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ORIGINAL ARTICLE
Year : 2011  |  Volume : 59  |  Issue : 4  |  Page : 548-552

Endovascular treatment for wide-necked intracranial aneurysms with the Enterprise stent


1 Department of Neurosurgery, Jinan University Affiliated First Hospital, Guangzhou, China
2 Department of Neurosurgery, Jilin University Affiliated First Bethune Hospital, Changchun, China

Date of Submission27-Mar-2011
Date of Decision22-Apr-2011
Date of Acceptance27-Apr-2011
Date of Web Publication30-Aug-2011

Correspondence Address:
Xu Kan
Neurosurgery Department, Jilin University, Bethune Hospital, 130 021, Changchun
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0028-3886.84335

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 » Abstract 

Background: The development of self-expanding stents dedicated to intracranial use has significantly widened the applicability of endovascular therapy to many intracranial aneurysms Objective: To report the angiographic and clinical outcomes of wide-necked intracranial aneurysms treated using the Enterprise stent. Material and Methods: Forty-six patients with 50 wide-necked and fusiform aneurysms (19 aneurysms with dissections), admitted between June 2009 and December 2010, were treated using Enterprise stents. Demographic information, procedural data, and technical complication were reviewed. Angiographic and clinical outcomes were evaluated at a 9.1-month follow-up. Results: Stent deployment was successful in all the 50 lesions, and additional coil embolization was performed in 48. Complete or near-complete occlusion immediately after stent deployment was achieved in 44 aneurysms, whereas, no immediate coil embolization was chosen in two cases. There was one (2%) procedure-related complication, which resulted in death. At mean 9.1-month follow-up, the result was good (GOS ≤2) in 45 patients. Angiographic recurrences arose in two cases, one of which was re-treated completely. Conclusions: The Enterprise stent is very useful for endovascular embolization of wide-necked intracranial aneurysms, because it is easy to navigate and place precisely. The overall morbidity and mortality rates are low.


Keywords: Enterprise stent, intracranial aneurysm, stent-assisted coiling


How to cite this article:
Wang H, Xu D, Xiang Y, Li W, Chen Z, Chen S, Kan X. Endovascular treatment for wide-necked intracranial aneurysms with the Enterprise stent. Neurol India 2011;59:548-52

How to cite this URL:
Wang H, Xu D, Xiang Y, Li W, Chen Z, Chen S, Kan X. Endovascular treatment for wide-necked intracranial aneurysms with the Enterprise stent. Neurol India [serial online] 2011 [cited 2019 Nov 17];59:548-52. Available from: http://www.neurologyindia.com/text.asp?2011/59/4/548/84335



 » Introduction Top


The development of self-expanding stents dedicated to intracranial use has significantly widened the applicability of endovascular therapy to many intracranial aneurysms. [1] The recent Enterprise stent has added a new option for self-expanding stent-assisted intracranial aneurysm coiling. [2] We report angiographic and clinical outcomes and rates of complications in wide-necked intracranial aneurysms treated by using Enterprise stents.


 » Material and Methods Top


Between June 2009 and December 2010, 46 patients with 50 wide-necked cerebral aneurysms were treated endovascularly using Enterprise stents, in our center. Demographic information included the following: Reason for presentation, patient age and sex, aneurysm size, and aneurysm location. Procedural data included percentage of occlusion (at the completion of the initial procedure), and technical complications. Before all the procedures, the patients underwent conventional angiography of both internal carotid arteries (ICA) and vertebral arteries (VA) and three-dimensional angiography. The characteristics of the patients and aneurysms are summarized in [Table 1].
Table 1: Characteristics of 50 aneurysms

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Indications

The Enterprise is intended for use with embolic coils for the treatment of wide-necked (defined as having a neck width >4 mm or a dome-to-neck ratio of <2) saccular or dissecting intracranial aneurysms arising from a parent vessel, with a diameter between 3 and 4 mm. The diagnosis of a dissecting aneurysm is classically made by the angiographic appearance with a double lumen, a focal vessel wall irregularity, a pre-aneurysmal narrowing and a fusiforme dilatation. On magnetic resonance imaging (MRI), when a vessel wall flab is seen, it is diagnosed as dissection.

Endovascular procedure

All procedures consisted of stent delivery across the aneurysm (in the case of a fusiform aneurysm) or its neck (wide-necked aneurysms) and subsequent coiling of the sac. Endovascular treatment was performed on a biplane, flat panel digital subtraction unit. Patients with no subarachnoid hemorrhage (SAH) were pretreated with 200 mg of aspirin and 75 mg of clopidogrel (Plavix; Bristol-Myers Squibb/Sanofi Pharmaceuticals, NY) for three to five days preceding stent placement and patients with SAH were pretreated with 300 mg of aspirin and 300 mg of clopidogrel, two hours before the procedure. The endovascular procedures were performed under general anesthesia and systemic heparinization. The bolus infusion of heparin was 4000 IU followed by 1000 IU/hour with the purpose of anticoagulation. Systemic heparinization was prolonged for 24 hours in all patients. Unilateral femoral access was obtained through a percutaneous femoral artery puncture, and one 6-French Envoy MPD (Cordis Neurovascular, Inc.) guiding catheter was inserted into the parent vessel. A 2.3-French Prowler Plus microcatheter with an internal diameter of 0.021 inch was then advanced over a 0.014-inch Transend or Synchro microguidewire (Target Therapeutics, Fremont, CA) into the normal distal artery beyond the aneurysm, by 2 cm. The guide-wire was then removed, and the stent was introduced into the hub of the catheter via the delivery system. Under road-mapping, the stent was then pushed through the microcatheter and aligned directly across the neck of the aneurysm. When proper alignment was achieved, the microcatheter was gently pulled back to unsheath the stent, while gentle forward tension was maintained on the stent system to keep it in place [Figure 1]. We waited for the distal flared end to be completely open, and then the stent was deployed to as much as 70% of its opening; the positioning was confirmed by direct visualization. If the stent required repositioning, it was re-sheathed, repositioned, and then redeployed. Once the stent was fully deployed, the microcatheter and introducing system were removed. A smaller microcatheter, Echelon 10/14 (M.T.I-ev3), was then introduced through the guiding catheter, and with direct fluoroscopic visualization and road-mapping, guided through the interstices of the stent and into the aneurysm. Microplex coils (MicroVention, Aliso Viejo, CA) were then delivered within the aneurysm through the microcatheter. After treatment, the fluid balance, neurological status, and blood pressure were carefully monitored. The patients were maintained on aspirin and clopidogrel for one month and aspirin (100 mg per day) for six months.
Figure 1: Picture of the Enterprise stent

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Angiographic and clinical results

The initial procedural outcome was categorized as: Complete occlusion (100%), nearly complete (>90%), and incomplete (≤90%). [3] The outcome according to the Glasgow Outcome Scale [4] was evaluated at a 9.1 month follow-up (range 1 - 18 months). Follow-up angiograms were performed after one to nine months.


 » Results Top


Demographic data

In total, 46 patients (20 males and 26 females) with 50 wide-necked cerebral aneurysms underwent 50 attempted stent deployments. The mean age was 51.2±11.5 years. The most common location was the paraclinoid region (in 17 patients) followed by, in decreasing frequency, VA (in 13 patients), basilar artery (not tip) (in 11 patients), posterior communicating artery (in five patients), cavernous ICA (in three patients) and basilar tip (in one patient). Initial presentation was: Incidental in 18 patients; SAH in 16 patients; visual impairment in six patients; ophthalmoplegia in three patients; hemiparesis in three patients; routine follow-up of a previously coiled aneurysm demonstrating recurrence in one patient; and tetraplegia in one patient. Mean aneurysm size was 10.3±5.5 mm [Table 1]. Thirty-one aneurysms were saccular and 19 were dissecting.

Treatment

Forty-eight aneurysms were treated by Enterprise stent-assisted coiling [Figure 2] and [Figure 3], and two aneurysms with dissection and without aneurysmal dilation, were treated with stent alone. A parallel technique (aneurysmal catheterization was performed prior to stent releasing) was used in all stent-assisted coiling embolization. Complete and nearly complete occlusion was achieved in 44 aneurysms (88%) and incomplete in six aneurysms (12%). One complication occurred in this group.
Figure 2: (a) 45-year-old woman presented with visual disturbance on the left side. A, three-dimensional reconstruction of rotational angiographic image demonstrating 15.3-mm supraclinoidal ICA wide-necked aneurysm, with the ICA measuring 4.4 mm. (b) and (c), digital subtraction images of the left ICA after placement of a 4.5 ¥ 28 mm Enterprise stent and coil embolization. Demonstrating a less than 90% occlusion of the aneurysm

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Figure 3: (a) 56-year-old man presented with an unruptured aneurysm of the right ICA. A, angiogram showing a 4.5 22-mm Enterprise stent was placed (arrows) and coils were delivered. (b) final angiogram showing the complete obliteration of the aneurysm

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Complication

In total, one patient died (2% mortality rate). This death occurred in one patient with an unruptured aneurysm. The death was due to microcatheter dome perforation during coiling (post-stent placement) of an unruptured large basilar trunk aneurysm.

Follow-up

Clinical and angiographic follow-up examinations were performed in 45 (97.8%) patients for 49 aneurysms, after a mean time of 9.1 months (range 1 - 18 months). Forty-seven lesions were unchanged (complete occlusion in 42, residual neck in 5). One aneurysm exhibited increasing spontaneous thrombosis after stent deployment, without coil embolization. Two (4%) recurrences were evident. Subsequently, one of these was completely occluded by coil embolization. During the follow-up period, no angiographic narrowing of the vessels was seen and the outcome was good in 45 patients.


 » Discussion Top


This study shows that the Enterprise stent is a very useful tool for endovascular embolization of wide-necked intracranial aneurysms. Higashida et al., [5] reported their experience with stent-assisted coiling of intracranial aneurysms in five patients with the Enterprise stent, with 100% accurate deployment; there were no adverse events or morbidity. More recently, Weber et al., [6] reported a larger series of 30 patients with 31 aneurysms, with 100% successful deployment, and two 'possible or probable device-related serious adverse events during the six-month follow-up period'. However, despite these events, there was no procedural-related morbidity or death. In our study the use of the Enterprise stent was associated with a 90% rate of occlusion in 88% of the cases with no morbidity and 2% mortality. These data compare well with the previously published data for Neuroform and Enterprise, as well as with the non-stent related surgical and endovascular studies. [7],[8],[9],[10],[11],[12],[13],[14],[15],[16],[17],[18] The current Neuroform and Enterprise data report initial rates of >90% occlusion with a range of 35.3 to 80% for intracranial aneurysms. [9],[10],[11] Our experience favors the upper limit of this range.

The early published experience with Neuroform demonstrated: Rates for the inability to navigate or deploy 4-14%, rates for inaccurate deployment 8-7.8%, and rates for 'difficulty' in deployment 24-31%. [8],[9],[11] However, newer Neuroform iterations have resulted in some improvement in navigability, with only 4% inaccurate deployment rate for Neuroform, and it was 1.3% for Enterprise. [9],[10],[11] We experienced no inaccurate deployment rate and no inability in deployment with the Enterprise. Our series confirms the efficacy and safety of stent-assisted coiling with the Enterprise device, and the parallel technique was used frequently in our center. We did not encountered difficulties in selecting the aneurysm through the stent strut. Moreover, the Enterprise stent appears very easy to navigate and to position, on account of its delivery system. Indeed, this stent is delivered through a conventional coiling catheter that is easy to navigate. It is approved for use in parent vessels with a diameter of 2.5 to 4.0 mm. The major disadvantage is the fact that it is available in only one diameter, despite being available in multiple lengths.

The Neuroform stent (Boston Scientific/Target Therapeutics, Fremont CA), approved in 2002, was the first stent available in the United States market. Other aneurysm stents or vascular reconstruction devices are available outside the United States market and include the Leo stent (Balt Extrusion, Montmorency, France), [19] Solo stent (ev3, Inc., Irvine, CA), [20] and the Pipeline device (Chestnut Medical Technologies, Inc., Menlo Park, CA). [21] The first retractable stent to be released was the Leo stent. The Leo stent presents a limiting characteristic: The need for progressively larger and stiffer delivery catheters, to place larger stents. [22]

 
 » References Top

1.Bendok BR, Parkinson RJ, Hage ZA, Adel JG, Gounis MJ. The effect of vascular reconstruction device-assisted coiling on packing density, effective neck coverage, and angiographic outcome: An in vitro study. Neurosurgery 2007;61:835-41.  Back to cited text no. 1
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2.Food and Drug Administration. Cordis Enterprise Vascular Reconstruction Device and Delivery System. New Humanitarian Device Approval. H-60001. HUD Number: 04-0147. Available from: http://www.fda.gov/cdrh/mda/docs/H060001.html. [accessed on 2008 Apr 9].  Back to cited text no. 2
    
3.Kang HS, Han MH, Kwon BJ, Kwon OK, Kim SH, Choi SH, et al. Short-term outcome of intracranial aneurysms treated with polyglycolic acid/lactide copolymer-coated coils compared to historical controls treated with bare platinum coils: A singlecenter experience. AJNR Am J Neuroradiol 2005;26:1921-8.  Back to cited text no. 3
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4.Jennett B, Bond M. Assessment of outcome after severe brain damage. Lancet 1975;1:480-4.  Back to cited text no. 4
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5.Higashida RT, Halbach VV, Dowd CF, Juravsky L, Meagher S. Initial clinical experience with a new self-expanding nitinol stent for the treatment of intracranial cerebral aneurysms: The Cordis Enterprise stent. AJNR Am J Neuroradiol 2005;26:1751-6.  Back to cited text no. 5
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6.Weber W, Bendszus M, Kis B, Boulanger T, Solymosi L, Kuhne D. A new self-expanding nitinol stent (Enterprise) for the treatment of wide-necked intracranial aneurysms: Initial clinical and angiographic results in 31 aneurysms. Neuroradiology 2007;49:555-61.  Back to cited text no. 6
    
7.Akpek S, Arat A, Morsi H, Klucznick RP, Strother CM, Mawad ME. Self-expandable stent-assisted coiling of widenecked intracranial aneurysms: A single-center experience. AJNR Am J Neuroradiol 2005;26:1223-31.  Back to cited text no. 7
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8.Benitez RP, Silva MT, Klem J, Veznedaroglu E, Rosenwasser RH. Endovascular occlusion of wide-necked aneurysms with a new intracranial microstent (Neuroform) and detachable coils. Neurosurgery 2004;54:1359-68.  Back to cited text no. 8
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10.Fiorella D, Albuquerque FC, Deshmukh VR, McDougall CG. Usefulness of the Neuroform stent for the treatment of cerebral aneurysms: Results at initial (3-6-mo) follow-up. Neurosurgery 2005;56:1191-202.  Back to cited text no. 10
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11.Mocco J, Snyder KV, Albuquerque FC, Bendok BR, Alan SB, Carpenter JS, et al. Treatment of intracranial aneurysms with the Enterprise stent: A multicenter registry. J Neurosurg 2009;110:35-9.  Back to cited text no. 11
    
12.Gallas S, Drouineau J, Gabrillargues J, Pasco A, Cognard C, Pierot L, et al. Feasibility, procedural morbidity and mortality, and long-term follow-up of endovascular treatment of 321 unruptured aneurysms. AJNR Am J Neuroradiol 2008;29:63-8.  Back to cited text no. 12
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13.International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms-risk of rupture and risks of surgical intervention. N Engl J Med 1998;339:1725-33.  Back to cited text no. 13
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14.Jabbour P, Koebbe C, Veznedaroglu E, Benitez RP, Rosenwasser R. Stent-assisted coil placement for unruptured cerebral aneurysms. Neurosurg Focus 2004;17:E10.  Back to cited text no. 14
    
15.Katsaridis V, Papagiannaki C, Violaris C. Embolization of acutely ruptured and unruptured wide-necked cerebral aneurysms using the Neuroform2 stent without pretreatment with antiplatelets: A single center experience. AJNR Am J Neuroradiol 2006;27:1123-8.  Back to cited text no. 15
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18.Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, et al. Unruptured intracranial aneurysms: Natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet 2003;362:103-10.  Back to cited text no. 18
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20.Yavuz K, Geyik S, Pamuk AG, Koc O, Saatci I, Cekirge HS. Immediate and midterm follow-up results of using an electrodetachable, fully retrievable SOLO stent system in the endovascular coil occlusion of wide-necked cerebral aneurysms. J Neurosurg 2007;107:49-55.  Back to cited text no. 20
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21.Fiorella D, Woo HH, Albuquerque FC, Nelson PK. Definitive reconstruction of circumferential, fusiform intracranial aneurysms with the Pipeline embolization device. Neurosurgery 2008;62:1115-21.  Back to cited text no. 21
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    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1]

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