Medina® Embolization Device for the Treatment of Intracranial Aneurysms: Safety and Angiographic Effectiveness at 6 Months

Neurosurgery ◽  
2017 ◽  
Vol 82 (2) ◽  
pp. 155-162 ◽  
Author(s):  
Nader-Antoine Sourour ◽  
Saskia Vande Perre ◽  
Federico Di Maria ◽  
Chrysanthi Papagiannaki ◽  
Joseph Gabrieli ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Artery Aneurysm ◽  
Thromboembolic Complication ◽  
Anterior Communicating Artery ◽  
Clinical Consequence ◽  
Detachable Coil ◽  
New Device ◽  
Flow Disruption ◽  
Occlusion Rate

Abstract BACKGROUND The Medina Embolization Device (MED) is a new concept device that combines the design of a detachable coil and the one of an intrasaccular flow disruption device. OBJECTIVE To evaluate the feasibility, safety, and 6- to 9-mo effectiveness of this new device for the treatment of intracranial wide-necked aneurysms. METHODS Twelve patients (10 females, mean age = 56 yr) with 13 wide-necked intracranial aneurysms (3 ruptured; 10 unruptured) were treated by means of the MED from January 2015 to October 2015. In 15% of the cases, MEDs were used in a standalone fashion; in 85% of the cases, additional regular coils were used. Adjunctive compliant balloon was used in 4 of 13 cases (31%). Procedure-related complications were systematically recorded; discharge and 6- to 9-mo follow-up modified Rankin Scale was assessed. Angiographic follow-up was performed with a mean delay of 5.5 ± 1.7 mo. Occlusion rate was evaluated in postprocedure and at midterm follow-up using the Roy–Raymond scale. RESULTS The deployment of the MED was feasible in all cases. No perforation was recorded. One case of thromboembolic complication was observed in a ruptured anterior communicating artery aneurysm, without any clinical consequence at follow-up. Grade A occlusion rate was 61.5% in postprocedure and 83% at 6-mo follow-up. Two cases (17%) of recanalization were documented angiographically. CONCLUSION The MED is a new generation device combining the design of a detachable coil and an intrasaccular flow disruption device. According to our early experience, this device is safe and provides a satisfactory occlusion rate at angiographic follow-up of 6 mo.

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.

Abstract 122: Intra-aneurysmal Flow Disruption: A New Approach for the Endovascular Treatment of Intracranial Aneurysms. Clinical Experience in a Multicenter Series of 66 Patients with 68 Aneurysms.

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Laurent Pierot ◽  
Anne-Christine Januel ◽  
Laurent Spelle ◽  
Chrysanthi Papagiannaki ◽  
Hélène Raoult ◽  
...  
Keyword(s):  
Clinical Experience ◽  
Intracranial Aneurysms ◽  
Thromboembolic Complication ◽  
Anterior Communicating Artery ◽  
Total Occlusion ◽  
Flow Disruption ◽  
Knowing That ◽  
Large And Giant Aneurysms ◽  
Intraoperative Rupture

Purpose: Standard coiling is now the first line approach for the treatment of intracranial aneurysms. However, this technique has some limitations, including treatment of wide-neck and large and giant aneurysms and recanalizations. Therefore, new techniques and devices are needed. The objective of intra-saccular flow disruption is the modification of aneurysmal flow by placing a device in the aneurysm sac. Clinical experience with this new technique is analyzed in a series collected in 11 French centers. Materials and Methods: The WEB (Sequent, Aliso Viejo, CA) is a self-expanding, oblate, braided nitinol mesh, composed of an inner and outer braid held together by proximal, middle, and distal radio-opaque markers and creating two compartments: one distal and one proximal. 66 patients (49F/17M, age: 36-75 years) harbouring 68 aneurysms (ruptured: 5, unruptured: 57 or recanalized: 6) were treated between June 2011 and July 2013. Aneurysm location was middle cerebral artery (39 aneurysms), basilar artery (16), anterior communicating artery (7), and internal carotid artery (6). Results: The device was successfully deployed in all but 4 cases (failure rate: 5.9%). Additional coiling was performed in 6 aneurysms, remodeling in 2 cases, and stenting in 1 case. One intraoperative rupture was observed in a ruptured aneurysm (1.5%). Six thromboembolic events (8.8%) were observed with transient clinical worsening and good clinical outcome in 5 cases (mRS ≤2). No delayed rupture or remote hematoma was observed. Finally mortality was 0.0% and morbidity 1.5% (in a patient who both had intraoperative rupture and thromboembolic complication). Anatomical follow-up was obtained in 32 patients 3 to 15 months after the treatment. Total occlusion was obtained in 15/32 aneurysms (46.9%), neck remnant in 14/32 aneurysms (43.8%), and aneurysm remnant in 3/32 aneurysms (9.4%). Conclusion: In the present series reporting the initial clinical experience with intra-saccular flow disruption using WEB in 11 French centers, the feasibility of treatment is high, the safety profile similar to coiling, and anatomical results are quite satisfactory knowing that some neck remnants are in fact just opacification of the proximal recess of the device.

scholarly journals Radiological Changes in Infantile Dissecting Anterior Communicating Artery Aneurysm Treated Endovascularly

2014 ◽  
Vol 20 (6) ◽  
pp. 796-803 ◽  
Author(s):  
Kenji Yatomi ◽  
Hidenori Oishi ◽  
Munetaka Yamamoto ◽  
Yasuo Suga ◽  
Senshu Nonaka ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Blood Coagulation ◽  
Intracranial Aneurysms ◽  
Artery Aneurysm ◽  
Dissecting Aneurysm ◽  
Anterior Communicating Artery ◽  
Anterior Communicating Artery Aneurysm ◽  
Radiological Changes ◽  
Dissecting Aneurysms

Intracranial aneurysms are extremely rare in infants, and to our knowledge only seven infants treated for ruptured spontaneous dissecting aneurysms have been reported. Good outcomes have been achieved with endovascular treatment of infantile aneurysm. We the endovascular treatment of a one-month-old girl for ruptured dissecting aneurysm located in the anterior communicating artery, and the unique radiological changes that were observed during the perioperative and follow-up periods. These changes suggest that blood coagulation and fibrinolytic response play a part in the repair and healing processes of dissecting aneurysms. Careful neuroradiological surveys are needed for pediatric dissecting aneurysms treated endovascularly.

scholarly journals Endovascular treatment of wide-necked intracranial aneurysms using the novel Contour Neurovascular System: a single-center safety and feasibility study

2020 ◽  
Vol 12 (10) ◽  
pp. 987-992 ◽  
Author(s):  
Christopher Yusuf Akhunbay-Fudge ◽  
Kenan Deniz ◽  
Atul Kumar Tyagi ◽  
Tufail Patankar
Keyword(s):  
Intracranial Aneurysms ◽  
Medical Condition ◽  
Superior Cerebellar Artery ◽  
Anterior Communicating Artery ◽  
New Device ◽  
System A ◽  
Radiological Data ◽  
Cerebellar Artery ◽  
Class 1

Background and purposeWide-necked bifurcation aneurysms pose a significant challenge to the treating clinician. The Contour Neurovascular System embolization device is a novel tool for the treatment of such intracranial aneurysms. We report on our experience with this device.MethodsProspective clinical and radiological data were collected for all patients treated with the Contour device at our center. All our patients were treated on an elective basis.ResultsWe have treated 11 patients successfully with the Contour device to date. All patients were women with a mean (SD) age of 65.0 (6.4) years. In total, four basilar tip, two internal carotid artery, three middle cerebral artery, one anterior communicating artery, and one superior cerebellar artery aneurysms were treated. At 1-year follow-up, complete occlusion (Raymond Class 1) was seen in 55.56% (5/9) of cases, with 44.44% (4/9) having small neck remnants (Raymond Class 2). One patient declined 1-year catheter angiography and another had no further follow-up due to an unrelated medical condition. For six patients, 2-year radiological follow-up is available and shows stability. At 6 weeks, nine of the 11 patients had a modifed Rankin Scale score of 0, with two patients scoring 1 for headaches. Two patients had thromboembolic events, but there were no complications leading to permanent neurological disability or death. We additionally had three patients where the Contour device was attempted but was unable to be successfully used.ConclusionInitial results are promising although larger case numbers and longer follow-up are necessary to draw further conclusions on the utility and risk profile of this new device.

Midterm results of T-stent–assisted coiling of wide-necked and complex intracranial bifurcation aneurysms using low-profile stents

2017 ◽  
Vol 127 (6) ◽  
pp. 1288-1296 ◽  
Author(s):  
Kubilay Aydin ◽  
Serra Sencer ◽  
Mehmet Barburoglu ◽  
Mynzhylky Berdikhojayev ◽  
Yavuz Aras ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Intracranial Aneurysms ◽  
Anterior Communicating Artery ◽  
Total Occlusion ◽  
Technical Success Rate ◽  
Low Profile ◽  
Scale Scores ◽  
Occlusion Rate ◽  
Double Stent

OBJECTIVECoiling of wide-necked and complex bifurcation aneurysms frequently requires implantation of double stents in various configurations. T-stent–assisted coiling involves the nonoverlapping implantation of 2 stents to protect the daughter vessels of bifurcation and is followed by coiling of the aneurysm. The authors studied the feasibility, efficacy, and safety of the T-stent–assisted coiling procedure as well as the midterm angiographic/clinical outcomes of patients with wide-necked bifurcation intracranial aneurysms treated using this technique.METHODSThe authors retrospectively identified patients with wide-necked bifurcation intracranial aneurysms treated using double-stent–assisted coiling with a T-stent configuration.RESULTSTwenty-four patients with 24 aneurysms and a mean of age of 51.91 years were identified. The most common locations were the middle cerebral bifurcation (45.8%) and anterior communicating artery (35.7%). T stentings were performed using low-profile stents. The procedures were performed with a technical success rate of 95.8%, and an immediate total occlusion rate of 79.2% was achieved. We observed periprocedural complications in 16.7% of cases and a delayed thromboembolic event in 4.2%. The complications caused permanent morbidity in 1 patient (4.2%). No deaths occurred. The mean angiographic follow-up duration was 9.3 months. The total occlusion rate at the last follow-up was 81.2%. The recanalization rate was 4.5%. Modified Rankin Scale scores of all patients at the last follow-ups were between zero and 2.CONCLUSIONST-stent–assisted coiling using low-profile stents is a feasible, effective, and relatively safe endovascular technique used to treat wide-necked and complex intracranial aneurysms. The midterm angiographic and clinical outcomes are outstanding.

scholarly journals Initial Experience with LVIS EVO Stents for the Treatment of Intracranial Aneurysms

2020 ◽  
Vol 9 (12) ◽  
pp. 3966
Author(s):  
Wojciech Poncyljusz ◽  
Kinga Kubiak
Keyword(s):  
Cerebral Artery ◽  
Intracranial Aneurysms ◽  
Internal Carotid ◽  
Cerebral Aneurysms ◽  
Thromboembolic Complication ◽  
Anterior Communicating Artery ◽  
Unruptured Aneurysms ◽  
Low Profile ◽  
Class 1 ◽  
Occlusion Rate

Background: Over the years, a variety of intracranial stents have been developed, which has expanded the therapy options available for cerebral aneurysms. The Low profile visible intraluminal support (LVIS) EVO stents are new devices, which officially appeared on the market in 2020. The purpose of the study is to report the initial technical and clinical experience with the new stent in the treatment of intracranial aneurysms. Materials and Methods: Between February and September 2020, 30 patients with 35 intracranial aneurysms (29 unruptured and 6 ruptured) were treated using the LVIS EVO stent in our department. The aneurysms were located within internal carotid artery (ICA) (42.9%), middle cerebral artery (MCA) (31.4%), anterior communicating artery (AComA) (11.4%), basilar artery (BA) (11.4%) and anterior cerebral artery (ACA) (2.9%). Stent-assisted coil embolization was performed in all cases. Results: All stents were deployed successfully in the desired position. Immediate complete occlusion of the treated aneurysms, described as Raymond–Roy occlusion classification (RROC) class 1, was achieved in all cases. No technical complications were observed. One thromboembolic complication occurred in the group of unruptured aneurysms and one patient died due to cerebral edema from aneurysms rupture group. Conclusion: In our observation, the showed a satisfactory safety profile LVIS EVO stents seem to be very flexible, can be safely maneuvered and deployed in tortuous vessels. They showed a good initial occlusion rate when used for treating intracranial aneurysms with SAC (stent-assisted coiling).

Determination of filling volumes in HydroCoil-treated aneurysms by using three-dimensional computerized tomography angiography

2005 ◽  
Vol 18 (2) ◽  
pp. 1-5 ◽  
Author(s):  
Eric M. Deshaies ◽  
Sandeep Bagla ◽  
Celso Agner ◽  
Alan S. Boulos
Keyword(s):  
Computerized Tomography ◽  
Coil Embolization ◽  
Intracranial Aneurysms ◽  
Three Dimensional ◽  
Artery Aneurysm ◽  
Anterior Communicating Artery ◽  
Filling Volume ◽  
Computerized Tomography Angiography ◽  
Surgical Clip

Object Coil embolization of aneurysms has been shown to be as safe and effective as surgical clip ligation, but has a higher recurrence rate. Advances in coil technology aim to reduce aneurysm recurrence by coating the devices with biological substances. An example of this is MicroVention's HydroCoil, which is a platinum coil coated with hydro-gel that improves filling volumes by swelling when it contacts blood. The goal of this study was to determine whether this new coil type significantly reduced or prevented recurrences of aneurysms. Methods The authors used three-dimensional computerized tomography angiography to determine aneurysm volumes accurately in 12 patients prior to coil embolization. The percentage filling volume was subsequently calculated for each aneurysm after treatment with HydroCoils and the immediate and 6-month follow-up angiographically confirmed occlusions were evaluated. The data demonstrated that both anterior and posterior intracranial aneurysms with diameters of 3 to 25 mm and volumes of 0.03 to 4.8 ml had filling volumes of 0.02 to 1.36 ml, resulting in filling volumes from 23% in a giant ophthalmic artery aneurysm to 80% in a small anterior communicating artery aneurysm. All of the aneurysms except for the giant one demonstrated stable occlusion on angiographic studies obtained at the 6-month follow-up review. Conclusions HydroCoil embolization of intracranial aneurysms is safe and effective for small, large, and very large aneurysms. The percentage filling volume is greater than that reported for bare platinum coils in every case except the giant aneurysm. Nevertheless, angiographically confirmed occlusion is not directly related to percentage filling volume, but rather to the ability to occlude the aneurysm neck.

scholarly journals LVIS Jr. stent for treatment of intracranial aneurysms with parent vessel diameter of 2.5 mm or less

2018 ◽  
Vol 24 (3) ◽  
pp. 246-253 ◽  
Author(s):  
Alejandro Santillan ◽  
Srikanth Boddu ◽  
Justin Schwarz ◽  
Ning Lin ◽  
Y Pierre Gobin ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Artery Aneurysm ◽  
Vessel Diameter ◽  
Aneurysm Rupture ◽  
Anterior Communicating Artery ◽  
Parent Vessel ◽  
Low Profile ◽  
Aneurysm Occlusion ◽  
Middle Cerebral Artery Aneurysms

Background and purpose This retrospective study evaluates the safety, effectiveness, and long-term clinical and angiographic follow-up of intracranial aneurysms treated with the Low-Profile Visualized Intraluminal Support Junior (LVIS Jr.) stent and parent vessels of diameter equal to or less than 2.5 mm. Materials and methods We included all patients treated with the LVIS Jr. stent in aneurysms with small parent vessel diameter between March 2015 and July 2017. Periprocedural adverse events, immediate aneurysm occlusion rates, and clinical and angiographic follow-up are reported. Results A total of 35 patients with 35 aneurysms were included. Ten aneurysms were ruptured (28.6%) and 25 were unruptured (71.4%). The parent arteries measured 0.9 mm to 2.5 mm in diameter (mean, 2.2 mm). Intra-procedural thromboembolic complications occurred in four patients (11.4%) and there was an intraoperative aneurysm rupture in one patient (2.8%). Immediate complete aneurysm occlusion was noted in 21 out of 35 patients (60%). Clinical follow-up ranged between one and 25 months (mean, 10.5 months) and magnetic resonance angiography follow-up ranged between four and 24 months (mean, 10.4 months). Complete aneurysm occlusion was achieved in 21 out of 29 patients (72.4%) at last angiographic follow-up (mean, 9.4 months; range four to 23 months). In-stent stenosis occurred in one out of 29 patients (3.4%), who was asymptomatic. Of the four patients with in-stent thrombosis, three patients were treated with “Y configuration” (two patients with middle cerebral artery aneurysms and one patient with an anterior communicating artery aneurysm). Mortality rate was 0%. Neurological morbidity was 2.9%. Conclusions Stenting with the LVIS Jr. stent allowed us to treat complex intracranial aneurysms with parent vessel diameter of 2.5 mm or less with an acceptable safety profile.

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.

Flow redirection endoluminal device (FRED) for treatment of intracranial aneurysms: A systematic review

2021 ◽  
pp. 159101992110279
Author(s):  
Muhammad Waqas ◽  
Rimal H Dossani ◽  
Modhi Alkhaldi ◽  
Jocelyn Neveu ◽  
Justin M Cappuzzo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Intracranial Aneurysms ◽  
Flow Diverter ◽  
Complication Rates ◽  
Mesh Terms ◽  
Aneurysm Occlusion ◽  
Occlusion Rate ◽  
Layered Flow ◽  
Comparative Safety

Introduction The Flow Redirection Endoluminal Device (FRED; MicroVention) is a dual-layered flow diverter used for the treatment of intracranial aneurysms. The objective of this systematic review was to compile device-related safety and effectiveness data. Methods The literature from January 1, 2013 to April 30, 2021 was searched for studies describing use of the FRED for intracranial aneurysm treatment irrespective of aneurysm location and morphology. The review included anterior and posterior circulation ruptured and unruptured saccular, fusiform or dissection, and blister aneurysms. MeSH terms related to “flow re-direction endoluminal device” and “FRED for aneurysms” were used. Data related to indication, complications, and rates of aneurysm occlusion were retrieved and analyzed. Results Twenty-two studies with 1729 intracranial aneurysms were included in this review. Overall reported morbidity was 3.9% (range 0–20%). Overall procedure-related mortality was 1.4% (range 0–6%). Complication rates fell into 5 categories: technical (3.6%), ischemic (3.8%), thrombotic or stenotic (6%), hemorrhagic (1.5%), and non-neurological (0.8%). The aneurysm occlusion rate between 0 and 3 months (reported in 11 studies) was 47.8%. The occlusion rate between 4 and 6 months (reported in 14 studies) was 73.8%. Occlusion rates continued to increase to 75.1% at 7–12 months (reported in 10 studies) and 86.6% for follow-up beyond 1 year (reported in 10 studies). Conclusion This review indicated that the FRED is a safe and effective for the treatment of intracranial aneurysms. Future studies should directly compare the FRED with other flow diverters for a better understanding of comparative safety and effectiveness among the different devices.

Sign in / Sign up

Export Citation Format

Share Document