Endovascular treatment for thoracic aortic disease from the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: Global Registry for Endovascular Aortic Treatment (GREAT) is an international prospective multicenter registry collecting real-world data on performance of W. L. Gore thoracic and abdominal aortic endografts. This analysis evaluated the long-term differences in patient survival and device performance in patients undergoing thoracic endovascular aortic repair (TEVAR) for any thoracic aortic pathology. METHODS: From August 2010 to October 2016, 5014 patients were enrolled in GREAT. The population of interest was comprised of only patients treated for thoracic aortic pathologies. Through 5 years, primary outcomes were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, paraplegia, and any reintervention through 5 years, grouped by pathology. Secondary outcomes were reintervention rate and freedom from serious device- and aortic-related events. RESULTS: The 578 patients with thoracic aortic pathologies enrolled in GREAT and identified for this analysis were categorized by common pathologies: thoracic aneurysm (n = 239), thoracic dissection (n = 203), arch (n = 26), and other (n = 110). The mean age of this population was 66.1 ± 12.8 years, and 64.7% were male. Procedure survival was 99.7%. In the overall group, at index procedure to 30 days and 31 days to 5 years, Kaplan-Meier estimates of freedom from all-cause mortality were 99.6% and 66.4%, respectively, and for aortic-related mortality were 97.7% and 94.6%, respectively. Aortic rupture rate was 0.5% (n = 3) at 30 days and 1.4% (n = 8) through 5 years. Stroke and spinal cord ischemic events were 1.9% (n = 11) and 1.6% (n = 9) at 30 days and at 5 years were 3.6% (n = 20), 0.5% (n = 3), respectively. Reinterventions were required in 7.3% (n = 42) at 30 days and 12.4% (n = 69) through 5 years. The number of patients with endoleaks at 30 days was 2.1% (n = 12): n = 3 (1.1%) for each of types IA, 1B, and II; n = 2 (0.3%) for type III; and n = 4 (0.7%) for unspecified. Through 5 years, the percentage of patients was 8.3% (n = 40): n = 15 (3.1%) for type IA; n = 10 (2.1%) for type IB; n = 11 (2.3%) for type II; and n = 9 (1.9%) for unspecified. One patient (0.2%) had stent migration at 30 days (aneurysm group); none were reported through 5 years. There were no incidents of stent compression or fracture from index procedure through 5 years. CONCLUSIONS: Data herein demonstrates durability and support for treatment of thoracic aortic disease with the GORE TAG conformable thoracic stent graft, including no incidents of stent compression/fracture and high freedom from aortic-related mortality. The planned analysis of follow-up to 10 years in GREAT will be beneficial.

Brazilian Society for Angiology and Vascular Surgery guidelines on abdominal aortic aneurysm.

The Brazilian Society of Angiology and Vascular Surgery, through the Guidelines Project, presents new Abdominal Aortic Aneurysm Guidelines, on the subject of care for abdominal aortic aneurysm patients. Its development prioritized descriptive guidelines, using the EMBASE, LILACS, and PubMed databases. References include randomized controlled trials, systematic reviews, meta-analyses, and cohort studies. Quality of evidence was evaluated by a pair of coordinators, aided by the RoB 2 Cochrane tool and the Newcastle Ottawa Scale forms. The subjects include juxtarenal aneurysms, infected aneurysms, and new therapeutic techniques, especially endovascular procedures. The current version of the guidelines include important recommendations for the primary topics involving diagnosis, treatment, and follow-up for abdominal aortic aneurysm patients, providing an objective guide for medical practice, based on scientific evidence and widely available throughout Brazil.

A Sociedade Brasileira de Angiologia e Cirurgia Vascular, por meio do projeto Diretrizes, apresenta as novas Diretrizes de Aorta Abdominal, referentes aos cuidados de pacientes com aneurisma de aorta abdominal. Para sua elaboração, foram priorizadas diretrizes descritivas, utilizando as bases EMBASE, LILACS e PubMed. As referências incluem ensaios clínicos randomizados, revisões sistemáticas, metanálises e estudos de coorte. A qualidade das evidências foi examinada por uma dupla de coordenadores, com auxílio da ferramenta RoB 2 da Colaboração Cochrane e dos formulários da Newcastle Ottawa Scale. Aneurismas justarrenais, infectados e novas técnicas terapêuticas, principalmente no âmbito endovascular, estão entre os temas estudados. A versão atual das Diretrizes apresenta importantes recomendações para os principais itens que envolvem o diagnóstico, tratamento e acompanhamento de pacientes com aneurisma de aorta abdominal, oferecendo um guia objetivo para prática médica, construído a partir de evidências científicas e amplamente acessível em todo o território nacional.

ZILVERPASS Study: ZILVER PTX Stent versus Prosthetic Above-the-Knee Bypass Surgery in Femoropopliteal Lesions, 5-year Results.

PURPOSE: To report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions. MATERIALS AND METHODS: Patients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass at 60 months. Survival rates after 5 years were also analyzed. RESULTS: 220 patients (mean age 68.6 ± 10.5 years; 159 men) were included and randomized to ZILVER PTX (n = 113, 51.40%) or BYPASS group (n = 107, 48.60%). The 60-month primary patency rate was 49.3% for the ZILVER PTX group versus 40.7% for the bypass group (p = 0.6915). Freedom from TLR was 63.8% for the ZILVER PTX group versus 52.8% for the bypass group (p = 0.2637). At 5 years, no significant difference in survival rate could be seen between the ZILVER PTX and the bypass group (69.1% vs. 71% respectively, p = 0.5503). CONCLUSION: Even at 5 years, non-inferior safety and effectiveness results of the ZILVER PTX could be seen. These findings confirmed that the use of ZILVER PTX stents can be considered as a valid alternative for bypass surgery when treating long and complex femoropopliteal lesions.

ZILVERPASS Study: ZILVER PTX Stent vs. Bypass Surgery in Femoropopliteal Lesions, 3 year results and economic analysis.

BACKGROUND: To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities. METHODS: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA. RESULTS: The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186). CONCLUSIONS: The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.

Brazilian Society for Angiology and Vascular Surgery guidelines on abdominal aortic aneurysm / Projeto Diretrizes, Sociedade Brasileira de Angiologia e Cirurgia Vascular: aneurisma da aorta abdominal

Abstract The Brazilian Society of Angiology and Vascular Surgery, through the Guidelines Project, presents new Abdominal Aortic Aneurysm Guidelines, on the subject of care for abdominal aortic aneurysm patients. Its development prioritized descriptive guidelines, using the EMBASE, LILACS, and PubMed databases. References include randomized controlled trials, systematic reviews, meta-analyses, and cohort studies. Quality of evidence was evaluated by a pair of coordinators, aided by the RoB 2 Cochrane tool and the Newcastle Ottawa Scale forms. The subjects include juxtarenal aneurysms, infected aneurysms, and new therapeutic techniques, especially endovascular procedures. The current version of the guidelines include important recommendations for the primary topics involving diagnosis, treatment, and follow-up for abdominal aortic aneurysm patients, providing an objective guide for medical practice, based on scientific evidence and widely available throughout Brazil.

Resumo A Sociedade Brasileira de Angiologia e Cirurgia Vascular, por meio do projeto Diretrizes, apresenta as novas Diretrizes de Aorta Abdominal, referentes aos cuidados de pacientes com aneurisma de aorta abdominal. Para sua elaboração, foram priorizadas diretrizes descritivas, utilizando as bases EMBASE, LILACS e PubMed. As referências incluem ensaios clínicos randomizados, revisões sistemáticas, metanálises e estudos de coorte. A qualidade das evidências foi examinada por uma dupla de coordenadores, com auxílio da ferramenta RoB 2 da Colaboração Cochrane e dos formulários da Newcastle Ottawa Scale. Aneurismas justarrenais, infectados e novas técnicas terapêuticas, principalmente no âmbito endovascular, estão entre os temas estudados. A versão atual das Diretrizes apresenta importantes recomendações para os principais itens que envolvem o diagnóstico, tratamento e acompanhamento de pacientes com aneurisma de aorta abdominal, oferecendo um guia objetivo para prática médica, construído a partir de evidências científicas e amplamente acessível em todo o território nacional.

Laboratory "In-vitro" Evaluation of the Parallel Stent Graft Association for the Iliac Sandwich Technique.

OBJECTIVES: The Iliac Sandwich is an off-label technique that uses parallel stent grafts to treat aortoiliac aneurysms. The purpose of this experimental study is to evaluate the conformability and juxtaposition of stent grafts combinations used in this technique through in-vitro mechanical evaluation, computed tomography (CT) analyses, and a controlled pulsatile flow system. METHODS: The combinations of two Viabahn® ("V-V") or Viabahn® and Excluder® iliac extension ("V-E") were analysed using CT imaging with measurement of the gutter area by two independent analysts before and after balloon angioplasty. In a second phase, the parallel stent combinations were also evaluated using CT imaging after being implanted in the aortic aneurysm model with a pulsatile flow system with controlled temperature, viscosity, and density. RESULTS: The "V-E" group had a better conformability when compared to the "V-V" group, ensuring smaller gutter areas (0.0064 cm2 ± 0.01 vs. 0.0228 cm2 ± 0.03, p < 0.001). Post dilatation with two non-compliant balloons resulted in enlargement of the gutter area (Area A, p 0.065; Area B, p 0.071). Conversely, post dilatation with a non-compliant balloon for the internal iliac component and a compliant balloon for the external iliac device reduced the gutter area (Area A, p 0.008; Area B, p 0.010). CONCLUSION: The combination of Viabahn® and Excluder® iliac extension device ("V-E") had a smaller gutter area compared to two Viabahn® parallel stents for the Iliac Sandwich Technique. Post dilatation using a non-compliant balloon for the internal iliac device and a compliant balloon for the external iliac provided superior conformability and juxtaposition.

Use of 1,470 nm laser for treatment of superficial venous insufficiency.

BACKGROUND: There are several ways to treat varicose veins of the lower limbs, among which use of 1470nm diode lasers stands out. This technique can be used to treat patients in outpatient settings, with early return to work, good esthetic results, and low rates of complications. However, variables such as the laser wavelength, the power administered in each area, the type of fiber, and the linear intravenous energy density (LEED) are still extensively discussed. OBJECTIVES: To analyze the results of superficial venous insufficiency treatment with a 1470nm diode laser. METHODS: Retrospective study conducted at a private clinic in a private hospital in Florianopolis, based on a database collected prospectively. The sample comprised 287 patients who underwent surgery to treat superficial venous insufficiency with 1470nm diode laser, from January 2016 to December 2018, totaling 358 great saphenous veins (GSVs) and 84 small saphenous veins (SSVs) treated. RESULTS: The total occlusion rates after 12 months of surgery were 94.4% in the GSVs, with an average LEED of 45.90 J/cm, and 96.4% in the SSVs, with an average LEED of 44.07 J/cm. CONCLUSIONS: During the follow-up period, the 1470nm diode laser proved to be a safe treatment, with great efficacy and low rates of complications (pain, edema, bruising, deep vein thrombosis, and endothermal heat-induced thrombosis - EHIT).

Uso do laser de 1. 470 nm para o tratamento de insuficiência venosa superficial / Use of 1, 470 nm laser for treatment of superficial venous insufficiency

Resumo Contexto Existem diversas formas de tratamento de varizes de membros inferiores. Entre elas, destaca-se o uso do laser diodo de 1.470 nm. Essa técnica proporciona aos pacientes uma cirurgia em regime ambulatorial, com retorno precoce à atividade ocupacional, bom resultado estético e baixo índice de complicações. No entanto, ainda se discute exaustivamente variáveis como comprimento de onda do laser, potência aplicada em cada área, tipo de fibra, necessidade ou não de tumescência e densidade de energia endovenosa linear. Objetivos Analisar os resultados do tratamento da insuficiência venosa superficial com laser diodo de 1.470 nm. Métodos Estudo retrospectivo, realizado em uma clínica privada de um hospital privado em Florianópolis a partir de dados colhidos prospectivamente. As amostras eram de 287 pacientes submetidos à cirurgia para tratamento da insuficiência venosa superficial com laser diodo de 1.470 nm, de janeiro de 2016 a dezembro de 2018, totalizando 358 veias safenas magnas e 84 veias safenas parvas tratadas. Resultados A taxa de oclusão total após 12 meses de cirurgia foi de 94,4%, com densidade de energia endovenosa linear média de 45,90 J/cm nas veias safenas magnas e de 96,4% com densidade de energia endovenosa linear média de 44,07 J/cm nas veias safenas parvas. Conclusões No período acompanhado, o laser diodo de 1.470 nm mostrou-se um tratamento seguro, muito efetivo e com baixas taxas de complicações (dor, edema, equimose, trombose venosa profunda e trombose induzida pelo calor endovenoso).

Abstract Background There are several ways to treat varicose veins of the lower limbs, among which use of 1470nm diode lasers stands out. This technique can be used to treat patients in outpatient settings, with early return to work, good esthetic results, and low rates of complications. However, variables such as the laser wavelength, the power administered in each area, the type of fiber, and the linear intravenous energy density (LEED) are still extensively discussed. Objectives To analyze the results of superficial venous insufficiency treatment with a 1470nm diode laser. Methods Retrospective study conducted at a private clinic in a private hospital in Florianopolis, based on a database collected prospectively. The sample comprised 287 patients who underwent surgery to treat superficial venous insufficiency with 1470nm diode laser, from January 2016 to December 2018, totaling 358 great saphenous veins (GSVs) and 84 small saphenous veins (SSVs) treated. Results The total occlusion rates after 12 months of surgery were 94.4% in the GSVs, with an average LEED of 45.90 J/cm, and 96.4% in the SSVs, with an average LEED of 44.07 J/cm. Conclusions During the follow-up period, the 1470nm diode laser proved to be a safe treatment, with great efficacy and low rates of complications (pain, edema, bruising, deep vein thrombosis, and endothermal heat-induced thrombosis - EHIT).

Numerical study on the effect of stent shape on suture forces in stent-grafts.

Second-generation stent-grafts (SGs) have addressed many of the mechanical problems reported for first-generation endoprostheses, such as graft tear and stent rupture; however, suture wear and detachment due to pulsatile fatigue remains an issue. Numerical studies on the mechanical behavior of these endoprostheses usually model the attachment between stents and graft as a continuous ''tie'' constraint, which does not provide information on the mechanical loads acting on individual sutures. This paper presents a suitable approach for Finite Element (FE) simulations of SGs which allows for a qualitative evaluation of the loads acting on sutures. Attachment between stents and graft is modeled as rigid beams at discrete locations of the endoprostheses, and the reaction forces on the beams are analyzed. This modeling strategy is employed for four different SG models (two Z-stented commercial models and two circular-stented models) subjected to a severe 180° U-bend, followed by intraluminal pressurization. Results show that, for all models, the majority of sutures is experiencing fluctuating forces within a cardiac cycle (between 80 and 120 mmHg), which points to pulsatile fatigue as potential failure mode. In addition, the highest loads are concentrated in kinks and, for Z-stented models, at the apexes of stents. Moreover, suture loads for circular-stented models are lower than for Z-stented models, indicating better resistance to suture detachment. All these observations are in line with experimental results published in the literature, and, therefore, the procedure herein proposed may serve as a valuable tool in the development of new SG models with better suture resistance to pulsatile wear and fatigue.

ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions.

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.

Technical aspects and 30-day outcomes of the prospective early feasibility study of the GORE EXCLUDER Thoracoabdominal Branched Endoprosthesis (TAMBE) to treat pararenal and extent IV thoracoabdominal aortic aneurysms.

OBJECTIVE: This study reports the technical aspects and 30-day outcomes of the prospective, multicenter early feasibility study designed to evaluate the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE; W. L. Gore & Associates, Flagstaff, Ariz). METHODS: Thirteen patients with pararenal or extent IV thoracoabdominal aortic aneurysms were prospectively enrolled at five U.S sites and one non-U.S. site from 2014 to 2016. The TAMBE included four portals with either retrograde or antegrade renal portal configuration and used GORE VIABAHN Balloon-Expandable Endoprosthesis (W. L. Gore & Associates) for stenting of the renal and mesenteric arteries. The primary end point was procedural safety at 30 days, defined by absence of major adverse events, including any-cause mortality, myocardial infarction, stroke, paraplegia, bowel ischemia, respiratory failure, severe acute kidney injury (>50% decline in estimated glomerular filtration rate), dialysis, and procedural blood loss >1000 mL. RESULTS: There were 11 male and two female patients with a mean age of 69 ± 8 years. Mean aneurysm diameter was 61 ± 13 mm. A total of 52 renal and mesenteric arteries were incorporated (4 vessels/patient). Technical success was achieved in 12 patients (92%). One patient had inadvertent occlusion of a right renal artery due to dissection. There was no mortality, aneurysm rupture, conversion to open repair, dialysis, or spinal cord injury. Mean length of hospital stay was 5 ± 3 days. At 30 days, four patients (31%) had major adverse events, all due to procedural blood loss >1000 mL. One patient had a type I endoleak at the distal renal branch, which was successfully treated by placement of an additional renal stent before dismissal. Computed tomography angiography at 30 days showed patent target vessels and no type I or type III endoleak. CONCLUSIONS: This study confirms the early feasibility of the TAMBE for treatment of pararenal and extent IV thoracoabdominal aortic aneurysms. The high technical success, no mortality, and low morbidity rate support continuation of clinical investigation in a larger population of patients.

O uso da rivaroxabana como monoterapia no tratamento do tromboembolismo venoso baseado em evidências / The use of rivaroxaban as single drug in the treatment of venous thromboembolism based on evidence

O tromboembolismo venoso, que compreende a trombose venosa profunda e a embolia pulmonar, tem início com a formação de trombos no sistema venoso profundo, principalmente dos membros inferiores. Essa doença é uma importante causa de morbimortalidade na população, sendo seu tratamento precoce e adequado fundamental para evitar maiores consequências. Tradicionalmente, utiliza-se na sua terapêutica fármacos anticoagulantes, tais como as heparinas e os antagonistas de vitamina K. Nos últimos anos, novos anticoagulantes vêm sendo estudados com o objetivo de superar algumas limitações dessa terapia convencional. Esses novos anticoagulantes orais, tal como a rivaroxabana, inibem uma única enzima da cascata de coagulação, possuem ação, metabolização e eliminação estáveis, com poucas interações medicamentosas e alimentares e menos variações individuais, com isso podem ser administrados em doses fixas e sem a necessidade de monitorização laboratorial, fornecendo uma opção mais cômoda e com facilidade posológica. Sua eficácia, avaliada através de grandes estudos controlados, é semelhante ao esquema convencional, com a vantagem de possuir menor incidência de sangramento. Contudo, esses medicamentos ainda não possuem antídotos específicos em caso de sangramentos mais graves durante seu uso. Mais estudos a longo prazo são necessários para verificar seus efeitos e sua real aplicabilidade. O objetivo desse artigo foi realizar uma revisão dos novos anticoagulantes orais, com ênfase na rivaroxabana, baseada nos estudos mais recentes sobre o assunto. Algumas bases de dados foram consultadas em busca de artigos nacionais e internacionais, além da melhor evidência científica possível.

The venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism, begins with the development of thrombus in the deep venous system, mainly at the legs. This disease is a major cause of morbidity and mortality in the population and an early and correct treatment is crucial to avoid its complications. Traditionally, anticoagulants are used to treat this condition, such as heparins and vitamin K antagonists. In the last few years, new oral anticoagulants have been studied to overcome the limitations of this conventional therapy. The new anticoagulants, such as rivaroxaban, inhibit one enzyme in the coagulation cascade. They have stable action, metabolization and elimination, with few interactions with other medications or foods and less variation between patients. Therefore, these anticoagulants can be used at fixed-dose regimen, without the need for laboratorial monitoring, providing an easier option in the treatment of the venous thromboembolism. These drugs are as effective as the conventional therapy, with the advantage of having lower incidence of haemorrhagic events, according to large clinical trials. However, there is not a specific antidote if a major bleeding happens. More researches are needed to verify your effects and real applicability. The goal of this paper was to make a review about the new anticoagulants, mainly rivaroxaban, based in the recent studies about this subject. National and international papers and the best cientific evidence have been searched in some data bases.

Tratamento da trombose venosa profunda aguda com rivaroxabana / Treatment of acute deep vein thrombosis with rivaroxaban

A rivaroxabana é um anticoagulante oral, utilizado em dose fixa diária, sem necessidade de monitorização laboratorial, que já se mostrou eficaz e seguro no tratamento do tromboembolismo venoso como monoterapia. O objetivo desse trabalho foi acompanhar a evolução e o possível surgimento de efeitos colaterais em pacientes com trombose venosa profunda aguda em uso da rivaroxabana como monoterapia. Os pacientes incluídos no estudo utilizaram rivaroxabana durante 6 meses, sendo acompanhados através de avaliação clínica, eco-Doppler, exames laboratoriais e raio X de tórax. A análise estatística foi realizada através do teste exato de Fisher. Entre junho de 2012 e maio de 2015, 23 pacientes foram incluídos neste estudo, sendo 60,86% do sexo feminino e 39,13% do sexo masculino. Cirurgia recente foi o principal fator predisponente observado, seguido de imobilização. Em 56,52% dos casos a TVP se localizava na veia poplítea e/ou nas veias da perna, denominado grupo 1, e em 39,13% no território ilíaco-femoral, denominado de grupo 2. Dois pacientes apresentaram eventos tromboembólicos durante o período de observação. Os pacientes do grupo 1 obtiveram recanalização completa do segmento venoso acometido em 100% dos casos comparado com 33,33% naqueles do grupo 2 (p<0,05). Nenhum paciente foi a óbito ou desenvolveu eventos hemorrágicos durante o seguimento. Dor abdominal e queda na taxa de filtração glomerular foram os efeitos colaterais encontrados. Nesse trabalho, a rivaroxabana se mostrou efetiva e segura no tratamento da TVP aguda, sendo a localização da trombose um importante preditor da evolução do trombo.

Rivaroxaban is an oral anticoagulant, used in a fixed-dose regimen, without the need for laboratorial monitoring, which is effective and safe for the treatment of venous thromboembolism monotherapy. The goal of this study was to observe the evolution and the possible development of side effects in patients with acute deep vein thrombosis in use of rivaroxaban as monotherapy. Patients included in this study used rivaroxaban for 6 months, followed during the treatment by clinical evaluation, Doppler ultrasound, laboratory tests and chest X-ray . These patients were followed, by clinical evaluation, eco-Doppler, laboratorial testing and chest X-rays. Statistical analysis was performed using Fisher 's exact test. Between june 2012 and may 2015, 23 patients were included in this study. 60,86% were women and 39,13% men. Recent surgery was the main risk factor observed, followed by immobilization. In 56,52% of the cases the DVT was located at the popliteal vein and/or leg veins, named group 1, and 39,13% were at iliofemoral territory, named group 2. Two patients had thromboembolic events during the follow-up. The group 1 patients achieved complete recanalization of the venous segment affected in 100 % of cases compared with 33.33 % in those in group 2 (p< 0,05). No patient died or developed bleeding events during follow-up. Abdominal pain and decrease of the glomerular filtration were adverse events observed. In this study, rivaroxaban was effective and safe in the treatment of acute DVT. DVT location was an important predictor of the thrombus evolution.

Safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery: prospective and multicentric trial.

BACKGROUND: The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA). METHODS: From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were: initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months. RESULTS: Most patients (56.6%) were men and the mean age was 68.59 (33.1-99.15) years. 25.3% of the total population had intermittent claudication and 73.5% presented with critical limb ischemia. Most lesions were total occlusions (75.9%) and the mean lesion length was 71.16 mm. Contralateral femoral access was performed in 26.5%cases, and ipsilateral femoral approach was used for the remaining 73.5% patients. Technical and arteriographic success was obtained in all 83 (100.00%) patients. Duplex controlled primary patency rate at 6 and 12 months was 95.8% and 76.1%, respectively. The freedom from target lesion revascularization rate was 98.7% and 92.6% at 6 and 12 months, respectively. No stent fractures were observed in this study. Major adverse event rate at 1 year (clinically driven TLR, major amputation, and all-cause mortality) was 15.7%: two target lesion revascularizations (2.4%), one major amputation (1.2%) and ten deaths not related to the procedure (12%). CONCLUSIONS: In conclusion, this study demonstrates the safety and efficacy of the EPIC™ Nitinol Vascular Stent System for the treatment of SFA lesions.

An experimental methodology for arterial walls / Análise experimental de paredes arteriais

Numerical simulations of arterial walls allow a better understanding of the interaction between biological tissue and endoprosthesis (stents), which are used in aneurysms or atherosclerosis stenosis treatment. A reliable understanding of this interaction may help one to select, or even design, the best structure for a given clinical indication. The development of a realistic numerical simulation requires an appropriated definition of a constitutive model and the obtainment of experimental data useful to a parameter identification procedure. Biological tissues have different mechanical characteristics of materials commonly used for engineering applications, however the experimental data acquisition is a major challenge. Some examples of technical difficulties of experimental test in biological tissue are associated to the obtainment of samples, temperature and humidity control during storage, suitable gripping and geometric and strain measurements methods. Therefore, this paper presents an experimental methodology to perform uniaxial mechanical tests in pig arteries in order to provide useful information for material models of arterial walls. This study proposes the experimental procedure from the sample obtainment to the uniaxial experimental testing of the tissue in two directions (circumferential and longitudinal) at two strain rates. In order to shown the use of the experimental data into a suitable numerical model for arterial walls, a parameter identification procedure was performed to obtain material parameters of a viscoelastic anisotropic model with fiber dispersion for finite strains. Through the experimental methodology proposed it was possible to obtain useful data for the parameter identification. Moreover, the results demonstrate that the arterial walls mechanical behavior was properly represented by the selected model.

Simulações numéricas de paredes arteriais permitem um melhor entendimento da interação entre tecido biológico e endopróteses (stents), os quais são utilizados no tratamento de aneurismas e lesões obstrutivas ateroscleróticas. O melhor entendimento desta interação pode auxiliar na seleção do modelo ou no projeto da estrutura da endoprótese mais adequada para uma dada indicação clínica. A realização de simulações numéricas realísticas requer a definição apropriada de um modelo constitutivo e a obtenção de dados experimentais adequados para um procedimento de identificação de parâmetros. Diferentemente dos materiais usados comumente em engenharia, a aquisição de dados experimentais de tecidos biológicos representa um grande desafio. Alguns exemplos das dificuldades técnicas associadas aos testes experimentais de tecidos biológicos estão na obtenção de amostras, no controle de temperatura e humidade durante o armazenamento, na fixação adequada e na medição geométrica e de deformações. Portanto, o presente artigo apresenta uma metodologia experimental para realização de testes uniaxiais em artérias suínas, visando fornecer informações adequadas para modelos materiais de paredes arteriais. Este estudo propõe um procedimento experimental que abrange desde a obtenção da amostra até o ensaio uniaxial do tecido em duas direções (circunferencial e longitudinal), com duas taxas de velocidades. Para exemplificar o uso dos dados experimentais em um modelo numérico adequado para paredes arteriais, um procedimento de identificação de parâmetros foi realizado, obtendo parâmetros materiais de um modelo viscoelástico anisotrópico com dispersão de fibras para deformações finitas. Através da metodologia experimental proposta foi possível obter dados úteis para identificação de parâmetros. Além disso, os resultados demonstraram que o comportamento mecânico de paredes arteriais foi representado adequadamente pelo modelo selecionado.

In vivo evaluation of a new vena cava filter / Avaliação in vivo de um novo filtro de veia cava

Background Pulmonary embolism is an important cause of cardiovascular death. Inferior vena cava filters have been shown to be effective for prevention of this condition. Objectives To determine the safety, performance and efficacy of a new inferior vena cava filter in an ovine model. Methods BKone1 filters are self-centering with over-the-wire deployment, have three filtering regions and are made from nickel-titanium alloy. Eight of these filters were implanted in 8 sheep. The sheep were divided into 4 groups of two animals (A and B) and the number of clots injected differed by group. Two clots were injected in group 2, four in group 3, eight in group 4 and zero clots in group 1. A animals underwent euthanasia soon after the procedure and B animals were observed for 30 days and then euthanized after a control cavography. All inferior vena cavas were processed for histological examination. Clots were prepared in a metal mold, sectioned and then radiopaque markers were inserted. Clot capture was analyzed by identifying the radiopaque marker on fluoroscopy. Results No clot migration was observed during follow-up. Control cavographies showed patent inferior vena cavas. Pathological examination indicated little inflammatory tissue response. All clots were captured in the condition with 2 clots, only one clot was missed in the group injected with 4 clots and in the condition of 8 clots, they were partly captured. Conclusions The filters were deployed safely. There was a reduction in efficacy as the number of blood clots increased.

Contexto Embolia pulmonar é uma importante causa de morte cardiovascular. Filtros de veia cava inferior têm se mostrado efetivos na sua prevenção. Objetivos Determinar a segurança, o desempenho e a eficácia de um novo filtro de veia cava inferior em estudo experimental utilizando modelos ovinos. Métodos Filtros BKone1 são autocentrantes, over-the-wire (OTW), compostos por três regiões de filtragem e construídos em liga de níquel-titânio. Oito filtros foram implantados em oito ovelhas. As ovelhas foram divididas em quatro grupos, de acordo com o número de êmbolos injetados, com dois animais em cada grupo (A e B). Foram injetados dois êmbolos no grupo 2, quatro no grupo 3, oito no grupo 4 e nenhum êmbolo no grupo 1. Os animais denominados A foram submetidos a eutanásia logo após o procedimento e os animais B foram observados por 30 dias, sendo submetidos a eutanásia após a realização de uma cavografia de controle. Após a eutanásia, todos os animais foram submetidos a explante do segmento de veia cava inferior contendo o filtro para análise anatomopatológica. Os êmbolos foram preparados em molde metálico e seccionados, adicionando-se marcadores radiopacos. A retenção dos êmbolos foi constatada através da identificação da marca radiopaca na seção de captura do filtro, via fluoroscopia. Resultados Não foi observada migração do filtro após o período de 30 dias. As cavografias de controle mostraram perviedade das veias cava inferior. Os resultados dos exames anatomopatológicos indicaram pouca resposta inflamatória dos tecidos. Os êmbolos foram capturados totalmente na condição com dois êmbolos, apenas um êmbolo não foi capturado no grupo com quatro êmbolos e na condição de oito êmbolos, eles foram parcialmente capturados. Conclusões Os filtros foram entregues com segurança. Há uma queda na eficácia de captura com o aumento da quantidade de êmbolos.

Tomographic Measurement of Gutters and Analysis of the Conformability of Stent Grafts in the Octopus Technique for Endovascular Thoracoabdominal Aneurysm Repair.

BACKGROUND: The Octopus technique is an off-label and off-the-shelf strategy used as an option in the management of some specific and selected cases of thoracoabdominal aortic aneurysms (TAAA). We sought to compare 2 different methods of measurements on computed tomography (CT) slices and to evaluate the accommodation and conformability, before and after ballooning, of the components used in the Octopus technique. METHODS: The CT gutter analysis between the 3 stent grafts within the short docking limb of the Excluder(®) was made using Viabahns(®) of 8, 7, and 6 mm in diameter. Each of the 10 possible combinations underwent a CT established protocol. The best axial image of the docking limb was submitted for an evaluation by 2 independent analysts, using 2 different methods. We also performed a postballooning evaluation, and the same CT protocol was used. RESULTS: There was no significant difference between the formats of measurement type "A" and type "B." Furthermore, there was no significant difference between the measurements made by the independent analysts. The tomography analyses demonstrated that the combination of stent grafts (Viabahn) of 8 and 7 mm diameter, inside the short docking limb of the bifurcated endoprosthesis, had the best possible relationship between the diameters used. These combinations showed better conformability and juxtaposition, with smaller areas of gutters and theoretically less possibility of endoleak. In addition, we found that postimplant balloon dilatation impaired the conformability and juxtaposition of the stent grafts (Viabahn) in the optimum combinations. CONCLUSIONS: In this analysis, we demonstrated a feasible, reliable, and reproducible form of CT measurement of the gutters in the Octopus technique for endovascular repair of TAAAs. Based on these measurements, there is a preferable combination of Viabahn sizes to be used in the Octopus technique and that postdilatation impairs the conformability and juxtaposition.

The Gore Global Registry for Endovascular Aortic Treatment: Objectives and Design.

BACKGROUND: The Global Registry for Endovascular Aortic Treatment (GREAT) is a prospective observational multicenter cohort registry that was initiated in November 2011. The aim of the GREAT is to collect contemporary real-world data on the performance of all Gore aortic endografts in the treatment of multiple aortic pathologies. The primary and secondary objectives, design, and future directions of the GREAT are described. METHODS: The GREAT aims to enroll 5000 consecutive patients with Gore thoracic and abdominal aortic endografts from multiple centers throughout the world. The GREAT has broad inclusion criteria with minimal exclusion criteria to reflect real-world practice such as including off-label use, nonstandard indications and devices deployed outside instruction for use. Follow-up will extend to 10 years providing major insights into the long-term durability and behavior of Gore aortic endografts. Primary end points include the incidence and timing of (1) endoleak of any type, (2) endograft migration and/or stent fracture, (3) endograft explantation, and (4) aortic rupture. Secondary end points include the following: (1) incidence of serious device events by pathology, (2) incidence of serious device events by aortic segment (ascending aorta, arch of aorta, descending thoracic aorta, abdominal aorta), (3) long-term survival by pathology, and (4) aorta-related mortality by pathology. RESULTS: As of June 2015, 2960 patients have been enrolled into the GREAT from 78 centers in Europe, the United States, Australia, New Zealand, and Brazil. The majority of patients and centers are from Europe and the United States. Completion of enrollment is anticipated to be in 2017 with interim results planned to be published during enrollment and on follow-up. CONCLUSIONS: Upon completion, the GREAT will be among the largest clinical registry to date of abdominal and thoracic aortic devices manufactured by a single sponsor. It will provide valuable real-world data on the use and durability of Gore aortic endografts in the treatment of a variety of aortic pathologies and devices deployed within and outside instruction for use.

In vivo evaluation of a new vena cava filter.

BACKGROUND: Pulmonary embolism is an important cause of cardiovascular death. Inferior vena cava filters have been shown to be effective for prevention of this condition. OBJECTIVES: To determine the safety, performance and efficacy of a new inferior vena cava filter in an ovine model. METHODS: BKone1 filters are self-centering with over-the-wire deployment, have three filtering regions and are made from nickel-titanium alloy. Eight of these filters were implanted in 8 sheep. The sheep were divided into 4 groups of two animals (A and B) and the number of clots injected differed by group. Two clots were injected in group 2, four in group 3, eight in group 4 and zero clots in group 1. A animals underwent euthanasia soon after the procedure and B animals were observed for 30 days and then euthanized after a control cavography. All inferior vena cavas were processed for histological examination. Clots were prepared in a metal mold, sectioned and then radiopaque markers were inserted. Clot capture was analyzed by identifying the radiopaque marker on fluoroscopy. RESULTS: No clot migration was observed during follow-up. Control cavographies showed patent inferior vena cavas. Pathological examination indicated little inflammatory tissue response. All clots were captured in the condition with 2 clots, only one clot was missed in the group injected with 4 clots and in the condition of 8 clots, they were partly captured. CONCLUSIONS: The filters were deployed safely. There was a reduction in efficacy as the number of blood clots increased.

CONTEXTO: Embolia pulmonar é uma importante causa de morte cardiovascular. Filtros de veia cava inferior têm se mostrado efetivos na sua prevenção. OBJETIVOS: Determinar a segurança, o desempenho e a eficácia de um novo filtro de veia cava inferior em estudo experimental utilizando modelos ovinos. MÉTODOS: Filtros BKone1 são autocentrantes, over-the-wire (OTW), compostos por três regiões de filtragem e construídos em liga de níquel-titânio. Oito filtros foram implantados em oito ovelhas. As ovelhas foram divididas em quatro grupos, de acordo com o número de êmbolos injetados, com dois animais em cada grupo (A e B). Foram injetados dois êmbolos no grupo 2, quatro no grupo 3, oito no grupo 4 e nenhum êmbolo no grupo 1. Os animais denominados A foram submetidos a eutanásia logo após o procedimento e os animais B foram observados por 30 dias, sendo submetidos a eutanásia após a realização de uma cavografia de controle. Após a eutanásia, todos os animais foram submetidos a explante do segmento de veia cava inferior contendo o filtro para análise anatomopatológica. Os êmbolos foram preparados em molde metálico e seccionados, adicionando-se marcadores radiopacos. A retenção dos êmbolos foi constatada através da identificação da marca radiopaca na seção de captura do filtro, via fluoroscopia. RESULTADOS: Não foi observada migração do filtro após o período de 30 dias. As cavografias de controle mostraram perviedade das veias cava inferior. Os resultados dos exames anatomopatológicos indicaram pouca resposta inflamatória dos tecidos. Os êmbolos foram capturados totalmente na condição com dois êmbolos, apenas um êmbolo não foi capturado no grupo com quatro êmbolos e na condição de oito êmbolos, eles foram parcialmente capturados. CONCLUSÕES: Os filtros foram entregues com segurança. Há uma queda na eficácia de captura com o aumento da quantidade de êmbolos.

Síndrome da congestão venosa pélvica e resultados do tratamento endovascular: série de casos / Pelvic congestion syndrome case series: results of endovascular treatment

A Síndrome da Congestão Venosa Pélvica (SCVP) é uma causa de dor pélvica crônica, que afeta principalmente mulheres multíparas em idade reprodutiva. Para o tratamento desta síndrome, a embolização de varizes pélvicas tem demonstrado excelentes resultados. Relatamos uma série inicial de pacientes submetidas a tratamento com embolização de varizes pélvicas e os respectivos resultados de acompanhamento pós-operatório. São apresentados dados clínicos, detalhes do procedimento e resultados do acompanhamento e de exames de imagem de seis pacientes. Dentre estas pacientes, o sucesso técnico foi de 100% e não houve relato de complicações trans ou pós-operatórias graves. Em todos os casos, pôde-se observar alívio dos sintomas e melhora nos resultados de exames de imagens no acompanhamento de curto prazo. Os resultados nesta pequena série de casos indicam que a embolização é um tratamento seguro e efetivo para a SCVP.

Pelvic Congestion Syndrome (PCS) is a cause of chronic pelvic pain that primarily affects multiparous women of reproductive age. Embolization of pelvic varicose veins offers excellent results for treatment of this syndrome. We describe an initial series of patients treated with embolization of pelvic varicose veins and their respective postoperative follow-up results. We provide clinical data, details of the procedures performed and results of follow-up and imaging exams for six patients. The technical success rate with these patients was 100% and there were no reports of serious intraoperative or postoperative complications. In all cases there was relief from symptoms and improvements in the results of imaging exams during short-term follow-up. The results of this small series of cases indicate that embolization is a safe and effective treatment for PCS.