Faculty Bibliography

OBJECTIVE: There are few data regarding the effect of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial results on the management of intracranial atherosclerotic disease (ICAD). We sought to understand the impact of the SAMMPRIS trial on current ICAD clinical practices and future trial design. METHODS: During the ICAD symposium at the 2012 International Stroke Conference, electronic data were collected regarding attendees' clinical management of ICAD and opinions on the feasibility of future trials post-SAMMPRIS. RESULTS: 217 attendees from different specialties, including neurologists (57%), neurointerventionalists (9%) and neurosurgeons (5%), participated in the session. The majority of respondents (77%) indicated that the results of SAMMPRIS have impacted their consideration for intracranial stenting. Post-SAMMPRIS, 84% selected 'SAMMPRIS-style' medical management for the treatment of ICAD. For patients with ICAD who failed aggressive medical therapy, 82% would consider an alternative approach to continuing medical therapy (30% considered clinical trial enrollment, 28% suggested angioplasty and stenting and 24% angioplasty). The majority of participants (85%) were willing to randomize patients with symptomatic ICAD in future trials. For the next ICAD trial, 29% indicated that angioplasty alone should be compared with aggressive medical therapy. CONCLUSIONS: Our polling results suggest that the SAMMPRIS trial has had an impact on the current treatment of ICAD. Treatment of patients who failed medical therapy varied widely from aggressive medical therapy to balloon angioplasty, stenting or enrollment in future clinical trials. The willingness to continue clinical trials and randomize patients supports the need for future ICAD studies.

BACKGROUND AND PURPOSE: Low-porosity endoluminal devices for the treatment of intracranial aneurysms, also known as flow diverters, have been in experimental and clinical use for close to 10 years. Despite rigorous evidence of their safety and efficacy in well-controlled trials, a number of key factors concerning their use remain poorly defined. Among these, none has received more attention to date than the debate on how many devices are optimally required to achieve a safe, effective, and economical outcome. Additional, related questions concern device sizing relative to the parent artery and optimal method of deployment of the devices. While some or all of these issues may be ultimately answered on an empiric basis via subgroup analysis of growing treatment cohorts, we believe that careful in vitro examination of relevant device properties can also help guide its in vivo use. MATERIALS AND METHODS: We conducted a number of benchtop experiments to investigate the varied porosity of Pipeline Embolization Devices deployed in a simulated range of parent vessel diameters and applied these results toward conceptualizing optimal treatment strategies of fusiform and wide-neck aneurysms. RESULTS: The results of our studies confirm a predictable parabolic variability in device porosity based on the respective comparative sizes of the device and recipient artery, as well as device curvature. Even modest oversizing leads to a significant increase in porosity. CONCLUSIONS: The experiments demonstrate various deleterious effects of device oversizing relative to the parent artery and provide strategies for addressing size mismatches when they are unavoidable.

SUMMARY:Does the world need another ICA classification scheme? We believe so. The purpose of proposed angiography-driven classification is to optimize description of the carotid artery from the endovascular perspective. A review of existing, predominantly surgically-driven classifications is performed, and a new scheme, based on the study of NYU aneurysm angiographic and cross-sectional databases is proposed. Seven segments - cervical, petrous, cavernous, paraophthlamic, posterior communicating, choroidal, and terminus - are named. This nomenclature recognizes intrinsic uncertainty in precise angiographic and cross-sectional localization of aneurysms adjacent to the dural rings, regarding all lesions distal to the cavernous segment as potentially intradural. Rather than subdividing various transitional, ophthalmic, and hypophyseal aneurysm subtypes, as necessitated by their varied surgical approaches and risks, the proposed classification emphasizes their common endovascular treatment features, while recognizing that many complex, trans-segmental, and fusiform aneurysms not readily classifiable into presently available, saccular aneurysm-driven schemes, are being increasingly addressed by endovascular means. We believe this classification may find utility in standardizing nomenclature for outcome tracking, treatment trials and physician communication.

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.

BACKGROUND: : Stereotactic radiosurgery is an effective treatment modality for small arteriovenous malformations (AVMs) of the brain. For larger AVMs, the treatment dose is often lowered to reduce potential complications, but this decreases the likelihood of cure. One strategy is to divide large AVMs into smaller anatomic volumes and treat each volume separately. OBJECTIVE: : To prospectively assess the long-term efficacy and complications associated with staged-volume radiosurgical treatment of large, symptomatic AVMs. METHODS: : Eighteen patients with AVMs larger than 15 mL underwent prospective staged-volume radiosurgery over a 13-year period. The median AVM volume was 22.9 mL (range, 15.7-50 mL). Separate anatomic volumes were irradiated at 3- to 9-month intervals (median volume, 10.9 mL; range, 5.3-13.4 mL; median marginal dose, 15 Gy; range, 15-17 Gy). The AVM was divided into 2 volumes in 10 patients, 3 volumes in 5 patients, and 4 volumes in 3 patients. Seven patients underwent retreatment for residual disease. RESULTS: : Actuarial rates of complete angiographic occlusion were 29% and 89% at 5 and 10 years. Five patients (27.8%) had a hemorrhage after radiosurgery. Kaplan-Meier analysis of cumulative hemorrhage rates after treatment were 12%, 18%, 31%, and 31% at 2, 3, 5, and 10 years, respectively. One patient died after a hemorrhage (5.6%). CONCLUSION: : Staged-volume radiosurgery for AVMs larger than 15 mL is a viable treatment strategy. The long-term occlusion rate is high, whereas the radiation-related complication rate is low. Hemorrhage during the lag period remains the greatest source of morbidity and mortality. ABBREVIATION:: AVM, arteriovenous malformation.

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.

BACKGROUND AND PURPOSE: Stent-supported aneurysm coiling has been utilized with increasing frequency over the past few years, particularly for addressing treatment of complex and wide-neck aneurysms. A sizable body of literature describing various experiences with stent-supported coiling now exists. The purpose of this research was to carry out a comprehensive literature survey of stent-supported aneurysm coiling. MATERIALS AND METHODS: A survey of papers reporting results with stent-assisted aneurysm coiling through January 2011 was conducted to identify the prevalence of stent-related and other complications, occlusion rates, and clinical and angiographic follow-up data. RESULTS: Thirty-nine articles with 1517 patients met inclusion criteria for initial analysis, follow-up analysis, or both. Overall, 9% of cases were confounded by a technical stent-related issue, including 4% failure of deployment. The overall procedure complication rate was 19%, with periprocedural mortality of 2.1%. Approximately 45% of aneurysms were completely occluded at first treatment session, increasing to 61% on follow-up. Approximately 3.5% in-stent stenosis and 0.6% stent occlusion were observed at angiographic follow-up. Delayed stroke or transient ischemic attack was reported in 3% of subjects. Within a subset of articles, the incidence of stent-related issues in the first 10 patients was significantly higher than in subsequent subjects, supporting the notion of a procedural "learning curve." CONCLUSIONS: In experienced hands, the morbidity of stent-supported coiling is somewhat higher compared with "traditional" coiling. As might be expected, execution of the procedure appears improved with experience. Complete occlusion rates remain somewhat low. More and longer term angiographic follow-up information is needed to understand delayed stent-related issues and to better define the durability of treatment.

BACKGROUND AND PURPOSE: Endoluminal reconstruction with flow diverting devices represents a novel constructive technique for the treatment of cerebral aneurysms. We present the results of the first prospective multicenter trial of a flow-diverting construct for the treatment of intracranial aneurysms. MATERIALS AND METHODS: Patients with unruptured aneurysms that were wide-necked (>4 mm), had unfavorable dome/neck ratios (<1.5), or had failed previous therapy were enrolled in the PITA trial between January and May 2007 at 4 (3 European and 1 South American) centers. Aneurysms were treated with the PED with or without adjunctive coil embolization. All patients underwent clinical evaluation at 30 and 180 days and conventional angiography 180 days after treatment. Angiographic results were adjudicated by an experienced neuroradiologist at a nonparticipating site. RESULTS: Thirty-one patients with 31 intracranial aneurysms (6 men; 42-76 years of age; average age, 54.6 years) were treated during the study period. Twenty-eight aneurysms arose from the ICA (5 cavernous, 15 parophthalmic, 4 superior hypophyseal, and 4 posterior communicating segments), 1 from the MCA, 1 from the vertebral artery, and 1 from the vertebrobasilar junction. Mean aneurysm size was 11.5 mm, and mean neck size was 5.8 mm. Twelve (38.7%) aneurysms had failed (or recurred after) a previous endovascular treatment. PED placement was technically successful in 30 of 31 patients (96.8%). Most aneurysms were treated with either 1 (n = 18) or 2 (n = 11) PEDs. Fifteen aneurysms (48.4%) were treated with a PED alone, while 16 were treated with both PED and embolization coils. Two patients experienced major periprocedural stroke. Follow-up angiography demonstrated complete aneurysm occlusion in 28 (93.3%) of the 30 patients who underwent angiographic follow-up. No significant in-construct stenosis (>/=50%) was identified at follow-up angiography. CONCLUSIONS: Intracranial aneurysm treatment with the PED is technically feasible and can be achieved with a safety profile analogous to that reported for stent-supported coil embolization. PED treatment elicited a very high rate (93%) of complete angiographic occlusion at 6 months in a population of the most challenging anatomic subtypes of cerebral aneurysms

Purpose: To evaluate safety and effectiveness of Pipeline Embolization Device for the treatment of complex intracranial aneurysms. Materials and Methods: 108 patients with large and giant, wide neck aneurysms involving the petrous, cavernous, and paraclinoid segments of the internal carotid artery were enrolled in this prospective, multicenter, single arm study. All subjects but one underwent successful treatment of the target aneurysm with Pipeline. Clinical follow-up was performed at 30 days, 180 days, and 1 year post treatment. Angiographic follow-up was obtained at 180 days (n=99) and 1 year (n=91). Completeness of aneurysm occlusion was assessed by a core laboratory. The results were compared to a predefined target aneurysm occlusion rate derived from exhaustive literature review. Safety outcomes were similarly compared to a historically defined threshold. Results: Complete aneurysm occlusion was observed in a high proportion of cases at both time points of angiographic assessments, representing a highly statistically significant result as compared to the predefined target complete occlusion rate. The safety profile of the device was acceptable, with primary safety events statistically significantly below the predefined threshold. Conclusion: Pipeline Embolization Device is effective and safe for treatment of petrous, cavernous, and paraclinoid aneurysms