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Maksim Shapiro, Tibor Becske and Peter K. Nelson

OBJECTIVE

A detailed analysis was performed of anterior circulation aneurysms treated with a Pipeline Embolization Device (PED) that did not progress to complete occlusion by 1-year follow-up. Angiography was performed with the purpose of identifying specific factors potentially responsible for these failed outcomes.

METHODS

From among the first 100 patients with anterior circulation aneurysms, 92 underwent 1-year follow-up angiography and were individually studied through review of their pre- and postembolization studies.

RESULTS

Nineteen aneurysms (21%) remained unoccluded at 12 months. Independent predictors of treatment failure, identified by logistic regression analysis, were found to be fusiform aneurysm morphology, decreasing dome-to-neck ratio, and the presence of a preexisting laser-cut stent. Further examination of individual cases identified several common mechanisms—device malapposition, inadequate coverage of the aneurysm neck with persistent exchange across the device, and the incorporation of a branch vessel into the aneurysm fundus—potentially contributing to failed treatment in these settings.

CONCLUSIONS

Attention to specific features of the aneurysm and device construct can frequently identify cases predisposed to treatment failure and suggest strategies to maximize favorable outcomes.

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Matthew B. Potts, Maksim Shapiro, Daniel W. Zumofen, Eytan Raz, Erez Nossek, Keith G. DeSousa, Tibor Becske, Howard A. Riina and Peter K. Nelson

OBJECTIVE

The Pipeline Embolization Device (PED) is now a well-established option for the treatment of giant or complex aneurysms, especially those arising from the anterior circulation. Considering the purpose of such treatment is to maintain patency of the parent vessel, postembolization occlusion of the parent artery can be regarded as an untoward outcome. Antiplatelet therapy in the posttreatment period is therefore required to minimize such events. Here, the authors present a series of patients with anterior circulation aneurysms treated with the PED who subsequently experienced parent vessel occlusion (PVO).

METHODS

The authors performed a retrospective review of all anterior circulation aneurysms consecutively treated at a single institution with the PED through 2014, identifying those with PVO on follow-up imaging. Aneurysm size and location, number of PEDs used, and follow-up digital subtraction angiography results were recorded. When available, pre- and postembolization platelet function testing results were also recorded.

RESULTS

Among 256 patients with anterior circulation aneurysms treated with the PED, the authors identified 8 who developed PVO after embolization. The mean aneurysm size in this cohort was 22.3 mm, and the number of PEDs used per case ranged from 2 to 10. Six patients were found to have asymptomatic PVO discovered incidentally on routine follow-up imaging between 6 months and 3 years postembolization, 3 of whom had documented “delayed” PVO with prior postembolization angiograms confirming aneurysm occlusion and a patent parent vessel at an earlier time. Two additional patients experienced symptomatic PVO, one of which was associated with early discontinuation of antiplatelet therapy.

CONCLUSIONS

In this large series of anterior circulation aneurysms, the authors report a low incidence of symptomatic PVO, complicating premature discontinuation of postembolization antiplatelet or anticoagulation therapy. Beyond the subacute period, asymptomatic PVO was more common, particularly among complex fusiform or very large–necked aneurysms, highlighting an important phenomenon with the use of PED for the treatment of anterior circulation aneurysms, and suggesting that extended periods of antiplatelet coverage may be required in select complex aneurysms.

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Tibor Becske, Matthew B. Potts, Maksim Shapiro, David F. Kallmes, Waleed Brinjikji, Isil Saatci, Cameron G. McDougall, István Szikora, Giuseppe Lanzino, Christopher J. Moran, Henry H. Woo, Demetrius K. Lopes, Aaron L. Berez, Daniel J. Cher, Adnan H. Siddiqui, Elad I. Levy, Felipe C. Albuquerque, David J. Fiorella, Zsolt Berentei, Miklós Marosföi, Saruhan H. Cekirge and Peter K. Nelson

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)

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Daniel H. Sahlein, Mohammad Fouladvand, Tibor Becske, Isil Saatci, Cameron G. McDougall, István Szikora, Giuseppe Lanzino, Christopher J. Moran, Henry H. Woo, Demetrius K. Lopes, Aaron L. Berez, Daniel J. Cher, Adnan H. Siddiqui, Elad I. Levy, Felipe C. Albuquerque, David J. Fiorella, Zsolt Berentei, Miklos Marosfoi, Saruhan H. Cekirge, David F. Kallmes and Peter K. Nelson

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.

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Daniel H. Sahlein, Paloma Mora, Tibor Becske and Peter K. Nelson

Object

Nidal embolization of brain arteriovenous malformations (bAVMs) has become an increasingly important component of bAVM treatment. However, controversy exists as to the relative efficacy and safety of single-stage versus multistage approaches to bAVM embolization, with recent literature favoring multistage strategies. The authors present a series of consecutive bAVMs embolized at their institution, demonstrating the safety and efficacy of a predominantly single-stage embolization strategy. The safety and efficacy of embolization are reported in the context of predetermined treatment strategies to provide more generalizable insight into treatment outcome.

Methods

One hundred thirty consecutive patients with 131 bAVMs underwent endovascular embolization at a single center. Diagnostic angiography with superselective microcatheterizations was performed in all patients. Postembolization angiograms were reviewed by 3 neuroradiologists for degree of occlusion and angiographic evidence of procedural complications. Patients were divided into cohorts based on the prospectively determined treatment strategy, which included the following: global devascularization of the bAVM (Devasc); targeting of a focal angioarchitectural weakness (Target), typically as an adjunct to surgery or Gamma Knife treatment; and primary occlusion of the bAVM by embolization alone (Occlude). Safety and efficacy were evaluated in the context of these treatment groups.

Results

The 131 bAVMs were treated over an average of 1.28 embolization sessions per bAVM; 105 bAVMs (80%) were treated in a single stage. The average percentage devascularization in the Devasc arm was 85.3%, which was statistically significantly greater than the 72% aggregate devascularization reported in 8 modern N-butyl cyanoacrylate and Onyx papers based on 1-sample Wilcoxon rank-sum testing (p < 0.001). Focal angioarchitectural weaknesses were successfully embolized for all 24 bAVMs in the Target group, directly with the embolic agent in 23 bAVMs and indirectly in 1 bAVM with a venous aneurysm/pseudoaneurysm by reducing arterial inflow and inducing venous thrombosis. Lesions in all patients in the Occlude arm were 100% occluded with embolization alone. Overall, the bAVMs in the Occlude arm were significantly smaller and required embolization of fewer pedicles than those in the Devasc group. One patient (0.8%) experienced significant morbidity following embolization, and 1 patient in the cohort died (0.8%).

Conclusions

This research communicates the authors' experience in developing a largely single-stage strategy for embolization of bAVMs. The results suggest that an aggressive, single-stage embolization may be implemented with a margin of safety and effectiveness similar to the multistage approaches more commonly reported in the literature. This work additionally introduces the importance of prospective assignment to a treatment strategy in assessing procedural outcome in bAVM embolization, thereby improving generalizability of the results and allowing for more rigorous interpretation of efficacy and safety.

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Stephen P. Kalhorn, Anthony K. Frempong-Boadu, Irina Mikolaenko, Tibor Becske and David H. Harter

Metameric lesions of the spine are rare. The authors present a case of patient with a complex metameric vascular lesion of the thoracic spine and describe a management strategy for this entity.