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Original research
Early post-Humanitarian Device Exemption experience with the Neuroform Atlas stent
  1. Jenny P Tsai,
  2. Julian Hardman,
  3. Nina Z Moore,
  4. M Shazam Hussain,
  5. Mark D Bain,
  6. Peter A Rasmussen,
  7. Thomas J Masaryk,
  8. Mohammed H Elgabaly,
  9. Lila Sheikhi,
  10. Gabor Toth
  1. Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA
  1. Correspondence to Dr Gabor Toth, Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio 44195, USA; tothg{at}ccf.org

Abstract

Introduction The low-profile Neuroform Atlas stent received FDA Humanitarian Device Exemption status (HDE) in January 2018 for stent-assisted coil embolization of wide-necked saccular aneurysms. We review and report our results with the Atlas stent in our institution within the first year after its HDE approval.

Methods Our retrospective chart review identified patients treated with the Atlas stent. We analyzed the patient demographics, aneurysm characteristics, stent parameters and configuration, complications, angiographic, and clinical outcomes at discharge.

Results From January to December 2018, 76 Atlas stents were deployed in 58 patients (average 1.3 stents/patient). Median patient age was 63.5 (IQR 56–71) years. Fifty-six (96.6%) patients had elective embolization of unruptured aneurysms, while two (3.4%) patients underwent embolization of a ruptured aneurysm within 2 weeks of subarachnoid hemorrhage. Forty (69.0%) patients were treated with a single stent, 15 (25.9%) with a Y-stent, and three (5.2%) with X-stent configuration. All stent deployments were technically successful. Most stents (82.9%) were the smallest 3 mm diameter devices. Procedural complications included transient stent-associated thrombosis in three (5.2%) patients and aneurysm rupture in one (1.7%). None had distal embolization, associated cerebral infarction, or permanent neurological deficits. Immediate Raymond–Roy 1 occlusion was achieved in 41 (70.7%) patients. Median hospital length of stay for elective aneurysm embolization was 1 day. Excellent outcomes with median National Institute of Health Stroke Scale score 0 (IQR 0–0) and modified Rankin Score 0 (IQR 0–1) were seen for elective patients at discharge.

Conclusion The Neuroform Atlas stent provided a reliable technical and safety profile for the treatment of intracranial wide-neck aneurysms. Further experience is needed to determine long-term durability and safety of this device.

  • aneurysm
  • angiography
  • device
  • intervention
  • stent
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Footnotes

  • Contributors JT: drafting of manuscript, interpretation of data, data analysis, acquisition of data, critical revision of manuscript. JH: drafting of manuscript, acquisition of data, interpretation of data, critical revision of manuscript. NM, ME: acquisition of data, critical revision of manuscript. MSH, MB, PAR, LS: interpretation of data, critical revision of manuscript. TM: acquisition of data, interpretation of data, critical revision of manuscript. GT: study conception and supervision, drafting of manuscript, acquisition of data, interpretation of data, critical revision of manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests MB is a consultant for Rebound Therapeutics and Stryker Neurovascular. MSH is a consultant for Cerenovus. PAR is on the Medical Advisory Board for Mehana Medical, Stryker Neurovascular, Medtronic Neurovascular, Perflow Medical, and has an Equity Position in Mehana Medical, Perflow Medical, and Bard Neurovascular. GT is a consultant for Dynamed EBSCO.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Anonymized data may be shared by request from a qualified investigator in compliance with our Institution’s data sharing policies.

  • Patient consent for publication Not required.

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