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Original research
Real-world outcomes associated with the use of the EmboTrap revascularization device for ischemic stroke in the United States
  1. Waleed Brinjikji1,
  2. Shelly Ikeme2,
  3. Emilie Kottenmeier2,
  4. Alia Khaled2,
  5. Sidharth M3,
  6. Rahul Khanna4
  1. 1Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA
  2. 2Franchise Health Economics and Market Access, Johnson and Johnson, Irvine, California, USA
  3. 3Mu Sigma, Inc, Bangalore, Karnataka, India
  4. 4Medical Device Epidemiology and Real-World Data Sciences, Johnson and Johnson, New Brunswick, New Jersey, USA
  1. Correspondence to Dr Rahul Khanna, Medical Device Epidemiology and Real-World Data Sciences, Johnson and Johnson, New Brunswick, New Jersey, 08901, USA; rkhann14{at}its.jnj.com

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.

  • stroke
  • thrombectomy

Data availability statement

Data are available upon reasonable request.

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Data availability statement

Data are available upon reasonable request.

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Footnotes

  • Contributors SI, EK, AK, and RK were involved in study design, results interpretation, and manuscript development. RK and SM were involved in data analysis. WB was involved in results interpretation and manuscript development. RK is is responsible for the overall content as the guarantor.

  • Funding This study was sponsored by CERENOVUS, Johnson & Johnson.

  • Competing interests SI, EK, AK, and RK are Johnson and Johnson employees. SM is an employee of MuSigma Inc, which has a consulting agreement with Johnson and Johnson. WB consults for Johnson and Johnson, Medtronic, Stryker, Microvention, and MIVI Neuroscience.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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