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

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.

2017 ◽  
Vol 10 (2) ◽  
pp. 127-132 ◽  
Author(s):  
Benjamin Mine ◽  
Alexandra Goutte ◽  
Denis Brisbois ◽  
Boris Lubicz

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.


2004 ◽  
Vol 10 (2) ◽  
pp. 93-102 ◽  
Author(s):  
J. Raymond ◽  
P. Leblanc ◽  
M. Chagnon ◽  
G. Gévry ◽  
J.-P. Collet ◽  
...  

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.


2020 ◽  
pp. 159101992095689
Author(s):  
Malia B McAvoy ◽  
Justin M Cappuzzo ◽  
Christopher J Stapleton ◽  
Matthew J Koch ◽  
Scott B Raymond ◽  
...  

Background The Penumbra SMART coil is a novel device that becomes progressively softer from its distal to proximal end to maximize coil packing and prevent microcatheter prolapse or coil migration. Here, we report a large series of patients detailing the long-term experience of a single institution using the SMART coil among patients with intracranial aneurysms (IAs). Methods Prospective data of 105 consecutive patients with 106 IAs treated using SMART coils was collected between March 2015 and July 2018. Clinical and angiographic data were analyzed. Results Forty-nine patients (46.7%) presented with subarachnoid hemorrhage and 16 (14.2%) had recurrent aneurysms. Two patients had minor intraprocedural ruptures and remained neurologically stable. One patient had a thromboembolic complication with progressive neurologic decline. There was only one case microcatheter prolapse related to placement of a stent before coiling. An initial post-treatment modified Raymond-Roy Occlusion Classification (mRROC) I or II closure was achieved in 56 (52.8%) aneurysms. The average time to last follow-up was 8.4 months at which 70 (81.4%) aneurysms had mRROC I or II occlusion and a major recurrence was seen in 5 (5.8%) patients. Thirteen (12.3%) aneurysms required re-treatment of which one aneurysm was clipped. Conclusions The Penumbra SMART coil is safe and effective for the endovascular treatment of appropriately selected IAs. Additional studies at multiple centers comparing safety and efficacy profile over long-term periods to other mainstream coils are necessary.


2021 ◽  
Vol 12 ◽  
Author(s):  
Victoria Hellstern ◽  
Marta Aguilar-Pérez ◽  
Elina Henkes ◽  
Carmen Serna-Candel ◽  
Christina Wendl ◽  
...  

Objective: Flow diverter (FD) stents have become one of the most common tools for treating intracranial aneurysms; however, their role in treating posterior circulation aneurysms is still discussed with controversy. In this study, we evaluated the safety and effectiveness of p64 FD for the treatment of saccular, unruptured aneurysms in the posterior circulation over a long-term follow-up period in a single center.Methods: From our prospectively maintained database, we retrospectively identified patients who underwent treatment of an intracranial saccular aneurysm arising from the posterior circulation with ≥1 p64 FD implanted or attempted between October 2012 and December 2019. Aneurysms could have been treated with prior or concomitant saccular treatment (e.g., coiling, intra-aneurysmal flow diversion). Aneurysms with parent vessel implants other than p64, fusiform aneurysms, and dissections were excluded. Peri- and postprocedural complications, clinical outcome, and clinical and angiographic follow-up results were evaluated.Results: In total, 54 patients (45 female, 9 male; mean age 55.1 years) with 54 intracranial aneurysms met the inclusion criteria. In 51 cases (94.4%), one p64 was implanted; in 2 cases (3.7 %), two p64s were implanted; in one case, deployment of the p64 was not feasible. Procedural complications occurred in 3.7% and postprocedural complications in 9.3 %, respectively. Hemorrhagic complications occurred in 2/54 patients (3.7%), thereof one fatal parenchymal hemorrhage. Ischemic complications were observed in 5/54 patients (9.3%). Early, mid-term, and long-term angiographic follow-up examinations showed complete or near-complete aneurysm occlusion, defined according to the O'Kelly –Marotta (OKM) scale as OKM C + D in 56, 75.6, and 82.9 %, respectively. Asymptomatic side vessel occlusions occurred in 3.8%, each during the first follow-up.Conclusions: The implantation of a p64 FD is a safe and effective device for endovascular treatment of posterior circulation saccular aneurysms with a high success rate and low morbi-mortality.


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.


2021 ◽  
Vol 11 (5) ◽  
pp. 344
Author(s):  
Ching-Feng Wu ◽  
Jui-Ying Fu ◽  
Chi-Tsung Wen ◽  
Chien-Hung Chiu ◽  
Ming-Ju Hsieh ◽  
...  

Intravenous ports serve as vascular access and are indispensable in cancer treatment. Most studies are not based on a systematic and standardized approach. Hence, the aim of this study was to demonstrate long-term results of port implantation following a standard algorithm. A total of 2950 patients who underwent intravenous port implantation between March 2012 and December 2018 were included. Data of patients managed following a standard algorithm were analyzed for safety and long-term outcomes. The cephalic vein was the predominant choice of entry vessel. In female patients, wire assistance without use of puncture sheath was less likely and echo-guided puncture via internal jugular vein (IJV) with use of puncture sheath was more likely to be performed, compared to male patients (p < 0.0001). The procedure-related complication rate was 0.07%, and no pneumothorax, hematoma, catheter kinking, catheter fracture, or pocket erosion was reported. Catheter implantations by echo-guided puncture via IJV notably declined from 4.67% to 0.99% (p = 0.027). Mean operative time gradually declined from 37.88 min in 2012 to 23.20 min in 2018. The proposed standard algorithm for port implantation reduced the need for IJV echo-guided approach and eliminated procedure-related catastrophic complications. In addition, it shortened operative time and demonstrated good functional results.


2021 ◽  
Author(s):  
Marta Aguilar Pérez ◽  
Elina Henkes ◽  
Victoria Hellstern ◽  
Carmen Serna Candel ◽  
Christina Wendl ◽  
...  

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.


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