An analysis of more than 2,000 patients from a large US real-world database finds that patients who underwent a non-emergent high-risk percutaneous coronary intervention (PCI) with the Impella heart pump (n=1,447) had significantly improved survival, reduced myocardial infarction, reduced cardiogenic shock after PCI and shorter length of stay than matched patients treated with an intra-aortic balloon pump (IABP) (n=709).
The study’s findings are consistent with and reinforce the results of other peer-reviewed studies over the past 10 years. The study was published in the American Journal of Cardiology, and was led by Alexandra Lansky (Yale School of Medicine, New Haven, USA).
“This study from a large contemporary, real-world database is further evidence of the benefits of using Impella during high-risk PCI to stabilise haemodynamics, prevent haemodynamic collapse, enable optimal revascularisation and improve clinical outcomes,” said Lansky.
The study examined patients in the Premier Healthcare Database treated between 2016 and 2019 with Impella or IABP for non-emergent high-risk PCI. Patients were matched using propensity-score methods to control for baseline, procedure and post-PCI medical treatment differences between the groups. The study found in-hospital survival was significantly higher with Impella compared to IABP (unadjusted 95.3% vs. 91.0%, p=0.0002; adjusted odds ratio (OR) 1.55, 95% confidence interval (CI) 1.02, 2.36, p=0.042), and that myocardial infarction (MI) was significantly reduced with Impella compared to IABP (unadjusted 2.5% vs. 11.9%, p<0.0001; adjusted OR 0.29, 95% CI 0.18, 0.46, p<0.0001).
Additionally, cardiogenic shock after PCI was significantly reduced with Impella compared to IABP (8.3% vs. 18.9% p<0.0001; adjusted OR 0.54, 95% CI 0.39, 0.74, p=0.0001), and there was a shorter length of stay for Impella patients compared to IABP patients (unadjusted 3.1 days vs. 5.5 days, p<0.0001; adjusted 3.4 days vs. 4.8 days, p<0.0001).
Furthermore, the safety profile for bleeding and stroke were the same between the Impella and IABP groups. This is consistent with data demonstrating improvements in bleeding over time for large-bore devices, with the adoption of contemporary practices such as ultrasound-guided vascular access and optimal use of closure devices.
The authors analysed contemporary payer data from the years after Impella’s US Food and Drug Administration (FDA) approval for high-risk PCI, an era when best practices for Impella use had been established. Additionally, they used a more straightforward propensity-matched methodology than prior studies from similar datasets.