Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
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DOI：
10.1001/jama.2020.0254
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发表时间：
2020-02-25
影响因子：
120.7
通讯作者：
Desai, Nihar R.
中科院分区：
文献类型：
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作者：
Dhruva, Sanket S.;Ross, Joseph S.;Desai, Nihar R.
急性心肌梗死（AMI）并发心源性休克与高发病率和死亡率相关.尽管与主动脉内球囊泵（IABP）相比，血管内微轴左心室辅助装置（LVAD）提供了更大的血流动力学支持，但对临床实践中使用血管内微轴LVAD相关的临床结果知之甚少。目的探讨急性心肌梗死（AMI）合并心源性休克患者行经皮冠状动脉介入治疗（PCI）时应用机械循环支持（MCS）装置的疗效。设计、设置和参与者一项基于倾向匹配登记的回顾性队列研究，研究对象为2015年10月1日至2017年12月31日期间接受PCI治疗的AMI并发心源性休克患者，这些患者被纳入参与CathPCI和胸痛-MI登记的医院的数据中，这两项登记均为美国心脏病学会国家心血管数据登记的一部分。接受血管内微轴LVAD的患者与接受IABP的患者在人口统计学、临床病史、表现、梗死位置、冠状动脉解剖结构和临床实验室数据方面相匹配，最终随访至2017年12月31日。暴露于血流动力学支持，分类为仅使用血管内微轴LVAD、仅使用IABP、其他（例如使用经皮体外心室辅助系统、体外膜氧合或MCS器械组合使用）或仅药物治疗。主要结果和测量主要结果是住院死亡率和住院大出血。结果28304例AMI合并心源性休克行PCI患者中，平均年龄65.0（12.6）岁，男性占67.0%，81.3%为ST段抬高型心肌梗死，43.3%为心脏骤停。在AMI患者的研究期间，6.2%的患者使用血管内微轴LVAD，29.9%的患者使用IABP。在1680个倾向匹配的配对中，使用血管内微轴LVAD的住院死亡风险显著较高（45.0%）vs IABP（34.1% [绝对风险差，10.9个百分点{95% CI，7.6-14.2}; P <0.001），并且院内大出血的风险也更高（血管内微轴LVAD [31.3%] vs IABP [16.0%];绝对风险差异，15.4个百分点[95%CI，12.5-18.2]; P <0.001）。无论患者是在开始PCI之前还是之后接受器械，这些相关性都是一致的。结论和相关性在2015年至2017年接受PCI治疗AMI合并心源性休克的患者中，与IABP相比，使用血管内微轴LVAD与院内死亡和大出血并发症的校正风险较高相关，尽管研究解释受到观察性设计的限制。可能需要进一步的研究来了解这些患者的最佳装置选择。本研究使用注册数据比较了急性冠脉综合征和心源性休克患者使用血管内微轴左心室辅助装置（LVAD）与主动脉内球囊搏动（IABP）治疗的住院死亡率和大出血风险。问题：急性心肌梗死患者（血管内微轴左心室辅助装置（LVAD）与主动脉内球囊反搏（IABP）治疗AMI合并心源性休克的比较？结果在这项基于登记的回顾性队列研究中，包括3360例倾向匹配的AMI经皮冠状动脉介入治疗患者，血管内微轴LVAD治疗与IABP相比，院内死亡（45.0% vs 34.1%）和院内大出血（31.3% vs 16.0%）的风险显著较高。在接受经皮冠状动脉介入治疗的AMI和心源性休克患者中，与IABP相比，使用血管内微轴LVAD可能与更差的院内临床结局相关，尽管研究解释受到观察设计的限制。
Importance Acute myocardial infarction (AMI) complicated by cardiogenic shock is associated with substantial morbidity and mortality. Although intravascular microaxial left ventricular assist devices (LVADs) provide greater hemodynamic support as compared with intra-aortic balloon pumps (IABPs), little is known about clinical outcomes associated with intravascular microaxial LVAD use in clinical practice. Objective To examine outcomes among patients undergoing percutaneous coronary intervention (PCI) for AMI complicated by cardiogenic shock treated with mechanical circulatory support (MCS) devices. Design, Setting, and Participants A propensity-matched registry-based retrospective cohort study of patients with AMI complicated by cardiogenic shock undergoing PCI between October 1, 2015, and December 31, 2017, who were included in data from hospitals participating in the CathPCI and the Chest Pain-MI registries, both part of the American College of Cardiology's National Cardiovascular Data Registry. Patients receiving an intravascular microaxial LVAD were matched with those receiving IABP on demographics, clinical history, presentation, infarct location, coronary anatomy, and clinical laboratory data, with final follow-up through December 31, 2017. Exposures Hemodynamic support, categorized as intravascular microaxial LVAD use only, IABP only, other (such as use of a percutaneous extracorporeal ventricular assist system, extracorporeal membrane oxygenation, or a combination of MCS device use), or medical therapy only. Main Outcomes and Measures The primary outcomes were in-hospital mortality and in-hospital major bleeding. Results Among 28304 patients undergoing PCI for AMI complicated by cardiogenic shock, the mean (SD) age was 65.0 (12.6) years, 67.0% were men, 81.3% had an ST-elevation myocardial infarction, and 43.3% had cardiac arrest. Over the study period among patients with AMI, an intravascular microaxial LVAD was used in 6.2% of patients, and IABP was used in 29.9%. Among 1680 propensity-matched pairs, there was a significantly higher risk of in-hospital death associated with use of an intravascular microaxial LVAD (45.0%) vs with an IABP (34.1% [absolute risk difference, 10.9 percentage points {95% CI, 7.6-14.2}; P < .001) and also higher risk of in-hospital major bleeding (intravascular microaxial LVAD [31.3%] vs IABP [16.0%]; absolute risk difference, 15.4 percentage points [95% CI, 12.5-18.2]; P < .001). These associations were consistent regardless of whether patients received a device before or after initiation of PCI. Conclusions and Relevance Among patients undergoing PCI for AMI complicated by cardiogenic shock from 2015 to 2017, use of an intravascular microaxial LVAD compared with IABP was associated with higher adjusted risk of in-hospital death and major bleeding complications, although study interpretation is limited by the observational design. Further research may be needed to understand optimal device choice for these patients.This study uses registry data to compare risk of in-hospital mortality and major bleeding among patients with acute coronary syndrome and cardiogenic shock managed with an intravascular microaxial left ventricular assist device (LVAD) vs intra-aortic balloon pulsation (IABP).Question Is there a difference in clinical outcomes among patients with acute myocardial infarction (AMI) complicated by cardiogenic shock treated with intravascular microaxial left ventricular assist device (LVAD) vs intra-aortic balloon pump (IABP)? Findings In this registry-based retrospective cohort study that included 3360 propensity-matched patients undergoing percutaneous coronary intervention for AMI, treatment with intravascular microaxial LVAD vs IABP was associated with a significantly higher risk of in-hospital death (45.0% vs 34.1%) and in-hospital major bleeding (31.3% vs 16.0%). Meaning The use of intravascular microaxial LVAD compared with IABP may be associated with worse in-hospital clinical outcomes among patients with AMI and cardiogenic shock undergoing percutaneous coronary intervention, although study interpretation is limited by the observational design.