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Felipe C. Albuquerque, David J. Fiorella, Patrick P. Han, Vivek R. Deshmukh, Louis J. Kim and Cameron G. Mcdougall

Object

Intracranial vertebral artery (VA) dissecting aneurysms often present with severe subarachnoid hemorrhage (SAH) and dramatic neurological injury. The authors reviewed the management of 23 cases in an effort to evaluate treatment efficacy and outcomes.

Methods

The records of 23 patients who underwent endovascular treatment were reviewed to determine symptoms, type of therapy, complications, and clinical outcomes. All patients were evaluated using records kept in a prospectively maintained database.

Ten men and 13 women (age range 35–72 years; mean age 49 years) were treated over an 8-year period. Twelve patients presented with poor-grade SAH, five with good-grade SAH, three with headache, and two with stroke. The other patient's aneurysm was discovered incidentally. Treatment included coil occlusion of the artery at the aneurysm in 21 patients and stent-assisted coil placement in two. Parent artery sacrifice was successful in all cases, whereas both patients treated with stent-assisted coil insertion suffered recurrences. No patient sustained permanent complications as a result of treatment. Two patients died due to the severity of their original SAH. Findings were normal in 14 patients on follow-up review (including five of the 12 presenting with poor-grade SAH), five had fixed neurological deficits but were able to care for themselves, and one was permanently disabled.

Conclusions

Despite their often aggressive neurological presentation, intracranial VA dissecting aneurysms can be managed safely with coil occlusion of the lesion and/or parent artery. Even patients presenting in poor neurological condition may improve dramatically.

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Shervin R. Dashti, David Fiorella, Robert F. Spetzler, Elisa Beres, Cameron G. McDougall and Felipe C. Albuquerque

Cavernous malformations (CMs) or hemangiomas arising from within the dural sinuses are rare entities that differ from their parenchymal counterparts in that they are highly vascular lesions. While parenchymal CMs are typically angiographically occult, intrasinus malformations may have large, dural-based arterial feeding vessels that are amenable to preoperative embolization. The novel liquid embolic Onyx (ev3, Inc.) is an ideal agent for the embolization of these lesions. The authors present the first known case of a giant intrasinus CM embolized with Onyx before gross-total resection.

The authors report the case of a 9-year-old boy with brief apneic episodes in whom MR imaging revealed a giant CM arising from within the right transverse and sigmoid sinuses and infiltrating the right tentorium cerebelli. At another institution, the patient had undergone 1 prior embolization and 2 unsuccessful attempts at resection. Both surgeries had been complicated by massive blood loss and were aborted.

Under the authors' care, the patient underwent preoperative transarterial embolization with Onyx during which a substantial volume of the mass lesion was filled with embolisate. Subsequently, complete circumferential excision of the mass from the tentorium was accomplished with minimal intraoperative blood loss.

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David F. Kallmes, Waleed Brinjikji, Saruhan Cekirge, David Fiorella, Ricardo A. Hanel, Pascal Jabbour, Demetrius Lopes, Pedro Lylyk, Cameron G. McDougall and Adnan Siddiqui

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.

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Yin C. Hu, Vivek R. Deshmukh, Felipe C. Albuquerque, David Fiorella, Randal R. Nixon, Donald V. Heck, Stanley L. Barnwell and Cameron G. McDougall

Object

Delayed ipsilateral intraparenchymal hemorrhage has been observed following aneurysm treatment with the Pipeline Embolization Device (PED). The relationship of this phenomenon to the device and/or procedure remains unclear. The authors present the results of histopathological analyses of the brain sections from 3 patients in whom fatal ipsilateral intracerebral hemorrhages developed several days after uneventful PED treatment of supraclinoid aneurysms.

Methods

Microscopic analyses revealed foreign material occluding small vessels within the hemorrhagic area in all patients. Further analyses of the embolic materials using Fourier transform infrared (FTIR) spectroscopy was conducted on specimens from 2 of the 3 patients. Although microscopically identical, the quantity of material recovered from the third patient was insufficient for FTIR spectroscopy.

Results

FTIR spectroscopy showed that the foreign material was polyvinylpyrrolidone (PVP), a substance that is commonly used in the coatings of interventional devices.

Conclusions

These findings are suggestive of a potential association between intraprocedural foreign body emboli and post-PED treatment–delayed ipsilateral intraparenchymal hemorrhage.

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L. Fernando Gonzalez, David Fiorella, Neil R. Crawford, Robert C. Wallace, Iman Feiz-Erfan, Denise Drumm, Stephen M. Papadopoulos and Volker K.H. Sonntag

Object. The authors sought to establish radiological criteria for the diagnosis of C1–2 vertical distraction injuries.

Methods. Conventional radiography, computerized tomography (CT), and magnetic resonance (MR) imaging findings in five patients with a C1–2 vertical distraction injury were correlated with their clinical history, operative findings, and autopsy findings. The basion—dens interval (BDI) and the C-1 and C-2 lateral mass interval (LMI) were measured in 93 control patients who underwent CT angiography; these measurements were used to define the normal BDI and LMI. The MR imaging results obtained in 30 healthy individuals were used to characterize the normal signal intensity of the C1–2 joint. The MR imaging results were compared with MR images obtained in five patients with distraction injuries.

In the 93 patients, the BDI averaged 4.7 mm (standard deviation [SD] 1.7 mm, range 0.6–9 mm) and the LMI averaged 1.7 mm (SD 0.48 mm, range 0.7–3.3 mm). Based on CT scanning in the five patients with distraction injuries, the BDIs (mean 11.9 mm, SD 3.2 mm; p < 0.001) and LMIs (mean 5.5 mm, SD 2 mm; p < 0.0001) were significantly greater than in the control group. Fast—spin echo inversion-recovery MR images obtained in these five patients revealed markedly increased signal distributed throughout the C1–2 lateral mass articulations bilaterally.

Conclusions. In 95% of healthy individuals, the LMI ranged between 0.7 and 2.6 mm. An LMI greater than 2.6 mm indicates the possibility of a distraction injury, which can be confirmed using MR imaging. Patients with a suspected C1–2 distraction injury may be candidates for surgical fusion of C1–2.

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Jeffrey D. Klopfenstein, Robert F. Spetzler, Louis J. Kim, Iman Feiz-Erfan, Patrick P. Han, Joseph M. Zabramski, Randall W. Porter, Felipe C. Albuquerque, Cameron G. McDougall and David J. Fiorella

Object

Whether routine intraoperative angiography is necessary for cerebral aneurysm surgery is currently under debate. In this study the authors prospectively assessed the cerebrovascular surgeon's accuracy in predicting the need for intraoperative angiography.

Methods

Between January 2002 and January 2003, 200 consecutive patients (141 female and 59 male patients, mean age 52.8 years) with 235 aneurysms underwent routine intraoperative angiography. Before the operation, the surgeons indicated whether they believed that intraoperative angiography was necessary. Their responses were recorded as “intraoperative angiography necessary” or “intraoperative angiography unnecessary.” Regardless of the response, all patients underwent intraoperative angiography after the aneurysm had been clipped. Changes in treatment resulting from intraoperative angiography were compared with surgeons' preoperative predictions of the need for intraoperative angiography.

Intraoperative angiography was predicted to be necessary in 41 cases (20%) and unnecessary in 159 cases (80%). Its use altered treatment in 14 patients. Seven of these patients were among the group in which intraoperative angiography was deemed necessary and seven were in the group in which it was considered unnecessary. In the latter group, two patients had residual aneurysms, three had parent vessel occlusion, and two had previously undiagnosed aneurysms. Only one patient (0.5%) sustained a major intraoperative complication attributed to angiography.

Conclusions

Given the frequency of significant disease that remains undetected if intraoperative angiography is used on a selective basis and the low complication rate associated with the procedure, the use of intraoperative angiography should be considered in the majority of aneurysm cases.

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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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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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J Mocco, Kenneth V. Snyder, Felipe C. Albuquerque, Bernard R. Bendok, Alan S. Boulos, Jeffrey S. Carpenter, David J. Fiorella, Brian L. Hoh, Jay U. Howington, Brian T. Jankowitz, Kenneth M. Liebma N, Ansaar T. Rai, Rafael Rodriguez-Mercado, Adnan H. Siddiqui, Erol Veznedaroglu, L. Nelson Hopkins and Elad I. Levy

Object

The development of self-expanding stents dedicated to intracranial use has significantly widened the applicability of endovascular therapy to many intracranial aneurysms that would otherwise have been untreatable by endovascular techniques. Recent Food and Drug Administration approval of the Enterprise Vascular Reconstruction Device and Delivery System (Cordis) has added a new option for self-expanding stent-assisted intracranial aneurysm coiling.

Methods

The authors established a collaborative registry across multiple institutions to rapidly provide largevolume results regarding initial experience in using the Enterprise in real-world practice. Ten institutions (University at Buffalo, Thomas Jefferson University, University of Florida, Cleveland Clinic, Northwestern University, West Virginia University, University of Puerto Rico, Albany Medical Center Hospital, the Neurological Institute of Savannah, and the Barrow Neurological Institute) have provided consecutive data regarding their initial experience with the Enterprise.

Results

In total, 141 patients (119 women) with 142 aneurysms underwent 143 attempted stent deployments. The use of Enterprise assistance with aneurysm coiling was associated with a 76% rate of ≥ 90% occlusion. An inability to navigate or deploy the stent was experienced in 3% of cases, as well as a 2% occurrence of inaccurate deployment. Procedural data demonstrated a 6% temporary morbidity, 2.8% permanent morbidity, and 2% mortality (0.8% unruptured, 12% ruptured).

Conclusions

The authors report initial results of the largest series to date in using the Enterprise for intracranial aneurysm treatment. The Enterprise is associated with a high rate of successful navigation and low occurrence of inaccurate stent deployment. The overall morbidity and mortality rates were low; however, caution should be exercised when considering Enterprise deployment in patients with subarachnoid hemorrhage as the authors' experience demonstrated a high rate of associated hemorrhagic complications leading to death.