Multicenter Postmarket Analysis of the Neuroform Atlas Stent for Stent-Assisted Coil Embolization of Intracranial Aneurysms

J-K Burkhardt; V Srinivasan; A Srivatsan; F Albuquerque; A F Ducruet; B Hendricks; B A Gross; B T Jankowitz; A J Thomas; C S Ogilvy; G A Maragkos; A Enriquez-Marulanda; R W Crowley; M R Levitt; L J Kim; C J Griessenauer; C M Schirmer; S Dalal; K Piper; M Mokin; E A Winkler; A A Abla; C McDougall; L Birnbaum; J Mascitelli; M Litao; O Tanweer; H Riina; J Johnson; S Chen; P Kan

doi:10.3174/ajnr.A6581

Multicenter Postmarket Analysis of the Neuroform Atlas Stent for Stent-Assisted Coil Embolization of Intracranial Aneurysms

AJNR Am J Neuroradiol. 2020 Jun;41(6):1037-1042. doi: 10.3174/ajnr.A6581. Epub 2020 May 28.

Authors

J-K Burkhardt¹, V Srinivasan², A Srivatsan², F Albuquerque³, A F Ducruet³, B Hendricks³, B A Gross⁴, B T Jankowitz⁵, A J Thomas⁶, C S Ogilvy⁶, G A Maragkos⁶, A Enriquez-Marulanda⁷, R W Crowley⁸, M R Levitt⁹, L J Kim⁹, C J Griessenauer^{10

11}, C M Schirmer^{10

11}, S Dalal¹⁰, K Piper¹², M Mokin¹², E A Winkler¹³, A A Abla¹³, C McDougall¹⁴, L Birnbaum¹⁴, J Mascitelli¹⁴, M Litao¹⁵, O Tanweer^{2

15}, H Riina¹⁵, J Johnson², S Chen², P Kan²

Affiliations

¹ From the Department of Neurosurgery (J.-K.B., V.S., A.S., O.T., J.J., S.C., P.K.), Baylor College of Medicine, Houston, Texas [email protected].
² From the Department of Neurosurgery (J.-K.B., V.S., A.S., O.T., J.J., S.C., P.K.), Baylor College of Medicine, Houston, Texas.
³ Department of Neurosurgery (F.A., A.F.D., B.H.), Barrow Neurological Institute, Phoenix, Arizona.
⁴ Department of Neurological Surgery (B.A.G.), University of Pittsburgh Medical Center Presbyterian, Pittsburgh, Pennsylvania.
⁵ Department of Neurosurgery (B.T.J.), Cooper University, Camden, New Jersey.
⁶ Beth Israel Deaconess Medical Center (A.J.T., C.S.O., G.A.M.), Harvard Medical School, Boston, Massachusetts.
⁷ Boston Medical Center (A.E.-M.), Boston, Massachusetts.
⁸ Department of Neurosurgery (R.W.C.), Rush Medical College, Chicago, Illinois.
⁹ Department of Neurological Surgery (M.R.L., L.J.K.), University of Washington, Seattle, Washington.
¹⁰ Department of Neurosurgery (C.J.G., C.M.S., S.D.), Geisinger Health, Danville, Pennsylvania.
¹¹ Research Institute of Neurointervention (C.J.G., C.M.S.), Paracelsus Medical University, Salzburg, Austria.
¹² Department of Neurosurgery (K.P., M.M.), University of Southern Florida College of Public Health, Tampa, Florida.
¹³ Department of Neurological Surgery (E.A.W., A.A.A.), University of California, San Francisco, San Francisco, California.
¹⁴ Department of Neurosurgery (C.M., L.B., J.M.), University of Texas Health San Antonio, San Antonio, Texas.
¹⁵ Department of Neurosurgery (M.L., O.T., H.R.), NYU Langone Medical Center, New York, New York.

Abstract

Background and purpose: The Neuroform Atlas is a new microstent to assist coil embolization of intracranial aneurysms that recently gained FDA approval. We present a postmarket multicenter analysis of the Neuroform Atlas stent.

Materials and methods: On the basis of retrospective chart review from 11 academic centers, we analyzed patients treated with the Neuroform Atlas after FDA exemption from January 2018 to June 2019. Clinical and radiologic parameters included patient demographics, aneurysm characteristics, stent parameters, complications, and outcomes at discharge and last follow-up.

Results: Overall, 128 aneurysms in 128 patients (median age, 62 years) were treated with 138 stents. Risk factors included smoking (59.4%), multiple aneurysms (27.3%), and family history of aneurysms (16.4%). Most patients were treated electively (93.7%), and 8 (6.3%) underwent treatment within 2 weeks of subarachnoid hemorrhage. Previous aneurysm treatment failure was present in 21% of cases. Wide-neck aneurysms (80.5%), small aneurysm size (<7 mm, 76.6%), and bifurcation aneurysm location (basilar apex, 28.9%; anterior communicating artery, 27.3%; and middle cerebral artery bifurcation, 12.5%) were common. A single stent was used in 92.2% of cases, and a single catheter for both stent placement and coiling was used in 59.4% of cases. Technical complications during stent deployment occurred in 4.7% of cases; symptomatic thromboembolic stroke, in 2.3%; and symptomatic hemorrhage, in 0.8%. Favorable Raymond grades (Raymond-Roy occlusion classification) I and II were achieved in 82.9% at discharge and 89.5% at last follow-up. mRS ≤2 was determined in 96.9% of patients at last follow-up. The immediate Raymond-Roy occlusion classification grade correlated with aneurysm location (P < .0001) and rupture status during treatment (P = .03).

Conclusions: This multicenter analysis provides a real-world safety and efficacy profile for the treatment of intracranial aneurysms with the Neuroform Atlas stent.

Publication types

Multicenter Study

MeSH terms

Adult
Aged
Blood Vessel Prosthesis*
Embolization, Therapeutic / instrumentation*
Female
Humans
Intracranial Aneurysm / therapy*
Male
Middle Aged
Product Surveillance, Postmarketing*
Retrospective Studies
Stents*
Treatment Outcome

Grants and funding

R21 NS109575/NS/NINDS NIH HHS/United States