Accepted Manuscript Title: TREATMENT OF INTRACRANIAL ANEURYSMS BY FLOW DIVERTER DEVICES: LONG-TERM RESULTS FROM A SINGLE CENTER Author: Francesco Briganti Manuela Napoli Giuseppe Leone Mariano Marseglia Giuseppe Mariniello Ferdinando Caranci Fabio Tortora Francesco Maiuri PII: DOI: Reference:
S0720-048X(14)00266-6 http://dx.doi.org/doi:10.1016/j.ejrad.2014.05.029 EURR 6800
To appear in:
European Journal of Radiology
Received date: Revised date: Accepted date:
13-3-2014 28-4-2014 15-5-2014
Please cite this article as: Briganti F, Napoli M, Leone G, Marseglia M, Mariniello G, Caranci F, Tortora F, Maiuri F, TREATMENT OF INTRACRANIAL ANEURYSMS BY FLOW DIVERTER DEVICES: LONG-TERM RESULTS FROM A SINGLE CENTER, European Journal of Radiology (2014), http://dx.doi.org/10.1016/j.ejrad.2014.05.029 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
TREATMENT OF INTRACRANIAL ANEURYSMS BY FLOW DIVERTER DEVICES: LONG-TERM RESULTS FROM A SINGLE CENTER
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Authors Francesco Briganti, MD; Manuela Napoli, MD; Giuseppe Leone, MD; Mariano Marseglia, MD; Dario Piccolo, MD; Fabio Tortora, MD, PhD; Francesco Maiuri, MD
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Affiliations Francesco Briganti: Unit of Interventional Neuroradiology, Department of Advanced Biomedical Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817464251; e-mail [email protected]
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Manuela Napoli: Department of Advanced Biomedical Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817462563; e-mail [email protected]
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Giuseppe Leone: Department of Advanced Biomedical Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817462563; e-mail [email protected]
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Mariano Marseglia: Department of Advanced Biomedical Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817462563; e-mail [email protected]
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Giuseppe Mariniello: Division of Neurosurgery, Department of Neurosciences, Reproductive and Odontostomatological Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817463280; e-mail [email protected] Ferdinando Caranci: Department of Advanced Biomedical Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817464646; e-mail [email protected] Fabio Tortora: Chair of Neuroradiology, “Magrassi Lanzara” Clinical-Surgical Department, Second University of Naples, Italy. Work Address: Viale Colli Aminei, 21, 80131 Naples, Italy. Work Phone +39 0817464251; e-mail [email protected] Francesco Maiuri: Division of Neurosurgery, Department of Neurosciences, Reproductive and Odontostomatological Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817463280; e-mail [email protected]
Corresponding Author FRANCESCO BRIGANTI Department of Advanced Biomedical Sciences, Unit of Interventional Neuroradiology, Federico II University, Naples, Italy 1 Page 1 of 25
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Work Address: Via S.Pansini, 5. 80131, Naples, Italy Work Phone +39 0817464251 Mobile Phone 0039- 337666040 e-mail [email protected]
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TREATMENT OF INTRACRANIAL ANEURYSMS BY FLOW DIVERTER DEVICES: LONG-TERM RESULTS FROM A SINGLE CENTER
ABSTRACT
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OBJECTIVES: Flow-Diverter Devices (FDD) are a new generation stents designed for the treatment of the intracranial aneurysms. This article reports the long-term results (2 to 4 years) of this treatment from a single-center.
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METHODS: From November 2008 to January 2012, 35 patients (29 females and 6
males; mean age 53.9y) with 39 intracranial aneurysms were treated by FDD. Five
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patients (14.3%) had ruptured aneurysms and 30 (85.7%) had no previous hemorrhage. The procedures were performed in 5 patients (14.3%) with SILK and in 30 (85.7%)
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with PED. In 3 patients FDDs were used as a second treatment after failure of previous coiling (2 cases) or stenting (one case).
The 39 aneurysms were in supraclinoid ICA in 26 (66,7%), cavernous ICA in 2
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(5.1%), PCoA in 4 (10,2%), MCA in 5 (12.9%), SCA in 1 (2.6%) and PICA in 1 (2.6%). The aneurysms were small ( 6 months) or partial occlusion. CONCLUSION: FDD are a safe and efficacious treatment of intracranial aneurysms, resulting in high occlusion rate and low incidence of complications. It should be the treatment of choice for the large-neck aneurysm of the ICA. 3 Page 3 of 25
INTRODUCTION The endovascular treatment of intracranial aneurysms may be realized by several techniques, including coiling [1,2], balloon-assisted coiling (BAC) [3,4], stenting and stent-assisted coiling (SAC) [5-10]. These last techniques have been developed to associated with relatively large rates of periprocedural complications.
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improve the occlusion rate and decrease the recanalization. However, they are Flow-diverter devices (FDD) are new and important tools in the treatment of
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intracranial aneurysms [11].
They are able to form a high-coverage mesh that induces thrombosis of the
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aneurysmal sac; the rationale of the FDD use is to induce the development of the neointima in the inner surface of the vessel with a complete reconstruction, while that can cure the diseased aneurysm vessel.
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preserving patency of the adjacent small vessels [12]. These are now the only devices FDD mainly used in patients with more complex aneurysms (especially large, giant
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and wide-neck aneurysms) and more difficult locations; however, with increasing experience, a wider use also for aneurysms of different forms and size is suggested [13-25]. The main problem of these devices is the not immediate aneurysm occlusion;
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thus a long-term follow-up is necessary.
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The first two FDDs approved for the treatment of intracranial aneurysms were the Pipeline Embolization Device (PED) (Covidien, Mansfield, Massachusetts) and the
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Silk (Balt Extrusion, Montmorency, France). The PED is a flexible, meshlike tube of 48 interwoven microfilaments consisting of 25% platinum-tungsten and 75% cobaltchromium-nickel alloy; it provides 30% to 35% metal coverage of the surface of the target vessel. When deployed, it remains flexible and able to conform to tortuous vessel anatomy. The Silk flow diverter is constructed from 48 braided nitinol and 4 platinum microfilaments, with a pore size of 110 to 250 mm and 35% to 55% metal coverage at its nominal vessel diameter; it is also a flexible mesh stent. We report a retrospective study on 35 patients with intracranial aneurysms treated by FDD at the Interventional Neuroradiology Unit of “Federico II” University of Naples. Fourteen of these 35 patients were also included in the Italian multicenter study of FDD for intracranial aneurysms [14]. The aim of the present report is to discuss the indications, results and complications of this new kind of device, as compared with those of the other endovascular procedures.
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MATERIALS AND METHODS Patient population From the series of intracranial aneurysms treated by different surgical and endovascular procedures at the Federico II University of Naples between November
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2008 and January 2012, 35 patients who underwent insertion of FDD were retrospectively reviewed. The 35 patients are 29 females and 6 males, ranging in age between 32 and 74 years (average 53.9 years).
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All included patients had complete clinical-radiological pre- and post-procedural data
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and follow-up of at least 2 years. Clinical data (table 1)
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The clinical evaluation was made by the same neurosurgeon (F.M.) at admission, immediately before and after the procedure and at the patient discharge. Patients with subarachnoid hemorrhage were classified according to the Hunt-Hess classification
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[26].
The radiological definition was obtained in all cases by the same neuroradiologist, (F.C.) not involved in the interventional procedures. Computed Tomography
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Angiography (CTA), by using the native images and the 2D Multi-Planar in all patients.
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Reconstructions (MPR), and Digital Subtraction Angiography (DSA) were performed
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The aneurysm location and size, the aneurysm neck and the neck/diameter ratio were considered. The aneurysm size was classified as small (25mm).
Five patients (14.3%) had ruptured aneurysms with previous subarachnoid hemorrhage; the hemorrhagic episode occurred 250-300 seconds. The Clopidogrel (75mg) and Aspirin (100mg) were administered daily until the aneurysm occlusion was confirmed by DSA; then, only Aspirin was continued indefinitely. In 2 cases with a minor nasal bleeding caused by Clopidogrel hypersensitivity, this treatment was replaced by Ticlopidine (500 mg/daily). In our series corticosteroids were no administered both before and after the procedure. 6 Page 6 of 25
Intra-aneurysmal contrast stasis was observed in 24 patients (75%) immediately at the end of the procedure.
Follow-up schedule
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All patients underwent clinical examination and CTA 1, 3, 6 and 12 months after the procedure. A case with polycystic kidney and chronic renal failure was evaluated only with 3-month CTA.
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The complete aneurysm occlusion was confirmed in all cases DSA. MRI with angiographic sequences was performed every year.
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The actual follow-up ranges between 24 and 62 months (mean 41 months).
Peri-procedural technical problems
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RESULTS
Technical problems occurred in 4 procedures (11,4%). In one patient with large,
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wide-neck intracavernous carotid aneurysm, the primary SILK deployment was impossible due to the large defect of the artery wall, with the device falling into the sac; after many attempts and evaluation of the collateral flow with occlusion test, a
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LEO stent (3,5x35- Balt Extrusion) was first inserted; then a PED device was placed
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into the first stent one month later. In a patient with rupture of the PED microwire, it
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was captured with GooseNeck ®(Covidien) device, without any clinical problem. In one patient treated with Silk for a small carotid ophthalmic aneurysm, ICA vasospasm occurred few minutes after the successful procedure, with reduction of distal FDD’s diameter. After many dilatation attempts with balloon and evaluation of the contralateral flow supply with balloon-occlusion-test, the ICA was occluded with coils, with no neurological sequelae. Finally, one patient had a femoral pseudoaneurysm, resolved with compressive medication.
The periprocedural complications were not correlated with the type of FD used. Post-procedural neurological complications In early post-procedural period 2 patients had neurologic deficits. One with middle cerebral artery (MCA) aneurysm developed aphasia; another patient with superior cerebellar artery (SCA) aneurysm had difficult and late awakening. Both were treated 7 Page 7 of 25
with Abciximab (Reopro®) administration (intravenous bolus dose of 0.25 mg/kg followed by a continuous infusion of 0.125 μg · kg−1 · min−1 for 12 hours), with complete resolution of the symptoms. No early or delayed aneurysm rupture, no-subarachnoid and parenchymal hemorrhage
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nor ischemic troubles occurred. Occlusion rate and related factors (tables 3 and 4)
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The aneurysm occlusion was evaluated in 38 aneurysms (the case with periprocedural
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occlusion of the ICA was excluded).
Complete occlusion was obtained in 35/38 aneurysms (92.1%). Three (7.9%) were partially occluded at follow-up of 24 months; two of them were at M1 segment of the
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MCA and one at the PCoA. Thus, according to the aneurysm location, the complete occlusion was obtained in all 27 aneurysms of the ICA (100%), in 3 among 4 of the in one among 3 MCA aneurysms.
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PCoA (Posterior Communicating Artery), in the SCA and PICA aneurysms and only The 3 aneurysms with partial occlusion at the 24 months (2 of the MCA and one at
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the PCoA) showed a vessel arising from the aneurysm sac, and were stable without signs of aneurysm reperfusion.
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Among 35 aneurysms with complete occlusion, it occurred within 3 months in 24
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cases (68.5%), between 3 and 6 months in 9 (25.7%), at 12 months in one (2.9%) (Fig.1 and 2) and at 18 months in one (2.9%); this last case (fig.3) with very late occlusion was a giant (33x20mm), partially thrombosed carotid-ophthalmic aneurysm with atherosclerotic irregularity of the surface of the parent vessel and stenosis
proximal to the aneurysm neck. In this case the PED was probably oversized, resulting in decrease of the flow diversion effect. The correlation between the occlusion time and aneurysm size and neck (table 4) showed as follows. No significant difference of distribution of aneurysm size was evidenced regarding the occlusion time, excepting for the very late occlusion (18 months) of the unique giant aneurysm. The neck/sac ratio (ranging from 0.5 to 1.0) showed rather uniform distribution in the group of aneurysms with early occlusion (within 3 months); on the other hand, 10 among 14 aneurysms with late occlusion (6 months or more) or partial occlusion had larger neck (neck/sac ratio 0.9 or 1.0).
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Thus, the data of the study suggest that an early and complete occlusion after endovascular treatment with FDD is less probable for middle cerebral artery aneurysms, for those with larger neck, and for those with a vessel arising from the
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aneurysm sac.
DISCUSSION
The endosaccular coil placement is considered a safe treatment for intracranial
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aneurysms [1]; however the incidence of recurrence is high in the different series
(33.6% at 12 months after the treatment) [2]. For aneurysms with unfavourable
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features, especially those large or giant with wide neck, the incidence of recurrence is ever higher, with recanalization rate of 50.6% and 52.3%, respectively [2]. To
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improve the results in term of occlusion rate and stability, the coils were used with stent [5-10] and balloon [3,4], but these techniques are associated with relatively high rates of aneurysm recanalization and complications [3-5].
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The FDDs were initially used for giant and dissecting aneurysms, with the aim to achieve the reconstruction of parent vessel and the definitive aneurysm treatment [12]. After their introduction, several series evaluated the results with the use of these
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new devices [13-25, 27] (table 5); despite the initial good results in term of aneurysm
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occlusion, several complications, such as delayed aneurysm rupture [28,29], intraparenchymal haemorrhage [30] and adverse technical events were reported.
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The aim of many single or multicenter series was to evaluate the short and mid-term follow-up results [13-25,27].
Berge at al [13] reported a retrospective review of 77 aneurysms in 65 patients, treated with FDD in 6 different French centers; the morbidity rate was 7.8% and the mortality was 3% (2 patients with delayed aneurysm rupture and complications of systemic anti-aggregation, respectively). In the Canadian experience on 97 patients with the PED in 7 different centers, O’Kelly et al [27] reported a morbidity rate of 4.3% and mortality 6.4%; in particular the mortality rate was significantly higher in the group of patients with posterior circulation aneurysms (4/9 or 45%). In the Italian multicenter experience with FDD in 273 patients, Briganti et al [25] found a morbidity and mortality rate of 3.7% and 5.9%, respectively.
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Several factors must be considered when analyzing the indication and results of the endovascular treatment with FDD. These include the aneurysm location and size, the neck wideness and neck/sac ratio and the presence of a vessel arising from the sac. The rate and time of the aneurysm occlusion were evaluated in several studies of
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patients treated with FDD [13-25, 27]. From a review of 29 series of the literature Brinjikji et al [24] found a 76% rate of complete occlusion at 6 months. In our series of 39 aneurysms we have found a 86.8% rate of complete occlusion at 6 months (33
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among 38 aneurysms with follow-up), with two other cases undergoing complete
occlusion within 12 and 18 months (overall 35/38 or 92.1%); besides, the 3 cases with occlusion in later neuroradiological control studies.
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partial occlusion had a 6 months follow-up, thus suggesting chances of complete
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The better results of our series are likely due to several factors, including the realization of all procedures by the same neuroradiologist and the low rate of giant (one case) and posterior circulation (2 cases) aneurysms. It is also noteworthy that all
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three aneurysms partially occluded at 6 months (two MCA and one PCoA aneurysms) showed a vessel arising from the sac; this may result in flow reversal and later occlusion. The data of our series confirm that the occlusion rate is not correlated with
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the aneurysm size. On the other hand, the aneurysm neck and the neck/sac ratio seem occlusion).
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to be relevant (high neck/sac ratio of 0.9 or 1.0 in 9/11 aneurysms with late or partial
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According to the location, aneurysms of the ICA and circle of Willis seem to do better than those of the MCA; for aneurysms of the posterior circulation no conclusions may be defined due to the low number of the cases (2/39). On the whole, the results of the treatment with FDD, show that the rate of aneurysm occlusion (49% to 95%) (table 5) is higher than that of cases treated by different (no flow-diverter) devices (43 to 76%) (table 6). Thus, from the data of our study we recommend the use of FDD for large-neck aneurysms of the ICA siphon. Distal aneurysms, such as those of the MCA and those with vessels arising from the sac, represent a lesser indication. Several technical problems may occur during the procedure with FDD. These mainly include difficulty in the devices deployment, particularly in giant aneurysms with large neck. Silk devices may undergo coartation due to loss of radial force. Besides, PED do not completely retrieve. We have experienced in one case of our series severe vasospasm of the ICA requiring the vessel occlusion with no neurological sequelae. 10 Page 10 of 25
The treatment of cerebral aneurysms with FDD is not risk-free. In a recent review of 29 studies, Brinjikji et al [24] found mortality rates from 0% to 7% (mean 4%) and morbidity rates from 0% to 12% (mean 5%). Postprocedural complications, which may lead to permanent morbidity or death mainly include subarachnoid hemorrhage,
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intracerebral hemorrhage and ischemic stroke. Delayed rupture was reported particularly for giant and fusiform aneurysms, and for those of the posterior circulation [28-30].
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FDD do not resolve the problem of rapid flow decrease, as they cause massive intra-
aneurysmal platelet aggregation with rupture of the aneurysm wall. The concomitant
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use of endosaccular coils does not prevent the rupture, probably because of increased turbulence at the neck level, or peripheral persistent fresh thrombus that might
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promote the rupture. Ischemic stroke is reported with a 6% incidence, mainly with large/giant aneurysms and for these of the posterior circulation including perforators in the aneurysm wall. The sudden flow decrease in the perforator territories may
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account for the often severe consequences of a brainstem infarction. We did not
CONCLUSION
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observe hemorrhagic nor ischemic postprocedural events in our series.
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FDD represent a reasonably, safe and effective treatment option for intracranial aneurysms, associated with high rate of aneurysm occlusion and low risk of
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complication. We recommend this treatment mainly for large-neck aneurysms of ICA siphon, where it should be considered the procedure of first choice. On the other hand, treatment of posterior circulation aneurysms, particularly those involving perforators, should be avoided, due to the high rate of ischemic events. FDDs of last generation of are more sophisticate and probably will reduce the incidence of technical adverse events.
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FIGURE LEGEND Fig.1 (A) A 68-year-old woman harboring a 12-mm ophthalmic aneurysm (DSA). (B)
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1-month follow-up angiography show complete occlusion of the aneurysm
Fig.2 (A) A 67-year-old woman harboring a MCA aneurysm (DSA). (B) 6-month
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follow-up angiography show complete occlusion of the sac.
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Fig.3 (A) A 61-year-old woman with a giant (26x22mm) partially-trombosed
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cavernous ICA aneurysm (DSA). (B) 18-month follow-up angiography show
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complete occlusion of the sac
Fig.4 (A) A 45-year-old woman with a large (20x14mm) wide-neck intracavernous
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ICA aneurysm (DSA). (B) the primary SILK deployment was impossible due to the
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large defect of the artery wall, with the device falling into the sac (DSA); (C) a LEO stent (3,5x35- Balt Extrusion) was first inserted, then a PED device was placed into
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the first stent one month later (D).
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7. Kis B, Weber W, Gotz F, Becker H, Berlit P, Kuhne D. Endovascular treatment of cerebral aneurysms using the Leo stent: long term follow-up and expansion of indications. Clin Neuradiol 2007; 17:167-179
8. Maldonado IL, Machi P, Costalat V, Mura T, Bonafé A. Neuroform stentassisted coiling of unruptured intracranial aneurysms: short- and mid-term results from a single-center experience with 68 patients. AJNR Am J Neuroradiol. 2011; 32:131-6
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Am J Neuroradiol 2013; 34:381-7 28. Kulcsar Z, Houdart E, Bonafe A, et al. Intra-aneurysmal thrombosis as a possible cause of delayed aneurysm rupture after flow-diversion treatment. AJNR Am J Neuroradiol 2011; 32:20-25 29. Turowski B, Macht S, Kulcsar Z, Hanggi D, Stummer W. Early fatal hemorrhage after endovascular cerebral aneurysm treatment with a flow 15 Page 15 of 25
diverter (SILK-Stent): do we need to rethink our concepts? Neuroradiology 2011; 53:37-41. 30. Cruz PJ, Crow M, O’Kelly C, Marotta B, Spears L. Delayed ipsilateral parenchymal hemorrage following flow diversion for the treatment of the
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anterior circulation aneurysms. AJNR Am J Neuroradiol 2012; 33: 603-08
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Table 1. Endovascular devices (35 patients) Type of FDD
30 (85.7%)
SILK
5 (14.3%)
FDD alone
32 (91.4%)
Previous coiling
2 (5.7%)
Previous non FD stent
1 (2.9%)
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Adjunctive devices
PED
29 (82.9%) F
Sex
6 (17.1%) M
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Table 2. Clinical-radiological characteristics (35 patients with 39 aneurysms)
32-74 years (average 53.9y)
Clinical presentation
Ruptured (previous SHA) 5 (14.3%)
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Age (years)
(35 patients)
Hunt-Hess 1 (3 patients) Hunt-Hess 1A (2 patients)
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No previous hemorrhage 30 (85.7%)
Asymptomatic 15 (50%) Headache 8 (26.7%) Cranial nerve palsy 5 (16.7%) Ischemia 1 (3.3%) T.I.A. 1 (3.3%)
Supraclinoid ICA
26 (66.7%)
Cavernous ICA
2 (5.1%)
PCoA
4 (10.2%)
MCA
5 (12.9%)
SCA
1 (2.6%)
PICA
1 (2.6%)
Small (25mm)
1 (2.6%)
Aneurysm neck/sac ratio
0.5
2 (5.1%)
(39 aneurysms)
0.6
4 (10.3%)
0.7
9 (23.1%)
0.8
5 (12.8%)
0.9
11 (28.2%)
1.0
7 (17.9%)
fusiform
1 (2.6%)
Aneurysm location
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(39 aneurysms)
Aneurysm size (39 aneurysms)
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Occlusion rate
Complete
35 (92.1%)
(38 aneurysms)
Partial
3 (7.9%)
Time of complete occlusion
Within 3 mo
24 (68.5%)
(35 aneurysms)
3 to 6 mo
9 (25.7%)
6 to 12 mo
1 (2.9%)
12 to 18 mo
1 (2.9%) N.cases
Complete occlusion
Supraclinoid ICA
25
25
Cavernous ICA
2
2
PCoA
4
3
MCA
5
3
SCA
1
PICA
1
total
38
cr
-
1 2
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to aneurysm location
Partial occlusion
1
-
1
-
35
3
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Complete occlusion related
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Table 3. Data on the aneurysm occlusion (38 aneurysms)*
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* a case with periprocedural ICA occlusion (supraclinoid ICA aneurysm) was excluded
Table 4. Correlation of the occlusion time with aneurysm size and neck (38 aneurysms*) n.
timing
cases
Aneurysm size
Neck-sac ratio
small
large
giant
0.5
0.6
0.7
0.8
0.9
1.0
fusif
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Occlusion and
Complete
S0720-048X(14)00266-6 http://dx.doi.org/doi:10.1016/j.ejrad.2014.05.029 EURR 6800
To appear in:
European Journal of Radiology
Received date: Revised date: Accepted date:
13-3-2014 28-4-2014 15-5-2014
Please cite this article as: Briganti F, Napoli M, Leone G, Marseglia M, Mariniello G, Caranci F, Tortora F, Maiuri F, TREATMENT OF INTRACRANIAL ANEURYSMS BY FLOW DIVERTER DEVICES: LONG-TERM RESULTS FROM A SINGLE CENTER, European Journal of Radiology (2014), http://dx.doi.org/10.1016/j.ejrad.2014.05.029 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
TREATMENT OF INTRACRANIAL ANEURYSMS BY FLOW DIVERTER DEVICES: LONG-TERM RESULTS FROM A SINGLE CENTER
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Authors Francesco Briganti, MD; Manuela Napoli, MD; Giuseppe Leone, MD; Mariano Marseglia, MD; Dario Piccolo, MD; Fabio Tortora, MD, PhD; Francesco Maiuri, MD
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Affiliations Francesco Briganti: Unit of Interventional Neuroradiology, Department of Advanced Biomedical Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817464251; e-mail [email protected]
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Manuela Napoli: Department of Advanced Biomedical Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817462563; e-mail [email protected]
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Giuseppe Leone: Department of Advanced Biomedical Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817462563; e-mail [email protected]
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Mariano Marseglia: Department of Advanced Biomedical Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817462563; e-mail [email protected]
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Giuseppe Mariniello: Division of Neurosurgery, Department of Neurosciences, Reproductive and Odontostomatological Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817463280; e-mail [email protected] Ferdinando Caranci: Department of Advanced Biomedical Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817464646; e-mail [email protected] Fabio Tortora: Chair of Neuroradiology, “Magrassi Lanzara” Clinical-Surgical Department, Second University of Naples, Italy. Work Address: Viale Colli Aminei, 21, 80131 Naples, Italy. Work Phone +39 0817464251; e-mail [email protected] Francesco Maiuri: Division of Neurosurgery, Department of Neurosciences, Reproductive and Odontostomatological Sciences, “Federico II” University, Naples, Italy. Work Address: Via S.Pansini, 5. 80131, Naples, Italy. Work Phone +39 0817463280; e-mail [email protected]
Corresponding Author FRANCESCO BRIGANTI Department of Advanced Biomedical Sciences, Unit of Interventional Neuroradiology, Federico II University, Naples, Italy 1 Page 1 of 25
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Work Address: Via S.Pansini, 5. 80131, Naples, Italy Work Phone +39 0817464251 Mobile Phone 0039- 337666040 e-mail [email protected]
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TREATMENT OF INTRACRANIAL ANEURYSMS BY FLOW DIVERTER DEVICES: LONG-TERM RESULTS FROM A SINGLE CENTER
ABSTRACT
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OBJECTIVES: Flow-Diverter Devices (FDD) are a new generation stents designed for the treatment of the intracranial aneurysms. This article reports the long-term results (2 to 4 years) of this treatment from a single-center.
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METHODS: From November 2008 to January 2012, 35 patients (29 females and 6
males; mean age 53.9y) with 39 intracranial aneurysms were treated by FDD. Five
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patients (14.3%) had ruptured aneurysms and 30 (85.7%) had no previous hemorrhage. The procedures were performed in 5 patients (14.3%) with SILK and in 30 (85.7%)
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with PED. In 3 patients FDDs were used as a second treatment after failure of previous coiling (2 cases) or stenting (one case).
The 39 aneurysms were in supraclinoid ICA in 26 (66,7%), cavernous ICA in 2
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(5.1%), PCoA in 4 (10,2%), MCA in 5 (12.9%), SCA in 1 (2.6%) and PICA in 1 (2.6%). The aneurysms were small ( 6 months) or partial occlusion. CONCLUSION: FDD are a safe and efficacious treatment of intracranial aneurysms, resulting in high occlusion rate and low incidence of complications. It should be the treatment of choice for the large-neck aneurysm of the ICA. 3 Page 3 of 25
INTRODUCTION The endovascular treatment of intracranial aneurysms may be realized by several techniques, including coiling [1,2], balloon-assisted coiling (BAC) [3,4], stenting and stent-assisted coiling (SAC) [5-10]. These last techniques have been developed to associated with relatively large rates of periprocedural complications.
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improve the occlusion rate and decrease the recanalization. However, they are Flow-diverter devices (FDD) are new and important tools in the treatment of
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intracranial aneurysms [11].
They are able to form a high-coverage mesh that induces thrombosis of the
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aneurysmal sac; the rationale of the FDD use is to induce the development of the neointima in the inner surface of the vessel with a complete reconstruction, while that can cure the diseased aneurysm vessel.
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preserving patency of the adjacent small vessels [12]. These are now the only devices FDD mainly used in patients with more complex aneurysms (especially large, giant
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and wide-neck aneurysms) and more difficult locations; however, with increasing experience, a wider use also for aneurysms of different forms and size is suggested [13-25]. The main problem of these devices is the not immediate aneurysm occlusion;
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thus a long-term follow-up is necessary.
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The first two FDDs approved for the treatment of intracranial aneurysms were the Pipeline Embolization Device (PED) (Covidien, Mansfield, Massachusetts) and the
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Silk (Balt Extrusion, Montmorency, France). The PED is a flexible, meshlike tube of 48 interwoven microfilaments consisting of 25% platinum-tungsten and 75% cobaltchromium-nickel alloy; it provides 30% to 35% metal coverage of the surface of the target vessel. When deployed, it remains flexible and able to conform to tortuous vessel anatomy. The Silk flow diverter is constructed from 48 braided nitinol and 4 platinum microfilaments, with a pore size of 110 to 250 mm and 35% to 55% metal coverage at its nominal vessel diameter; it is also a flexible mesh stent. We report a retrospective study on 35 patients with intracranial aneurysms treated by FDD at the Interventional Neuroradiology Unit of “Federico II” University of Naples. Fourteen of these 35 patients were also included in the Italian multicenter study of FDD for intracranial aneurysms [14]. The aim of the present report is to discuss the indications, results and complications of this new kind of device, as compared with those of the other endovascular procedures.
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MATERIALS AND METHODS Patient population From the series of intracranial aneurysms treated by different surgical and endovascular procedures at the Federico II University of Naples between November
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2008 and January 2012, 35 patients who underwent insertion of FDD were retrospectively reviewed. The 35 patients are 29 females and 6 males, ranging in age between 32 and 74 years (average 53.9 years).
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All included patients had complete clinical-radiological pre- and post-procedural data
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and follow-up of at least 2 years. Clinical data (table 1)
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The clinical evaluation was made by the same neurosurgeon (F.M.) at admission, immediately before and after the procedure and at the patient discharge. Patients with subarachnoid hemorrhage were classified according to the Hunt-Hess classification
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[26].
The radiological definition was obtained in all cases by the same neuroradiologist, (F.C.) not involved in the interventional procedures. Computed Tomography
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Angiography (CTA), by using the native images and the 2D Multi-Planar in all patients.
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Reconstructions (MPR), and Digital Subtraction Angiography (DSA) were performed
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The aneurysm location and size, the aneurysm neck and the neck/diameter ratio were considered. The aneurysm size was classified as small (25mm).
Five patients (14.3%) had ruptured aneurysms with previous subarachnoid hemorrhage; the hemorrhagic episode occurred 250-300 seconds. The Clopidogrel (75mg) and Aspirin (100mg) were administered daily until the aneurysm occlusion was confirmed by DSA; then, only Aspirin was continued indefinitely. In 2 cases with a minor nasal bleeding caused by Clopidogrel hypersensitivity, this treatment was replaced by Ticlopidine (500 mg/daily). In our series corticosteroids were no administered both before and after the procedure. 6 Page 6 of 25
Intra-aneurysmal contrast stasis was observed in 24 patients (75%) immediately at the end of the procedure.
Follow-up schedule
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All patients underwent clinical examination and CTA 1, 3, 6 and 12 months after the procedure. A case with polycystic kidney and chronic renal failure was evaluated only with 3-month CTA.
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The complete aneurysm occlusion was confirmed in all cases DSA. MRI with angiographic sequences was performed every year.
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The actual follow-up ranges between 24 and 62 months (mean 41 months).
Peri-procedural technical problems
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RESULTS
Technical problems occurred in 4 procedures (11,4%). In one patient with large,
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wide-neck intracavernous carotid aneurysm, the primary SILK deployment was impossible due to the large defect of the artery wall, with the device falling into the sac; after many attempts and evaluation of the collateral flow with occlusion test, a
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LEO stent (3,5x35- Balt Extrusion) was first inserted; then a PED device was placed
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into the first stent one month later. In a patient with rupture of the PED microwire, it
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was captured with GooseNeck ®(Covidien) device, without any clinical problem. In one patient treated with Silk for a small carotid ophthalmic aneurysm, ICA vasospasm occurred few minutes after the successful procedure, with reduction of distal FDD’s diameter. After many dilatation attempts with balloon and evaluation of the contralateral flow supply with balloon-occlusion-test, the ICA was occluded with coils, with no neurological sequelae. Finally, one patient had a femoral pseudoaneurysm, resolved with compressive medication.
The periprocedural complications were not correlated with the type of FD used. Post-procedural neurological complications In early post-procedural period 2 patients had neurologic deficits. One with middle cerebral artery (MCA) aneurysm developed aphasia; another patient with superior cerebellar artery (SCA) aneurysm had difficult and late awakening. Both were treated 7 Page 7 of 25
with Abciximab (Reopro®) administration (intravenous bolus dose of 0.25 mg/kg followed by a continuous infusion of 0.125 μg · kg−1 · min−1 for 12 hours), with complete resolution of the symptoms. No early or delayed aneurysm rupture, no-subarachnoid and parenchymal hemorrhage
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nor ischemic troubles occurred. Occlusion rate and related factors (tables 3 and 4)
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The aneurysm occlusion was evaluated in 38 aneurysms (the case with periprocedural
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occlusion of the ICA was excluded).
Complete occlusion was obtained in 35/38 aneurysms (92.1%). Three (7.9%) were partially occluded at follow-up of 24 months; two of them were at M1 segment of the
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MCA and one at the PCoA. Thus, according to the aneurysm location, the complete occlusion was obtained in all 27 aneurysms of the ICA (100%), in 3 among 4 of the in one among 3 MCA aneurysms.
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PCoA (Posterior Communicating Artery), in the SCA and PICA aneurysms and only The 3 aneurysms with partial occlusion at the 24 months (2 of the MCA and one at
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the PCoA) showed a vessel arising from the aneurysm sac, and were stable without signs of aneurysm reperfusion.
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Among 35 aneurysms with complete occlusion, it occurred within 3 months in 24
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cases (68.5%), between 3 and 6 months in 9 (25.7%), at 12 months in one (2.9%) (Fig.1 and 2) and at 18 months in one (2.9%); this last case (fig.3) with very late occlusion was a giant (33x20mm), partially thrombosed carotid-ophthalmic aneurysm with atherosclerotic irregularity of the surface of the parent vessel and stenosis
proximal to the aneurysm neck. In this case the PED was probably oversized, resulting in decrease of the flow diversion effect. The correlation between the occlusion time and aneurysm size and neck (table 4) showed as follows. No significant difference of distribution of aneurysm size was evidenced regarding the occlusion time, excepting for the very late occlusion (18 months) of the unique giant aneurysm. The neck/sac ratio (ranging from 0.5 to 1.0) showed rather uniform distribution in the group of aneurysms with early occlusion (within 3 months); on the other hand, 10 among 14 aneurysms with late occlusion (6 months or more) or partial occlusion had larger neck (neck/sac ratio 0.9 or 1.0).
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Thus, the data of the study suggest that an early and complete occlusion after endovascular treatment with FDD is less probable for middle cerebral artery aneurysms, for those with larger neck, and for those with a vessel arising from the
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aneurysm sac.
DISCUSSION
The endosaccular coil placement is considered a safe treatment for intracranial
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aneurysms [1]; however the incidence of recurrence is high in the different series
(33.6% at 12 months after the treatment) [2]. For aneurysms with unfavourable
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features, especially those large or giant with wide neck, the incidence of recurrence is ever higher, with recanalization rate of 50.6% and 52.3%, respectively [2]. To
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improve the results in term of occlusion rate and stability, the coils were used with stent [5-10] and balloon [3,4], but these techniques are associated with relatively high rates of aneurysm recanalization and complications [3-5].
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The FDDs were initially used for giant and dissecting aneurysms, with the aim to achieve the reconstruction of parent vessel and the definitive aneurysm treatment [12]. After their introduction, several series evaluated the results with the use of these
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new devices [13-25, 27] (table 5); despite the initial good results in term of aneurysm
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occlusion, several complications, such as delayed aneurysm rupture [28,29], intraparenchymal haemorrhage [30] and adverse technical events were reported.
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The aim of many single or multicenter series was to evaluate the short and mid-term follow-up results [13-25,27].
Berge at al [13] reported a retrospective review of 77 aneurysms in 65 patients, treated with FDD in 6 different French centers; the morbidity rate was 7.8% and the mortality was 3% (2 patients with delayed aneurysm rupture and complications of systemic anti-aggregation, respectively). In the Canadian experience on 97 patients with the PED in 7 different centers, O’Kelly et al [27] reported a morbidity rate of 4.3% and mortality 6.4%; in particular the mortality rate was significantly higher in the group of patients with posterior circulation aneurysms (4/9 or 45%). In the Italian multicenter experience with FDD in 273 patients, Briganti et al [25] found a morbidity and mortality rate of 3.7% and 5.9%, respectively.
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Several factors must be considered when analyzing the indication and results of the endovascular treatment with FDD. These include the aneurysm location and size, the neck wideness and neck/sac ratio and the presence of a vessel arising from the sac. The rate and time of the aneurysm occlusion were evaluated in several studies of
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patients treated with FDD [13-25, 27]. From a review of 29 series of the literature Brinjikji et al [24] found a 76% rate of complete occlusion at 6 months. In our series of 39 aneurysms we have found a 86.8% rate of complete occlusion at 6 months (33
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among 38 aneurysms with follow-up), with two other cases undergoing complete
occlusion within 12 and 18 months (overall 35/38 or 92.1%); besides, the 3 cases with occlusion in later neuroradiological control studies.
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partial occlusion had a 6 months follow-up, thus suggesting chances of complete
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The better results of our series are likely due to several factors, including the realization of all procedures by the same neuroradiologist and the low rate of giant (one case) and posterior circulation (2 cases) aneurysms. It is also noteworthy that all
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three aneurysms partially occluded at 6 months (two MCA and one PCoA aneurysms) showed a vessel arising from the sac; this may result in flow reversal and later occlusion. The data of our series confirm that the occlusion rate is not correlated with
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the aneurysm size. On the other hand, the aneurysm neck and the neck/sac ratio seem occlusion).
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to be relevant (high neck/sac ratio of 0.9 or 1.0 in 9/11 aneurysms with late or partial
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According to the location, aneurysms of the ICA and circle of Willis seem to do better than those of the MCA; for aneurysms of the posterior circulation no conclusions may be defined due to the low number of the cases (2/39). On the whole, the results of the treatment with FDD, show that the rate of aneurysm occlusion (49% to 95%) (table 5) is higher than that of cases treated by different (no flow-diverter) devices (43 to 76%) (table 6). Thus, from the data of our study we recommend the use of FDD for large-neck aneurysms of the ICA siphon. Distal aneurysms, such as those of the MCA and those with vessels arising from the sac, represent a lesser indication. Several technical problems may occur during the procedure with FDD. These mainly include difficulty in the devices deployment, particularly in giant aneurysms with large neck. Silk devices may undergo coartation due to loss of radial force. Besides, PED do not completely retrieve. We have experienced in one case of our series severe vasospasm of the ICA requiring the vessel occlusion with no neurological sequelae. 10 Page 10 of 25
The treatment of cerebral aneurysms with FDD is not risk-free. In a recent review of 29 studies, Brinjikji et al [24] found mortality rates from 0% to 7% (mean 4%) and morbidity rates from 0% to 12% (mean 5%). Postprocedural complications, which may lead to permanent morbidity or death mainly include subarachnoid hemorrhage,
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intracerebral hemorrhage and ischemic stroke. Delayed rupture was reported particularly for giant and fusiform aneurysms, and for those of the posterior circulation [28-30].
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FDD do not resolve the problem of rapid flow decrease, as they cause massive intra-
aneurysmal platelet aggregation with rupture of the aneurysm wall. The concomitant
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use of endosaccular coils does not prevent the rupture, probably because of increased turbulence at the neck level, or peripheral persistent fresh thrombus that might
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promote the rupture. Ischemic stroke is reported with a 6% incidence, mainly with large/giant aneurysms and for these of the posterior circulation including perforators in the aneurysm wall. The sudden flow decrease in the perforator territories may
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account for the often severe consequences of a brainstem infarction. We did not
CONCLUSION
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observe hemorrhagic nor ischemic postprocedural events in our series.
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FDD represent a reasonably, safe and effective treatment option for intracranial aneurysms, associated with high rate of aneurysm occlusion and low risk of
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complication. We recommend this treatment mainly for large-neck aneurysms of ICA siphon, where it should be considered the procedure of first choice. On the other hand, treatment of posterior circulation aneurysms, particularly those involving perforators, should be avoided, due to the high rate of ischemic events. FDDs of last generation of are more sophisticate and probably will reduce the incidence of technical adverse events.
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FIGURE LEGEND Fig.1 (A) A 68-year-old woman harboring a 12-mm ophthalmic aneurysm (DSA). (B)
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1-month follow-up angiography show complete occlusion of the aneurysm
Fig.2 (A) A 67-year-old woman harboring a MCA aneurysm (DSA). (B) 6-month
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follow-up angiography show complete occlusion of the sac.
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Fig.3 (A) A 61-year-old woman with a giant (26x22mm) partially-trombosed
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cavernous ICA aneurysm (DSA). (B) 18-month follow-up angiography show
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complete occlusion of the sac
Fig.4 (A) A 45-year-old woman with a large (20x14mm) wide-neck intracavernous
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ICA aneurysm (DSA). (B) the primary SILK deployment was impossible due to the
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large defect of the artery wall, with the device falling into the sac (DSA); (C) a LEO stent (3,5x35- Balt Extrusion) was first inserted, then a PED device was placed into
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the first stent one month later (D).
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7. Kis B, Weber W, Gotz F, Becker H, Berlit P, Kuhne D. Endovascular treatment of cerebral aneurysms using the Leo stent: long term follow-up and expansion of indications. Clin Neuradiol 2007; 17:167-179
8. Maldonado IL, Machi P, Costalat V, Mura T, Bonafé A. Neuroform stentassisted coiling of unruptured intracranial aneurysms: short- and mid-term results from a single-center experience with 68 patients. AJNR Am J Neuroradiol. 2011; 32:131-6
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13. Berge J, Biondi A, Machi P, Brunel H, Pierot L. 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
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14. Briganti F, Napoli M, Tortora F, et al. Italian multicenter experience with flow-diverter devices for intracranial unruptured aneurysm treatment with 2012; 54: 1145-1152
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Am J Neuroradiol 2013; 34:381-7 28. Kulcsar Z, Houdart E, Bonafe A, et al. Intra-aneurysmal thrombosis as a possible cause of delayed aneurysm rupture after flow-diversion treatment. AJNR Am J Neuroradiol 2011; 32:20-25 29. Turowski B, Macht S, Kulcsar Z, Hanggi D, Stummer W. Early fatal hemorrhage after endovascular cerebral aneurysm treatment with a flow 15 Page 15 of 25
diverter (SILK-Stent): do we need to rethink our concepts? Neuroradiology 2011; 53:37-41. 30. Cruz PJ, Crow M, O’Kelly C, Marotta B, Spears L. Delayed ipsilateral parenchymal hemorrage following flow diversion for the treatment of the
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anterior circulation aneurysms. AJNR Am J Neuroradiol 2012; 33: 603-08
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Table 1. Endovascular devices (35 patients) Type of FDD
30 (85.7%)
SILK
5 (14.3%)
FDD alone
32 (91.4%)
Previous coiling
2 (5.7%)
Previous non FD stent
1 (2.9%)
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Adjunctive devices
PED
29 (82.9%) F
Sex
6 (17.1%) M
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Table 2. Clinical-radiological characteristics (35 patients with 39 aneurysms)
32-74 years (average 53.9y)
Clinical presentation
Ruptured (previous SHA) 5 (14.3%)
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Age (years)
(35 patients)
Hunt-Hess 1 (3 patients) Hunt-Hess 1A (2 patients)
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No previous hemorrhage 30 (85.7%)
Asymptomatic 15 (50%) Headache 8 (26.7%) Cranial nerve palsy 5 (16.7%) Ischemia 1 (3.3%) T.I.A. 1 (3.3%)
Supraclinoid ICA
26 (66.7%)
Cavernous ICA
2 (5.1%)
PCoA
4 (10.2%)
MCA
5 (12.9%)
SCA
1 (2.6%)
PICA
1 (2.6%)
Small (25mm)
1 (2.6%)
Aneurysm neck/sac ratio
0.5
2 (5.1%)
(39 aneurysms)
0.6
4 (10.3%)
0.7
9 (23.1%)
0.8
5 (12.8%)
0.9
11 (28.2%)
1.0
7 (17.9%)
fusiform
1 (2.6%)
Aneurysm location
Ac ce p
(39 aneurysms)
Aneurysm size (39 aneurysms)
17 Page 17 of 25
Occlusion rate
Complete
35 (92.1%)
(38 aneurysms)
Partial
3 (7.9%)
Time of complete occlusion
Within 3 mo
24 (68.5%)
(35 aneurysms)
3 to 6 mo
9 (25.7%)
6 to 12 mo
1 (2.9%)
12 to 18 mo
1 (2.9%) N.cases
Complete occlusion
Supraclinoid ICA
25
25
Cavernous ICA
2
2
PCoA
4
3
MCA
5
3
SCA
1
PICA
1
total
38
cr
-
1 2
us
to aneurysm location
Partial occlusion
1
-
1
-
35
3
an
Complete occlusion related
ip t
Table 3. Data on the aneurysm occlusion (38 aneurysms)*
te
d
M
* a case with periprocedural ICA occlusion (supraclinoid ICA aneurysm) was excluded
Table 4. Correlation of the occlusion time with aneurysm size and neck (38 aneurysms*) n.
timing
cases
Aneurysm size
Neck-sac ratio
small
large
giant
0.5
0.6
0.7
0.8
0.9
1.0
fusif
Ac ce p
Occlusion and
Complete
