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Abstract
PurposeThe purpose of this study was to analyze the safety and efficacy of the pREset device, a stent retriever system, for endovascular mechanical thrombectomy (MT) in acute ischemic stroke (AIS) after middle cerebral artery (MCA) occlusion.MethodsRetrospectively, 48 consecutive patients (mean age ± standard deviation, 71.0 ± 11.9 years; 24 women) treated for acute MCA occlusion using pREset solely or in combination with other MT devices were identified. Recanalization success was evaluated using the modified thrombolysis in cerebral infarction score (TICI), and complications were detected by 24-h follow-up computed tomography or magnetic resonance imaging. MCA anatomy was assessed in angiograms. Clinical outcome was evaluated with National Institutes of Health Stroke Scale (NIHSS) score at admission and discharge, and modified Rankin scale (mRS) score at discharge and follow-up.ResultsSuccessful recanalization (TICI 2b/3) was achieved in 39 patients (81.3 %). Rate of procedure-related complications was 8.3 %. In four patients, a subarachnoid hemorrhage occurred (8.3 %), and parenchymal hematoma was detected in four patients (8.3 %). None of those events was associated with clinical deterioration. MCA curvature significantly influenced recanalization success (P < 0.005).Successful recanalization correlated significantly with lower NIHSS scores and favorable clinical outcome (mRS score 0–2) at discharge (P < 0.05). Mortality within 90 days was significantly lower in patients with TICI 2b/3 (P < 0.005).ConclusionsHigh recanalization rates, low complication rates, and a significantly improved outcome after successful recanalization strongly suggest that MT with pREset is an adequate therapy for AIS after MCA occlusion. Vessel curvature is a significant determining factor for recanalization success.
Highlights
Acute ischemic stroke (AIS) is one of the leading causes of morbidity and mortality in industrialized countries, with increasing importance due to the aging population [1]
We have shown that treatment of AIS caused by middle cerebral artery (MCA) occlusion using the pREset stent retriever is associated with high recanalization rates and a low risk of procedurerelated complications such as vessel perforation, dissection, or thrombus dispersion
Compared with the results reported by postmarketing registries such as the North American Solitaire Stent Retriever Registry (42 %) and the European Endostroke Registry (41 %), the percentage of patients included in this study presenting with a favorable neurological outcome at mid-term follow-up was very similar (41.9 %) [17, 37]
Summary
Acute ischemic stroke (AIS) is one of the leading causes of morbidity and mortality in industrialized countries, with increasing importance due to the aging population [1]. Previous randomized controlled trials (RCT), which analyzed clinical outcome after the treatment of AIS, after using first-generation devices such as the Penumbra aspiration system (Penumbra, Alameda, CA, USA) or Merci Retriever (Concentric Medical, Mountain View, CA, USA), showed no significant superiority of MT over IV rtPA [5,6,7]. Second-generation self-expanding, removable, stent-like thrombectomy devices—named stent retrievers—were developed. They are designed to be deployed within the thrombus, where the stent mesh partially penetrates the thrombotic material while expanding. This leads to adhesion of the clot to the stent retriever wall. Both the device and the thrombus are retrieved into an aspiration or guiding catheter
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