scholarly journals Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study

2017 ◽  
Vol 9 (8) ◽  
pp. 772-776 ◽  
Author(s):  
Mario Martínez-Galdámez ◽  
Saleh M Lamin ◽  
Konstantinos G Lagios ◽  
Thomas Liebig ◽  
Elisa F Ciceri ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Primary Study ◽  
Prospective Clinical Study ◽  
Serious Adverse Events ◽  
Clinical Trial Registration ◽  
Post Procedure ◽  
Unruptured Intracranial Aneurysms ◽  
Long Term Follow Up ◽  
Procedural Success

Background and purposeThe Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer.Materials and methodsThe Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1 year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes.ResultsFifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15 mm. Thirty-eight aneurysms (76%) were small (<10 mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period.ConclusionsThe results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods.Clinical trial registrationNCT02390037.

Long-term follow-up study of unruptured intracranial aneurysms

1997 ◽  
Vol 99 ◽  
pp. S41
Author(s):  
Nobuyuki Yasui ◽  
Akufumi Suzuki ◽  
Hiromi Nishimura ◽  
Kazuo Suzuki ◽  
Takako Abe
Keyword(s):  
Intracranial Aneurysms ◽  
Follow Up Study ◽  
Unruptured Intracranial Aneurysms ◽  
Long Term Follow Up

scholarly journals Long-term outcomes of coil embolization of unruptured intracranial aneurysms

2018 ◽  
Vol 129 (6) ◽  
pp. 1492-1498 ◽  
Author(s):  
Masaomi Koyanagi ◽  
Akira Ishii ◽  
Hirotoshi Imamura ◽  
Tetsu Satow ◽  
Kazumichi Yoshida ◽  
...  
Keyword(s):  
Coil Embolization ◽  
Intracranial Aneurysms ◽  
Additional Treatment ◽  
Long Term Outcomes ◽  
Unruptured Intracranial Aneurysms ◽  
Risk Of Rupture ◽  
Long Term Follow Up ◽  
Multiple Stroke

OBJECTIVELong-term follow-up results of the treatment of unruptured intracranial aneurysms (UIAs) by means of coil embolization remain unclear. The aim of this study was to analyze the frequency of rupture, retreatment, stroke, and death in patients with coiled UIAs who were followed for up to 20 years at multiple stroke centers.METHODSThe authors retrospectively analyzed data from cases in which patients underwent coil embolization between 1995 and 2004 at 4 stroke centers. In collecting the late (≥ 1 year) follow-up data, postal questionnaires were used to assess whether patients had experienced rupture or retreatment of a coiled aneurysm or any stroke or had died.RESULTSOverall, 184 patients with 188 UIAs were included. The median follow-up period was 12 years (interquartile range 11–13 years, maximum 20 years). A total of 152 UIAs (81%) were followed for more than 10 years. The incidence of rupture was 2 in 2122 aneurysm-years (annual rupture rate 0.09%). Nine of the 188 patients with coiled UIAs (4.8%) underwent additional treatment. In 5 of these 9 cases, the first retreatment was performed more than 5 years after the initial treatment. Large aneurysms were significantly more likely to require retreatment. Nine strokes occurred over the 2122 aneurysm-years. Seventeen patients died in this cohort.CONCLUSIONSThis study demonstrates a low risk of rupture of coiled UIAs with long-term follow-up periods of up to 20 years. This suggests that coiling of UIAs could prevent rupture for a long period of time. However, large aneurysms might need to be followed for a longer time.

Neurointerventional procedures for unruptured intracranial aneurysms under procedural sedation and local anesthesia: a large-volume, single-center experience

2011 ◽  
Vol 114 (1) ◽  
pp. 120-128 ◽  
Author(s):  
Christopher S. Ogilvy ◽  
Xinyu Yang ◽  
Osama A. Jamil ◽  
Erik F. Hauck ◽  
L. Nelson Hopkins ◽  
...  
Keyword(s):  
Hospital Stay ◽  
Local Anesthesia ◽  
Intracranial Aneurysms ◽  
Conscious Sedation ◽  
Modified Rankin Scale ◽  
Unruptured Intracranial Aneurysms ◽  
Long Term Follow Up ◽  
Neurointerventional Procedures

Object In this paper, the authors' goal was to report the outcome of patients with unruptured intracranial aneurysms undergoing endovascular treatment under conscious sedation (local anesthesia). Methods Between November 5, 2001, and February 5, 2009, the authors treated 340 patients with 358 unruptured aneurysms by using neurointerventional procedures at Millard Fillmore Gates Hospital (Buffalo, New York). The data were retrospectively reviewed for periprocedural safety and long-term follow-up. Results A total of 496 procedures were performed under local anesthesia. Of those, 370 procedures (74.6%) were completed successfully. In 82 procedures (16.5%), an associated medical or technical event occurred. Forty-four procedures (8.9%) were aborted. Rates of overall procedure-related morbidity and mortality were 1.2% (6 of 496) and 0.6% (3 of 496), respectively. The average hospital stay was 1.5 ± 2.5 days. Long-term follow-up was available in 261 (82.1%) of 318 patients whose procedures were performed with local anesthesia. Of those, 246 patients (94.3%) had a good outcome (modified Rankin Scale score ≤ 2), 6 patients (2.3%) had an unfavorable outcome, not related to the procedure, and 9 patients (3.4%) had a poor outcome (modified Rankin Scale score > 2) as a result of the intervention. Conclusions Interventional treatment under conscious sedation (local anesthesia) can be effectively performed in most patients with unruptured intracranial aneurysms and is associated with a short hospital stay and low morbidity and mortality.

Stent-assisted coiling of unruptured intracranial aneurysms: Long-term follow-up in 164 patients with 183 aneurysms

2014 ◽  
Vol 41 (5) ◽  
pp. 322-328 ◽  
Author(s):  
Benjamin Mine ◽  
Ali Aljishi ◽  
Jean-Bernard D’Harcour ◽  
Denis Brisbois ◽  
Laurent Collignon ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Unruptured Intracranial Aneurysms ◽  
Long Term Follow Up

Delayed thromboembolic events after coiling of unruptured intracranial aneurysms in a prospective cohort of 335 patients

2020 ◽  
pp. neurintsurg-2020-016654
Author(s):  
Laurent Pierot ◽  
Coralie Barbe ◽  
Denis Herbreteau ◽  
Jean-Yves Gauvrit ◽  
Anne-Christine Januel ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Intracranial Aneurysms ◽  
Rare Complication ◽  
Thromboembolic Events ◽  
Clinical Trial Registration ◽  
Unruptured Aneurysms ◽  
Post Procedure ◽  
Unruptured Intracranial Aneurysms ◽  
Two Factors ◽  
Autosomal Dominant Polycystic Kidney

BackgroundCoiling is the first-line treatment for the management of unruptured intracranial aneurysms (UIAs), but delayed thromboembolic events (TEEs) can occur after such treatment. ARETA (Analysis of Recanalization after Endovascular Treatment of Intracranial Aneurysm) is a prospective multicenter study conducted to analyze aneurysm recanalization. We analyzed delayed TEEs in the UIA subgroup.MethodsSixteen neurointerventional departments prospectively enrolled patients treated for ruptured and unruptured aneurysms between December 2013 and May 2015. Participant demographics, aneurysm characteristics, and endovascular techniques were recorded. Data were analyzed from participants with UIA treated by coiling or balloon-assisted coiling. We assessed the rates, timing, management, clinical outcomes, and risk factors for delayed TEEs using univariable and multivariable analyses.ResultsThe rate of delayed TEEs was 2.4% (95% CI 1.0% to 4.6%) in patients with unruptured aneurysms, with all events occurring in the week following the procedure. In multivariate analysis, two factors were associated with delayed TEEs: autosomal dominant polycystic kidney disease (ADPKD): 20.0% in patients with ADPKD vs 1.9% in patients without ADPKD (OR 27.3 (95% CI 3.9 to 190.2), p=0.0008) and post-procedure aneurysm remnant: 9.4% in patients with post-procedure aneurysm remnant vs 1.6% in patients with adequate occlusion (OR 9.9 (95% CI 1.0 to 51.3), p=0.006). We describe modalities of management as well as clinical outcomes.ConclusionsDelayed TEE is a relatively rare complication after coiling of UIAs. In this series, all occurred in the week following the initial procedure. Two factors were associated with delayed TEE: ADPKD and aneurysm remnant at procedure completion.Clinical trial registrationNCT01942512

scholarly journals Scoring of Growth of Unruptured Intracranial Aneurysms

2020 ◽  
Vol 9 (10) ◽  
pp. 3339
Author(s):  
Seppo Juvela
Keyword(s):  
Intracranial Aneurysms ◽  
Meta Analysis ◽  
Area Under The Curve ◽  
Receiver Operating Curve ◽  
Female Sex ◽  
Unruptured Intracranial Aneurysms ◽  
Long Term Follow Up ◽  
Better Than

The purpose was to obtain a reliable scoring for growth of unruptured intracranial aneurysms (UIAs) in a long-term follow-up study from variables known at baseline and to compare it with the ELAPSS (Earlier subarachnoid hemorrhage, Location of the aneurysm, Age > 60 years, Population, Size of the aneurysm, and Shape of the aneurysm) score obtained from an individual-based meta-analysis. The series consists of 87 patients with 111 UIAs and 1669 person-years of follow-up between aneurysm size measurements (median follow-up time per patient 21.7, range 1.2 to 51.0 years). These were initially diagnosed between 1956 and 1978, when UIAs were not treated in our country. ELAPSS scores at baseline did not differ between those with and those without aneurysm growth. The area under the curve (AUC) for the receiver operating curve (ROC) of the ELAPSS score for predicting long-term growth was fail (0.474, 95% CI 0.345–0.603), and the optimal cut-off point was obtained at ≥7 vs. <7 points for sensitivity (0.829) and specificity (0.217). In the present series UIA growth was best predicted by female sex (4 points), smoking at baseline (3 points), and age <40 years (2 points). The AUC for the ROC of the new scoring was fair (0.662, 95% CI 0.546–0.779), which was significantly better than that of ELAPSS score (p < 0.05). The optimal cut-off point was obtained at ≥4 vs. <4 points for sensitivity (0.971) and specificity (0.304). A new simple scoring consisting of only female sex, cigarette smoking and age <40 years predicted growth of an intracranial aneurysm in long-term follow-up, significantly better than the ELAPSS score.

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