Shah Atman P, Retzer Elizabeth M, Nathan Sandeep, Paul Jonathan D, Friant Janet, Dill Karin E, Thomas Joseph L
The University of Chicago, 5841 South Maryland, MC 6080, Chicago, IL 60637 USA.
J Invasive Cardiol. 2015 Mar;27(3):148-54.
Comparative effectiveness research (CER) is taking a more prominent role in formalizing hospital treatment protocols and health-care coverage policies by having health-care providers consider the impact of new devices on costs and outcomes. CER balances the need for innovation with fiscal responsibility and evidence-based care. This study compared the clinical and economic impact of percutaneous ventricular assist devices (pVAD) with intraaortic balloon pumps for high-risk patients undergoing percutaneous coronary intervention (PCI).
This study conducted a review of all comparative randomized control trials of the pVADS (Impella and TandemHeart) vs IABP for patients undergoing high-risk percutaneous coronary intervention (PCI). A retrospective analysis of the 2010 and 2011 Medicare MEDPAR data files was also performed to compare procedural costs and hospital length of stay (LOS). Readmission rates between the devices were also studied.
Based on available trials, there is no significant clinical benefit with pVAD compared to IABP. Use of pVADs is associated with increased length of Intensive Care Unit stay and a total longer LOS. The incremental budget impact for pVADs was $33,957,839 for the United States hospital system (2010-2011).
pVADs are not associated with improved clinical outcomes, reduced hospital length of stay, or reduced readmission rates. Management of high-risk PCI and cardiogenic shock patients with IABP is more cost effective than a routine use of pVADS. Use of IABP as initial therapy in high-risk PCI and cardiogenic shock patients may result in savings of up to $2.5 billion annually of incremental costs to the hospital system.
比较效果研究（CER）在规范医院治疗方案和医疗保健覆盖政策方面正发挥着越来越重要的作用，它促使医疗保健提供者考虑新设备对成本和治疗结果的影响。CER在创新需求与财政责任及循证医疗之间取得平衡。本研究比较了经皮心室辅助装置（pVAD）与主动脉内球囊泵对接受经皮冠状动脉介入治疗（PCI）的高危患者的临床和经济影响。
本研究对所有比较pVADS（Impella和TandemHeart）与IABP用于高危经皮冠状动脉介入治疗（PCI）患者的随机对照试验进行了综述。还对2010年和2011年医疗保险MEDPAR数据文件进行了回顾性分析，以比较手术成本和住院时间（LOS）。还研究了两种装置之间的再入院率。
根据现有试验，与IABP相比，pVAD没有显著的临床益处。使用pVAD与重症监护病房住院时间延长和总住院时间延长相关。美国医院系统（2010 - 2011年）pVAD的增量预算影响为33957839美元。
pVAD与改善临床结果、缩短住院时间或降低再入院率无关。对于高危PCI和心源性休克患者，使用IABP进行管理比常规使用pVADS更具成本效益。在高危PCI和心源性休克患者中，将IABP作为初始治疗可能每年为医院系统节省高达25亿美元的增量成本。
