scholarly journals The LUNA aneurysm embolization system for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results

2018 ◽  
Vol 10 (12) ◽  
pp. e34-e34 ◽  
Author(s):  
Michel Piotin ◽  
Alessandra Biondi ◽  
Nader Sourour ◽  
Charbel Mounayer ◽  
Maciej Jaworski ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Minor Stroke ◽  
Clinical Trial Registration ◽  
Neck Size ◽  
Aneurysm Embolization ◽  
Post Market ◽  
Endovascular Approach ◽  
Aneurysm Occlusion

Background and purposeIntrasaccular aneurysm flow disruption represents an emerging endovascular approach to treat intracranial aneurysms. The purpose of this study was to determine the clinical and angiographic outcomes of using the LUNA aneurysm embolization system (AES) for treatment of intracranial aneurysms.Materials and methodsThe LUNA AES Post-Market Clinical Follow-Up study is a prospective, multicenter, single-arm study that was designed to evaluate device safety and efficacy. Bifurcation and sidewall aneurysms were included. Aneurysm occlusion was assessed using the Raymond-Roy classification scale. Disability was assessed using the Modified Rankin Scale (mRS). Morbidity was defined as mRS >2 if baseline mRS ≤2, increase in mRS of 1 or more if baseline mRS >2, or mRS >2 if aneurysm was ruptured at baseline. Clinical and angiographic follow-up was conducted at 6, 12 and 36 months.ResultsSixty-three subjects with 64 aneurysms were enrolled. Most aneurysms were unruptured (60/63 (95.2%)); 49 were bifurcation or terminal (49/64 (76.6%)). Mean aneurysm size was 5.6±1.8 mm (range, 3.6–14.9 mm), and mean neck size was 3.8±1.0 mm (range, 1.9–8.7 mm). Though immediate postoperative adequate occlusion was low (11/63, 18%), adequate occlusion was achieved in 78.0% (46/59) and 79.2% (42/53) of the aneurysms at 12 months and 36 months, respectively. Four patients were retreated by the 12-month follow-up (4/63 (6.3%)) and three patients were retreated by the 36-month follow-up (3/63 (4.8%)). There were two major strokes (2/63 (3.2%)), one minor stroke (1/63 (1.6%)) and three incidents of intracranial hemorrhage in two subjects (2/63 (3.2%)) prior to the 12-month follow-up. There was one instance of mortality (1/63, 1.6%). Morbidity was 0% (0/63) and 1.8% (1/63) at the 12-month and 36-month follow-ups, respectively.ConclusionsLUNA AES is safe and effective for the treatment of bifurcation and sidewall aneurysms.Clinical trial registrationISRCTN72343080; Results.

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 Usefulness of 3D T1-SPACE in Combination With 3D-TOF MRA for Follow-Up Evaluation of Intracranial Aneurysms Treated With Pipeline Embolization Devices

2020 ◽  
Vol 11 ◽  
Author(s):  
Qiuji Shao ◽  
Qiaowei Wu ◽  
Qiang Li ◽  
Tianxiao Li ◽  
Li Li ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Coincidence Rate ◽  
Space Sequence ◽  
Stent Patency ◽  
Tof Mra ◽  
Long Term Follow Up ◽  
Aneurysm Occlusion ◽  
Imaging Artifacts

Object: Follow-up evaluation of intracranial aneurysms treated by flow-diverting stents using MRI is challenging due to the presence of imaging artifacts. This study evaluated 3D T1-SPACE in combination with 3D-TOF sequence for follow-up evaluation of intracranial aneurysms treated with Pipeline embolization devices.Methods: Forty patients with 53 intracranial aneurysms who were treated with Pipeline Embolization Devices from October 2018 to July 2019 were enrolled in this study. All patients were evaluated for aneurysm occlusion and stent patency 4 to 7 months post-treatment using 3D T1-SPACE sequence, 3D-TOF MRA, and DSA examinations.Results: With regards to aneurysm occlusion, the intermodality (DSA and 3D-TOF MRA) agreement was good (κ = 0.755). The specificity of 3D-TOF MRA was 94.4% (34/36), the sensitivity was 76.5% (13/17), the total coincidence rate was 88.7% (47/53). With regards to the patency of the stented arteries after PED treatment, 3D T1-SPACE sequence was more accurate compared to 3D-TOF MRA (Z = −6.283, P < 0.001), with a no-artifact rate of 95.7% (44/46).Conclusions: 3D T1-SPACE sequence provides better image quality and higher accuracy for evaluating stented parent arteries compared to TOF-MRA. 3D-TOF MRA may be valuable in the evaluation of aneurysm occlusion. The combination of these two modalities may be used for long-term follow-up of intracranial aneurysms treated with Pipeline Embolization Devices.

scholarly journals Endovascular treatment of bifurcation intracranial aneurysms with the WEB SL/SLS: 6-month clinical and angiographic results

2015 ◽  
Vol 21 (4) ◽  
pp. 462-469 ◽  
Author(s):  
Patricia Bozzetto Ambrosi ◽  
Benjamin Gory ◽  
Rotem Sivan-Hoffmann ◽  
Roberto Riva ◽  
Francesco Signorelli ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Single Layer ◽  
Additional Treatment ◽  
Anterior Communicating Artery ◽  
Neck Size ◽  
Aneurysm Occlusion ◽  
Web Device ◽  
The Web

Background The WEB device is a recent intrasaccular flow disruption technique developed for the treatment of wide-necked intracranial aneurysms. To date, a single report on the WEB Single-Layer (SL) treatment of intracranial aneurysms has been published with 1-months' safety results. The aim of this study is to report our experience and 6-month clinical and angiographic follow-up of endovascular treatment of wide-neck aneurysm with the WEB SL. Methods Ten patients with 10 unruptured wide-necked aneurysms were prospectively enrolled in this study. Feasibility, intraoperative and postoperative complications, and outcomes were recorded. Immediate and 6-month clinical and angiographic results were evaluated. Results Failure of WEB SL placement occurred in two cases. Eight aneurysms were successfully treated using one WEB SL without additional treatment. Three middle cerebral artery, four anterior communicating artery, and one basilar artery aneurysms were treated. Average dome width was 7.5 mm (range 5.4–10.7 mm), and average neck size was 4.9 mm (range 2.6–6.5 mm). No periprocedural complication was observed, and morbi-mortality at discharge and 6 months was 0.0%. Angiographic follow-up at 6 months demonstrated complete aneurysm occlusion in 2/8 aneurysms, neck remnant in 5/8 aneurysms, and aneurysm remnant in 1/8 aneurysm. Conclusions From this preliminary study, treatment of bifurcation intracranial aneurysms using WEB SL is feasible. WEB SL treatment seems safe at 6 months; however, the rate of neck remnants is not negligible due to compression of the WEB SL. Further technical improvements may be needed in order to ameliorate the occlusion in the WEB SL treatment.

Five-year experience in using coil embolization for ruptured intracranial aneurysms: outcomes and incidence of late rebleeding

1999 ◽  
Vol 90 (4) ◽  
pp. 656-663 ◽  
Author(s):  
James V. Byrne ◽  
Min-Joo Sohn ◽  
Andrew J. Molyneux
Keyword(s):  
Coil Embolization ◽  
Intracranial Aneurysms ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Content Type ◽  
Aneurysm Embolization ◽  
Aneurysm Occlusion ◽  
The Stability ◽  
Ruptured Intracranial Aneurysms ◽  
Fine Print

Object. During a 5-year period 317 patients presenting with aneurysmal subarachnoid hemorrhage were successfully treated by coil embolization within 30 days of hemorrhage. The authors followed patients to assess the stability of aneurysm occlusion and its longer-term efficacy in protecting patients against rebleeding.Methods. Patients were followed for 6 to 65 months (median 22.3 months) by clinical review, angiography performed at 6 months posttreatment, and annual questionnaires. Stable angiographic occlusion was evident in 86.4% of small and 85.2% of large aneurysms with recurrent filling in 38 (14.7%) of 259 aneurysms. Rebleeding was caused by aneurysm recurrence in four patients (between 11 and 35 months posttreatment) and by rupture of a coincidental untreated aneurysm in one patient. Annual rebleeding rates were 0.8% in the 1st year, 0.6% in the 2nd year, and 2.4% in the 3rd year after aneurysm embolization, with no rebleeding in subsequent years. Rebleeding occurred in three (7.9%) of 38 recurrent aneurysms and in one (0.4%) of 221 aneurysms that appeared stable on angiography.Conclusions. Periodic follow-up angiography after coil embolization is recommended to identify aneurysm recurrence and those patients at a high risk of late rebleeding.

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

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.

Long-term Clinical and Angiographic Results of Neuroform Stent-Assisted Coil Embolization in Wide-Necked Intracranial Aneurysms

Neurosurgery ◽  
2011 ◽  
Vol 70 (5) ◽  
pp. 1232-1237 ◽  
Author(s):  
Alejandro Santillan ◽  
Edward Greenberg ◽  
Athos Patsalides ◽  
Kimberly Salvaggio ◽  
Howard A. Riina ◽  
...  
Keyword(s):  
Coil Embolization ◽  
Intracranial Aneurysms ◽  
Univariate Analysis ◽  
High Rate ◽  
Long Term Results ◽  
Aneurysm Occlusion ◽  
The Mean ◽  
Neuroform Stent

Abstract BACKGROUND: Neuroform stent-assisted coil embolization facilitates the endovascular treatment of wide-necked intracranial aneurysms. However, the safety and efficacy of its long-term use have not been fully elucidated. OBJECTIVE: To retrospectively examine the long-term results of Neuroform stent usage in conjunction with coil embolization in wide-necked intracranial aneurysms. METHODS: Between November 2002 and December 2010, 79 patients harboring wide-necked intracranial aneurysms were treated with use of the Neuroform stent. The stenting procedure failed in 2 patients. Therefore, 77 patients harboring 79 intracranial aneurysms were included for analysis. Patient and aneurysm characteristics, progression of aneurysm occlusion, and occurrence of complications were analyzed. Follow-up imaging included digital subtraction angiography (DSA) or magnetic resonance angiography (MRA). Kaplan-Meier analysis, as well as univariate analysis were performed to determine the progression of aneurysm occlusion and to examine the predictive factors for complete aneurysm occlusion, respectively. RESULTS: Overall, complete aneurysm occlusion was observed in 42.4% of the cases immediately after treatment and progressed to 96.5% at 7-year follow-up. The mean angiographic follow-up time was 25.8 months (range, 0–84 months). Eleven aneurysms (14%) were re-treated. Sixty-eight patients (88.3%) had favorable clinical outcome with a modified Rankin Scale (mRS) ⩽ 1, 3 patients (3.9%) had an mRS of 2, and 5 patients (6.5%) did not have a clinical follow-up. The mean clinical follow-up time was 45.4 months (range, 3–92 months). One patient (1.3%) died of a procedure-related hemorrhage. CONCLUSION: Neuroform stent-assisted coil embolization of wide-necked intracranial aneurysms prevents hemorrhage and provides a high rate of aneurysm occlusion at long-term follow-up.

scholarly journals Derivo embolization device in the treatment of unruptured intracranial aneurysms: a prospective multicenter study

2020 ◽  
pp. neurintsurg-2020-016303
Author(s):  
Christian A Taschner ◽  
Christian Paul Stracke ◽  
Franziska Dorn ◽  
Krzysztof Bartosz Kadziolka ◽  
Kornelia Kreiser ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Multicenter Trial ◽  
Morbidity Rate ◽  
Major Morbidity ◽  
Unruptured Aneurysms ◽  
Unruptured Intracranial Aneurysms ◽  
Neurological Morbidity ◽  
Aneurysm Occlusion

BackgroundFlow diverters (FD) are used regularly for the endovascular treatment of unruptured intracranial aneurysms. We aimed to assess the safety and effectiveness of the Derivo embolization device (DED) with respect to long-term clinical and angiographic outcomes.MethodsA prospective multicenter trial was conducted at 12 centers. Patients presenting with modified Rankin Score (mRS) of 0–1, treated for unruptured intracranial aneurysms with DED were eligible. Primary endpoint was the mRS assessed at 18 months with major morbidity defined as mRS 3–5. Satisfactory angiographic occlusion was defined as 3+4 on the Kamran scale.ResultsBetween July 2014 and February 2018, 119 patients were enrolled. Twenty-three patients were excluded. Ninety-six patients, 71 (74%) female, mean age 54±12.0 years, were included in the analysis. Mean aneurysm size was 14.2±16.9 mm. The mean number of devices implanted per patient was 1.2 (range 1–3). Clinical follow-up at 18 months was available in 90 (94%) patients, resulting in a mean follow-up period of 14.8±5.2 months. At last available follow-up of 96 enrolled patients, 91 (95%) remained mRS 0–1. The major morbidity rate (mRS 3–5) was 3.1% (3/96), major stroke rate was 4.2% (4/96), and mortality was 0%. Follow-up angiographies were available in 89 (93%) patients at a median of 12.4±5.84 months with a core laboratory adjudicated satisfactory aneurysm occlusion in 89% (79/89).ConclusionOur results suggest that DED is a safe and effective treatment for unruptured aneurysms with high rates of satisfactory occlusion and comparably low rates of permanent neurological morbidity and mortality.Trial registrationDRKS00006103

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

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.

Aneurysm remnant after clipping: the risks and consequences

2016 ◽  
Vol 125 (5) ◽  
pp. 1249-1255 ◽  
Author(s):  
Ramazan Jabbarli ◽  
Daniela Pierscianek ◽  
Karsten Wrede ◽  
Philipp Dammann ◽  
Marc Schlamann ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cerebral Artery ◽  
University Hospital ◽  
Vascular Control ◽  
Clinical Trial Registration ◽  
Younger Age ◽  
Aneurysm Occlusion ◽  
Aneurysmal Bleeding

OBJECTIVE The complete clipping of a cerebral aneurysm usually warrants its sustained occlusion, while clip remnants may have far-reaching consequences. The aim of this study is to identify the risk factors for clip remnants requiring retreatment and/or exhibiting growth. METHODS All consecutive patients with primary aneurysm clipping performed at University Hospital of Essen between January 1, 2003, and December 31, 2013, were eligible for this study. Aneurysm occlusion was judged on obligatory postoperative digital subtraction angiography and the need for repeated vascular control. The identified clip remnants were correlated with various demographic and clinical characteristics of the patients, aneurysm features, and surgery-related aspects. RESULTS Of 616 primarily clipped aneurysms, postoperative angiography revealed 112 aneurysms (18%) with clip remnants requiring further control (n = 91) or direct retreatment (n = 21). Seven remnants exhibited growth during follow-up, whereas 2 cases were associated with aneurysmal bleeding. Therefore, a total of 28 aneurysms (4.5%) were retreated as clip remnants (range 1 day to 67 months after clipping). In the multivariate analysis, the need for retreatment of clip remnant was correlated with the aneurysm's initial size (> 12 mm; OR 3.22; p = 0.035) and location (anterior cerebral artery > internal carotid artery > posterior circulation > middle cerebral artery; OR 1.85; p = 0.003). Younger age with a cutoff at 45 years (OR 33.31; p = 0.004) was the only independent predictor for remnant growth. CONCLUSIONS The size and location of the aneurysm are the main risk factors for clip remnants requiring retreatment. Because of the risk for growth, younger individuals (< 45 years old) with clip remnants require a long-term (> 5 years) vascular follow-up. Clinical trial registration no: DRKS00008749 (Deutsches Register Klinischer Studien)

scholarly journals Five-year experience in using coil embolization for ruptured intracranial aneurysms: outcomes and incidence of late rebleeding

1999 ◽  
Vol 6 (2) ◽  
pp. E2
Author(s):  
James V. Byrne ◽  
Min-Joo Sohn ◽  
Andrew J. Molyneux ◽  
B. Chir
Keyword(s):  
Subarachnoid Hemorrhage ◽  
High Risk ◽  
Coil Embolization ◽  
Intracranial Aneurysms ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Aneurysm Embolization ◽  
Aneurysm Occlusion ◽  
The Stability ◽  
Ruptured Intracranial Aneurysms

Object During a 5-year period 317 patients presenting with aneurysmal subarachnoid hemorrhage were successfully treated by coil embolization within 30 days of hemorrhage. The authors followed these cases to assess the stability of aneurysm occlusion and its longer-term efficacy in protecting patients against rebleeding. Methods These cases were followed for 6 to 65 months (median 22.3 months) by clinical review, angiography performed at 6 months posttreatment, and annual postal questionnaires. Conclusions Stable angiographic occlusion was evident in 86.4% of small and 85.2% of large aneurysms with recurrent filling in 38 (14.7%) of 259 aneurysms. Rebleeding was caused by aneurysm recurrence in four patients (between 11 and 35 months posttreatment) and by rupture of a coincidental untreated aneurysm in one patient. Annual rebleeding rates were 0.8% in the 1st year, 0.6% in the 2nd year, and 2.4% in the 3rd year after aneurysm embolization, with no rebleeding in subsequent years. Rebleeding occurred in three (7.9%) of 38 recurrent aneurysms and in one (0.4%) of 221 aneurysms that appeared stable on angiography. Periodic follow-up angiography after coil embolization is recommended to identify aneurysm recurrence and those patients at a high risk of late rebleeding.

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