p64 flow diverter: Results in 108 patients from a single center

Tom De Beule, T Boulanger, S Heye, W J van Rooij, W H van Zwam, L Stockx, Tom De Beule, T Boulanger, S Heye, W J van Rooij, W H van Zwam, L Stockx

Abstract

Background and purpose: Flow diverters are increasingly used to treat intracranial aneurysms. We report the safety and efficacy of the p64 flow diverter, a resheathable and detachable device for intracranial aneurysms.

Materials and methods: We retrospectively reviewed 108 patients with 109 aneurysms treated with the p64 between March 2014 and July 2019. There were 87 women and 21 men, mean age 57 years. Of 109 aneurysms, 74 were discovered incidentally, 12 were symptomatic, 18 were previously treated, and five were ruptured dissection aneurysms. A total of 10 aneurysms were located in the posterior circulation. The mean aneurysm or remnant size was 8.1 mm.

Results: Hemorrhage by perforation with the distal guidewire occurred in two patients with permanent neurological deficits in one. In one patient, acute in-stent occlusion caused infarction with a permanent deficit. Permanent morbidity was 1.9% (2 of 108, 95%CI 0.1-6.9%); there was no mortality. During follow-up, three in-stent occlusions occurred, all asymptomatic. There were no delayed hemorrhagic complications. At six months, 77 of 96 aneurysms (80.2%) were completely occluded, and at last follow-up, this increased to 93 of 96 aneurysms (96.9%). In-stent stenosis at any degree occurred in 11 patients, progressing to asymptomatic complete occlusion in one. In the other patients, stenosis resolved or improved at further follow-up.

Conclusion: The p64 offers an effective and safe treatment option. Aneurysm occlusion rate was 97% at last follow-up, mostly achieved with a single device. There were no delayed hemorrhagic complications. Delayed in-stent stenosis infrequently progresses to occlusion but remains a matter of concern.

Keywords: Flow diversion; flow diverter; interventional radiology; intracranial aneurysm.

Conflict of interest statement

Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
A 37-year-old woman with an incidental para-ophthalmic aneurysm. 3D (a) and 2D (b) angiogram showing small para-ophthalmic aneurysm. (c) The position of the p64 flow diverter. (d) Angiogram at two weeks made because of intermittent sensibility disturbances shows 50% stenosis at the distal end of the p64. (e) Angiogram at six months demonstrates a normal caliber of the carotid artery. The aneurysm is occluded. (f) MRA at two years is unchanged with six months angiogram.
Figure 2.
Figure 2.
A 38-year-old woman with an incidental supraclinoid aneurysm treated with a p64 flow diverter and progressive stenosis and occlusion at follow-up. Initial images of the procedure are lost. The patient remained asymptomatic with good collateral flow. (a) Follow-up angiogram at six months shows severe stenosis at the distal end of the p64. (b) Angiogram at 12 months shows progressive distal stenosis. (c) Angiogram at two years demonstrates complete occlusion. (d) Position of the p64 with deformation at both ends.
Figure 3.
Figure 3.
A 72-year-old man with an incidentally found fusiform middle cerebral artery aneurysm. (a) AP carotid angiogram shows a fusiform aneurysm on M1. (b) Position of the p64 flow diverter. (c) Angiogram after six months demonstrates complete occlusion of the aneurysm.
Figure 4.
Figure 4.
A 74-year-old man with an incidentally found carotid-ophthalmic aneurysm. Carotid angiogram (a) and 3D angiogram (b) reveals a wide-necked ophthalmic aneurysm. (c) Lateral radiograph shows the position of p64 flow diverter. (d) Complete aneurysm occlusion on 6 months follow-up angiogram.

References

    1. Guglielmi G, Viñuela F, Duckwiler G, et al. Endovascular treatment of posterior circulation aneurysms by electrothrombosis using electrically detachable coils. J Neurosurg 1992; 77: 515–524.
    1. Molyneux AJ, Kerr RS, Yu LM, et al. International subarachnoid aneurysm trial (ISAT)of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomized comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet 2005; 366: 809–817.
    1. Johnston SC, Zhao S, Dudley RA, et al. Treatment of unruptured cerebral aneurysms in California. Stroke 2001; 32: 597–605.
    1. Henkes H, Weber W. The past, present, and future of endovascular aneurysm treatment. Clin Neuroradiol 2015; 25(Suppl 2): 317–324.
    1. Shapiro M, Raz E, Becske T, et al. Variable porosity of the Pipeline Embolization Device in straight and curved vessels: a guide for optimal deployment strategy. AJNR Am J Neuroradiol 2014; 35: 727–733.
    1. Luecking H, Engelhorn T, Lang S, et al. FRED Flow Diverter: a study on safety and efficacy in a consecutive group of 50 patients. AJNR Am J Neuroradiol 2017; 38: 596–602.
    1. Anzai H, Falcone JL, Chopard B, et al. Optimization of strut placement in flow diverter stents for four different aneurysm configurations. J Biomech Eng 2014; 136: 061006.
    1. Hodis S, Ding YH, Dai D, et al. Relationship between aneurysm occlusion and flow diverting device oversizing in a rabbit model. J Neurointerv Surg 2016; 8: 94–98.
    1. Cekirge HS, Saatci I. A new aneurysm occlusion classification after the impact of flow modification AJNR Am J Neuroradiol 2016; 37: 19–24.
    1. Fischer S, Aguilar-Pérez M, Henkes E, et al. Initial experience with p64: a novel mechanically detachable flow diverter for the treatment of intracranial saccular sidewall aneurysms. AJNR Am J Neuroradiol 2015; 36: 2082–2089.
    1. Sirakov S, Sirakov A, Bhogal P, et al. The p64 flow diverter – mid-term and long-term results from a single center. Clin Neuroradiol Epub ahead of print Aug 9 2019. DOI: 10.1007/s00062-019-00823-y.
    1. Briganti F, Leone G, Marseglia M, et al. p64 Flow Modulation Device in the treatment of intracranial aneurysms: initial experience and technical aspects. J Neurointerventional Surg 2016; 8: 173–180.
    1. Morais R, Mine B, Bruyère PJ, et al. Endovascular treatment of intracranial aneurysms with the p64 flow diverter stent: mid-term results in 35 patients with 41 intracranial aneurysms. Neuroradiology 2017; 59: 263–269.
    1. Briganti F, Leone G, Maiuri F, et al. Mid-term and long-term follow-up of intracranial aneurysms treated by the p64 Flow Modulation Device: a multicenter experience. NeuroIntervent Surg 2017; 9: 70–76.
    1. Berge J, Biondi A, Machi P, et al. Flow-diverter Silk stent for the treatment of intracranial aneurysms: 1-year follow-up in a multicenter study. AJNR Am J Neuroradiol 2012; 33: 1150–1155.
    1. De Vries J, Boogaarts J, Van Norden A, et al. New generation of flow diverter (Surpass) for unruptured intracranial aneurysms: a prospective single-center study in 37 patients. Stroke 2013; 44: 1567–1577.
    1. Becske T, Kallmes DF, Saatci I, et al. Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology 2013; 267: 858–868.
    1. Lylyk P, Miranda C, Ceratto R, et al. Curative endovascular reconstruction of cerebral aneurysms with the Pipeline embolization device: the Buenos Aires experience. Neurosurgery 2009; 64: 632–642.
    1. D’Urso PI, Lanzino G, Cloft HJ, et al. Flow diversion for intracranial aneurysms: a review. Stroke 2011; 42: 2363–2368.
    1. Zhou Y, Yang PF, Fang YB, et al. A novel flow-diverting device(Tu- bridge) for the treatment of 28 large or giant intracranial aneurysms: a single-center experience. AJNR Am J Neuroradiol 2014; 35: 2326–2333.
    1. Brinjikji W, Murad MH, Lanzino G, et al. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke 2013; 44: 442–447.
    1. Fiorella D, Gache L, Frame D, et al. How safe and effective are flow diverters for the treatment of unruptured small/medium intracranial aneurysms of the internal carotid artery? Meta-analysis for evidence-based performance goals. J Neurointerv Surg. Epub ahead of print 31 Jan 2020. DOI: 10.1136/neurintsurg-2019-015535.
    1. Caroff J, Iacobucci M, Rouchaud A, et al. The occurrence of neointimal hyperplasia after flow-diverter implantation is associated with cardiovascular risk factors and the stent design. J NeuroIntervent Surg 2019; 11: 610–613.
    1. Murthy SB, Shah S, Shastri A, et al. The SILK flow diverter in the treatment of intracranial aneurysms. J Clin Neurosci 2014; 21: 203–206.
    1. Texakalidis P, Bekelis K, Atallah E, et al. Flow diversion with the Pipeline embolization device for patients with intracranial aneurysms and antiplatelet therapy: a systematic literature review. Clin Neurol Neurosurg 2017; 161: 78–87.
    1. Aguilar Pérez M, Bhogal P, Henkes E, et al. In-stent stenosis after p64 flow diverter treatment. Clin Neuroradiol 2018; 28: 563–568.
    1. Cohen JE, Gomori JM, Moscovici S, et al. Delayed complications after flow-diverter stenting: reactive in-stent stenosis and creeping stents. J Clin Neurosci 2014; 21: 1116–1122.
    1. Kadirvel R, Ding YH, Dai D, et al. Cellular mechanisms of aneurysm occlusion after treatment with a flow diverter. Radiology 2014; 270: 94–399.
    1. Li W, Tian Z, Zhu W, et al. Hemodynamic analysis of postoperative rupture of unruptured intracranial aneurysms after placement of flow-diverting stents: a matched case-control study. AJNR Am J Neuroradiol 2019; 40: 1916–1923.
    1. Kulcsàr Z, Szikora I. The ESMINT Retrospective Analysis of Delayed Aneurysm Ruptures after Flow Diversion (RADAR) study. J Eur Soc Minim Invas Neurol Ther 2012; 1244000088. (2012, accessed 29 December 2019).

Source: PubMed

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