scholarly journals The SMART Registry: Long-Term Results on the Utility of the Penumbra SMART COIL System for Treatment of Intracranial Aneurysms and Other Malformations

2021 ◽  
Vol 12 ◽  
Author(s):  
Alejandro M. Spiotta ◽  
Min S. Park ◽  
Richard J. Bellon ◽  
Bradley N. Bohnstedt ◽  
Albert J. Yoo ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Vascular Lesions ◽  
Long Term Results ◽  
Adverse Event Rate ◽  
Serious Adverse Events ◽  
Smart System ◽  
Post Procedure ◽  
Bifurcation Aneurysm ◽  
Retreatment Rate

Introduction: Penumbra SMART COIL® (SMART) System is a novel generation embolic coil with varying stiffness. The study purpose was to report real-world usage of the SMART System in patients with intracranial aneurysms (ICA) and non-aneurysm vascular lesions.Materials and Methods: The SMART Registry is a post-market, prospective, multicenter registry requiring ≥75% Penumbra Coils, including SMART, PC400, and/or POD coils. The primary efficacy endpoint was retreatment rate at 1-year and the primary safety endpoint was the procedural device-related serious adverse event rate.Results: Between June 2016 and August 2018, 995 patients (mean age 59.6 years, 72.1% female) were enrolled at 68 sites in the U.S. and Canada. Target lesions were intracranial aneurysms in 91.0% of patients; 63.5% were wide-neck and 31.8% were ruptured. Adjunctive devices were used in 55.2% of patients. Mean packing density was 32.3%. Procedural device-related serious adverse events occurred in 2.6% of patients. The rate of immediate post-procedure adequate occlusion was 97.1% in aneurysms and the rate of complete occlusion was 85.2% in non-aneurysms. At 1-year, the retreatment rate was 6.8%, Raymond Roy Occlusion Classification (RROC) I or II was 90.0% for aneurysms, and Modified Rankin Scale (mRS) 0-2 was achieved in 83.1% of all patients. Predictors of 1-year for RROC III or retreatment (incomplete occlusion) were rupture status (P < 0.0001), balloon-assisted coiling (P = 0.0354), aneurysm size (P = 0.0071), and RROC III immediate post-procedure (P = 0.0086) in a model that also included bifurcation aneurysm (P = 0.7788). Predictors of aneurysm retreatment at 1-year was rupture status (P < 0.0001).Conclusions: Lesions treated with SMART System coils achieved low long-term retreatment rates.Clinical Trial Registration:https://www.clinicaltrials.gov/, identifier NCT02729740.

Abstract WP130: Long Term Outcome of Large and Giant Unruptured Intracranial Aneurysms

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Issei Kan ◽  
Toshihiro Ishibashi ◽  
Ichiro Yuki ◽  
Masayuki Ebara ◽  
Hideki Arakawa ◽  
...  
Keyword(s):  
Endovascular Therapy ◽  
Intracranial Aneurysms ◽  
Long Term Results ◽  
Final Visit ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Unruptured Intracranial Aneurysms ◽  
Retreatment Rate

Objectives: Long term outcome of large / giant unruptured intracranial aneurysms (LG-UIAs) after endovascular therapy is still unknown. We retrospectively analyzed long-term results of patients with LG-UIAs who were followed up more than 5 years after endovascular therapy. Methods: We included patients from our complete database with UIAs greater than 10mm and treated at our hospital from January 2003 to December 2013. Retreatment rate of targeted aneurysms, rupture rate, and the modified Rankin scale (mRS) at last visit were evaluated till December 2018. Results: From 142 patients treated during the period were excluded 3 patients with perioperative rupture and 38 patients with less than 5 years follow-up period, finally analyzing 101 patients. The median aneurysm size was 12.0 mm (IQR 10.8-15). The median follow-up period was 9.4 years (IQR: 7-11), the longest being 13.3 years. Retreatment was performed on 36 patients (35.6%). Comparing cumulative re-treatment rates in groups with aneurysm sizes <15 mm and> 20 mm, it was predominantly higher for aneurysms> 20 mm (P = 0.02, Figure1 ). Rupture of targeted aneurysms was observed in 2 cases (1.98%, Figure2 ), and the longest period from last treatment was up to 12 years. The mRS 0-1 at the first treatment and the final visit were 98% and 93%, respectively, and mRS deterioration remained at 5%. Conclusion: The retreatment rate tended to increase in proportion to the size of the aneurysm, however the final neurological outcome was favorable when considering the natural history of these aneurysms. Since aneurysmal rupture could occur after 12 years of treatment, long-term follow-up should be considered for LG-UIAs.

scholarly journals Endovascular Treatment of Anterior Circulation Aneurysms With the p64 Flow Modulation Device: Mid- and Long-Term Results in 617 Aneurysms From a Single Center

2021 ◽  
Author(s):  
Marta Aguilar Pérez ◽  
Elina Henkes ◽  
Victoria Hellstern ◽  
Carmen Serna Candel ◽  
Christina Wendl ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
High Rate ◽  
Long Term Results ◽  
Effective Treatment Option ◽  
Anterior Circulation ◽  
Acute Hemorrhage ◽  
Unruptured Aneurysms ◽  
Long Term Follow Up

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.

A Reappraisal of Anterior Communicating Artery Aneurysms

Neurosurgery ◽  
2015 ◽  
Vol 78 (2) ◽  
pp. 200-207 ◽  
Author(s):  
Leonardo B.C. Brasiliense ◽  
Jang W. Yoon ◽  
Josiah N. Orina ◽  
David A. Miller ◽  
Rabih G. Tawk ◽  
...  
Keyword(s):  
Distal Segment ◽  
Long Term Results ◽  
Anterior Communicating Artery ◽  
Post Intervention ◽  
Stent Deployment ◽  
Anterior Communicating Artery Aneurysms ◽  
Hemorrhagic Events ◽  
Retreatment Rate

ABSTRACT BACKGROUND: Wide-necked anterior communicating artery aneurysms represent a subset of lesions with challenging endovascular treatment despite new endoluminal and intrasaccular devices. OBJECTIVE: To assess the long-term clinical and angiographic outcomes of stent-assisted embolization for wide-necked anterior communicating artery aneurysms. METHODS: Between March 2008 and March 2014, 32 patients with unruptured wide-necked AComm aneurysms were treated using stent-assisted embolization. The Glasgow Outcome Scale was reviewed at the time of discharge and at latest follow-up. Ischemic and hemorrhagic events were also recorded and analyzed. Aneurysm occlusion was evaluated post-intervention and on subsequent follow-up evaluations. RESULTS: Successful stent deployment was achieved in all cases, but in 1 patient the coils could not be contained inside the aneurysm, and the procedure was aborted without complications. The distal segment of the stent was positioned in the ipsilateral A2 in 16 patients, in the contralateral A2 in 15 patients, and in the contralateral A1 in 1 patient. There were no periprocedural thromboembolic or hemorrhagic complications. The rate of major complications was 6%. One patient developed intracranial hemorrhage related to antiplatelet therapy and another had ischemic events due to in-stent stenosis. Angiographic follow-up was available for 26 aneurysms and during a mean follow-up of 22 months, 81% of the lesions were completely occluded and 8% had a small residual neck. The retreatment rate for residual aneurysms was 3%. CONCLUSION: Our long-term results suggest that stent-assisted embolization for anterior communicating artery aneurysms may be considered an excellent treatment option with an adequate combination of safety profile and effectiveness.

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

scholarly journals Early experience with the Penumbra SMART coil in the endovascular treatment of intracranial aneurysms: Safety and efficacy

2016 ◽  
Vol 22 (6) ◽  
pp. 654-658 ◽  
Author(s):  
Christopher J Stapleton ◽  
Collin M Torok ◽  
Aman B Patel
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Thromboembolic Complication ◽  
Flow Diversion ◽  
Long Term Results ◽  
Conformational Structure ◽  
Safety And Efficacy ◽  
Endovascular Coil Embolization ◽  
Male Patients

Background Penumbra SMART coils differ from traditional microcoils used for endovascular coil embolization of intracranial aneurysms (IAs) in that they (1) become progressively softer from their distal to proximal end, rather than being of uniform stiffness, (2) have a tight conformational structure, and (3) have a more robust stretch-resistance platform. These properties aid in preventing microcatheter prolapse and coil herniation during coil deployment and in filling small pockets of the aneurysm sac. Objective/Methods To determine the safety and efficacy of this device, the records of 17 consecutive patients with IAs treated with SMART coils were retrospectively analyzed. Results Thirteen female and four male patients were identified. Eleven patients presented with subarachnoid hemorrhage, four had recurrent aneurysms, and two had incidentally discovered aneurysms. Twelve aneurysms (two of which were recurrent) were treated with stand-alone coiling, three were treated with stent-assisted coiling, and two with flow diversion with adjuvant coiling. Microcatheter prolapse occurred in one case of a recurrent aneurysm, due to mechanical limitations imposed by a stent placed during prior coiling. Raymond-Roy Occlusion Classification (RROC) I or II occlusion was achieved in 12 aneurysms, including all 10 undergoing primary stand-alone coiling. Of the five RROC III occlusions, two were expected given treatment with flow diversion, while the other three occurred in complex, recurrent aneurysms. One patient suffered a thromboembolic complication of unclear clinical significance. Conclusions The Penumbra SMART coil is a safe and effective device for the endovascular treatment of IAs. Follow-up studies are required to establish long-term results.

Treatment of intracranial aneurysms by flow diverter devices: Long-term results from a single center

2014 ◽  
Vol 83 (9) ◽  
pp. 1683-1690 ◽  
Author(s):  
Francesco Briganti ◽  
Manuela Napoli ◽  
Giuseppe Leone ◽  
Mariano Marseglia ◽  
Giuseppe Mariniello ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Long Term Results ◽  
Single Center ◽  
Flow Diverter Devices

Endovascular treatment of intracranial aneurysms with the Woven EndoBridge device: mid term and long term results

2017 ◽  
Vol 10 (2) ◽  
pp. 127-132 ◽  
Author(s):  
Benjamin Mine ◽  
Alexandra Goutte ◽  
Denis Brisbois ◽  
Boris Lubicz
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Long Term Results ◽  
Results Of Treatment ◽  
Long Term Follow Up ◽  
Device Placement ◽  
Woven Endobridge ◽  
Web Device

PurposeTo evaluate the clinical and anatomical results of treatment of intracranial aneurysms (IA) with the Woven EndoBridge (WEB) device, with emphasis on mid term and long term follow-up.MethodsBetween November 2010 and November 2015, we retrospectively identified, in our prospectively maintained database, all patients treated by WEB device placement for an IA at three institutions. Clinical charts, procedural data, and angiographic results were reviewed.Results48 patients with 49 IAs were identified. There were 35 women and 13 men with a mean age of 57 years (range 35–76 years). All IA were wide necked. Mean aneurysm size was 8.6 mm. There were 44 unruptured IA and 5 ruptured IA. During endovascular treatment (EVT), adjunctive devices were used in 22.4% of procedures. A good clinical outcome (modified Rankin Scale score ≤2) was achieved in 44/48 patients (92%). There was no mortality. Mean follow-up was 25 months (range 3–72 months; median 24 months). Between mid term and long term follow-up, occlusion was stable in 19/23 IA (82.6%), improved in 2/23 IA (8.7%), and worsened in 2/23 IA (8.7%). Retreatment was performed in 8/49 IA (16.3%). At the latest available follow-up, there were 34/47 (72.3%) complete occlusions and 13/47 (27.7%) neck remnants.ConclusionsOur study suggests that EVT of IA with the WEB device provides adequate and stable long term occlusion.

scholarly journals New Devices Designed to Improve the Long-Term Results of Endovascular Treatment of Intracranial Aneurysms

2004 ◽  
Vol 10 (2) ◽  
pp. 93-102 ◽  
Author(s):  
J. Raymond ◽  
P. Leblanc ◽  
M. Chagnon ◽  
G. Gévry ◽  
J.-P. Collet ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Intracranial Aneurysms ◽  
Controlled Trial ◽  
Long Term Results ◽  
Secondary Outcome ◽  
Endovascular Coiling ◽  
Double Blind Study ◽  
Double Blind ◽  
Term Efficacy

Endovascular coiling can improve the outcome of patients with ruptured intracranial aneurysms, but angiographic recurrences are frequent compared to surgical clipping. New coils or devices have been introduced to improve long-term results of endovascular treatment but none have been the object of a valid clinical trial. We have proposed a multicentric randomized double-blind study comparing radioactive and standard coil occlusion of aneurysms. The purpose of this article is to review issues that are specific to the design of clinical trials to assess embolic agents that could improve the long-term efficacy of endovascular treatment of intracranial aneurysms. The proposed trial is a randomized, multi-center, prospective, controlled trial comparing the new generation coils to standard platinum coils. Blinding, if at all possible, is preferable to minimize bias, at least for follow-up angiographic studies that should cover a period of 18 months. All patients with an intracranial aneurysm eligible for endovascular treatment would be proposed to participate. The study would enrol approximately 500 patients equally divided between the two groups, recruited within two years, to demonstrate a decrease in the recurrence rate, the primary outcome measure, from 20% to 10%. Secondary outcome measures should assure that complications, initial clinical and angiographic results remain unchanged. Independent data safety and monitoring committees are crucial to the credibility of trials and to ensure scientific rigor and objectivity. The scientific demonstration of an improved long-term efficacy, without significant compromise regarding safety, is mandatory before considering the widespread use of a new embolic device for the endovascular treatment of aneurysms.

Long-term results of transjugular coil embolisation for pelvic vein reflux – Results of the abolition of venous reflux at 6–8 years

2016 ◽  
Vol 31 (7) ◽  
pp. 456-462 ◽  
Author(s):  
Scott J Dos Santos ◽  
Judy M Holdstock ◽  
Charmaine C Harrison ◽  
Mark S Whiteley
Keyword(s):  
Varicose Veins ◽  
Long Term Results ◽  
Duplex Ultrasonography ◽  
Venous Reflux ◽  
Pelvic Vein ◽  
Post Procedure ◽  
Long Term Follow Up ◽  
One Year

Background Pelvic venous reflux is known to be associated with lower limb varicose veins in 20% of women with a history of at least one previous vaginal delivery. Pelvic vein embolisation with coils has been shown to be a successful treatment in the short term. The objective of this study was to ascertain the long-term outcomes of pelvic vein embolisation for pelvic venous reflux. Methods Patients who had undergone pelvic vein embolisation in 2005–2007 were invited back to a specialist vein unit for transvaginal duplex ultrasonography in the summer of 2013. A total of 110 women were contacted. Pre-embolisation transvaginal duplex ultrasonography results were compared to those obtained six weeks post-procedure and at long-term follow-up. Results Twenty-eight female patients aged 40 to 75 years (mean 53.5) attended (response rate 25.5%), with parity prior to embolisation ranging from 1–5 children (mean 2.8). Mean follow-up time was 7.5 years. Six weeks post-procedure, 25 women had complete or virtual elimination of all reflux, and three had persistent reflux in at least one vein. At long-term follow-up, 11 women had complete elimination of all reflux, seven had elimination of all truncal reflux but minor reflux in vulval veins, six had minor reflux in one truncal vein, and four had significant reflux in one or more truncal veins (one of these gave birth one-year post-pelvic vein embolisation and another had coils removed during gynaecological surgery). Conclusions Transjugular pelvic vein embolisation is a durable technique for the abolition of reflux in the pelvic veins and is particularly adept at treating reflux in the ovarian veins.

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.

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