Observational multicentre registry of patients treated with IMPella mechanical circulatory support device in ITaly: the IMP-IT registry

Abstract

The aim of this study was to investigate nationwide trends and clinical outcomes of the Impella device for cardiogenic shock (CS) and high-risk percutaneous coronary intervention (HR-PCI). The IMP-IT study was a multicentre observational national registry which enrolled all patients treated with Impella 2.5, Impella CP, Impella 5.0 and Impella RP, both for CS and HR-PCI indications, across 17 Italian centres from 2004 to June 2018. A total of 406 patients were included: 229 had CS (56.4%) and 177 underwent HR-PCI (43.6%). The use of Impella increased significantly during the study period (average annual percent change 39.8%, 95% confidence interval: 30.4 to 49.9; p<0.0001) for both indications. The Impella 2.5 was the most commonly used device (N=242; 59.6%). Rates of in-hospital and one-year all-cause death in patients with CS were 46.9% and 57.0%, respectively; 18.5% underwent left ventricular assist device implantation or heart transplant at one year. Rates of in-hospital and one-year all-cause death in patients who underwent HR-PCI were 5.7% and 15.6%, respectively. Rates of device-related complications were 37.1% and 10.7% in the setting of CS and HR-PCI, respectively. Use of the Impella for CS and HR-PCI is increasing substantially in Italy, despite relatively high rates of device-related complications.