Safety, Technical and Clinical Success of the Aperio Hybrid Thrombectomy Device in Acute Ischemic Stroke, a Prospective Post-market Clinical Follow-up Study (HYBRID)

TL;DR

This study evaluates the Aperio Hybrid Thrombectomy Device for treating acute ischemic stroke, finding it to be safe and effective in real-world clinical settings.

Contribution

The study provides real-world clinical data on the Aperio Hybrid device's safety and effectiveness in treating stroke.

Findings

Technical recanalization success was achieved in 84.4% of cases using the AHD.

Good clinical outcomes (mRS ≤ 2 at 90 days) were observed in 68.8% of patients.

The device showed a high first-pass success rate of 47.4%.

Abstract

Stentretrievers 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® Hybrid/Hybrid17|21 thrombectomy device (AHD) in routine clinical use.

We conducted a prospectively monitored, multicenter, national registry study with single-arm data collection including patients with acute intracranial vessel occlusion (anterior and posterior circulation, including medium vessel occlusions) who were treated with the AHD in Germany between November 2020 and June 2023. Patients (n = 173) with low pre-stroke morbidity (modified Rankin Scale [mRS] ≤ 2) were included. We assessed technical recanalization success (mTICI ≥ 2b), the occurrence of periprocedural symptomatic intracranial hemorrhages (sICH), good clinical outcome (mRS ≤ 2 at 90 days), and secondary outcomes.

Recanalization mTICI ≥ 2b was achieved in 84.4% with the AHD only, including 47.4% first pass success. Good clinical outcome at 90 days (mRS ≤ 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.

The 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.

The online version of this article (10.1007/s00062-025-01578-5) contains supplementary material, which is available to authorized users.

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