Extending the Indications of Flow Diversion to Small, Unruptured, Saccular Aneurysms of the Anterior Circulation (original) (raw)
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World Neurosurgery, 2019
BACKGROUND: Flow-diverting stents have revolutionized the endovascular treatment of intracranial aneurysms. The purpose of this study is to identify predictors of adverse outcomes associated with the pipeline embolization device (PED).-METHODS: A retrospective analysis of all patients treated with PED at a single high-volume center from January 2014 to September 2018. Patient outcomes, neurologic morbidity/mortality, and other clinical variables were analyzed.-RESULTS: We treated 204 aneurysms in 170 patients with PED. Mean length of follow-up was 11 months. Most (181) aneurysms (89%) were located in the anterior circulation, and 23 (11%) were found in the posterior circulation. Most aneurysms were saccular (82%), followed by fusiform (11%), blister (4%), and dissecting pseudoaneurysms (3%). Mean aneurysm size was 8.2 D 5.7 mm with 145 (71%) small aneurysms (£10 mm), 53 (26%) large aneurysms (between 10 and 25 mm), and 6 (3%) giant aneurysms (‡25 mm). Ninety-two percent of aneurysms were unruptured, and 8% were ruptured. The overall major neurologic morbidity/mortality was 4.7% and 1.8%, respectively. The all-cause mortality was 2.9%. Predictors of neurologic morbidity/mortality included the baseline modified Rankin Scale (P [ 0.001), aneurysm neck size (P [ 0.003), aneurysm size (P [ 0.006), anterior versus posterior location (P [ 0.02), and rupture at presentation (0.006). The P2Y12 Reactivity Unit, parent vessel diameter, and patient age did not correlate with adverse events.-CONCLUSIONS: The PED has a satisfactory safety profile in both on-and off-label indications. A poor clinical patient baseline, wider aneurysm neck or larger size, and rupture predict an increased risk of an unfavorable outcome.
Treatment of unruptured intracranial aneurysms with the pipeline embolization device
Journal of Clinical Neuroscience, 2014
The pipeline embolization device (PED; ev3 Endovascular, Plymouth, MN, USA) is a flow-diverter used in the endovascular treatment of intracranial aneurysms, particularly those with unfavorable configurations. It causes progressive flow redirection leading to aneurysm thrombosis. This study aimed to present a systematic review of the published literature on the clinical outcomes of PED. A Medline search of the English language literature was performed using the keywords ''intracranial aneurysms'' and ''pipeline embolization device'' or ''flow diverters''. The inclusion criteria were: n > 10 patients; unruptured aneurysms; documentation of complications; and at least 3 months of follow-up. A total of 13 studies, with 905 patients and 1043 aneurysms, were included. The mean age was 53.8 years, with women comprising 76.3% of patients. The mean aneurysm diameter was 11.1 mm with 37% classed as large aneurysms and 10% classed as giant. The cumulative mortality rate was 2.3%. Seventeen patients had a stroke (1.9%), while 19 (2.0%) had a transient ischemic attack and 21 patients (2.3%) had an intracranial hemorrhage. The two outcome measures were the cumulative event rate (16.7%) and the 6 month aneurysm occlusion rate (79.7%). A funnel plot with study size plotted against the two outcome measures revealed publication bias. Data from recent studies suggest that complication and mortality rates associated with PED may be similar to other contemporary endovascular techniques, with a better 6 month aneurysm occlusion rate. More prospective clinical trials are warranted to further validate these results.
The Pipeline Embolization Device for the Intracranial Treatment of Aneurysms Trial
American Journal of Neuroradiology, 2010
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 (Ͼ4 mm), had unfavorable dome/neck ratios (Ͻ1.5), 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 ϭ 18) or 2 (n ϭ 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 (Ն50%) 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.
Early single centre experience of flow diverting stents for the treatment of cerebral aneurysms
British Journal of Neurosurgery, 2013
morbidity and mortality and high aneurysm exclusion rate. 3 However, subsequent reports have shown higher rates of complications with lower aneurysm exclusion rates. 4 In our unit, Silk FDS (Balt Extrusion, Montmorency, France) have been used from March 2008 and Pipeline Embolisation Device (PED) (ev3, Irvine, CA, USA) from July 2009 till the present. In the USA, the Centre for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) approval letter for the use of PED states that this device is indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. 5 In the UK, there is no such restriction, and as will be seen, FDS have been used for a variety of aneurysms locations. Methods Retrospective review of prospectively built clinical database was done. Variables studied included patient age, clinical presentation, functional status using modifi ed Rankin scale, indication for treatment, aneurysm size and location, type and number of stents used, use of adjunctive coils or balloon remodelling, intra-procedural events, complications and clinical status at follow-up including functional performance status. Cerebral angiograms were retrospectively reviewed by documenting aneurysm location, size and shape. Treatment responses of aneurysms were graded according to O ' Kelly-Marotta (OKM) grading scale for assessment of aneurysms treated by fl ow diversion. 5,6 Th is simple scale accounts for both the amount of aneurysm fi lling and the degree of contrast stasis was seen. An angiographic run, extending into the venous phase, is required for determination of the appropriate grade. Aneurysm fi lling is graded as: A-complete (Ͼ 95%); B-incomplete (5%-95%); C-neck remnant (Ͻ 5%); and D-no fi lling (0%). Th e stasis grade is determined by the timing of contrast clearance from the aneurysm sac as defi ned by the phases of the angiogram:
American Journal of Neuroradiology, 2013
BACKGROUND AND PURPOSE: Flow-diverting stents, such as the PED, have emerged as a novel means of treating complex intracranial aneurysms. This retrospective analysis of the initial Canadian experience provides insight into technical challenges, clinical and radiographic outcomes, and complication rates after the use of flow-diverting stents for unruptured aneurysms. MATERIALS AND METHODS: Cases were compiled from 7 Canadian centers between July 2008 and December 2010. Each center prospectively tracked their initial experience; these data were retrospectively updated and pooled for analysis. RESULTS: During the defined study period, 97 cases of unruptured aneurysm were treated with the PED, with successful stent deployment in 94 cases. The overall complete or near-complete occlusion rate was 83%, with a median follow-up at 1.25 years (range 0.25-2.5 years). Progressive occlusion was witnessed over time, with complete or near-complete occlusion in 65% of aneurysms followed through 6 months, and 90% of aneurysms followed through 1 year. Multivariate analysis found previous aneurysm treatment and female sex predictive of persistent aneurysm filling. Most patients were stable or improved (88%), with the most favorable outcomes observed in patients with cavernous carotid aneurysms. The overall mortality rate was 6%. Postprocedural aneurysm hemorrhage occurred in 3 patients (3%), while ipsilateral distal territory hemorrhage was observed in 4 patients (3.4%). CONCLUSIONS: Flow-diverting stents represent an important tool in the treatment of complex intracranial aneurysms. The relative efficacy and morbidity of this treatment must be considered in the context of available alternate interventions.
Off-Label Application of Pipeline Embolization Device for Intracranial Aneurysms
Neurointervention, 2019
The Pipeline embolization device (PED) is approved in the USA for treating giant and large aneurysms arising from the petrous to superior hypophyseal segments of the internal carotid artery in patients older than 21 years of age. This study investigates off-label PED results in a large cohort. Materials and Methods: Retrospective, single-center review of all patients who had off-label PED surgery. Results: Sixty-two aneurysms (48 patients) underwent off-label PED treatment from 2012-2017. There were 44 females and four males (age 21 to 75 years; mean/median, 54.3/55.0 years). The most common presenting symptom was headache (47/62, 75.8%). All aneurysms were in the anterior circulation. Aneurysm size ranged from 1.4 to 25.0 mm (mean/median, 7.6/6.9 mm). Fifty-two aneurysms had post-operative imaging with total/near-complete occlusion of 84.6% (44/52). Aneurysm-based operative near-term complication rate was 9.7% while there were no permanent complications. For aneurysms and headache, 86.7% improved/resolved after embo-surgery, and were four times more likely to have a better clinical outcome (resolved or improved symptoms) after surgery (odds ratio [OR], 4.333; P=0.0325). Left-sided aneurysms had a higher occlusion rate (OR, 20; P=0.0073). Hypertension (OR, 4.2; P=0.0332) and smoking (OR, 7; P=0.0155) were more prone towards aneurysm occlusion. Patients without a family history were 14 times more likely to have favorable imaging outcome (P=0.0405). There is no difference of occlusion rates between untreated and previously treated aneurysms (P=0.6894). Overall, occlusion rate decreased by 14% with an increase of aneurysm size by 1 mm (P=0.0283). Conclusion: For anterior circulation aneurysms, the off-label application of PED is as effective and safe as reported for on-label intracranial aneurysms.
Comparison of Flow Diversion and Coiling in Large Unruptured Intracranial Saccular Aneurysms
Stroke, 2013
E ndovascular techniques have been gaining ground in the management of intracranial aneurysms. Although coiling was shown to be safe and effective, large aneurysms often fail to achieve complete and durable occlusion, which leaves patients at risk of aneurysm rupture. 1-3 Recently, flow diversion has been introduced as an alternative approach to aneurysm treatment. 4-6 Flow diverters promote aneurysm occlusion through a process of endoluminal reconstruction of the parent artery and by redirecting blood flow away from the aneurysm sac. The Pipeline Embolization Device (PED) is a dedicated flow diverter that received Food and Drug Administration approval in 2011 for large and giant wide-necked aneurysms of the internal carotid artery. The safety and efficacy of the PED has been demonstrated in several recent series, but most of these series did not include a control group of patients treated with traditional embolization strategies. 7-11 We present the results of the first study comparing PED and coiling in patients with unruptured, large and giant (≥10 mm) saccular aneurysms. Methods The Jefferson Hospital for Neuroscience Institutional Review Board approval was obtained before data collection. Patients with unruptured, large or giant (≥10 mm) aneurysms treated with PED (2011-2012) or coiling (2004-2011) at our institution were identified from a prospectively maintained database. A total of 229 patients, 54 treated with PED and 175 with coiling, were identified. Initial analysis of these patients demonstrated that patients treated with PED were significantly older, had significantly larger aneurysms, and had aneurysms that were more likely to be fusiform in morphology. As there were significant differences between patients treated with PED and coils, fusiform aneurysms (more treated with PED) and anterior communicating artery aneurysms (none treated with PED) were eliminated; no other patients were excluded. Blinded to outcome, 40 PED and 120 coil patients were matched in a 1:3 fashion, respectively, on the basis of patient age and aneurysm size. Patients undergoing PED therapy received 75 mg/d of clopidogrel and 81 mg/d of aspirin for 10 days before the intervention. Platelet function tests were routinely performed using aspirin assay and P2Y12 assay (VerifyNow; Accumetrics, San Diego, CA) to ascertain that the level of platelet inhibition was between 30% and 90%. Patients with inhibition <30% were reloaded and the assay was rechecked. Patients found to be poor responders to clopidogrel Background and Purpose-Flow diversion has emerged as an important tool for the management of intracranial aneurysms. The purpose of this study was to compare flow diversion and traditional embolization strategies in terms of safety, efficacy, and clinical outcomes in patients with unruptured, large saccular aneurysms (≥10 mm). Methods-Forty patients treated with the Pipeline Embolization Device (PED) were matched in a 1:3 fashion with 120 patients treated with coiling based on patient age and aneurysm size. Fusiform and anterior communicating artery aneurysms were eliminated from the analysis. Procedural complications, angiographic results, and clinical outcomes were analyzed and compared. Results-There were no differences between the 2 groups in terms of patient age, sex, aneurysm size, and aneurysm location. The rate of procedure-related complications did not differ between the PED (7.5%) and the coil group (7.5%; P=1). At the latest follow-up, a significantly higher proportion of aneurysms treated with PED (86%) achieved complete obliteration compared with coiled aneurysms (41%; P<0.001). In multivariable analysis, coiling was an independent predictor of nonocclusion. Retreatment was necessary in fewer patients in the PED group (2.8%) than the coil group (37%; P<0.001). A similar proportion of patients attained a favorable outcome (modified Rankin Scale, 0-2) in the PED group (92%) and in the coil group (94%; P=0.8). Conclusions-The PED provides higher aneurysm occlusion rates than coiling, with no additional morbidity and similar clinical outcomes. These findings suggest that the PED might be a preferred treatment option for large unruptured saccular aneurysms.
Stent-Assisted Coiling of Intracranial Aneurysms
Stroke, 2013
E ndovascular therapy is a well-established treatment modality for intracranial aneurysms. Large, complex, wide-necked, and fusiform aneurysms were initially considered unamenable to endovascular coil embolization. With the advent of stents designed specifically for the intracranial circulation, such aneurysms can now be safely and efficiently managed endovascularly. 1 Self-expanding stents allow denser aneurysm packing with increased neck coverage and may also improve treatment durability through a combination of flowdiversion, parent vessel straightening, and fibroelastic tissue formation along the neck of the aneurysm. 2,3 The US Food and Drug Administration approved the Neuroform stent (Stryker Neurovascular, Fremont, California) in 2002, followed by the Enterprise stent (Cordis Neurovascular, Miami, Florida) in 2007, for use in coil embolization of wide-necked intracranial aneurysms. The results of stent-assisted coiling (SAC) have varied widely across different studies. In a French series of 216 aneurysms treated with stents, the rates of permanent morbidity and mortality were as high as 7.4% and 4.6%, respectively. Elsewhere, morbidity and mortality rates with SAC were found to be low. 4-7 Several questions remain unanswered: Does the type of stent (open versus closed-cell design) affect the rates of complication and recanalization? Should stents or coils be delivered first? Does staging the procedure provide any benefit for procedural complications or patient outcome? Is stenting of acutely ruptured aneurysms associated with higher complication rates and worse outcomes? We assess the safety and the long-term efficacy of stentassisted techniques and determine the predictors of complications, initial aneurysm occlusion, recanalization, and immediate outcome in a series of 552 aneurysms treated at our institution. Materials and Methods Thomas Jefferson University institutional review board approval was obtained before data collection. We searched our database for all patients, who were treated with Neuroform and Enterprise stents at our institution between January 2006 and October 2010. A total of 508 consecutive patients with 552 aneurysms met the study criteria and constituted our study population. Medical charts and imaging studies were reviewed to determine patient age, sex, size of aneurysm, location Background and Purpose-Self-expanding stents are increasingly used for treatment of complex intracranial aneurysms. We assess the safety and the efficacy of intracranial stenting and determine predictors of treatment outcomes. Methods-A total of 508 patients with 552 aneurysms were treated with Neuroform and Enterprise stents between 2006 and 2011 at our institution. A multivariate analysis was conducted to identify predictors of complications, recanalization, and outcome. Results-Of 508 patients, 461 (91%) were treated electively and 47 (9%) in the setting of subarachnoid hemorrhage. Complications occurred in 6.8% of patients. In multivariate analysis, subarachnoid hemorrhage, delivery of coils before stent placement, and carotid terminus/middle cerebral artery aneurysm locations were independent predictors of procedural complications. Angiographic follow-up was available for 87% of patients at a mean of 26 months. The rates of recanalization and retreatment were, respectively, 12% and 6.4%. Older age, previously coiled aneurysms, larger aneurysms, incompletely occluded aneurysms, Neuroform stent, and aneurysm location were predictors of recanalization. Favorable outcomes were seen in 99% of elective patients and 51% of subarachnoid hemorrhage patients. Patient age, ruptured aneurysms, and procedural complications were predictors of outcome. Conclusions-Stent-assisted coiling of intracranial aneurysms is safe, effective, and provides durable aneurysm closure. Higher complication rates and worse outcomes are associated with treatment of ruptured aneurysms. Stent delivery before coil deployment reduces the risk of procedural complications. Staging the procedure may not improve procedural safety. Closed-cell stents are associated with significantly lower recanalization rates. (Stroke. 2013;44:1348-1353.