Stent-assisted coil embolization of challenging intracranial aneurysms: initial and mid-term results with low-profile ACCLINO devices.

BACKGROUND: Stent-assisted coiling using low-profile, self-expandable and retrievable stents is a valid option in endovascular treatment of challenging intracranial aneurysms. This study aims to evaluate the feasibility and efficacy of ACCLINO 1.9 F and ACCLINO Flex stent systems, designed for use as adjunctive products in coil embolization of intracranial aneurysms. METHODS: Case files of 47 patients, and 52 aneurysms in total, treated with at least one ACCLINO 1.9 F or ACCLINO Flex stent were retrospectively evaluated. Technical success, complications, and angiographic outcomes were assessed based on immediate post-procedural controls along with 6th and 12th month angiograms. RESULTS: Mechanical untoward event rate, including asymptomatic complications, is 9.6 % (five out of 52 aneurysms). Failed dual-stenting attempt rate is 15.4 % (two out of 13). Overall procedure-related morbidity is 4.2 % with no neurologic sequelae. Initial occlusion rate is 90.4 % (47 aneurysms). One patient had residual filling in the aneurysm neck, which was stable throughout follow-up. The remaining four cases had spontaneous follow-up occlusion. Recanalization rate at 6th month is 2.1 % with one aneurysm requiring retreatment. One patient was lost to follow-up. There is no mortality associated with treatment. CONCLUSIONS: Stent-assisted coil embolization with ACCLINO stents in single or dual configurations is a feasible treatment option for challenging intracranial aneurysms. Follow-up results are encouraging; techniques were effective in complex cases and there were no clinically significant adverse outcomes.

Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial.

PURPOSE: To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms. MATERIALS AND METHODS: The Pipeline for Uncoilable or Failed Aneurysms is a multicenter, prospective, interventional, single-arm trial of PED for the treatment of uncoilable or failed aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was occurrence of major ipsilateral stroke or neurologic death at 180 days. RESULTS: PED placement was technically successful in 107 of 108 patients (99.1%). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4%) were giant (>25 mm). Of the 106 aneurysms, 78 met the study's primary effectiveness endpoint (73.6%; 95% posterior probability interval: 64.4%-81.0%). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6%; 95% posterior probability interval: 2.6%-11.7%). CONCLUSION: PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.

Safety and Efficacy of the FRED Jr Flow Re-Direction Endoluminal Device for Intracranial Aneurysms: Retrospective Multicenter Experience With Emphasis on Midterm Results.

Background and Purpose: Flow diversion is increasingly used as an endovascular treatment for intracranial aneurysms. In this retrospective multicenter study, we analyzed the safety and efficacy of the treatment of intracranial, unruptured, or previously treated but recanalized aneurysms using Flow Re-Direction Endoluminal Device (FRED) Jr with emphasis on midterm results. Materials and Methods: Clinical and radiological records of 150 patients harboring 159 aneurysms treated with FRED Jr at six centers between October 2014 and February 2020 were reviewed and consecutively included. Clinical outcome was measured by using the modified Rankin Scale (mRS). Anatomical results were assessed according to the O'Kelly-Marotta (OKM) scale and the Cekirge-Saatci Classification (CSC) scale. Results: The overall complication rate was 24/159 (16%). Thrombotic-ischemic events occurred in 18/159 treatments (11%). These resulted in long-term neurological sequelae in two patients (1%) with worsening from pre-treatment mRS 0-2 and mRS 4 after treatment. Complete or near-complete occlusion of the treated aneurysm according to the OKM scale was reached in 54% (85/158) at 6-month, in 68% (90/133) at 1-year, and in 83% (77/93) at 2-year follow-up, respectively. The rates of narrowing or occlusion of a vessel branch originating from the treated aneurysm according to the CSC scale were 11% (12/108) at 6-month, 20% (17/87) at 1-year, and 23% (13/57) at 2-year follow-up, respectively, with all cases being asymptomatic. Conclusions: In this retrospective multicenter study, FRED Jr was safe and effective in the midterm occlusion of cerebral aneurysms. Most importantly, it was associated with a high rate of good clinical outcome.

First clinical multicenter experience with the new Scepter Mini microballoon catheter.

BACKGROUND: Balloon-assisted techniques can improve the endovascular treatment of cerebrospinal vascular malformations. The aim of this study was to report the first clinical multicenter experience with the new Scepter Mini dual-lumen microballoon catheter. METHODS: Patients with cerebral or spinal vascular malformations treated with the Scepter Mini at seven European neurovascular centers were retrospectively reviewed. Clinical data, angiographic features of the vascular malformations, procedural parameters including the type of application, navigability, technical failures, complications and embolization success were assessed. RESULTS: The usage of 34 Scepter Mini microballoon catheters in 20 patients was analyzed. Most treated malformations (80.0%) were cerebral arteriovenous malformations. Four different applications were reported: embolization via Scepter Mini (n=23, 67.6%), balloon-occlusion with simultaneous embolization via a second microcatheter (n=3, 8.8%), diagnostic angiography with simultaneous balloon-inflation for flow arrest (n=4, 11.8%), and navigation support (n=4, 11.8%). The mean diameter of the blood vessels in which the Scepter Mini was inflated was 1.9±0.5 mm. The navigability of the Scepter Mini was rated as 'easy' or 'very easy' in 88.2% of cases. Complete occlusion of the malformation was achieved in 60.9% of cases. Technical failures occurred in 4/23 embolization procedures, and all were related to insufficient stability of the balloon within the vessel. No complications related to the Scepter Mini were observed, while unrelated complications occurred in three patients (15.0%). CONCLUSIONS: The Scepter Mini is a promising new device for balloon-assisted embolization of cerebrospinal vascular malformations via small feeders. Beyond embolization, the Scepter Mini can also be used for other applications, such as superselective flow arrest and navigation support.

Stent-graft applications in peripheral non-atherosclerotic arterial lesions.

PURPOSE: To retrospectively evaluate peripheral arterial lesions treated with stent-grafts in various territories and to identify the role of computed tomography angiography (CTA), both in diagnosis and follow-up. MATERIALS AND METHODS: The study included 19 patients (11 male, 8 female) aged between 24 and 85 years. In all, 24 stent-grafts were used to seal an extravasation in 3 patients, a pseudoaneurysm/aneurysm in 12 patients, and an arteriovenous fistula in 4 patients. Self-expandable and balloon-expandable stent-grafts were used, all of which were covered with polytetrafluoroethylene material. Iatrogenic etiologies were responsible in 11 of the patients. In total, 5 superficial femoral, 2 deep femoral, 4 external iliac, 3 common iliac, 1 common carotid, 1 internal carotid, 1 subclavian, 1 renal artery, and 1 thyrocervical trunk lesion were treated. RESULTS: The technical success rate was 100%, with no periprocedural complications. Mean follow-up was 18 months (range: 1-72 months). CTA was performed in 10 patients for diagnosis and in 7 patients for follow- up. There was no stent migration, but 1 stent crush. The total vessel occlusion rate was 16.6%, all diagnosed using CTA. CONCLUSION: Stent-graft applications offer quick, single-step treatment, with few procedural complications. However, long-term durability remains a major concern. CTA is a very valuable tool, both for diagnosis and follow- up. Pseudoaneurysms and extravasations can be demonstrated successfully, as well as incomplete arteriovenous fistula closure, and patent or occluded stent-grafts.

Venous outflow of the brain after bilateral complete jugular ligation.

A case of a patient with bilateral internal, external, posterior external and anterior jugular vein ligations and excisions performed in the neck due to a larynx tumor is presented. Radical neck dissection is a standard otorhinolaryngological procedure in the management of head and neck cancer patients with bilateral lymph node metastasis to the neck. Sacrifice of both internal and external jugular veins bilaterally has been recognized as a dangerous approach leading to intracranial hypertension with subsequent neurological sequela and death. In this report, we aimed to demonstrate how venous outflow from the brain diverts after jugular venous system obliteration. After bilateral jugular vein ligations, digital subtraction angiography (DSA) showed that the venous drainage route of the brain had been diverted from the jugular veins to the vertebral venous plexus.

Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) study.

INTRODUCTION: The WEB Intra-saccular Therapy (WEB-IT) trial is an investigational device exemption study to demonstrate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. The neurovascular replicator (Vascular Simulations, Stony Brook, New York, USA) creates a physical environment that replicates patient-specific neurovascular anatomy and hemodynamic physiology, and allows devices to be implanted under fluoroscopic guidance. OBJECTIVE: To report the results of a unique neurovascular replicator-based training program, which was incorporated into the WEB-IT study to optimize technical performance and patient safety. METHODS: US investigators participated in a new training program that incorporated full surgical rehearsals on a neurovascular replicator. No roll-in cases were permitted within the trial. Custom replicas of patient-specific neurovascular anatomy were created for the initial cases treated at each center, as well as for cases expected to be challenging. On-site surgical rehearsals were performed before these procedures. RESULTS: A total of 48 participating investigators at 25 US centers trained using the replicator. Sessions included centralized introductory training, on-site training, and patient-specific full surgical rehearsal. Fluoroscopy and procedure times in the WEB-IT study were not significantly different from those seen in two European trials where participating physicians had significant WEB procedure experience before study initiation. CONCLUSIONS: A new program of neurovascular-replicator-based physician training was employed within the WEB-IT study. This represents a new methodology for education and training that may be an effective means to optimize technical success and patient safety during the introduction of a new technology.

Morbidity and Mortality in Patients With Posterior Circulation Aneurysms Treated With the Pipeline Embolization Device: A Subgroup Analysis of the International Retrospective Study of the Pipeline Embolization Device.

BACKGROUND: The safety of PipelineTM Embolization Device (PED; Medtronic Inc, Dublin, Ireland) in posterior circulation aneurysms is still controversial. OBJECTIVE: To study complications associated with the treatment of posterior circulation aneurysms by conducting a subgroup analysis from the International Retrospective Study of PED registry. METHODS: Data from 91 consecutive patients with 95 posterior circulation aneurysms at 17 centers between July 2008 to February 2013 were analyzed. The primary endpoint was defined as any complication leading to neurological morbidity or death. The outcome predictors were calculated using Kaplan-Meier and Cox regression methods. RESULTS: The mean aneurysm size was 13.8 mm. Aneurysm types were saccular (36.8%), fusiform (29.5%), dissecting (28.4%), and others (5.3%). The median follow-up was 21.1 mo. Twelve (13.2%) patients encountered a primary endpoint event. In multivariate analysis for the primary endpoint, use of ≥3 PEDs and fusiform shape compared with other shapes had hazard ratios (HRs) of 7.77 (95% confidence interval [CI], 2.48-25.86; P = .0007) and 3.48 (95% CI, 1.06-13.39; P = .0488), respectively. The multivariate HR of aneurysm size for neurological morbidity after PED implantation was 1.11 (95% CI, 1.04-1.18; P = .0015), and HRs of ruptured aneurysm and age for neurological mortality were 8.1 (95% CI, 1.31-41.26; P = .0197) and 1.07 (95% CI, 1.02-1.15; P = .0262), respectively. Basilar artery aneurysm had an HR of 3.54 (95% CI, 1.12-14.18, P = .0529) in the univariate analysis for major outcomes. CONCLUSION: PED implantation may be considered for the treatment of posterior circulation aneurysms, especially of saccular or dissecting type. Our major complications appear to be comparable to those reported previously after clipping and coiling in the literature. Neurointerventionists should consider the shape, size, rupture, and location of complex posterior circulation aneurysms as well as age and PED number before the PED placement.

Safety and efficacy of the Pipeline embolization device for treatment of intracranial aneurysms: a pooled analysis of 3 large studies.

OBJECTIVE The authors performed a pooled analysis of 3 studies-IntrePED (International Retrospective Study of the Pipeline Embolization Device), PUFS (Pipeline for Uncoilable or Failed Aneurysms Study), and ASPIRe (Aneurysm Study of Pipeline in an Observational Registry)-in order to assess angiographic outcomes and clinical safety of the Pipeline embolization device (PED). METHODS IntrePED was a retrospective study, while PUFS and ASPIRe were prospective studies. For each patient included in these studies, the authors collected baseline demographic data, aneurysm characteristics, and procedural details. The primary outcomes for this combined analysis were clinical outcomes, including neurological morbidity and mortality and major ipsilateral intracranial hemorrhage and ischemic stroke. The secondary outcomes were angiographic occlusion rates, which were available for ASPIRe and PUFS only. RESULTS A total of 1092 patients with 1221 aneurysms were included across the 3 studies. The mean aneurysm size was 12.0 ± 7.8 mm and the mean neck size was 6.6 ± 4.8 mm. The major ipsilateral ischemic stroke rate was 3.7% (40/1091). The major ipsilateral intracranial hemorrhage rate was 2.0% (22/1091). The major neurological morbidity rate was 5.7% (62/1091). The neurological mortality rate was 3.3% (36/1091). The combined major morbidity and neurological mortality rate was 7.1% (78/1091). The complete occlusion rates were 75.0% at 180 days (111/148) and 85.5% at 1 year (94/110). The overall aneurysm retreatment rate was 3.0% (33/1091) at a mean follow-up time of 10.2 ± 10.8 months. CONCLUSIONS Endovascular treatment of intracranial aneurysms with the PED is safe and effective. Angiographic occlusion rates progressed with follow-up. Rates of stroke, hemorrhage, morbidity and mortality, and retreatment were low, especially given the fact that the aneurysms treated were generally large and wide necked.

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

OBJECTIVE The long-term effectiveness of endovascular treatment of large and giant wide-neck aneurysms using traditional endovascular techniques has been disappointing, with high recanalization and re-treatment rates. Flow diversion with the Pipeline Embolization Device (PED) has been recently used as a stand-alone therapy for complex aneurysms, showing significant improvement in effectiveness while demonstrating a similar safety profile to stent-supported coil treatment. However, relatively little is known about its long-term safety and effectiveness. Here the authors report on the 3-year safety and effectiveness of flow diversion with the PED in a prospective cohort of patients with large and giant internal carotid artery aneurysms enrolled in the Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial. METHODS The PUFS trial is a prospective study of 107 patients with 109 aneurysms treated with the PED. Primary effectiveness and safety end points were demonstrated based on independently monitored 180-day clinical and angiographic data. Patients were enrolled in a long-term follow-up protocol including 1-, 3-, and 5-year clinical and imaging follow-up. In this paper, the authors report the midstudy (3-year) effectiveness and safety data. RESULTS At 3 years posttreatment, 74 subjects with 76 aneurysms underwent catheter angiography as required per protocol. Overall, complete angiographic aneurysm occlusion was observed in 71 of these 76 aneurysms (93.4% cure rate). Five aneurysms were re-treated, using either coils or additional PEDs, for failure to occlude, and 3 of these 5 were cured by the 3-year follow-up. Angiographic cure with one or two treatments of Pipeline embolization alone was therefore achieved in 92.1%. No recanalization of a previously completely occluded aneurysm was noted on the 3-year angiograms. There were 3 (2.6%) delayed device- or aneurysm-related serious adverse events, none of which led to permanent neurological sequelae. No major or minor late-onset hemorrhagic or ischemic cerebrovascular events or neurological deaths were observed in the 6-month through 3-year posttreatment period. Among 103 surviving patients, 85 underwent functional outcome assessment in which modified Rankin Scale scores of 0-1 were demonstrated in 80 subjects. CONCLUSIONS Pipeline embolization is safe and effective in the treatment of complex large and giant aneurysms of the intracranial internal carotid artery. Unlike more traditional endovascular treatments, flow diversion results in progressive vascular remodeling that leads to complete aneurysm obliteration over longer-term follow-up without delayed aneurysm recanalization and/or growth. Clinical trial registration no.: NCT00777088 (clinicaltrials.gov).

Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial.

BACKGROUND: Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies. OBJECTIVE: To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial. METHODS: In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded. RESULTS: The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed. CONCLUSION: Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.

Carotid artery stenting and endarterectomy have different effects on heart rate variability.

OBJECTIVE: Due to their close proximity to the carotid sinus baroreceptor region, carotid endarterectomy (CEA) and carotid angioplasty/stenting (CAS) carry an inherent risk of affecting baroreflex-mediated regulation of the heart rate. Variations in the heart rate can be studied by measuring heart rate variability (HRV), in which distinct frequency bands in the power spectrum represent sympathetic and parasympathetic modulations on sinus node pacemaker activity. We aimed to investigate the influence of CEA and CAS on HRV. METHODS: One-hour recordings of R-R intervals on ECG were obtained before and after CEA (10 patients) or CAS (12 patients). The power spectrum of the R-R time series was estimated using the FFT technique. The power in low frequency (LF) and high frequency (HF) bands were computed and normalized to their total power (TP). The LF/HF ratio, an index of sympathovagal balance, was calculated. RESULTS: Compared to preoperative levels, LF/HF exhibited 85%, 96%, and 70% increase on the second, third, and fourth days after CEA, respectively. In contrast, LF/HF decreased by 26%, 32%, and 26% on the respective days following CAS; the difference between groups was significant (p=0.0069). Normalized LF increased after CEA and decreased after CAS, while the opposite was observed for normalized HF (p=0.0217). There was no significant change in TP. CONCLUSIONS: CEA and CAS have differential effects on the sympathovagal balance on the heart. The relative increase in sympathetic modulation after CEA and parasympathetic modulation after CAS are likely mediated by alterations in the sensitivity of carotid sinus baroreceptors. Altered cardiac autonomic modulation may play a role in the occurrence of cardiac disturbances following carotid interventions.

Iatrogenic femoral arteriovenous fistula: endovascular treatment with covered stent implantation and 4-year follow-up.

Puncture site complications such as arteriovenous fistula after femoral arterial catheterizations are becoming more common with the increasing number of endovascular procedures being performed by interventional radiologists and cardiologists. Covered stent placement with endovascular technique for these lesions represents an appealing treatment alternative because it is only minimally invasive and requires less hospitalization and recovery time compared to surgical repair. Herein, we present an adult patient with a post-catheterization deep femoral artery- to-femoral vein fistula, which was successfully treated with a balloon-expandable Jostent peripheral stent-graft placement. Fourth year follow-up angiography showed the covered stent to be patent.

Prenatal diagnosis of intracranial pial arteriovenous fistula and endovascular treatment during the neonatal period.

We present a case with prenatal diagnosis of an intracranial high-flow pial arteriovenous fistula that was draining into the vein of Galen in the third trimester of pregnancy. The child was treated by transcatheter embolization with N-butyl 2-cyanoacrylate (NBCA) via the umbilical artery in the early neonatal period due to intractable cardiac failure. Hydrocephalus developed and a ventriculoperitoneal shunt was placed. At the time this report was prepared, the patient was 20 months old and without cardiac failure, but with a delay in neurological development. Prenatal diagnosis and endovascular treatment in the early neonatal period is important in preventing heart failure and resultant mortality due to such high-flow vascular malformations. To the best of our knowledge, the combination of prenatal diagnosis of an intracranial high-flow pial arteriovenous fistula draining into the vein of Galen and endovascular treatment in the early neonatal period is presented here for the first time.

Subcutaneous venous port implantation in adult patients: a single center experience.

PURPOSE: To present the midterm follow-up results of subcutaneous venous chest ports in adult patients. MATERIALS AND METHODS: Between January 2001 and November 2005, 476 subcutaneous venous chest ports were placed in 472 adult patients. Five patients underwent port implantation twice. All the ports had single lumen catheters. The procedures were performed under intravenous sedation as well as local anesthesia. All ports were placed on the anterior chest wall, except one, which was placed on the trapezius muscle. RESULTS: The technical success rate was 99.8%. The procedure- related minor complication rate was 0.63% (total: 3 cases; 1 hematoma during local anesthesia application, and 2 early hematomas) and there were no major complications. Mean duration of catheter usage was 376 days (total: 178,997 catheter days; range: 2 to 1522 catheter days). Late complications occurred at a rate of 10.7% (51 cases). Among those 51 cases, 36 (7.6%) developed minor complications in which port removal was not needed; however, 15 ports (3.15%) had to be removed due to major complications. Seven ports (1.47%) were explanted due to treatment-resistant bacteremia and sepsis, in addition to 2 other ports (0.42%) because of port pocket infections. An additional 6 ports (1.26%) required explantation for the following reasons: skin necrosis (0.21%); incision dehiscence (0.21%); broken or torn catheter (0.42%); jugular vein thrombosis (0.21%); thrombosis of superior caval vein (0.21%). CONCLUSION: Radiological implantation of subcutaneous venous ports can be performed with similar or lower complication rates as compared to the surgical literature, due to the obvious advantage of imaging guidance. Hence, we think that port implantation with imaging guidance will become the preferred implantation method in the future.

Aneurysm Study of Pipeline in an Observational Registry (ASPIRe).

BACKGROUND AND OBJECTIVE: Few prospective studies exist evaluating the safety and efficacy of the Pipeline Embolization Device (PED) in the treatment of intracranial aneurysms. The Aneurysm Study of Pipeline In an observational Registry (ASPIRe) study prospectively analyzed rates of complete aneurysm occlusion and neurologic adverse events following PED treatment of intracranial aneurysms. MATERIALS AND METHODS: We performed a multicenter study prospectively evaluating patients with unruptured intracranial aneurysms treated with PED. Primary outcomes included (1) spontaneous rupture of the Pipeline-treated aneurysm; (2) spontaneous nonaneurysmal intracranial hemorrhage (ICH); (3) acute ischemic stroke; (4) parent artery stenosis, and (5) permanent cranial neuropathy. Secondary endpoints were (1) treatment success and (2) morbidity and mortality at the 6-month follow-up. Vascular imaging was evaluated at an independent core laboratory. RESULTS: One hundred and ninety-one patients with 207 treated aneurysms were included in this registry. The mean aneurysm size was 14.5 ± 6.9 mm, and the median imaging follow-up was 7.8 months. Twenty-four aneurysms (11.6%) were small, 162 (78.3%) were large and 21 (10.1%) were giant. The median clinical follow-up time was 6.2 months. The neurological morbidity rate was 6.8% (13/191), and the neurological mortality rate was 1.6% (3/191). The combined neurological morbidity/mortality rate was 6.8% (13/191). The most common adverse events were ischemic stroke (4.7%, 9/191) and spontaneous ICH (3.7%, 7/191). The complete occlusion rate at the last follow-up was 74.8% (77/103). CONCLUSIONS: Our prospective postmarket study confirms that PED treatment of aneurysms in a heterogeneous patient population is safe with low rates of neurological morbidity and mortality. Patients with angiographic follow-up had complete occlusion rates of 75% at 8 months.

Advanced reconstructive endovascular techniques for the treatment of cerebral aneurysms.

Endovascular treatment of cerebral aneurysms with detachable coils has now been proven to be a superior alternative to open microsurgery in terms of disability-free survival 1 year following treatment. Despite this, recurrence due to recanalization of these aneurysms in 10-20% of patients after coiling is still the main drawback of the endovascular technique. In the last 5 years, access devices and endovascular tools based on new concepts, materials and endovascular reconstruction techniques that go beyond simply coiling have been described for cerebral aneurysm treatment, especially for more complicated broad-necked, fusiform and large/giant aneurysms. In this article, we review our recent experience in the treatment of complex cerebral aneurysms by means of multiple novel endovascular techniques for arterial reconstruction.

Proposed classification of segments of the internal carotid artery: anatomical study with angiographical interpretation.

The nomenclature and borders of the segments of the internal carotid artery (ICA) remain confusing. A classification of segments of the ICA is proposed based on constant anatomical structures, such as the carotid foramen and canal, the petrous bone, the petrolingual ligament (PLL), and the proximal and distal dural rings. The bilateral ICAs were dissected in 15 cadaveric head specimens using different neurosurgical approaches. The bilateral lacerum foramina were studied in five dry skulls. The bilateral segments of the ICA were also examined on carotid angiograms of 10 normal patients and another with the ophthalmic artery originating from the intracavernous portion of the ICA. The present classification divides the ICA into five segments in the direction of the blood flow. The cervical segment is extradural and extracranial, the petrous segment is extradural and intraosseous, the cavernous segment is interdural and intracavernous, the clinoidal segment is interdural and paracavernous, and the cisternal segment is intradural and intracisternal. The ICA did not pass through the lacerum foramen in any specimen. In all specimens, 1/8 to 5/8 of the lacerum foramen was under the deep dural layer of the cavernous sinus. The term 'lacerum segment' as used previously and called the 'trigeminal segment' by us cannot be justified. The PLL is the posterolateral border of the cavernous sinus and the lacerum and trigeminal segments should be included in the cavernous and petrous segments. The ophthalmic artery may originate from the clinoidal ICA, from the cavernous ICA, or from the middle meningeal artery. Instead of using the term 'ophthalmic segment,' the term 'cisternal segment' should be used for the anatomically distinct ICA in the subarachnoid space. This classification should be minimally affected by anatomical variations.

Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results.

OBJECT: Neuroophthalmological morbidity is commonly associated with large and giant cavernous and supraclinoid internal carotid artery (ICA) aneurysms. The authors sought to evaluate the neuroophthalmological outcomes after treatment of these aneurysms with the Pipeline Embolization Device (PED). METHODS: The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial was an international, multicenter prospective trial evaluating the safety and efficacy of the PED. All patients underwent complete neuroophthalmological examinations both before the PED procedure and at a 6-month follow-up. All examinations were performed for the purpose of this study and according to study criteria. RESULTS: In total, 108 patients were treated in the PUFS trial, 98 of whom had complete neuroophthalmological follow-up. Of the patients with complete follow-up, 39 (40%) presented with a neuroophthalmological baseline deficit that was presumed to be attributable to the aneurysm, and patients with these baseline deficits had significantly larger aneurysms. In 25 of these patients (64%), the baseline deficit showed at least some improvement 6 months after PED treatment, whereas in 1 patient (2.6%), the deficits only worsened. In 5 patients (5%), new deficits had developed at the 6-month follow-up, while in another 6 patients (6%), deficits that were not originally assumed to be related to the aneurysm had improved by that time. A history of diabetes was associated with failure of the baseline deficits to improve after the treatment. The aneurysm maximum diameter was significantly larger in patients with a new deficit or a worse baseline deficit at 6 months postprocedure. CONCLUSIONS: Patients treated with the PED for large and giant ICA aneurysms had excellent neuroophthalmological outcomes 6 months after the procedure, with deficits improving in most of the patients, very few deficits worsening, and few new deficits developing.

Cerebral Aneurysm Multicenter European Onyx (CAMEO) trial: results of a prospective observational study in 20 European centers.

BACKGROUND AND PURPOSE: This study was designed to investigate the safety and efficacy of the Onyx liquid embolic system in treating a selected population of patients with intracranial aneurysms that presented difficulties for surgical or endovascular alternatives. METHODS: A prospective observational study was conducted in 20 European centers enrolling a consecutive series of 119 patients with 123 aneurysms judged suitable for Onyx treatment. The series consists of findings collected in 97 of 119 patients with 100 of 123 aneurysms, because one center declined to provide data to the study sponsor or allow outside audit. Clinical and angiographic outcomes were recorded at discharge, 3 months, and 12 months. All adverse events and re-treatments were recorded. Seventy-nine aneurysms were large or giant. RESULTS: Twelve-month follow-up angiography findings were available for 71 aneurysms. This angiographic follow-up showed complete occlusion in 56 (79%) aneurysms, subtotal occlusion in nine (13%), and incomplete occlusion in six (8%). Procedure- or device-related permanent neurologic morbidity at final follow-up was present in eight of 97 patients. Seven patients died: two deaths were procedure related; one, disease related; and four, unrelated causes. Seventy-five of the 82 patients alive and with follow-up at 12 months were at Rankin 2 or better status. Delayed occlusion of the parent vessel occurred in nine patients; delayed occlusion was asymptomatic in five and resulted in permanent neurologic deficit in two. CONCLUSION: In selected patients with aneurysms that are unsuitable for coil treatment or in whom previous treatment has failed to occlude the aneurysm, Onyx treatment offers an endovascular alternative. Aneurysm occlusion rates are superior to reported rates of coil occlusion, and treatment morbidity is comparable to that of published prospective data on endovascular results for this subgroup of patients.