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AJNR. American Journal of Neuroradiology Jun 2009We report a preclinical study of a second-generation endoluminal device (Pipeline Embolization Device [PED-2] for aneurysmal occlusion and compare the PED-2 with its...
BACKGROUND AND PURPOSE
We report a preclinical study of a second-generation endoluminal device (Pipeline Embolization Device [PED-2] for aneurysmal occlusion and compare the PED-2 with its first-generation predecessor (PED-1).
MATERIALS AND METHODS
Our Institutional Animal Care and Use Committee approved all studies. The PED-2 is a braided endoluminal, flow-diverting device and was implanted across the necks of 18 elastase-induced aneurysms in New Zealand white rabbits and followed for 1 month (n = 6), 3 months (n = 6), and 6 months (n = 6). A second PED-2 was implanted in the abdominal aorta to cover the origins of the lumbar arteries. Angiographic occlusion rates were documented as complete, near-complete, and incomplete. Parent artery percent diameter stenosis was calculated. Results were compared with a previous publication focused on the PED-1, with use of the same model. We compared ordinal outcomes using Fisher Exact or chi(2) tests. We compared continuous data using analysis of variance.
RESULTS
Occlusion rates (complete and incomplete) for the PED-2 were noted in 17 cases (94%) and 1 (6%), respectively, compared with 9 cases of complete (53%) and 8 (47%) of incomplete occlusion with the PED-1 (P = .0072). No incidents of branch artery occlusion or distal emboli in vessels downstream of the parent artery were observed with the PED-2. Parent artery neointimal hyperplasia was minimal in most cases and was significantly less than in the PED-1.
CONCLUSIONS
The PED-2 is a biocompatible and hemocompatible device that occludes saccular aneurysms while preserving the parent artery and small-branch vessels in our animal model.
Topics: Animals; Blood Vessel Prosthesis; Embolization, Therapeutic; Equipment Design; Equipment Failure Analysis; Intracranial Aneurysm; Rabbits; Radiography; Treatment Outcome
PubMed: 19369609
DOI: 10.3174/ajnr.A1530 -
Radiologic Clinics of North America Mar 2000This two-part article first discusses the role of bronchial artery transcatheter embolotherapy in the management of patients with hemoptysis. Following this discussion,... (Review)
Review
This two-part article first discusses the role of bronchial artery transcatheter embolotherapy in the management of patients with hemoptysis. Following this discussion, the authors review pulmonary arteriovenous malformations, their embolization, follow-up protocols, and outcome criteria as currently practiced at the authors' Vascular Malformation Center.
Topics: Angiography; Arteriovenous Malformations; Bronchi; Bronchography; Contraindications; Embolization, Therapeutic; Humans; Pulmonary Artery; Pulmonary Circulation; Pulmonary Embolism; Pulmonary Veins; Treatment Outcome
PubMed: 10765399
DOI: 10.1016/s0033-8389(05)70172-x -
AJNR. American Journal of Neuroradiology Dec 2019The recently introduced Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is the third generation of Pipeline flow-diverter devices. It has a...
BACKGROUND AND PURPOSE
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.
MATERIALS AND METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Vessel Prosthesis; Embolization, Therapeutic; Female; Humans; Intracranial Aneurysm; Male; Middle Aged; Stents; Treatment Outcome; Young Adult
PubMed: 31727754
DOI: 10.3174/ajnr.A6314 -
Neurosurgery Feb 2020Flow modification has caused a paradigm shift in the management of intracranial aneurysms. Since the FDA approval of the Pipeline Embolization Device (Medtronic, Dublin,... (Review)
Review
Flow modification has caused a paradigm shift in the management of intracranial aneurysms. Since the FDA approval of the Pipeline Embolization Device (Medtronic, Dublin, Ireland) in 2011, it has grown to become the modality of choice for a range of carefully selected lesions, previously not amenable to conventional endovascular techniques. While the vast majority of flow-diverting stents operate from within the parent artery (ie, endoluminal stents), providing a scaffold for endothelial cells growth at the aneurysmal neck while inducing intra-aneurysmal thrombosis, a smaller subset of endosaccular flow disruptors act from within the lesions themselves. To date, these devices have been used mostly in Europe, while only utilized on a trial basis in North America. To the best of our knowledge, there has been no dedicated review of these devices. We therefore sought to present a comprehensive review of currently available endosaccular flow disruptors along with high-resolution schematics, presented with up-to-date available literature discussing their technical indications, procedural safety, and reported outcomes.
Topics: Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Embolization, Therapeutic; Endovascular Procedures; Female; Humans; Intracranial Aneurysm; Male; Regional Blood Flow; Self Expandable Metallic Stents; Treatment Outcome
PubMed: 30834934
DOI: 10.1093/neuros/nyz017 -
Journal of Neurointerventional Surgery Oct 2020The Pipeline Vantage Embolization Device with Shield Technology is a next generation flow diverter developed to improve aneurysm occlusion and implant endothelialization...
BACKGROUND
The 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 the in vivo biocompatibility and in vitro hemocompatibility performance of the Pipeline Vantage Embolization Device with Shield Technology (Vantage) compared with the Pipeline Flex Embolization Device (Flex).
METHODS
Biocompatibility (via histology), aneurysm occlusion and vessel patency (via angiography), and endothelial coverage (via scanning electron microscopy (SEM)) for the Vantage and Flex devices were assessed in the rabbit elastase aneurysm model at 90 days (n=29) and 180 days (n=27). In vitro thrombogenicity for Flex and Vantage (n=16) was assessed using a human blood flow loop model at low heparin concentration (0.6 U/mL) with thrombin generation, platelet activation and thrombus visualization as outputs.
RESULTS
Raymond Roy Occlusion Classification grade 1 was higher for Vantage (61%) compared with Flex (46%), but was not statistically significant (p>0.05). All branch vessels were patent. Histological measures for both devices were similar (p>0.05). Endothelial coverage of the implant was significantly better for Vantage compared with Flex (p<0.05). In vitro measurements of thrombin generation (thrombin-antithrombin complex (µg/mL): Vantage 0.49±0.45; Flex 10.57±9.84) and platelet activation (β-thromboglobulin (IU/µl): Vantage 0.41±0.19; Flex 4.14±2.38) were both statistically lower (p0.05) for Vantage compared with Flex. High resolution microscopy showed less accumulation of thrombus on Vantage as compared with Flex.
CONCLUSION
Vantage improved aneurysm occlusion and implant endothelialization and had significantly lower thrombogenicity as compared with Flex, while preserving the biocompatibility safety profile of Flex.
Topics: Animals; Blood Vessel Prosthesis; Embolization, Therapeutic; Hemodynamics; Humans; Intracranial Aneurysm; Platelet Activation; Rabbits; Treatment Outcome
PubMed: 32487767
DOI: 10.1136/neurintsurg-2020-016043 -
Neurology India 2022To analyze the complications of the standard proximal plug technique in arteriovenous malformations (AVMs) embolization by Onyx and promote ante-grade drifting technique... (Review)
Review
To analyze the complications of the standard proximal plug technique in arteriovenous malformations (AVMs) embolization by Onyx and promote ante-grade drifting technique for AVM embolization. Seven publications reporting complications of AVM embolization by Onyx were identified and reviewed. Render descriptive statistics regarding causes of ischemic and hemorrhagic complications within 1 month following treatment were provided. A novel Onyx injection technique was proposed to overcome these problems. All reported transarterial Onyx AVM embolizations were conducted by employing the proximal plug technique. Causes of complications elicited by utilizing this strategy may generally be attributed to long-fluoroscopy and long-procedure times, embolisate reflux across a considerable extent of the vessel, catheter entrapment, extravasation of Onyx from the arterial lumen, catheter transgression through the arterial wall, the use of an Onyx volume exceeding, and venous occlusion preceding arterial feeder shutdown. Complications occurring during the course of attempts at embolizing AVMs utilizing Onyx constitute unfortunate causes of patient morbidity resulting from this conventional technique. We suggest that institution of a novel "ante-grade drifting technique" for Onyx injection may avoid these commonly elicited deficits. The proximal plug technique has a series of drawbacks that lead to serious adverse outcomes of AVM embolization. The Onyx embolization technology for AVM could be updated to improve clinical outcomes.
Topics: Catheters; Embolization, Therapeutic; Humans; Intracranial Arteriovenous Malformations; Polyvinyls; Treatment Outcome
PubMed: 36076641
DOI: 10.4103/0028-3886.355140 -
Turkish Neurosurgery 2024To compare endovascular coiling and surgical clipping for the evaluation of clinical outcomes in patients with unruptured intracranial aneurysms. (Meta-Analysis)
Meta-Analysis
AIM
To compare endovascular coiling and surgical clipping for the evaluation of clinical outcomes in patients with unruptured intracranial aneurysms.
MATERIAL AND METHODS
We searched MEDLINE, EMBASE, the Cochrane Library and three Chinese domestic electronic databases, namely, Wanfang, CNKI and VIP for studies published between January 1990 and January 2018. We included controlled clinical studies comparing clinical outcomes between surgical clipping and endovascular coiling treatments. Two researchers extracted the data and assessed the quality of the studies, and a meta-analysis was performed using RevMan 5 software.
RESULTS
We analysed a total of 23 controlled clinical studies including 117,796 cases. Meta-analysis demonstrated similar ischaemia rates between clipping and coiling with an odds ratio [OR] of 1.36 (95% CI: 0.77?2.40). The occlusion rate and bleeding risk were higher with clipping than coiling; the pooled ORs were 5.31 (95% CI: 3.07?9.19) and 2.39 (95% CI: 1.82?3.13), respectively. In addition, clipping resulted in a longer hospital stay (OR = 2.90, 95% CI: 2.14?3.65) than coiling did. Patients who underwent clipping had a higher short-term mortality (OR = 1.99, 95% CI: 1.70?2.33) and neurological deficit rate (OR = 2.05, 95% CI: 1.73? 2.44) compared with those who underwent coiling. However, 1 year mortality and deficit rate were similar for both clipping and coiling, with pooled ORs of 0.75 (95% CI: 0.41?1.38) and 0.94 (95% CI: 0.53?1.67), respectively. Funnel plots did not demonstrate a publication bias, with the exception of ischaemic outcome, and sensitivity analysis showed consistent results.
CONCLUSION
Our study demonstrates that coiling is associated with a lower rate of occlusion, shorter hospital stay, lower bleeding risk and lower short-term mortality and morbidity compared with clipping. In terms of ischaemic risk, 1 year mortality and morbidity, coiling and clipping bear a similar risk. In addition, we speculate that surgical clipping may have a better outcome than endovascular coiling in the long term especially in young patients. Further research is needed to confirm our conclusion.
Topics: Humans; Intracranial Aneurysm; Endovascular Procedures; Treatment Outcome; Surgical Instruments; Neurosurgical Procedures; Embolization, Therapeutic
PubMed: 38650551
DOI: 10.5137/1019-5149.JTN.23729-18.1 -
British Heart Journal Nov 1994To assess the incidence and subsequent management of misplaced devices as a complication of therapeutic embolisation procedures.
OBJECTIVE
To assess the incidence and subsequent management of misplaced devices as a complication of therapeutic embolisation procedures.
DESIGN
Retrospective review of case notes, cardiac catheterisation reports, and angiograms.
SETTING
Tertiary referral centre for congenital heart disease.
PATIENTS
205 consecutive children and adults undergoing therapeutic embolisation for congenital heart disease in the 10 years up to 1 April 1993. This group had 231 therapeutic embolisation procedures at 241 sites using coils, umbrella devices, or detachable balloons.
MAIN OUTCOME MEASURES
Incidences of misplacement and retrieval of the device; morbidity and mortality.
RESULTS
The incidence of misplacement was 3% (10/332) of devices deployed and 4.3% (10/231) of procedures performed. Retrieval from distal pulmonary arteries was not attempted in two patients, but transcatheter retrieval of coils and umbrellas from systemic and pulmonary vessels, using snares or retrieval baskets, was successful in the remaining eight. There were no deaths or serious sequelae related to the procedure, but one patient required femoral arteriotomy for removal of an umbrella device retrieved only as far as the groin. In four of the five most recent cases, the misplaced device was retrieved and the therapeutic embolisation was completed at the same procedure.
CONCLUSIONS
Misplacement of a device during therapeutic embolisation is a recognised complication that can be satisfactorily dealt with by transcatheter retrieval without recourse to surgery. For retrieval to be successful it is important to have a wide selection of retrieval equipment available and to be conversant with its use.
Topics: Adolescent; Adult; Aged; Cardiac Catheterization; Child; Child, Preschool; Embolization, Therapeutic; Foreign Bodies; Humans; Infant; Middle Aged; Retrospective Studies
PubMed: 7818967
DOI: 10.1136/hrt.72.5.470 -
Journal of Vascular and Interventional... Jun 2022This study evaluated fundal arteriole angiographic revascularization after embolization with embolic microspheres of 3 different diameters in a swine model (16 swine, 31...
This study evaluated fundal arteriole angiographic revascularization after embolization with embolic microspheres of 3 different diameters in a swine model (16 swine, 31 arterioles). In the 50-μm group, 7 of 11 (64%) arterioles recanalized completely, 3 of 11 (27%) arterioles recanalized partially, and 1 of 11 (9%) arterioles had collateralization (no recanalization). In the 100- to 300-μm group, 7 of 10 (70%) arterioles recanalized completely and 3 of 10 (30%) arterioles) recanalized partially. In the 300- to 500-μm group, 7 of 10 (70%) arterioles recanalized completely, 1 of 10 (10%) arterioles recanalized partially, and 2 of 10 (20%) arterioles had collateralization. No difference was found between the groups in the degree of recanalization (P = .64). All embolized arterioles exhibited some degree of angiographic revascularization, irrespective of the microsphere size.
Topics: Angiography; Animals; Bariatrics; Embolization, Therapeutic; Humans; Microspheres; Swine; Vascular Surgical Procedures
PubMed: 35636834
DOI: 10.1016/j.jvir.2022.02.018 -
Interventional Neuroradiology : Journal... Dec 2019Endovascular treatment of large complex morphology aneurysms is challenging. High recanalization rates have been reported with techniques such as stent-assisted coiling...
BACKGROUND
Endovascular treatment of large complex morphology aneurysms is challenging. High recanalization rates have been reported with techniques such as stent-assisted coiling and balloon-assisted coiling. Flow diverter devices have been introduced to improve efficacy outcomes and recanalization rates. Thromboembolic complications and in-device stenosis are certainly more worrisome when treatment of bilateral internal carotid arteries has been performed. This study aimed to report our experience with mid-term imaging follow-up of staged bilateral Pipeline embolization device placement for the treatment of bilateral internal carotid artery aneurysms.
METHODS
We reviewed the clinical, angiographic, and follow-up imaging data in all consecutive patients treated with bilateral internal carotid artery aneurysms who underwent elective Pipeline embolization.
RESULTS
Six female patients were treated, harboring a total of 13 aneurysms. Of these, 60% were asymptomatic. Diplopia and headache were the most common symptoms. The most common location was the paraclinoid segment (6/13), including by cavernous segment (4/13) and ophthalmic segment (2/13). Successful delivery of the device was achieved in 12 cases. Difficult distal access precluded the deployment of the device in one case. The treatment was always staged with at least eight weeks' difference between the two procedures. All aneurysm necks were covered completely. There were no periprocedural complications. Angiographic follow-up ranged between 3 and 12 months, and computed tomography angiogram follow-up ranged between 2 and 24 months. Complete aneurysm occlusion was achieved in all cases.
CONCLUSION
In our series, Pipeline deployment for the treatment of bilateral internal carotid artery aneurysms in a staged fashion is safe and feasible. Mid-term imaging follow-up showed permanent occlusion of all the treated aneurysms.
Topics: Adult; Aged; Angiography, Digital Subtraction; Blood Vessel Prosthesis; Carotid Artery Diseases; Carotid Artery, Internal; Cerebral Angiography; Embolization, Therapeutic; Female; Follow-Up Studies; Humans; Intracranial Aneurysm; Middle Aged
PubMed: 31159632
DOI: 10.1177/1591019919853586