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First-Pass Recanalization with EmboTrap II in Acute Ischemic Stroke (FREE-AIS): A Multicenter Prospective Study

  • Jang-Hyun Baek (Department of Neurology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine) ;
  • Byung Moon Kim (Interventional Neuroradiology, Department of Radiology, Severance Stroke Center, Severance Hospital, Yonsei University College of Medicine) ;
  • Sang Hyun Suh (Department of Radiology, Gangnam Severance Hospital, Yonsei University College of Medicine) ;
  • Hong-Jun Jeon (Department of Neurosurgery, Kangdong Sacred Heart Hospital, Hallym University College of Medicine) ;
  • Eun Hyun Ihm (Department of Neurosurgery, Andong Hospital) ;
  • Hyungjong Park (Department of Neurology, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine ) ;
  • Chang-Hyun Kim (Department of Neurosurgery, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine) ;
  • Sang-Hoon Cha (Department of Radiology, Chungbuk National University Hospital) ;
  • Chi-Hoon Choi (Department of Radiology, Chungbuk National University Hospital) ;
  • Kyung Sik Yi (Department of Radiology, Chungbuk National University Hospital) ;
  • Jun-Hwee Kim (Department of Radiology, Yongin Severance Hospital, Yonsei University College of Medicine) ;
  • Sangil Suh (Department of Radiology, Korea University Guro Hospital, Korea University College of Medicine) ;
  • Byungjun Kim (Department of Radiology, Korea University Anam Hospital, Korea University College of Medicine) ;
  • Yoonkyung Chang (Department of Neurology, Mokdong Hospital, Ewha Womans University College of Medicine) ;
  • So Yeon Kim (Department of Neurosurgery, International St. Mary's Hospital, Catholic Kwandong University) ;
  • Jae Sang Oh (Department of Neurosurgery, College of Medicine, Soonchunhyang University, Cheonan Hospital) ;
  • Ji Hoe Heo (Department of Neurology, Severance Stroke Center, Severance Hospital, Yonsei University College of Medicine) ;
  • Dong Joon Kim (Interventional Neuroradiology, Department of Radiology, Severance Stroke Center, Severance Hospital, Yonsei University College of Medicine) ;
  • Hyo Suk Nam (Department of Neurology, Severance Stroke Center, Severance Hospital, Yonsei University College of Medicine) ;
  • Young Dae Kim (Department of Neurology, Severance Stroke Center, Severance Hospital, Yonsei University College of Medicine)
  • Received : 2022.08.25
  • Accepted : 2022.12.11
  • Published : 2023.02.01

Abstract

Objective: We aimed to evaluate the efficacy of EmboTrap II in terms of first-pass recanalization and to determine whether it could yield favorable outcomes. Materials and Methods: In this multicenter, prospective study, we consecutively enrolled patients who underwent mechanical thrombectomy using EmboTrap II as a front-line device. The primary outcome was the first pass effect (FPE) rate defined by modified Thrombolysis In Cerebral Infarction (mTICI) grade 2c or 3 by the first pass of EmboTrap II. In addition, modified FPE (mFPE; mTICI grade 2b-3 by the first pass of EmboTrap II), successful recanalization (final mTICI grade 2b-3), and clinical outcomes were assessed. We also analyzed the effect of FPE on a modified Rankin Scale (mRS) score of 0-2 at 3 months. Results: Two hundred-ten patients (mean age ± standard deviation, 73.3 ± 11.4 years; male, 55.7%) were included. Ninety-nine patients (47.1%) had FPE, and mFPE was achieved in 150 (71.4%) patients. Successful recanalization was achieved in 191 (91.0%) patients. Among them, 164 (85.9%) patients underwent successful recanalization by exclusively using EmboTrap II. The time from groin puncture to FPE was 25.0 minutes (interquartile range, 17.0-35.0 minutes). Procedure-related complications were observed in seven (3.3%) patients. Symptomatic intracranial hemorrhage developed in 14 (6.7%) patients. One hundred twenty-three (58.9% of 209 completely followed) patients had an mRS score of 0-2. Sixteen (7.7% of 209) patients died during the follow-up period. Patients who had successful recanalization with FPE were four times more likely to have an mRS score of 0-2 than those who had successful recanalization without FPE (adjusted odds ratio, 4.13; 95% confidence interval, 1.59-10.8; p = 0.004). Conclusion: Mechanical thrombectomy using the front-line EmboTrap II is effective and safe. In particular, FPE rates were high. Achieving FPE was important for an mRS score of 0-2, even in patients with successful recanalization.

Keywords

Acknowledgement

This study (CSS-CNV-19-007) was investigator-initiated and supported by a grant from Cerenovus.

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