Budget Impact Associated with the Introduction of the Impella 5.0® Mechanical Circulatory Support Device for Cardiogenic Shock in France

Alexandre Le Guyader,1 Mathieu Pernot,2 Clément Delmas,3 Stéphane Roze,4 Isabelle Fau,5 Erwan Flecher,6 Guillaume Lebreton7 1Department of Thoracic and Cardiovascular Surgery, Dupuytren University Hospital, Limoges, France; 2Department of Cardiology and Cardio‐Vascular Surgery, Haut-Lévèque University Hospital, Bordeaux, France; 3Cardiology Department, Rangueil University Hospital, Toulouse, France; 4Vyoo Agency, Lyon, France; 5SGE Consulting, Paris, France; 6Department of Cardio-Thoracic and Vascular Surgery, Pontchaillou University Hospital, Rennes, France; 7Cardiac Surgery Department, Pitié-Salpétrière Hospital, Sorbonne University, Paris, FranceCorrespondence: Isabelle Fau Email isabelle.fau@sge-consulting.orgAim: Cardiogenic shock (CS), if not diagnosed and treated rapidly, can lead to irreversible multiorgan damage and death. An economic analysis was conducted to determine the budget impact of the introduction of Impella 5.0®, a mechanical circulatory support (MCS) device that directly unloads the left ventricle, into clinical practice in patients with left ventricular CS in France.Methods: A budget impact model was developed to compare the cost of Impella 5.0 with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) from the perspective of the French national healthcare insurer. Costs associated with Impella 5.0, plus complication-related costs for VA-ECMO or Impella 5.0 from 2019 were included and clinical input data relating to complication rates and time spent on device were sourced from published literature. Extensive scenario and one-way deterministic sensitivity analyses were performed to explore the influence of uncertainty around key input parameters.Results: Over a time horizon of 5 years, the introduction of Impella 5.0 was associated with cumulative savings of EUR 4.3 million. The results were driven by the lower risk of device-related complications associated with Impella 5.0. Savings were apparent from Year 1 onwards, with savings in excess of EUR 375,000 projected in Year 1 alone. On a per-patient level, in Year 1, estimated savings with the introduction of Impella 5.0 totaled EUR 616 per patient. Sensitivity analyses showed that the findings of the analysis were robust.Conclusion: The Impella 5.0 device was associated with cumulative cost savings in excess of EUR 4 million over a 5-year period compared with current practice. Projected savings were driven by a lower rate of device-related complications with Impella 5.0 compared with VA-ECMO.Keywords: cardiogenic shock, left-ventricular assist devices, Impella 5.0®, budget impact, France