Background We studied patients treated with the EmboTrap revascularization device in a prospective registry which is core laboratory evaluated by physicians from external centers. The goal was to determine how the EmboTrap would perform under the everyday conditions of a high-volume stroke center.
Methods We examined all patients with acute stroke treated with the Embotrap device from October 2013 to March 2017 in our center. Imaging parameters and times were adjudicated by core laboratory personnel blinded to clinical information, treating physician, and clinical outcomes. Clinical evaluation was performed by independent neurologists and entered in a national registry. Evaluated endpoints were: successful revascularization (modified Thrombolysis in Cerebral Infarction (mTICI) 2b–3) and good clinical outcomes at 3 months (modified Rankin Scale (mRS) 0–2).
Results 201 consecutive patients with a median NIH Stroke Scale (NIHSS) score of 15 (range 2–30) were included. 170 patients (84.6%) achieved mTICI 2b–3 reperfusion. The median number of attempts was 2 (range 1–10) with 52.8% of the population achieving good functional outcomes (mRS 0–2) at 3 months. On univariate analysis, good functional outcome was associated with the number of attempts, puncture-to-reperfusion time, anterior circulation occlusion, and NIHSS score. On multivariate analysis, pre-treatment NIHSS (OR 0.845 per point, 95% CI 0.793 to 0.908, P<0.001) and puncture-to-reperfusion time (OR 0.9952 per min, 95% CI 0.9914 to 0.9975, P=0.023) were associated with good functional outcomes at 3 months.
Conclusion The Embotrap device has a high rate of successful reperfusion. Our core laboratory-audited single-center experience suggests the technical feasibility and safety of the Embotrap for first-line use in a real-world setting.
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Contributors PAB, AH, TA, MS: data gathering, editing and direction of the manuscript. LLLY: drafting the manuscript and data analysis. JK, AK, MO, SH, VKG, MA, PB: data gathering and editing of the manuscript.
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests TA, PAB and MS are consultants for Cerenovus. TA is a consultant for Ablynx, Amnis Therapeutics, Medtronic, Cerenovus, Rapid Medical and Stryker. PAB is a consultant for Medtronic, Stryker, Cerenovus and BALT. MS is a consultant for Medtronic, Cerenovus and Neurvana. PB is a consultant for Neurvana and Phenox. LLLY has received substantial grant funding from the National Medical Research Council (NMRC), Singapore, substantial grant funding from the Ministry of Health (MOH), Singapore and moderate grant funding from I2R, A-STAR, Singapore.
Patient consent Detail has been removed from this case description/these case descriptions to ensure anonymity. The editors and reviewers have seen the detailed information available and are satisfied that the information backs up the case the authors are making.
Ethics approval The study protocol was approved by the regional ethical committee in Stockholm (Regionala etikprövningsnämnden i Stockholm) Diarienr: 2016/1041-31/4.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Further data can be obtained by email request to the corresponding author.