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1.
Trends Biotechnol ; 39(5): 505-518, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33019966

RESUMEN

Surgically bypassing or replacing a severely damaged artery using a biodegradable synthetic vascular graft is a promising treatment that allows for the remodeling and regeneration of the graft to form a neoartery. Elastin-based structures, such as elastic fibers, elastic lamellae, and laminae, are key functional components in the arterial extracellular matrix. In this review, we identify the lack of elastin in vascular grafts as a key factor that prevents their long-term success. We further summarize advances in vascular tissue engineering that are focused on either de novo production of organized elastin or incorporation of elastin-based biomaterials within vascular grafts to mitigate failure and enhance enduring in vivo performance.


Asunto(s)
Prótesis Vascular , Elastina , Ingeniería de Tejidos , Materiales Biocompatibles , Prótesis Vascular/normas , Prótesis Vascular/tendencias , Elastina/metabolismo , Matriz Extracelular/metabolismo , Humanos , Ingeniería de Tejidos/tendencias
2.
J Neurointerv Surg ; 13(2): 153-158, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-32611622

RESUMEN

BACKGROUND: Flow diversion is a common endovascular treatment for cerebral aneurysms, but studies comparing different types of flow diverters are scarce. OBJECTIVE: To perform a propensity score matched cohort study comparing the Pipeline Embolization Device (PED) and Flow Redirection Intraluminal Device (FRED) for posterior circulation aneurysms. METHODS: Consecutive aneurysms of the posterior circulation treated at 25 neurovascular centers with either PED or FRED were collected. Propensity score matching was used to control for age, duration of follow-up imaging, adjunctive coiling, and aneurysm location, size, and morphology; previously ruptured aneurysms were excluded. The two devices were compared for the following outcomes: procedural complications, aneurysm occlusion, and functional outcome. RESULTS: A total of 375 aneurysms of the posterior circulation were treated in 369 patients. The PED was used in 285 (77.2%) and FRED in 84 (22.8%) procedures. Aneurysms treated with the PED were more commonly fusiform and larger than those treated with FRED. To account for these important differences, propensity score matching was performed resulting in 33 PED and FRED unruptured aneurysm pairs. No differences were found in occlusion status and neurologic thromboembolic or hemorrhagic complications between the two devices. The proportion of patients with favorable functional outcome was higher with FRED (100% vs 87.9%, p=0.04). CONCLUSION: Comparative analysis of PED and FRED for the treatment of unruptured posterior circulation aneurysms did not identify significant differences in aneurysm occlusion or neurologic complications. Variations in functional outcomes warrant additional investigations.


Asunto(s)
Aneurisma Roto/terapia , Prótesis Vascular/normas , Embolización Terapéutica/normas , Aneurisma Intracraneal/terapia , Puntaje de Propensión , Stents Metálicos Autoexpandibles/normas , Adulto , Anciano , Aneurisma Roto/diagnóstico por imagen , Estudios de Cohortes , Embolización Terapéutica/métodos , Femenino , Estudios de Seguimiento , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento
3.
J Thorac Cardiovasc Surg ; 161(2): 581-590.e6, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-31879167

RESUMEN

BACKGROUND: This study examined whether the presence of a sinus of Valsalva equivalent in the KONECT RESILIA aortic valved conduit (Edwards Lifesciences, Irvine, Calif) improves valve hemodynamics, kinematics, and performance. METHODS: A 28-mm KONECT RESILIA aortic valved conduit was used to create an in vitro flow test model, and the same aortic valved conduit model without a sinus section was used as a control. Particle image velocimetry and hydrodynamic characterization experiments were conducted in the vicinity of the valves in a validated left-heart simulator at 3 cardiac output levels. In addition, leaflet kinematics of the valves were determined through en face high-speed imaging. RESULTS: The KONECT RESILIA aortic valved conduit model exhibited lower mean and peak transvalvular pressure gradients than the control model at all 3 cardiac outputs. In addition, its leaflets opened more fully than did those of the valved conduit without the sinuses, yielding greater effective and geometric orifice areas. It was found that the presence of the sinuses not only facilitated the development of larger and more stable vortices at the initial stages of the cardiac cycle but also helped to maintain these vortices during the late stages of the cardiac cycle, leading to smoother valve closure. CONCLUSIONS: The KONECT RESILIA aortic valved conduit reproduces the bulged section of the aortic root corresponding to the sinuses of Valsalva. With this Valsalva-type conduit, larger orifice areas were observed, improving valve hemodynamics that may enhance performance.


Asunto(s)
Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas , Aorta/anatomía & histología , Aorta/fisiología , Aorta/cirugía , Válvula Aórtica/anatomía & histología , Válvula Aórtica/fisiología , Fenómenos Biomecánicos , Velocidad del Flujo Sanguíneo , Prótesis Vascular/normas , Prótesis Valvulares Cardíacas/normas , Hemodinámica , Humanos , Técnicas In Vitro , Seno Aórtico/anatomía & histología , Seno Aórtico/fisiología
4.
World Neurosurg ; 142: 339-351, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32360671

RESUMEN

BACKGROUND: Endovascular therapy is a viable alternative to surgical clipping for the treatment of intracranial aneurysms; however, aneurysms arising at bifurcations remain a challenge. The purpose of this technical report is to share the nuances of treating aneurysms with the PulseRider (PR), including device selection and positioning strategy, from authors who are highly experienced in its use. METHODS: We offer a comprehensive guide for neuroendovascular surgeons less experienced with PR applications to include design, general coil embolization technique, principles of deployment and detachment, positioning options, and geometric challenges and their solutions. RESULTS: In our experience, the PR is well suited for addressing the challenges of treating bifurcation aneurysms. CONCLUSIONS: PR use is intuitive and straightforward for use in bifurcation aneurysms with ideal favorable. PR can also be safely and effectively used to address a much broader and more challenging range of geometries.


Asunto(s)
Prótesis Vascular , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Aneurisma Intracraneal/cirugía , Diseño de Prótesis/métodos , Stents , Prótesis Vascular/normas , Embolización Terapéutica/instrumentación , Procedimientos Endovasculares/instrumentación , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Stents/normas , Resultado del Tratamiento
5.
J Neurointerv Surg ; 12(10): 968-973, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32111727

RESUMEN

INTRODUCTION: During flow diversion, the choice of the length, diameter, and location of the deployed stent are critical for the success of the procedure. Sim&Size software, based on the three-dimensional rotational angiography (3D-RA) acquisition, simulates the release of the stent, suggesting optimal sizing, and displaying the degree of the wall apposition. OBJECTIVE: To demonstrate technical and clinical impacts of the Sim&Size simulation during treatment with the Pipeline Flex Embolization Device. METHODS: Consecutive patients who underwent aneurysm embolization with Pipeline at our department were retrospectively enrolled (January 2015-December 2017) and divided into two groups: treated with and without simulation. Through univariate and multivariate models, we evaluated: (1) rate of corrective intervention for non-optimal stent placement, (2) duration of intervention, (3) radiation dose, and (4) stent length. RESULTS: 189 patients, 95 (50.2%) without and 94 (49.7%) with software assistance were analyzed. Age, sex, comorbidities, aneurysm characteristics, and operator's experience were comparable among the two groups. Procedures performed with the software had a lower rate of corrective intervention (9% vs 20%, p=0.036), a shorter intervention duration (46 min vs 52 min, p=0.002), a lower median radiation dose (1150 mGy vs 1558 mGy, p<0.001), and a shorter stent length (14 mm vs 16 mm, p<0.001). CONCLUSIONS: In our experience, the use of the virtual simulation during Pipeline treatment significantly reduced the need for corrective intervention, the procedural time, the radiation dose, and the length of the stent.


Asunto(s)
Simulación por Computador/normas , Embolización Terapéutica/normas , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Stents Metálicos Autoexpandibles/normas , Programas Informáticos/normas , Adulto , Anciano , Prótesis Vascular/normas , Embolización Terapéutica/instrumentación , Femenino , Humanos , Imagenología Tridimensional/métodos , Imagenología Tridimensional/normas , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento
6.
J Neurointerv Surg ; 12(6): 585-590, 2020 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31959632

RESUMEN

BACKGROUND: A Pipeline embolization device (PED; Medtronic, Dublin, Ireland) can be deployed using either a biaxial or a triaxial catheter delivery system. OBJECTIVE: To compare the use of these two catheter delivery systems for intracranial aneurysm treatment with the PED. METHODS: A retrospective study of patients undergoing PED deployment with biaxial or triaxial catheter systems between 2014 and 2016 was conducted. Experienced neurointerventionalists performed the procedures. Patients who received multiple PEDs or adjunctive coils were excluded. The two groups were compared for PED deployment time, total fluoroscopy time, patient radiation exposure, complications, and cost. RESULTS: Eighty-two patients with 89 intracranial aneurysms were treated with one PED each. In 49 cases, PEDs were deployed using biaxial access; triaxial access was used in 33 cases. Time (min) from guide catheter run to PED deployment was significantly shorter in the biaxial group (24.0±18.7 vs 38.4±31.1, P=0.006) as was fluoroscopy time (28.8±23.0 vs 50.3±27.1, P=0.001). Peak radiation skin exposure (mGy) in the biaxial group was less than in the triaxial group (1243.7±808.2 vs 2074.6±1505.6, P=0.003). No statistically significant differences were observed in transient and permanent complication rates or modified Rankin Scale scores at 30 days. The triaxial access system cost more than the biaxial access system (average $3285 vs $1790, respectively). Occlusion rates at last follow-up (mean 6 months) were similar between the two systems (average 88.1%: biaxial, 89.2%: triaxial). CONCLUSION: Our results indicate near-equivalent safety and effectiveness between biaxial and triaxial approaches. Some reductions in cost and procedure time were noted with the biaxial system.


Asunto(s)
Prótesis Vascular , Catéteres , Embolización Terapéutica/métodos , Aneurisma Intracraneal/terapia , Stents Metálicos Autoexpandibles , Adulto , Anciano , Prótesis Vascular/economía , Prótesis Vascular/normas , Catéteres/economía , Estudios de Cohortes , Embolización Terapéutica/economía , Embolización Terapéutica/normas , Femenino , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/economía , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Estudios Retrospectivos , Stents Metálicos Autoexpandibles/economía , Stents Metálicos Autoexpandibles/normas , Resultado del Tratamiento
7.
Ann Anat ; 228: 151434, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-31704146

RESUMEN

BACKGROUND: Using animal models in experimental medicine requires mapping of their anatomical variability. Porcine common carotid arteries (CCA) are often preferred for the preclinical testing of vascular grafts due to their anatomical and physiological similarity to human small-diameter arteries. Comparing the microscopic structure of animal model organs to their human counterparts reveals the benefits and limitations of translational medicine. METHODS: Using quantitative histology and stereology, we performed an extensive mapping of the regional proximodistal differences in the fractions of elastin, collagen, and smooth muscle actin as well as the intima-media and wall thicknesses among 404 segments (every 1 cm) of porcine CCAs collected from male and female pigs (n = 21). We also compared the microscopic structure of porcine CCAs with segments of human coronary arteries and one of the preferred arterial conduits used for the coronary artery bypass grafting (CABG), namely, the internal thoracic artery (ITA) (n = 21 human cadavers). RESULTS: The results showed that the histological structure of left and right porcine CCA can be considered equivalent, provided that gross anatomical variations of the regular branching patterns are excluded. The proximal elastic carotid (51.2% elastin, 4.2% collagen, and 37.2% actin) transitioned to more muscular middle segments (23.5% elastin, 4.9% collagen, 54.3% actin) at the range of 2-3 centimeters and then to even more muscular distal segments (17.2% elastin, 4.9% collagen, 64.0% actin). The resulting morphometric data set shows the biological variability of the artery and is made available for biomechanical modeling and for performing a power analysis and calculating the minimum number of samples per group when planning further experiments with this widely used large animal model. CONCLUSIONS: Comparison of porcine carotids with human coronary arteries and ITA revealed the benefits and the limitations of using porcine CCAs as a valid model for testing bioengineered small-diameter CABG vascular conduits. Morphometry of human coronary arteries and ITA provided more realistic data for tailoring multilayered artificial vascular prostheses and the ranges of values within which the conduits should be tested in the future. Despite their limitations, porcine CCAs remain a widely used and well-characterized large animal model that is available for a variety of experiments in vascular surgery.


Asunto(s)
Prótesis Vascular , Arterias Carótidas/anatomía & histología , Puente de Arteria Coronaria/métodos , Animales , Prótesis Vascular/clasificación , Prótesis Vascular/normas , Cadáver , Arterias Carótidas/cirugía , Femenino , Corazón/anatomía & histología , Humanos , Inmunohistoquímica , Masculino , Modelos Animales , Proyectos Piloto , Porcinos , Ingeniería de Tejidos
8.
J Neurointerv Surg ; 12(6): 616-620, 2020 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31723048

RESUMEN

BACKGROUND AND PURPOSE: Flow diverters are increasingly used to treat a broad category of cerebral aneurysms. We conducted an in vitro study to angiographically compare the flow diversion effect of Surpass Evolve from Stryker Neurovascular with the Pipeline Shield Embolization Device from Medtronic Neurovascular. METHODS: Three copies each of three carotid aneurysm geometries were manufactured from silicone. Evolve and Pipeline flow diverters were deployed in one copy of each geometry; the third copy was used as Control. High-speed angiography was acquired under pulsatile flow in each replica, contrast concentration-time curves within the aneurysms were recorded, and the curves were quantified with six parameters. The parameters were statistically evaluated to compare the flow diversion effect of both devices. RESULTS: The Evolve showed greater flow diversion trends in almost all intra-geometry comparisons than the Pipeline. When aggregated over the three geometries, the Evolve was statistically significantly better than the Pipeline in four of the six parameters, and about the same or better (not statistically significant) than the Pipeline in the other two parameters. CONCLUSIONS: The Evolve device demonstrated greater in vitro flow diversion effects than Pipeline. Comparative efficacy of the devices will need to be adjudicated based on clinical outcomes.


Asunto(s)
Prótesis Vascular , Angiografía Cerebral/métodos , Embolización Terapéutica/métodos , Aneurisma Intracraneal/terapia , Stents Metálicos Autoexpandibles , Anciano , Prótesis Vascular/normas , Angiografía Cerebral/normas , Embolización Terapéutica/normas , Femenino , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Stents Metálicos Autoexpandibles/normas , Resultado del Tratamiento
9.
Neurosurgery ; 86(2): 170-181, 2020 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-30834934

RESUMEN

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.


Asunto(s)
Implantación de Prótesis Vascular/tendencias , Prótesis Vascular/tendencias , Procedimientos Endovasculares/tendencias , Aneurisma Intracraneal/cirugía , Flujo Sanguíneo Regional/fisiología , Prótesis Vascular/normas , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/métodos , Embolización Terapéutica/instrumentación , Embolización Terapéutica/métodos , Embolización Terapéutica/tendencias , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/métodos , Femenino , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Masculino , Stents Metálicos Autoexpandibles/tendencias , Resultado del Tratamiento
10.
J Neurointerv Surg ; 12(2): 214-219, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-31320551

RESUMEN

BACKGROUND: Rapid development in endovascular aneurysm therapy continuously drives demand for suitable neurointerventional training opportunities. OBJECTIVE: To investigate the value of an integrated modular neurovascular training environment for aneurysm embolization using additively manufactured vascular models. METHODS: A large portfolio of 30 patient-specific aneurysm models derived from different treatment settings (eg, coiling, flow diversion, flow disruption) was fabricated using additive manufacturing. Models were integrated into a customizable neurointerventional simulator with interchangeable intracranial and cervical vessel segments and physiological circuit conditions ('HANNES'; Hamburg ANatomic Neurointerventional Endovascular Simulator). Multiple training courses were performed and participant feedback was obtained using a questionnaire. RESULTS: Training for aneurysm embolization could be reliably performed using HANNES. Case-specific clinical difficulties, such as difficult aneurysm access or coil dislocation, could be reproduced. During a training session, models could be easily exchanged owing to standardized connectors in order to switch to a different treatment situation or to change from 'treated' back to 'untreated' condition. Among 23 participants evaluating hands-on courses using a five-point scale from 1 (strongly agree) to 5 (strongly disagree), HANNES was mostly rated as 'highly suitable for practicing aneurysm coil embolization' (1.78±0.79). CONCLUSION: HANNES offers a wide variability and flexibility for case-specific hands-on training of intracranial aneurysm treatment, providing equal training conditions for each situation. The high degree of standardization offered may be valuable for analysis of device behavior or assessment of physician skills. Moreover, it has the ability to reduce the need for animal experiments.


Asunto(s)
Prótesis Vascular/normas , Procedimientos Endovasculares/métodos , Procedimientos Endovasculares/normas , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Animales , Implantación de Prótesis Vascular/métodos , Embolización Terapéutica/métodos , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
11.
Sci Rep ; 9(1): 17379, 2019 11 22.
Artículo en Inglés | MEDLINE | ID: mdl-31758013

RESUMEN

The abdominal aortic aneurysm (AAA) anatomy influences the technical success of the endovascular aneurysm repair (EVAR), yet very few data regarding the aortic tree angles exist in the literature. This poses great limitations in the numerical analyses of endografts, constraining their design improvement as well as the identification of their operational limitations. In this study, a matrix Φ of 10 angles was constructed for the description of the pathological region and was implemented on a large dataset of anatomies. More specifically, computed tomography angiographies from 258 patients were analysed and 10 aortic angles were calculated per case, able to adequately describe the overall AAA shape. 9 dimensional variables (i.e. diameters and lengths) were also recorded. The median and extreme values of these variables were computed providing a detailed quantification of the geometrical landscape of the AAA. Moreover, statistical analysis showed that the identified angles presented no strong correlation with each other while no lateral or anterior/posterior symmetry of the AAA was identified. These findings suggest that endograft designers are free to construct any extreme case-studies with the values provided in a mix-and-match manner. This strategy can have a powerful effect in EVAR stent graft designing, as well as EVAR planning.


Asunto(s)
Aorta Abdominal/anatomía & histología , Aorta Abdominal/patología , Aneurisma de la Aorta Abdominal/patología , Prótesis Vascular , Diseño de Prótesis , Anciano , Anciano de 80 o más Años , Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Prótesis Vascular/normas , Implantación de Prótesis Vascular , Angiografía por Tomografía Computarizada , Conjuntos de Datos como Asunto/estadística & datos numéricos , Procedimientos Endovasculares , Femenino , Estudios de Seguimiento , Humanos , Imagenología Tridimensional , Masculino , Persona de Mediana Edad , Tamaño de los Órganos , Diseño de Prótesis/métodos , Diseño de Prótesis/normas , Valores de Referencia , Estudios Retrospectivos , Stents/normas , Tomografía Computarizada por Rayos X
12.
Semin Thorac Cardiovasc Surg ; 31(4): 674-678, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31271851

RESUMEN

Aggressive strategies for thoracic aortic graft infection, including resection of all infected tissues, in situ replacement with a rifampicin-bonded graft, and omental flap installation, resulted in improved survival.


Asunto(s)
Aorta Torácica/cirugía , Implantación de Prótesis Vascular/efectos adversos , Prótesis Vascular/efectos adversos , Materiales Biocompatibles Revestidos , Remoción de Dispositivos , Epiplón/cirugía , Infecciones Relacionadas con Prótesis/cirugía , Colgajos Quirúrgicos , Anciano , Anciano de 80 o más Años , Antibacterianos/administración & dosificación , Aorta Torácica/diagnóstico por imagen , Aorta Torácica/microbiología , Prótesis Vascular/normas , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/mortalidad , Implantación de Prótesis Vascular/normas , Materiales Biocompatibles Revestidos/normas , Remoción de Dispositivos/efectos adversos , Remoción de Dispositivos/mortalidad , Remoción de Dispositivos/normas , Femenino , Humanos , Masculino , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto , Diseño de Prótesis , Infecciones Relacionadas con Prótesis/diagnóstico por imagen , Infecciones Relacionadas con Prótesis/microbiología , Infecciones Relacionadas con Prótesis/mortalidad , Reoperación , Rifampin/administración & dosificación , Medición de Riesgo , Factores de Riesgo , Colgajos Quirúrgicos/efectos adversos , Colgajos Quirúrgicos/normas , Resultado del Tratamiento
13.
Ann Vasc Surg ; 59: 54-62, 2019 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-30802590

RESUMEN

BACKGROUND: The goals of this study were to evaluate mid-term outcome in endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA) using a GORE C3 EXCLUDER and compare results between patients treated within and outside the instructions for use (IFU). METHODS: Over a 3-year period spanning October 2013 to September 2016, consecutive patients undergoing EVAR for AAA using the C3 EXCLUDER at Tokyo Medical University Hospital were registered on a prospectively maintained database. The data thus obtained were retrospectively analyzed. RESULTS: A total of 109 AAA patients underwent EVAR using the C3 EXCLUDER. The median follow-up duration was 729 days (interquartile range, 542-1,069 days). Technical success was achieved in 98.2% of cases. Adjunctive, unplanned proximal cuff-extender implantation was required in 8 patients (9.2%). Of the total number, 29 (24.8%) were categorized as being treated outside the IFU. No significant difference was observed in freedom from overall mortality or aneurysm-related mortality between patients treated within and outside the IFU. Freedom from reintervention tended to be lower in patients treated outside the IFU. There was aneurysm sac shrinkage (≥5 mm) in 30.3% and 39.1%; stable aneurysm sac in 69.7% and 56.3%; and aneurysm sac expansion (≥5 mm) in 0% and 4.7% of cases at 1 and 2 years, respectively. No significant difference was observed in aneurysm sac shrinkage between patients treated within and outside the IFU. CONCLUSIONS: The C3 EXCLUDER showed good clinical performance and aneurysm sac shrinkage, regardless of whether the patient was treated within or outside the IFU. The results suggest, however, that in those treated outside the IFU, precise planning, careful operative procedure, and subsequent follow-up are required to obtain short-term and mid- to long-term success in EVAR for AAA using the C3 EXCLUDER.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Etiquetado de Productos , Stents , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/mortalidad , Prótesis Vascular/normas , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Implantación de Prótesis Vascular/normas , Bases de Datos Factuales , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Procedimientos Endovasculares/normas , Femenino , Adhesión a Directriz , Humanos , Masculino , Complicaciones Posoperatorias/etiología , Guías de Práctica Clínica como Asunto , Supervivencia sin Progresión , Diseño de Prótesis , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Stents/normas , Factores de Tiempo , Tokio
14.
J Biomech ; 86: 132-140, 2019 03 27.
Artículo en Inglés | MEDLINE | ID: mdl-30799078

RESUMEN

Woven Dacron grafts are currently used for the surgical treatment of aortic aneurysm and acute dissection, two otherwise fatal pathologies when aortic wall rupture occurs. While Dacron is chosen for aortic grafts because of characteristics such as biocompatibility and durability, few data are available about the dynamic response of Dacron prosthetic devices and about their side effects on the cardiovascular system. In this study, a Dacron graft was subjected to physiological flow conditions in a specifically-developed mock circulatory loop. Experiments were conducted at different physiological pulsation-per-minute rates. Results show that, in comparison to an aortic segment of the same length, the prosthesis is extremely stiffer circumferentially, thus limiting the dynamical radial expansion responsible for the Windkessel effect in human arteries. The prosthesis is instead excessively compliant in the axial direction and develops preferentially bending oscillations. This very different dynamic behaviour with respect to the human aorta can alter cardiovascular pressure and flow dynamics resulting in long-term implant complications.


Asunto(s)
Prótesis Vascular/efectos adversos , Hidrodinámica , Tereftalatos Polietilenos , Aorta/cirugía , Presión Arterial/fisiología , Prótesis Vascular/normas , Humanos , Modelos Cardiovasculares
15.
Phys Med Biol ; 64(7): 075001, 2019 03 21.
Artículo en Inglés | MEDLINE | ID: mdl-30736021

RESUMEN

Cardiovascular disease is the leading cause of mortality in the United States. Peripheral artery disease (PAD) affects a substantial portion of the elderly population (>70 years). PAD can be symptomatic or asymptomatic, and treatment is directed towards improving functional vessel patency and limb salvage. Revascularization surgical treatments are needed in some cases, and it is not always possible to use autologous veins for vascular grafting. In this case, synthetic materials may be used. Synthetic materials such as expanded polytetrafluoroethylene (ePTFE) and poly (ethylene terephthalate) (Dacron) have been used. These materials are much stiffer compared to normal arterial vessels so developing alternative materials is an active area of research. One such potential material is a p olyvinyl alcohol cryogel reinforced arterial model (PRAM). In this study we used shear wave elastography (SWE) techniques to compare the mechanical behavior of excised aortas and anastomoses formed between the aortas and the Dacron, ePTFE, and PRAM materials. Different initial longitudinal strains (0%-40%) and transmural pressures (20-180 mmHg) were used to test a wide range of parameters that are within physiological ranges. We found that the PRAM materials had similar mechanical behavior in terms of group velocity measured in the vessel wall with respect to the excised aortas compared to the Dacron and ePTFE that had higher values of group velocity. The ratios of the group velocity for the PRAM material with respect to the aortas ranged from 0.83 to 1.13 where the Dacron and ePTFE had ranges of 1.12-2.22 and 1.91-3.10 for the same stretch and pressure ranges. The PRAM materials provide an alternative vascular material with better mechanical matching with excised aortas.


Asunto(s)
Prótesis Vascular/normas , Diagnóstico por Imagen de Elasticidad , Tereftalatos Polietilenos/química , Politetrafluoroetileno/química , Anciano , Anastomosis Quirúrgica/instrumentación , Anastomosis Quirúrgica/métodos , Aorta/cirugía , Arteria Femoral/cirugía , Humanos , Masculino , Tereftalatos Polietilenos/efectos adversos , Politetrafluoroetileno/efectos adversos , Grado de Desobstrucción Vascular
16.
J Biomech ; 85: 210-217, 2019 03 06.
Artículo en Inglés | MEDLINE | ID: mdl-30704763

RESUMEN

Thoracic endovascular aortic repair (TEVAR) has been introduced as a less invasive approach to the treatment of thoracic aortic aneurysm (TAA). However, the effectiveness of TEVAR in the treatment of TAA is often limited due to the complex anatomy of aortic arch. Flow preservation at the three supra-aortic branches further increases the overall technical difficulty. This study proposes a novel stent graft design with slit perforations that can positively alter the hemodynamics at the aortic arch while maintaining blood flow to supra-aortic branches. We carried out a computational fluid dynamic (CFD) analysis to evaluate flow characteristics near stented aortic arch in simplified TAA models, followed by in-vitro experiments using particle image velocimetry (PIV) in a mock circulatory loop. The hemodynamics result was studied in terms of time-averaged wall shear stress (TAWSS), oscillating shear index (OSI), and endothelial cell action potential (ECAP). The results showed that the stent graft with slit perforations can reduce the disturbed flow region considerably. Furthermore, the effect of the slits on flow preservation to the supra-aortic branches was simulated and compared with experimental results. The effectiveness of the stent graft with slit perforations in preserving flow to the branches was demonstrated by both simulated and experimental results. Low TAWSS and elevated ECAP were observed in the aortic arch aneurysm after the placement of the stent graft with slits, implying the potential of thrombus formation in the aneurysm. On the other hand, the effects of the stent grafts with full-slit design and half-slit design on the shear stress did not differ significantly. The present analysis indicated that not only could the stent graft with slit perforations shield the aneurysm from rupture, but also it resulted in a favorable environment for thrombus that can contribute to the shrinkage of the aneurysm.


Asunto(s)
Aneurisma de la Aorta Torácica , Prótesis Vascular , Hemodinámica , Diseño de Prótesis , Aneurisma de la Aorta Torácica/fisiopatología , Aneurisma de la Aorta Torácica/terapia , Prótesis Vascular/normas , Hemodinámica/fisiología , Humanos , Modelos Cardiovasculares , Stents/normas , Estrés Mecánico , Trombosis , Resultado del Tratamiento
17.
Circulation ; 137(24): 2635-2650, 2018 06 12.
Artículo en Inglés | MEDLINE | ID: mdl-29891620

RESUMEN

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.


Asunto(s)
Bioprótesis/normas , Implantación de Prótesis Vascular/normas , Prótesis Vascular/normas , Vasos Coronarios/cirugía , Diseño de Prótesis/normas , Stents/normas , Estenosis de la Válvula Aórtica , Ensayos Clínicos como Asunto , Consenso , Humanos
18.
Medicine (Baltimore) ; 97(23): e10987, 2018 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-29879055

RESUMEN

The technique of stent-assisted coil embolization has been widely used in the clinic, while its efficacy and safety have yet to be evaluated. This study investigates the values of computed tomography angiography (CTA), magnetic resonance angiography (MRA), and digital subtraction angiography (DSA) in evaluating the Enterprise stent-assisted coil embolization in the treatment of intracranial wide-necked aneurysm.A total of 578 intracranial wide-necked aneurysm patients confirmed by MRA + CTA + DSA examinations were included and treated with Enterprise stent-assisted coil embolization in this study. All patients were assigned into complete embolization (CE) group and incomplete embolization (IE) group according to the results of postoperative MRA + CTA + DSA examinations and Raymond grades. Hunt-Hess grades, incidence of complication and Glasgow Outcome Scale (GOS) grades of patients were investigated to assess the therapeutic effect of Enterprise stent-assisted coil embolization in intracranial wide-necked treatment. Multivariate logistic regression analysis was performed to assess risk factors for the therapeutic effect of Enterprise stent-assisted coil embolization in intracranial wide-necked aneurysm.CTA images offered a better and clearer view than MRA and DSA images in both the CE and IE groups. Both the sensitivity and specificity of CTA were apparently higher than those of MRA. Patients in the CE group enjoyed a higher good GOS rate but a lower incidence of complication than those in the IE group. In Enterprise stent-assisted coil embolization treatment, the Hunt-Hess grade, hypertension, and size of artery aneurysm were independent factors affecting the therapeutic effect of Enterprise stent-assisted coil embolization in intracranial wide-necked aneurysm.Compared with MRA, CTA shows a higher value in evaluating the therapeutic effect of Enterprise stent-assisted coil embolization for the treatment of intracranial wide-necked aneurysm, and can thus serve as an important means of predicting the therapeutic effect of endovascular intervention in treating patients with intracranial wide-necked aneurysm.


Asunto(s)
Prótesis Vascular/normas , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Stents/normas , Adulto , Angiografía de Substracción Digital/métodos , Angiografía por Tomografía Computarizada/métodos , Embolización Terapéutica/efectos adversos , Embolización Terapéutica/clasificación , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Escala de Consecuencias de Glasgow , Humanos , Angiografía por Resonancia Magnética/métodos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/diagnóstico por imagen , Diseño de Prótesis , Factores de Riesgo , Resultado del Tratamiento
19.
Ann Vasc Surg ; 49: 144-151, 2018 May.
Artículo en Inglés | MEDLINE | ID: mdl-29428533

RESUMEN

BACKGROUND: The Nellix was introduced to Asia in 2014. Data in Asians have been sparse. Two balloon-expandable stents, each surrounded by a polymer-filled endobag, are deployed in parallel to obliterate and seal the aneurysm. This paradigm shift to treating abdominal aortic aneurysms confers advantages for certain adverse aneurysm morphology that is outside the instruction-for-use (IFU) for standard endovascular aneurysm repair (EVAR) devices. We examine outcomes of 15 Asian patients with concomitant infrarenal aortic and iliac artery aneurysms treated with the Nellix at our institution. METHOD: Between July 2014 and August 2016, 15 male patients underwent elective EVAS at a single tertiary center by the same team of vascular surgeons and interventional radiologists. Patient demographics, clinical presentations, aneurysm morphology, perioperative complications, and follow-up imaging according to the standardized protocol were studied. Preoperative CT images were analyzed using validated automatic 3-dimensional sizing software EndoSize. RESULT: The novel stent-graft deployment proves consistent and achieved a 100% technical success. Eleven patients (70%) complied within specified Nellix IFU, as compared to 20% if standard endovascular aneurysm repair (EVAR) IFU was applied. The difference is due to the presence of concurrent common iliac aneurysms (n = 5), short neck length (n = 3), and angulated necks (n = 3). Adjunct procedures included 3 open access endarterectomy with embolectomy, 1 coil embolization of internal iliac artery, 1 bilateral renal artery chimneys, and 1 proximal stent deployment. There was no conversion to open surgery. Average operative time was 133 min. Median length of stay was 4 days. Thirty-day mortality was 0%. Perioperative morbidity included exacerbation of pre-existing renal impairment (n = 6), peripheral vascular disease (n = 3), and postimplantation syndrome (n = 5). One endoleak (7%) and 2 instances of stent migration (14%) were detected. There was no complication of aneurysm or endobag rupture, limb thromboses, or fracture. CONCLUSIONS: Early data in our center are encouraging and highlight high procedural success with minimal complications despite challenging patient anatomy.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Adhesión a Directriz , Aneurisma Ilíaco/cirugía , Pautas de la Práctica en Medicina , Stents , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aortografía/métodos , Prótesis Vascular/normas , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/normas , Toma de Decisiones Clínicas , Angiografía por Tomografía Computarizada , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/normas , Adhesión a Directriz/normas , Humanos , Aneurisma Ilíaco/diagnóstico por imagen , Tiempo de Internación , Masculino , Persona de Mediana Edad , Tempo Operativo , Complicaciones Posoperatorias/etiología , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en Medicina/normas , Diseño de Prótesis , Interpretación de Imagen Radiográfica Asistida por Computador , Singapur , Stents/normas , Centros de Atención Terciaria , Factores de Tiempo , Resultado del Tratamiento
20.
Presse Med ; 47(2): 135-139, 2018 Feb.
Artículo en Francés | MEDLINE | ID: mdl-29478789

RESUMEN

Endovascular treatment of thoracoabdominal aneurysms: what's new? Thoracoabdominal aneurysms (T-AAA) are aortic aneurysms that involve both the thoracic and abdominal segments of the aorta and its associated visceral branches. Although the first successful open repair was reported over 50 years ago, the risks of treatment remain considerable. As the first generations of devices available for endovascular aneurysm repair (EVAR) were relatively simple tubes or bifurcated grafts, initial attempts to extend the benefits of EVAR to patients with T-AAA lead to "hybrid solution". Good results with hybrid repairs have not been universal and the approach does not exploit all of the potential advantages of a "pure" endovascular approach (lesser surgical insult). This unmet need, together with rapid technological advances, has encouraged the development of custom-made endografts with fenestrations and/or branches (F-BEVAR) for extension into the visceral vessel ostia. F-BEVAR requires considerably more complex device design and planning than conventional EVAR. Deployment is more technically demanding and takes longer to complete. Thus, patient, aneurysm anatomy and surgical team selection is paramount. Favorable outcomes have been widely reported following T-AAA repair with F-BEVAR in expert centers; more complex aortic lesions such as T-AAA in the context of chronic dissection or arch aneurysms are thus now also offered endovascular repair with F-BEVAR.


Asunto(s)
Aneurisma de la Aorta Abdominal/diagnóstico , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Torácica/diagnóstico , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Abdominal/epidemiología , Aneurisma de la Aorta Torácica/epidemiología , Prótesis Vascular/efectos adversos , Prótesis Vascular/normas , Diagnóstico por Imagen/métodos , Técnicas de Diagnóstico Cardiovascular , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos , Procedimientos Endovasculares/tendencias , Humanos , Monitoreo Intraoperatorio/métodos , Quirófanos
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