across US hospitals in patients undergoing percutaneous coronary intervention (PCI) treated with MCS (Impella or intra-aortic balloon pump). Methods: From the Premier Healthcare Database, we analyzed 48 306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016. Association analyses were performed at 3 levels: time period, hospital, and patient. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury, stroke, length of stay, and hospital costs). Results: Among patients undergoing PCI treated with MCS, 4782 (9.9%) received Impella; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella use across hospitals (>5-fold variation). Specifically, among patients receiving Impella, there was a wide variation in outcomes of bleeding (>2.5-fold variation), and death, acute kidney injury, and stroke (all ≈1.5-fold variation). Adverse outcomes and costs were higher in the Impella era (years 2008–2016) versus the pre-Impella era (years 2004–2007). Hospitals with higher Impella use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella use was associated with death: odds ratio, 1.24 (95% CI, 1.13–1.36); bleeding: odds ratio, 1.10 (95% CI, 1.00–1.21); and stroke: odds ratio, 1.34 (95% CI, 1.18–1.53), although a similar, nonsignificant result was observed for acute kidney injury: odds ratio, 1.08 (95% CI, 1.00–1.17). Conclusions: Impella use is rapidly increasing among patients undergoing PCI treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the hospital level or the patient level, Impella use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI.

Patient Characteristics, Treatment and Outcome in Non-Ischemic vs. Ischemic Cardiogenic Shock

“…Especially, left-ventricular unloading using a pLVAD seems to be intriguing for treatment of non-ischemic CS, as this device could support the failing myocardium and thereby enhance its chances to recover/stabilize [17]. However, there is currently no randomized evidence which supports the use of ECMO/pLVAD in CS, and observational studies even indicated harm with the use of pLVAD in CS [12,18,19]. As use of mechanical circulatory support is inevitably linked to an increase in complications, such as vascular complications at the access site or bleedings, more research is needed to determine which patients do have a favorable benefit/risk ratio with this approach.…”

Advances in Clinical Cardiology 2019: A Summary of Key Clinical Trials

“…However, severe or life-threatening bleeding was more common with Impella (8.5% vs. 3.0%), as were peripheral vascular complications (9.8% vs. 3.8%). Separately, a propensity adjusted analysis of the Premier Healthcare Database registry (including 4782 Impella cases up to 2016) reported that Impella use was associated with higher odds of death, bleeding and stroke [77]. A large prospective randomised trial is thus urgently required.…”

Pre-PCI versus immediate post-PCI Impella initiation in acute myocardial infarction complicated by cardiogenic shock

“…The Impella 2.5 and CP can be inserted percutaneously and provide a maximum output of respectively 2.5 L/min and 3.7 L/minute, whereas the Impella 5.0 needs to be inserted surgically and generates a maximum output of 5 L/min. Despite increased hemodynamic support with Impella, compared to IABP, there is conflicting evidence regarding the effect of Impella on clinical outcome [14][15][16][17][18][19]. However, in the studies with neutral or negative effect of Impella, most patients received Impella after primary PCI, while it has been suggested that Impella initiation prior to primary PCI might be a better strategy to improve survival than Impella initiation after primary PCI [20][21][22].…”