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1.
Trials ; 22(1): 595, 2021 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-34488845

RESUMO

BACKGROUND: Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatment, based on antiplatelet therapy and statins, has demonstrated deficient improvement of the disease. In recent years, research has shown that it is possible to improve tissue perfusion through therapeutic angiogenesis. Both in animal models and humans, it has been shown that cell therapy can induce therapeutic angiogenesis, making mesenchymal stromal cell-based therapy one of the most promising therapeutic alternatives. The aim of this study is to evaluate the feasibility, safety, and efficacy of cell therapy based on mesenchymal stromal cells derived from adipose tissue intramuscular administration to patients with type 2 diabetes mellitus with critical limb ischemia and without possibility of revascularization. METHODS: A multicenter, randomized double-blind, placebo-controlled trial has been designed. Ninety eligible patients will be randomly assigned at a ratio 1:1:1 to one of the following: control group (n = 30), low-cell dose treatment group (n = 30), and high-cell dose treatment group (n = 30). Treatment will be administered in a single-dose way and patients will be followed for 12 months. Primary outcome (safety) will be evaluated by measuring the rate of adverse events within the study period. Secondary outcomes (efficacy) will be measured by assessing clinical, analytical, and imaging-test parameters. Tertiary outcome (quality of life) will be evaluated with SF-12 and VascuQol-6 scales. DISCUSSION: Chronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future. TRIAL REGISTRATION: ClinicalTrials.gov NCT04466007 . Registered on January 07, 2020. All items from the World Health Organization Trial Registration Data Set are included within the body of the protocol.


Assuntos
COVID-19 , Diabetes Mellitus Tipo 2 , Transplante de Células-Tronco Hematopoéticas , Células-Tronco Mesenquimais , Noma , Tecido Adiposo , Animais , Ensaios Clínicos Fase II como Assunto , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/terapia , Método Duplo-Cego , Humanos , Isquemia/diagnóstico , Isquemia/terapia , Estudos Multicêntricos como Assunto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Resultado do Tratamento
2.
Diagn Interv Radiol ; 25(2): 166-168, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30774093

RESUMO

Aneurysms of the portal vein and its branches have been rarely described. Their natural history is unknown although large ones (>3 cm in diameter) have been reported to cause rupture, thrombosis, duodenal or biliary obstruction, inferior vena cava compression and/or portal hypertension. We report the case of an incidentally diagnosed 4.5 cm splenic vein aneurysm repaired by endovascular treatment through a transhepatic route. The aneurysm was successfully excluded using a covered stent (Viabahn, Gore). The transhepatic route opens the possibility of offering a minimally invasive approach to vascular lesions of the portal vein system. Splenic vein aneurysms were first reported in 1953 (1) and they are part of the extrahepatic portal vein aneurysm group (2). Their mechanism of development is not well understood. Etiology may include congenital causes (inherent weakness of the vessel wall) or acquired causes (trauma, inflammation such as pancreatitis, liver disease, or portal hypertension). However, portal aneurysms do not seem to be the result of an isolated portal hypertension since they are extremely rare even in patients with this condition (3). The demographic characteristics of extrahepatic portal vein aneurysm include a female-to-male ratio of 2:1 and the median age of 52 years (range, 5-77 years). The size of the reported aneurysms ranges from 1.9 to 8 cm. The most common location of the aneurysm is in the main portal vein trunk, the junction of the superior mesenteric vein and the splenic vein, or at the hepatic hilus; intrahepatic venous aneurysms are rare (4, 5). Here, for the first time, we report the successful endovascular treatment of a splenic vein aneurysm through transhepatic percutaneous approach using a Viabahn stent.


Assuntos
Aneurisma/terapia , Procedimentos Endovasculares/métodos , Veia Porta/cirurgia , Veia Esplênica/patologia , Assistência ao Convalescente , Idoso , Aneurisma/diagnóstico por imagem , Angiografia por Tomografia Computadorizada/métodos , Feminino , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Veia Porta/patologia , Resultado do Tratamento
3.
Handchir Mikrochir Plast Chir ; 50(1): 52-56, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29590705

RESUMO

In 1934 von Rosen first described a posttraumatic thrombosis of the distal ulnar artery resulting from blunt a trauma to the hypothenar region. But it was Conn in 1970 who named it the "hypothenar hammer syndrome (HHS)" 1-2.


Assuntos
Arteriopatias Oclusivas , Traumatismos da Mão , Trombose , Artéria Ulnar , Arteriopatias Oclusivas/etiologia , Mãos , Traumatismos da Mão/complicações , Humanos , Síndrome , Trombose/etiologia
4.
Hosp Pract (1995) ; 45(3): 70-75, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28618844

RESUMO

OBJECTIVES: Superior Vena Cava obstruction results in severe oedema of the upper thorax. Endovascular treatment allows a rapid restoration of the blood flow with a rapid resolution of symptoms. We retrospectively report a single institution's experience in stent placement for malignant Superior Vena Cava Syndrome (SVCS) caused by lung cancer. METHODS: Thirty-three consecutive patients (23 men, 10 women; median age, 57.6 years; range 34-71 years) who underwent endovascular SVCS palliative treatment were enrolled between August 2002 and June 2015. All patients presented SVCS secondary to lung cancer. Signs and symptoms of SVCS were scored. RESULTS: All procedures were successfully completed (100% technical success rate). Twenty-eight patients showed a progressive clinical improvement after endovascular treatment of SVCS (84.8% clinical success rate) within 48 hours, there were five clinical failures which improved progressively with posterior radiotherapy. During follow-up, three patients (9%) suffered intra or post-procedural complications (1 cardiac arrhythmia, 2 stent thrombosis). CONCLUSIONS: Stent placement in malignant SVCS seems to be an effective and rapid treatment for the relief of symptoms and quality of life improvement with a relatively low complications rate with a rapid resolution of symptoms. Therefore, it should be seriously considered as the first option in the SVC obstruction treatment.


Assuntos
Procedimentos Endovasculares/métodos , Neoplasias Pulmonares/complicações , Stents , Síndrome da Veia Cava Superior/etiologia , Síndrome da Veia Cava Superior/cirurgia , Adulto , Idoso , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Complicações Intraoperatórias/epidemiologia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Qualidade de Vida , Estudos Retrospectivos , Índice de Gravidade de Doença
5.
Ann Vasc Surg ; 27(7): 974.e1-6, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23993115

RESUMO

In the last 20 years, endovascular procedures have radically altered the treatment of diseases of the aorta. The objective of endovascular treatment of dissections is to close the entry point to redirect blood flow toward the true lumen, thereby achieving thrombosis of the false lumen. In extensive chronic dissections that have evolved with the formation of a large aneurysm, the dissection is maintained from the end of the endoprosthesis due to multiple orifices, or reentries, that communicate with the lumens. In addition, one of the primary limitations of this technique is when the visceral arteries have disease involvement. In this report we present a case where, despite having treated the entire length of the descending thoracic aorta, the dissection was maintained distally, leading to progression of the diameter of the aneurysm. After reviewing the literature, and to the best of our knowledge, we describe the first case in which renal autotransplant was performed to allow for subsequent exclusion of the aorta at the thoracoabdominal level using a fenestrated endoprosthesis for the celiac trunk and the superior mesenteric artery.


Assuntos
Aneurisma Dissecante/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular , Procedimentos Endovasculares , Transplante de Rim , Idoso , Aneurisma Dissecante/diagnóstico , Aneurisma da Aorta Torácica/diagnóstico , Aortografia/métodos , Prótese Vascular , Implante de Prótese Vascular/instrumentação , Artéria Celíaca/cirurgia , Procedimentos Endovasculares/instrumentação , Feminino , Humanos , Laparoscopia , Artéria Mesentérica Superior/cirurgia , Nefrectomia/métodos , Desenho de Prótese , Reoperação , Stents , Tomografia Computadorizada por Raios X , Transplante Autólogo , Resultado do Tratamento
6.
Ann Vasc Surg ; 24(7): 930-4, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20598852

RESUMO

BACKGROUND: Endoluminal laser ablation has emerged as a new method for treating greater saphenous vein insufficiency. However, the procedure is not completely painless and requires applying tumescent anesthesia. The aim of this study was to evaluate the safety and efficacy of ultrasound-guided femoral nerve block in patients subjected to endoluminal laser ablation of the greater saphenous vein. METHODS: Two consecutive groups of 25 patients subjected to ambulatory endoluminal laser ablation of the greater saphenous vein were analyzed in this study. Tumescent anesthesia only was applied in the first group. In the second group, before applying tumescent anesthesia, ultrasound-guided femoral nerve block was performed with 20 mL of 1% lidocaine. The pain during the application of tumescent anesthesia and vein ablation was evaluated by the patients using a 5-point scale. The heart rate and blood pressure was monitored during the procedures. The duration of the postprocedure stay in the recovery area was also recorded. The results were analyzed using statistical methods. RESULTS: No complications associated with performing the femoral nerve block were observed. The pain associated with applying the tumescent anesthesia and that of performing the ablation was more intense in group 1 (p > 0.001). The volume of tumescent anesthesia solution was lower in group 2, 240 (±73) mL, compared to 399 (±137) mL in group 1, (p < 0.001). The group 2 patients had less hemodynamic changes during the procedure (p = 0.01). CONCLUSIONS: In conclusion, ultrasound-guided femoral nerve block was shown to be a safe and effective option to decrease intraoperative discomforts associated with tumescent anesthesia and endoluminal laser ablation of the greater saphenous vein.


Assuntos
Nervo Femoral/diagnóstico por imagem , Terapia a Laser , Bloqueio Nervoso/métodos , Dor Pós-Operatória/prevenção & controle , Veia Safena/cirurgia , Ultrassonografia de Intervenção , Insuficiência Venosa/cirurgia , Adulto , Idoso , Procedimentos Cirúrgicos Ambulatórios , Pressão Sanguínea , Feminino , Frequência Cardíaca , Humanos , Terapia a Laser/efeitos adversos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Dor Pós-Operatória/etiologia , Estudos Prospectivos , Espanha , Fatores de Tempo , Resultado do Tratamento , Insuficiência Venosa/diagnóstico por imagem
7.
Cir. Esp. (Ed. impr.) ; 86(4): 213-218, oct. 2009. ilus
Artigo em Espanhol | IBECS | ID: ibc-114694

RESUMO

Introducción Las lesiones profundas del pie diabético constituyen un importante problema terapéutico. El objetivo de este estudio es presentar la experiencia resultante de la utilización del sistema de cierre asistido al vacío (VAC) en el tratamiento del pie diabético avanzado y complicado. Material y métodos Se realizó un estudio prospectivo de 5 casos de pie diabético avanzado tratados mediante VAC. Del total, a 3 pacientes se los diagnosticó de insuficiencia renal, entre ellos uno que recibió tratamiento inmunosupresor debido a un trasplante renal. En 4 de los casos se habían realizado intervenciones quirúrgicas locales sin éxito. Conforme a la clasificación de Wagner, las lesiones se catalogaron como de grado 3 o 4. En todos los casos se realizó un desbridamiento extenso, que en 4 de los pacientes dio lugar a amputaciones menores abiertas a la altura del metatarso, mientras que en uno se tradujo en una resección de la articulación metatarsofalángica. En el mismo acto, en cada uno de los pacientes se colocó VAC. La mediana de seguimiento posprocedimiento fue de 9 meses. Resultados Se consiguió salvar la extremidad en todos los casos. La mediana de cambios de VAC fue de 16 durante un período mediano de 8 semanas. La mitad de los cambios se realizó de modo ambulatorio. No ocurrieron complicaciones mayores. En ningún caso se produjeron signos clínicos de la infección. En uno de los pacientes, antes de comenzar el tratamiento con VAC, se llevó a cabo una angioplastia de arteria ilíaca y femoral superficial. Se necesitaron otros procedimientos adicionales: 2 revascularizaciones distales y 2 amputaciones parciales del antepié, después de que se iniciara el tratamiento con VAC. Conclusione El sistema VAC parece ser muy eficaz en el tratamiento del pie diabético avanzado (AU)


Introduction Deep diabetic foot lesions pose an enormous therapeutic problem. The purpose of this study was to present the experience of the use of vacuum assisted closure (VAC) in the treatment of advanced and complicated diabetic foot lesions. Material and methods Five cases of advanced diabetic foot that were treated with VAC were prospectively studied. Three patients were diagnosed with renal failure, including one with renal transplant, who were receiving immunosuppression therapy. Four patients had undergone local foot surgery. The foot lesions were classified as grade 3 or 4 according to the Wagner classification. In all patients extensive debridement was performed that resulted in open minor amputations in four cases and resection of the metatarsophalangeal joint in one case. The VAC was applied during the same procedure. The median follow-up period of the patients was 9 months. Results Foot salvage was achieved in all cases. The median number of changes of VAC was 16 within median period of 8 weeks. Half of the changes were performed as an outpatient procedure. There were no major complications or clinical signs of infection observed. In one case before treatment with VAC began, angioplasty of the iliac artery and superficial femoral artery was performed. Other interventions carried out after the treatment was started were, two distal revascularizations and two partial transmetatarsal amputations. Conclusions VAC appears to be very useful in the treatment of advanced diabetic foot lesions (AU)


Assuntos
Humanos , Pé Diabético/cirurgia , Técnicas de Fechamento de Ferimentos , Desbridamento/métodos , Estudos Prospectivos , Angiopatias Diabéticas/complicações
8.
Cir Esp ; 86(4): 213-8, 2009 Oct.
Artigo em Espanhol | MEDLINE | ID: mdl-19683224

RESUMO

INTRODUCTION: Deep diabetic foot lesions pose an enormous therapeutic problem. The purpose of this study was to present the experience of the use of vacuum assisted closure (VAC) in the treatment of advanced and complicated diabetic foot lesions. MATERIAL AND METHODS: Five cases of advanced diabetic foot that were treated with VAC were prospectively studied. Three patients were diagnosed with renal failure, including one with renal transplant, who were receiving immunosuppression therapy. Four patients had undergone local foot surgery. The foot lesions were classified as grade 3 or 4 according to the Wagner classification. In all patients extensive debridement was performed that resulted in open minor amputations in four cases and resection of the metatarsophalangeal joint in one case. The VAC was applied during the same procedure. The median follow-up period of the patients was 9 months. RESULTS: Foot salvage was achieved in all cases. The median number of changes of VAC was 16 within median period of 8 weeks. Half of the changes were performed as an outpatient procedure. There were no major complications or clinical signs of infection observed. In one case before treatment with VAC began, angioplasty of the iliac artery and superficial femoral artery was performed. Other interventions carried out after the treatment was started were, two distal revascularizations and two partial transmetatarsal amputations. CONCLUSIONS: VAC appears to be very useful in the treatment of advanced diabetic foot lesions.


Assuntos
Pé Diabético/terapia , Tratamento de Ferimentos com Pressão Negativa , Idoso , Progressão da Doença , Humanos , Estudos Prospectivos
9.
Ann Vasc Surg ; 23(5): 688.e1-5, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19540089

RESUMO

The coexistence of internal carotid artery (ICA) stenosis and intracranial aneurysm, although uncommon, can be a therapeutic dilemma. We present a case of a 73-year-old woman with a history of arterial hypertension and diabetes who had a severe symptomatic ICA stenosis (>90%) and an incidental ipsilateral cerebral aneurysm. The carotid stenosis was treated with angioplasty and stenting using a distal cerebral protection system. The patient was anticoagulated and maintained on antiplatelet therapy according to a standard protocol. Microcoil embolization of the aneurysm was performed 5 months after an intracranial stent was implanted. No growth has been observed in the aneurysm of the arterial lumen since the carotid intervention. There were no complications after the procedures during the postoperative period. This case shows that the incidental presence of an ipsilateral intracranial aneurysm does not appear to be a contraindication for the endovascular treatment of a carotid artery stenosis.


Assuntos
Angioplastia com Balão/instrumentação , Artéria Carótida Interna , Estenose das Carótidas/terapia , Achados Incidentais , Aneurisma Intracraniano/complicações , Stents , Idoso , Anticoagulantes/uso terapêutico , Artéria Carótida Interna/diagnóstico por imagem , Estenose das Carótidas/complicações , Estenose das Carótidas/diagnóstico por imagem , Angiografia Cerebral/métodos , Terapia Combinada , Embolização Terapêutica , Feminino , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Inibidores da Agregação Plaquetária/uso terapêutico , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X , Resultado do Tratamento
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