Declining complication rates with flow diversion of anterior circulation aneurysms after introduction of the Pipeline Flex: analysis of a single-institution series of 568 cases

Restricted access

OBJECTIVE

The second-generation Pipeline embolization device (PED), Flex, has several design upgrades, including improved opening and the ability to be resheathed, in comparison with the original device (PED classic). The authors hypothesized that Flex is associated with a lower rate of major complications.

METHODS

A prospective, IRB-approved, single-institution database was analyzed for all patients with anterior circulation aneurysms treated by flow diversion. The PED classic was used from August 2011 to January 2015, and the Pipeline Flex has been used since February 2015.

RESULTS

A total of 568 PED procedures (252 classic and 316 Flex) were performed for anterior circulation aneurysms. The average aneurysm size was 6.8 mm. Patients undergoing treatment with the Flex device had smaller aneurysms (p = 0.006) and were more likely to have undergone previous treatments (p = 0.001). Most aneurysms originated along the internal carotid artery (89% classic and 75% Flex) but there were more anterior cerebral artery (18%) and middle cerebral artery (7%) deployments with Flex (p = 0.001). Procedural success was achieved in 96% of classic and 98% of Flex cases (p = 0.078). Major morbidity or death occurred in 3.5% of cases overall: 5.6% of classic cases, and 1.9% of Flex cases (p = 0.019). On multivariate logistic regression, predictors of major complications were in situ thrombosis (OR 4.3, p = 0.006), classic as opposed to Flex device (OR 3.7, p = 0.008), and device deployment in the anterior cerebral artery or middle cerebral artery as opposed to the internal carotid artery (OR 3.5, p = 0.034).

CONCLUSIONS

Flow diversion of anterior circulation cerebral aneurysms is associated with an overall low rate of major complications. The complication rate is significantly lower since the introduction of the second-generation PED (Flex).

ABBREVIATIONS ACA = anterior cerebral artery; Cat5 = AXS Catalyst 5; ICA = internal carotid artery; ICH = intracranial hemorrhage; IntrePED = International Retrospective Study of the Pipeline Embolization Device; MCA = middle cerebral artery; PED = Pipeline embolization device; PRU = P2Y12 reaction units; PUFS = Pipeline for Uncoilable or Failed Aneurysms; SAH = subarachnoid hemorrhage; TIA = transient ischemic attack.
Article Information

Contributor Notes

Correspondence Alexander Coon: Johns Hopkins Medicine, Baltimore, MD. acoon2@jhmi.edu.INCLUDE WHEN CITING Published online January 12, 2018; DOI: 10.3171/2017.7.JNS171289.

Drs. Colby and Bender share first authorship of this work.

Disclosures Dr. Colby: consultant for MicroVention; and research support from and participant in clinical trials for Medtronic and Stryker. Dr. Lin: consultant for Medtronic Neurovascular; and receives research support from MicroVention and Stryker. Dr. Huang: ownership in Longeviti. Dr. Coon: consultant and proctor for Stryker Neurovascular, Medtronic, and MicroVention.

© AANS, except where prohibited by US copyright law.

Headings
References
  • 1

    Becske TKallmes DFSaatci IMcDougall CGSzikora ILanzino G: Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology 267:8588682013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 2

    Bender MTLin LMColby GPLubelski DHuang JTamargo RJ: P2Y12 hyporesponse (PRU>200) is not associated with increased thromboembolic complications in anterior circulation Pipeline. J Neurointerv Surg 9:9789812017

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 3

    Briganti FDelehaye LLeone GSicignano CBuono GMarseglia M: Flow diverter device for the treatment of small middle cerebral artery aneurysms. J Neurointerv Surg 8:2872942016

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 4

    Brinjikji WLanzino GCloft HJSiddiqui AHBoccardi ECekirge S: Risk factors for ischemic complications following Pipeline Embolization Device treatment of intracranial aneurysms: results from the IntrePED study. AJNR Am J Neuroradiol 37:167316782016

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 5

    Burrows AMCloft HKallmes DFLanzino G: Periprocedural and mid-term technical and clinical events after flow diversion for intracranial aneurysms. J Neurointerv Surg 7:6466512015

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6

    Chalouhi NZanaty MWhiting AYang STjoumakaris SHasan D: Safety and efficacy of the Pipeline Embolization Device in 100 small intracranial aneurysms. J Neurosurg 122:149815022015

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 7

    Colby GPBender MTLin LMBeaty NHuang JTamargo RJ: Endovascular flow diversion for treatment of anterior communicating artery region cerebral aneurysms: a single-center cohort of 50 cases. J Neurointerv Surg 9:6796852017

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8

    Colby GPLin LMCaplan JMJiang BHuang JTamargo RJ: Immediate procedural outcomes in 44 consecutive Pipeline Flex cases: the first North American single-center series. J Neurointerv Surg 8:7027092016

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9

    Colby GPLin LMGomez JFPaul ARHuang JTamargo RJ: Immediate procedural outcomes in 35 consecutive pipeline embolization cases: a single-center, single-user experience. J Neurointerv Surg 5:2372462013

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 10

    Colby GPLin LMXu RBeaty NBender MTJiang B: Utilization of a novel, multi-durometer intracranial distal access catheter: nuances and experience in 110 consecutive cases of aneurysm flow diversion. Interv Neurol 6:901042017

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 11

    Delgado Almandoz JECrandall BMScholz JMFease JLAnderson REKadkhodayan Y: Last-recorded P2Y12 reaction units value is strongly associated with thromboembolic and hemorrhagic complications occurring up to 6 months after treatment in patients with cerebral aneurysms treated with the pipeline embolization device. AJNR Am J Neuroradiol 35:1281352014

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 12

    Griessenauer CJOgilvy CSForeman PMChua MHHarrigan MRHe L: Pipeline Embolization Device for small intracranial aneurysms: evaluation of safety and efficacy in a multicenter cohort. Neurosurgery 80:5795872017

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 13

    Jabbour PChalouhi NTjoumakaris SGonzalez LFDumont ASRandazzo C: The Pipeline Embolization Device: learning curve and predictors of complications and aneurysm obliteration. Neurosurgery 73:1131202013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 14

    Kallmes DFBrinjikji WBoccardi ECiceri EDiaz OTawk R: Aneurysm Study of Pipeline in an Observational Registry (ASPIRe). Interv Neurol 5:89992016

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 15

    Kallmes DFHanel RLopes DBoccardi EBonafé ACekirge S: International retrospective study of the pipeline embolization device: a multicenter aneurysm treatment study. AJNR Am J Neuroradiol 36:1081152015

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16

    Le EJMiller TSerulle YShivashankar RJindal GGandhi D: Use of Pipeline Flex is associated with reduced fluoroscopy time, procedure time, and technical failure compared with the first-generation Pipeline embolization device. J Neurointerv Surg 9:1881912016

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 17

    Lin LMColby GPBender MTXu RHuang JTamargo RJ: Use of the 0.027-inch VIA microcatheter for delivery of Pipeline Flex: a technical note. J Neurointerv Surg 9:6896932017

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 18

    Lin LMColby GPKim JEHuang JTamargo RJCoon AL: Immediate and follow-up results for 44 consecutive cases of small (<10 mm) internal carotid artery aneurysms treated with the pipeline embolization device. Surg Neurol Int 4:1141232013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19

    Martínez-Galdámez MGil ACaniego JLGonzalez EBárcena EPérez S: Preliminary experience with the Pipeline Flex Embolization Device: technical note. J Neurointerv Surg 7:7487512015

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 20

    Martínez-Galdámez MPérez SVega ARuiz PCaniego JLBárcena E: Endovascular treatment of intracranial aneurysms using the Pipeline Flex embolization device: a case series of 30 consecutive patients. J Neurointerv Surg 8:3964012016

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 21

    Martínez-Galdámez MRomance AVega PVega ACaniego JLPaul L: Pipeline endovascular device for the treatment of intracranial aneurysms at the level of the circle of Willis and beyond: multicenter experience. J Neurointerv Surg 7:8168232015

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 22

    Mooney MAMoon KGross BADucruet AFAlbuquerque FC: Incidence of delivery wire recapture failure with the Pipeline Flex device. J Neurointerv Surg 9:5715732017

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 23

    Yu SCKwok CKCheng PWChan KYLau SSLui WM: Intracranial aneurysms: midterm outcome of pipeline embolization device—a prospective study in 143 patients with 178 aneurysms. Radiology 265:8939012012

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
TrendMD
Metrics

Metrics

All Time Past Year Past 30 Days
Abstract Views 712 712 105
Full Text Views 342 342 14
PDF Downloads 250 250 9
EPUB Downloads 0 0 0
PubMed
Google Scholar