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Journal of Neurointerventional Surgery Dec 2015Flow diverter stents (FDS) have been described as a breakthrough in the treatment of intracranial aneurysms. Of the various flow diverter models, the Pipeline device has...
BACKGROUND
Flow diverter stents (FDS) have been described as a breakthrough in the treatment of intracranial aneurysms. Of the various flow diverter models, the Pipeline device has been the main approved and used device, with established and good long-term results.
OBJECTIVE
To present the first series of patients treated with its new version, the Pipeline Flex device. This has kept the same device design and configuration but redesigned and completely modified the delivery system.
METHODS
In this technical report, we include 10 consecutive patients harboring 12 saccular aneurysms of the anterior circulation. We report the main changes on the system, immediate results, and technical nuances with illustrative cases.
RESULTS
We implanted 12 devices, including 11 Pipeline Flex and one Pipeline device. We used the old version in one case that required a second layer with a short length not available in the Pipeline Flex size range. All attempts at treatment were successful and no device was discharged or removed. Recovery was required or used in half of the cases with good or excellent performance, except in one case that presented with multiple proximal loops and tight curves. We had two transitory events without ischemic lesions on MRI that recovered 1 and 4 h after all patients were discharged home asymptomatic.
CONCLUSIONS
Pipeline Flex represents a major advance in FDS technology. The redesigned system has significantly improved the deployment of the Pipeline stent, by enabling the operator to resheath the device. It has the potential to continue revolutionizing the endovascular approach for intracranial aneurysms.
Topics: Adult; Aged; Blood Flow Velocity; Cerebral Angiography; Embolization, Therapeutic; Endovascular Procedures; Equipment Design; Female; Humans; Intracranial Aneurysm; Male; Middle Aged; Stents
PubMed: 25280568
DOI: 10.1136/neurintsurg-2014-011347 -
World Neurosurgery Oct 2019Despite widespread use of flow diverters, wide-necked large and giant aneurysms are still treated with other techniques as well. A contemporary review of results from... (Review)
Review
BACKGROUND
Despite widespread use of flow diverters, wide-necked large and giant aneurysms are still treated with other techniques as well. A contemporary review of results from different endovascular treatments is timely.
METHODS
A literature review of the English language literature since 2011 was conducted using PubMed and Science Direct. Keywords and Medical Subheadings included large and giant aneurysms, ruptured aneurysms, aneurysms located in posterior circulation, and aneurysm occlusion status. Case reports were excluded. A combined model was built including both flow diverter and coil treatments in addition to separate models. Efficacy and safety were pooled using random effects analysis and regression.
RESULTS
The review comprised 29 studies. For coiling techniques, complete occlusion was 40.2%-82.8%, and adjusted regression resulted in 53% (95% confidence interval [CI] 22%-81%). Flow diverter complete occlusion rate was 40.5%-87.8%, and adjusted regression resulted in 87% (95% CI 76%-93%). Overall occlusion rate for both techniques combined was 62%-75%, and adjusted regression resulted in 81% (95% CI 68%-89%). Overall stroke and death regression rate was 5% (95% CI 3%-10%); flow diverters showed slightly higher rates than coiling (6% vs. 3%).
CONCLUSIONS
All current treatments of large and giant wide-necked aneurysms have comparable safety and efficacy with a trend of superiority of efficacy toward flow diverters. Results of future treatment options and devices can be compared with current technology to evaluate feasibility.
Topics: Embolization, Therapeutic; Endovascular Procedures; Humans; Intracranial Aneurysm; Neurosurgical Procedures; Stents; Treatment Outcome
PubMed: 31279111
DOI: 10.1016/j.wneu.2019.06.201 -
Acta Biomaterialia Sep 2022Embolization with microspheres is a therapeutic strategy based on the selective occlusion of the blood vessels feeding a tumor. This procedure is intraarterially... (Review)
Review
Embolization with microspheres is a therapeutic strategy based on the selective occlusion of the blood vessels feeding a tumor. This procedure is intraarterially performed in the clinical setting for the treatment of liver cancer. The practice has evolved over the last decade through the incorporation of drug loading ability, biodegradability and imageability with the subsequent added functionality for the physicians and improved clinical outcomes for the patients. This review highlights the evolution of the embolization systems developed through the analysis of the marketed embolic microspheres for the treatment of malignant hepatocellular carcinoma, namely the most predominant form of liver cancer. Embolic microspheres for the distinct modalities of embolization (i.e., bland embolization, chemoembolization and radioembolization) are here comprehensively compiled with emphasis on material characteristics and their impact on microsphere performance. Moreover, the future application of the embolics under clinical investigation is discussed along with the scientific and regulatory challenges ahead in the field. STATEMENT OF SIGNIFICANCE: Embolization therapy with microspheres is currently used in the clinical setting for the treatment of most liver cancer conditions. The progressive development of added functionalities on embolic microspheres (such as biodegradability, imageability or drug and radiopharmaceutical loading capability) provides further benefit to patients and widens the therapeutic armamentarium for physicians towards truly personalized therapies. Therefore, it is important to analyze the possibilities that advanced biomaterials offer in the field from a clinical translational perspective to outline the future trends in therapeutic embolization.
Topics: Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Embolization, Therapeutic; Humans; Liver Neoplasms; Microspheres; Radiopharmaceuticals
PubMed: 35842035
DOI: 10.1016/j.actbio.2022.07.019 -
Advanced Materials (Deerfield Beach,... Jan 2022Embolization is a catheter-based minimally invasive procedure that deliberately occludes diseased blood vessels for treatment purposes. A novel silk-based embolic...
Embolization is a catheter-based minimally invasive procedure that deliberately occludes diseased blood vessels for treatment purposes. A novel silk-based embolic material (SEM) that is developed and optimized to provide tandem integration of both embolization and the delivery of therapeutics is reported. Natural silk is processed into fibroin proteins of varying lengths and is combined with charged nanoclay particles to allow visibility and injectability using clinical catheters as small as 600 μm in diameter at lengths >100 cm. SEMs loaded with fluorochrome labeled bovine albumin and Nivolumab, which is among the most used immunotherapy drugs worldwide, demonstrate a sustained release profile in vitro over 28 days. In a porcine renal survival model, SEMs with labeled albumin and Nivolumab successfully embolize porcine arteries without recanalization and lead to the delivery of both albumin and Nivolumab into the interstitial space of the renal cortex. Mechanistically, it is shown that tissue delivery is most optimal when the internal elastic membrane of the embolized artery is disrupted. SEM is a potential next-generation multifunctional embolic agent that can achieve embolization and deliver a wide range of therapeutics to treat vascular diseases including tumors.
Topics: Animals; Arteries; Catheters; Cattle; Drug Delivery Systems; Embolization, Therapeutic; Silk; Swine
PubMed: 34695275
DOI: 10.1002/adma.202106865 -
BMJ Case Reports Jan 2015This case outlines an unusual complication of coronary intervention, the likely mechanisms leading to this and possible retrieval options. It is the first case to the... (Review)
Review
This case outlines an unusual complication of coronary intervention, the likely mechanisms leading to this and possible retrieval options. It is the first case to the best of our knowledge reporting this complication. A 78-year-old Caucasian man underwent coronary stenting. During the procedure kinking and subsequent fracture of a non-compliant percutaneous transluminal coronary angioplasty (PTCA) balloon occurred. Injection of contrast down the guide to opacify the coronary arteries resulted in 'inflation' of the balloon with air, and embolisation of the inflated balloon into the proximal left anterior descending artery. The embolised balloon was retrieved by removal of the guide catheter and wire as a unit. The patient had a good angiographic outcome. This case highlights risks associated with usage of kinked balloons catheters, and describes for the first time to our knowledge, the inflation of a PTCA balloon with air from its shaft within the catheter, causing 'floatation' embolisation into the coronary artery.
Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Device Removal; Embolization, Therapeutic; Equipment Failure; Humans; Intraoperative Complications; Stents; Treatment Outcome
PubMed: 25576524
DOI: 10.1136/bcr-2014-205307 -
Journal of Vascular and Interventional... Sep 2019The presence of branching vessels, a wide aneurysm neck, and/or fusiform morphology represents a challenge to conventional endovascular treatment of visceral artery... (Review)
Review
The presence of branching vessels, a wide aneurysm neck, and/or fusiform morphology represents a challenge to conventional endovascular treatment of visceral artery aneurysms. A variety of techniques and devices have emerged for the treatment of intracranial aneurysms, in which more aggressive treatment algorithms aimed at smaller and morphologically diverse aneurysms have driven innovation. Here, modified neurointerventional techniques including the use of compliant balloons, scaffold- or stent-assisted coil embolization, and flow diversion are described in the treatment of visceral aneurysms. Neurointerventional devices and their mechanisms of action are described in the context of their application in the peripheral arterial system.
Topics: Aneurysm; Balloon Occlusion; Embolization, Therapeutic; Endovascular Procedures; Humans; Prosthesis Design; Regional Blood Flow; Stents; Treatment Outcome; Vascular Access Devices; Viscera
PubMed: 31036460
DOI: 10.1016/j.jvir.2018.12.733 -
World Neurosurgery Jul 2021A variety of recently introduced devices have allowed more complex aneurysms to be rendered for endovascular embolization. Tiny and sophisticated implants are nowadays...
A variety of recently introduced devices have allowed more complex aneurysms to be rendered for endovascular embolization. Tiny and sophisticated implants are nowadays designed to provide further either temporary or permanent remodeling of the wide-necked aneurysms and improve coil occlusion rates. Such improvements in the technical armamentarium include the Woven EndoBridge (Sequent Medical, California, USA), the Medina Embolic Device (Medtronic, Irvine, California, USA), The Contour Neurovascular System (Cerus Endovascular, Fremont, California, USA), and pCONUS 2 HPC (Phenox, GmbH, Bohum, Germany). Intrasaccular neck bridging is a conceptually new technique descending from the theoretical combination of intrasaccular flow diversion and temporary-stent assisted coiling. The Nautilus (EndoStream Medical, Tel Aviv, Israel) is an intrasaccular bridging device that offers complete neck reconstruction in coil embolization of wide-neck cerebral aneurysms. It has been granted a CE mark by the European Union. The detachable intrasaccular implant comprises flexible and "tornado-like"-shaped Nitinol-based layers. The device is compatible with a standard microcatheter with minimal 0.0165″ inner diameter and is fully radiopaque and fully resheathable. The device's intrasaccular nature and the fact that it does not harbor any intraluminal satellite parts suggest that the implant can be safely used in both unruptured and ruptured case scenarios without the need for dual antiplatelet therapy. This is what we consider a great advantage of the proposed technique over the alternative options of intrasaccular and intraluminal flow diversion. This technical video (Video 1) demonstrates the successful obliteration of a complex posterior communicating artery aneurysm with Nautilus-assisted endovascular coiling. To our knowledge, this is the first technical video demonstrating an in-vivo and step-by-step implementation of this novel device.
Topics: Aneurysm, Ruptured; Animals; Arteries; Blood Vessel Prosthesis; Embolization, Therapeutic; Endovascular Procedures; Humans; Intracranial Aneurysm; Nautilus
PubMed: 33989820
DOI: 10.1016/j.wneu.2021.04.139 -
Journal of Neurointerventional Surgery Jul 2017The Pipeline Embolization Device (PED; Medtronic Neurovascular, Irvine, California, USA) is designed for delivery through a 0.027″ microcatheter. Challenges with the... (Review)
Review
BACKGROUND
The Pipeline Embolization Device (PED; Medtronic Neurovascular, Irvine, California, USA) is designed for delivery through a 0.027″ microcatheter. Challenges with the second-generation PED Flex include limited support from the Marksman microcatheter for consistent resheathing and transmission of push forces for device delivery. The VIA27 (Sequent Medical/MicroVention Terumo, Tustin, California, USA) is an alternative 0.027″ microcatheter originally designed for intrasaccular flow diverter delivery. Here we describe our experience with the VIA27 in the delivery of PED Flex.
METHODS
We retrospectively identified patients who underwent PED Flex treatment with the VIA27 microcatheter at our institution. Patient demographics, aneurysm characteristics, equipment utilized, and procedural details were documented.
RESULTS
A total of 127 cases were completed using the VIA27 microcatheter for PED Flex implantation. Mean patient age was 56.8±12.4 years (range 21-86 years). All but one of the cases were treatments for intracranial aneurysms. Average aneurysm size was 6.5±6 mm (range 2-38 mm). Of the 127 cases, 120 (95%) were anterior circulation cases and 7 (6%) were posterior circulation cases. Significant cervical internal carotid artery (ICA) tortuosity was present in 33/120 cases (28%). Moderate to severe cavernous ICA tortuosity was present in 54/120 cases (45%). Mean fluoroscopy time was 34.1±22.7 min. Large diameter PED devices (4.5-5 mm) were used in 42/127 cases (33%). Balloon post-processing of the PED was used in 15/127 cases (12%) to improve vessel wall apposition of the PED.
CONCLUSIONS
The VIA27 is a microcatheter capable of successful PED Flex delivery in neurointervention. We have shown its utility in enhancing both resheathing and push for optimal PED Flex implantation. The VIA27 microcatheter may be a useful and safe adjunct to the traditional Marksman microcatheter in PED Flex treatment of the cerebrovasculature.
Topics: Adult; Aged; Aged, 80 and over; Carotid Artery, Internal; Catheterization, Peripheral; Catheters; Embolization, Therapeutic; Endovascular Procedures; Female; Humans; Intracranial Aneurysm; Male; Middle Aged; Prospective Studies; Retrospective Studies
PubMed: 28151413
DOI: 10.1136/neurintsurg-2016-012971 -
Interventional Neuroradiology : Journal... Dec 2019Intracranial aneurysms are increasingly being treated by the placement of flow diverters; however, the factors affecting the outcome of aneurysms treated using flow...
BACKGROUND
Intracranial aneurysms are increasingly being treated by the placement of flow diverters; however, the factors affecting the outcome of aneurysms treated using flow diverters remain unclarified.
METHODS
The present study investigated 94 aneurysms treated with pipeline embolisation device placement, and used a computational fluid dynamics method to explore the factors influencing the outcome of aneurysms.
RESULTS
Seventy-six completely occluded aneurysms and 18 incompletely occluded aneurysms were analysed. Before treatment, inflow jets were found in 13 (72.2%) aneurysms in the incompletely occluded group and 34 (44.7%) in the completely occluded group ( = 0.292). After deployment of the pipeline embolisation device, inflow jets remained in nine (50%) aneurysms in the incompletely occluded group and nine (11.8%) in the completely occluded group ( = 0.001). In the incompletely occluded group, regions with inflow jets after treatment corresponded with the patent areas shown on follow-up digital subtraction angiography. The mean reduction ratios of velocity in the whole aneurysm and on the neck plane were lower in the incompletely occluded than in the completely occluded group ( = 0.003; = 0.017). Multivariate analysis revealed that the only independent risk factors for incomplete aneurysm occlusion were the reduction ratios of velocity (in the whole aneurysm, threshold 0.362, = 0.005; on the neck plane, threshold 0.273, = 0.015).
CONCLUSIONS
After pipeline embolisation device placement, reduction ratios of velocity in the whole aneurysm of less than 0.362 and on the neck plane of less than 0.273 are significantly associated with a greater risk of aneurysm incomplete occlusion. In addition, the persistence of inflow jets in aneurysms is associated with incomplete occlusion in the inflow jet area.
Topics: Adolescent; Adult; Aged; Blood Vessel Prosthesis; Child; Embolization, Therapeutic; Female; Hemodynamics; Humans; Hydrodynamics; Intracranial Aneurysm; Male; Middle Aged
PubMed: 31088244
DOI: 10.1177/1591019919849673 -
Journal of Materials Chemistry. B Sep 2020Liquid formulations have a well-established role in therapeutic embolisation of blood vessels with the widespread use of cyanoacrylate glues, precipitating polymer... (Review)
Review
Liquid formulations have a well-established role in therapeutic embolisation of blood vessels with the widespread use of cyanoacrylate glues, precipitating polymer suspensions, sclerosing agents and viscous emulsions of oil and chemotherapeutic agents. There is currently an emerging market for next generation liquid embolics which aim to address some of the short-comings of the currently used products. These next generation systems use varying chemistries in their approach to formulate new systems including polymerising, precipitating and phase-transitioning mechanisms to form solidified masses in situ within the vasculature. Some of these emerging technologies have been developed to possess improved imaging properties such as inherent radiopacity, rather than relying on having to mixing with radiopaque materials such as tantalum powder and reduction of X-ray imaging artefacts (streaking). Others offer solvent-free formulations which gel on contact with blood thereby allowing precise control over gel formation during the embolisation process without the use of potentially toxic solvents. In this review, we discuss the role of liquid agents in therapeutic embolisation and the potential of emerging technologies under development for use in the next generation of embolics.
Topics: Animals; Chemical Precipitation; Embolization, Therapeutic; Gels; Humans; Phase Transition; Polymerization; Polymers
PubMed: 32813005
DOI: 10.1039/d0tb01576h