Impella versus VA-ECMO for the treatment of patients with cardiogenic shock: the Impella Network Project – observational study protocol for cost-effectiveness and budget impact analyses
2 Department of Anesthesia and Intensive Care, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milano, Italy
Mario Iannaccone
8 Division of Cardiology, San Giovanni Bosco Hospital, ASL Città di Torino, Torino, Italy
Carla Rognoni
1 Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milano, Italy
Giuseppe Tarantini
19 Department of Cardiac, Thoracic, Vascular Sciences and Public Health, Università degli Studi di Padova, Padova, Italy
Italo Porto
16 DICATOV-CardioThoracic and Vascular, Ospedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l`Oncologia, Genova, Italy
Davide Pacini
13 University of Bologna, Bologna, Italy
Antonio Loforte
9 Dipartimento di Scienze Chirurgiche, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy
Gino Gerosa
7 Cardiac Surgery Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy
Vittoria Ardito
1 Centre for Research on Health and Social Care Management (CERGAS), SDA Bocconi School of Management, Bocconi University, Milano, Italy
Marina Pieri
2 Department of Anesthesia and Intensive Care, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milano, Italy
Alessandro Barbone
4 IRCCS Humanitas Research Hospital, Rozzano, Italy
Introduction The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. The aim of this study is, therefore, to collect and comparatively assess clinical and socioeconomic data of Impella versus VA-ECMO for the treatment of patients with severe CS, to ultimately conduct both a cost-effectiveness (CEA) and budget impact (BIA) analyses.Methods and analysis This is a prospective plus retrospective, multicentre study conducted under the scientific coordination of the Center for Research on Health and Social Care Management of SDA Bocconi School of Management and clinical coordination of Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute in Milan. The Impella Network stemmed for the purposes of this study and comprises 17 Italian clinical centres from Northern to Southern Regions in Italy. The Italian network qualifies as a subgroup of the international Impella Cardiac Surgery Registry. Patients with CS treated with Impella pumps (CP, 5.0 or 5.5) will be prospectively recruited, and information on clinical outcomes, resource use and QoL collected. Economic data will be retrospectively matched with data from comparable patients treated with VA-ECMO. Both CEA and BIA will be conducted adopting the societal perspective in Italy. This study will contribute to generate new socioeconomic evidence to inform future coverage decisions.Ethics and dissemination As of May 2024, most of the clinical centres submitted the documentation to their ethical committee (N=13; 76%), six centres received ethical approval and two centres started to enrol patients. Study results will be published in peer-reviewed publications and disseminated through conference presentations.
