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Trends in Impella Use in the United States
Study Questions:
What are the trends and variations in use, cost, and clinical outcomes related to Impella use for mechanical circulatory support (MCS) among patients undergoing percutaneous coronary intervention (PCI) and MCS?
Methods:
Data were analyzed from 48,306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016 in the Premier Healthcare Database. Association analyses were performed at three levels: time-period, hospitals, and patients. Trends and variations in the proportion of Impella use and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury [AKI], stroke, length of stay, and hospital costs) were examined.
Results:
Among PCI patients treated with MCS, 4,782 (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 Impella patients, there was wide variation in outcomes of bleeding (>2.5-fold variation), and death, AKI, 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 [OR], 1.24; 95% confidence interval [CI], 1.13–1.36); bleeding (OR, 1.10; 95% CI, 1.00–1.21); and stroke (OR, 1.34; 95% CI, 1.18–1.53), although a similar, nonsignificant result was observed for AKI (OR, 1.08; 95% CI, 1.00–1.17).
Conclusions:
Impella use is rapidly increasing among PCI patients 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.
Perspective:
Barring the limitation of an observational analysis from an administrative database, study results highlight increasing utilization of Impella for MCS since its approval in 2008 (up to a third of patients undergoing PCI and requiring MCS). With increasing application, Impella use was varied across hospitals, and was associated with increased costs and increased risk of death, bleeding, and AKI. When comparing Impella to intra-aortic balloon pump, there was a higher risk of death, bleeding, and stroke with Impella. Findings suggest that use of this expensive support device comes at a higher cost and without improved clinical outcomes (and may even be associated with worse outcomes). There may be a need to develop an evidence-based ‘appropriate use criteria’ for Impella among patients undergoing PCI (with and without shock) to optimize its application.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support
Keywords: AHA Annual Scientific Sessions, AHA19, Acute Kidney Injury, Hemorrhage, Hospital Costs, Intra-Aortic Balloon Pumping, Length of Stay, Percutaneous Coronary Intervention, Risk, Secondary Prevention, Stroke
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