Safety and efficacy of the Pipeline Embolization Device in 100 small intracranial aneurysms

OBJECT Flow diverters are increasingly used for treatment of intracranial aneurysms. In most series, the Pipeline Embolization Device (PED) was used for the treatment of large, giant, complex, and fusiform aneurysms. Little is known about the use of the PED in small aneurysms. The purpose of this study was to assess the safety and efficacy of the PED in small aneurysms (≤ 7 mm). METHODS A total of 100 consecutive patients were treated with the PED at the authors' institution between May 2011 and September 2013. Data on procedural safety and efficacy were retrospectively collected. RESULTS The mean aneurysm size was 5.2 ± 1.5 mm. Seven patients (7%) had sustained a subarachnoid hemorrhage. All except 5 aneurysms (95%) arose from the anterior circulation. The number of PEDs used was 1.2 per aneurysm. Symptomatic procedure-related complications occurred in 3 patients (3%): 1 distal parenchymal hemorrhage that was managed conservatively and 2 ischemic events. At the latest follow-up (mean 6.3 months), 54 (72%) aneurysms were completely occluded (100%), 10 (13%) were nearly completely occluded (≥ 90%), and 11 (15%) were incompletely occluded (< 90%). Six aneurysms (8%) required further treatment. Increasing aneurysm size (OR 3.8, 95% CI 0.99–14; p = 0.05) predicted retreatment. All patients achieved a favorable outcome (modified Rankin Scale Score 0–2) at follow-up. CONCLUSIONS In this study, treatment of small aneurysms with the PED was associated with low complication rates and high aneurysm occlusion rates. These findings suggest that the PED is a safe and effective alternative to conventional endovascular techniques for small aneurysms. Randomized trials with long-term follow-up are necessary to determine the optimal treatment that leads to the highest rate of obliteration and the best clinical outcomes.

Download Full-text

Use of the Pipeline embolization device for recurrent and residual cerebral aneurysms: a safety and efficacy analysis with short-term follow-up

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2016-012772 ◽

2016 ◽

Vol 9 (12) ◽

pp. 1208-1213 ◽

Cited By ~ 12

Author(s):

Anna Luisa Kühn ◽

Katyucia de Macedo Rodrigues ◽

J Diego Lozano ◽

David E Rex ◽

Francesco Massari ◽

...

Keyword(s):

Intimal Hyperplasia ◽

Cerebral Aneurysms ◽

Device Performance ◽

Anterior Circulation ◽

Pipeline Embolization Device ◽

Safety And Efficacy ◽

Efficacy Analysis ◽

Unruptured Intracranial Aneurysms ◽

Aneurysm Occlusion

ObjectiveEvaluation of the safety and efficacy of the Pipeline embolization device (PED) when used as second-line treatment for recurrent or residual, pretreated ruptured and unruptured intracranial aneurysms (IAs).MethodsRetrospective review of our database to include all patients who were treated with a PED for recurrent or residual IAs following surgical clipping or coiling. We evaluated neurological outcome and angiograms at discharge, 6- and 12-months’ follow-up and assessed intimal hyperplasia at follow-up.ResultsTwenty-four patients met our inclusion criteria. Most IAs were located in the anterior circulation (n=21). No change of preprocedure modified Rankin Scale score was seen at discharge or at any scheduled follow-up. Complete or near-complete aneurysm occlusion on 6- and 12-month angiograms was seen in 94.4% (17/18 cases) and 93.3% (14/15 cases), respectively. Complete or near-complete occlusion was seen in 100% of previously ruptured and 85.7% (6/7 cases) and 83.3% (5/6 cases) of previously unruptured cases at the 6- and 12-months’ follow-up, respectively. One case of moderate intimal hyperplasia was observed at 6 months and decreased to mild at the 12-months’ follow-up. No difference in device performance was observed among pretreated unruptured or ruptured IAs.ConclusionsTreatment of recurrent or residual IAs with a PED after previous coiling or clipping is feasible and safe. There is no difference in device performance between ruptured or unruptured IAs.

Download Full-text

EVALUATION OF ONYX HD-500 EMBOLIC SYSTEM IN THE TREATMENT OF 84 WIDE-NECK INTRACRANIAL ANEURYSMS

Neurosurgery ◽

10.1227/01.neu.0000340977.68347.51 ◽

2009 ◽

Vol 64 (5) ◽

pp. E865-E875 ◽

Cited By ~ 45

Author(s):

Ronie L. Piske ◽

Luis H. Kanashiro ◽

Eric Paschoal ◽

Celso Agner ◽

Sergio S. Lima ◽

...

Keyword(s):

Intracranial Aneurysms ◽

High Rate ◽

Anterior Circulation ◽

Complete Occlusion ◽

Aneurysm Occlusion ◽

Incomplete Occlusion ◽

Wide Neck ◽

Small Aneurysms ◽

Platinum Coils

Abstract OBJECTIVE We report our results using Onyx HD-500 (Micro Therapeutics, Inc., Irvine, CA) in the endovascular treatment of wide-neck intracranial aneurysms, which have a high rate of incomplete occlusion and recanalization with platinum coils. METHODS Sixty-nine patients with 84 aneurysms were treated. Most of the aneurysms were located in the anterior circulation (80 of 84 aneurysms), were unruptured (74 of 84 aneurysms), and were incidental. Ten presented with subarachnoid hemorrhage, and 15 were symptomatic. All aneurysms had wide necks (neck >4 mm and/or dome-to-neck ratio <1.5). Fifty aneurysms were small (<12 mm), 30 were large (12 to <25 mm) and 4 were giant. Angiographic follow-up was available for 65 of the 84 aneurysms at 6 months, for 31 of the 84 aneurysms at 18 months, and for 5 of the 84 aneurysms at 36 months. RESULTS Complete aneurysm occlusion was seen in 65.5% of aneurysms on immediate control, in 84.6% at 6 months, and in 90.3% at 18 months. The rates of complete occlusion were 74%, 95.1%, and 95.2% for small aneurysms and 53.3%, 70%, and 80% for large aneurysms at the same follow-up periods. Progression from incomplete to complete occlusion was seen in 68.2% of all aneurysms, with a higher percentage in small aneurysms (90.9%). Aneurysm recanalization was observed in 3 patients (4.6%), with retreatment in 2 patients (3.3%). Procedural mortality was 2.9%. Overall morbidity was 7.2%. CONCLUSION Onyx embolization of intracranial wide-neck aneurysms is safe and effective. Morbidity and mortality rates are similar to those of other current endovascular techniques. Larger samples and longer follow-up periods are necessary.

Download Full-text

Safety and efficacy of the Derivo Embolization Device for the treatment of ruptured intracranial aneurysms

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2018-014166 ◽

2018 ◽

Vol 11 (3) ◽

pp. 290-295 ◽

Cited By ~ 14

Author(s):

Lukas Goertz ◽

Franziska Dorn ◽

Bastian Kraus ◽

Jan Borggrefe ◽

Marc Schlamann ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Flow Diverter ◽

Anterior Circulation ◽

Aspiration Thrombectomy ◽

Safety And Efficacy ◽

Posterior Circulation Aneurysms ◽

Aneurysm Morphology ◽

Aneurysm Occlusion ◽

Ruptured Intracranial Aneurysms

BackgroundThe Derivo Embolization Device (DED) is a novel flow diverter with advanced X-ray visibility, potentially lower thrombogenicity, and an improved delivery system.ObjectiveTo evaluate the safety and efficacy of the DED for emergency treatment of ruptured intracranial aneurysms.MethodsBetween February 2016 and March 2018, 10 patients (median age 54.5 years, seven women) with 11 aneurysms were treated with the DED at three neurovascular centers. Procedural details, complications, morbidity, and aneurysm occlusion (O’Kelly-Marotta scale, OKM) were retrospectively reviewed.ResultsAmong 11 aneurysms treated, there were nine anterior circulation and two posterior circulation aneurysms. Aneurysm morphology was saccular in four cases, dissecting in three, blister-like in three, and fusiform in one. In each case, a single DED was implanted and deployment was technically successful without exception. Adjunctive coiling was performed in two aneurysms. We observed one in-stent thrombosis, presumably due to low response to clopidogrel 4 days after the procedure, which remained with a mild hemiparesis after aspiration thrombectomy. No further thromboembolic or hemorrhagic events occurred. Favorable outcome (modified Rankin scale score ≤2) at last follow-up was achieved in all patients. Among 10 aneurysms available for angiographic follow-up, complete aneurysm occlusion (OKM D) was obtained in nine cases (90.0%).ConclusionsIn this pilot study, endovascular treatment of ruptured intracranial aneurysms with the DED was feasible and not associated with any incidence of rebleeding. Larger series with longer follow-up are warranted to reach a definite conclusion about this device.

Download Full-text

Aneurysms with persistent filling after failed treatment with the Pipeline embolization device

Journal of Neurosurgery ◽

10.3171/2017.12.jns163090 ◽

2019 ◽

Vol 130 (4) ◽

pp. 1376-1382 ◽

Cited By ~ 5

Author(s):

Badih Daou ◽

Elias Atallah ◽

Nohra Chalouhi ◽

Robert M. Starke ◽

Jeffrey Oliver ◽

...

Keyword(s):

Cerebral Aneurysms ◽

Previous Treatment ◽

Anterior Circulation ◽

Pipeline Embolization Device ◽

Aneurysm Size ◽

Paraclinoid Aneurysms ◽

Long Term Follow Up ◽

The Mean ◽

Anterior Choroidal

OBJECTIVEThe Pipeline embolization device (PED) has become a valuable tool in the treatment of cerebral aneurysms. Although failures with PED treatment have been reported, the characteristics and course of these aneurysms remain a topic of uncertainty.METHODSElectronic medical records and imaging studies were reviewed for all patients treated with the PED between July 2010 and March 2015 to identify characteristics of patients and aneurysms with residual filling after PED treatment.RESULTSOf 316 cases treated at a single institution, 281 patients had a long-term follow-up. A total of 52 (16.4%) aneurysms with residual filling were identified and constituted the study population. The mean patient age in this population was 58.8 years. The mean aneurysm size was 10.1 mm ± 7.15 mm. Twelve aneurysms were fusiform (23%). Of the aneurysms with residual filling, there were 20 carotid ophthalmic (CO) aneurysms (20% of all CO aneurysms treated), 10 other paraclinoid aneurysms (16.4% of all paraclinoid aneurysms), 7 posterior communicating artery (PCoA) aneurysms (21.9% of all PCoA aneurysms), 7 cavernous internal carotid artery (ICA) aneurysms (14.9% of all cavernous ICA aneurysms), 4 vertebrobasilar (VB) junction aneurysms (14.8% of all VB junction aneurysms), and 3 middle cerebral artery (MCA) aneurysms (25% of all MCA aneurysms). Eleven patients underwent placement of more than one PED (21.2%), with a mean number of devices of 1.28 per case. Eight of 12 aneurysms were previously treated with a stent (15.4%). Nineteen patients underwent re-treatment (36.5%); the 33 patients who did not undergo re-treatment (63.5%) were monitored by angiography or noninvasive imaging. In multivariate analysis, age older than 65 years (OR 2.65, 95% CI 1.33–5.28; p = 0.05), prior stent placement across the target aneurysm (OR 2.94, 95% CI 1.15–7.51; p = 0.02), aneurysm location in the distal anterior circulation (MCA, PCoA, and anterior choroidal artery: OR 2.72, 95% CI 1.19–6.18; p = 0.017), and longer follow-up duration (OR 1.06, 95% CI 1.03–1.09; p < 0.001) were associated with incomplete aneurysm occlusion.CONCLUSIONSWhile the PED can allow for treatment of large, broad-necked aneurysms with high efficacy, treatment failures do occur (16.4%). Aneurysm size, shape, and previous treatment may influence treatment outcome.

Download Full-text

Endovascular Treatment of Anterior Circulation Aneurysms With the p64 Flow Modulation Device: Mid- and Long-Term Results in 617 Aneurysms From a Single Center

Operative Neurosurgery ◽

10.1093/ons/opaa425 ◽

2021 ◽

Author(s):

Marta Aguilar Pérez ◽

Elina Henkes ◽

Victoria Hellstern ◽

Carmen Serna Candel ◽

Christina Wendl ◽

...

Keyword(s):

Intracranial Aneurysms ◽

High Rate ◽

Long Term Results ◽

Effective Treatment Option ◽

Anterior Circulation ◽

Acute Hemorrhage ◽

Unruptured Aneurysms ◽

Long Term Follow Up

Abstract BACKGROUND Flow diverters have become an important tool in the treatment of intracranial aneurysms, especially when dealing with difficult-to-treat or complex aneurysms. The p64 is the only fully resheathable and mechanically detachable flow diverter available for clinical use. OBJECTIVE To evaluate the safety and effectiveness of p64 for the treatment of intracranial saccular unruptured aneurysms arising from the anterior circulation over a long-term follow-up period. METHODS We retrospectively reviewed our prospectively maintained database to identify all patients who underwent treatment for an intracranial saccular (unruptured or beyond the acute hemorrhage phase) aneurysm arising from the anterior circulation with ≥1 p64 between December 2011 and December 2019. Fusiform aneurysms and dissections were excluded. Aneurysms with prior or concomitant saccular treatment (eg, coiling and clipping) were included. Aneurysms with parent vessel implants other than p64 were excluded. Anatomic features, intraprocedural complications, clinical outcome, as well as clinical and angiographic follow-ups were all recorded. RESULTS In total, 530 patients (388 females; median age 55.9 yr) with 617 intracranial aneurysms met the inclusion criteria. The average number of devices used per aneurysm was 1.1 (range 1-3). Mean aneurysm dome size was 4.8 mm (range 1-27 mm). Treatment-related morbimortality was 2.4%. Early, mid-term, and long-term angiographic follow-up showed complete or near-complete aneurysm occlusion in 76.8%, 89.7%, and 94.5%, respectively. CONCLUSION Treatment of intracranial saccular unruptured aneurysms of the anterior circulation using p64 is a safe and effective treatment option with high rate of occlusion at long-term follow-up and low morbimortality.

Download Full-text

Flow redirection endoluminal device (FRED) for treatment of intracranial aneurysms: A systematic review

Interventional Neuroradiology ◽

10.1177/15910199211027991 ◽

2021 ◽

pp. 159101992110279

Author(s):

Muhammad Waqas ◽

Rimal H Dossani ◽

Modhi Alkhaldi ◽

Jocelyn Neveu ◽

Justin M Cappuzzo ◽

...

Keyword(s):

Systematic Review ◽

Intracranial Aneurysms ◽

Flow Diverter ◽

Complication Rates ◽

Mesh Terms ◽

Aneurysm Occlusion ◽

Occlusion Rate ◽

Layered Flow ◽

Comparative Safety

Introduction The Flow Redirection Endoluminal Device (FRED; MicroVention) is a dual-layered flow diverter used for the treatment of intracranial aneurysms. The objective of this systematic review was to compile device-related safety and effectiveness data. Methods The literature from January 1, 2013 to April 30, 2021 was searched for studies describing use of the FRED for intracranial aneurysm treatment irrespective of aneurysm location and morphology. The review included anterior and posterior circulation ruptured and unruptured saccular, fusiform or dissection, and blister aneurysms. MeSH terms related to “flow re-direction endoluminal device” and “FRED for aneurysms” were used. Data related to indication, complications, and rates of aneurysm occlusion were retrieved and analyzed. Results Twenty-two studies with 1729 intracranial aneurysms were included in this review. Overall reported morbidity was 3.9% (range 0–20%). Overall procedure-related mortality was 1.4% (range 0–6%). Complication rates fell into 5 categories: technical (3.6%), ischemic (3.8%), thrombotic or stenotic (6%), hemorrhagic (1.5%), and non-neurological (0.8%). The aneurysm occlusion rate between 0 and 3 months (reported in 11 studies) was 47.8%. The occlusion rate between 4 and 6 months (reported in 14 studies) was 73.8%. Occlusion rates continued to increase to 75.1% at 7–12 months (reported in 10 studies) and 86.6% for follow-up beyond 1 year (reported in 10 studies). Conclusion This review indicated that the FRED is a safe and effective for the treatment of intracranial aneurysms. Future studies should directly compare the FRED with other flow diverters for a better understanding of comparative safety and effectiveness among the different devices.

Download Full-text

Abstract 1122‐000142: Safety and Efficacy of Surpass Streamline for Intracranial Aneurysms: A Multicenter US Real‐World Experience (SESSIA)

Stroke: Vascular and Interventional Neurology ◽

10.1161/svin.01.suppl_1.000142 ◽

2021 ◽

Vol 1 (S1) ◽

Author(s):

Juan Vivanco‐Suarez ◽

Alan Mendez‐Ruiz ◽

Farooqui Mudassir ◽

Cynthia B Zevallos ◽

Milagros Galecio‐Castillo ◽

...

Keyword(s):

Real World ◽

Intracranial Aneurysms ◽

The United States ◽

Chromium Alloy ◽

Cobalt Chromium ◽

Anterior Circulation ◽

Safety And Efficacy ◽

Post Marketing ◽

The Mean

Introduction : Flow diversion has established itself as standard treatment of wide complex intracranial aneurysms (IA). Its recognition has been validated with positive occlusion rates and favorable clinical outcomes. The Surpass Streamline (SS) flow diverter (FD) is a braided cobalt/chromium alloy implant with 72 or 96 wires approved by the FDA in 2018. The aim of this study is to determine the safety and efficacy of the SS in a post‐marketing large US cohort. Methods : We performed a multicenter, retrospective study for consecutive patients treated with the SS FD for IA between January 2018 and June 2021 in the United States. Inclusion criteria for participants were: 1. Adults (≥ 18 years) and 2. Treatment with SS FD for IA. Primary safety end point was a major ipsilateral stroke (increase in National Institutes of Health Stroke Scale Score of ≥ 4) or neurological death within 12 months. Primary efficacy was assessed using the 3‐point Raymond‐Roy (RR) occlusion scale on digital subtraction angiography (DSA) at 6‐12‐month follow‐up. Results : A total of 276 patients with 313 aneurysms were enrolled. The median age was 59 years and 199 (72%) were females. The most common comorbidities included hypertension in 156 (57%) subjects followed by hyperlipidemia in 76 (28%) patients. One hundred and twenty‐two (44%) patients were asymptomatic while subarachnoid hemorrhage was present in only 10 (4%) patients. A total of 143 (46%) aneurysms were left‐sided. Aneurysms were located as follows: 274 (88%) were in the anterior circulation with paraophthalmic being the most common in 120 (38%) followed by petrocavernous ICA in 81 (26%); 33 (11%) aneurysms were located in the posterior circulation with basilar trunk being the most common in 14 (5%). The mean maximum aneurysm dome width was 5.77 ± 4.7 mm, neck width 4.22 ± 3.8 mm and dome to neck ratio was 1.63 ± 1.3 mm. The mean number of SS FD implanted per aneurysm was 1.06 (range 1–3) with more than one SS FD implanted in 21 (7%) aneurysms. Modified Rankin Scale (mRS) of 0–2 was present in 206/213 (97%) patients at 6–12 month follow‐up. The complete aneurysm occlusion (RR 1) rate was 145/175 (83%) among subjects who had angiographic follow‐up at 6–12 months. Major stroke and death was encountered in 7 (2%) and 5 (1.8%) of the patients respectively. Conclusions : Our data represent the largest real‐world study using SS FD. These results corroborate its post‐marketing safety and efficacy for the treatment of intracranial aneurysms showing more favorable rates to the initial experience during SCENT trial.

Download Full-text

Very delayed discontinuation of telescoped Pipeline embolization devices: a case report

Interventional Neuroradiology ◽

10.1177/1591019918809932 ◽

2018 ◽

Vol 25 (2) ◽

pp. 182-186

Author(s):

Manoj Bohara ◽

Kosuke Teranishi ◽

Kenji Yatomi ◽

Takashi Fujii ◽

Takayuki Kitamura ◽

...

Keyword(s):

Internal Carotid ◽

Flow Diversion ◽

Total Occlusion ◽

Pipeline Embolization Device ◽

Complete Occlusion ◽

Radiological Features ◽

Long Term Follow Up ◽

Aneurysm Occlusion

Background Flow diversion with the Pipeline embolization device (PED) is a widely accepted treatment modality for aneurysm occlusion. Previous reports have shown no recanalization of aneurysms on long-term follow-up once total occlusion has been achieved. Case description We report on a 63-year-old male who had a large internal carotid artery cavernous segment aneurysm. Treatment with PED resulted in complete occlusion of the aneurysm. However, follow-up angiography at four years revealed recurrence of the aneurysm due to disconnection of the two PEDs placed in telescoping fashion. Conclusion Herein, we present the clinico-radiological features and discuss the possible mechanisms resulting in the recanalization of aneurysms treated with flow diversion.

Download Full-text

Treatment Of Ruptured Tiny Intracranial Aneurysms By Electrocoagulation With Guidewire Manipulation:12 Cases Report

10.21203/rs.3.rs-30106/v1 ◽

2020 ◽

Author(s):

Lixia Xia ◽

Zhongfei Hao ◽

Hongjun Wang ◽

Yan Feng ◽

Yongxuan Zhan ◽

...

Keyword(s):

Intracranial Aneurysm ◽

Intracranial Aneurysms ◽

Large Scale ◽

Posterior Circulation ◽

Suitable Method ◽

Anterior Circulation ◽

Long Term Follow Up

Abstract Background: Ruptured tiny intracranial aneurysm (RTIA) is particularly rare seen. Treatment of RTIA is more difficult and not under control.Methods: We hereby present twelve rare cases of RTIA that were diagnosed based on DSA. These patients were found due to spontaneous or traumatic SAH, 11 of whom were treated only by electrocoagulation, and one of whom was treated by stent-assisted coiling and electrocoagulation.Results: There were eight patients with aneurysms located in posterior circulation and four patients with aneurysms located in anterior circulation. 11 patients were cured only by electrocoagulation merely: ten patient’ RTIA disappeared completely and immediately and another patient’s RTIA was thrombosed two months later. The twelfth patient was carried out stent-assisted coiling and electrocoagulation. The twelve patients’ average follow-up time was 12.5 months and the outcomes were all surprisingly excellent. No revascularization of aneurysm was found. Conclusions: Electrocoagulation with guidewire manipulation is a suitable method to treat RTIA. While large-scale studies with long-term follow-up are required to validate these promising results.

Download Full-text

A2, M2, P2 aneurysms and beyond: results of treatment with pipeline embolization device in 65 patients

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2018-014631 ◽

2019 ◽

Vol 11 (9) ◽

pp. 903-907 ◽

Cited By ~ 9

Author(s):

Christopher T Primiani ◽

Zeguang Ren ◽

Peter Kan ◽

Ricardo Hanel ◽

Vitor Mendes Pereira ◽

...

Keyword(s):

Clinical Outcome ◽

Cerebral Artery ◽

Intracranial Aneurysms ◽

Flow Diversion ◽

Vascular Pathology ◽

Parent Vessel ◽

Rare Type ◽

Pipeline Embolization Device ◽

Aneurysm Size

BackgroundIntracranial aneurysms located in the distal vessels are rare and remain a challenge to treat through surgical or endovascular interventions.ObjectiveTo describe a multicenter approach with flow diversion using the pipeline embolization device (PED) for treatment of distal intracranial aneurysms.MethodsCases of distal intracranial aneurysms defined as starting on or beyond the A2 anterior cerebral artery, M2 middle cerebral artery, and P2 posterior cerebral artery segments were included in the final analysis.Results65 patients with distal aneurysms treated with the PED were analyzed. Median aneurysm size at the largest diameter was 7.0 mm, 60% were of a saccular morphology, and 9/65 (13.8%) patients presented in the setting of acute rupture. Angiographic follow-up data were available for 53 patients, with a median follow-up time of 6 months: 44/53 (83%) aneurysms showed complete obliteration, 7/53 (13.2%) showed reduced filling, and 2/53 (3%) showed persistent filling. There was no association between patient characteristics, including aneurysm size (P=0.36), parent vessel diameter (P=0.27), location (P=0.81), morphology (P=0.63), ruptured status on admission (P=0.57), or evidence of angiographic occlusion at the end of the embolization procedure (P=0.49). Clinical outcome data were available for 60/65 patients: 95% (57/60) had good clinical outcome (modified Rankin Scale score of 0–2) at 3 months.ConclusionsThis large multicenter study of patients with A2, M2, and P2 distal aneurysms treated with the PED showed that flow diversion may be an effective treatment approach for this rare type of vascular pathology. The procedural compilation rate of 7.7% indicates the need for further studies as the flow diversion technology constantly evolves.

Download Full-text