Alaide Chieffo1, MD; Marco B. Ancona1, MD; Francesco Burzotta2, MD; Vittorio Pazzanese3, MD; Carlo Briguori4, MD; Carlo Trani2, MD; Tommaso Piva5, MD; Federico De Marco6, MD; Maurizio Di Biasi7, MD; Paolo Pagnotta8, MD; Gavino Casu9, MD; Gennaro Giustino10, MD; Matteo Montorfano1, MD; Federico Pappalardo3, MD; Giuseppe Tarantini11, MD; Roberto Garbo12, MD; Gerlando Preti13, MD; Elisa Nicolini5, MD; Rocco Sclafani14, MD; Giuseppe Colonna15, MD; Marco Mojoli16, MD; Massimo Siviglia17, MD; Cristiana Denurra18, MD; Francesco Caprioglio19, MD
1. Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; 2. Institute of Cardiology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy; 3. Advanced Heart Failure and Mechanical Circulatory Support Program, San Raffaele Scientific Institute, Vita Salute University, Milan, Italy; 4. Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy; 5. Interventional Cardiology Unit, Ospedali Riuniti di Ancona, Ancona, Italy; 6. Department of Clinical and Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy; 7. Interventional Cardiology Unit, Ospedale Luigi Sacco, Milan, Italy; 8. Cardiovascular Department , Humanitas Research Hospital, Rozzano, Milan, Italy; 9. Interventional Cardiology Unit, Ospedale San Francesco, Nuoro, Italy; 10. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 11. Department of Cardiac, Thoracic and Vascular Science, University of Padova, Italy; 12. Interventional Cardiology, Ospedale San Giovanni Bosco, Turin, Italy; 13. Interventional Cardiology Unit, Ospedale di Conegliano, Italy; 14. Interventional Cardiology Unit, Azienda Ospedaliera di Perugia, Italy; 15. Interventional Cardiology Unit, Vito Fazzi Hospital, Lecce; 16. SS Emodinamica Interventistica, AAS5, Ospedale di Pordenone, Italy; 17. Interventional Cardiology Unit, A.O. Bianchi Melacrino Morelli, Reggio Calabria, Italy; 18. Interventional Cardiology Unit, Ospedale SS Annunziata, Sassari, Italy; 19. Interventional Cardiology Unit, Mestre General Hospital, Mestre, Italy
Aims: 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).
Methods and results: 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.
Conclusions: Use of the Impella for CS and HR-PCI is increasing substantially in Italy, despite relatively high rates of device-related complications.
Visual summary. Impella Italian Registry (IMP-IT). 406 patients enrolled across 17 centres in Italy.
