A Srivatsan1, V M Srinivasan1, R M Starke2, E C Peterson2, D R Yavagal2, A E Hassan3,4, A Alawieh5, A M Spiotta5, Y Saleem1, K M Fargen6, S Q Wolfe6, R A de Leacy7, I P Singh7, I L Maier8, J N Johnson1, J-K Burkhardt1, S R Chen9, P Kan10. 1. From the Department of Neurosurgery and Neurology (A.S., V.M.S., Y.S., J.N.J., J.-K.B., P.K.), Baylor College of Medicine, Houston, Texas. 2. Department of Neurosurgery (R.M.S., E.C.P., D.R.Y.), University of Miami Miller School of Medicine, Miami, Florida. 3. Department of Neurology and Radiology (A.E.H.), University of Texas Health Science Center San Antonio, San Antonio, Texas. 4. Department of Neurology (A.E.H.), University of Texas Rio Grande Valley, Harlingen, Texas. 5. Department of Neurosurgery (A.A., A.M.S.), Medical University of South Carolina, Charleston, South Carolina. 6. Department of Neurosurgery (K.M.F., S.Q.W.), Wake Forest University School of Medicine, Winston-Salem, North Carolina. 7. Department of Neurosurgery (R.A.d.L., I.P.S.), Mt. Sinai Icahn School of Medicine, New York, New York. 8. Department of Neurology (I.L.M.), University Medical Center Göttingen, Göttingen, Germany. 9. Department of Interventional Radiology (S.R.C.), MD Anderson Cancer Center, Houston, Texas. 10. From the Department of Neurosurgery and Neurology (A.S., V.M.S., Y.S., J.N.J., J.-K.B., P.K.), Baylor College of Medicine, Houston, Texas ptkan@utmb.edu.
Abstract
BACKGROUND AND PURPOSE: EmboTrap II is a novel stent retriever with a dual-layer design and distal mesh designed for acute ischemic stroke emergent large-vessel occlusions. We present the first postmarket prospective multicenter experience with the EmboTrap II stent retriever. MATERIALS AND METHODS: A prospective registry of patients treated with EmboTrap II at 7 centers following FDA approval was maintained with baseline patient characteristics, treatment details, and clinical/radiographic follow-up. RESULTS: Seventy patients were treated with EmboTrap II (mean age, 69.9 years; 48.6% women). Intravenous thrombolysis was given in 34.3%, and emergent large-vessel occlusions were located in the ICA (n = 18), M1 (n = 38), M2 or M3 (n = 13), and basilar artery (n = 1). The 5 × 33 mm device was used in 88% of cases. TICI ≥ 2b recanalization was achieved in 95.7% (82.3% in EmboTrap II-only cases), and first-pass efficacy was achieved in 35.7%. The NIHSS score improved from a preoperative average of 16.3 to 12.1 postprocedure and to 10.5 at discharge. An average of 2.5 [SD, 1.8] passes was recorded per treatment, including non-EmboTrap attempts. Definitive treatment was performed with an alternative device (aspiration or stent retriever) in 9 cases (12.9%). Some hemorrhagic conversion was noted in 22.9% of cases, of which 4.3% were symptomatic. There were no device-related complications. CONCLUSIONS: Initial postmarket results with the EmboTrap II stent retriever are favorable and comparable with those of other commercially available stent retrievers. Compared with EmboTrap II, the first-generation EmboTrap may have a higher first-pass efficacy; however, data are limited by retrospective case analysis, incomplete clinical follow-up, and small sample size, necessitating future trials.
BACKGROUND AND PURPOSE: EmboTrap II is a novel stent retriever with a dual-layer design and distal mesh designed for acute ischemic stroke emergent large-vessel occlusions. We present the first postmarket prospective multicenter experience with the EmboTrap II stent retriever. MATERIALS AND METHODS: A prospective registry of patients treated with EmboTrap II at 7 centers following FDA approval was maintained with baseline patient characteristics, treatment details, and clinical/radiographic follow-up. RESULTS: Seventy patients were treated with EmboTrap II (mean age, 69.9 years; 48.6% women). Intravenous thrombolysis was given in 34.3%, and emergent large-vessel occlusions were located in the ICA (n = 18), M1 (n = 38), M2 or M3 (n = 13), and basilar artery (n = 1). The 5 × 33 mm device was used in 88% of cases. TICI ≥ 2b recanalization was achieved in 95.7% (82.3% in EmboTrap II-only cases), and first-pass efficacy was achieved in 35.7%. The NIHSS score improved from a preoperative average of 16.3 to 12.1 postprocedure and to 10.5 at discharge. An average of 2.5 [SD, 1.8] passes was recorded per treatment, including non-EmboTrap attempts. Definitive treatment was performed with an alternative device (aspiration or stent retriever) in 9 cases (12.9%). Some hemorrhagic conversion was noted in 22.9% of cases, of which 4.3% were symptomatic. There were no device-related complications. CONCLUSIONS: Initial postmarket results with the EmboTrap II stent retriever are favorable and comparable with those of other commercially available stent retrievers. Compared with EmboTrap II, the first-generation EmboTrap may have a higher first-pass efficacy; however, data are limited by retrospective case analysis, incomplete clinical follow-up, and small sample size, necessitating future trials.
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