Safety and efficacy of pipeline embolization device treatments for intradural internal carotid artery aneurysms in a single center in a Japanese population.

Background: The pipeline embolization device (PED) is the most common flow diverter device in the world. To date, there have been no reports of treatment outcomes specific to intradural internal carotid artery (ICA) aneurysms. The safety and efficacy of the PED treatments for intradural ICA aneurysms are reported. Methods: 131 patients with 133 aneurysms underwent PED treatments for intradural ICA aneurysms. The mean aneurysm dome size and neck length were 12.7 ± 4.3 mm and 6.1 ± 2.2 mm, respectively. We used adjunctive endosaccular coil embolization for 88 aneurysms (66.2%). A total of 113 aneurysms (85%) were angiographically followed up 6 months following the procedure, and 93 aneurysms (69.9%) were followed up for 1 year. Results: The angiographic outcome at 6 months showed that 94 (83.2%) aneurysms had O'Kelly-Marotta (OKM) grade D, 6 (5.3%) had C, 10 (8.8%) had B, and 3 (2.7%) had A. At 1 year, 82 (88.2%) aneurysms had OKM grade D, 6 (6.5%) had C, 3 (3.2%) had B, and 2 (2.2%) had A. Multivariate analysis showed that aneurysm neck size and adjunctive coiling were statistically significant in aneurysm occlusion status. Major morbidity modified Rankin Scale >2 and mortality rates related to procedures were 3.0% and 0%, respectively. Delayed aneurysm ruptures were not observed. Conclusion: These results reveal that PED treatment of intradural ICA aneurysms is safe and efficacious. The combined use of adjunctive coil embolization not only prevents delayed aneurysm ruptures but also contributes to an increase in the rate of complete occlusion.

Long-term outcomes of Y-stent-assisted coil embolization using Low-profile Visualized Intraluminal Support Junior (LVIS Jr) for intracranial bifurcation aneurysms.

OBJECTIVE: Y-stent-assisted coil embolization is indicated for the treatment of complex intracranial bifurcation aneurysms. However, the long-term outcomes associated with this technique remain unclear. The purpose of this study was to evaluate the long-term outcomes of Y-stent-assisted coil embolization using the Low-profile Visualized Intraluminal Support Junior (LVIS Jr) device. METHODS: We retrospectively reviewed our databases to identify patients treated with Y-stent-assisted coiling using LVIS Jr. Digital subtraction angiography, silent magnetic resonance angiography (MRA), and time-of-flight MRA were performed at 1 year after the procedure. Patients also received an annual follow-up using MRA. Aneurysm occlusion status was classified into complete occlusion (CO), neck remnant (NR), and body filling (BF). Clinical outcomes were assessed using the modified Rankin Scale. RESULTS: Twenty-one patients (22 aneurysms) were included in this study. All procedures were performed successfully. Immediate postprocedural angiograms showed CO in 13 aneurysms (59.1%), NR in two aneurysms (9.1%), and BF in seven aneurysms (31.8%). One-year follow-up angiograms revealed CO in 86.4% of patients. Only one patient had a major recurrence and required retreatment. The mean follow-up duration was 43.5 months. The last angiographic studies demonstrated CO in 18 aneurysms (81.8%), NR in three aneurysms (13.6%), and BF in one aneurysm (4.5%). Periprocedural and delayed complications occurred in two patients and one patient, respectively. There was no permanent morbidity or death. The modified Rankin Scale scores at last clinical follow-up were equal to those before the procedures in all patients. CONCLUSION: Y-stent-assisted coil embolization using LVIS Jr for intracranial bifurcation aneurysms has favorable long-term angiographic and clinical outcomes.

Long-term Follow-up Results after Flow Diverter Therapy Using the Pipeline Embolization Device for Large or Giant Unruptured Internal Carotid Artery Aneurysms: Single-center Retrospective Analysis in the Japanese Population.

Flow diverter (FD) therapy using Pipeline embolization device (PED) has become an important alternative to treat internal carotid artery (ICA) aneurysms. Herein, we report the long-term outcome for 3 years after FD therapy using PED for ICA aneurysms in Japan. The patients who underwent angiographical and/or clinical follow-up for 3 years after the FD therapy using PED of large or giant unruptured ICA aneurysms from December 2012 at our university hospital are the subjects of this study. We retrospectively reviewed the in- and outpatients' medical charts, and written operative and radiological records. There were 84 patients with 90 aneurysms who could be clinically and/or angiographically followed up for 3 years. Of these, 7 aneurysms were only available for clinical follow-up. Of the remaining 83 aneurysms, 6 aneurysms had vessel occlusion due to stent thrombosis or parent artery occlusion, and 60 of the remaining 77 (77.9%) had complete occlusion. In multivariate analysis, older age (>70 years), wide neck, and non-adjunctive coiling contributed statistically significantly to incomplete occlusion. Of the 84 patients, 2 patients (2.4%) had delayed complications between 6 months and 3 years after the initial FD placement. Three patients (3.6%) had poor outcome due to postoperative major stroke complications, 2 of which were acute complications. The long-term results after FD therapy are good both angiographically and clinically. Endothelialization of the aneurysmal neck and intra-aneurysmal thrombosis contribute to complete occlusion. The primary reason for the somewhat low complete occlusion in Japan may be the patients are generally older.

Outcomes following aneurysmal coil embolization with intentionally shortened low-profile visible intraluminal support stent deployment.

PURPOSE: Among all stents available for neuroendovascular therapy, the low-profile visible intraluminal support stent bears the highest metal coverage ratio. We deployed a low-profile visible intraluminal support stent with a delivery wire or/and microcatheter system push action to shorten the low-profile visible intraluminal support stent and thus achieve a flow diversion effect. We report our single-institution experience with the use of low-profile visible intraluminal support stents for intentionally shortened deployment (shortening group) and non-shortened deployment (non-shortening group) for unruptured intracranial aneurysms. METHODS: We retrospectively reviewed the medical records of 130 patients with 131 intracranial aneurysms who were treated with low-profile visible intraluminal support stent-assisted coil embolization from February 2016-January 2019. All perioperative complications were noted. Every 6 months, we re-examined the patients with cerebral angiography or magnetic resonance angiography. The outcomes of aneurysm occlusion were evaluated by the modified Raymond-Roy occlusion classification. We used the finite element method and computational fluid dynamics to investigate the hemodynamics after shortened low-profile visible intraluminal support stent deployment. RESULTS: Immediately after treatment, the modified Raymond-Roy occlusion classification was significantly better in the shortening group than in the non-shortening group (p<0.05). The latest angiographic outcomes showed the same tendency. Hemodynamic analysis by computational fluid dynamics suggested an adequate flow diversion effect with the use of our intentional shortening method. CONCLUSIONS: Stent-assisted coil embolization using this technique showed good results of a high complete occlusion rate and low complication rate. These findings suggest that shortened low-profile visible intraluminal support stent deployment yields a flow diversion effect and may lead to early intra-aneurysmal thrombus formation.

Defective Endothelialization of Pipeline Embolization Device after Flow Diverter Therapy: An Autopsy Case Report.

The authors report a rare autopsy case. A 59-year-old woman underwent flow diverter (FD) therapy using a pipeline embolization device (PED) for a large paraclinoid internal carotid artery aneurysm. Follow-up magnetic resonance (MR) examinations were performed 6 months after the treatment. Although the T2-weighted images showed progressive thrombosis of the aneurysm, the silent MR angiography (MRA) clearly showed the residual blood flow within the aneurysm. The patient committed suicide 2 months after the follow-up MR examinations. An autopsy specimen showed a small section of the defective membranes with the PED that matched the entry point of residual blood flow seen clearly in the silent MRA. Macroscopic photograph and hematoxylin and eosin stained sections showed defective endothelialization. In contrast, complete endothelialization was observed in membranes covering the PED. The autopsy findings after FD therapy showed defective endothelialization that perfectly matched and corroborated the silent MRA findings.

Endovascular Treatment for Lateral Wall Paraclinoid Aneurysms and the Influence of Internal Carotid Artery Angle.

Lateral wall paraclinoid aneurysms (LPA) are a rare type of aneurysm located on the lesser curve side of the internal carotid artery (ICA) bend, at the level of the anterior clinoid process. The objective of this study was to assess the influence of flexion of the ICA on the morphology of aneurysms and outcome of endovascular treatment. Between 2003 and 2018, we treated 643 cases of unruptured paraclinoid aneurysms with endovascular therapy in our institution. Of those cases, aneurysms projecting laterally on preoperative angiography were defined as LPA. The degree of bending of the ICA (ICA angle) was measured and statistically analyzed in relation to the aneurysm characteristics and the occlusion status after treatment. In all, 43 aneurysms were identified. ICA angle was positively correlated with the maximum dome size of the aneurysm (P <0.01) and the aspect ratio (P <0.01), and negatively correlated with the volume coil embolization ratio (P <0.01). Complete occlusion (CO) was achieved in 23 cases (53.5%) immediately after treatment, and in 35 cases (81.4%) at follow-up. The mean ICA angle in the incomplete occlusion group was significantly larger than in the CO group (P = 0.01). Larger ICA angle resulted in recurrence, whereas smaller ICA angle was more likely to obtain progressive thrombosis (P = 0.02). Endovascular treatment for LPA was safe and effective. The degree of flexion of the ICA may contribute to the level of hemodynamic stress on the aneurysm, its morphology, and the embolization effect.

Analysis for Stroke Etiology in Duplicated/Accessory MCA-Related Cerebral Infarction: Two Case Report and Brief Literature Review.

Duplication and accessory of the middle cerebral artery (MCA) constitute a rare congenital variation. MCA anomalies are found at a lesser frequency than the vascular anomalies of the other major intracranial arteries. Duplicated/accessory MCA was usually noted incidentally with subarachnoid hemorrhage, due to resulted aneurysmal formation. However, duplicated/accessory MCA-related cerebral infarction is rarer. We report two cases of cerebral infarction due to dissection at the entry of the duplicate/accessory MCA. Both cases were similar in dissected site and clinical course, without headache or injury. In 20 previously reported cases and our two cases of duplicated/accessory MCA-related infarction, mean age (55.8 ± 21.2 years) was slightly younger for cerebral infarction, and stroke etiology was mainly embolism. The main etiologies of stroke were embolism and dissection. Considering embolism etiology, proximal site of arterial diameter changing lesion was a common site for embolism, as duplicated/accessory MCA was usually smaller than normal M1 segment. In cerebral dissection cases, the dissected site was similar to our cases. Numerous mechanisms of dissection were considered, but they mainly included dysfunction of the media and endothelium or shearing stress at the entry of duplication. As the detailed mechanisms of cerebral dissection remain unknown, clinicians should include a differential diagnosis for MCA dissection.

Pioglitazone Prevents Hemorrhagic Infarction After Transient Focal Ischemia in Type 2 Diabetes.

Pioglitazone (PGZ), a PPARγ agonist, has been used for diabetic patients as an insulin-sensitizing agent. Recent studies have demonstrated that PGZ increases adiponectin (APN) levels and provides vascular protection in ischemic conditions. This study was designed to assess the neuroprotective effects of PGZ against cerebral ischemia-reperfusion injury via an APN-related mechanism. Type 2 diabetic leptin-deficient mice (db/db) were administered PGZ for 1 week, and plasma insulin and APN levels were measured. These mice received a middle cerebral artery occlusion and reperfusion injury, and they were evaluated for the infarct volume and by immunohistochemistry and western blotting analysis at several time points after ischemia. PGZ-administered db/db mice showed improved insulin sensitivity, and the hemorrhagic rate and infarct volume were decreased (P < 0.05). In the PGZ-administered group, plasma APN levels increased compared with the vehicle group. In the db/db group, PGZ administration significantly suppressed inflammatory reactions and oxidative stress after reperfusion (P < 0.05). PGZ may be applicable for acute cerebral ischemia treatment in metabolic syndrome patients as well as antidiabetic agents.

Cerebral artery dissection secondary to antiphospholipid syndrome: A report of two cases and a literature review.

INTRODUCTION: Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by thromboembolic events, including ischemic stroke or complications in pregnancy, and the presence of antiphospholipid antibodies. Cervical artery dissection (CAD) is not an uncommon cause of stroke in young adults. The concomitant presence of APS and CAD is extremely rare. METHODS: Two cases with APS who developed acute ischemic strokes related to CAD are reported. A comprehensive systematic literature search using the PubMed database was also conducted. RESULTS: In Case 1, a 36-year-old woman who had been diagnosed with systemic lupus erythematosus and had been repeatedly positive for lupus anticoagulant tests developed an ischemic stroke caused by a vertebral artery dissection (VAD). After admission, she had a recurrent ischemic stroke, followed by considerable changes in steno-occlusive lesions of the vertebrobasilar artery system. In Case 2, a 36-year-old man developed multiple brain infarcts due to bilateral VAD with aneurysmal formations and associated with pulmonary embolism. The anticardiolipin antibody titer was repeatedly elevated after stroke. The literature review identified 8 patients with CAD associated with APS, involving the internal carotid artery in 6 patients and the middle cerebral artery and vertebral artery in 1 patient each. The patients were predominantly young and female, infrequently had atherosclerotic vascular risk factors, and were positive for various antiphospholipid antibodies. CONCLUSIONS: The current report described two rare cases of ischemic stroke caused by CAD secondary to APS, along with a review of the literature; the patients displayed characteristic clinical manifestations, implying specific mechanisms for cerebral artery disorders secondary to APS.

Flow diverter device placement for cerebral aneurysm is not effective for the patient with parent artery occlusion for contralateral aneurysm.

PURPOSE: There have been many reports on the risks of enlargement and rupture of residual aneurysms and de novo aneurysm formation in the contralateral internal carotid artery after parent artery occlusion (PAO). In the present study, we investigated the efficacy of flow diverter device placement (FDDP) for the treatment of contralateral internal carotid artery aneurysms after PAO. METHODS: After 11 patients, who had bilateral large or giant internal carotid aneurysms, were treated for either side with PAO or FDDP, they underwent FDDP for residual lesions in our hospital between October 2015 and June 2018. The patients were divided into two groups, depending on the prior procedure: PAO or FDDP. The embolic state after subsequent FDDP was evaluated by angiography. The embolic state was graded using the O'Kelly Marotta scale. Patients' characteristics and the embolic state of intracranial aneurysms after FDDP were compared between the two groups. RESULTS: Comparing patients' characteristics between the PAO group and FDDP group, statistically significant differences were observed in laterality of the lesions and the interval between prior treatment and FDDP for residual aneurysms (p < 0.05). The embolic state at the one-year follow-up revealed that there could be significantly sufficient embolisation in the FDDP group (p < 0.05). CONCLUSION: When FDDP is performed for the contralateral lesion after PAO treatment, it is difficult to attain sufficient embolisation of intracranial aneurysms because haemodynamic load in this procedure is large compared to that in a regular FDDP.

Stent-assisted coil embolization of unruptured middle cerebral artery aneurysms using LVIS Jr. stents.

Authors reported the anatomical and clinical results of the stent assisted coiling (SAC) of unruptured middle cerebral artery (MCA) aneurysms using Low-profile Visualized Intraluminal Support Junior (LVIS Jr.). Forty-seven MCA aneurysms in 46 patients were the subjects of this study. The mean aneurysm size, neck width were 4.5 ± 1.8 mm, 3.0 ± 1.0 mm, respectively. Immediate anatomical outcomes were class Ⅰ in 31 (65.0%), class Ⅱ in 5 (10.6%) and class III in 11 (23.4%) patients according to Raymond-Roy classification. The latest anatomical outcomes were class Ⅰ in 33 (86.8%), class Ⅱ in 2 (5.3%) and class III in 3 (7.9%) patients. The change of aneurysm obliteration status were unchanged in 27 (71.0%), improved in 9 (23.7%) and worsen in 2 (5.3%). There were no recurrence necessitating additional treatment. Two patients suffered from angiographically evident in-stent thrombosis, but their clinical outcomes remain good. The modified Rankin scale at discharge were 0 in 45 patients, 1 in 1 patient. No patient showed clinical worsening during the clinical follow-up period at outpatient clinic (mean, 27.4 months). SAC of unruptured MCA aneurysms using LVIS Jr. provide safe and durable effect with high complete obliteration rate recurrence rate.

Outcome of flow diverter placement for intracranial aneurysm with dual antiplatelet therapy and oral anticoagulant therapy.

PURPOSE: Antiplatelet therapy initiated before flow diverter placement is effective for the prevention of ischemic complications. However, the effectiveness of oral anticoagulant treatment is unclear. This retrospective study evaluated the complications and obliteration rates after flow diverter placement in patients taking anticoagulants. METHODS: A total of 155 cases were treated by Pipeline Flex placement for unruptured large and giant cerebral aneurysms in our hospital between October 2015 and June 2019. The groups of 8 patients taking anticoagulants before operation and 147 patients not taking anticoagulants were compared. RESULTS: Clopidogrel oral dose (P = 0.002) was significantly lower in the anticoagulant group. Delayed aneurysm rupture (P = 0.002) and additional treatment (P = 0.009) rates were significantly higher and complete obliteration rate (P = 0.011) was lower in the anticoagulant group. CONCLUSIONS: Additional oral anticoagulant administration before flow diverter placement does not reduce ischemic complications compared to dual antiplatelet therapy, but does increase hemorrhagic complications, especially delayed aneurysm rupture. Complete obliteration of the cerebral aneurysm is difficult to achieve in patients taking anticoagulants.

Delayed Complications Due to Polymer Coating Embolism after Endovascular Treatment.

There have recently been reports of patients who developed postprocedural symptoms or alterations due to delayed foreign body embolisms observed in imaging findings. Polymer coating of devices have been described as a possible cause of foreign body embolisms, manifesting in delayed granulomatous responses and exhibiting characteristic imaging findings. In four of 4,025 patients who underwent coil embolization in our hospital or its affiliated facilities, similar findings were observed. Delayed lesions appeared between 1 month and 1 year after the procedures. There was extensive edema in the perfusion area of the treated vessels. In two cases examined by contrast-enhanced magnetic resonance imaging, multiple solid enhancing lesions within vasogenic edema were observed. Biopsy revealed a membranous foreign body in a blood vessel with surrounding foreign body granuloma formation in 1 case. Because these findings are similar to those of cases reported previously, they were considered as a foreign body embolism due to coating separations from the devices. Polymer coating separation occurs most frequently from guidewires. Especially if a metal introducer is used, the risk of separation increases. Surgeons should carefully follow the manufacturers' instructions when they use these devices and should acknowledge and report any events that may occur. Although these complications are extremely rare, further studies are warranted of similar cases; and we should prepare and share information on these intravascular devices for wide-scale dissemination in the industry.

Histological and Transmission Electron Microscopy Results after Embolization with HydroSoft/HydroFrame Coils in Experimental Swine Aneurysm.

Coiling and clipping are standard treatment strategies for cerebral aneurysms. Regardless of the strategy used, recanalization may affect the patient's prognosis. The aim of this study was to histologically and morphologically compare the tissue proliferation after coil embolization using bare platinum coils versus second-generation hydrogel coils (HydroSoft/HydroFrame; MicroVention, Inc., Aliso Viejo, CA, USA). Endothelial-like cell proliferation was seen in both groups at 2 weeks after surgery. Macroscopic findings showed a tighter layer at 4 weeks in the hydrogel coil group, and histological and immunohistochemical findings revealed endothelial cell proliferation. This layer became much thicker and tighter at 4 weeks after surgery. Aneurysms treated with second-generation hydrogel coils may be more stable and have a lower incidence of recanalization than those treated with bare platinum coils because of the tight endothelial layer proliferation.

[Three Cases of Esophageal Submucosal Hematoma after Coiling for Unruptured Cerebral or Intracranial Aneurysms].

We report three cases of esophageal submucosal hematoma after treatment of unruptured intracranial aneurysms. All cases were in women with a mean age of 67.7 years. They were administered anti-platelet drugs before undergoing operations to deliver stents. All cases were administered general heparinization during the operation. All three cases developed sudden-onset hemoptysis or epigastric pain. The medical treatments included the temporary cessation or reduction of antiplatelet therapy and all cases were discharged with symptom cure and with the appearance of gastric intestinal fiber on computed tomography imaging. Esophageal submucosal hematoma has a good prognosis with medical therapy. We should consider the potential for esophageal submucosal hematoma after hemoptysis or epigastric pain after coiling of unruptured intracranial aneurysms that require antiplatelet or anticoagulant therapies.

Pipeline embolization device implantation in large carotid cavernous aneurysm associated with situs inversus totalis.

Situs anomalies are a heterogenous class of inborn visceral and vascular abnormalities with a broad range of radiographic characteristics. Situs inversus totalis is characterized by mirror image location of the heart and viscera relative to situs solitus (normal position). Few aberrations involving the neuraxis, and rarely intracranial aneurysms, have been reported in association with situs inversus totalis. We describe the radiological findings and endovascular management of one of the first of its kind: the association of bilateral carotid cavernous aneurysms (one large and the other small-sized) with situs inversus totalis.

Flow Diverter Therapy of a Giant Fusiform Vertebrobasilar Junction Aneurysm in a Child: Case Report.

The management of giant vertebrobasilar junction (VBJ) aneurysms is extremely challenging. Flow diverter (FD) therapy has become an important alternative to treat difficult intracranial aneurysms for both open surgery and conventional endovascular therapy. Herein, we report a rare case of a giant fusiform VBJ aneurysm in a child that is successfully treated with FD therapy.

Very delayed discontinuation of telescoped Pipeline embolization devices: a case report.

BACKGROUND: Flow diversion with the Pipeline embolization device (PED) is a widely accepted treatment modality for aneurysm occlusion. Previous reports have shown no recanalization of aneurysms on long-term follow-up once total occlusion has been achieved. CASE DESCRIPTION: We report on a 63-year-old male who had a large internal carotid artery cavernous segment aneurysm. Treatment with PED resulted in complete occlusion of the aneurysm. However, follow-up angiography at four years revealed recurrence of the aneurysm due to disconnection of the two PEDs placed in telescoping fashion. CONCLUSION: Herein, we present the clinico-radiological features and discuss the possible mechanisms resulting in the recanalization of aneurysms treated with flow diversion.

Patency of anterior choroidal artery after flow diverter deployment with assessment of magnetic resonance imaging follow-up.

PURPOSE: We aimed to analyse the patency rate of the anterior choroidal artery, and presented imaging and neurological findings, after deployment of a flow diverter in the anterior choroidal artery in the treatment of patients with intracranial aneurysms. METHODS: Among the 139 patients who underwent a flow diverter deployment from December 2012 to September 2017 in our hospital, there were 21 patients (15.1%) for whom their anterior choroidal artery was covered for the procedure with a flow diverter. The patients' age, sex, size of aneurysm and the presence or absence of an anterior choroidal artery occlusion, neurological findings and postoperative infarction in the anterior choroidal artery region were analysed retrospectively. RESULTS: The mean age of the six male and 15 female patients was 61.5 years (range 32-77 years). The mean maximal diameter of the aneurysms was 16.4 mm (range 10.0-29.4 mm). The anterior choroidal artery was patent in all 21 patients; however, a haemodynamic alteration in the anterior choroidal artery was detected in one patient. Postoperatively, hemiparesis was observed in two patients (9.5%) and a visual field defect in one patient (4.8%), both of which were the symptoms of infarction of the cortical branch of the middle cerebral artery or retinal artery ischaemia. However, no patients had symptoms due to ischaemia of the anterior choroidal artery confirmed with magnetic resonance imaging. CONCLUSIONS: In all patients who underwent flow diverter deployment, the anterior choroidal artery was patent and no ischaemia was detected in the imaging or evidenced by neurological findings. Therefore, flow diverter deployment in the anterior choroidal artery was considered to be a safe procedure.

Flow Diverter Therapy Using a Pipeline Embolization Device for 100 Unruptured Large and Giant Internal Carotid Artery Aneurysms in a Single Center in a Japanese Population.

Flow diverters (FDs) have been developed for intracranial aneurysms difficult to treat with conventional endovascular therapy and surgical clipping. We reviewed 94 patients with 100 large or giant unruptured internal carotid artery (ICA) aneurysms treated with Pipeline embolization device (PED) embolization from December 2012 to June 2017 at Juntendo University Hospital. The patients' mean age was 63.4 years (range, 19-88), and there were 90 women 89.4%. Aneurysm locations were: C4 (45), C3 (4), and C2 (51) in ICA segments. Mean aneurysm size and neck width were 16.9 ± 6.8 mm and 8.3 ± 4.4 mm, respectively, in 40 symptomatic and 60 asymptomatic aneurysms. Follow-up catheter angiographies of 85 patients with 90 aneurysms showed no filling in 62 aneurysms (68.9%), entry remnant in 16 (17.8%), subtotal filling in 11 (12.2), and total filling in 1 (1.1%) with a mean follow-up of 10.2 ± 5.6 months. In-stent stenosis occurred in 1 patient and parent artery occlusion in 2 during follow-up. Hemorrhagic complications occurred in 4 (4.3%): delayed aneurysm rupture (2) and intraparenchymal hemorrhage (2). Ischemic complications with neurological symptoms occurred in 2 (2.1%): very delayed device occlusion (1) and intraprocedural distal embolism (1). Eighteen patients (45%) showed improvement in pre-existing cranial nerve dysfunction because of the aneurysm's mass effect, 3 patients (7.5%) worsened. One patient died of systemic organ failure unassociated with the procedure. Morbidity and mortality rates were 4.3% and 1.1%, respectively. PED embolization for unruptured large and giant ICA aneurysms is safe and efficacious. Physicians should be observant of characteristic risks associated with FD therapy.