The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support
The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support
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DOI：
10.1161/circulationaha.119.044007
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发表时间：
2020-01-28
期刊：
影响因子：
37.8
通讯作者：
Rao, Sunil, V
中科院分区：
文献类型：
--
作者：
Amin, Amit P.;Spertus, John A.;Rao, Sunil, V
背景：Impella于2008年被批准用于机械循环支持（MCS），但缺乏关于其使用的大规模真实数据。我们的目的是描述美国各医院使用MCS（Impella或主动脉内球囊反搏泵）进行经皮冠状动脉介入治疗（PCI）的患者中Impella使用、临床结局和成本的趋势和变化。方法：我们从Premier Healthcare数据库中分析了2004年1月至2016年12月期间在432家医院接受MCS PCI的48306例患者。相关性分析在3个层面进行：时间段、医院和患者。采用倾向调整的分层模型进行关联分析。我们检查了Impella使用比例的趋势和变化，以及相关的临床结局（院内死亡率、需要输血的出血、急性肾损伤、卒中、住院时间和住院费用）。结果：在接受MCS治疗的PCI患者中，4782例（9.9%）接受Impella治疗;其使用率随时间推移而增加，2016年达到MCS的31.9%。各医院之间Impella的使用存在很大差异（>5倍差异）。具体而言，在接受Impella治疗的患者中，出血（>2.5倍变异）和死亡、急性肾损伤和卒中（均接近1.5倍变异）的结局差异很大。Impella时代（2008-2016年）的不良结局和成本高于Impella时代（2004-2007年）。Impella使用率较高的医院有较高的不良结局发生率和成本。在调整倾向评分后，并考虑到医院对患者的聚集性，Impella的使用与死亡相关：比值比为1.24（95% CI，1.13-1.36）;出血：比值比，1.10（95% CI，1.00-1.21）;卒中：比值比，1.34（95% CI，1.18-1.53），尽管在急性肾损伤中观察到相似的非显著性结果：比值比，1.08（95%CI，1.00-1.17）。结论：在接受MCS治疗的PCI患者中，Impella的使用迅速增加，其使用和相关结局存在显著差异。尽管无法排除未测量的混杂因素，但当按时间段或医院水平或患者水平进行分析时，Impella的使用与更高的不良事件发生率和成本相关。需要更多的数据来确定MCS在接受PCI的患者中的适当作用。
Background:Impella was approved for mechanical circulatory support (MCS) in 2008, but large-scale, real-world data on its use are lacking. Our objective was to describe trends and variations in Impella use, clinical outcomes, and costs across US hospitals in patients undergoing percutaneous coronary intervention (PCI) treated with MCS (Impella or intra-aortic balloon pump).Methods:From the Premier Healthcare Database, we analyzed 48 306 patients undergoing PCI with MCS at 432 hospitals between January 2004 and December 2016. Association analyses were performed at 3 levels: time period, hospital, and patient. Hierarchical models with propensity adjustment were used for association analyses. We examined trends and variations in the proportion of Impella use, and associated clinical outcomes (in-hospital mortality, bleeding requiring transfusion, acute kidney injury, stroke, length of stay, and hospital costs).Results:Among patients undergoing PCI treated with MCS, 4782 (9.9%) received Impella; its use increased over time, reaching 31.9% of MCS in 2016. There was wide variation in Impella use across hospitals (>5-fold variation). Specifically, among patients receiving Impella, there was a wide variation in outcomes of bleeding (>2.5-fold variation), and death, acute kidney injury, and stroke (all approximate to 1.5-fold variation). Adverse outcomes and costs were higher in the Impella era (years 2008-2016) versus the pre-Impella era (years 2004-2007). Hospitals with higher Impella use had higher rates of adverse outcomes and costs. After adjustment for the propensity score, and accounting for clustering of patients by hospitals, Impella use was associated with death: odds ratio, 1.24 (95% CI, 1.13-1.36); bleeding: odds ratio, 1.10 (95% CI, 1.00-1.21); and stroke: odds ratio, 1.34 (95% CI, 1.18-1.53), although a similar, nonsignificant result was observed for acute kidney injury: odds ratio, 1.08 (95% CI, 1.00-1.17).Conclusions:Impella use is rapidly increasing among patients undergoing PCI treated with MCS, with marked variability in its use and associated outcomes. Although unmeasured confounding cannot be ruled out, when analyzed by time periods, or at the hospital level or the patient level, Impella use was associated with higher rates of adverse events and costs. More data are needed to define the appropriate role of MCS in patients undergoing PCI.