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1.
Cardiovasc Intervent Radiol ; 31(1): 8-13, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-17479207

RESUMO

The activation of the platelet GP IIb/IIIa receptor is the final and common pathway in platelet aggregation. By blocking this receptor, platelet aggregation can be inhibited independently of the stimulus prompted the targeting of this receptor. Several years ago, three drugs have been approved for coronary artery indications. Since that time, there is increasing evidence that GP IIb/IIIa receptor blockade might have also an important role in peripheral arterial intervention. This article summarizes the action and differences of GP Ilb/IIIa receptor inhibitors and its possible indication in peripheral arteries.


Assuntos
Doenças Vasculares Periféricas/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Angioplastia Coronária com Balão/métodos , Fibrinolíticos/uso terapêutico , Humanos , Doenças Vasculares Periféricas/terapia , Ativação Plaquetária/efeitos dos fármacos , Agregação Plaquetária/efeitos dos fármacos
2.
Eur Radiol ; 17(1): 265-71, 2007 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-16733677

RESUMO

Image quality, visible lumen and patency of lower limb stents was assessed by multidetector-row computed tomography (MDCT) angiography using various reconstruction parameters and the results compared with conventional angiography. Fourteen patients (25 stents) were evaluated. From MDCT datasets, axial and coronal oblique reformations were reconstructed using differing reconstruction parameters (slice thickness, kernel, views). Artifacts and image quality were assessed using a five-degree scale (1=excellent, 5=poor). Visible stent diameter was measured. Stenosis severity was compared with calibrated catheter angiography. The image quality of medium and sharp image kernels were good/fair (1.9-2.4), while smooth kernel provided only acceptable/poor image quality (3.9-4.4). Coronal oblique images were rated superior to assess in-stent lumen rather than axial. Using medium and sharp kernels, the visible stent lumen was significantly greater than using smooth kernel (P<0.001). thirteen out of fourteen patients (24/25 stents) were correctly classified as patent. In one patient, in-stent stenosis (> or =50%) was falsely diagnosed using CT angiography (CTA) with smooth kernel and was, therefore, rated as false positive. Coronal oblique views, as well as medium and sharp kernels, have shown the best results regarding image quality to assess stent patency in the lower limb. Therefore, MDCT could be a valuable non-invasive modality for stent imaging in the peripheral vasculature.


Assuntos
Angiografia Digital , Angiografia/métodos , Arteriopatias Oclusivas/diagnóstico por imagem , Arteriopatias Oclusivas/cirurgia , Artefatos , Perna (Membro)/irrigação sanguínea , Stents , Tomografia Computadorizada por Raios X , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tomografia Computadorizada por Raios X/métodos
3.
J Endovasc Ther ; 13(6): 701-10, 2006 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-17154704

RESUMO

PURPOSE: To review clinical outcomes of patients with chronic limb ischemia and TASC type C lesions treated with sirolimus-eluting versus bare SMART nitinol self-expanding stents. METHODS: Data were obtained from a randomized, multicenter, double-blinded study conducted in 2 phases. All 93 patients had chronic limb ischemia and superficial femoral artery (SFA) occlusions or stenoses (average lesion length 8.3 cm). In total, 47 patients (31 men; mean age 66.3+/-9.1 years, range 50-84) received the sirolimus-eluting SMART stent and 46 patients (36 men; mean age 65.9 +/-10.8 years, range 38-83) received a bare SMART nitinol stent. Both groups were followed for a mean 24 months. RESULTS: Both the sirolimus-eluting and the bare SMART stents were effective in revascularizing the diseased SFA and in sustaining freedom from restenosis. For both types of stents, improvements in ankle-brachial indices (ABI) and symptoms of claudication were maintained over 24 months (median 24-month ABI 0.96 for the sirolimus group versus 0.87 for the bare stent group, p>0.05). At 24 months, the restenosis rate in the sirolimus group was 22.9% versus 21.1% in the bare stent group (p>0.05). The cumulative in-stent restenosis rates according to duplex ultrasound were 4.7%, 9.0%, 15.6%, and 21.9%, respectively, at 6, 9, 18, and 24 months; the rates did not differ significantly between the treatment groups. The TLR rate for the sirolimus group was 6% and for the bare stent group 13%; the TVR rates were somewhat higher: 13% and 22%, respectively. Mortality rates did not differ significantly between the groups. CONCLUSION: These data demonstrate that the sirolimus-eluting and the bare SMART stent are effective, safe, and free from restenosis in a majority of patients for up to 24 months. Because the restenosis rate in the bare stent group is unexpectedly low, no significant difference could be found between the sirolimus-eluting and the bare SMART stents.


Assuntos
Ligas , Angioplastia com Balão/métodos , Antibacterianos , Aterosclerose/terapia , Implante de Prótese Vascular/métodos , Artéria Femoral , Sirolimo , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Aterosclerose/complicações , Aterosclerose/diagnóstico , Implante de Prótese Vascular/efeitos adversos , Materiais Revestidos Biocompatíveis , Método Duplo-Cego , Portadores de Fármacos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Falha de Prótese , Recidiva , Segurança , Stents/efeitos adversos , Resultado do Tratamento
4.
J Endovasc Ther ; 13(5): 609-15, 2006 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-17042654

RESUMO

PURPOSE: To compare quantitative and qualitative parameters obtained from digital subtraction angiography (DSA) with multislice computed tomographic angiography (MSCTA) in the follow-up of superficial femoral artery (SFA) stents. METHODS: Thirteen patients who had SMART stents implanted in the SFA were examined systematically with DSA and MSCTA (16-row scanner) at 6 months. Quantitative analysis and morphological assessment were performed on DSA images by an independent core laboratory, while the MSCTA images were analyzed by 2 radiologists in consensus. DSA measurements included stent length, minimal lumen diameter and reference diameter at mid stent and 5 mm either side of the stent, and percentage of stenosis. For MSCTA images, lumen area and the minimum, maximum, and mean diameters were also recorded. The images were analyzed qualitatively for diameter stenosis (<50%, 50% to 70%, 71% to 99%, and occlusion), bends, fractures, and calcifications. RESULTS: There were no statistical differences between lengths of stented segments, diameter measurements, or percentages of stenosis from DSA and MSCTA images. The Bland-Altman method showed good agreement between the 2 methods of measurement. MSCTA detected in-stent proliferation with a diameter stenosis <50% in all 13 cases diagnosed on DSA (there was no stenosis >50%). There were no bends or stent fractures on either set of images. The agreement between DSA and MSCTA for the presence and grading of calcifications was moderate (kappa=0.5). CONCLUSION: MSCTA provided quantitative and qualitative data comparable with DSA in the analysis of SFA nitinol stents.


Assuntos
Ligas , Angiografia Digital , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/cirurgia , Stents , Tomografia Computadorizada por Raios X , Idoso , Idoso de 80 Anos ou mais , Aterosclerose/diagnóstico por imagem , Aterosclerose/cirurgia , Implante de Prótese Vascular , Calcinose/diagnóstico por imagem , Calcinose/cirurgia , Feminino , Artéria Femoral/patologia , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Interpretação de Imagem Radiográfica Assistida por Computador , Projetos de Pesquisa , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X/métodos , Resultado do Tratamento
5.
Radiology ; 239(3): 892-900, 2006 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-16641342

RESUMO

PURPOSE: To prospectively compare the safety and efficacy of combination therapy with the glycoprotein IIb/IIIa antagonist abciximab plus the third-generation thrombolytic agent reteplase versus those of therapy with the standard thrombolytic agent urokinase plus abciximab. MATERIALS AND METHODS: The study was approved by the local ethics committee, and patient informed consent was obtained. Patients with peripheral arterial occlusions less than 60 days old (n=120) were enrolled in the study: 50 patients (32 men, 18 women; mean age, 67 years; range, 23-88 years) received reteplase plus abciximab and 70 patients (36 men, 34 women; mean age, 68 years; range, 28-88 years) received urokinase plus abciximab. Study end points were the rate of major complications at 30 days, therapeutic success, and survival without open surgery or major amputation at follow-up. Fisher exact test was used to compare treatment groups with respect to dichotomous variables, and the event-free-survival probabilities were calculated with the Kaplan-Meier method. For the comparison of the lengths of occlusions among the groups, a two-sample t test was used. RESULTS: Therapeutic success (P=.7) did not differ between the groups, whereas the time required for thrombolysis was lower in the urokinase-plus-abciximab group (P=.001). Patients who received reteplase plus abciximab tended to develop more minor complications (mainly bleeding events) (P<.001). During long-term follow-up (2-4 years), no group differences were observed. The reocclusion rate was 48% (22 of 46) in the reteplase-plus-abciximab group and 45% (29 of 64) in the urokinase-plus-abciximab group. Only two of 120 major amputations were counted in the follow-up period. CONCLUSION: The proposed regimen resulted in only a limited number of major complications, and the low amputation rate in both groups may be attributed to abciximab.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Arteriopatias Oclusivas/tratamento farmacológico , Fragmentos Fab das Imunoglobulinas/uso terapêutico , Doenças Vasculares Periféricas/tratamento farmacológico , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Terapia Trombolítica , Ativador de Plasminogênio Tecidual/uso terapêutico , Abciximab , Adulto , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais/efeitos adversos , Combinação de Medicamentos , Feminino , Fibrinolíticos/administração & dosagem , Fibrinolíticos/efeitos adversos , Fibrinolíticos/uso terapêutico , Seguimentos , Hemorragia/induzido quimicamente , Humanos , Fragmentos Fab das Imunoglobulinas/administração & dosagem , Fragmentos Fab das Imunoglobulinas/efeitos adversos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/uso terapêutico , Recidiva , Segurança , Terapia Trombolítica/efeitos adversos , Fatores de Tempo , Ativador de Plasminogênio Tecidual/administração & dosagem , Ativador de Plasminogênio Tecidual/efeitos adversos , Resultado do Tratamento , Ativador de Plasminogênio Tipo Uroquinase/administração & dosagem , Ativador de Plasminogênio Tipo Uroquinase/efeitos adversos , Ativador de Plasminogênio Tipo Uroquinase/uso terapêutico
6.
Strahlenther Onkol ; 182(3): 164-71, 2006 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-16520911

RESUMO

BACKGROUND AND PURPOSE: Due to its properties rhenium-188 (188Re) seems to be a promising radionuclide for stent coating to reduce restenosis following percutaneous transluminal angioplasty (PTA). In order to characterize the early effects of local 188Re treatment, human aortic smooth muscle cells (HaSMCs) were incubated with different doses of 188Re. MATERIAL AND METHODS: 2 days after plating, HaSMCs were treated for a period of 5 days with 188Re. The total radiation doses applied were 1 Gy, 4 Gy, 8 Gy, 16 Gy, and 32 Gy. On days 1, 3, 5, and 7 (i.e., 2 days after the end of 188Re incubation), cell growth, clonogenic activity, cell migration, cell-cycle distribution, as well as matrix synthesis were evaluated. RESULTS: From the 1st day on, a dose-dependent growth inhibition was observed. Cumulative doses of > or = 8 Gy completely inhibited colony formation. The results of the migration tests were contradictory; on day 3 the migratory activity of all treated cells was increased compared to the controls, on day 5 it was reduced. Cumulative radiation doses of > or = 8 Gy resulted in an increased fraction of cells in G2/M-phase. The synthesis of the extracellular matrix protein tenascin was not affected by the treatment. CONCLUSION: Incubating human smooth muscle cells with 188Re for a period of 5 days (i.e., seven half-lives) results in an effective inhibition of muscle cell proliferation and colony formation. Partially, this is due to a radiation-induced G2/M-phase block. Cell migration and matrix synthesis were not effectively affected in the presented in vitro system.


Assuntos
Divisão Celular/efeitos da radiação , Movimento Celular/efeitos da radiação , Músculo Liso Vascular/efeitos da radiação , Radioisótopos/farmacologia , Rênio/farmacologia , Aorta , Linhagem Celular , Células Cultivadas , Relação Dose-Resposta à Radiação , Humanos , Músculo Liso Vascular/citologia , Músculo Liso Vascular/fisiologia
7.
Eur Radiol ; 16(6): 1316-22, 2006 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-16489440

RESUMO

Treatment of the superficial femoral artery (SFA) has been among the least effective of all endovascular procedures in terms of long-term patency. The relatively small vessel lumen, in conjunction with a high plaque burden, slow flow, and a high frequency of primary occlusions, contributes to a considerable rate of acute technical failures. Because of these technical limitations a much effort has been made during the past years. This manuscript should summarize the hopes and limitations of different approaches such as brachytherapy, cutting balloons, stents and stent grafts, drug-eluting stents, and drug-coated balloons.


Assuntos
Artéria Femoral/patologia , Doenças Vasculares Periféricas/terapia , Angioplastia com Balão , Sistemas de Liberação de Medicamentos , Desenho de Equipamento , Humanos , Recidiva , Stents , Grau de Desobstrução Vascular , Procedimentos Cirúrgicos Vasculares
8.
Biomaterials ; 27(4): 643-50, 2006 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-16095686

RESUMO

The material and the surface patterns of intravascular stents play a pivotal role in activating platelets and triggering adherence of inflammatory cells that consecutively leads to renarrowing caused by neointimal hyperplasia. To improve these features, besides mechanical and chemical modifications, ways of masking the stent by covering have been developed. In addition, polymer-coated stents are used as vehicle for local drug delivery. But as substances used for this application are described to possess an inflammatory potential, this aspect has to be evaluated. In the present study we compared different approaches to surface alterations applied to a nitinol stent design. Besides commonly used techniques like passivation and electropolishing, we evaluated coatings with heparin, aluminium and a polyurethane polymer regarding their thrombogenic and inflammatory characteristics. By weaving thin elastomer fibres a graft was generated. The previously described Chandler loop was used to simulate arterial flow conditions ex vivo using rotating PVC tubings filled with human blood. All stents received 120 min of blood contact. To determine thrombocyte activation and inflammatory reaction, the platelet count and levels of beta-TG, TAT and PMN-elastase were assessed. Scanning electron microscopy was used to visualize the reactions. Mechanical polishing and passivation did not improve the stent surface characteristics while sandblasting, electropolishing and aluminium covering decreased activation of the coagulation cascade. In terms of thrombogenicity, the heparin coating had no beneficial effect. The lowest thrombogenic potential was found in the Polyurethane-coated stent group. All stents showed similar levels of polymorph nuclear granulocyte elastase except for the membrane design. While mechanical and chemical modifications are able to reduce thrombogenicity, coating with this particular polyurethane polymer seems to be superior to these approaches regarding the parameters assessed in this experimental setting. The Chandler loop is a valuable tool to test polymeric coatings ex vivo since these modifications may reduce drug performance by inducing inflammatory reaction themselves.


Assuntos
Ligas/química , Prótese Vascular/efeitos adversos , Análise de Falha de Equipamento , Heparina/administração & dosagem , Ativação Plaquetária/efeitos dos fármacos , Trombose/prevenção & controle , Ligas/efeitos adversos , Anticoagulantes/administração & dosagem , Células Cultivadas , Materiais Revestidos Biocompatíveis/química , Materiais Revestidos Biocompatíveis/uso terapêutico , Heparina/química , Humanos , Teste de Materiais , Ativação Plaquetária/imunologia , Stents , Propriedades de Superfície , Trombose/etiologia , Trombose/imunologia
9.
J Magn Reson Imaging ; 23(1): 70-6, 2006 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-16315215

RESUMO

PURPOSE: To develop an incubation chamber that is compatible with MRI, while avoiding sources of error due to the experimental setup. MATERIALS AND METHODS: Two identical and gas-tight chambers were constructed of Plexiglas. The temperature and the CO(2) concentration were adjustable. Temperature variations within and between both chambers were measured. The pH values of the cell culture media were measured under different environmental settings. For each environment a colony formation test was carried out. The homogeneity of the magnetic field inside the chambers was estimated by phantom tests. RESULTS: The temperature variations within the chambers were <0.3 degrees C, and the variation between the chambers was on average <0.05 degrees C. After eight hours the pH values of the cell culture media were 7.47 and 7.48 in the reference and measurement chambers, respectively; 7.41 in the CO(2) incubator; and 8.73 in ambient air. In colony formation tests the survival fraction in the Plexiglas chamber was comparable to that in the CO(2) incubator. No distortions of the magnetic field from the incubation chamber were observed. CONCLUSION: The incubation system presented can provide the conditions of a CO(2) incubator without alteration of the magnetic flux density.


Assuntos
Técnicas de Cultura de Células/instrumentação , Imageamento por Ressonância Magnética , Dióxido de Carbono/análise , Ambiente Controlado , Desenho de Equipamento , Umidade , Concentração de Íons de Hidrogênio , Incubadoras , Imagens de Fantasmas , Polimetil Metacrilato , Estatísticas não Paramétricas , Temperatura
10.
Stroke ; 37(2): 492-4, 2006 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-16385094

RESUMO

BACKGROUND AND PURPOSE: To test the feasibility of self-expanding drug-coated nitinol stents for prevention of restenosis in an animal model. Stent implantation in the carotid artery (CA) has been shown to be feasible for treatment of CA stenosis. Even though the restenosis rate in CA is reported to be lower than in the coronary and peripheral arteries, problems may arise with increasing numbers of treated patients and lengthier follow-up. METHODS: After predilatation with 8-mm balloons, 8 Goettinger minipigs were randomly selected to receive a sirolimus-eluting self-expanding nitinol stent (7 mm/80 mm) as well as the same stent without sirolimus/polymer coating in the right or left CA. Aspirin was given starting 3 days before the intervention and administered for an additional 4 weeks. Clopidogrel was administered for 10 days. RESULTS: After 6 weeks, 2 subacute occlusions were observed in both groups. In the remaining vessels, the neointima was significantly reduced by sirolimus/polymer-coated stents (5.9+/-2.5 versus 0.7+/-1.0 mm2). CONCLUSIONS: Sirolimus self-expanding nitinol stents may be an effective tool in reducing neointimal formation in CA.


Assuntos
Ligas/farmacologia , Aterosclerose/terapia , Artérias Carótidas/patologia , Reestenose Coronária/prevenção & controle , Sirolimo/farmacologia , Angioplastia Coronária com Balão/métodos , Animais , Anti-Inflamatórios não Esteroides/farmacologia , Aspirina/farmacologia , Clopidogrel , Angiografia Coronária , Modelos Animais de Doenças , Masculino , Polímeros/química , Stents , Suínos , Ticlopidina/análogos & derivados , Ticlopidina/farmacologia , Fatores de Tempo , Ultrassom
11.
Invest Radiol ; 40(11): 725-8, 2005 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-16230905

RESUMO

RATIONALE AND OBJECTIVES: The objective of this study was to evaluate the safety and the effectiveness of the Outback catheter for intraluminal re-entry after subintimal dissection in the crossing of chronic arterial occlusions. METHODS: This study was a proof-of-concept feasibility. Ten patients with totally occluded arteries in the iliac artery to the distal femoral artery (mean occlusion length, 13.1 cm; range, 5-25 cm) were treated with the novel catheter. After successful re-entry, PTA or PTA plus stenting was performed. RESULTS: No perforations, dissections, lacerations, or device complications occurred. The procedural re-entry success rate with the Outback catheter was 50% (5/10 patients). CONCLUSIONS: Although the Outback catheter is safe, the percentage of intraluminal reaccess should be ameliorated through engineering improvements because there is some evidence to suggest that subintimal recanalization could produce improved long-term results.


Assuntos
Cateterismo/instrumentação , Claudicação Intermitente/terapia , Idoso , Idoso de 80 Anos ou mais , Cateterismo/métodos , Estudos de Viabilidade , Feminino , Artéria Femoral , Humanos , Artéria Ilíaca , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Túnica Íntima
12.
Cardiovasc Intervent Radiol ; 28(5): 632-7, 2005.
Artigo em Inglês | MEDLINE | ID: mdl-16059762

RESUMO

The aim of this study was to analyze the feasibility of (188)Re-labeled stents to reduce neointimal formation in a rabbit atherosclerosis model and to test the long-term effects at 7 and 26 weeks. Fifty-nine male New Zealand White rabbits were fed a 0.5% cholesterol diet for 4 weeks before balloon angioplasty and insertion of Palmaz stents in the infrarenal aorta. The animals were sacrificed 7 and 26 weeks after stent implantation. Control stents were compared with (188)Re stents: (dose 1) 11.3 +/- 1.8 MBq; (dose 2) 37.3 +/- 4.2 MBq, and (dose 3) 80.1 +/- 7.8 MBq. Each activity group consisted of a short-term (7 weeks) and a long-term group (26 weeks), resulting in a total of eight study groups. No thrombotic occlusion was observed. The neointimal formation in the control group was 2.11 [95% confidence interval (CI): 0.68--6.52] mm(2) at 7 weeks and 2.10 (0.62--7.11) at 26 weeks. In the treatment groups, neointima reduction was detectable at 7 weeks [dose 1: 0.33 (0.09--1.22) mm(2); dose 2: 0.17 (0.05--0.57) mm(2); dose 3: 0.03 (0.01--0.13) mm(2)]. After 26 weeks, a catch-up of neointimal formation in the radioactive groups was most obvious in the low-dose group [dose 1: 0.80 (0.28--2.29) mm(2); dose 2: 0.18([0.06--0.52) mm(2); dose 3: 0.50 (0.17--1.42) mm(2)]. Compared to the long-term control group, neointimal reduction was still >60%. No induction of neointimal formation was observed at the edges of the stents. Radiation resulted in delayed re-endothelialization. (188)Re stents were capable to reduce intimal hyperplasia and did not cause thrombosis. The edge effect, which was the major limitation of (32)P stents, was not observed in (188)Re stents.


Assuntos
Radioisótopos , Rênio , Stents , Túnica Íntima/patologia , Túnica Íntima/cirurgia , Animais , Aorta Abdominal/citologia , Aorta Abdominal/patologia , Aorta Abdominal/cirurgia , Implante de Prótese Vascular , Proliferação de Células/efeitos dos fármacos , Modelos Animais de Doenças , Relação Dose-Resposta a Droga , Células Endoteliais/patologia , Estudos de Viabilidade , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/prevenção & controle , Hiperplasia/cirurgia , Masculino , Coelhos , Compostos Radiofarmacêuticos , Fatores de Tempo , Túnica Íntima/citologia
13.
J Endovasc Ther ; 12(2): 240-6, 2005 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-15823072

RESUMO

PURPOSE: To evaluate the technical performance, safety, and 1-year clinical efficacy of polytetrafluoroethylene (PTFE)-covered nitinol stents in the treatment of atherosclerotic iliac and superficial femoral artery (SFA) disease. METHODS: The multicenter, prospective, nonrandomized COVENT study involved 98 patients (70 men; mean age 64+/-10 years) who received PTFE-covered nitinol stents in 107 arteries (60 iliac and 47 SFAs) after predilation. The average lesion length was 50 mm in the SFA and 45 mm in the iliac arteries. Postdilation was performed when necessary. Duplex ultrasound and ankle-brachial index (ABI) were performed at discharge and at 1, 6, and 12 months in follow-up. RESULTS: In total, 130 stents were placed successfully in 97 (99%) of 98 patients. One stent was misplaced during deployment and required subsequent surgical removal. The average stenosis grade was reduced from 98% to 6% in the SFAs and from 96% to 4% in the iliac arteries after covered stent placement. There was a significant rise of the mean ABI from 0.64 at baseline to 0.97 and 0.95 at 1 and 12 months, respectively (p<0.001). There were 7 primary covered stent occlusions (6.5% of 107 stented lesions: 3 not treated, 2 bypassed, 2 dilated or stented) and 5 (4.7%) recurrent in-stent occlusions (1 bypassed, 2 dilated, 2 untreated) during the 1-year follow-up. Primary patency rates were 92% at 6 months and 89.8% at 12 months for the entire cohort. Secondary patency rates were 98% and 95.6%, respectively. No statistically significant differences were observed in the primary patency rates for the SFAs (89.3% at both 6 and 12 months) versus the iliac arteries (94.3% at 6 months and 90.7% at 12 months). CONCLUSIONS: Primary implantation of PTFE-covered nitinol stents in the iliac and superficial femoral arteries is technically feasible, safe, and effective, with excellent 1-year patency.


Assuntos
Ligas , Arteriopatias Oclusivas/terapia , Artéria Femoral , Artéria Ilíaca , Politetrafluoretileno , Stents , Idoso , Angioplastia com Balão , Estudos de Viabilidade , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
15.
J Vasc Interv Radiol ; 16(3): 331-8, 2005 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-15758128

RESUMO

PURPOSE: To investigate further the safety and efficacy of the sirolimus-eluting S. M.A.R.T. Nitinol Self-expanding Stent by comparison with a bare stent in superficial femoral artery (SFA) obstructions. MATERIALS AND METHODS: This randomized, double-blind study involved 57 patients (29 in the sirolimus-eluting stent group and 28 in the bare stent group) with chronic limb ischemia and SFA occlusions (66.7%) or stenoses (average lesion length, 81.5 mm +/- 41.2). Stent implantation followed standard interventional techniques and a maximum of two stents could be implanted. The primary endpoint was the in-stent mean lumen diameter at 6 months as determined by quantitative angiography. RESULTS: Both stent types were effective in revascularizing the diseased SFA and allowing sustained patency for at least 6 months. There was no statistically significant difference between treatment groups in the in-stent mean lumen diameter at 6 months (4.94 mm +/- 0.69 and 4.76 mm +/- 0.54 mm for sirolimus-eluting and bare stent groups, respectively; P = .31). Although the diameter of the target lesion tended to be larger and percent stenosis tended to be lower with the sirolimus-eluting stent, there were no statistically significant differences between treatments in terms of any of the variables. The mean late loss values were 0.38 mm +/- 0.64 and 0.68 mm +/- 0.97 for the sirolimus-eluting stent group and the bare stent group, respectively (P = .20). The binary restenosis rates, with a cutoff of 50% at 6 months, were zero in the sirolimus-eluting stent group and 7.7% in the bare stent group (P = .49). Clinical outcomes matched angiographic outcomes with improvements in ankle-brachial index and symptoms of claudication. There was no significant difference between treatments in terms of adverse events. CONCLUSION: Although there is a trend for greater efficacy in the sirolimus-eluting stent group, there were no statistically significant differences in any of the variables.


Assuntos
Arteriopatias Oclusivas/tratamento farmacológico , Artéria Femoral , Oclusão de Enxerto Vascular/prevenção & controle , Imunossupressores/administração & dosagem , Sirolimo/administração & dosagem , Stents , Idoso , Ligas/química , Angiografia , Arteriopatias Oclusivas/diagnóstico por imagem , Método Duplo-Cego , Feminino , Humanos , Imunossupressores/farmacocinética , Perna (Membro)/irrigação sanguínea , Masculino , Recidiva , Sirolimo/farmacocinética , Estatísticas não Paramétricas , Resultado do Tratamento
16.
J Vasc Interv Radiol ; 15(12): 1457-62, 2004 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-15590805

RESUMO

PURPOSE: To compare steering of a novel magnetic guide wire with a standard 0.014-inch guide wire within a vascular phantom. MATERIALS AND METHODS: The magnetic guiding system (MGS) was composed of two permanent magnets on each long side of the fluoroscopy table generating a 0.1-T magnetic field, and a C-arm angiography system. The magnetic field was created according to vectors drawn onto two radiographic projections. Consequently, the tip of the intravascular guide wire containing a permanent magnet was deflected parallel to the magnetic field. Ninety-six catheterizations were performed in water-filled polyvinyl chloride tubes imitating the arterial tree of a female pelvis. This vascular phantom resembled a total of 12 uterine arteries with three different calibers (inner diameters: 1.1 mm, 1.7 mm, and 4.2 mm). Fluoroscopy and procedure times were measured to compare magnetic-assisted and conventional catheterization. RESULTS: Catheterization to every predefined target was successful for all attempts with both guiding techniques. The fluoroscopy time during magnetic navigation was significantly shorter in vessels of all three sizes compared with conventional navigation (means of 19.6 sec, 5.9 sec, and 4.8 sec vs. 48.8 sec, 49.8 sec, and 32.7 sec for small, medium, and large vessels, respectively; P < .05). Procedure times with use of the magnetic guide wire (149.6 sec, 52.1 sec, and 39.9 sec) were not significantly different than those with conventional navigation (60.4 sec, 68.6 sec, and 47.7 sec). CONCLUSIONS: The MGS enables exact endovascular navigation with shorter fluoroscopy time in an in vitro model. The MGS may offer opportunities to reduce x-ray exposure to patients and staff.


Assuntos
Cateterismo/métodos , Embolização Terapêutica/métodos , Magnetismo/instrumentação , Útero/irrigação sanguínea , Desenho de Equipamento , Feminino , Fluoroscopia , Humanos , Técnicas In Vitro , Imagens de Fantasmas , Estatísticas não Paramétricas , Interface Usuário-Computador
17.
Invest Radiol ; 39(9): 565-71, 2004 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-15308939

RESUMO

PURPOSE: We sought to evaluate the growth-modulating potential of paclitaxel on cultured human arterial smooth muscle cells depending on the administered dose. MATERIAL AND METHODS: For all experiments human arterial smooth muscle cells (SMCs) were used. SMCs were either cultured for 5 days or for 20 days with paclitaxel (doses: 10(-7) M, 10(-8) M, 10(-9) M). For a total period of 20 days, proliferation kinetics of the SMC were analyzed. To assess the clonogenic activity of the SMC colony-forming assays were performed. Drug- and dose-dependent cell cycle changes were analyzed by flow cytometry. The effect on cell migration was examined in a 2-chamber migration system. The effects of paclitaxel on the synthesis of tenascin were examined via immunofluorescence. RESULTS: Depending on the dose administered, paclitaxel proved to inhibit SMC proliferation effectively when administered during the total period of 20 days. When incubated for 5 days with doses of paclitaxel ranging between 10(-8) M and 10(-9) M, SMCs showed clear signs of regeneration. When being incubated with 10(-7) M of paclitaxel, however, SMCs reacted with a reduction in cell proliferation, a reduced clonogenic activity, and a drug-induced G2/M phase block. SMC migration was inhibited effectively as well as extracellular matrix formation. CONCLUSION: Paclitaxel is a potent inhibitor of SMC proliferation, SMC migration, and extracellular matrix formation in vitro, with all three phases of the restenosis process inhibited effectively.


Assuntos
Divisão Celular/efeitos dos fármacos , Movimento Celular/efeitos dos fármacos , Músculo Liso Vascular/citologia , Paclitaxel/farmacologia , Tenascina/biossíntese , Angioplastia com Balão , Artérias/patologia , Ciclo Celular/efeitos dos fármacos , Células Cultivadas , Ensaio de Unidades Formadoras de Colônias , Constrição Patológica , Relação Dose-Resposta a Droga , Humanos , Músculo Liso Vascular/efeitos dos fármacos , Músculo Liso Vascular/metabolismo , Recidiva
18.
J Vasc Interv Radiol ; 15(8): 843-52, 2004 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-15297588

RESUMO

PURPOSE: To evaluate the radiopacity of endovascular stents based on the fluoroscopy mode in a phantom of the human pelvis. MATERIALS AND METHODS: The following stents were included in this study: Medtronic AVE Bridge, Medtronic AVE Bridge X, Cordis Covered Nitinol (Covent), Guidant Dynalink, Luminexx, Guidant Megalink, Memotherm Flexx, Palmaz Medium, Palmaz-Schatz Long-Medium, Palmaz Corinthian PQ394Q and PQ294Q, SelfX, SMART without markers, SMART with radiopaque markers, Easy Wallstent. To evaluate radiopacity, images of the stents placed in four different positions (lumbosacral junction left and right, iliosacral joint left and right) of a pelvic phantom were taken at the following modes: spotfilm, continuous fluoroscopy, 15 pulses per second, 7.5 pulses per second, and 3 pulses per second. Images were presented at random to four independent readers and radiopacity scores were assessed: 0 = not visible, 1 = poor visibility, 2 = average visibility, 3 = good visibility, and 4 = very good visibility. RESULTS: The Covent stent had the highest overall radiopacity score (3.25), followed by the Luminexx (3.04) and the Medtronic AVE Bridge X (2.74) stents. At the spotfilm mode, the best visible stents were the Medtronic AVE Bridge X, the Covent and the Easy Wallstent stents and at the continuous fluoroscopy mode, the Covent, the Luminexx, and the Medtronic AVE Bridge X stents. Decreasing the fluoroscopy mode went hand in hand with a reduction of the radiopacity scores of all stents. At the standard fluoroscopy mode of 7.5 pulses per second, the Covent stent was seen well or very well in 96.9%, followed by the Luminexx (76.9%), and the Medtronic AVE Bridge X (41.25%) stents. CONCLUSIONS: Stent radiopacity directly depends on the fluoroscopy mode; if the pulse frequency decreased, detecting the stents became more difficult. Stent mass correlates with stent radiopacity (e.g., Cordis Covered Nitinol, Bridge X). Radiopaque markers may improve stent radiopacity dramatically (e.g., Luminexx vs Memotherm Flexx).


Assuntos
Imagens de Fantasmas , Stents , Implante de Prótese Vascular/estatística & dados numéricos , Desenho de Equipamento , Análise de Falha de Equipamento/estatística & dados numéricos , Fluoroscopia , Humanos , Variações Dependentes do Observador , Pelve/diagnóstico por imagem , Pelve/cirurgia , Stents/estatística & dados numéricos
19.
J Vasc Interv Radiol ; 15(7): 727-35, 2004 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-15231887

RESUMO

PURPOSE: This study compared the expansion parameters of four different new-generation balloon-expandable stents in a curved stenotic phantom model. MATERIALS AND METHODS: Five stents for each length and type, each with a 3.5-mm diameter (AVE, 12 mm and 18 mm; Penta, 13 mm and 18 mm; BX-Sonic, 13 mm and 18 mm; and Jostent Flex Master, 12 mm and 16 mm), were implanted in curved silicon models 3.25 mm in diameter with 58% concentric elastic stenoses. The forces exerted on the inner curvature were continuously registered. Minimal luminal diameter (MLD) and reference luminal diameter (RLD) of the stents, inflated balloon diameter at both ends of the stents during inflation (BD(ref)), and balloon diameter at the stenotic site during inflation (BD(min)) were determined by magnification radiography. RESULTS: The Penta and AVE stents presented greater RLD (Penta, 3.78 mm +/- 0.08; AVE, 3.75 mm +/- 0.13; BX-Sonic, 3.47 mm +/- 0.06; Jostent, 3.28 mm +/- 0.06) and MLD values (Penta, 2.94 mm +/- 0.18; AVE, 3.05 mm +/- 0.19; BX-Sonic, 2.68 mm +/- 0.06; Jostent, 2.53 mm +/- 0.09) than the BX-Sonic and Jostent stents. Displacement forces after stent placement were greater for AVE (0.034 N +/- 0.015) and Penta stents (0.023 N +/- 0.017) than for BX-Sonic (0.013 N +/- 0.007) and Jostent stents (0.009 N +/- 0.007; P <.05). BD(min) was correlated in a linear fashion with MLD (r = 0.84; P <.001), as was BD(ref) with RLD (r = 0.92; P <.001), for all stents. CONCLUSIONS: Inflated balloon diameter was the main determinant of stent expansion. The AVE and Penta stents gained larger MLD values than the BX-Sonic and Jostent stents, but they excessively dilated the nonstenotic region of the model.


Assuntos
Arteriopatias Oclusivas/terapia , Cateterismo , Stents , Análise de Variância , Fenômenos Biomecânicos , Técnicas In Vitro , Modelos Lineares , Modelos Anatômicos , Silicones , Estatísticas não Paramétricas
20.
Eur J Radiol ; 51(1): 19-26, 2004 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-15186880

RESUMO

OBJECTIVE: A software program was developed simulating a compartmental model of blood circulation based on differential equations. The aim of this study was to compare software-simulated levels of hepatic enhancement with the true values in patients and to test how many patients reach the simulated hepatic enhancement level. METHODS: As software program the CT application software carebolus 2 (Siemens, Forchheim, Germany) was used. Hepatic contrast-enhancement curves were simulated prior to CT examinations to evaluate a patient specific time delay after contrast application. At the time delay, when the simulation curve showed an enhancement threshold of 40 Hounsfield Units (HU), the CT spiral scan was started applying 120 ml contrast media with 2 ml/s. The simulated curves were compared with the empiric curves of each patient. RESULTS: 25 of 28 patients (89%) achieved 40 HU. The mean enhancement of empiric patients curves was 46.32 +/- 11.9 HU, the mean simulated enhancement was 46.62 +/- 4.3 HU S.D. (P= 0.48). 4.4 values per patient liver could be compared with the simulation curve (122 points for 28 patients): 50% of the patient curves were within a range of 5 HU compared with the simulation curve. CONCLUSION: Software simulation of contrast enhancement curves of the liver is a feasible and valuable method to predict individual liver enhancement curves. Improvements concerning the integration of cardiovascular parameters and preexisting liver parenchymal diseases into the simulation software have to be arranged.


Assuntos
Simulação por Computador , Meios de Contraste/administração & dosagem , Iohexol/análogos & derivados , Iohexol/administração & dosagem , Circulação Hepática , Software , Tomografia Computadorizada Espiral , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes
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