The cost-effectiveness of a new percutaneous ventricular assist device for high-risk PCI patients: mid-stage evaluation from the European perspective
- 14 December 2012
- journal article
- research article
- Published by Informa Healthcare in Journal of Medical Economics
- Vol. 16 (3), 381-390
- https://doi.org/10.3111/13696998.2012.762004
Abstract
Objective: A new and smaller percutaneous ventricular assist device (pVAD, Impella, Abiomed, Danvers, MA) has been developed to provide circulatory support in hemodynamically unstable patients and to prevent hemodynamic collapse during high-risk percutaneous coronary interventions (PCI). The objective of the study was to assess the cost-effectiveness of this specific device compared to the intra-aortic balloon pump (IABP) from the European perspective. Additional analysis on extracorporeal membrane oxygenation was conducted for observational purposes only, given its use in some European countries. Methods: A combination of a decision tree and Markov model was developed to assess the cost-effectiveness of the small, pVAD. The short-term (30-day) effectiveness and safety (early survival, risk of bleeding, and stroke) were modeled, as well as long-term risk of major adverse cardiovascular events (recurrent myocardial infarction, stroke, and heart failure). The short-term effectiveness and safety data for the device were obtained from two registries (the Europella and USpella), both of which are large multi-center studies in high-risk patient groups. Probabilities of long-term major adverse cardiovascular events were obtained from various published clinical studies. The economic analysis was conducted from a German statutory health insurance perspective and only direct medical costs were included. Cost-effectiveness was estimated over a 10-year time horizon. Results: Compared with IABP, the pVAD generated an incremental quality-adjusted life-year (QALY) of 0.22 (with Euro-registry data) and 0.27 (with US-registry data). The incremental cost-effectiveness ratio (ICER) of the device varied between €38,069 (with Euro-registry data) and €31,727 (with US-registry data) per QALY compared with IABP. Key limitations: Unadjusted, indirect comparisons of short-term effectiveness and safety between the interventions were used in the model. Cost and utility data were retrieved from various sources. Therefore, differences in patient populations may bias the estimated cost-effectiveness. Conclusions: Compared with IABP, the pVAD is a cost-effective intervention for high-risk PCI patients, with ICERs well-below the conventional cost-effectiveness threshold.Keywords
This publication has 37 references indexed in Scilit:
- Intraaortic Balloon Support for Myocardial Infarction with Cardiogenic ShockThe New England Journal of Medicine, 2012
- A Prospective, Randomized Clinical Trial of Hemodynamic Support With Impella 2.5 Versus Intra-Aortic Balloon Pump in Patients Undergoing High-Risk Percutaneous Coronary InterventionCirculation, 2012
- Real‐world use of the Impella 2.5 circulatory support system in complex high‐risk percutaneous coronary intervention: The USpella RegistryCatheterization and Cardiovascular Interventions, 2012
- Use and Effectiveness of Intra-Aortic Balloon Pumps Among Patients Undergoing High Risk Percutaneous Coronary Intervention: Insights From the National Cardiovascular Data RegistryCirculation: Cardiovascular Quality and Outcomes, 2012
- Use of the Impella 2.5 for prophylactic circulatory support during elective high-risk percutaneous coronary interventionCardiovascular Revascularization Medicine, 2011
- Intra-aortic Balloon Counterpulsation and Infarct Size in Patients With Acute Anterior Myocardial Infarction Without ShockJama-Journal Of The American Medical Association, 2011
- Elective Intra-aortic Balloon Counterpulsation During High-Risk Percutaneous Coronary InterventionA Randomized Controlled TrialJama-Journal Of The American Medical Association, 2010
- A systematic review and meta-analysis of intra-aortic balloon pump therapy in ST-elevation myocardial infarction: should we change the guidelines?European Heart Journal, 2008
- The economic burden of complications during percutaneous coronary interventionQuality and Safety in Health Care, 2007
- Cardiogenic shock complicating acute myocardial infarction Prognostic impact of early and late shock developmentEuropean Heart Journal, 2003