Pipeline for uncoilable or failed aneurysms: 3-year follow-up results

Tibor Becske Departments of Radiology,
Neurology, and

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Matthew B. Potts Departments of Radiology,
Neurological Surgery, Neurointerventional Service, NYU School of Medicine, NYU Langone Medical Center, New York, New York;

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Maksim Shapiro Departments of Radiology,
Neurology, and

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David F. Kallmes Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota;

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Waleed Brinjikji Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota;

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Isil Saatci Department of Radiology, Bayindir Hospital, Ankara, Turkey;

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Cameron G. McDougall Department of Neurological Surgery, Barrow Neurological Institute, Phoenix, Arizona;

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István Szikora National Institute of Neurosciences, Budapest, Hungary;

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Giuseppe Lanzino Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota;

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Christopher J. Moran Division of Interventional Neuroradiology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri;

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Henry H. Woo Department of Neurosurgery, Stony Brook Hospital, Stony Brook, New York;

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Demetrius K. Lopes Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois;

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Aaron L. Berez Alembic, LLC, Mountain View;

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Daniel J. Cher Wild Iris Consulting, Palo Alto, California; and

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Adnan H. Siddiqui Departments of Neurological Surgery and Radiology, University of Buffalo, Buffalo, New York

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Elad I. Levy Departments of Neurological Surgery and Radiology, University of Buffalo, Buffalo, New York

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Felipe C. Albuquerque Department of Neurological Surgery, Barrow Neurological Institute, Phoenix, Arizona;

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David J. Fiorella Department of Neurosurgery, Stony Brook Hospital, Stony Brook, New York;

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Zsolt Berentei National Institute of Neurosciences, Budapest, Hungary;

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Miklós Marosföi National Institute of Neurosciences, Budapest, Hungary;

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Saruhan H. Cekirge Department of Radiology, Bayindir Hospital, Ankara, Turkey;

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Peter K. Nelson Departments of Radiology,
Neurological Surgery, Neurointerventional Service, NYU School of Medicine, NYU Langone Medical Center, New York, New York;

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OBJECTIVE

The long-term effectiveness of endovascular treatment of large and giant wide-neck aneurysms using traditional endovascular techniques has been disappointing, with high recanalization and re-treatment rates. Flow diversion with the Pipeline Embolization Device (PED) has been recently used as a stand-alone therapy for complex aneurysms, showing significant improvement in effectiveness while demonstrating a similar safety profile to stent-supported coil treatment. However, relatively little is known about its long-term safety and effectiveness. Here the authors report on the 3-year safety and effectiveness of flow diversion with the PED in a prospective cohort of patients with large and giant internal carotid artery aneurysms enrolled in the Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial.

METHODS

The PUFS trial is a prospective study of 107 patients with 109 aneurysms treated with the PED. Primary effectiveness and safety end points were demonstrated based on independently monitored 180-day clinical and angiographic data. Patients were enrolled in a long-term follow-up protocol including 1-, 3-, and 5-year clinical and imaging follow-up. In this paper, the authors report the midstudy (3-year) effectiveness and safety data.

RESULTS

At 3 years posttreatment, 74 subjects with 76 aneurysms underwent catheter angiography as required per protocol. Overall, complete angiographic aneurysm occlusion was observed in 71 of these 76 aneurysms (93.4% cure rate). Five aneurysms were re-treated, using either coils or additional PEDs, for failure to occlude, and 3 of these 5 were cured by the 3-year follow-up. Angiographic cure with one or two treatments of Pipeline embolization alone was therefore achieved in 92.1%. No recanalization of a previously completely occluded aneurysm was noted on the 3-year angiograms. There were 3 (2.6%) delayed device- or aneurysm-related serious adverse events, none of which led to permanent neurological sequelae. No major or minor late-onset hemorrhagic or ischemic cerebrovascular events or neurological deaths were observed in the 6-month through 3-year posttreatment period. Among 103 surviving patients, 85 underwent functional outcome assessment in which modified Rankin Scale scores of 0–1 were demonstrated in 80 subjects.

CONCLUSIONS

Pipeline embolization is safe and effective in the treatment of complex large and giant aneurysms of the intracranial internal carotid artery. Unlike more traditional endovascular treatments, flow diversion results in progressive vascular remodeling that leads to complete aneurysm obliteration over longer-term follow-up without delayed aneurysm recanalization and/or growth.

Clinical trial registration no.: NCT00777088 (clinicaltrials.gov)

ABBREVIATIONS

CEC = clinical events committee; CRL = core radiology laboratory; CTA = CT angiography; DSA = digital subtraction angiography; ICA = internal carotid artery; MRA = MR angiography; mRS = modified Rankin Scale; PED = Pipeline Embolization Device; PITA = Pipeline Embolization Device for the Intracranial Treatment of Aneurysms; PUFS = Pipeline for Uncoilable or Failed Aneurysms.
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  • 1

    Albuquerque FC, Park MS, Abla AA, Crowley RW, Ducruet AF, McDougall CG: A reappraisal of the Pipeline embolization device for the treatment of posterior circulation aneurysms. J Neurointerv Surg [epub ahead of print], 2014

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 2

    Becske T, Kallmes DF, Saatci I, McDougall CG, Szikora I, Lanzino G, et al.: Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology 267:858868, 2013

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

    Briganti F, Napoli M, Leone G, Marseglia M, Mariniello G, Caranci F, et al.: Treatment of intracranial aneurysms by flow diverter devices: long-term results from a single center. Eur J Radiol 83:16831690, 2014

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

    Briganti F, Napoli M, Tortora F, Solari D, Bergui M, Boccardi E, et al.: Italian multicenter experience with flow-diverter devices for intracranial unruptured aneurysm treatment with periprocedural complications—a retrospective data analysis. Neuroradiology 54:11451152, 2012

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

    Burrows AM, Zipfel G, Lanzino G: Treatment of a pediatric recurrent fusiform middle cerebral artery (MCA) aneurysm with a flow diverter. J Neurointerv Surg 5:e47, 2013

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

    Chalouhi N, Starke RM, Yang S, Bovenzi CD, Tjoumakaris S, Hasan D, et al.: Extending the indications of flow diversion to small, unruptured, saccular aneurysms of the anterior circulation. Stroke 45:5458, 2014

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

    Chalouhi N, Tjoumakaris S, Dumont AS, Gonzalez LF, Randazzo C, Starke RM, et al.: Treatment of posterior circulation aneurysms with the pipeline embolization device. Neurosurgery 72:883889, 2013

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

    Chalouhi N, Tjoumakaris S, Gonzalez LF, Dumont AS, Starke RM, Hasan D, et al.: Coiling of large and giant aneurysms: complications and long-term results of 334 cases. AJNR Am J Neuroradiol 35:546552, 2014

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

    Chow M, McDougall C, O'Kelly C, Ashforth R, Johnson E, Fiorella D: Delayed spontaneous rupture of a posterior inferior cerebellar artery aneurysm following treatment with flow diversion: a clinicopathologic study. AJNR Am J Neuroradiol 33:E46E51, 2012

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 10

    Çinar C, Bozkaya H, Oran I: Endovascular treatment of cranial aneurysms with the pipeline flow-diverting stent: preliminary mid-term results. Diagn Interv Radiol 19:154164, 2013

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 11

    Clarençon F, Di Maria F, Biondi A, Chiras J, Sourour NA: Distant and delayed (>7 days) hemorrhage after treatment by flow-diverter stents in intracranial aneurysms: a rare but potentially serious complication. AJNR Am J Neuroradiol 34:E81E82, 2013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 12

    Colby GP, Lin LM, Gomez JF, Paul AR, Huang J, Tamargo RJ, et al.: Immediate procedural outcomes in 35 consecutive pipeline embolization cases: a single-center, single-user experience. J Neurointerv Surg 5:237246, 2013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13

    Cruz JP, Chow M, O'Kelly C, Marotta B, Spears J, Montanera W, et al.: Delayed ipsilateral parenchymal hemorrhage following flow diversion for the treatment of anterior circulation aneurysms. AJNR Am J Neuroradiol 33:603608, 2012

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

    de Barros Faria M, Castro RN, Lundquist J, Scrivano E, Ceratto R, Ferrario A, et al.: The role of the pipeline embolization device for the treatment of dissecting intracranial aneurysms. AJNR Am J Neuroradiol 32:21922195, 2011

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 15

    Fischer S, Vajda Z, Aguilar Perez M, Schmid E, Hopf N, Bäzner H, et al.: Pipeline embolization device (PED) for neurovascular reconstruction: initial experience in the treatment of 101 intracranial aneurysms and dissections. Neuroradiology 54:369382, 2012

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

    Jabbour P, Chalouhi N, Tjoumakaris S, Gonzalez LF, Dumont AS, Randazzo C, et al.: The Pipeline Embolization Device: learning curve and predictors of complications and aneurysm obliteration. Neurosurgery 73:113120, 2013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 17

    Kan P, Siddiqui AH, Veznedaroglu E, Liebman KM, Binning MJ, Dumont TM, et al.: Early postmarket results after treatment of intracranial aneurysms with the pipeline embolization device: a U.S. multicenter experience. Neurosurgery 71:10801088, 2012

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 18

    Lin LM, Colby GP, Kim JE, Huang J, Tamargo RJ, Coon 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 4:114, 2013

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

    Lylyk P, Miranda C, Ceratto R, Ferrario A, Scrivano E, Luna HR, et al.: Curative endovascular reconstruction of cerebral aneurysms with the pipeline embolization device: the Buenos Aires experience. Neurosurgery 64:632643, N6, 2009

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

    McAuliffe W, Wycoco V, Rice H, Phatouros C, Singh TJ, Wenderoth J: Immediate and midterm results following treatment of unruptured intracranial aneurysms with the pipeline embolization device. AJNR Am J Neuroradiol 33:164170, 2012

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

    Meckel S, McAuliffe W, Fiorella D, Taschner CA, Phatouros C, Phillips TJ, et al.: Endovascular treatment of complex aneurysms at the vertebrobasilar junction with flow-diverting stents: initial experience. Neurosurgery 73:386394, 2013

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

    Monteith SJ, Tsimpas A, Dumont AS, Tjoumakaris S, Gonzalez LF, Rosenwasser RH, et al.: Endovascular treatment of fusiform cerebral aneurysms with the Pipeline Embolization Device. J Neurosurg 120:945954, 2014

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

    Munich SA, Tan LA, Keigher KM, Chen M, Moftakhar R, Lopes DK: The Pipeline Embolization Device for the treatment of posterior circulation fusiform aneurysms: lessons learned at a single institution. J Neurosurg 121:10771084, 2014

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 24

    Murayama Y, Nien YL, Duckwiler G, Gobin YP, Jahan R, Frazee J, et al.: Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience. J Neurosurg 98:959966, 2003

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 25

    Nanda A, Sonig A, Banerjee AD, Javalkar VK: Microsurgical management of giant intracranial aneurysms: a single surgeon experience from Louisiana State University, Shreveport. World Neurosurg 81:752764, 2014

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 26

    Nelson PK, Lylyk P, Szikora I, Wetzel SG, Wanke I, Fiorella D: The pipeline embolization device for the intracranial treatment of aneurysms trial. AJNR Am J Neuroradiol 32:3440, 2011

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 27

    Nossek E, Chalif DJ, Chakraborty S, Setton A: Modifying flow in the ICA bifurcation: Pipeline deployment from the supraclinoid ICA extending into the M1 segment-clinical and anatomic results. AJNR Am J Neuroradiol 35:21252129, 2014

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 28

    O'Kelly CJ, Spears J, Chow M, Wong J, Boulton M, Weill A, et al.: Canadian experience with the pipeline embolization device for repair of unruptured intracranial aneurysms. AJNR Am J Neuroradiol 34:381387, 2013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 29

    Park MS, Albuquerque FC, Nanaszko M, Sanborn MR, Moon K, Abla AA, et al.: Critical assessment of complications associated with use of the Pipeline Embolization Device. J Neurointerv Surg 7:652659, 2015

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 30

    Phillips TJ, Wenderoth JD, Phatouros CC, Rice H, Singh TP, Devilliers L, et al.: Safety of the pipeline embolization device in treatment of posterior circulation aneurysms. AJNR Am J Neuroradiol 33:12251231, 2012

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 31

    Piano M, Valvassori L, Quilici L, Pero G, Boccardi E: Midterm and long-term follow-up of cerebral aneurysms treated with flow diverter devices: a single-center experience. J Neurosurg 118:408416, 2013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 32

    Puffer RC, Piano M, Lanzino G, Valvassori L, Kallmes DF, Quilici L, et al.: Treatment of cavernous sinus aneurysms with flow diversion: results in 44 patients. AJNR Am J Neuroradiol 35:948951, 2014

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 33

    Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, et al.: Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke 34:13981403, 2003

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 34

    Saatci I, Yavuz K, Ozer C, Geyik S, Cekirge HS: Treatment of intracranial aneurysms using the pipeline flow-diverter embolization device: a single-center experience with long-term follow-up results. AJNR Am J Neuroradiol 33:14361446, 2012

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 35

    Samuels OB, Joseph GJ, Lynn MJ, Smith HA, Chimowitz MI: A standardized method for measuring intracranial arterial stenosis. AJNR Am J Neuroradiol 21:643646, 2000

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 36

    Siddiqui AH, Abla AA, Kan P, Dumont TM, Jahshan S, Britz GW, et al.: Panacea or problem: flow diverters in the treatment of symptomatic large or giant fusiform vertebrobasilar aneurysms. J Neurosurg 116:12581266, 2012

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 37

    Sluzewski M, Menovsky T, van Rooij WJ, Wijnalda D: Coiling of very large or giant cerebral aneurysms: long-term clinical and serial angiographic results. AJNR Am J Neuroradiol 24:257262, 2003

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 38

    Sughrue ME, Saloner D, Rayz VL, Lawton MT: Giant intracranial aneurysms: evolution of management in a contemporary surgical series. Neurosurgery 69:12611271, 2011

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 39

    Toma AK, Robertson F, Wong K, Joshi Y, Haridas A, Grieve J, et al.: Early single centre experience of flow diverting stents for the treatment of cerebral aneurysms. Br J Neurosurg 27:622628, 2013

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 40

    Tomas C, Benaissa A, Herbreteau D, Kadziolka K, Pierot L: Delayed ipsilateral parenchymal hemorrhage following treatment of intracranial aneurysms with flow diverter. Neuroradiology 56:155161, 2014

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 41

    Toth G, Bain M, Hussain MS, Moskowitz S, Masaryk T, Rasmussen P, et al.: Posterior circulation flow diversion: a single-center experience and literature review. J Neurointerv Surg 7:574583, 2015

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 42

    van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J: Interobserver agreement for the assessment of handicap in stroke patients. Stroke 19:604607, 1988

  • 43

    Velat GJ, Fargen KM, Lawson MF, Hoh BL, Fiorella D, Mocco J: Delayed intraparenchymal hemorrhage following pipeline embolization device treatment for a giant recanalized ophthalmic aneurysm. J Neurointerv Surg 4:e24, 2012

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 44

    Wiebers DO: Unruptured intracranial aneurysms: natural history and clinical management. Update on the International Study of Unruptured Intracranial Aneurysms. Neuroimaging Clin N Am 16:383390, vii, 2006

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 45

    Wiebers DO, Whisnant JP, Huston J III, Meissner I, Brown RD Jr, Piepgras DG, et al.: Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet 362:103110, 2003

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 46

    Yavuz K, Geyik S, Saatci I, Cekirge HS: Endovascular treatment of middle cerebral artery aneurysms with flow modification with the use of the pipeline embolization device. AJNR Am J Neuroradiol 35:529535, 2014

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 47

    Yu SCH, Kwok CK, Cheng PW, Chan KY, Lau SS, Lui WM, et al.: Intracranial aneurysms: midterm outcome of pipeline embolization device—a prospective study in 143 patients with 178 aneurysms. Radiology 265:893901, 2012

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 48

    Zanaty M, Chalouhi N, Tjoumakaris SI, Gonzalez LF, Rosenwasser R, Jabbour P: Flow diversion for complex middle cerebral artery aneurysms. Neuroradiology 56:381387, 2014

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation

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