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

Neurosurgery ◽  
2009 ◽  
Vol 64 (5) ◽  
pp. E865-E875 ◽  
Author(s):  
Ronie L. Piske ◽  
Luis H. Kanashiro ◽  
Eric Paschoal ◽  
Celso Agner ◽  
Sergio S. Lima ◽  
...  

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.

2015 ◽  
Vol 122 (6) ◽  
pp. 1498-1502 ◽  
Author(s):  
Nohra Chalouhi ◽  
Mario Zanaty ◽  
Alex Whiting ◽  
Steven Yang ◽  
Stavropoula Tjoumakaris ◽  
...  

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.


2021 ◽  
pp. neurintsurg-2021-017445
Author(s):  
Huibin Kang ◽  
Bin Luo ◽  
Jianmin Liu ◽  
Hongqi Zhang ◽  
Tianxiao Li ◽  
...  

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.


2021 ◽  
pp. neurintsurg-2021-018054
Author(s):  
Ricardo A Hanel ◽  
Andre Monteiro ◽  
Peter K Nelson ◽  
Demetrius K Lopes ◽  
David F Kallmes

BackgroundFlow 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.MethodsWe 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.Results25 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).ConclusionsThe 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.


2021 ◽  
Author(s):  
Marta Aguilar Pérez ◽  
Elina Henkes ◽  
Victoria Hellstern ◽  
Carmen Serna Candel ◽  
Christina Wendl ◽  
...  

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.


1993 ◽  
Vol 79 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Alfredo E. Casasco ◽  
Armand Aymard ◽  
Y. Pierre Gobin ◽  
Emmanuel Houdart ◽  
André Rogopoulos ◽  
...  

✓ Seventy-one intracranial aneurysms were treated by endovascular techniques, with the placement of minicoils inside the aneurysmal sac. Most aneurysms were manifest by hemorrhage (67 cases), and 43 of these were treated within the first 3 days after presentation. At the 1-year follow-up examination, the outcome was scored as good in 84.5% of cases, but the morbidity and mortality rates were 4.2% and 11.3%, respectively. Twenty-nine aneurysms in the anterior circulation and 42 in the posterior circulation were treated. In this series, 23 patients were classified as Hunt and Hess neurological Grade I, 27 as Grade II, 12 as Grade III, nine as Grade IV, and none as Grade V. Thirty-three aneurysms were less than 10 mm in diameter, 28 were 10 to 25 mm, and 10 were larger than 25 mm. The preliminary results from this study appear to justify the emergency treatment of aneurysms by this approach. Aneurysms in the posterior circulation are particularly well suited for this type of surgery.


2021 ◽  
pp. 197140092110428
Author(s):  
Hanna Styczen ◽  
Sebastian Fischer ◽  
Matthias Gawlitza ◽  
Lukas Meyer ◽  
Lukas Goertz ◽  
...  

Background Data on outcome after endovascular treatment of basilar artery fenestration aneurysms (BAFAs) is limited. This study presents our multi-centre experience of BAFAs treated by different reconstructive techniques including coils, stent-assisted coiling (SAC), flow diversion and intra-saccular flow disruption with the Woven Endobridge (WEB). Methods Retrospective analysis of 38 BAFAs treated endovascularly between 2003 and 2020. The primary endpoint was complete aneurysm obliteration defined as Raymond–Roy occlusion classification (RROC) I on immediate and follow-up (FU) angiography. The secondary endpoints were procedure-related complications, rate of re-treatment, and clinical outcome. Results Endovascular treatment was feasible in 36/38 aneurysms (95%). The most frequent strategy was coiling (21/36, 58%), followed by SAC (7/36, 19%), WEB embolization (6/36, 17%) and flow diversion (2/36, 6%). A successful aneurysm occlusion (defined as RROC 1 and 2) on the final angiogram was achieved in 30/36 (83%) aneurysms including all patients presenting with baseline subarachnoid haemorrhage and 25/36 (69%) were occluded completely. Complete occlusion (RROC 1) was more frequently achieved in ruptured BAFAs (15/25, 60% v. 2/11, 18%; p = 0.031). Procedure-related complications occurred in 3/36 (8%) aneurysms. Re-treatment was executed in 12/36 (33%) aneurysms. After a median angiography FU of 38 months, 30/31 (97%) BAFAs were occluded successfully and 25/31 (81%) showed complete occlusion. Conclusion Reconstructive endovascular treatment of BAFAs is technically feasible with a good safety profile. Although in some cases re-treatment was necessary, a high rate of final aneurysm occlusion was achieved.


2018 ◽  
Vol 11 (9) ◽  
pp. e5-e5 ◽  
Author(s):  
Felipe Padovani Trivelato ◽  
Alexandre Cordeiro Ulhôa ◽  
Marco Tulio Rezende ◽  
Luis Henrique Castro-Afonso ◽  
Daniel Giansante Abud

Treatment with a pipeline embolization device (PED) is widely accepted as an excellent option for patients harboring giant, wide neck, saccular intracranial aneurysms. It has been shown to be safe and very effective. We describe a previously unreported case of a large middle cerebral artery aneurysm, related to the carotid tip, that was treated with a PED and coils. The 6 month follow-up angiogram demonstrated complete occlusion of the aneurysm. However, the 9 month angiogram revealed recurrent filling of the aneurysm sac. To our knowledge, this is the first report to describe recanalization of an aneurysm totally occluded on the control angiography after treatment with a PED. Unanswered questions include the mechanism of recanalization and the need for additional control angiograms and MRI following a previous examination revealing total aneurysm occlusion.


2018 ◽  
Vol 130 (1) ◽  
pp. 259-267 ◽  
Author(s):  
Matthew T. Bender ◽  
Geoffrey P. Colby ◽  
Li-Mei Lin ◽  
Bowen Jiang ◽  
Erick M. Westbroek ◽  
...  

OBJECTIVEFlow diversion requires neointimal stent overgrowth to deliver aneurysm occlusion. The existing literature on aneurysm occlusion is limited by heterogeneous follow-up, variable antiplatelet regimens, noninvasive imaging modalities, and nonstandard occlusion assessment. Using a large, single-center cohort with low attrition and standardized antiplatelet tapering, the authors evaluated outcomes after flow diversion of anterior circulation aneurysms to identify predictors of occlusion and aneurysm persistence.METHODSData from a prospective, IRB-approved database was analyzed for all patients with anterior circulation aneurysms treated by flow diversion with the Pipeline embolization device (PED) at the authors’ institution. Follow-up consisted of catheter cerebral angiography at 6 and 12 months postembolization. Clopidogrel was discontinued at 6 months and aspirin was reduced to 81 mg daily at 12 months. Occlusion was graded as complete, trace filling, entry remnant, or aneurysm filling. Multivariate logistic regression was performed to identify predictors of aneurysm persistence.RESULTSFollow-up catheter angiography studies were available for 445 (91%) of 491 PED procedures performed for anterior circulation aneurysms between August 2011 and August 2016. Three hundred eighty-seven patients accounted for these 445 lesions with follow-up angiography. The population was 84% female; mean age was 56 years and mean aneurysm size was 6.6 mm. Aneurysms arose from the internal carotid artery (83%), anterior cerebral artery (13%), and middle cerebral artery (4%). Morphology was saccular in 90% of the lesions, and 18% of the aneurysms has been previously treated. Overall, complete occlusion was achieved in 82% of cases at a mean follow-up of 14 months. Complete occlusion was achieved in 72%, 78%, and 87% at 6, 12, and 24 months, respectively. At 12 months, adjunctive coiling predicted occlusion (OR 0.260, p = 0.036), while male sex (OR 2.923, p = 0.032), aneurysm size (OR 3.584, p = 0.011), and incorporation of a branch vessel (OR 2.206, p = 0.035) predicted persistence. Notable variables that did not predict aneurysm occlusion were prior treatments, vessel of origin, fusiform morphology, and number of devices used.CONCLUSIONSThis is the largest single-institution study showing high rates of anterior circulation aneurysm occlusion after Pipeline embolization. Predictors of persistence after flow diversion included increasing aneurysm size and incorporated branch vessel, whereas adjunctive coiling predicted occlusion.


2021 ◽  
Vol 12 ◽  
Author(s):  
Jinlu Yu ◽  
Xianli Lv

Background: Few reports have shown the therapeutic outcomes of flow diversion (FD) for intracranial aneurysms beyond the circle of Willis, and the efficacy of this technique remains unclear.Materials and methods: A retrospective study was performed on 22 consecutive patients, diagnosed with intracranial aneurysms beyond the circle of Willis, and treated with pipeline embolization device (PED) (Medtronic, Irvine, California, USA) between January 2015 and December 2019.Result: The 22 patients were between 16 and 66 years old (mean 44.5 ± 12.7 years), and six patients were male (27.3%, 6/22). Twenty-two patients had 23 aneurysms. The 23 aneurysms were 3–25 mm in diameter (12.2 ± 7.1 mm on average). The diameter of the parent artery was 1.3–3.0 mm (2.0 ± 0.6 mm on average). The 23 aneurysms were located as follows: 17 (73.9%, 17/23) were in the anterior circulation, and 6 (26.1%, 6/23) were in the posterior circulation. PED deployment was technically successful in all cases. Two overlapping PEDs were used to cover the aneurysm neck in 3 cases. One PED was used to overlap the two tandem P1 and P2 aneurysms. Other cases were treated with single PED. Coil assistance was used to treat 7 aneurysms, including 4 recurrent aneurysms and 3 new cases requiring coiling assistance during PED deployment. There were no cases of complications during PED deployment. All patients were available at the follow-up (mean, 10.9 ± 11.4 months). All patients presented with a modified Rankin Score (mRS) of 0. During angiographic follow-up, complete embolization was observed in 22 aneurysms in 21 patients, and one patient had subtotal embolization with the prolongation of stasis in the arterial phase.Conclusion: PED deployment for intracranial aneurysms beyond the circle of Willis is feasible and effective, with high rates of aneurysm occlusion.


2018 ◽  
Vol 11 (3) ◽  
pp. 290-295 ◽  
Author(s):  
Lukas Goertz ◽  
Franziska Dorn ◽  
Bastian Kraus ◽  
Jan Borggrefe ◽  
Marc Schlamann ◽  
...  

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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