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

  1. Claudia Klüner
  2. Benedikt Sundermann
  3. Catalin George Iacoban
  4. Daniel Behme
  5. Kai Kallenberg
  6. Olaf Wunderlich
  7. Bernd Turowski
  8. Wolfgang Reith
  9. Thomas Liman
  10. Thilo Rusche
  11. Hannes Nordmeyer
  12. Christian Mathys
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Abstract

Background and Purpose

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/Hybrid 17|21 thrombectomy device (AHD) in routine clinical use.

Materials and Methods

Prospective 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.

Results

Recanalization mTICI ≥ 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 ≤ 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.

Conclusions

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.

Key messages

  • The most important instruments for endovascular stroke treatment, the stent retrievers, differ significantly in design and knowledge about the effects of these differences is limited.

  • The APERIO® Hybrid/Hybrid 17|21 thrombectomy device (AHD) is effective and safe.

  • Further studies are warranted to clarify, whether the superior outcomes identified in this registry study reflect true advantages of the AHD.

Article activity feed

  1. Version published to 10.1101/2025.04.01.25324903v1 on medRxiv