Abstract

Introduction: Larger distal access catheter systems for treatment of acute intracranial vessel occlusion enable both clot aspiration and introduction of flow restoration devices. We present the first clinical data of a large lumen hyperflexible intracranial distal aspiration catheter (ReFlex™ 5F, 058” ID x 125cm, Covidien, Irvine, CA) combined with the ReStore™ Thrombectomy microcatheter (Reverse Medical, Irvine, CA) for endovascular treatment of acute ischemic stroke. Patients and Methods: The ReStore™ consists of a flexible, tapered microcatheter with a braided mesh retrieval element attached to its distal segment. The retrieval element is deployed through the advancement of a guidewire or the ReAct™ stylet through the lumen to radially expand the retrieval element. Infusion of rt-PA within the thrombus is possible through small side holes of the ReStore™. Nine patients (62 y - 88 y, 5f/4m) with acute occlusion of the MCA were treated with the combination of ReStore™ and the ReFlex™ aspiration catheter within 6 hours after symptom onset. Median NIHSS score upon arrival was 16 (range 8 - 18). TICI flow in the target vessel segment was assessed prior and after recanalization procedure. Results: Thrombectomy with the combination of ReStore™ and ReFlex™ was performed as initial mechanical treatment in 8 cases. In one case, prior treatment with other stentriever systems failed, whereas the combination of ReStore™ and ReFlex™ lead to TICI 3. TICI 2b or 3 was achieved in 7 patients (77.8%); in 2 patients, TICI 2a was achieved. Immediate flow restoration while activating ReStore™ was accomplished in all 9 cases. Mean time from first angiopgraphy to first perfusion was 39.1 min (range 9-88 min). In 4 cases, additional rt-PA (10 mg) was administered directly into the thrombus through the ReStore™. In 2 cases, subsequent implantation of a permanent intracranial stent was performed. The mean number of ReStore™ activations to achieve final TICI score was 2.2 ± 1.1. One patient experienced periprocedural subarachnoid hemorrhage as a severe adverse event. Conclusion: The combination of ReStore™ and the ReFlex™ aspiration catheter is a promising new treatment option for both flow restoration and aspiration in patients suffering from acute intracranial arterial occlusion.

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