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美国 EmboTrap 再通装置治疗缺血性脑卒中的真实世界结局。

Real-world outcomes associated with the use of the EmboTrap revascularization device for ischemic stroke in the United States.

机构信息

Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.

Franchise Health Economics and Market Access, Johnson and Johnson, Irvine, California, USA.

出版信息

J Neurointerv Surg. 2022 Nov;14(11):1068-1072. doi: 10.1136/neurintsurg-2021-018175. Epub 2021 Nov 8.

DOI:10.1136/neurintsurg-2021-018175
PMID:34750107
Abstract

BACKGROUND

Mechanical thrombectomy (MT) has become the standard of care for the treatment of acute ischemic stroke (AIS). The EmboTrap revascularization device (CERENOVUS, Johnson & Johnson Medical Devices, Irvine, California, USA) has an innovative, dual layer feature designed to facilitate thrombus retrieval.

OBJECTIVE

To investigate the real-world clinical and economic outcomes among patients with AIS undergoing MT using the EmboTrap device in the United States (US).

METHODS

Adult patients (≥18 years) who underwent MT for AIS using the EmboTrap device between July 2018 and December 2020 were identified from the Premier Healthcare Database. Patient outcomes included discharge status (including in-hospital mortality), mean length of stay (LOS), intracranial hemorrhage (ICH), mean hospital costs, and 30-day readmissions (all-cause, cardiovascular (CV)-related, and AIS-related).

RESULTS

A total of 318 patients (mean age 68.5±14.6 years) with AIS treated with the EmboTrap device as the only stent retriever used were identified. Approximately 25% of patients were discharged to home/home health organization, and the in-hospital mortality rate was 10.7%. The rate of ICH was 16.7%. Mean hospital LOS was 9.9±11.3 days, and the mean hospital costs were US$47 367±30 297. The 30-day readmission rate was 9.6% for all-causes, 5.9% for CV-related causes, and 2.6% for AIS-related causes.

CONCLUSIONS

This is the first study in the US to report real-world outcomes sourced by retrospective database analysis among patients with AIS undergoing MT using the EmboTrap device. Further research is needed to better understand performance of the EmboTrap device in real-world settings.

摘要

背景

机械血栓切除术(MT)已成为治疗急性缺血性脑卒中(AIS)的标准治疗方法。EmboTrap 再通装置(CERENOVUS,强生医疗器材公司,美国加利福尼亚州欧文市)具有创新性的双层设计,旨在促进血栓取出。

目的

在美国(US)使用 EmboTrap 装置治疗 AIS 的患者中,调查真实世界的临床和经济结局。

方法

从 Premier Healthcare Database 中确定了 2018 年 7 月至 2020 年 12 月期间使用 EmboTrap 装置进行 MT 的成年 AIS 患者。患者结局包括出院状态(包括院内死亡率)、平均住院时间(LOS)、颅内出血(ICH)、平均医院费用和 30 天再入院(全因、心血管(CV)相关和 AIS 相关)。

结果

共确定了 318 例(平均年龄 68.5±14.6 岁)使用 EmboTrap 装置作为唯一支架取栓器治疗的 AIS 患者。约 25%的患者出院回家/家庭健康组织,院内死亡率为 10.7%。ICH 发生率为 16.7%。平均住院 LOS 为 9.9±11.3 天,平均医院费用为 47367 美元±30297 美元。全因 30 天再入院率为 9.6%,CV 相关原因 5.9%,AIS 相关原因 2.6%。

结论

这是美国第一项使用 EmboTrap 装置治疗 AIS 的 MT 患者进行回顾性数据库分析的真实世界结局研究。需要进一步研究以更好地了解 EmboTrap 装置在真实环境中的表现。

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