GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device

2017 ◽  
Vol 10 (1) ◽  
pp. 83-87 ◽  
Author(s):  
Waleed Brinjikji ◽  
Arun P Amar ◽  
Josser E Delgado Almandoz ◽  
Orlando Diaz ◽  
Pascal Jabbour ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Perioperative Complications ◽  
Major Complication ◽  
Clinical Results ◽  
Ease Of Use ◽  
Complete Occlusion ◽  
Aneurysm Neck ◽  
Registration Number ◽  
Occlusion Rate

Background and purposeThe HydroSoft coil was developed as a finishing coil, ideally to be placed along the aneurysm neck to enhance intracranial aneurysm healing. The GEL THE NEC (Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil) multicenter registry was developed to assess the safety and efficacy of HydroSoft coils in treating intracranial aneurysms. We report angiographic and clinical results of this prospective registry.Materials and methodsGEL THE NEC was performed at 27 centers in five countries. Patients aged 21–90 years with a ruptured or unruptured aneurysm 3–15 mm in size were eligible for enrollment. The following variables were obtained: demographics/comorbidities, aneurysm geometry, adjunctive devices used, proportion of patients in whom HydroSoft coils were successfully placed, and long-term angiographic outcomes (graded by an independent core laboratory using the Modified Raymond Scale), and procedure-related adverse events. Predictors of good angiographic outcome were studied using χ2 and t-tests.ResultsA total of 599 patients with 599 aneurysms were included in this study. HydroSoft coils were successfully deployed in 577 (96.4%) patients. Procedure-related major morbidity and mortality were 0.5% (3/599) and 1.3% (8/599), respectively. The most common perioperative complications were iatrogenic vasospasm (30/599, 5.0%), thromboemboli (27/599, 4.5%), and aneurysm perforation (16/599, 2.7%). At last angiographic follow-up (mean 9.0±6.3 months), the complete occlusion rate was 63.2% (280/442) and near complete occlusion rate was 25.2% (107/442). The core laboratory read recanalization rate was 10.8% (46/425) and the retreatment rate was 3.4% (20/599).ConclusionsEndovascular treatment of intracranial aneurysms with HydroSoft coils resulted in complete/near complete occlusion rates of 88% and a major complication rate of 1.8%.Trial registration numberNCT01000675.

Intracranial aneurysms managed by parent artery reconstruction using Tubridge: Study protocol for a prospective, multicenter, post-market clinical trial

2020 ◽  
pp. 159101992097623
Author(s):  
Qiaowei Wu ◽  
Li Li ◽  
Qiuji Shao ◽  
Tianming Xu ◽  
Kaitao Chang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intracranial Aneurysms ◽  
Parent Artery ◽  
Reconstruction Technique ◽  
Long Term Outcomes ◽  
Complete Occlusion ◽  
Post Market ◽  
Occlusion Rate

Background As a new endovascular reconstruction technique, flow diverter (FD) shows excellent efficacy and safety for treatment of intracranial aneurysms. In a previous multicenter, randomized, controlled, pre-market study, Tubridge FD showed remarkably higher complete occlusion rate compared with traditional stent-assisted coiling. However, a nonsignificant higher complication rate in the Tubridge group was noted. Considering the learning curve, the safety, and long-term outcomes of Tubridge FD should be verified in new prospective, real world, multicenter, post-market trials. Methods This study is a prospective, multicenter, single-arm, post-market clinical trial that evaluates the safety and efficacy of Tubridge in the treatment of patients with intracranial aneurysms by reconstructing parent artery. We expect 200 participants who meet the inclusion and exclusion criteria to be included. Clinical information and angiographic results (Raymond–Roy grading scale, RRGS) will be recorded objectively. The primary endpoint will be the complete occlusion rate of the target aneurysm (RRGS 1) at 12-month follow-up. Secondary endpoints will include the adequate occlusion rate (RRGS 1 & 2) and the rate of major in-stent stenosis (>50%) at 12-month follow-up, technique success rate, changes of modified Rankin Scale before and after the procedure, the rate of aneurysm related disability, neurological mortality, and all-cause mortality within follow-up period. Discussion This post-market, prospective trial may offer more information on the safety and long-term outcomes of Tubridge FD. When the study is complete, the results may provide us a new strategy for the treatment of intracranial aneurysms. Trial registration: WHO-Chinese Clinical Trial Registry: ChiCTR2000032282.

scholarly journals Hemodynamic Analysis for Endovascular Treatment in Small Unruptured Intracranial Aneurysms: A Matched Comparison Study of Flow Diverter Versus LVIS

2021 ◽  
Author(s):  
Jian Liu ◽  
Wenqiang Li ◽  
Yisen Zhang ◽  
Kun Wang ◽  
Xinjian Yang ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Clinical Analysis ◽  
Complete Occlusion ◽  
Aneurysm Neck ◽  
Unruptured Intracranial Aneurysms ◽  
Key Factor ◽  
Occlusion Rate ◽  
Two Parameters

Abstract BackgroundWe compared the treatment of small unruptured intracranial aneurysms (UIAs) with flow diverter and LVIS assisted coiling to determine the effects of hemodynamic changes caused by different stent and coil packing in endovascular treatment.MethodsFifty-one UIAs in 51 patients treated with pipeline embolization device (PED) were included in this study, and defined as the PED group. We matched controls 1:1 and enrolled 51 UIAs who treated with LVIS stent, which defined as the LVIS group. Computational fluid dynamics were performed to assess hemodynamic alterations between PED and LVIS. Clinical analysis was also performed between these two groups after the match.ResultsThere was no difference in procedural complications between two groups (P=0.558). At the first angiographic follow-up, the complete occlusion rate was significantly higher in the LVIS group compared with that in the PED group (98.0% vs 82.4%, P = 0.027). However, during the further angiographic follow-up, the complete occlusion rate in PED group achieved 100%, which was higher than that in LVIS group (98.0%). Compared with the LVIS group after treatment, cases in PED group showed a higher value of velocity in the aneurysm (0.03 ± 0.09 vs 0.01 ± 0.01, P=0.037) and WSS on the aneurysm (2.32 ± 5.40 vs 0.33 ± 0.47, P=0.011). Consequently, the reduction ratios of these two parameters were also showed statistical differences. These parameters in LVIS group showed much higher reduction ratios. However, the reduction ratio of the velocity on the neck plane was comparable between two groups. ConclusionsBoth LVIS and PED were safe and effective for the treatment of small UIAs. However, LVIS-assisted coiling produced greater hemodynamic alterations in the aneurysm sac compared with PED. The hemodynamics in the aneurysm neck may be a key factor for aneurysm outcome.

scholarly journals Hemodynamic analysis for endovascular treatment in small unruptured intracranial aneurysms: a matched comparison study of flow diverter versus LVIS

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Jian Liu ◽  
Wenqiang Li ◽  
Yisen Zhang ◽  
Kun Wang ◽  
Xinjian Yang ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Clinical Analysis ◽  
Complete Occlusion ◽  
Aneurysm Neck ◽  
Unruptured Intracranial Aneurysms ◽  
Occlusion Rate ◽  
Two Parameters

Abstract Background We compared the treatment of small unruptured intracranial aneurysms (UIAs) with flow diverter and LVIS-assisted coiling to determine the effects of hemodynamic changes caused by different stent and coil packing in endovascular treatment. Methods Fifty-one UIAs in 51 patients treated with pipeline embolization device (PED) were included in this study and defined as the PED group. We matched controls 1:1 and enrolled 51 UIAs who were treated with LVIS stent, which were defined as the LVIS group. Computational fluid dynamics were performed to assess hemodynamic alterations between PED and LVIS. Clinical analysis was also performed between these two groups after the match. Results There was no difference in procedural complications between the two groups (P = 0.558). At the first angiographic follow-up, the complete occlusion rate was significantly higher in the LVIS group compared with that in the PED group (98.0% vs. 82.4%, P = 0.027). However, during the further angiographic follow-up, the complete occlusion rate in the PED group achieved 100%, which was higher than that in the LVIS group (98.0%). Compared with the LVIS group after treatment, cases in the PED group showed a higher value of velocity in the aneurysm (0.03 ± 0.09 vs. 0.01 ± 0.01, P = 0.037) and WSS on the aneurysm (2.32 ± 5.40 vs. 0.33 ± 0.47, P = 0.011). Consequently, the reduction ratios of these two parameters also showed statistical differences. These parameters in the LVIS group showed much higher reduction ratios. However, the reduction ratio of the velocity on the neck plane was comparable between two groups. Conclusions Both LVIS and PED were safe and effective for the treatment of small UIAs. However, LVIS-assisted coiling produced greater hemodynamic alterations in the aneurysm sac compared with PED. The hemodynamics in the aneurysm neck may be a key factor for aneurysm outcome.

scholarly journals Evaluation of the Accero Stent for Stent-Assisted Coiling of Unruptured Wide-Necked Intracranial Aneurysm Treatment with Short-Term Follow-Up

2020 ◽  
Vol 9 (9) ◽  
pp. 2808
Author(s):  
Wojciech Poncyljusz ◽  
Kinga Kubiak ◽  
Leszek Sagan ◽  
Bartosz Limanówka ◽  
Katarzyna Kołaczyk
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Intracranial Aneurysms ◽  
Clinical Results ◽  
Class I ◽  
Unruptured Aneurysms ◽  
Patient Demographics ◽  
Stent Deformation ◽  
Unruptured Intracranial Aneurysms ◽  
Occlusion Rate

Background: Stent-assisted coiling is an effective method of treating intracranial aneurysms. The aim of the study was to assess the safety and efficacy of the new Accero stent for the treatment of intracranial aneurysms. Materials and Methods: It was a retrospective, single-center study. Eighteen unruptured intracranial aneurysms were treated using the stent-assisted coiling method with the Accero stent. Patient demographics, aneurysm characteristics, procedural parameters, grade of occlusion, complications, and clinical results were analyzed. Follow-up magnetic resonance (MR) was performed 6 months after intervention. Results: Seventeen patients with 18 incidental unruptured aneurysms were electively treated with coiling and the Accero stent. The aneurysms were located on internal carotid artery (ICA), middle cerebral artery (MCA) and basilar artery (BA). All stents were deployed successfully. Immediate complete occlusion rate Raymond-Roy occlusion classification (RROC) class I was achieved in 13 cases and class II in 4 cases. Complications occurred in 2/17 treatments and included guidewire stent perforation with subarachnoid hemorrhage (SAH) and stent deformation. Vascular spasm in the subarachnoid hemorrhage (SAH) patient subsided before discharge. Ninety days after intervention, the modified Rankin Scale (mRS) value was 0. RROC class I was observed in 88.23% of cases in follow-up. Conclusion: The Accero stent provides excellent support for coil mass. It constitutes an efficacious device with good initial occlusion rate for treating wide-necked unruptured intracranial aneurysms.

Medina embolization device for the treatment of intracranial aneurysms: 18 months’ angiographic results

2018 ◽  
Vol 11 (5) ◽  
pp. 516-522 ◽  
Author(s):  
Idriss Haffaf ◽  
Frédéric Clarençon ◽  
Eimad Shotar ◽  
Claudia Rolla-Bigliani ◽  
Saskia Vande Perre ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Thromboembolic Complication ◽  
Detachable Coil ◽  
Mean Delay ◽  
Scale Scores ◽  
Long Term Follow Up ◽  
Occlusion Rate ◽  
Wide Neck

Background and purposeThe Medina embolization device (MED) is a new flow disruption device combining the design of a detachable coil with an intrasaccular flow disrupter. Safety and short-term angiographic effectiveness of this device have recently been reported. However, long-term angiographic results are lacking. We report herein the 18 months’ angiographic outcome in patients treated for a wide-neck intracranial aneurysm with the MED.Materials and methodsNineteen patients (17 female, mean age 50 years) with 20 wide-neck intracranial aneurysms (six ruptured; 14 unruptured) were treated by the MED between January 2015 and June 2016. Procedure-related complications were systematically recorded; discharge and 6–9 months' follow-up modified Rankin Scale scores were assessed. Angiographic mid-term and long-term follow-up were performed with a mean delay of 6.4±1.5 months (n=16 aneurysms) and 17.7±4.2 months (n=15 aneurysms), respectively. Occlusion rates were evaluated after the procedure and at the mid-term and long-term follow-up using the Roy-Raymond scale.ResultsEmbolization with the MED was feasible in all except two cases (2/20, 10%). One per-procedural perforation was recorded (1/20, 5%) and one MED deployment failed because of the aneurysm’s shape (1/20, 5%). Three cases of thromboembolic complications were observed (3/20, 15%). Only one thromboembolic complication was responsible for clinical sequelae. Grade A occlusion rate was 61% (11/18) after the procedure, 75% at 6 months' follow-up (12/16), and 80% (12/15) at long-term follow-up. Two cases (2/18, 11%) of recanalization at mid-term were documented angiographically. No recanalization occurred between the mid-term and long-term follow-up.ConclusionMED is a hybrid embolization device, combining properties of a conventional coil with those of an intrasaccular flow disrupter. Our series focusing on long-term angiographic follow-up shows a satisfactory long-term occlusion rate. Larger series with longer angiographic follow-up times are warranted to confirm these preliminary results.

scholarly journals Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up

2018 ◽  
Vol 11 (4) ◽  
pp. 396-399 ◽  
Author(s):  
Mario Martínez-Galdámez ◽  
Saleh M Lamin ◽  
Konstantinos G Lagios ◽  
Thomas Liebig ◽  
Elisa F Ciceri ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Technical Success ◽  
First Line ◽  
Post Procedure ◽  
Safety Outcomes ◽  
Registration Number ◽  
Aneurysm Diameter ◽  
Major Stroke

PurposeThe Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs.Materials and methodsThe Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year.ResultsFifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment.ConclusionsOur 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs.Trial registration numberNCT02390037

Morbidity and mortality after spinal deformity surgery in patients 75 years and older: complications and predictive factors

2011 ◽  
Vol 15 (6) ◽  
pp. 667-674 ◽  
Author(s):  
Frank L. Acosta ◽  
Jamal McClendon ◽  
Brian A. O'Shaughnessy ◽  
Heiko Koller ◽  
Chris J. Neal ◽  
...  
Keyword(s):  
Predictive Factors ◽  
Spinal Deformity ◽  
Complication Rate ◽  
Perioperative Complications ◽  
Major Complication ◽  
Major Complications ◽  
Spinal Deformity Surgery ◽  
Perioperative Complication ◽  
The Mean

Object As the population continues to age, relatively older geriatric patients will present more frequently with complex spinal deformities that may require surgical intervention. To the authors' knowledge, no study has analyzed factors predictive of complications after major spinal deformity surgery in the very elderly (75 years and older). The authors' objective was to determine the rate of minor and major complications and predictive factors in patients 75 years of age and older who underwent major spinal deformity surgery requiring a minimum 5-level arthrodesis procedure. Methods Twenty-one patients who were 75 years of age or older and underwent thoracic and/or lumbar fixation and arthrodesis across 5 or more levels for spinal deformity were analyzed retrospectively. The medical and surgical records were reviewed in detail. Age, diagnosis, comorbidities, operative data, hospital data, major and minor complications, and deaths were recorded. Factors predictive of perioperative complications were identified by logistic regression analysis. Results The mean patient age was 77 years old (range 75–83 years). There were 14 women and 7 men. The mean follow-up was 41.2 months (range 24–81 months). Fifteen patients (71%) had at least 1 comorbidity. A mean of 10.5 levels were fused (range 5–15 levels). Thirteen patients (62%) had at least 1 perioperative complication, and 8 (38%) had at least one major complication for a total of 17 complications. There were no perioperative deaths. Increasing age was predictive of any perioperative complication (p = 0.03). However, major complications were not predicted by age or comorbidities as a whole. In a subset analysis of comorbidities, only hypertension was predictive of a major complication (OR 10, 95% CI 1.3–78; p = 0.02). Long-term postoperative complications occurred in 11 patients (52%), and revision fusion surgery was necessary in 3 (14%). Conclusions Patients 75 years and older undergoing major spinal deformity surgery have an overall perioperative complication rate of 62%, with older age increasing the likelihood of a complication, and a long-term postoperative complication rate of 52%. Patients in this age group with a history of hypertension are 10 times more likely to incur a major perioperative complication. However, the mortality risk for these patients is not increased.

scholarly journals Long-term occlusion results with SILK flow diversion in 28 aneurysms: Do recanalizations occur during follow-up?

2015 ◽  
Vol 21 (3) ◽  
pp. 300-310 ◽  
Author(s):  
Anastasios Mpotsaris ◽  
Martin Skalej ◽  
Oliver Beuing ◽  
Bernd Eckert ◽  
Daniel Behme ◽  
...  
Keyword(s):  
Prospective Study ◽  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Success Rates ◽  
Imaging Data ◽  
Complete Occlusion ◽  
Complex Aneurysms ◽  
Multicenter Prospective Study

Background and purpose The purpose of this article is to report on the long-term success rates of Silk flow-diverter (FD) treatment in a multicenter prospective study for the treatment of complex aneurysms. Methods Between May 2008 and January 2011, all consecutive patients featuring complex intracranial aneurysms eligible for FD treatment with the Silk in three neurovascular centers were included. Clinical and imaging data were assessed during hospitalization and follow-up. Results Five patients were initially asymptomatic, 20 patients showed various neurological symptoms. Twenty-eight FDs were implanted in 25 patients treating 28 aneurysms. The immediate procedure-related morbidity was 8% (two of 25), mortality 0%. One procedure-related death was observed during follow-up (in-stent thrombosis). Compared to the immediate result nearly two of three aneurysms improved during follow-up; all angiographically confirmed inflow changes took place within six months after treatment. Final anatomic outcome in 24 aneurysms of 22 patients comprised 14 (59%) with complete occlusion, seven (29%) with a neck remnant, two (8%) with residual filling <50%, none with residual filling >50% and one (4%) unchanged in comparison to its pretreatment status. Postinterventional recanalizations were seen in three of 13 (23%) aneurysms treated with FD alone; none were observed in 15 aneurysms treated with adjunctive coiling. Conclusion Anatomic presentation and location are key for successful FD treatment. The rate of successful occlusion increases during follow-up. Postinterventional monitoring for at least six months is paramount, as anatomic outcome is not reliably predictable and recanalizations may occur in initially completely occluded aneurysms.

Impact of perioperative complications on clinical outcome scores in lumbar fusion surgery

2013 ◽  
Vol 18 (3) ◽  
pp. 265-268 ◽  
Author(s):  
Manish P. Lambat ◽  
Steven D. Glassman ◽  
Leah Y. Carreon
Keyword(s):  
Clinical Outcome ◽  
Clinical Outcomes ◽  
Lumbar Fusion ◽  
Perioperative Complications ◽  
Major Complication ◽  
Postoperative Outcome ◽  
Minor Complication ◽  
Sf 36 ◽  
Outcome Scores

Object Although lumbar fusion is effective in well-selected patients, it is not without complications associated with short-term morbidity. There is a paucity of literature on the effect of these complications on long-term clinical outcomes. The purpose of this study was to determine whether perioperative complications—that is, those occurring within 30 days after surgery—alter the long-term clinical outcomes after lumbar fusion. Methods The authors retrospectively reviewed surgical and clinical databases for the period from 2001 to 2008 to identify patients who had undergone instrumented lumbar spinal fusion and had complete preoperative and 2-year postoperative outcome measures data. Outcome measures included the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary, SF-36 Mental Component Summary, Oswestry Disability Index (ODI), and Numeric Rating Scales (0–10) for back and leg pain. Three patient groups were created for comparison—one with major complications, one with only minor complications, and another with no complications—using propensity matching techniques based on demographics, baseline clinical outcome scores, and surgical characteristics. Preoperative and 2-year postoperative outcome scores in the groups were compared. One-way ANOVA was used to compare continuous variables, and the Fisher exact test was used to compare categorical variables between the groups. Significance was set at p < 0.001. Results In the database with 1144 patients, 81 had a major complication. Of these 81 patients, 78 were propensity matched to a similar group of patients with minor complications and another group with no complications. Comparison of the 3 groups revealed that 2-year postoperative outcomes were not statistically different for any of the measures. Overall ODI at 2 years was better in patients having no complications (39.6) or only minor complications (37.0) than in those having major complications (44.5), but this difference was not statistically significant (p = 0.074). The proportion of patients reaching a minimum clinically important difference (MCID) for ODI was statistically significantly smaller in the major complication group (31%) than in the minor complication (51%) and no complication groups (65%; p < 0.001). Conclusions A smaller proportion of patients achieved MCID for ODI 2 years after a major perioperative complication following lumbar fusion than after a minor complication or no complications.

Clinical Results and Problems in Embolization for Intracranial Aneurysms Using Electrically Detachable Coils

1998 ◽  
Vol 4 (1_suppl) ◽  
pp. 71-73
Author(s):  
M. Tsuura ◽  
T. Terada ◽  
H. Yokote ◽  
Y. Kinoshita ◽  
K. Nakai ◽  
...  
Keyword(s):  
Intracranial Aneurysm ◽  
Intracranial Aneurysms ◽  
Clinical Results ◽  
Thromboembolic Complications ◽  
Complete Occlusion ◽  
Detachable Coils ◽  
Incomplete Occlusion

Nineteen patients with intracranial aneurysm were treated using electrically detachable coils (GDC or IEDC) and angiographic results and complications were assessed. In 18 aneurysms treated by endosaccular occlusion, 11 (61%), 3 (17%) and 4 (22%) resulted in complete occlusion, neck remnant and dome filling, respectively. Neither haemorrhagic nor thromboembolic complications occurred in 19 patients. Embolization using electrically detachable coils seemed to be a safe and useful procedure without complications, but we should give attention to avoiding complications and incomplete occlusion in particular in a case of 1) wide-necked, 2) small (> 3 mm) or 3) complex-shaped aneurysms.

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