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1.
Cardiovasc Intervent Radiol ; 44(2): 318-324, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33179161

RESUMEN

PURPOSE: The first-pass effect during mechanical thrombectomy improves clinical outcomes regardless of first-line treatment approach, but current success rates for complete clot capture with one attempt are still less than 40%. We hypothesize that the ThrombX retriever (ThrombX Medical Inc.) can better engage challenging clot models during retrieval throughout tortuous vasculature in comparison with a standard stent retriever without increasing distal emboli. MATERIALS AND METHODS: Thrombectomy testing with the new retriever as compared to the Solitaire stent retriever was simulated in a vascular replica with hard and soft clot analogs to create a challenging occlusive burden. Parameters included analysis of distal emboli generated per clot type, along with the degree of recanalization (complete, partial or none) by retrieval device verified by angiography. RESULTS: The ThrombX device exhibited significantly higher rates of first-pass efficacy (90%) during hard clot retrieval in comparison with the control device (20%) (p < 0.009), while use of both techniques during soft clot retrieval resulted in equivalent recanalization. The soft clot model generated higher numbers of large emboli (>200 µm) across both device groups (p = 0.0147), and no significant differences in numbers of distal emboli were noted between the ThrombX and Solitaire techniques. CONCLUSIONS: Irrespective of clot composition, use of the ThrombX retriever demonstrated high rates of complete recanalization at first pass in comparison with a state-of-the-art stent retriever and proved to be superior in the hard clot model. Preliminary data suggest that risk of distal embolization associated with the ThrombX system is comparable to that of the control device.


Asunto(s)
Embolia Intracraneal/cirugía , Trombectomía/instrumentación , Trombectomía/métodos , Diseño de Equipo , Estudios de Evaluación como Asunto , Humanos , Embolia Intracraneal/diagnóstico por imagen , Angiografía por Resonancia Magnética/métodos , Resultado del Tratamiento
2.
J Korean Neurosurg Soc ; 63(1): 14-25, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31591997

RESUMEN

Proximal flow control achieved with a balloon guide catheter (BGC) during endovascular treatment of acute ischemic stroke is reviewed in this article. In clinical practice, BGCs offer a multi-faceted approach for clot retrieval by creating proximal flow arrest, reducing embolic burden, and shortening procedure time. Evaluation of frontline thrombectomy procedures with BGCs revealed advantages of combined use over the conventional guide catheter (CGC), notably in the significant reduction of distal emboli to both the affected and previously unaffected territories. Recently, new measures of early and complete reperfusion at first thrombectomy pass have been identified as independent predictors of improved outcomes, which were consistently demonstrated with use of BGC as a safe and effective option to minimize number of passes during intervention. Prior randomized controlled trials reported the positive correlation between BGC-treated patients and a lower risk of mortality as well as shortened procedure time. While BGC use is more common in stent retriever-mediated mechanical thrombectomy, preliminary data has shown the potential benefit of device application during contact aspiration thrombectomy to achieve successful recanalization. However, the question of which major endovascular strategy reigns superior as a frontline remains to be answered. Along with clinical case assessments, BGC performance during in-vitro simulation was analyzed to further understand mechanisms for optimization of thrombectomy technique.

3.
J Neurointerv Surg ; 11(12): 1243-1248, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31103992

RESUMEN

PURPOSE: To develop a preclinical model of stroke with a large vessel occlusion treated with mechanical thrombectomy. MATERIALS AND METHODS: An ischemic stroke model was created in dogs by the introduction of an autologous clot into the middle cerebral artery (MCA). A microcatheter was navigated to the clot and a stent retriever thrombectomy was performed with the goal to achieve Thrombolysis in Cerebral Ischemia (TICI) 2b/3 reperfusion. Perfusion and diffusion MRI was acquired after clot placement and following thrombectomy to monitor the progression of restricted diffusion as well as changes in ischemia as a result of mechanical thrombectomy. Post-mortem histology was done to confirm MCA territory infarct volume. RESULTS: Initial MCA occlusion with TICI 0 flow was documented in all six hound-cross dogs entered into the study. TICI 2b/3 revascularization was achieved with one thrombectomy pass in four of six animals (67%). Intra-procedural events including clot autolysis leading to spontaneous revascularization (n=1) and unresolved vasospasm (n=1) accounted for thrombectomy failure. In one case, iatrogenic trauma during microcatheter navigation resulted in a direct arteriovenous fistula at the level of the cavernous carotid. Analysis of MRI indicated that a volume of tissue from the initial perfusion deficit was spared with reperfusion following thrombectomy, and there was also a volume of tissue that infarcted between MRI and ultimate recanalization. CONCLUSION: We describe a large animal stroke model in which mechanical thrombectomy can be performed. This model may facilitate, in a preclinical setting, optimization of complex multimodal stroke treatment paradigms for clinical translation.


Asunto(s)
Isquemia Encefálica/cirugía , Modelos Animales de Enfermedad , Accidente Cerebrovascular/cirugía , Trombectomía/métodos , Animales , Isquemia Encefálica/diagnóstico por imagen , Revascularización Cerebral/métodos , Perros , Femenino , Imagen por Resonancia Magnética , Estudios Retrospectivos , Accidente Cerebrovascular/diagnóstico por imagen , Resultado del Tratamiento
4.
Stroke ; 50(7): 1907-1910, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-31138084

RESUMEN

Background and Purpose- Nearly 30% of large vessel occlusion acute ischemic stroke clots are from an unknown source. We assessed histological clot composition in a series of patients with large vessel occlusion and investigated correlations between clot composition and stroke pathogenesis. Methods- As part of the multi-institutional STRIP registry (Stroke Thromboembolism Registry of Imaging and Pathology), consecutive emboli retrieved during mechanical thrombectomy were stained using Martius Scarlett Blue and analyzed using machine learning software. We assessed proportions of red blood cells, fibrin, platelets, and white blood cells. Correlations between clot components and stroke pathogenesis (large artery atherosclerosis, cardioembolism, and stroke of undetermined pathogenesis) were assessed using SPSS22. Results- One hundred five patients were included. The proportion of platelet-rich clots (55.0% versus 21.2%; P=0.005) and percentage of platelet content (22.1±4.2% versus 13.9±14.2%; P=0.03) was significantly higher in the large artery atherosclerosis group compared with the cardioembolic group. The proportion of platelet-rich clots (50.0% versus 21.2%; P=0.024) was also significantly higher in the cryptogenic group compared with cardioembolic cases. Large artery atherosclerosis and cryptogenic cases had a similar proportion of platelet-rich clots (55.0% versus 50.0%; P=0.636). There was no significant difference between stroke pathogenesis and the other major clot components. Conclusions- High platelet content of emboli is associated with a large artery atherosclerosis etiology of large vessel occlusion.


Asunto(s)
Arteriopatías Oclusivas/sangre , Plaquetas/patología , Enfermedades Arteriales Cerebrales/sangre , Arteriosclerosis Intracraneal/sangre , Embolia Intracraneal/sangre , Adulto , Anciano , Anciano de 80 o más Años , Recuento de Células Sanguíneas , Retracción del Coagulo , Trombosis Coronaria/sangre , Femenino , Humanos , Aprendizaje Automático , Masculino , Persona de Mediana Edad , Sistema de Registros , Accidente Cerebrovascular/sangre , Trombectomía , Tromboembolia/sangre , Tromboembolia/patología
5.
J Neurointerv Surg ; 11(9): 931-936, 2019 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-30718384

RESUMEN

BACKGROUND: Evidence is mounting that first-pass complete recanalization during mechanical thrombectomy is associated with better clinical outcomes in patients presenting with an emergent large vessel occlusion. We hypothesize that aspiration achieving complete clot ingestion results in higher first-pass successful recanalization with quantitative reduction in distal emboli. METHODS: A patient-specific cerebrovascular replica was connected to a flow loop. Occlusion of the middle cerebral artery was achieved with clot analogs. Independent variables were the diameter of the aspiration catheter (0.054-0.088in) and aspiration pattern (static versus cyclical). Outcome measures were the first-pass rates of complete clot ingestion, the extent of recanalization, and the particle-size distribution of distal emboli. RESULTS: All aspiration catheters were successfully navigated to the occlusion. Complete clot ingestion during aspiration thrombectomy resulted in first-pass complete recanalization in every experiment, only achieved in 21% of experiments with partial ingestion (P<0.0001). Aspiration through the large bore 0.088in device resulted in the highest rates of complete clot ingestion (90%). Cyclical aspiration (18-29 inHg, 0.5 Hz) significantly increased the rate of complete clot ingestion (OR21 [1.6, 266]; P=0.04). In all experiments, complete clot ingestion resulted in fewer and smaller distal emboli. CONCLUSIONS: Complete clot ingestion results in fewer distal emboli and the highest rates of first-pass complete recanalization. The rate of complete ingestion during aspiration thrombectomy is a function of both the inner diameter of the aspiration catheter and use of cyclical aspiration.


Asunto(s)
Catéteres , Trombectomía/instrumentación , Trombectomía/métodos , Trombosis/cirugía , Animales , Bovinos , Trastornos Cerebrovasculares/cirugía , Embolización Terapéutica/métodos , Humanos , Arteria Cerebral Media/cirugía , Procedimientos de Cirugía Plástica/instrumentación , Procedimientos de Cirugía Plástica/métodos , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/cirugía , Resultado del Tratamiento
6.
J Neurointerv Surg ; 11(3): 271-274, 2019 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-30177546

RESUMEN

BACKGROUND: Despite high recanalization rates achieved with endovascular treatment of acute ischemic strokes, around 50% of eligible patients will not achieve a good outcome. Parameters that may determine patient outcomes include: time from puncture to recanalization, the collateral status, the anesthesia regimen, blood pressure management, and distal emboli. Characterization of distal emboli generated during mechanical thrombectomy has been performed in previous studies. OBJECTIVE: To further investigate the risk of distal embolization associated with microcatheter navigation across the clot. METHODS: A contrast-enhanced clot analog was used in an in vitro model that mimicked a middle cerebral artery occlusion within a complete circle of Willis vascular replica. The clot was crossed with one of the following microcatheters: Pro18, XT-27 or 3MAX. The emboli generated during the procedure were collected and measured. RESULTS: The use of Pro18 and XT-27 resulted in a significant reduction of visible particles (size ≥500 µm) as compared with the 3MAX catheter (P<0.003). For the size range between 8 and 200 µm, there was a trend for Pro18 to generate fewer particles (-18%) than XT-27 but without statistical significance (P>0.05). In comparison with previously published data, acquired under the same conditions, it was found that the clot crossing maneuver accounts approximately for 12% of the total number of small emboli (<200 µm) induced during a stent retriever-mediated mechanical thrombectomy procedure via a balloon guide catheter. CONCLUSIONS: The clot crossing maneuver has a significant effect on the total number of small particles induced during mechanical thrombectomy. Smaller microcatheter sizes should be favored when possible.


Asunto(s)
Catéteres , Infarto de la Arteria Cerebral Media/cirugía , Modelos Anatómicos , Neuronavegación/métodos , Trombosis/cirugía , Cateterismo/instrumentación , Cateterismo/métodos , Embolización Terapéutica/instrumentación , Embolización Terapéutica/métodos , Humanos , Neuronavegación/instrumentación , Trombectomía/instrumentación , Trombectomía/métodos
7.
J Neurointerv Surg ; 10(2): 143-149, 2018 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-28280114

RESUMEN

BACKGROUND AND PURPOSE: Currently, there is neither a standard protocol for vessel wall MR imaging of intracranial atherosclerotic disease (ICAD) nor a gold standard phantom to compare MR sequences. In this study, a plaque phantom is developed and characterized that provides a platform for establishing a uniform imaging approach for ICAD. MATERIALS AND METHODS: A patient specific injection mold was 3D printed to construct a geometrically accurate ICAD phantom. Polyvinyl alcohol hydrogel was infused into the core shell mold to form the stenotic artery. The ICAD phantom incorporated materials mimicking a stenotic vessel and plaque components, including fibrous cap and lipid core. Two phantoms were scanned using high resolution cone beam CT and compared with four different 3 T MRI systems across eight different sites over a period of 18 months. Inter-phantom variability was assessed by lumen dimensions and contrast to noise ratio (CNR). RESULTS: Quantitative evaluation of the minimum lumen radius in the stenosis showed that the radius was on average 0.80 mm (95% CI 0.77 to 0.82 mm) in model 1 and 0.77 mm (95% CI 0.74 to 0.81 mm) in model 2. The highest CNRs were observed for comparisons between lipid and vessel wall. To evaluate manufacturing reproducibility, the CNR variability between the two models had an average absolute difference of 4.31 (95% CI 3.82 to 5.78). Variation in CNR between the images from the same scanner separated by 7 months was 2.5-6.2, showing reproducible phantom durability. CONCLUSIONS: A plaque phantom composed of a stenotic vessel wall and plaque components was successfully constructed for multicenter high resolution MRI standardization.


Asunto(s)
Imagenología Tridimensional/instrumentación , Arteriosclerosis Intracraneal/diagnóstico por imagen , Imagen por Resonancia Magnética/instrumentación , Fantasmas de Imagen , Insuficiencia Vertebrobasilar/diagnóstico por imagen , Tomografía Computarizada de Haz Cónico/instrumentación , Tomografía Computarizada de Haz Cónico/métodos , Humanos , Imagenología Tridimensional/métodos , Imagen por Resonancia Magnética/métodos , Reproducibilidad de los Resultados
8.
Interv Neurol ; 6(3-4): 268-276, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-29118805

RESUMEN

BACKGROUND: Over the course of the thrombectomy procedure, clot fragments may become dislodged and lead to downstream emboli due to manipulation of an endovascular device. The EmboTrap thrombectomy system features an inner stent channel with an outer stent trap design that may potentially reduce the risk of distal clot fragmentation during clot removal. We tested the hypothesis that distal emboli to both the same and new territory generated during mechanical thrombectomy are a function of device design. METHODS: EmboTrap and Solitaire thrombectomy were conducted in an in vitro model system that mimicked a middle-cerebral artery (MCA) occlusion within a complete circle of Willis vascular replica and a contrast-enhanced clot analog. Emboli generated during the procedure with a size >1,000 µm were collected and measured with calipers. The Coulter principle was used to characterize emboli with a size between 200 and 1,000 µm. RESULTS: EmboTrap thrombectomy resulted in a significant reduction in the risk of large emboli (>1,000 µm) formation as compared to first-generation stent retriever thrombectomy (p = 0.031, Fisher exact test). The majority of emboli >1,000 µm (∼80%) were found in the MCA, regardless of device type. There was no significant difference between the EmboTrap and Solitaire in 200 to 1,000 µm emboli formation (p = 0.89, Mann-Whitney test). When combining all emboli in the most dangerous range (>200 µm), EmboTrap offered a size reduction of emboli (p = 0.022). CONCLUSION: The risk of distal embolization can be altered with improved stent retriever design. When encountering fragment-prone clots, EmboTrap thrombectomy may lower the risk of distal embolization.

9.
J Neurointerv Surg ; 9(2): 183-187, 2017 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-26919972

RESUMEN

BACKGROUND: Formation of clot fragments during mechanical thrombectomy for acute ischemic stroke can occlude the distal vasculature, which may reduce the rate of good clinical outcome. OBJECTIVE: To examine the hypothesis that distal embolization can be reduced using stent retriever thrombectomy in combination with Lazarus Cover technology. METHODS: Hard, fragment-prone clots were used to create middle cerebral artery occlusions in a vascular phantom. Three different treatment strategies using Solitaire FR included: group 1-proximal flow control with an 8F balloon guide catheter (BGC), group 2-thrombectomy through a 6F conventional guide catheter (CGC), and group 3-a similar thrombectomy procedure to group 2 but including the Lazarus Cover device. The primary endpoint was distal emboli quantified by the number and size of the clot debris. RESULTS: The Cover-assisted stent retriever thrombectomy significantly reduced the generation of clot fragments >200 µm as compared with thrombectomy with a CGC, and was similar to the BGC group. Particle size distribution <200 µm was similar across the groups. All groups were associated with high rates of recanalization, with only one failed recanalization with partial clot retention after three passes in one experiment of stent retriever thrombectomy through a CGC. Use of the adjunctive Cover device did not prolong the procedure as compared with control groups. CONCLUSIONS: For a fragment-prone clot, Solitaire thrombectomy in conjunction with the Cover device may lower the risk of distal embolization and is comparable to BGC-protected embolectomy.


Asunto(s)
Remoción de Dispositivos/efectos adversos , Embolización Terapéutica/métodos , Embolia Intracraneal/etiología , Stents , Trombectomía/efectos adversos , Trombectomía/métodos , Isquemia Encefálica/cirugía , Angiografía Cerebral , Remoción de Dispositivos/métodos , Infarto de la Arteria Cerebral Media/cirugía , Embolia Intracraneal/diagnóstico por imagen , Tamaño de la Partícula , Accidente Cerebrovascular/cirugía , Resultado del Tratamiento
10.
J Neurointerv Surg ; 8(12): 1278-1282, 2016 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26833539

RESUMEN

PURPOSE: Rapid revascularization in emergent large vessel occlusion with endovascular embolectomy has proven clinical benefit. We sought to measure device-clot interaction as a potential mechanism for efficient embolectomy. METHODS: Two different radiopaque clot models were injected to create a middle cerebral artery occlusion in a patient-specific vascular phantom. A radiopaque stent retriever was deployed within the clot by unsheathing the device or a combination of unsheathing followed by pushing the device (n=8/group). High-resolution cone beam CT was performed immediately after device deployment and repeated after 5 min. An image processing pipeline was created to quantitatively evaluate the volume of clot that integrates with the stent, termed the clot integration factor (CIF). RESULTS: The CIF was significantly different for the two deployment variations when the device engaged the hard clot (p=0.041), but not the soft clot (p=0.764). In the hard clot, CIF increased significantly between post-deployment and final imaging datasets when using the pushing technique (p=0.019), but not when using the unsheathing technique (p=0.067). When we investigated the effect of time on CIF in the different clot models disregarding the technique, the CIF was significantly increased in the final dataset relative to the post-deployment dataset in both clot models (p=0.004-0.007). CONCLUSIONS: This study demonstrates in an in vitro system the benefit of pushing the Trevo stent during device delivery in hard clot to enhance integration. Regardless of delivery technique, clot-device integration increased in both clot models by waiting 5 min.

11.
J Neurointerv Surg ; 8(2): 197-202, 2016 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25540180

RESUMEN

BACKGROUND: There is a discrepancy in clinical outcomes and the achieved recanalization rates with stent retrievers in the endovascular treatment of ischemic stroke. It is our hypothesis that procedural release of embolic particulate may be one contributor to poor outcomes and is a modifiable risk. The goal of this study is to assess various treatment strategies that reduce the risk of distal emboli. METHODS: Mechanical thrombectomy was simulated in a vascular phantom with collateral circulation. Hard fragment-prone clots (HFC) and soft elastic clots (SECs) were used to generate middle cerebral artery (MCA) occlusions that were retrieved by the Solitaire FR devices through (1) an 8 Fr balloon guide catheter (BGC), (2) a 5 Fr distal access catheter at the proximal aspect of the clot in the MCA (Solumbra), or (3) a 6 Fr guide catheter with the tip at the cervical internal carotid artery (guide catheter, GC). Results from mechanical thrombectomy were compared with those from direct aspiration using the Penumbra 5MAX catheter. The primary endpoint was the size distribution of emboli to the distribution of the middle and anterior cerebral arteries. RESULTS: Solumbra was the most efficient method for reducing HFC fragments (p<0.05) while BGC was the best method for preventing SEC fragmentation (p<0.05). The risk of forming HFC distal emboli (>1000 µm) was significantly increased using GC. A non-statistically significant benefit of direct aspiration was observed in several subgroups of emboli with size 50-1000 µm. However, compared with the stent-retriever mechanical thrombectomy techniques, direct aspiration significantly increased the risk of SEC fragmentation (<50 µm) by at least twofold. CONCLUSIONS: The risk of distal embolization is affected by the catheterization technique and clot mechanics.


Asunto(s)
Remoción de Dispositivos/métodos , Embolización Terapéutica/efectos adversos , Stents , Trombectomía/efectos adversos , Remoción de Dispositivos/efectos adversos , Embolización Terapéutica/métodos , Humanos , Factores de Riesgo , Trombectomía/métodos
12.
Stroke ; 46(12): 3507-13, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26493676

RESUMEN

BACKGROUND AND PURPOSE: The goal of this study is to combine temporary endovascular bypass (TEB) with a novel shear-activated nanotherapeutic (SA-NT) that releases recombinant tissue-type plasminogen activator (r-tPA) when exposed to high levels of hemodynamic stress and to determine if this approach can be used to concentrate r-tPA at occlusion sites based on high shear stresses created by stent placement. METHODS: A rabbit model of carotid vessel occlusion was used to test the hypothesis that SA-NT treatment coupled with TEB provides high recanalization rates while reducing vascular injury. We evaluated angiographic recanalization with TEB alone, intra-arterial delivery of soluble r-tPA alone, or TEB combined with 2 doses of intra-arterial infusion of either the SA-NT or soluble r-tPA. Vascular injury was compared against stent-retriever thrombectomy. RESULTS: Shear-targeted delivery of r-tPA using the SA-NT resulted in the highest rate of complete recanalization when compared with controls (P=0.0011). SA-NT (20 mg) had a higher likelihood of obtaining complete recanalization as compared with TEB alone (odds ratio 65.019, 95% confidence interval 1.77, >1000; P=0.0231), intra-arterial r-tPA alone (odds ratio 65.019, 95% confidence interval 1.77, >1000; P=0.0231), or TEB with soluble r-tPA (2 mg; odds ratio 18.78, 95% confidence interval 1.28, 275.05; P=0.0322). Histological analysis showed circumferential loss of endothelium restricted to the area where the TEB was deployed; however, there was significantly less vascular injury using a TEB as compared with stent-retriever procedure (odds ratio 12.97, 95% confidence interval 8.01, 21.02; P<0.0001). CONCLUSIONS: A novel intra-arterial, nanoparticle-based thrombolytic therapy combined with TEB achieves high rates of complete recanalization. Moreover, this approach reduces vascular trauma as compared with stent-retriever thrombectomy.


Asunto(s)
Arteriopatías Oclusivas/patología , Arteriopatías Oclusivas/terapia , Procedimientos Endovasculares/métodos , Nanopartículas/administración & dosificación , Resistencia al Corte , Animales , Bovinos , Terapia Combinada , Femenino , Masculino , Nanopartículas/química , Conejos , Resultado del Tratamiento
13.
Stroke ; 46(10): 2991-7, 2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-26351362

RESUMEN

Imaging inflammation in large intracranial artery pathology may play an important role in the diagnosis of and risk stratification for a variety of cerebrovascular diseases. Looking beyond the lumen has already generated widespread excitement in the stroke community, and the potential to unveil molecular processes in the vessel wall is a natural evolution to develop a more comprehensive understanding of the pathogenesis of diseases, such as ICAD and brain aneurysms.


Asunto(s)
Encéfalo/diagnóstico por imagen , Trastornos Cerebrovasculares/diagnóstico , Vasculitis del Sistema Nervioso Central/diagnóstico , Vasos Sanguíneos/inmunología , Vasos Sanguíneos/patología , Encéfalo/inmunología , Encéfalo/patología , Angiografía Cerebral , Trastornos Cerebrovasculares/inmunología , Ecoencefalografía , Humanos , Imagen por Resonancia Magnética , Imagen Molecular , Tomografía de Emisión de Positrones , Vasculitis del Sistema Nervioso Central/diagnóstico por imagen
14.
J Neurointerv Surg ; 7(2): 114-7, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-24435960

RESUMEN

OBJECTIVE: To elucidate the early detachment of the Solitaire stent during mechanical thrombectomy, we tested the stent in vitro under various conditions and evaluated with microscopy. METHODS: A total of five stents were tested. Using a dynamic mechanical analysis machine, we calculated the tensile force needed for separation of the four stents from the pusher wire. Stent Nos 1 and 2 were tested without any prior manipulation. During the retraction test, no sheathing around the stent-wire junction was applied to stent No 1 whereas stent No 2 was partially covered with a sheath in accordance with instructions for use (IFU) recommendations. Stent No 3 was tested after deployment and retrieval were performed three times in an in vitro vascular replica with sheathing during retrieval. Stent No 4 was tested after one deployment and retrieval using the same replica as in stent No 3 without sheathing. In addition, forward pushing force was applied intentionally during retraction to induce excessive bending of the stent. Stent No 5 was pulled apart by both hands. After separation, stent tips and pusher wires were studied for all stents under the microscope. RESULTS: The tensile force needed for separation was about 6 N for stent Nos 1, 2, and 3, and about 4 N for stent No 4. All of the stents showed separation at the proximal marker, not at the detachment zone. CONCLUSIONS: Detachment of the Solitaire stent during thrombectomy can be due to separation around or inside the proximal marker. Adherence to the manufacturer's IFU of partial re-sheathing during retraction and not using the device for more than two passes might decrease the possibility of such device failure.


Asunto(s)
Revascularización Cerebral/métodos , Falla de Equipo , Ensayo de Materiales/métodos , Stents , Trombectomía/instrumentación , Isquemia Encefálica/cirugía , Revascularización Cerebral/instrumentación , Humanos , Técnicas In Vitro , Stents/efectos adversos , Accidente Cerebrovascular/cirugía , Trombectomía/efectos adversos , Factores de Tiempo , Resultado del Tratamiento
15.
J Neurointerv Surg ; 7(9): 676-81, 2015 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-25031179

RESUMEN

BACKGROUND: Rates of durable aneurysm occlusion following coil embolization vary widely, and a better understanding of coil mass mechanics is desired. The goal of this study is to evaluate the impact of packing density and coil uniformity on aneurysm permeability. METHODS: Aneurysm models were coiled using either Guglielmi detachable coils or Target coils. The permeability was assessed by taking the ratio of microspheres passing through the coil mass to those in the working fluid. Aneurysms containing coil masses were sectioned for image analysis to determine surface area fraction and coil uniformity. RESULTS: All aneurysms were coiled to a packing density of at least 27%. Packing density, surface area fraction of the dome and neck, and uniformity of the dome were significantly correlated (p<0.05). Hence, multivariate principal components-based partial least squares regression models were used to predict permeability. Similar loading vectors were obtained for packing and uniformity measures. Coil mass permeability was modeled better with the inclusion of packing and uniformity measures of the dome (r(2)=0.73) than with packing density alone (r(2)=0.45). The analysis indicates the importance of including a uniformity measure for coil distribution in the dome along with packing measures. CONCLUSIONS: A densely packed aneurysm with a high degree of coil mass uniformity will reduce permeability.


Asunto(s)
Embolización Terapéutica/métodos , Aneurisma Intracraneal/terapia , Circulación Cerebrovascular , Humanos , Aneurisma Intracraneal/patología , Modelos Anatómicos , Permeabilidad , Resultado del Tratamiento
18.
Stroke ; 44(5): 1396-401, 2013 May.
Artículo en Inglés | MEDLINE | ID: mdl-23493730

RESUMEN

BACKGROUND AND PURPOSE: To evaluate the impact of proximal flow control on efficacy and safety of mechanical thrombectomy in an in vitro middle cerebral artery occlusion. METHODS: Three independent variables, including clot type, device (Merci Retriever, Solitaire FR, and Trevo devices), and use of a balloon guide catheter, were used to ascertain the impact of proximal flow control on the size and number of distal emboli generated during thrombectomy. Secondary end points were the recanalization rate and amount of flow restored. RESULTS: Use of the balloon guide catheter during thrombectomy of the fragile, hard clot significantly reduced the formation of large distal emboli with a diameter >1 mm, regardless of the device used (P<0.01). Applying aspiration via the balloon guide catheter in place of the conventional guide catheter resulted in a significant increase of flow reversal (P<0.0001). Prior to thrombectomy, deployment of the stent-trievers produced immediate flow restoration through the soft and hard clot occlusions, 69.2 ± 27.3 and 45.5 ± 22.8 mL/min, respectively, that was preserved after the balloon inflation because of collateral flow via the posterior communication artery. After deployment but before thrombectomy, no flow was restored when using the Merci Retriever. After thrombectomy, complete flow restoration was achieved in a majority of cases. The Merci Retriever required more thrombectomy attempts to achieve hard clot removal compared with the stent-trievers when the conventional guide catheter was used (1.5 versus 1.1). CONCLUSIONS: The risk of distal embolization was significantly reduced with the use of the balloon guide catheter.


Asunto(s)
Infarto de la Arteria Cerebral Media/cirugía , Modelos Anatómicos , Accidente Cerebrovascular/cirugía , Trombectomía/métodos , Cateterismo , Humanos , Stents , Trombectomía/instrumentación , Resultado del Tratamiento
19.
Biomaterials ; 24(7): 1167-73, 2003 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-12527257

RESUMEN

The purpose of this study was to fine-tune the mechanical properties of high molecular-weight poly-L-lactic acid (PLLA), especially to increase its toughness without sacrificing too much of its original strength. Besides of its long degradation time, PLLA is usually hard and brittle, which hinders its usage in medical applications, i.e., orthopedic and dental surgery. Some modifications, such as the addition of plasticizers or surfactants/compatibilizers, are usually required to improve its original properties. PDLLA can degrade quickly due to its amorphous structure, thus shortening the degradation time of PLLA/PDLLA blends. Blends of biodegradable poly-L-lactic acid (PLLA) and poly-DL-lactic acid (PDLLA) or polycaprolactone (PCL), in addition to a third component, the surfactant-a copolymer of ethylene oxide and propylene oxide, were prepared by blending these three polymers at various ratios using dichloromethane as a solvent. The weight percentages of PLLA/PDLLA (or PCL) blends were 100%/0%, 80%/20%, 60%/40%, 50%/50%, 40%/60%, 20%/80% and 0%/100%, respectively. Physical properties such as the crystalline melting point, glass transition point (T(g)), phase behavior, degradation behavior, and other mechanical properties were characterized by thermogravimetric analysis, differential scanning calorimetry (DSC), infrared spectroscopy, gel permeation chromatography, and dynamic mechanical analysis (DMA). DSC data indicate that PLLA/PDLLA blends without the surfactant had two T(g)'s. With the addition of the surfactant, there was a linear shift of the single T(g) as a function of composition, with lower percentages of PLLA producing lower glass transition temperatures indicating that better miscibility had been achieved. DMA data show that the 40/60 PLLA/PDLLA blends without the surfactant had high elastic modulus and elongation, and similar results were observed after adding 2% surfactant into the blends. The 50/50 PLLA/PDLLA/2% surfactant blend had the highest elastic modulus, yield strength, and break strength compared with other ratios of PLLA/PDLLA/2% surfactant blends. The elongation at break of 50/50 PLLA/PDLLA was similar to that of PLLA. Again, the elongation at break of 50/50 PLLA/PDLLA/2% surfactant was almost 1.2-1.9 times higher than that of 50/50 PLLA/PDLLA and PLLA. Elongation of PLLA increased with the addition of PCL, but the strength decreased at the same time. In conclusions, adding PDLLA and surfactant to PLLA via solution-blending may be an effective way to make PLLA tougher and more suitable to use in orthopedic or dental applications.


Asunto(s)
Materiales Biocompatibles/síntesis química , Poliésteres/síntesis química , Poliésteres/metabolismo , Materiales Biocompatibles/química , Biodegradación Ambiental , Óxido de Etileno/química , Poliésteres/química , Tensoactivos/química
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