Observational Multicenter Registry of Patients Treated with IMPella Mechanical Circulatory Support Device in ITaly: The IMP-IT Registry
DOI: 10.4244/EIJ-D-19-00428
Main Authors: Alaide Chieffo1; Marco B Ancona2; Francesco Burzotta3; Vittorio Pazzanese4; Carlo Briguori5; Carlo Trani6; Tommaso Piva7; Federico De Marco8; Maurizio Di Biasi9; Paolo Pagnotta10; Gavino Casu11; Gennaro Giustino12; Matteo Montorfano13; Federico Pappalardo14; Giuseppe Tarantini15;
Collaborators: Roberto Garbo16; Gerlando Preti17; Elisa Nicolini18; Rocco Sclafani19; Giuseppe Colonna20; Marco Mojoli21; Massimo Siviglia22; Cristiana Denurra23; Francesco Caprioglio24;
1. Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy, Italy 2. Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy 3. Institute of Cardiology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy 4. Advanced Heart Failure and Mechanical Circulatory Support Program, San Raffaele Scientific Institute, Vita Salute University, Milan Italy 5. Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy 6. Institute of Cardiology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy 7. Interventional Cardiology Unit, Ospedali Riuniti di Ancona, Ancona, Italy 8. Department of Clinical and Interventional Cardiology, IRCCS Policlinico San Donato, Milan, Italy 9. Interventional Cardiology Unit, Ospedale Luigi Sacco, Milan, Italy 10. Cardiovascular Department , Humanitas Research Hospital, Rozzano (MI) 11. Interventional Cardiology Unit, Ospedale San Francesco, Nuoro, Italy 12. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, United States 13. Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy 14. Advanced Heart Failure and Mechanical Circulatory Support Program, San Raffaele Scientific Institute, Vita Salute University, Milan Italy 15. Department of Cardiac, Thoracic and Vascular Science, University of Padova, Italy 16. Interventional Cardiology, Ospedale San Giovanni Bosco, Turin, Italy 17. Interventional Cardiology Unit, Ospedale di Conegliano, Italy 18. Interventional Cardiology Unit, Ospedali Riuniti di Ancona, Ancona, Italy 19. Interventional Cardiology Unit, Azienda Ospedaliera di Perugia, Italy 20. Interventional Cardiology Unit, Vito Fazzi Hospital, Lecce 21. SS Emodinamica Interventistica, AAS5, Ospedale di Pordenone, Italy 22. Interventional Cardiology Unit, A.O. Bianchi Melacrino Morelli, Reggio Calabria, Italy 23. Interventional Cardiology Unit, Ospedale SS Annunziata, Sassari, Italy 24. Interventional Cardiology Unit, Mestre General Hospital, Mestre, Italy
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Aims: 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 multicenter observational national registry that 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 centers 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 1-year all-cause death in patients with CS were 46.9% and 57.0%, respectively. 18.5% underwent left ventricular assist device or heart transplant at 1 year. Rates of in-hospital and 1-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 Impella for CS and HR-PCI is increasing substantially in Italy, despite relatively high rates of device-related complications.
