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1.
J Vasc Interv Radiol ; 26(9): 1324-30, 2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26189046

RESUMO

The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it is through industry-sponsored trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in interventional radiology. This article reviews the potential areas of interface between the FDA and interventional radiology, as understanding these areas is necessary to continue the innovation that is the hallmark of this specialty.


Assuntos
Pesquisa Biomédica/legislação & jurisprudência , Aprovação de Equipamentos/legislação & jurisprudência , Regulamentação Governamental , Radiologia Intervencionista/instrumentação , Radiologia Intervencionista/legislação & jurisprudência , United States Food and Drug Administration/organização & administração , Estados Unidos
2.
J Vasc Interv Radiol ; 25(11): 1785-94.e17, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25255703

RESUMO

Under the auspices of the International Society for Neurovascular Disease (ISNVD), four expert panel committees were created from the ISNVD membership between 2011 and 2012 to determine and standardize noninvasive and invasive imaging protocols for detection of extracranial venous abnormalities indicative of chronic cerebrospinal venous insufficiency (CCSVI). The committees created working groups on color Doppler ultrasound (US), magnetic resonance (MR) imaging, catheter venography (CV), and intravascular US. Each group organized a workshop focused on its assigned imaging modality. Non-ISNVD members from other societies were invited to contribute to the various workshops. More than 60 neurology, radiology, vascular surgery, and interventional radiology experts participated in these workshops and contributed to the development of standardized noninvasive and invasive imaging protocols for the detection of extracranial venous abnormalities indicative of CCSVI. This ISNVD position statement presents the MR imaging and intravascular US protocols for the first time and describes refined color Doppler US and CV protocols. It also emphasizes the need for the use of for noninvasive and invasive multimodal imaging to diagnose adequately and monitor extracranial venous abnormalities indicative of CCSVI for open-label or double-blinded, randomized, controlled studies.


Assuntos
Transtornos Cerebrovasculares/diagnóstico , Imagem Multimodal/métodos , Doenças Vasculares/diagnóstico , Malformações Vasculares/diagnóstico , Insuficiência Venosa/diagnóstico , Humanos , Imageamento por Ressonância Magnética/métodos , Flebografia/métodos , Ultrassonografia Doppler em Cores/métodos , Ultrassonografia de Intervenção/métodos
3.
J Vasc Interv Radiol ; 23(1): 55-9, 2012 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-22088659

RESUMO

PURPOSE: To evaluate the safety of outpatient endovascular treatment in patients with multiple sclerosis (MS) and chronic cerebrospinal venous insufficiency (CCSVI). MATERIALS AND METHODS: A retrospective analysis was performed to assess complications occurring within 30 days of endovascular treatment of CCSVI. The study population comprised 240 patients; 257 procedures were performed over 8 months. The indication for treatment in all patients was symptomatic MS. Of the procedures, 49.0% (126 of 257) were performed in a hospital, and 51.0% (131 of 257) were performed in the office. Primary procedures accounted for 93.0% (239 of 257) of procedures, and repeat interventions accounted for 7% (18 of 257). For patients treated primarily, 87% (208 of 239) had angioplasty, and 11% (26 of 239) had stent placement; 5 patients were not treated. Of patients with restenosis, 50% (9 of 18) had angioplasty, and 50% (9 of 18) had stent placement. RESULTS: After the procedure, all but three patients were discharged within 3 hours. Headache after the procedure was reported in 8.2% (21 of 257) of patients; headache persisted > 30 days in 1 patient. Neck pain was reported in 15.6% (40 of 257); 52.5% (21 of 40) of these patients underwent stent placement. Three patients experienced venous thrombosis requiring retreatment within 30 days. Sustained intraprocedural arrhythmias were observed in three patients, and two required hospital admission. One of these patients, who was being retreated for stent thrombosis, was hospitalized because of a stress-induced cardiomyopathy. CONCLUSIONS: Endovascular treatment of CCSVI is a safe procedure; there is a 1.6% risk of major complications. Cardiac monitoring is essential to detect intraprocedural arrhythmias. Ultrasonography after the procedure is recommended to confirm venous patency and to identify patients experiencing acute venous thrombosis.


Assuntos
Transtornos Cerebrovasculares/etiologia , Transtornos Cerebrovasculares/cirurgia , Procedimentos Endovasculares/métodos , Esclerose Múltipla/complicações , Complicações Pós-Operatórias/epidemiologia , Insuficiência Venosa/etiologia , Insuficiência Venosa/cirurgia , Adulto , Idoso , Doença Crônica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Radiografia Intervencionista , Estudos Retrospectivos , Resultado do Tratamento , Grau de Desobstrução Vascular
4.
J Vasc Interv Radiol ; 22(12): 1681-90; quiz 1691, 2011 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-21975259

RESUMO

Chronic cerebrospinal venous insufficiency (CCSVI) represents a recently described condition that may potentially contribute to the symptoms experienced by patients with multiple sclerosis. The evaluation of a prospective patient for CCSVI often involves an invasive evaluation with venography of the internal jugular and azygos veins. The purpose of this article is to review the normal anatomy of the internal jugular, vertebral, and azygos veins, as an understanding of these veins is necessary for appropriate interpretation of the venograms obtained to evaluate patients for CCSVI.


Assuntos
Veia Ázigos/diagnóstico por imagem , Veia Ázigos/patologia , Veias Jugulares/patologia , Modelos Anatômicos , Flebografia/métodos , Radiografia Intervencionista/métodos , Insuficiência Venosa/patologia , Humanos
5.
Tech Vasc Interv Radiol ; 22(3): 127-134, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31623752

RESUMO

Intraductal biliary stones can result in significant acute and long-term complications. When patients' anatomy precludes more traditional management, the interventional radiologist may be called upon to provide well-established techniques for percutaneous biliary drainage and stone removal. This can be particularly challenging when the patient has excessively mobile, impacted, large or multiple stones. Percutaneous biliary endoscopy with adjunct interventional techniques can successfully treat these patients avoiding the patient dreaded "tube for life" scenario. Direct percutaneous visualization of the biliary tree can also diagnose and provide symptomatic relief for stone-mimicking pathologic conditions such as biliary tumors. This article will review the role, technique, and considerations for percutaneous biliary endoscopy and adjunct interventions in patients with isolated and complex, biliary stone disease and stone-mimicking pathologies.


Assuntos
Colelitíase/terapia , Drenagem/métodos , Endoscopia do Sistema Digestório/métodos , Radiografia Intervencionista/métodos , Colelitíase/diagnóstico por imagem , Diagnóstico Diferencial , Drenagem/efeitos adversos , Drenagem/instrumentação , Endoscopia do Sistema Digestório/efeitos adversos , Endoscopia do Sistema Digestório/instrumentação , Humanos , Seleção de Pacientes , Valor Preditivo dos Testes , Radiografia Intervencionista/efeitos adversos , Radiografia Intervencionista/instrumentação , Fatores de Risco , Resultado do Tratamento
6.
Tech Vasc Interv Radiol ; 15(2): 121-30, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22640501

RESUMO

Multiple sclerosis (MS) is a disorder characterized by damage to the myelin sheath insulation of nerve cells of the brain and spinal cord affecting nerve impulses which can lead to numerous physical and cognitive disabilities. The disease, which affects over 500,000 people in the United States alone, is widely believed to be an autoimmune condition potentially triggered by an antecedant event such as a viral infection, environmental factors, a genetic defect or a combination of each. Chronic cerebrospinal venous insufficiency (CCSVI) is a condition characterized by abnormal venous drainage from the central nervous system that has been theorized to have a possible role in the pathogenesis and symptomatology of MS (1). A significant amount of attention has been given to this theory as a possible explanation for the etiology of symptoms related to MS patients suffering from this disease. The work of Dr. Zamboni, et al, who reported that treating the venous stenoses causing CCSVI with angioplasty resulting in significant improvement in the symptoms and quality of life of patients with MS (2) has led to further interest in this theory and potential treatment. The article presented describes endovascular techniques employed to diagnose and treat patients with MS and CCSVI.


Assuntos
Veias Cerebrais/cirurgia , Procedimentos Endovasculares , Flebografia/métodos , Medula Espinal/irrigação sanguínea , Medula Espinal/cirurgia , Insuficiência Venosa/diagnóstico por imagem , Insuficiência Venosa/cirurgia , Cateterismo Periférico/métodos , Veias Cerebrais/diagnóstico por imagem , Doença Crônica , Humanos , Medula Espinal/diagnóstico por imagem
7.
Tech Vasc Interv Radiol ; 15(2): 153-7, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22640505

RESUMO

The Internet is being seen as a growing resource for health-related information for a large number of patients. It is undeniable that its widespread presence has led to the growth of awareness that chronic cerebrospinal venous insufficiency (CCSVI) as an entity that may contribute to the symptoms experienced by patients with multiple sclerosis (MS). Social networking and file-sharing Web sites have brought patients with MS together from all over the world and have facilitated the distribution of personal experiences and information derived from medical research as it relates to CCSVI. As a result, there has been an accelerated growth in the number of patients seeking treatment for this syndrome in light of the possibility that it may improve their present condition. This article will review this phenomenon, the Internet-based resources available to MS patients seeking information about CCSVI, and the responsibilities of physicians as they participate in these online discussions.


Assuntos
Veias Cerebrais/cirurgia , Disseminação de Informação/métodos , Educação de Pacientes como Assunto/métodos , Apoio Social , Medula Espinal/irrigação sanguínea , Insuficiência Venosa , Doença Crônica , Humanos , Internet
8.
J Vasc Interv Radiol ; 19(1): 58-65, 2008 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-18192468

RESUMO

PURPOSE: To determine the degree of leiomyoma infarction after uterine artery embolization (UAE) performed with tris-acryl gelatin microspheres or polyvinyl alcohol (PVA) microspheres. MATERIALS AND METHODS: Patients determined to be candidates and scheduled for UAE were randomized prospectively to receive tris-acryl gelatin microspheres or PVA microspheres. The manufacturers' recommended technique was used for both products during the UAE procedures (including the recently described refined protocol for PVA microspheres). All patients underwent magnetic resonance (MR) imaging of the pelvis with contrast agent enhancement before and after the UAE procedure. On the postprocedural MR study, the degree of tumor infarction was assessed on postcontrast images. These findings were classified as follows: 100% infarction, 90%-99% infarction, 50%-89% infarction, and less than 50% infarction. Treatment failure was defined by enhancement of more than 10% of a patient's entire tumor burden. RESULTS: A total of 53 patients were enrolled in this study. Twenty-seven (mean age, 44.9 years) received PVA microspheres and 26 (mean age, 45.1 years) received tris-acryl gelatin microspheres. There were no significant differences in the preprocedural uterine volume, dominant tumor volume, location of dominant tumor, and presenting symptoms between populations. In the PVA microsphere group, treatment failure was seen in eight patients (29.6%). In the tris-acryl gelatin microsphere group, treatment failure was seen in one patient (3.8%), which was a significant difference between groups (P < or = .025). CONCLUSIONS: There was a significantly greater degree of tumor infarction in patients treated with tris-acryl gelatin microspheres during UAE than in patients who received PVA microspheres administered in accordance with a newly refined protocol. Given the known risk of recurrence in patients with persistent tumor enhancement after UAE, it is concluded that tris-acryl gelatin microspheres should be the preferred agent for UAE at this time.


Assuntos
Resinas Acrílicas/uso terapêutico , Embolização Terapêutica/métodos , Gelatina/uso terapêutico , Leiomioma/terapia , Microesferas , Álcool de Polivinil/uso terapêutico , Neoplasias Uterinas/terapia , Útero/irrigação sanguínea , Adulto , Embolização Terapêutica/efeitos adversos , Feminino , Humanos , Infarto , Leiomioma/irrigação sanguínea , Leiomioma/patologia , Imageamento por Ressonância Magnética , Pessoa de Meia-Idade , Seleção de Pacientes , Estudos Prospectivos , Resultado do Tratamento , Neoplasias Uterinas/irrigação sanguínea , Neoplasias Uterinas/patologia , Útero/patologia
9.
J Vasc Interv Radiol ; 13(8): 785-90, 2002 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-12171981

RESUMO

PURPOSE: To determine long-term outcome in patients 50 years of age or younger treated with iliac artery stent placement. MATERIALS AND METHODS: The records of 412 patients who underwent iliac artery stent placement during a 62-month study period were reviewed retrospectively. Forty-two patients younger than age 50 (mean age = 45 y) at the time of stent placement were included in the study population. Presenting symptoms included claudication (47%), rest pain (17%), ulceration/tissue loss (31%), and blue toe syndrome (5%). Anatomic, hemodynamic, and clinical success rates of the stent placement procedure were assessed. Stent patency rates were calculated by life-table methods. RESULTS: Fifty-nine iliac lesions were treated with stents; 62% of patients underwent treatment of a single lesion whereas 38% had multiple lesions treated. Thirty-one percent were treated after a failed angioplasty procedure and 69% were treated with stent placement primarily. After stent placement, 34 patients (82%) experienced symptomatic relief, although eight of these patients (19%) underwent a planned ipsilateral infrainguinal bypass procedure during the same hospitalization. During follow-up, five patients (12%) required a bypass procedure as a result of stent failure and two patients (5%) required below-knee amputation. Seven patients (17%) required endovascular stent revision, with none requiring additional surgery. At 1, 2, and 3 years, the primary patency rates were 86%, 72%, and 65%, and the secondary patency rates were 90%, 88%, and 88%, respectively. CONCLUSIONS: Iliac stent placement successfully addresses the presenting symptoms of young patients with peripheral vascular disease and results in patency rates that are similar to those reported in a more general population. With appropriate postprocedural surveillance, restenosis can be addressed in many patients with use of endovascular techniques, limiting the need for surgical revision.


Assuntos
Arteriopatias Oclusivas/terapia , Artéria Ilíaca , Stents , Adulto , Fatores Etários , Angioplastia com Balão , Arteriopatias Oclusivas/cirurgia , Feminino , Humanos , Isquemia/terapia , Perna (Membro)/irrigação sanguínea , Masculino , Pessoa de Meia-Idade , Recidiva , Estudos Retrospectivos , Falha de Tratamento , Grau de Desobstrução Vascular
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