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  • Predictors of incomplete aneurysm occlusion after treatment with the Pipeline Embolization Device: PREMIER trial 1 year analysis

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Hemorrhagic stroke
Original research
Predictors of incomplete aneurysm occlusion after treatment with the Pipeline Embolization Device: PREMIER trial 1 year analysis
  1. Ricardo A Hanel1,
  2. Andre Monteiro1,
  3. Peter K Nelson2,
  4. Demetrius K Lopes3,
  5. David F Kallmes4
  1. 1 Cerebrovascular and Endovascular Surgery, Lyerly Neurosurgery and Baptist Medical Center, Jacksonville, FL, USA
  2. 2 Radiology, NYU Langone Medical Center Neuroradiology Section, New York, New York, USA
  3. 3 Brain and Spine Institute, Advocate Aurora Health, Park Ridge, Illinois, USA
  4. 4 Interventional Neuroradiology, Mayo Clinic, Rochester, Minnesota, USA
  1. Correspondence to Dr Ricardo A Hanel, Lyerly Neurosurgery, Baptist Medical Center Downtown, Jacksonville, FL 32207, USA; rhanel{at}lyerlyneuro.com

Abstract

Background Flow diverters have revolutionized the treatment of intracranial aneurysms. Nevertheless, some aneurysms fail to occlude with flow diversion. The Prospective Study on Embolization of Intracranial Aneurysms with the Pipeline Device (PREMIER) was a prospective, multicenter and single-arm trial of small and medium wide-necked unruptured aneurysms. In the current study, we evaluate the predictors of treatment failure in the PREMIER cohort.

Methods We analyzed PREMIER patients who had incomplete occlusion (Raymond-Roy >1) at 1 year angiographic follow-up and compared them with those who achieved Raymond-Roy 1, aiming to identify predictors of treatment failure.

Results 25 aneurysms demonstrated incomplete occlusion at 1 year. There was a median reduction of 0.9 mm (IQR 0.41–2.43) in maximum diameter between pre-procedure and 1 year measurements, with no aneurysmal hemorrhage. Patients with incomplete occlusion were significantly older than those with complete occlusion (p=0.011). Smoking (p=0.045) and C6 segment location (p=0.005) were significantly associated with complete occlusion, while location at V4 (p=0.01) and C7 (p=0.007) and involvement of a side branch (p<0.001) were significantly associated with incomplete occlusion. In multivariable logistic regression, significant predictors of incomplete occlusion were non-smoker status (adjusted OR 4.49, 95% CI 1.11 to 18.09; p=0.03) and side branch involvement (adjusted OR 11.68, 95% CI 3.84 to 35.50; p<0.0001), while C6 location had reduced odds of incomplete occlusion (adjusted OR 0.29, 95% CI 0.10 to 0.84; p=0.02).

Conclusions The results of our study are consistent with previous retrospective series and warrant consideration for technique adaptations to achieve higher occlusion rates. Further follow-up is needed to assess progression of aneurysm occlusion and clinical behavior in these cases.

  • aneurysm
  • flow diverter
  • intervention
  • hemorrhage

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/neurintsurg-2021-018054

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Twitter @andremonteiromd, @cure4stroke

    • Contributors In addition to the guarantor of this work (RH), all authors were involved and made substantial contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of the data; drafting the work or revising it critically for important intellectual content; final approval of the version published; and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

    • Funding The PREMIER study was supported by Medtronic, Inc.

    • Competing interests RAH is a consultant for Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel. He is on the advisory board for MiVI, eLum, Three Rivers, Shape Medical and Corindus. Unrestricted research grant from NIH, Interline Endowment, Microvention, Stryker, CNX. Ivestor/stockholder for InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. DKL reports conflicts of interest with Medtronic, being the national PI of the ADVANCE trial, receiving research grants and being part of their Advisory Board. All the other authors have no disclosure to report. PKN is a consultant for Phenox GmbH. DFK is president of Marblehead Medical and has patents pending in balloon catheter technologies. He has received research support from Medtronic, MicroVention, NeuroSave, Neurogami, Sequent Medical, NeuroSigma, and Insera, and also serves on the Scientific Advisory Board for Triticum and Boston Scientific. PKN is a consultant for Medtronic.

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

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.