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

Abstract

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

MASTRO I: Meta-Analysis and Systematic Review of thrombectomy stent retriever outcomes: comparing functional, safety and recanalization outcomes between EmboTrap, Solitaire and Trevo in acute ischemic stroke

“…ARISE II found that 5.3% of trial patients experienced a sICH, while the rate in real-world studies ranged from 0.0% to 6.3% [ 30 , 33 , 43 , 63 ]. These studies were recently published in a single-arm review of EmboTrap treatment that corroborates our EmboTrap-specific findings: Bai et al [ 76 ] meta-analyzed the aforementioned studies as well as two publications that report EmboTrap in combination with aspiration catheters [ 77 , 78 ]. Bai et al corroborated the findings of MASTRO I, in that rates of successful mTICI 2b–3 (90%) and mFPR mTICI 2b/3 (43%) were slightly higher than our findings, while FPR mTICI 2c/3 (36%) and mRS 0–2 (53%) were slightly lower.…”

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

“…Third, distal embolism during retraction may be limited by a distal closed structure at the tip of the stent [ 20 21 22 ]. Fourth, the inner closed-cell stent might stabilize the engaged clot during retrieval [ 28 29 ].…”

Thrombectomy Using the EmboTrap Clot-Retrieving Device for the Treatment of Acute Ischemic Stroke: A Glimpse of Clinical Evidence

“…8 Several trials have demonstrated the clinical benefit and superior reperfusion efficacy of MT using stent-retriever thrombectomy devices over standard medical therapy in treating AIS-LVO. [4][5][6][7][8][9][10] In the guidelines from American Heart Association/American Stroke Association, MT using stent retrievers has been recommended. 5 The EmboTrap Thrombectomy Device was originally designed for more effectively trapping, retaining, and removing clots through its unique design of dual-layer and a distal capture zone.…”

“…A total of 1230 patients were eligible for inclusion criteria. [8][9][10][11][12][19][20][21][22] Among the pooled studies, 6 studies and 1070 individuals used the EmboTrap II device only, and the remaining 3 studies and 160 individuals used the EmboTrap System only. The inclusion and exclusion criteria of patients in included studies are summarized in the Online Supplemental Data.…”

“…[6][7][8] The EmboTrap Revascularization Device is an innovative stent retriever used to retrieve clots and restore blood flow. [8][9][10][11][12] It offers a 2-layer structure designed with articulating petals and a distal capture zone for successful trapping, retention, and removal of diverse clot types to restore blood flow in AIS-LVO. The inner layer is a closed-cell stent, which aims to restore blood flow immediately.…”