Transpalpebral/Blepharoplasty Incision and Supraorbital Craniotomy for the Treatment of Ethmoidal Dural Arteriovenous Fistulas: A Case Series.

BACKGROUND AND OBJECTIVES: Inherent complex angioarchitecture associated with ethmoidal dural arteriovenous fistulas (dAVFs) can make endovascular treatment methods challenging. Many surgical approaches are accompanied by unfavorable cosmetic results such as facial scarring. Blepharoplasty incision of the eyelid offers a minimal, well-hidden scar compared with other incision sites while offering the surgeon optimal visualization of pathogenic structures. This case series aims to report an initial assessment of the safety and efficacy of supraorbital craniotomy by blepharoplasty transpalpebral (eyelid) incision for surgical disconnection of ethmoidal dAVFs. METHODS: Retrospective chart review was conducted for all patients who underwent blepharoplasty incision and craniotomy for disconnection of ethmoidal dAVFs at our institution between October 2011 and February 2023. Patient charts and follow-up imaging were reviewed to report clinical and angiographic outcomes as well as periprocedural and follow-up complications. RESULTS: Complete obliteration and disconnection of ethmoidal dAVF was achieved in all 6 (100%) patients as confirmed by intraoperative angiogram with no resulting morbidity or mortality. Periprocedural complications included one case of transient nasal cerebrospinal fluid leak that was self-limiting and resolved before discharge without intervention. CONCLUSION: Surgical treatment for ethmoidal dAVFs, specifically by transpalpebral incision and supraorbital craniotomy, is a safe and effective treatment option and affords the surgeon greater access to the floor of the anterior fossa when necessary. In addition, blepharoplasty incision addressed patient concerns for facial scarring compared with other incision sites by creating a more well-hidden, minimal scar in the natural folds of the eyelid for patients with an eyelid crease.

Quantitative Analysis of Parenchymal Effects and Flow of Large Arteriovenous Malformations Managed With Stereotactic Radiosurgery.

BACKGROUND AND OBJECTIVES: Stereotactic radiosurgery (SRS) of larger arteriovenous malformations (AVM) is associated with an elevated incidence of adverse radiation effects (ARE). To date, volume-response and dose-response models have been used to predict such effects. To understand radiological outcomes and their hemodynamic effects on the regional brain. METHODS: A retrospective analysis was conducted at our institution using a prospective registry of patients managed between 2014 and 2020. We included patients with AVM with a nidus larger than 5 cc who received either single-session or volume-staged Gamma Knife radiosurgery. AVM volume changes, volumes of parenchymal response, and obliteration were analyzed and correlated with transit times and diameters of feeding arteries and draining veins. RESULTS: Sixteen patients underwent single-session SRS, and 9 patients underwent volume-staged SRS. The average AVM volume was 12.6 cc (5.5-23). The AVM locations were predominantly lobar (80%) and 17 (68%) were in critical locations. The mean margin dose was 17.2 Gy (15-21), and the median V12Gy was 25.5 cc. Fourteen (56%) AVMs had a transit time shorter than 1 second. The median vein-artery ratio (sum diameter of the veins/sum diameter of feeding arteries) was 1.63 (range, 0.60-4.19). Asymptomatic parenchymal effects were detected in 13 (52%) patients and were symptomatic in 4 (16%) patients. The median time to ARE was 12 months (95% CI 7.6-16.4). On univariate analysis, significant predictors of ARE were lower vein-artery ratio ( P = .024), longer transit time ( P = .05), higher mean dose ( P = .028), and higher D95 ( P = .036). CONCLUSION: Transit times and vessel diameters are valuable predictors of the subsequent parenchymal response after SRS. A more quantitative understanding of blood flow is critical for predicting the effects on the regional brain after AVM radiosurgery.

Early Experience of Surgical Planning for STA-MCA Bypass Using Virtual Reality.

BACKGROUND: The superficial temporal artery (STA)-to-middle cerebral artery (MCA) bypass requires precise preoperative planning, and 3-dimensional virtual reality (VR) models have recently been used to optimize planning of STA-MCA bypass. In the present report, we have described our experience with VR-based preoperative planning of STA-MCA bypass. METHODS: Patients from August 2020 to February 2022 were analyzed. For the VR group, using 3-dimensional models from the patients' preoperative computed tomography angiograms, VR was used to locate the donor vessels, potential recipient, and anastomosis sites and plan the craniotomy, which were referenced throughout surgery. Computed tomography angiograms or digital subtraction angiograms were used to plan the craniotomy for the control group. The procedure time, bypass patency, craniotomy size, and postoperative complication rates were assessed. RESULTS: The VR group included 17 patients (13 women; age, 49 ± 14 years) with Moyamoya disease (76.5%) and/or ischemic stroke (29.4%). The control group included 13 patients (8 women; age, 49 ± 12 years) with Moyamoya disease (92.3%) and/or ischemic stroke (7.3%). For all 30 patients, the preoperatively planned donor and recipient branches were effectively translated intraoperatively. No significant difference were found in the procedure time or craniotomy size between the 2 groups. Bypass patency was 94.1% for the VR group (16 of 17) and 84.6% for the control group (11 of 13). No permanent neurological deficits occurred in either group. CONCLUSIONS: Our early experience has shown that VR can serve as a useful, interactive preoperative planning tool by enhancing visualization of the spatial relationship between the STA and MCA without compromising the surgical results.

Preoperative flow analysis of arteriovenous malformations and obliteration response after stereotactic radiosurgery.

OBJECTIVE: Morphological and angioarchitectural features of cerebral arteriovenous malformations (AVMs) have been widely described and associated with outcomes; however, few studies have conducted a quantitative analysis of AVM flow. The authors examined brain AVM flow and transit time on angiograms using direct visual analysis and a computer-based method and correlated these factors with the obliteration response after Gamma Knife radiosurgery. METHODS: A retrospective analysis was conducted at a single institution using a prospective registry of patients managed from January 2013 to December 2019: 71 patients were analyzed using a visual method of flow determination and 38 were analyzed using a computer-based method. After comparison and validation of the two methods, obliteration response was correlated to flow analysis, demographic, angioarchitectural, and dosimetric data. RESULTS: The mean AVM volume was 3.84 cm3 (range 0.64-19.8 cm3), 32 AVMs (45%) were in critical functional locations, and the mean margin radiosurgical dose was 18.8 Gy (range 16-22 Gy). Twenty-seven AVMs (38%) were classified as high flow, 37 (52%) as moderate flow, and 7 (10%) as low flow. Complete obliteration was achieved in 44 patients (62%) at the time of the study; the mean time to obliteration was 28 months for low-flow, 34 months for moderate-flow, and 47 months for high-flow AVMs. Univariate and multivariate analyses of factors predicting obliteration included AVM nidus volume, age, and flow. Adverse radiation effects were identified in 5 patients (7%), and 67 patients (94%) remained free of any functional deterioration during follow-up. CONCLUSIONS: AVM flow analysis and categorization in terms of transit time are useful predictors of the probability of and the time to obliteration. The authors believe that a more quantitative understanding of flow can help to guide stereotactic radiosurgery treatment and set accurate outcome expectations.

Salvage Superficial Temporal Artery to Middle Cerebral Artery Direct Bypass Using an Interposition Graft for Failed Encephaloduroarteriosynangiosis in Moyamoya Disease.

BACKGROUND: Moyamoya disease may present with either hemorrhagic or ischemic strokes. Surgical bypass has previously demonstrated superiority when compared to natural history and medical treatment alone. The best bypass option (direct vs. indirect), however, remains controversial in regard to adult ischemic symptomatic moyamoya disease. Multiple studies have demonstrated clinical as well as angiographic effectiveness of direct bypass in adult hemorrhagic moyamoya disease. In particular, there are limited data regarding strategies in the setting of failed indirect bypass with recurrent hemorrhagic strokes. Here, we describe a salvage procedure. METHODS: We describe a case of a 52-year-old man who presented with hemorrhagic moyamoya disease and failed previous bilateral encephaloduroarteriosynangiosis (EDAS) procedures at an outside institution. On a 3-year follow-up diagnostic cerebral angiogram, no synangiosis was noted on the right side and only minimal synangiosis was present on the left. The left hemisphere was significant for a left parietal hypoperfusion state. We performed a salvage left proximal superficial temporal artery to distal parietal M4 middle cerebral artery bypass using the descending branch of the lateral circumflex artery as an interposition graft with preservation of the existing EDAS sites. RESULTS: The patient underwent the procedure successfully and recovered well with resolution of headaches and no further strokes or hemorrhages on the 1-year follow-up magnetic resonance imaging of the brain. CONCLUSIONS: This case presents the use of a salvage direct bypass technique for recurrent symptomatic hemorrhagic moyamoya disease after failed EDAS. The strategy, approach, and technical nuances of this unique case have implications for revascularization options.

Predictors of incomplete aneurysm occlusion after treatment with the Pipeline Embolization Device: PREMIER trial 1 year analysis.

BACKGROUND: Flow diverters have revolutionized the treatment of intracranial aneurysms. Nevertheless, some aneurysms fail to occlude with flow diversion. The Prospective Study on Embolization of Intracranial Aneurysms with the Pipeline Device (PREMIER) was a prospective, multicenter and single-arm trial of small and medium wide-necked unruptured aneurysms. In the current study, we evaluate the predictors of treatment failure in the PREMIER cohort. METHODS: We analyzed PREMIER patients who had incomplete occlusion (Raymond-Roy >1) at 1 year angiographic follow-up and compared them with those who achieved Raymond-Roy 1, aiming to identify predictors of treatment failure. RESULTS: 25 aneurysms demonstrated incomplete occlusion at 1 year. There was a median reduction of 0.9 mm (IQR 0.41-2.43) in maximum diameter between pre-procedure and 1 year measurements, with no aneurysmal hemorrhage. Patients with incomplete occlusion were significantly older than those with complete occlusion (p=0.011). Smoking (p=0.045) and C6 segment location (p=0.005) were significantly associated with complete occlusion, while location at V4 (p=0.01) and C7 (p=0.007) and involvement of a side branch (p<0.001) were significantly associated with incomplete occlusion. In multivariable logistic regression, significant predictors of incomplete occlusion were non-smoker status (adjusted OR 4.49, 95% CI 1.11 to 18.09; p=0.03) and side branch involvement (adjusted OR 11.68, 95% CI 3.84 to 35.50; p<0.0001), while C6 location had reduced odds of incomplete occlusion (adjusted OR 0.29, 95% CI 0.10 to 0.84; p=0.02). CONCLUSIONS: The results of our study are consistent with previous retrospective series and warrant consideration for technique adaptations to achieve higher occlusion rates. Further follow-up is needed to assess progression of aneurysm occlusion and clinical behavior in these cases.

Remodeling of the Posterior Cerebral Artery P1-Segment after Pipeline Flow Diverter Treatment of Posterior Communicating Artery Aneurysms.

INTRODUCTION: Flow diverters such as the pipeline embolization device (PED) cause hemodynamic changes of the treated vessel segment. In posterior communicating artery (PcomA), aneurysms' unique anatomic consideration have to be taken in account due to the connection between the anterior and posterior circulation. We hypothesize that in conjunction with PcomA remodeling, there will also be remodeling of the ipsilateral P1 segment of the posterior cerebral artery (PCA) after PED treatment for PcomA aneurysms. METHODS: We retrospectively collected radiological as well as clinical data of PcomA aneurysm patients treated with PED including PcomA and P1 vessel diameters before and after treatment as well as patient and aneurysm characteristics. RESULTS: Overall, 14 PcomA aneurysm patients were included for analysis and PED treatment was performed without complications in all patients. In 10 out of 14 patients (71%), a decrease in PcomA diameter was observed and there was a significant mean decrease of 0.78 mm in PcomA diameter on angiographic last follow-up (LFU) (p = 0.003). In the same patient population (10 out of 14 patients), there was meanwhile a significant mean increase of 0.43 mm in the ipsilateral P1 segment diameter observed (p = 0.015). These vessel remodeling effects were in direct correlation with aneurysm occlusion since all of these patients showed aneurysm occlusion at LFU while 29% showed only partial occlusion without vessel remodeling effects. A decrease in PcomA diameter was directly associated with aneurysm occlusion (p = 0.042). There were no neurologic complications on LFU. CONCLUSION: In the treatment of PcomA aneurysms with PED, the P1 segment of the PCA increases in diameter while the PcomA diameter decreases. Our results suggest that this remodeling effect is associated with aneurysm occlusion and decrease of PcomA is hemodynamically compensated for by an increase in the ipsilateral P1 diameter.

Pipeline embolization of cerebral aneurysms in pediatric patients: combined systematic review of patient-level data and multicenter retrospective review.

OBJECTIVE: Cerebral aneurysms in the pediatric population are rare and optimal treatment strategies are not as well characterized as in adults. The Pipeline embolization device (PED) is an endoluminal flow diverter that is commonly used to treat aneurysms in adults, but experience with this device in children is limited. The authors sought to further characterize PED use and outcomes in this specific population by performing both a systematic review of patient-level data from studies reporting the use of the PED to treat pediatric aneurysms and a retrospective review of their experience. METHODS: A systematic review of the PubMed, Embase, and Scopus databases was performed to identify studies reporting the use of the PED in pediatric patients (age ≤ 18 years). Disaggregated data regarding demographics, aneurysm characteristics, treatment, and outcomes were collected. Retrospective data from the authors' two institutions were also included. RESULTS: Thirty studies comprising patient-level data on 43 pediatric patients with 47 aneurysms were identified. An additional 9 patients with 9 aneurysms were included from the authors' institutions for a total of 52 patients with 56 aneurysms. The mean patient age was 11.1 years. Presentations included aneurysm rupture (17.3%) and symptomatic mass effect (23.1%). Aneurysms were located in the anterior circulation in 55.4% of cases, and 73.2% were described as nonsaccular. Imaging follow-up was available for 89.3% with a mean follow-up of 13.3 months. Aneurysm occlusion was reported in 75%, with 1 case each (1.8%) demonstrating significant in-stent stenosis and parent vessel occlusion. Clinical follow-up was reported in 90.4% with a mean follow-up of 14.7 months. Good functional outcomes (modified Rankin Scale score of 0-1 or Glasgow Outcome Scale score of 5) were reported in 65.4% of the total population. Two major complications were reported, including 1 death. CONCLUSIONS: Despite substantial differences in aneurysm location and type between published pediatric and adult patient populations treated with the PED, the use of the PED in the pediatric population appears to be safe. While the short-term effectiveness is also similar to that of adults, additional studies are needed to further characterize the long-term outcomes and better define the use of this device in pediatric patients.

Anticoagulation use and Hemorrhagic Stroke in SARS-CoV-2 Patients Treated at a New York Healthcare System.

BACKGROUND AND PURPOSE: While the thrombotic complications of COVID-19 have been well described, there are limited data on clinically significant bleeding complications including hemorrhagic stroke. The clinical characteristics, underlying stroke mechanism, and outcomes in this particular subset of patients are especially salient as therapeutic anticoagulation becomes increasingly common in the treatment and prevention of thrombotic complications of COVID-19. METHODS: We conducted a retrospective cohort study of patients with hemorrhagic stroke (both non-traumatic intracerebral hemorrhage and spontaneous non-aneurysmal subarachnoid hemorrhage) who were hospitalized between March 1, 2020, and May 15, 2020, within a major healthcare system in New York, during the coronavirus pandemic. Patients with hemorrhagic stroke on admission and who developed hemorrhage during hospitalization were both included. We compared the clinical characteristics of patients with hemorrhagic stroke and COVID-19 to those without COVID-19 admitted to our hospital system between March 1, 2020, and May 15, 2020 (contemporary controls), and March 1, 2019, and May 15, 2019 (historical controls). Demographic variables and clinical characteristics between the individual groups were compared using Fischer's exact test for categorical variables and nonparametric test for continuous variables. We adjusted for multiple comparisons using the Bonferroni method. RESULTS: During the study period in 2020, out of 4071 patients who were hospitalized with COVID-19, we identified 19 (0.5%) with hemorrhagic stroke. Of all COVID-19 with hemorrhagic stroke, only three had isolated non-aneurysmal SAH with no associated intraparenchymal hemorrhage. Among hemorrhagic stroke in patients with COVID-19, coagulopathy was the most common etiology (73.7%); empiric anticoagulation was started in 89.5% of these patients versus 4.2% in contemporary controls (p ≤ .001) and 10.0% in historical controls (p ≤ .001). Compared to contemporary and historical controls, patients with COVID-19 had higher initial NIHSS scores, INR, PTT, and fibrinogen levels. Patients with COVID-19 also had higher rates of in-hospital mortality (84.6% vs. 4.6%, p ≤ 0.001). Sensitivity analyses excluding patients with strictly subarachnoid hemorrhage yielded similar results. CONCLUSION: We observed an overall low rate of imaging-confirmed hemorrhagic stroke among patients hospitalized with COVID-19. Most hemorrhages in patients with COVID-19 infection occurred in the setting of therapeutic anticoagulation and were associated with increased mortality. Further studies are needed to evaluate the safety and efficacy of therapeutic anticoagulation in patients with COVID-19.

Acute stroke care in a New York City comprehensive stroke center during the COVID-19 pandemic.

BACKGROUND AND PURPOSE: The coronavirus disease-2019 (COVID-19) pandemic caused unprecedented demand and burden on emergency health care services in New York City. We aim to describe our experience providing acute stroke care at a comprehensive stroke center (CSC) and the impact of the pandemic on the quality of care for patients presenting with acute ischemic stroke (AIS). METHODS: We retrospectively analyzed data from a quality improvement registry of consecutive AIS patients at New York University Langone Health's CSC between 06/01/2019-05/15/2020. During the early stages of the pandemic, the acute stroke process was modified to incorporate COVID-19 screening, testing, and other precautionary measures. We compared stroke quality metrics including treatment times and discharge outcomes of AIS patients during the pandemic (03/012020-05/152020) compared with a historical pre-pandemic group (6/1/2019-2/29/2020). RESULTS: A total of 754 patients (pandemic-120; pre-pandemic-634) were admitted with a principal diagnosis of AIS; 198 (26.3%) received alteplase and/or mechanical thrombectomy. Despite longer median door to head CT times (16 vs 12 minutes; p = 0.05) and a trend towards longer door to groin puncture times (79.5 vs. 71 min, p = 0.06), the time to alteplase administration (36 vs 35 min; p = 0.83), door to reperfusion times (103 vs 97 min, p = 0.18) and defect-free care (95.2% vs 94.7%; p = 0.84) were similar in the pandemic and pre-pandemic groups. Successful recanalization rates (TICI≥2b) were also similar (82.6% vs. 86.7%, p = 0.48). After adjusting for stroke severity, age and a prior history of transient ischemic attack/stroke, pandemic patients had increased discharge mortality (adjusted OR 2.90 95% CI 1.77 - 7.17, p = 0.021) CONCLUSION: Despite unprecedented demands on emergency healthcare services, early multidisciplinary efforts to adapt the acute stroke treatment process resulted in keeping the stroke quality time metrics close to pre-pandemic levels. Future studies will be needed with a larger cohort comparing discharge and long-term outcomes between pre-pandemic and pandemic AIS patients.

Endovascular Reconstruction of Intracranial Aneurysms with the Pipeline Embolization Device in Pediatric Patients: A Single-Center Series.

BACKGROUND: Pediatric intracranial aneurysms tend to differ in etiology, size, and location from their adult counterparts, and they are often less amenable to microsurgical clip reconstruction techniques. Endovascular treatment with detachable coils is an accepted treatment technique for pediatric patients, though high recurrence rates have been reported with coil embolization of large and giant aneurysms in this population. While the Pipeline Embolization Device (PED) is FDA-approved for adult intracranial aneurysms, the use of PEDs in pediatric patients is considered off-label. CASE DESCRIPTIONS: We present 3 cases of pediatric intracranial aneurysms in a 5-year-old male, a 12-year-old male, and a 12-year-old female who presented with symptoms including seizure, headache, and blurred vision. The 2 male patients were found to have intradural vertebral artery saccular aneurysms, while the female patient had a paraophthalmic right internal carotid complex aneurysm. After endovascular reconstruction of the aneurysms with PEDs, follow-up angiography showed complete occlusion of the previous aneurysms with no residual aneurysm filling in all 3 cases. CONCLUSION: While further investigation is needed, the evidence presented here supports the conclusion that the PED can be an effective and viable treatment strategy in the pediatric population.

Multicenter Study of Pipeline Flex for Intracranial Aneurysms.

BACKGROUND: The Pipeline Flex (PED Flex; Medtronic, Dublin, Ireland) was designed to facilitate deployment and navigation compared to its previous iteration to reduce the rate of technical events and complications. OBJECTIVE: To assess the neurological morbidity and mortality rates of the PED Flex at 30 d. METHODS: Information from 9 neurovascular centers was retrospectively obtained between July 2014 and March 2016. Data included patient/aneurysm characteristics, periprocedural events, clinical, and angiographic outcomes. Multivariate logistic regression was performed to determine predictors of unfavorable clinical outcome (modified Rankin Scale [mRS] > 2). RESULTS: A total of 205 patients harboring 223 aneurysms were analyzed. The 30-d neurological morbidity and mortality rates were 1.9% (4/205) and 0.5% (1/205), respectively. The rate of intraprocedural events without neurological morbidity was 6.8% (14/205), consisting of intraprocedural ischemic events in 9 patients (4.5%) and hemorrhage in 5 (2.4%). Other technical events included difficulty capturing the delivery wire in 1 case (0.5%) and device migration after deployment in another case (0.5%). Favorable clinical outcome (mRS 0-2) was achieved in 186 patients (94.4%) at discharge and in 140 patients (94.5%) at 30 d. We did not find predictors of clinical outcomes on multivariate analysis. CONCLUSION: The 30-d rates of neurological morbidity and mortality in this multicenter cohort using the PED Flex for the treatment of intracranial aneurysms were low, 1.9% (4/205) and 0.5% (1/205), respectively. In addition, technical events related to device deployment were also low, most likely due to the latest modifications in the delivery system.

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.

Parent vessel occlusion after Pipeline embolization of cerebral aneurysms of the anterior circulation.

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.

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).

Treatment of distal anterior cerebral artery aneurysms with the Pipeline Embolization Device.

Aneurysms of the anterior cerebral artery (ACA) located distal to the anterior communicating artery complex (ACOM) remain challenging to treat with surgical clip reconstruction as well as with endovascular coil-embolization strategies. We have treated five complex geometry distal ACA aneurysms with endoluminal reconstruction using the Pipeline Embolization Device (PED). Two aneurysms were of the dysplastic fusiform type. Three aneurysms were of complex saccular configuration. Three aneurysms were treated electively at the outset with PED. One patient had previously undergone aborted clip reconstruction, and one was treated for recurrent aneurysm growth after coil embolization. The mean diameter of the ACA in this cohort was 1.96mm proximal to the aneurysm and 1.79mm distal to the aneurysmal segment. A single PED of 2.5mm inner diameter was the sole treatment in four cases. Two PEDs, telescopically overlapped across the aneurysm, were used in the remaining case. All devices were deployed successfully. No parent artery occlusion or stenosis was observed. In all cases an associated branch vessel arising from the vicinity of the aneurysm or incorporated into its neck was covered by the endoluminal construct. At follow-up angiography, robust antegrade flow was maintained in the jailed branch. One patient experienced asymptomatic, delayed occlusion of the jailed branch. Complete aneurysm occlusion was seen in all patients. We confirm that PED can be deployed in parent vessels smaller than 2mm diameter, and that endoluminal reconstruction with the PED may be a safe and effective treatment alternative for selected distal ACA aneurysms.

Learning from failure: persistence of aneurysms following pipeline embolization.

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.

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.