Clinical impact of Sim & Size® simulation software in the treatment of patients with cerebral aneurysms with flow-diverter Pipeline stents

2021 ◽  
pp. 159101992110686
Author(s):  
Daniel Mantilla ◽  
Carlos A Ferreira-Prada ◽  
Melquisedec Galvis ◽  
Oliverio Vargas ◽  
Carolina Valenzuela-Santos ◽  
...  

Objectives This study evaluated the clinical impact of the Sim&Size® simulation software on the endovascular treatment with flow-diverter stents of patients with unruptured saccular intracranial aneurysms. Methods This monocentric retrospective study evaluated a cohort of patients treated with flow-divert stents between June 1, 2014, and December 31, 2019, for cerebral aneurysms. Patients belonged to two groups, patients treated with and without the Sim&Size® simulation software. Univariate, bivariate, and multivariate analyses were used to evaluate the clinical impact of simulation software. Results Out of the 73 interventions involving 68 patients analyzed by the study, 76.7% were simulated using the Sim&Size® simulation software, and 23.3% were not. Patients treated with the simulation software had shorter stent lengths (16.00 mm vs. 20.00 mm p-value = 0.001) and surgical time (100.00 min vs. 118.00 min p-value = 0.496). Also, fewer of them required more than one stent (3.6% vs. 17.6% p-value = 0.079). Three patients belonging to the non-stimulated group presented hemorrhagic complications. Conclusions Using the Sim&Size® simulation software for the endovascular treatment of intracranial aneurysms with pipeline flow-diverter stents reduces the stent length.

2020 ◽  
Vol 133 (1) ◽  
pp. 174-181 ◽  
Author(s):  
Mariangela Piano ◽  
Luca Valvassori ◽  
Emilio Lozupone ◽  
Guglielmo Pero ◽  
Luca Quilici ◽  
...  

OBJECTIVEThe introduction of flow-diverter devices (FDDs) has revolutionized the endovascular treatment of intracranial aneurysms. Here the authors present their Italian multicenter experience using the flow re-direction endoluminal device (FRED) in the treatment of cerebral aneurysms, evaluating both short- and long-term safety and efficacy of this device.METHODSBetween February 2013 and December 2014, 169 consecutive aneurysms treated using FRED in 166 patients were entered into this study across 30 Italian centers. Data collected included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and posttreatment modified Rankin Scale scores, as well as angiographic and cross-sectional CT/MRI follow-up at 3–6 months and/or 12–24 months per institutional standard of care. All images were reviewed and adjudicated by an independent core lab.RESULTSOf the 169 lesions initially entered into the study, 4 were later determined to be extracranial or nonaneurysmal by the core lab and were excluded, leaving 165 aneurysms in 162 patients treated in 163 procedures. Ninety-one (56.2%) patients were asymptomatic with aneurysms found incidentally. Of the 165 aneurysms, 150 (90.9%) were unruptured. One hundred thirty-four (81.2%) were saccular, 27 (16.4%) were fusiform/dissecting, and the remaining 4 (2.4%) were blister-like. One hundred thirty-seven (83.0%) arose from the anterior circulation.FRED deployment was impossible in 2/163 (1.2%) cases, and in an additional 4 cases (2.5%) the device was misdeployed. Overall mortality and morbidity rates were 4.3% and 7.3%, respectively, with rates of mortality and morbidity potentially related to FRED of up to 2.4% and 6.2%, respectively. Neuroimaging follow-up at 3–6 months showed complete or nearly complete occlusion of the aneurysm in 94% of cases, increasing to 96% at 12–24 months’ follow-up. Aneurysmal sac shrinkage was observed in 78% of assessable aneurysms.CONCLUSIONSThis preliminary experience using FRED for endovascular treatment of complex unruptured and ruptured aneurysms showed a high safety and efficacy profile that is comparable to those of other FDDs currently in use.


2013 ◽  
Vol 118 (2) ◽  
pp. 408-416 ◽  
Author(s):  
Mariangela Piano ◽  
Luca Valvassori ◽  
Luca Quilici ◽  
Guglielmo Pero ◽  
Edoardo Boccardi

Object The introduction of flow diverter devices is revolutionizing the endovascular approach to cerebral aneurysms. Midterm and long-term results of angiographic, cross-sectional imaging and clinical follow-up are still lacking. The authors report their experience with endovascular treatment of intracranial aneurysms using both the Pipeline embolization device and Silk stents. Methods From October 2008 to July 2011 a consecutive series of 104 intracranial aneurysms in 101 patients (79 female, 22 male; average age 53 years) were treated. Three of the 104 aneurysms were ruptured and 101 were unruptured. Silk stents were implanted in 47 of the aneurysms and Pipeline stents in the remaining 57. In 14 cases a combination of flow diverter devices and coils were used to treat larger aneurysms (maximum diameter > 15 mm). Patients underwent angiographic follow-up examination at 6 months after treatment, with or without CT or MRI, and at 1 year using CT or MRI, with or without conventional angiography. Results In all cases placement of flow diverter stents was technically successful. The mortality and morbidity rates were both 3%. Adverse events without lasting clinical sequelae occurred in 20% of cases. Angiography performed at 6 months after treatment showed complete aneurysm occlusion in 78 of 91 cases (86% of evaluated aneurysms) and subocclusion in 11 (12%); only in 2 cases were the aneurysms unchanged. Fifty-three aneurysms were evaluated at 1 year after treatment. None of these aneurysms showed recanalization, and 1 aneurysm, which was incompletely occluded at the 6-month follow-up examination, was finally occluded. Aneurysmal sac shrinkage was observed in 61% of assessable aneurysms. Conclusions Parent artery reconstruction using flow diverter devices is a feasible, safe, and successful technique for the treatment of endovascular treatment of cerebral aneurysms.


2008 ◽  
Vol 108 (6) ◽  
pp. 1230-1240 ◽  
Author(s):  
Thomas R. Marotta ◽  
Thorsteinn Gunnarsson ◽  
Ian Penn ◽  
Donald R. Ricci ◽  
Ian Mcdougall ◽  
...  

Object The authors describe a novel device for the endovascular treatment of intracranial aneurysms, the endovascular clip system (eCLIPs). Descriptions of the device and its delivery system as well as the results of flow model tests and the treatment of experimental aneurysms are provided. Methods The eCLIPs comprises a flexible hybrid implantable device (an anchor and a covered leaf) and a balloon catheter delivery system, designed to be positioned and activated in the parent vessel in such a way that the covered portion will abut the aneurysm neck. The eCLIPs was subjected to testing in glass, elastomeric, and cadaveric flow models to determine its navigability, orientation, and activation compared with commercially available stents. In a second experiment, 8 carotid artery sidewall aneurysms in swine were treated using eCLIPs. The degree of occlusion was observed on angiography immediately following and 30 days after device activation, and a histological analysis was performed at 30 days. Results The device could navigate tortuous glass models and human cadaveric vessels. Compared with commercially available stents, the eCLIPs performed well. It could be navigated, oriented, and activated easily and reliably. With regard to the 8 porcine experimental aneurysms, immediate postactivation angiograms confirmed complete occlusion of 4 lesions and near occlusion of the other 4. Angiographic follow-up at 30 days postactivation showed occlusion of all 8 aneurysms and patency of all parent vessels. Histopathological analysis revealed aneurysm healing, with smooth-muscle cells growing across the lesion neck to allow reendothelialization. Conclusions Aneurysm occlusion with a single extrasaccular endovascular device has potential advantages. The authors believe that eCLIPs may prove to be a useful tool in the endovascular treatment of cerebral aneurysms. The system should reduce risks associated with coiling, procedure time, costs, and radiation exposure. The device satisfactorily occluded 8 experimental sidewall aneurysms. The observed healing pattern is similar to that seen after microsurgical clipping.


Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Dhanya Anand ◽  
Steve M Cordina

Background: Cerebral aneurysms, their rupture and resultant neurological sequelae are a major cause of morbidity and mortality. Multiple studies have analyzed the etiology of cerebral aneurysms including hemodynamic and congenital factors. Since the arterial supply of the brain develops entirely from the third pharyngeal arch and the dorsal aorta, any insult to the developing vascular system increases the probability of development of variations, including aneurysms. Purpose: To identify the association of arterial variations with aneurysms. Methods: A total of 83 patients with 106 intracranial aneurysms diagnosed by cerebral angiography from January 2011 to July 2014 were analyzed for variations in the intracranial vasculature. The type and laterality of the vascular variants in relation to the aneurysms were also examined. Results: On evaluation of the aneurysms, 65 (61.3 %) had associated variations in the intracranial vasculature. Among these, 51 (78.5 %) had variations ipsilateral to the aneurysm. 90 (84.9%) were in the anterior circulation. 52 patients (62.7%) were female. Various vascular variations including hypoplasia of posterior communicating (P-Comm) artery (56.5 %), variant anterior cerebral (ACA) artery (17.39%), fetal type posterior cerebral (PCA) artery (21.7%), fenestration of vertebral artery (1.4%), superior cerebellar artery duplication (1.4%) and arteriovenous malformations were noted. Fetal type PCAs were significantly more common in patients with anterior communicating (A-comm) (p-value <0.0115) and P-Comm A aneurysms (p-value <0.0131). Also, variations of A1 segment of ACA were significantly more common in A-Comm aneurysms (p-value <0.0013). Conclusions: The distribution of aneurysms in the intracranial vasculature in our study is comparable to previous literature. Among the arterial variations we found that fetal type PCAs are significantly common among A-Comm and P-Comm aneurysms. Also, variations in the A1 segment of ACAs were commonly associated with A-Comm aneurysms. Although further conformation of these associations is required with a prospective randomized control trial, if established, screening for these variations could help in primary prevention and early treatment of these aneurysms.


2018 ◽  
Vol 24 (3) ◽  
pp. 237-245 ◽  
Author(s):  
Yon Kwon Ihn ◽  
Shang Hun Shin ◽  
Seung Kug Baik ◽  
In Sup Choi

Endovascular coiling for intracranial aneurysms has become an accepted treatment with good clinical results and provides adequate protection against rebleeding and rupture of aneurysms. However, despite the experience, preparation, or skill of the physician, complications during endovascular treatment still occur. The main complications of endovascular coiling are: procedural aneurysmal perforations by the microcatheter, micro-guidewire, or coil, and thromboembolic events. Such situations are unexpected, complex, and can have devastating consequences. In this article, we present a comprehensive review of the two most common complications, aneurysmal perforation and thromboembolism during endovascular coiling, and how we can prevent or overcome these complications to achieve a satisfactory outcome. In addition, as the flow diverter has been become an important tool for management of large, wide necked, and other anatomically challenging aneurysms, we also describe complications stemming from the use of the tool, which remains a novel treatment option for complex aneurysms.


2014 ◽  
Vol 37 (4) ◽  
pp. 359-365 ◽  
Author(s):  
Fatih Keskin ◽  
Fatih Erdi ◽  
Bülent Kaya ◽  
Necdet Poyraz ◽  
Suat Keskin ◽  
...  

2017 ◽  
Vol 10 (3) ◽  
pp. 245-248 ◽  
Author(s):  
J M Pumar ◽  
A Mosqueira ◽  
H Cuellar ◽  
B Dieguez ◽  
L Guimaraens ◽  
...  

BackgroundExperience with the endovascular treatment of unruptured small intracranial aneurysms by flow diverter devices is still limited.ObjectiveTo assess the safety and efficacy of the SILK flow diverter (SFD) in the treatment of small unruptured cerebral aneurysms (<10 mm).MethodsWe performed a retrospective review of a prospectively maintained database of patients treated with a SFD between July 2008 and December 2013 at 4 institutions in Spain to identify all patients with small unruptured aneurysms (<10 mm). Data for patient demographics, aneurysm characteristics, and technical procedures were analyzed. Angiographic and clinical findings were recorded during the procedure and at 6- and 12-month follow-ups.ResultsA total of 109 small aneurysms were treated with a SFD in 104 patients (78 women; 26 men; mean, median, and range of age: 55.2, 57.1, and 19–80 years, respectively). A total of 60 patients were asymptomatic (57.7%). All except 7 aneurysms (6.4%) arose from the anterior circulation. The mean size of the aneurysms was 4.7±1.9 mm. At 6 months, the neuromorbidity and neuromortality rates were 2.9% and 0.9%, respectively. Imaging at the 12-month follow-up showed complete occlusion, neck remnants, and residual aneurysm in 88.5% (69/78), 7.7% (6/78), and 3.3% (3/78) of cases, respectively. No delayed hemorrhage occurred.ConclusionsThe findings suggest that the indications for SFD can be safely extended to small intracranial aneurysms.


Stroke ◽  
2010 ◽  
Vol 41 (10) ◽  
pp. 2247-2253 ◽  
Author(s):  
Boris Lubicz ◽  
Laurent Collignon ◽  
Gaï Raphaeli ◽  
Jean-Pierre Pruvo ◽  
Michaël Bruneau ◽  
...  

Author(s):  
Islam El Malky ◽  
Ayman Zakaria ◽  
Essam Abdelhameed ◽  
Hazem Abdelkhalek

Introduction : Endovascular treatment for large and giant aneurysms has included either a reconstructive approach or a deconstructive approach by parent artery occlusion. 1,2 Stent‐assisted coiling and balloon‐assisted coiling were alternative techniques developed to deal with such complex aneurysms, but studies have shown less expected efficacy. This study aims to assess the safety and efficacy of the flow diverter stents for treating large and giant intracranial aneurysms and to examine possible predictors for radiological and clinical outcomes such as location and presence of branching artery, bifurcation, and adjuvant coiling. Methods : This study had been conducted on 65 consecutive patients with 65 large and giant aneurysms (size ≥ 10 mm) treated with flow diverters; Periprocedural complications were reported in all patients and clinical outcomes. Follow‐up angiography was done for 60 patients (92.3%) at 12 months. Results : The study included 65 patients who harbored 65 aneurysms. The median age was 55.5 years (IQR: 44.25 ‐ 62.75 years), the female represented 70.8 % of all patients. The clinical presentation had been reported (Headache, cranial nerve palsy, motor deficit, seizures, and visual field defect in 40 patients (61.5%), nine patients (13.8%), seven patients (10.8%), five patients (7.7%), and four patients (6.2%) respectively. The vascular risk factors had been reviewed (HTN, DM, smoking, and Hyperlipidemia in 25 patients (9.2%), Six patients (9.2%), sixteen (24.6%), and 10 patients (15.4%) respectively). The median size of aneurysms was 16.4 mm (IQR: 12.50 ‐ 23.85 mm) and the median neck width was 7.15 mm (IQR: 5.85‐10.24 mm). Fourteen aneurysms (21.4 %) had previous treatment, eleven aneurysms (16.9%) were treated by coils only, one case (1.5%) by assisted procedure, one case (1.5%) by previous FDS, and parent artery occlusion in one case (1.5%). Complete occlusion in 50 from 60 aneurysms (83.4%), neck remnant in 8 aneurysms (13.3%), and sac remnant in two aneurysms (3.3%). Periprocedural problems were encountered in 14 patients (21.5%) with morbidity in six patients (9.2%) and mortality in one patient (1.5%). Univariate and multivariate logistic regression analysis was used to discover possible predictors of combined mortality and morbidity and occlusion in Table (1). Conclusions : From this study, it could be concluded that Endovascular treatment of the large and giant aneurysms with flow diverters represents a safe method for treating this kind of complex intracranial aneurysms. Complex aneurysms with branching artery and bifurcation were associated with aneurysm persistence and complications respectively while the location of the aneurysm was the only predictor for clinical outcome.


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