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The endovascular assay of wide-neck aneurysms has been facilitated by the use of airship remodelling and stent assistance, abbreviating the recanalization ante that were apparent with braid alone.1–4 Added recently, a cardinal of flow-diverting accessories accept become accessible and are beneath evaluation.5–10 The PED (ev3, Irvine, California) is a self-expanding, microcatheter-delivered, 75% cobalt-nickel alloy, and 25% platinum cobweb tube with 30%–35% metal apparent advantage back absolutely deployed. Midterm after-effects accept been appear afresh in single-center registries11,12 and a multicenter all-embracing registry.13 All approved that assay of wide-neck aneurysms with PED about-face of the ancestor barge was accomplished safely. The purpose of this multicenter -to-be anthology was to assay analytic acquaintance as this breeze diverter is appear to the neurointerventional association and to appraise whether the antecedent after-effects can be generalized.

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The abstraction was a -to-be case anthology of all patients with lesions acceptable for PED at 3 Australian neurointerventional centers amid August 2009 and August 2010. Aneurysms with a avant-garde close (>4 mm), abortive dome/neck arrangement (<1.6), a ample (>10 mm), fusiform anatomy, and those that had bootless antecedent assay were selected. Each case was advised by a multidisciplinary team; afore accepted absolution of the PED, alone appliance for use of the PED on compassionate area was approved from both hospital administering and the Therapeutic Goods and Services Administration. Written abreast accord was obtained. Abstracts were calm prospectively with account to aneurysm morphology, symptoms, antecedent treatment, antiplatelet and anticoagulation regimens, and abstruse and analytic complications. Aftereffect for at atomic 6 months evaluated occlusion, accumulation effect, delayed complications, advancing antiplatelet therapy, and in-stent stenosis.

Antiplatelet protocols assorted amid operators. At 2 institutions, patients were pretreated with 75–150 mg circadian of clopidogrel for 5 days. The closing dosage has been apparent to action added reliable platelet inhibition.14 For at atomic 5 canicule afore therapy, 100 mg (enteric coated) to 150 mg of circadian aspirin was additionally given. If the accumulation aftereffect affection were advised added urgent, patients were emergently loaded with clopidogrel (300–600 mg immediately) and 300 mg of aspirin afore treatment. The college 600-mg dosage of clopidogrel is associated with added reliable levels of platelet inhibition.15 The added centermost chose to amount patients with 300 mg of clopidogrel and 300 mg of aspirin for 2 days, based on antecedent coronary stent adjustment data.16 One centermost had admission to a point-of-care platelet inhibition assemblage and could appoint added clopidogrel in patients with abstinent bare platelet inhibition.

Dual antiplatelet medication for 6 months was maintained in the antecedent apportionment in accordance with the better appear PED experience.17 Bifold agents were maintained in the afterwards apportionment for 12 months because this is a atypical assay with little appear abstracts on the accident of perforator occlusion currently available. Patients were monitored for clopidogrel acquiescence by absolute questioning. Aspirin assay was assigned life-long. All patients had intravenous heparin intraprocedurally with an activated array time of >200. Fifty-six of 57 patients had heparin beverage for at atomic 24 hours postprocedure (activated fractional thromboplastin time, ×2 normal).

Therapy was undertaken with the accommodating beneath accepted anesthesia. All PEDs were deployed by application high-magnification accession fluoroscopy through a Marksman (ev3, Irvine, California) 2.8F microcatheter. Antecedent acquaintance with deployment circuitous a aggregate of unsheathing the accessory and blame it out of the microcatheter. Added PEDs were deployed at the acumen of the operator. Indications for assorted PEDs included bare close coverage, fusiform aneurysm configuration, and an advancing jet into the aneurysm. Ideally, antithesis and a contrast/blood band were empiric at the abeyance of the procedure. In some cases, coils were placed as allotment of the action afore PED deployment or afterwards jailing a microcatheter.

Elective patients were accepted on the day of the action and absolved at 36–72 hours, with CTA or MRA, if possible, 1 ages posttreatment. A 6-month ascendancy angiogram was acquired and advised by 2 interventional neuroradiologists. Added angiography was performed if the aneurysm was accessible or in-construct absorption was present. In patients with accumulation effect, MR imaging or CT was additionally performed to appraise breach change afterwards assay and, if possible, afterwards clopidogrel cessation. Analytic aftereffect was performed at 1 and 6 months, in accession to absolute appraisal by a neurologist or neurosurgeon. Patients were additionally apparent added consistently if they had circuitous problems.

The primary end point was the angiographic actualization at 6 months with appraisal of aneurysm cease and ancestor barge stenosis. All analytic incidents (TIA, stroke, SAH, or accumulation effect) in the aboriginal 6 months posttreatment were documented. Accessory abstraction end credibility included appraisal of the access of PED on appropriate accumulation aftereffect and aneurysm occlusion at 4 weeks by application MRA or CTA in as abounding patients as possible. A longitudinal abstraction was undertaken above 6 months in patients with nonocclusion of the aneurysm (stopping clopidogrel at 6 months in the antecedent apportionment cases) or in-stent binding (maintaining clopidogrel).

Data on 68 aneurysms in 65 patients were calm amid August 2009 and August 2010. Eleven patients presenting with astute SAH were afar and will be appear separately. This exclusion larboard 57 aneurysms in 54 patients for analysis. Forty-four women and 10 men (4.4:1) with a beggarly age of 55.7 years (median, 58 years; range, 30–83) and beggarly aneurysm admeasurement of 13.1 mm (median, 11 mm; range, 4–34 mm) were included. Seven were behemothic (>25 mm); 32, ample (10–25 mm); and 18, baby (<10 mm). All 57 aneurysms had a close amplitude of >4 mm or an abortive dome/neck arrangement of <1.6. Forty-six were drupe and 11 were fusiform. Forty-six aneurysms were in the antecedent circulation, and 11 were in the afterwards circulation. Aneurysm characteristics are declared in Tables 1 and 2.

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Size of aneurysm, cardinal of PED, and use of coils

Type, size, and occlusion amount of aneurysms

Forty-one aneurysms were asymptomatic, and 16 patients had appropriate accumulation aftereffect with neurologic deficits. Sixteen patients had had above-mentioned treatment: 15 endovascular and 1 clipping. Four ahead advised patients presented with appropriate accumulation effect.

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Ninety-eight PEDs were placed in 57 aneurysms (1.72 per aneurysm). The PED was acclimated as the sole assay in 36 of 41 constituent asymptomatic cases. Coils were placed in 3 constituent cases. This best was operator-dependent and was performed in the afterward scenarios:

1) A actual wide-neck antecedent communicating aneurysm in which the PED was attention the A1/2 alliance and narrowing, but not absolutely covering, the close with accessory braid via the adverse A1

2) A carotico-ophthalmic aneurysm with the ophthalmic avenue advancing out of the anatomy of the aneurysm in an attack to assure the retinal avenue from embolism

3) A case adapted to PED afterwards antecedent fractional braid showed a close added than anticipated.

In the 16 cases with focal appropriate accumulation effect, PED was acclimated as the sole assay in 13 cases with added coils placed in 3 others due to the following:

1) An astute carotid alveolate fistula due to guidewire breach auspiciously acutely with PED and braid deployment afterwards sequelae.

2) A fusiform aneurysm in which the abettor did not appetite to overlap the PED in the basilar trunk

3) An operator-based accommodation in a alveolate aneurysm, ahead advised with coils.

A ailing opened PED astute angioplasty occurred in 1 case in which the PED did not absolutely accessible aural an Enterprise stent (Cordis, Miami Lakes, Florida) (Figure 1). Persistent bushing of the aneurysm appropriate airship angioplasty at 11 months with accelerating aneurysm occlusion axiomatic at 18 months.

A 30-year-old woman with a fusiform basilar block sidewall 12-mm aneurysm ahead advised with an Enterprise stent some months afore absolution of PED. A, Anteroposterior (AP) vertebrobasilar DSA demonstrates the stent (black arrowheads) aural the apparent aneurysm. B, High-resolution flat-panel CT browse afterwards deployment of a distinct PED aural the Enterprise stent demonstrates that the PED is not absolutely accessible and appears accountable aural the stent (white arrow). C, AP DSA 6-months afterwards PED admittance demonstrates some slowing of sac elimination but no change in aneurysm size. AP DSA at 11 months (not shown) was unchanged, and an angioplasty of the PED was performed by application a HyperGlide airship (ev3), with balmy advance in appearance. The accommodating remained on clopidogrel. D, AP DSA, at 18 months’ post-PED and 7 months’ postangioplasty, demonstrates apparent abridgement in the admeasurement of the sac. The accommodating charcoal on clopidogrel.

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An astute caroticocavernous fistula occurred in 1 accommodating during access of a wire above a behemothic partly thrombosed alveolate aneurysm. The fistula was advised with coils and PED with no analytic consequence.

PED clearing astute added assay occurred in 2 cases. A 47-year-old man (Fig 2) had a 1-month post-PED article CTA demonstrating delayed adjacent clearing of the device, apprehension the aneurysm neck. Two added PEDs were deployed the aforementioned day. Accession accommodating had abridgement of the distal PED, astute adjustment of an Enterprise stent to ballast the PED.

A 55-year-old man with recent-onset homonymous hemianopia. A 16-mm above hypophyseal aneurysm credibility upwards, burden the chiasm. A, Crabbed centralized carotid avenue DSA demonstrates the deployed PED able-bodied accoutrement the aneurysm close (black arrow). B, Sagittal CTA 48 hours afterwards PED deployment demonstrates the distal allowance of PED aloof accoutrement the neck. C, Sagittal CTA at 1 ages demonstrates adjacent clearing of the PED with a jet into the aneurysm. D, Sagittal CTA 1 ages afterwards the added PED demonstrates a acceptable position of the PED and occlusion of the aneurysm, which was accepted at 6-month DSA (not shown). Clopidogrel was stopped. The homonymous hemianopia bound at 5 months, and 12-month MR imaging (not shown) approved apparent abridgement in the admeasurement of the thrombosed aneurysm sac.

Retroperitoneal drain occurred in 1 patient, astute abeyance of heparin beverage at 8 hours and 2 hours of arranged cells. This acclimatized with no added intervention.

There were no cases in which array was detected during the case and no cases of stent thrombosis. No deaths, strokes, or delayed-aneurysm breach occurred. One astute TIA at day 2 and 3 delayed TIAs (2 at 3 months and 1 at 5 months) were recorded. All acclimatized with clopidogrel reloading. One case with a multilobular carotico-ophthalmic aneurysm had a retinal annex occlusion, with no analytic sequelae, afterwards confined braid of the locule from which the ophthalmic avenue arose.

Fifty-six of 57 aneurysms were accessible for imaging aftereffect at 6 months. One added patient, active in a alien location, had advancing analytic follow-up, with a 1- and 14-month CTA demonstrating 50% and 100% occlusion, respectively, with no stenosis.

CTA, MRA, and, in 1 patient, DSA were performed at 1 ages posttreatment in 31 patients (Table 3). Occlusion ante of 61.3% in aneurysms with no above-mentioned assay and 64.6% in ahead advised cases were recorded.

Treatment accessories and occlusion rates

DSA was performed in 54 patients with 2 accepting noninvasive CTA or MRA due to renal abortion or avant-garde age. Occlusion ante are abbreviated in Tables 2 and 3. Forty-eight of the 56 aneurysms beheld were chock-full at 6 months (85.7%). In patients not ahead treated, the occlusion amount was 92.5%. In 16 patients with above-mentioned assay of the ambition aneurysm, the occlusion amount was 68.7%. In 50 patients with no stent in situ, the occlusion amount was 90%. Only 3 of 6 cases with antecedent stent in situ were occluded. A absolute of 8 aneurysms advised at 6 months (14.3%) remained patent. All patients were on bifold antiplatelet agents at that time. Clopidoprel has been chock-full in all back then, with 2 added aneurysms occluding aural 12 months.

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Two cases (3.5%) of in-stent binding of ≥50% were detected at 6 months. One (Fig 3) had long-segment intrastent 70% narrowing, abbreviating to 30% at 12-month DSA. A added had 60% binding but had above-mentioned balmy absorption of the ancestor barge afore PED. Both patients were ex-smokers, and 1 was contumacious with clopidogrel. Both abide on bifold antiplatelet assay above 6 months, actual asymptomatic.

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A 43-year-old woman, ex-smoker, with a 9-mm wide-neck above hypophyseal aneurysm advised with a distinct PED. A, Crabbed centralized carotid avenue DSA pre-PED. B, Crabbed DSA 5 months afterwards PED deployment demonstrates asymptomatic all-encompassing long-segment in-stent stenosis. Clopidogrel and aspirin were continued. C, Crabbed DSA 12 months afterwards PED deployment shows apparent advance in the admeasurement as able-bodied as the amount of absorption (30%). Clopidogrel was ceased, but aspirin was to continue.

Sixteen patients presented with focal neurologic arrears from aneurysmal compression, 15 acutely and 1 with abiding homonymous hemianopia. Eight were accustomed 48 hours of steroid awning post-PED, and 3 had acting evidence worsening, which bound absolutely with time and best steroid cover. Ten cases bound aural 1 month, and an added 3, in 1–6 months (Fig 4). Two had advancing balmy diplopia at 6 months but were clearly improved, with no change in the accommodating with abiding homonymous hemianopia.

A 62-year-old woman who presented with 2 canicule of accretion dysarthria, argot weakness, and balmy quadriparesis. A, T2-weighted axial MR angel demonstrates a 30-mm aneurysm burden the medulla and the fourth ventricle. B, Crabbed DSA of the vertebrobasilar arrangement shows a fusiform aneurysm of the adjacent basilar trunk, accumulation the vertebrobasilar alliance and the distal larboard vertebral artery. Two 2.75 × 18 mm PEDs overlapping in the sac were deployed into the basilar avenue and larboard vertebral artery. Coils were abode in the distal appropriate vertebral avenue to stop an endoleak. The accommodating was placed on steroids but, 36 hours afterwards treatment, had deepening of quadriparesis and developed mutual ophthalmoplegia. MR imaging (not shown) did not absolutely authenticate an infarct, and CTA (not shown) approved occlusion of the aneurysm and patency of the PED. The accommodating was accustomed an added steroid bolus and recovered to accustomed bloom aural 3 days. C, Six-month crabbed larboard vertebral DSA demonstrates occlusion of the aneurysm with no stenosis. The coils in the appropriate vertebral avenue are arresting as artifact. CT at 12 months (not shown) did not appearance a abridgement in the admeasurement of the thrombosed aneurysm. Clopidogrel was ceased, and aspirin was continued. D, CTA at 18 months shows complete absorption of the aneurysm and absence of accumulation effect.

Large (>10 mm) wide-neck (>4 mm) aneurysms or those with an abortive dome/neck arrangement are added difficult to amusement and added decumbent to ceremony afterward endovascular therapy.18–20 The development of breeze diverters to reconstruct argosy and choke aneurysms has created abundant interest,21–25 and contempo single-center series11,12 and a multicenter13 anthology appearance occlusion ante of 93%, 94%, and 93%, respectively, at 6-month follow-up. The PITA trial13 advised 31 aneurysms with no contempo history of SAH; 71% were wide-neck (neck >4 mm or dome/neck arrangement <1.5). Twelve (38.7%) had undergone antecedent endovascular assay with coils or stent/coils. Bifold antiplatelet assay was maintained for a minimum of 30 days. Lylyk et al11 declared a alternation of 63 aneurysms, afterwards contempo SAH; 67% were wide-neck (dome/neck arrangement <2) or large, with 23 (37%) lesions ahead treated. Bifold antiplatelet medication was maintained for 6 months. Only 4 (6%) patients in the abstraction of Lylyk et al11 were advised with PED and coils, admitting 16 (51.6%) were advised appropriately in the PITA trial.13 Our abstraction citizenry of 57 aneurysms all had assay advised difficult to amusement or with a greater likelihood of ceremony (neck >4 mm and/or dome/neck arrangement <1.6).26,27 The admeasurement of our aneurysms (mean = 13.1 mm) additionally indicates a greater addiction to ceremony with accepted endovascular techniques.4,20

The all-embracing 6-month occlusion amount of 85.7% was lower in our alternation compared with added series.11,13 In cases not ahead treated, the occlusion amount was 92.5%, in band with antecedent results. All behemothic aneurysms were occluded. Eighty-nine percent of drupe and 63.6% with fusiform assay were chock-full at 6 months. In cases advised with no stent in situ, the occlusion amount at 6 months for this alternation was 90% (45/50) and at 14 months was 94.1% (48/51). These after-effects analyze with airship remodelling 77%–85% 27,28 or stent-assisted techniques,46%–74%.26,29 The attendance of a stent in the barge after-effects in a lower amount of occlusion, 50% in our baby accomplice of 6.

Our accident of peri- and postprocedural complications consistent in abiding morbimortality was 0% in 57 cases of asymptomatic aneurysms or those with accumulation effect. This compares agreeably with balloon-assisted braid morbimortality of 3.75%–14.1%.30,31 There were no delayed ruptures in this cohort. Ante of actual procedural-related thromboembolic achievement of 0 and 3.2 are additionally appear in added PED series. This low appear accident should be compared with 2 letters on accession breeze diverter, Silk (Balt Extrusion, Montmorency, France), in which 4/13 cases had appropriate thromboembolic complications anon associated with the procedure.32 A added article10 appear 15.4% (4/26) achievement and 4% (1/26) bloodshed with a 33% in-stent binding amount in a alternation of 26 patients in which the Silk breeze diverter (Balt Extrusion) was auspiciously built-in in nonruptured aneurysms. No intraprocedural array or stent occlusion occurred in our alternation or that of Lylyk et al,17 totalling 110 cases. Byrne et al6 appear an 11% accident of ancestor barge occlusion afterward Silk article in a alternation of 70 cases.

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The abstract has afresh accent delayed breach accompanying to breeze diverters in constituent cases.32,33 Kulcsar et al32 accurate 13 patients with delayed breach afterward Silk use, of which 2 may accept had SAH. Breach was authentic as aboriginal (2–48 days) in 10 patients or backward (3–5 months) in 3 patients who were no best on bifold antiplatelet therapy. Eleven patients had an arrival jet afterwards flow-diverter insertion. In all cases, it is our action to admit the PED until any apparent arrival jet is eliminated, if practicable. Cebral et al33 accurate 3 cases of breach afterward PED placement, all occurring aural 1 anniversary of the procedure; 2 of these had binding accompanying to the ancestor vessel. Cebral et al accent the accessible role of ancestor barge binding in aneurysm breach post-PED, suggesting that braid of these aneurysms may additionally be appropriate in that setting.

The achievability of delayed rupture,32,33 accumulated with beastly models demonstrating poor intraluminal alignment of array at 3–6 months, admitting abeyance of bifold antiplatlet awning at 1 month,24,25 would favor a beneath aeon of clopidogrel, conceivably 1–2 months. This advocacy needs to be counterbalanced adjoin the accident of delayed stroke, admitting low, with 5.3% accepting delayed TIA at 2- to 5-months afterwards implantation. If possible, we advance bifold antiplatelet awning for 12 months in built-in PEDs in the afterwards circulation, because the assay is atypical at this time and the sequelae of afterwards perforator achievement are significant. However, we accept 2 patients who chock-full clopidogrel, at 1 anniversary and 3 months, with no analytic sequelae or stenosis. A case of delayed PED occlusion was appear in the basilar avenue at 2 years.34

The amount of in-stent binding was low in our series. This has been empiric in beastly models24,25 and in animal series11,13 assuming a 0%–4.8% abstinent or astringent amount of asymptomatic binding with clopidogrel aliment of 1 and 6 months respectively. The amount of absorption anecdotally diminishes with time back comparing 3- and 6-month angiograms. We had 1 accommodating in whom this was demonstrated. Astute accumulation aftereffect at presentation was accurate in 16 patients, with 3 accepting brief abasement afterwards PED deployment. None had abiding sequelae and responded with time and advancing corticosteroids. No compatible action is followed with account to administering of steroids in ample aneurysms, but patients charge be empiric for abasement and ischemia charge be disqualified out by analytic appraisal and MR imaging, if necessary. In the 15 patients presenting with astute accumulation effect, affection bound (n = 13) or clearly bigger (n = 2) afterward PED implantation.

Deployment of the PED after-effects in abridgement of up to 50%–60%, depending on the admeasurement of the PED about to the barge and any alterity in adjacent and distal barge size. The accessory will tend to seek a beyond lumen (“melon-seeding”), brief proximally, if not well-expanded and anchored distally. As abettor acquaintance increased, the deployment address changed, with added accent on distal barge acquirement and advanced PED deployment, rather than unsheathing the device. In addition, axial reloading of the commitment catheter in the alveolate ICA is advantageous afore the final allocation of the PED is released. Nudging the adjacent allowance of the PED with the commitment catheter afterwards deployment promotes adjacent abridgement of the PED. Anecdotally we accept this lessens abeyant abridgement from the distal end, preventing adjacent migration.

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