p64 flow diverter: Results in 108 patients from a single center

Background and purpose Flow diverters are increasingly used to treat intracranial aneurysms. We report the safety and efficacy of the p64 flow diverter, a resheathable and detachable device for intracranial aneurysms. Materials and methods We retrospectively reviewed 108 patients with 109 aneurysms treated with the p64 between March 2014 and July 2019. There were 87 women and 21 men, mean age 57 years. Of 109 aneurysms, 74 were discovered incidentally, 12 were symptomatic, 18 were previously treated, and five were ruptured dissection aneurysms. A total of 10 aneurysms were located in the posterior circulation. The mean aneurysm or remnant size was 8.1 mm. Results Hemorrhage by perforation with the distal guidewire occurred in two patients with permanent neurological deficits in one. In one patient, acute in-stent occlusion caused infarction with a permanent deficit. Permanent morbidity was 1.9% (2 of 108, 95%CI 0.1–6.9%); there was no mortality. During follow-up, three in-stent occlusions occurred, all asymptomatic. There were no delayed hemorrhagic complications. At six months, 77 of 96 aneurysms (80.2%) were completely occluded, and at last follow-up, this increased to 93 of 96 aneurysms (96.9%). In-stent stenosis at any degree occurred in 11 patients, progressing to asymptomatic complete occlusion in one. In the other patients, stenosis resolved or improved at further follow-up. Conclusion The p64 offers an effective and safe treatment option. Aneurysm occlusion rate was 97% at last follow-up, mostly achieved with a single device. There were no delayed hemorrhagic complications. Delayed in-stent stenosis infrequently progresses to occlusion but remains a matter of concern.

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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.

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Flow-Diverter Devices for Intracranial Aneurysms

Neurosurgery ◽

10.1227/01.neu.0000430297.17961.f1 ◽

2013 ◽

Vol 73 (2) ◽

pp. 193-200 ◽

Cited By ~ 105

Author(s):

Ignacio Arrese ◽

Rosario Sarabia ◽

Rebeca Pintado ◽

Miguel Delgado-Rodriguez

Keyword(s):

Mortality Rate ◽

Intracranial Aneurysms ◽

Flow Diverter ◽

Morbidity Rate ◽

Late Mortality ◽

Late Morbidity ◽

Neurological Morbidity ◽

Flow Diverter Devices ◽

Aneurysm Occlusion

Abstract BACKGROUND: Although the introduction of flow-diverter devices (FDDs) has aroused great enthusiasm, the level of evidence supporting their use has not been systematically evaluated. OBJECTIVE: To report a systematic review of medical literature up to May 2012 on FDDs to assess the morbidity, case fatality rate, and efficacy of FDDs for intracranial aneurysms. METHODS: The literature was searched by using MEDLINE, Embase, and all Evidence-Based Medicine in the OVID database. Eligibility criteria were studies including at least 10 patients, reporting duration of follow-up and number of patients lost to follow-up, and documenting the rate of aneurysm occlusion and death and neurological complications. The endpoints were angiographic success, early and late mortality, and neurological morbidity. RESULTS: Fifteen studies were analyzed consisting of 897 patients with 1018 aneurysms. The mean value of methodological quality score was 14.4 using the STROBE score. The early mortality rate was 2.8% (95% confidence interval [CI]: 1.7-3.8; I2 = 93.4%) and the late mortality rate was 1.3% (95% CI: 0.2-2.3; I2 = 36.9%). The early neurological morbidity rate was 7.3% (95% CI: 5.7-9; I2 = 91.8%) and the late morbidity rate was 2.6% (95% CI: 1.1-4; I2 = 81.3%). The Egger test for early and late morbidity and aneurysm occlusion was <0.001. CONCLUSION: With the available data from the studies, both heterogeneity and publication biases imply that the current clinical use of FDDs is not supported by high-quality evidence. In the absence of reliable evidence, the use of FDDs in patients eligible for more conventional treatments should be restricted to controlled clinical trials.

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The value of long-term angiographic follow-up following Pipeline embolization of intracranial aneurysms

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2021-017745 ◽

2021 ◽

pp. neurintsurg-2021-017745

Author(s):

David C Lauzier ◽

Samuel J Cler ◽

Arindam R Chatterjee ◽

Joshua W Osbun ◽

Christopher J Moran ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Post Treatment ◽

Multiple Time ◽

Angiographic Data ◽

Aneurysm Occlusion ◽

Multiple Time Points ◽

Actionable Findings ◽

Stent Stenosis

BackgroundFlow diversion of intracranial aneurysms with the Pipeline Embolization Device (PED) is commonly performed, but the value of long-term angiographic follow-up has not been rigorously evaluated. Here we examine the prevalence of actionable findings of aneurysm recurrence and development of in-stent stenosis in a cohort of patients that underwent long-term angiographic follow-up at multiple time points.MethodsAngiographic data from eligible patients were retrospectively assessed for aneurysm occlusion, in-stent stenosis, and aneurysm regrowth or recurrence. Patients were included in this study if they underwent angiographic imaging at 6 months post-treatment and at least one later time point.Results100% (132/132) of aneurysms occluded at 6 months remained occluded at final follow-up. 85.7% (6/7), 56.3% (27/48), and 25% (6/24) of aneurysms with entry remnant, subtotal filling, and total filling, respectively, at 6 months were completely occluded at final follow-up. 98.7% (147/149) of PED constructs that demonstrated no stenosis at 6 months demonstrated no stenosis at final angiography, while 44.4% (8/18) of PED constructs demonstrating in-stent stenosis at 6 months had resolution of stenosis on final angiography.ConclusionsAmong patients who undergo treatment of intracranial aneurysms with PED, the value of long-term angiography in patients demonstrating complete aneurysm occlusion and no in-stent stenosis on 6 month post-treatment angiography is low.

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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.

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Intravenous versus intra-arterial digital subtraction angiography: Occlusion rate and complication assessment of experimental aneurysms after flow diverter treatment in rabbits

Interventional Neuroradiology ◽

10.1177/1591019918808537 ◽

2018 ◽

Vol 25 (2) ◽

pp. 157-163

Author(s):

Andreas Simgen ◽

Toshiki Tomori ◽

Hagen Bomberg ◽

Umut Yilmaz ◽

Christian Roth ◽

...

Keyword(s):

Digital Subtraction Angiography ◽

Good Alternative ◽

Flow Diverter ◽

Preclinical Study ◽

Digital Subtraction ◽

Intravenous Digital Subtraction Angiography ◽

Aneurysm Morphology ◽

Aneurysm Occlusion ◽

Stent Stenosis

Purpose Conventional intra-arterial digital subtraction angiography, which requires surgical exposure and ligation of the femoral or carotid artery, is a limited method of evaluating elastase-induced aneurysms in New Zealand white rabbits. The purpose of this study was to assess aneurysm morphology, occlusion rates and complications after flow diverter treatment comparing intravenous and intra-arterial digital subtraction angiography. Methods We previously published a preclinical study in which we evaluated the occlusion rates of elastase-induced aneurysms after treatment with a prototype flow diverter, by using intra-arterial digital subtraction angiography at three months ( n = 9) and six months ( n = 9). In addition to that intravenous digital subtraction angiography before treatment, after one month (early follow-up group) and after three months (late follow-up group) was performed. Occlusion rates were compared within the two groups by means of residual contrast filling. Results Baseline aneurysm characteristics revealed no significant differences between intra-arterial digital subtraction angiography and intravenous digital subtraction angiography. Aneurysm occlusion rates in both follow-up groups using intravenous digital subtraction angiography were significantly higher compared to intra-arterial digital subtraction angiography (early follow-up group: intravenous digital subtraction angiography (one month) versus intra-arterial digital subtraction angiography (three months); p = 0.03 and late follow-up group: intravenous digital subtraction angiography (three months) versus intra-arterial digital subtraction angiography (six months); p = 0.04). Intravenous digital subtraction angiography is feasible to detect and reproduce device occlusions, in-stent stenosis and post-stent stenosis. Conclusion Intravenous digital subtraction angiography can not give a sufficient statement on the aneurysm occlusion process compared to intra-arterial digital subtraction angiography and is therefore not recommended for imaging follow-up after flow diverter treatment in rabbits. Regarding untreated aneurysms and complications like device occlusions, in-stent stenosis and post-stent stenosis intravenous digital subtraction angiography proofed to be a good alternative to intra-arterial digital subtraction angiography in our study.

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Pipeline Embolization for Salvage Treatment of Previously Stented Residual and Recurrent Cerebral Aneurysms

Interventional Neurology ◽

10.1159/000489018 ◽

2018 ◽

Vol 7 (6) ◽

pp. 359-369 ◽

Cited By ~ 4

Author(s):

Matthew T. Bender ◽

Chau D. Vo ◽

Bowen Jiang ◽

Jessica K. Campos ◽

David A. Zarrin ◽

...

Keyword(s):

Internal Carotid ◽

Cerebral Aneurysms ◽

Vascular Reconstruction ◽

Flow Diverter ◽

Complication Rates ◽

Digital Subtraction ◽

Stent Occlusion ◽

Recent Treatment ◽

Previously Treated

Introduction: This study assessed the safety and effectiveness of the Pipeline embolization device (PED) for persistent and recurrent aneurysms previously treated with either a vascular reconstruction device (VRD) or a flow diverter (FD). Methods: A prospective, IRB-approved database was analyzed for patients treated with PED for aneurysms previously treated with a stent. Results: Twenty procedures were performed on 18 patients, 11 with prior FD, 7 with VRD, and 2 previously treated with both. Overall, 15 aneurysms were saccular (75%), and size was 13.5 ± 7.6 mm. Location was internal carotid artery (ICA) in 14 cases (70%) and posterior circulation in 6 cases (30%). Average prior treatments were 1.7. Previously FD cases were re-treated at an average of 18.1 months from most recent treatment. Each case used 1 device, 82% with distal coverage and 82% with proximal coverage of prior stent. Balloon remodeling was performed in 3 cases (27%) and no in-stent thrombosis was observed. Previously VRD stent-coiled cases were re-treated at an average of 87.5 months. These cases used on average 1.9 devices, 89% with distal and 100% proximal coverage. Adjunctive coiling was performed in 1 case (11%), balloon remodeling in 5 cases (56%), and 2 cases (28%) developed thrombosis that resolved with abciximab. Re-VRD cases were longer (59.1 vs. 33.7 min, p = 0.02) than re-FD. Angiographic follow-up was available for 16 cases (80%). In re-FD, occlusion was complete in 56% and partial progressive in 33% at 17.1 months digital subtraction angiography. In re-VRD, occlusion was complete in 57% and partial progressive in 27% at 8.1 months. Two complications occurred (10%), including one asymptomatic cervical ICA occlusion and one stent occlusion with associated mortality (5%). Clinical follow-up was 17.8 months on average (range 0.5–51.9). Conclusions: Salvage flow diversion for previously stented aneurysms is technically challenging but offers good prospects of aneurysm obliteration with acceptable complication rates.

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Postoperative occlusion degree after flow-diverter placement with adjunctive coiling: analysis of complications

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2021-017445 ◽

2021 ◽

pp. neurintsurg-2021-017445

Author(s):

Huibin Kang ◽

Bin Luo ◽

Jianmin Liu ◽

Hongqi Zhang ◽

Tianxiao Li ◽

...

Keyword(s):

Ischemic Stroke ◽

Functional Outcomes ◽

Intracranial Aneurysms ◽

Independent Predictor ◽

Flow Diverter ◽

Complete Occlusion ◽

Post Market ◽

Aneurysm Occlusion ◽

Incomplete Occlusion

BackgroundAlthough coiling with a flow diverter may provide immediate dome protection, no studies have evaluated the effect on complications of postoperative occlusion degree immediately postoperatively. The purpose of this study was to determine whether postoperative occlusion degree immediately after flow-diverter placement with adjunctive coiling was associated with complications.MethodsAll patients’ data were collected from the post-market multi-center cohort study of embolization of intracranial aneurysms with a pipeline embolization device (PED) in China (PLUS) registry. We divided patients into those treated with a PED alone (PED-only (PO) group), those treated with a PED with coils and incomplete occlusion (PED + coils + incomplete occlusion (PCIO) group), and those treated with a PED with coils and complete occlusion (PED + coils + complete occlusion (PCCO) group).ResultsWe evaluated 1171 consecutive patients with 1322 aneurysms treated with a PED: 685 aneurysms were treated with PO, 444 with PCIO, and 193 with PCCO. The PCCO group had a higher rate of aneurysm occlusion at the last follow-up than the PCIO and PO groups (P<0.0001). Multivariate analysis of the predictors of ischemic stroke and modified Rankin Scale score (mRS) deterioration showed that PCCO was an independent predictor of ischemic stroke (HR, 2.03; 95% CI, 1.12 to 3.67; P=0.019) and mRS deterioration (HR, 2.59; 95% CI, 1.57 to 4.26; P<0.0001).ConclusionsAlthough postoperative complete occlusion with a PED and adjunctive coiling can increase the rate of aneurysm occlusion, this approach may also increase the risk of ischemic stroke and lead to poor postoperative functional outcomes.

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Long-term Follow-up of In-stent Stenosis After Pipeline Flow Diversion Treatment of Intracranial Aneurysms

Neurosurgery ◽

10.1227/neu.0000000000001146 ◽

2016 ◽

Vol 78 (6) ◽

pp. 862-867 ◽

Cited By ~ 34

Author(s):

Seby John ◽

Mark D. Bain ◽

Ferdinand K. Hui ◽

M. Shazam Hussain ◽

Thomas J. Masaryk ◽

...

Keyword(s):

Intimal Hyperplasia ◽

Intracranial Aneurysms ◽

Clinical Symptoms ◽

Flow Diversion ◽

Parent Vessel ◽

Stent Occlusion ◽

Clinical Consequences ◽

Metallic Mesh ◽

Stent Stenosis

Abstract BACKGROUND: There is scant information on in-stent stenosis after flow diversion treatment of intracranial aneurysms with the Pipeline Embolization Device (PED). OBJECTIVE: To assess the incidence, severity, nature, and clinical consequences of in-stent stenosis on angiographic follow-up after treatment with the PED. METHODS: A retrospective study of patients who underwent aneurysm treatment with the PED was conducted. In-stent stenosis was assessed on subsequent follow-up angiography. Intimal hyperplasia was defined as a uniform growth process beyond the limits of the metallic mesh at <25%. In-stent stenosis represented an area of parent vessel narrowing, most often focal, graded as mild (25%-50%), moderate (50%-75%), or severe (>75%). RESULTS: Between June 2011 and April 2015, 80 patients were treated with the PED. Angiographic follow-up was available for 51 patients (representing 76% of available or 64% of all patients). Mean follow-up was 12.5 months. In-stent stenosis was detected in 5 patients (9.8%) at a median of 6 months. Stenosis was mild in 4 of 5 (80%) and moderate in 1 of 5 (20%) patients. There were no cases of severe stenosis. No stenosis caused flow limitation, clinical symptoms, or required re-treatment. Additional follow-up angiography was available in 2 of 5 stenosis patients showing marked improvement. Sixteen patients (31%) had intimal hyperplasia, and 28 patients (55%) had no stenosis. Asymptomatic stent occlusion occurred in 2 patients (4%) related to medication noncompliance. CONCLUSION: Treatment with the PED was associated with a 9.8% rate of in-stent stenosis, detected on first angiographic follow-up, at a median of 6 months. None were symptomatic or required re-treatment, and they showed significant improvement on follow-up.

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Safety and efficacy of the Derivo Embolization Device for the treatment of unruptured intracranial aneurysms: a multicentric study

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2018-013963 ◽

2018 ◽

Vol 11 (1) ◽

pp. 68-73 ◽

Cited By ~ 16

Author(s):

Bastian Kraus ◽

Lukas Goertz ◽

Bernd Turowski ◽

Jan Borggrefe ◽

Marc Schlamann ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Tertiary Care ◽

Flow Diverter ◽

Morbidity Rate ◽

Multicentric Study ◽

Safety And Efficacy ◽

Flow Diverter Stent ◽

Unruptured Intracranial Aneurysms ◽

Aneurysm Occlusion

BackgroundThe Derivo Embolization Device (DED) is a novel flow diverter stent that provides increased x-ray visibility, an improved delivery system, and potentially reduced thrombogenicity. The objective of this study was to evaluate the early safety and efficacy of the second-generation DED.MethodsWe retrospectively analyzed all patients with unruptured intracranial aneurysms (UIAs) treated with the DED between November 2015 and December 2017 in three German tertiary care centers. Procedural details, complications, and morbidity within 30 days after treatment, as well as the aneurysm occlusion rates after 6 months (O’Kelly–Marotta scale, OKM), were evaluated.ResultsImplantation of the DED was attempted in 42 patients with 42 aneurysms. All procedures were technically successful. Multiple DEDs were used in three aneurysms (7.2%) and adjunctive coiling in 11 (26.2%). Procedure-related complications occurred in four cases (9.5%) including three thromboembolic events and one aneurysm perforation. The morbidity rate was 2.4% and there was no mortality. One patient suffered an ischemic stroke with persistent aphasia at 30-day follow-up due to a thromboembolic infarct (modified Rankin Scale score 1). Among 33 patients (78.6%) available for angiographic follow-up, complete (OKM D) and favorable (OKM C+D) aneurysm occlusion was obtained in 72.7% (24/33) and 87.9% (29/33), respectively.ConclusionsEndovascular treatment of UIAs with the DED is associated with high procedural safety and adequate occlusion rates. Examinations at 1- and 2-year follow-up will provide data on the long-term safety and angiographic outcomes of this device.

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Flow diverter stents in the treatment of recanalized intracranial aneurysms

Interventional Neuroradiology ◽

10.1177/1591019921990507 ◽

2021 ◽

pp. 159101992199050

Author(s):

Erol Akgul ◽

Hasan Bilen Onan ◽

Irem Islek ◽

Mehmet Tonge ◽

Yavuz Durmus ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Demographic Data ◽

Previous Treatment ◽

Flow Diverter ◽

Serious Adverse Events ◽

Clinical Complications ◽

Tertiary Hospitals ◽

The Mean ◽

Technical Complication

Background We assessed the safety and efficacy of flow diverter stents (FDSs) in the treatment of recanalized or residual intracranial aneurysms treated endovascularly. Materials & Methods Patients whose recanalized or residual aneurysms were treated with FDSs in five tertiary hospitals were reviewed retrospectively. The patients’ demographic data, aneurysm characteristics, types of previous treatment, and clinical complications, or serious adverse events associated with FDSs, as well as the results of neurological and angiographic follow-up assessments, were recorded. Results Eighty-six patients (37 males) with 87 aneurysms were included in this study. Eighty (91.9%) aneurysms were in the anterior and seven (8.1%) in the posterior circulation. The initial treatment methods were the primary coiling or balloon remodeling technique in 69 (79.3%) and stent-assisted coiling in 18 (20.7%) aneurysms. The endovascular procedure was successful in all patients. Complications occurred in four patients, for a total complication rate of 4.6%. A technical complication developed in one patient (1.2%). An in-stent thrombosis treated with tirofiban was seen in two cases. Late in-stent stenosis exceeding 50% was treated with balloon angioplasty in one patient. The mean length of follow-up was 21.0 months. The first angiographic follow-up (3–6 months) revealed the complete occlusion of 74 aneurysms (85.1%). While 76 aneurysms (87.4%) were occluded at the last angiographic follow-up (mean: 26.0 months), 11 aneurysms (12.6%) were still filling. Morbimortality was zero. Conclusion The drawback of endovascular treatment is aneurysmal remnants or recurrences, which is safely and durably amenable to flow diversion.

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