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Safety, technical and clinical success of the Aperio Hybrid thrombectomy device in acute ischemic stroke, a prospective post-market clinical follow-up study (HYBRID)

Kluner, C.; Sundermann, B.; Iacoban, C.; Behme, D.; Kallenberg, K.; Wunderlich, O.; Turowski, B.; Reith, W.; Liman, T.; Rusche, T.; Nordmeyer, H.; Mathys, C.

2025-04-01 neurology
10.1101/2025.04.01.25324903 medRxiv
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Background and PurposeStentretrievers are key devices for endovascular treatment of acute ischemic stroke. Aim of this post market clinical follow-up study was to asses safety and outcomes of interventions using the APERIO(R) Hybrid/Hybrid17|21 thrombectomy device (AHD) in routine clinical use. Materials and MethodsProspective monitored multicentric national registry of patients with acute intracranial vessel occlusion treated with the AHD in Germany between 11/2020 and 06/2023. Inclusion of patients (n = 173) with low pre-stroke morbidity (mRS <= 2). Assessment of technical recanalization success (mTICI >= 2b), periprocedural symptomatic intracranial hemorrhages (sICH), good clinical outcome (mRS <= 2) at 90 days, and secondary outcomes. ResultsRecanalization mTICI [&ge;] 2b was achieved in 97.1 % of the patients, 84.4 % with the AHD only, including 47.4 % first pass success. Good clinical outcome at 90 days (mRS [&le;] 2) was observed in 68.8 %. Good primary safety outcome (no periprocedural sICH) was observed, notably even despite a high rate (79.8 %) of stentretriever oversizing. ConclusionsThe AHD is effective and safe. Technical success, primary safety and clinical outcomes surpassed earlier registries on different stentretrievers of the same and earlier generations. However, further studies are warranted to clarify whether these outcomes reflect true advantages of the device, improvements in thrombectomy setups and techniques, or selection biases. Key messagesO_LIThe most important instruments for endovascular stroke treatment, the stent retrievers, differ significantly in design and knowledge about the effects of these differences is limited. C_LIO_LIThe APERIO(R) Hybrid/Hybrid17|21 thrombectomy device (AHD) is effective and safe. C_LIO_LIFurther studies are warranted to clarify, whether the superior outcomes identified in this registry study reflect true advantages of the AHD. C_LI

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