Pipeline Flex Embolization Device Research Articles

The natural history of aneurysms incompletely occluded by placement of a flow diverter: a multiinstitutional study.

Treatment of intracranial aneurysms by flow diversion is safe and effective and is increasingly popular. However, the correct treatment paradigm for aneurysms incompletely treated by initial placement of a flow diverter has not been established, nor have the subsequent natural history and occlusion rates of such aneurysms. The authors sought to outline the natural history of such aneurysms, which to date have been considered partially treated. The authors retrospectively reviewed consecutive cases from 6 high-volume neurointerventional services, including all cases in which the first follow-up imaging after placement of a flow diverter showed incomplete occlusion of the aneurysm, and for which subsequent clinical and/or radiological follow-up was available. All included patients were treated with the Pipeline Flex embolization device or the Pipeline Flex embolization device with Shield Technology. Subsequent radiographic and clinical outcome data were collected and analyzed using the Kaplan-Meier survival function. A total of 263 patients with persistently patent aneurysms on first follow-up imaging after flow diversion were identified. Of these, 204 had clinical follow-up and 152 had additional imaging follow-up. Of this final cohort, 148 aneurysms were unruptured, and 4 were ruptured. The average aneurysm size by maximum dimension was 10.8 mm. The average recorded follow-up was 27.8 months in the cohort, with some patients followed for as long as 9 years from treatment. Over the course of 403 person-years of follow-up, no delayed aneurysm ruptures were recorded. Both with and without retreatment, aneurysms showed a trend toward progressive occlusion over time. Complications related to device placement were low. Aneurysms that have been incompletely treated by flow diversion have a benign natural history with progression toward occlusion over time, with or without retreatment.

Comparison of PED/PED Flex and PED Shield in the treatment of unruptured intracerebral aneurysms.

The object of this study was to compare the efficacy and safety profile of the Pipeline embolization device (PED)/Pipeline Flex embolization device (PED Flex) with that of the Pipeline Flex embolization device with Shield Technology (PED Shield). After introducing the first-generation PED and the second-generation PED Flex with its updated delivery system, the PED Shield was launched with a synthetic layer of phosphorylcholine surface modification to reduce thrombogenicity. This is a retrospective review of unruptured aneurysms treated with PED/PED Flex versus PED Shield between 2017 and 2022 at the authors' institution. Patients with ruptured aneurysms, adjunctive treatment, failed flow diverter deployment, and prior treatment of the target aneurysm were excluded. Baseline characteristics were collected for all patients, including age, sex, past medical history (hypertension, hyperlipidemia, diabetes mellitus), smoking status, aneurysm location, and aneurysm dimensions (neck, width, height) and morphology (saccular, nonsaccular). The primary outcome was procedural and periprocedural complication rates. The study cohort comprised 200 patients with 200 aneurysms, including 150 aneurysms treated with the PED/PED Flex and 50 treated with the PED Shield. With respect to intraprocedural and periprocedural complications, length of stay, length of follow-up, and functional outcome at discharge, there was no significant difference between the two cohorts. At the midterm follow-up, the rate of in-stent stenosis (PED/PED Flex: 14.2% vs PED Shield: 14.6%, p = 0.927), aneurysm occlusion (complete occlusion: 79.5% vs 80.5%, respectively; neck remnant: 4.7% vs 12.2%; dome remnant: 15.7% vs 7.3%; p = 0.119), and the need for retreatment (5.3% vs 0%, p = 0.097) were comparable between the two cohorts. This study suggests that, as compared to first- and second-generation PED and PED Flex, the third-generation PED Shield offers similar rates of complications, aneurysm occlusion, and in-stent stenosis at the midterm follow-up.

Comparison of the hemocompatibility of neurovascular flow diverters with anti-thrombogenic coatings

Despite the continual progress in technology, thromboembolic complications still occur following endovascular treatment of cerebral aneurysms and remain the primary contributor to morbidity and mortality. Thus, coating the surfaces of blood-contacting flow diverters may reduce thrombus-related complications in clinical use. In this study, the hemocompatibility of different commercially available flow diverters Pipeline Flex Embolization Device with Shield Technology (Medtronic), the p64 MW HPC (Phenox), and the DERIVO 2heal (Acandis) was investigated using an in vitro blood circulation model. The DERIVO 2 flow diverter was included in this study as an uncoated device. The markers of coagulation (thrombin-antithrombin complex (TAT)), thrombocytes (β-thromboglobulin (β-TG)), inflammation (PMN elastase), and complement system (SC5b-9, C3a, and C5a) activation were detected by enzyme-linked immunosorbent assay (ELISA). In addition to blood cell counts and hemolysis, thrombogenicity was determined using scanning electron microscopy. Flow diverters with anti-thrombogenic coatings resulted in significantly lower activation of coagulation (TAT) and platelets (β-TG) and lower adhesion of platelets compared with the uncoated DERIVO 2 flow diverter. There were no significant differences between the coated flow diverters in terms of TAT and β-TG levels, as well as platelet adhesion. However, significantly lower activation of the complement system (SC5b-9 and C5a) was observed for the DERIVO 2heal flow diverter in comparison with the Pipeline Flex Shield and the p64 MW HPC flow diverters emphasizing the improved hemocompatibility of the fibrin/heparin-coated DERIVO 2heal flow diverter.

Early Termination versus Standard Regimen Duration of Dual Antiplatelet Therapy in Intracranial Aneurysm Patients Treated With Pipeline Embolization Device Flex With Shield Technology: Preliminary Experience of 3 U.S. Centers

Pipeline Flex Embolization Device with Shield Technology (PED-Shield) is a third-generation flow diverter with reduced thromboembolic potential. However, safety profile and Dual AntiPlatelet Therapy (DAPT) recommendations with PED-Shield is not well-established. We aim to assess the safety and complication profile with early termination of DAPT with use of PED-Shield. Databases of 3 high-volume cerebrovascular centers were retrospectively reviewed. We identified patients with unruptured and ruptured intracranial aneurysms treated with PED-Shield. Patient demographics, aneurysm characteristics, complications and angiographic outcomes were extracted. All patients that had both early termination of DAPT, defined as <180-days, as well as standard duration were included. 37 patients, totaling 37 aneurysms, had early termination of DAPT while 24 patients with 24 aneurysms received standard duration (>180-days) of DAPT. There was no difference in pre-procedural DAPT regimens between the groups (P=0.503).Following DAPT termination, one major thromboembolic complication was observed in the early termination group while no major or minor thromboembolic or hemorrhagic complication was noted in the standard duration group. Time of angiographic follow-up was not statistically different (P=0.063) between the early termination (343 days, IQR 114-371) and the standard duration (175 days, IQR 111-224.5) groups. There were no statistically significant differences in complete aneurysm occlusion (p=0.857), residual neck (p=0.582) and aneurysm remnant (p=0.352) rates between the groups on angiography. Early termination of DAPT proves safe after PED-Shield treatment of intracranial aneurysms with comparable complete occlusion rates.

Diffusion-weighted imaging lesions after intracranial aneurysm treatment with Pipeline Flex and Pipeline Flex with Shield technology: a retrospective cohort analysis

BackgroundThe Pipeline Flex embolization device with Shield technology (PED Shield) is the first flow diverter for brain aneurysm treatment approved in the United States using surface-modified technology. The effect of...

Foreign Body Reaction After Endovascular Treatment with Pipeline Embolization Device (P8-5.031)

<h3>Objective:</h3> The following case elucidates a rare complication of a foreign body reaction to the hydrophilic coating fragments of the pipeline embolization device. <h3>Background:</h3> Intracranial aneurysms (IAs) are pathological dilatations of intracranial arteries. Unruptured IAs have a prevalence of 3% in the adult population worldwide. Endovascular treatment (EVT) is a common first line preventive repair for unruptured intracranial aneurysm. <h3>Design/Methods:</h3> NA <h3>Results:</h3> 50-year-old female presented to the ED with acute onset left-sided weakness of the upper and lower extremities and left-sided facial numbness 20 days following treatment of an unruptured anterior communicating artery aneurysm with Pipeline Flex Embolization Device (PED). Patient’s significant medical history includes multiple sclerosis (MS), rheumatoid arthritis, Crohn’s disease managed with Humira, and diabetes. The CT head without contrast showed confluent edema within the right MCA watershed region, suspicious for infarct. However, the CTA of head showed no vessel occlusion with a patent PED. Brain MRI identified numerous enhancing lesions throughout the right cerebral hemisphere with internal cavitations and significant perilesional vasogenic edema with regional mass effect without midline shift. Empiric antibiotics and antifungal were initiated to cover both typical and atypical causes due to Humira use for Crohn’s disease. Labs, blood cultures and CSF results were insignificant. Pulse-dose steroid for 5 days was started, after 72-hr negative blood cultures. Over time, the patient’s symptoms improved, and she regained her strength back. A repeat brain MRI after the course of steroids showed diminished enhancement, size, and number of brain lesions. The patient was discharged home on a long Prednisone taper and long-term intravenous vancomycin, ceftriaxone, and oral metronidazole. <h3>Conclusions:</h3> Foreign body reactions are rare complications of EVT. It is important to be aware of possible foreign body emboli in patients with the enhancing brain lesions located in the same vascular territory where the recent endovascular procedure was performed. <b>Disclosure:</b> Dr. Aung has nothing to disclose. Mr. Kaufman has nothing to disclose. Dr. Moroz has nothing to disclose. Dr. Axelband has nothing to disclose. Mr. Oselkin has nothing to disclose.

Safety and effect of pipeline flex embolization device for complex unruptured intracranial aneurysms

To investigate the safety and short-term effect of Pipeline Flex devices in the treatment of complex unruptured intracranial aneurysms, a retrospective study was performed for patients with complex unruptured intracranial aneurysms who were treated with the Pipeline Flex embolization device (PED Flex device) combined with or without coiling. The clinical, endovascular, and follow-up data were analyzed. One hundred and thirty-one patients with 159 complex unruptured cerebral aneurysms were treated with the PED Flex device, with 144 Flex devices deployed. Periprocedural complications occurred in four patients, resulting in the complication rate of 3.1%, including ischemic complications in three patients (2.3%) and hemorrhagic complication in one (0.8%). At discharge, the mRS was 0 in 101 (77.1%) patients, 1 in 25 (19.1%), 2 in four (3.1%), and 4 in one (0.8%), with the good prognosis rate (mRS 0–2) of 99.2%. Clinical follow-up was carried out in 87 (66.4%) patients 3–42 months after the procedure, with the mRS of 0 in 78 (89.7%), 1 in five (5.7%), 2 in three (3.4%), and 4 in one (1.1%). No significant (P = 0.16) difference existed in the mRS at discharge compared with that at clinical follow-up. Angiographic follow-up was performed in 61 (46.7%) patients with 80 (50.3%) aneurysms at 3–40 months, with the OKM grade of D in 57 (71.3%) aneurysms, C in eight (10%), and B in 15 (18.8%). Asymptomatic instent stenosis occurred in four patients (6.6%). In conclusion: The treatment of complex intracranial aneurysms with the Pipeline Flex embolization device may be safe and effective, with a high complete occlusion rate, a decreased complication rate, and a good prognosis rate at medium follow-up.

Abstract Number ‐ 136: Aspirin Desensitization in Cerebral Aneurysms and Management for the Neurointerventionalist

Introduction Aspirin (ASA) is the pillar of cerebrovascular and systemic vascular disease management. ASA allergy/hypersensitivity presents a challenge to the NeuroInterventionalist due to difficulties achieving optimum medical management prior to and after neurointerventional treatment. Currently there is vast cardiovascular literature describing successful ASA desensitization protocols, however the same cannot be said for neurointervention.The purpose of our study was to describe our experience with ASA hypersensitivity management in cerebrovascular disease and review of the relevant literature in patients with aneurysms. We present two cases of patients with cerebrovascular aneurysms requiring neurointervention with a pipeline embolization device who were successfully desensitized to their ASA hypersensitivity prior to treatment and the different variables encountered/approach for each patient. Methods N/A Results 37 yo F with history of pre‐eclampsia while pregnant with twins presented with complaints of a severe headache 22 days after delivery and on MRA head and neck had unruptured bilateral paraclinoid para‐ophthalmic internal carotid artery aneurysms. She was placed on Brilinta instead of Plavix due to subtherapeutic PruTest. She underwent successful endovascular coil embolization of the unruptured RIGHT paraclinoid para‐ophthalmic internal carotid artery aneurysm. Post coil embolization she underwent desensitization in the ICU for ASA under the care of the ICU physician and the allergist; 1mg, 5mg, 10mg, 20mg, 45mg ‐ each given 30 min apart. The protocol was followed by ASA 81mg the next morning and had successful endovascular flow diversion with Pipeline Flex Embolization Device for LEFT paraclinoid para‐ophthalmic internal carotid artery aneurysm. 71 yo F with history of uncontrolled HTN. During her hypertensive work‐up was found to have an approximately 6 mm unruptured right internal carotid artery aneurysm on CTA. She was successfully desensitized to ASA and optimized with Aspirin and Brilinta. She underwent successful endovascular flow diversion with Microvention FRED X Flow Diverter of the unruptured medially directed right paraclinoid ophthalmic segment internal carotid artery aneurysm. Conclusions There are few reports of ASA desensitization in patients with cerebral aneurysms ‐ due to this there are few established set protocols. We describe our protocol for high risk patients and post‐op management of patients undergoing neurointerventional procedures.We report these 2 case reports to help add to the current literature of ASA desensitization utilization in patients with CNS aneurysms and may help create more standardized protocols.

Abnormal foreshortening of a Flow Re-Direction Endoluminal Device caused by in-stent thrombosis immediately after deployment.

Thromboembolic complications are a concern in the treatment of cerebral aneurysms using a flow diverter. In this study, we report a case of abnormal foreshortening of a Flow Re-Direction Endoluminal Device (FRED) caused by in-stent thrombosis immediately after its deployment. A 72-year-old woman had a large cavernous carotid aneurysm, which caused ptosis and diplopia. FRED deployment was planned, and dual antiplatelet therapy was initiated 2 weeks before the procedure. Under systemic heparinization, FRED was deployed with local compaction over the aneurysm orifice. Cone-beam computed tomography subsequently revealed slightly poor wall apposition at the proximal side. While the balloon catheter was prepared for angioplasty, the stent became abnormally foreshortened, the proximal side slipped into the aneurysm, and the internal carotid artery became occluded. FRED was removed using a snare wire, and recanalization was obtained. The lumen of the removed FRED was filled with thrombus. The antiplatelet therapy was changed to triple regimen, and a Pipeline Flex embolization device was placed 1 month later. At that time, no thromboembolic complications were noted. It was considered that thrombotic occlusion was followed by foreshortening of FRED on the distal side because of antegrade blood flow. Multiple factors, such as increased mesh density by locally compacted stent deployment, slightly poor wall apposition, clopidogrel resistance, and the dual-layer structure of FRED, may have been involved in thrombus formation.

Safety and Efficacy of Flow Diverter Therapy for Unruptured Intracranial Aneurysm Compared to Traditional Endovascular Strategy : A Multi-Center, Randomized, Open-Label Trial

Endovascular treatment of large, wide-necked intracranial aneurysms by coil embolization is often complicated by low rates of complete occlusion and high rates of recurrence. A flow diverter device has been shown to be safe and effective for the treatment of not only large and giant unruptured aneurysms, but small and medium aneurysms. However, in Korea, its use has only recently been approved for aneurysms <10 mm. This study aims to compare the safety and efficacy of flow diversion and coil embolization for the treatment of unruptured aneurysms ≥7 mm. The participants will include patients aged between 19 and 75 years to be treated for unruptured cerebral aneurysms ≥7 mm for the first time or for recurrent aneurysms after initial endovascular coil embolization. Participants assigned to a flow diversion cohort will be treated using any of the following devices : Pipeline Flex Embolization Device with Shield Technology (Medtronic, Minneapolis, MN, USA), Surpass Evolve (Stryker Neurovascular, Fremont, CA, USA), and FRED or FRED Jr. (MicroVention, Tustin, CA, USA). Participants assigned to a coil embolization cohort will undergo traditional endovascular coiling. The primary endpoint will be complete occlusion confirmed by cerebral angiography at 12 months after treatment. Secondary safety outcomes will evaluate periprocedural and post-procedural complications for up to 12 months. The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. This article describes the aim and design of a multi-center, randomized, open-label trial to compare the safety and efficacy of flow diversion versus traditional endovascular treatment for unruptured cerebral aneurysms ≥7 mm.

Safety and Clinical Effectiveness of Pipeline Shield Device for Intracranial Aneurysms in an Australian Cohort (SCOPE‐AUS)

Background The Pipeline Flex Embolization Device (PED) with Shield Technology (PED‐Shield) is a third‐generation flow diverting stents with surface modification designed to reduce platelet adhesion and thrombogenicity. We report the long‐term safety and effectiveness of the PED‐Shield in the treatment of unruptured intracranial aneurysms in an Australian cohort. Methods SCOPE‐AUS (Safety and Clinical Effectiveness Of Pipeline Shield Embolization Device for Treatment of Intracranial Aneurysms in Australia) is a multicenter, single‐arm, retrospective study of patients with unruptured intracranial aneurysms treated with the PED‐Shield flow diverting stents at 3 high‐volume neurointervention centers in Australia between May 1, 2015, and June 30, 2018, evaluating safety and efficacy. The primary outcome was neurologic adverse event or neurologic‐related death at 1 year, and the secondary outcome was long‐term complete aneurysm occlusion. Results A total of 238 patients (mean age 55.8±11.0 years, 73.1% [174/238] female) and 278 aneurysms were treated via 247 procedures. Two (0.7%) aneurysms were retreated during the 18‐month follow‐up. Overall occlusion rates at 18 months or at last follow‐up imaging were 92.5% (233/252). There were 35 (14.7%) total primary end point events. The 12‐month neurologic morbidity and mortality rates were 3.8% (9/238) and 1.3% (3/238), respectively. For the subgroup of internal carotid artery aneurysms, mortality (0.7%) and morbidity (2.0%) rates were low, and the complete occlusion rate was 92.5% (147/155). Conclusions In this multicenter study, which includes a wide variety of both distal bifurcation and proximal unruptured intracranial aneurysms, the occlusion rates and safety outcomes of the PED‐Shield flow diverting stent demonstrate a high proportion of complete aneurysm occlusion, extremely low retreatment rates, and low complication rates.

Nickels and tines: the myth of nickel allergy in intracranial stents

BackgroundMost intracranial stents contain nickel alloy, and nickel allergy or hypersensitivity is common. Neurological injury following endovascular treatment with a nickel containing intracranial stent has been reported in patients with...

First U.S. Experience Using the Pipeline Flex Embolization Device with Shield Technology for Treatment of Intracranial Aneurysms

The Pipeline Flex Embolization Device with Shield technology (PED-Shield [Medtronic, Dublin, Ireland]) is a third-generation flow diverter. Surface modification of the mesh with phosphorylcholine covalently bound to the metal struts aims to reduce thrombogenicity. In the present study, we report the results from the first U.S. series of patients with intracranial aneurysms treated with the PED-Shield and a comprehensive systematic literature review. We retrospectively collected the patient demographics, aneurysm characteristics, procedural details, and periprocedural complications from our prospectively maintained endovascular database (April 2021 to July 2021). Our literature review encompassed 3 databases (PubMed, Embase, and MEDLINE). Ten patients with 11 anterior circulation unruptured wide-necked aneurysms (10 saccular, 1 fusiform) were included. The average patient age was 64.7 years (range, 45-86 years), and 9 were women. One device demonstrated insufficient distal opening. No other technical issues or intraprocedural complications had occurred. After the procedure, 1 patient had developed a groin hematoma and 1 had experienced a small intracranial hemorrhage, with no clinical repercussions. All patients were discharged with dual-antiplatelet therapy. In the review, we identified 15 studies. Most had been conducted in Europe and South America and 3 were U.S. case reports of compassionate use of the device. In our initial periprocedural experience with the PED-Shield for intracranial aneurysm treatment, the device demonstrated an excellent performance and no major complications. Further studies are required to evaluate the long-term follow-up results and the safety of different antiplatelet regimens.

Pipeline flex embolization device for the treatment of large unruptured posterior circulation aneurysms: Single-center experience

PurposeTo investigate the safety and effect of the Pipeline Embolization Device (PED) Flex device in the treatment of large unruptured posterior circulation aneurysms in a single center. Materials and methodsPatients with large unruptured posterior circulation aneurysms which were treated with the PED Flex device were enrolled. The clinical, endovascular and follow-up data were analyzed, and the O’Kelly-Marotta (OKM) grading system was used to assess the aneurysm occlusion status. ResultsFourteen patients with 14 large posterior circulation aneurysms who were treated with the PED Flex device were enrolled. The maximal diameter of aneurysm was 17.0 ± 3.9 mm. Fourteen PED Flex devices were deployed in 14 patients, with a technical success rate of 100%. All stents covered the aneurysm neck with good wall adherence and patent parent artery. Ten (71.4%) aneurysms were treated with a single PED Flex device each, and four (28.6%) patients experienced additional coiling. No neurological complications occurred in the periprocedural period. The mRS was 0 in eleven (78.6%) patients, 1 in two (14.3%), and 2 in one (7.1%) at discharge. All patients were followed up at 6–28 months (median 18), with an mRS score of 0 in all patients. Twelve (85.7%) patients experienced digital subtraction angiography 6–28 (median 18) months after the embolization procedure, and the OKM grade was D in nine (75%), C in two (16.7%), and B in one (8.3%). ConclusionThe Pipeline Flex Embolization Device can be safely applied to treat large unruptured posterior circulation aneurysms with a high complete aneurysm occlusion rate at follow-up.

Safety and Efficacy of Coils in Conjunction With the Pipeline Flex Embolization Device for the Treatment of Cerebral Aneurysms.

Background: Flow diverters (FD) have shown promising results in the treatment of intracranial aneurysms (IAs). However, there is still controversy whether pipeline flex embolization device (PED flex)-assisted coils can facilitate the curing of aneurysms. Our aim was to assess the safety and effectiveness of PED flex adjunctive with coils (PED flex + coil) in the treatment of IAs.Method: Patients who underwent PED flex treatment in combination with coiling between January 2018 and June 2020 were included in this study. The clinical and radiographic characteristics before and after treatments were retrospectively evaluated. The study cohort comprised of 125 patients with 140 IAs, which was subdivided into two subgroups: one group included patients treated only through PED alone, and the other group included patients treated through PED flex adjunctive with coil. Patient baseline characteristics, aneurysm characteristics, treatment-related factors, and outcomes were analyzed to determine the effectiveness of both techniques.Results: Aneurysms in the PED flex + coil group were larger (10.0 ± 5.8 mm, P < 0.001) and wider (7.2 ± 4.6 mm, P = 0.002) compared with those in the PED flex group. There was no statistical difference in the perioperative complication rate between the two groups. The overall complete occlusion rate was 75.7% at 6.2 months, with 71.7% at 6.2 ± 1.7 months in the PED flex group and 85.4% at 6.2 ± 1.8 months in the PED flex + coil group, respectively. A higher percentage of satisfactory angiography results was found in the PED flex + coil group during follow-up (92.7 vs. 78.8%, P = 0.047).Conclusion: PED flex placement with adjunctive coil embolization represents a safe alternative option for the treatment of IAs. In these cases, coil embolization increases the occlusion rate in PED flex-treated patients without increasing the periprocedural complications.

Cerebral vasospasm resulted in "stent shortening" after pipeline assisted coil embolization for blood blister aneurysms.

Blood blister aneurysms (BBAs) are intracranial arterial lesions appearing in nonbranching sites of the supraclinoid internal carotid artery as well as the basilar artery. Endovascular treatment of BBAs is still not well established because of the rarity of these lesions. We report incidences of BBAs with associated vasospasms. Treatment of the BBAs and associate vasospasms with single Pipeline Flex embolization device (PLED) assisted coiling resulted in seemly shorting of the PLEDs in 3 patients.A retrospective analysis of patients with BBAs who were treated with single PLED assisted coiling from July 2018 to October 2019 was conducted. Patients’ ethnic and medical records, aneurysmal characteristics, intraoperative-rupture, cerebral vasospasm (CVS), postprocedure contrast filling, follow-up imaging, and results were analyzed. Neurological examination at baseline and outcome based on modified Rankin scale (mRS) at discharge as well as follow-ups were also documented.Six patients consisting of 5 females and 1 male, with a mean age of 48.3 years (range from 34–67) were identified during our analysis. All the BBAs were located in nonbranching site of supra-clinoidal segment of internal carotid artery with a mean neck width of 4.5 mm and mean aneurysm size of 4.23 mm. PLED assisted coiling's were performed in all of them. CVS was observed in 3 patients while 1 patient had an intraoperative-rupture of the BBA. Postprocedure contrast filling was still present in 1 patient. All the patients had good outcomes with discharge and follow-up mRS scores ≤ 2 except 1 patient with mRS score = 3 with aphasia.PLED assisted endovascular coiling is very safe and efficient in treating patients with BBAs. Resolution of CVSs after treatment made the PLEDs seemly shorter. Furthermore, a combination of arterial lengthening after gaining their tensile strength back and radical expansion of the PLED could account for the shortening.

Safety and Effectiveness of the Pipeline Flex Embolization Device With Shield Technology for the Treatment of Intracranial Aneurysms: Midterm Results From a Multicenter Study.

The safety and efficacy of the first generation of the Pipeline Embolization Device (PED; Medtronic Inc) have been proven in large case series. Ischemic events are one of the most common complications following treatment of aneurysms with flow diverters. The new PED Flex with Shield technology (PED Shield; Medtronic Inc) was introduced to minimize the rate of complications. To evaluate the outcomes of patients harboring aneurysms treated with the PED Shield. This was an observational, prospective, single-arm multicenter study of patients treated with the PED Shield. The primary safety endpoint was the absence of major neurological complications and death. The secondary effectiveness endpoint was angiographic occlusion at 6 and 12 mo. Technical complications were also reported. Between November 2017 and December 2018, 151 patients from 7 centers with 182 aneurysms were enrolled. The mean aneurysm size was 7.0 mm; 27 (14.8%) aneurysms were large, and 7 (3.8%) were giant. In 141 of 151 patients (93.4%), the primary endpoint was reached. The overall rate of periprocedural complications was 7.3%. Of the aneurysms, 79.7% met the study's secondary endpoint of complete occlusion at 6 mo and 85.3% at 12 mo. The PED Shield is a safe and effective treatment for intracranial aneurysms. The results regarding total occlusion and ischemic complications did not differ from those obtained in case series using previous versions of the PED. Long-term follow-up and comparative studies are required to provide stronger conclusions regarding the reduced thrombogenicity of this device.

Preclinical safety and efficacy evaluation of the Pipeline Vantage Embolization Device with Shield Technology

BackgroundThe Pipeline Vantage Embolization Device with Shield Technology is a next generation flow diverter developed to improve aneurysm occlusion and implant endothelialization in addition to lowering thrombogenicity. We report here...

Preliminary study of 3D T1-SPACE combined with 3D-TOF MRA in the follow-up for the intracranial aneurysm treated with Pipeline Flex embolization device

Objective To evaluate the preliminary application of three dimensional T1-weighted sampling perfection with application-optimized contrasts by using different flip angle evolutions (3D T1-SPACE) combined with three dimensional time-of-flight magnetic resonance angiography (3D-TOF MRA) in the follow-up for the intracranial aneurysm treated with Pipeline Flex embolization device (FD). Methods A total of 20 patients with 25 intracranial aneurysms were treated with Pipeline Flex embolization at the Department of Cerebrovascular Intervention, People′s Hospital of Zhengzhou University, Henan Provincial People′s Hospital from September 2018 to April 2019 and were prospectively enrolled. All patients were followed up with 3.0T 3D T1-SPACE sequence, 3D-TOF MRA and digital subtraction angiography (DSA) examination. O′kelly-Marotta (OKM) grading scale was used to evaluate the aneurysm residual and the four-point scale was used to evaluate the in-stent lumen visibility. Results The follow-up period for all patients was 6.0±0.8 months (range: 4-7 months). The OKM scale of all aneurysms evaluated by DSA indicated 18 patients with grade D, 2 patients with grade C and 5 patients with grade B. For aneurysms evaluated by 3D-TOF MRA combined with source image, the results showed grade D in 19 patients, C in 2 and B in 4. The overall concordance rate between 3D-TOF MRA and DSA was 88.0% (22/25). Taking DSA as standard(grade 4), the four-point scale of in-stent lumen of all 20 patients treated with 23 Pipeline Flex embolization devices and evaluated by 3D-TOF MRA indicated grade 3 in 16 stents, 2 in 6 and 1 in 1. No one showed the same as DSA results. However, grade 4 was revealed in 21 stents and 3 in 2 based on the evaluation by 3D T1-SPACE. The total concordance rate of 3D T1-SPACE and DSA was 91.3% (21/23). Conclusions Preliminary observations show that compared with DSA, 3D-TOF MRA could better assess the aneurysmal occlusion after FD treatment of intracranial aneurysms. The 3D T1-SPACE sequence shows the in-stent lumen clearly. The combination of the two sequences can be used for follow-up after FD treatment of intracranial aneurysms. Key words: Intracranial aneurysm; Magnetic resonance imaging; Follow-up study; Flow diverter device

Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU).

The recently introduced Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is the third generation of Pipeline flow-diverter devices. It has a new stent-surface modification, which reduces thrombogenicity. We aimed to evaluate clinical and radiographic (safety and efficacy) outcomes of the Pipeline Shield. The 30-day and 1-year mortality and morbidity rates and the 6- and 18-month radiographic aneurysm occlusion outcomes for procedures performed between March 2016 and January 2018 were analyzed. 3D-TOF-MRA was used for follow-up. Forty-four attempted Pipeline Shield procedures were performed for 41 patients with 44 target aneurysms (total of 52 aneurysms treated). A total of 88.5% of devices were inserted in the anterior circulation, and 11.5%, in the posterior circulation; 49/52 (94.2%) aneurysms were saccular; and 1/52 (1.9%) was fusiform. One (1.9%) aneurysm was an iatrogenic pseudoaneurysm, and 1 (1.9%) was a dissecting aneurysm. Seventy-one percent (35/49) of the saccular aneurysms were wide-neck (neck, >4 mm), 34.6% (18/52) were large (≥10 mm), and 3.8% (2/52) were giant (≥25 mm). The mean aneurysm sac maximal diameter was 9.0 mm, and the mean neck width was 5.0 mm. The cumulative mortality and morbidity rates were 2.3% and 6.8% at 1 year, respectively. The adequate occlusion rate was 78.8% at 6 months and 90.3% at 18 months. In this pragmatic and non-industry-sponsored study, the occlusion rates and safety outcomes were similar to those seen in previously published studies with flow-diverter devices and earlier generation Pipeline Embolization Devices.