RESUMO
AIMS: Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs. low-dose (Ranger™) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 µg/mm2. METHODS AND RESULTS: Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2-4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of -10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) -5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference -1.6% (lower bound of the 90% two-sided CI -6.5%); Pnon-inferiority < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred. CONCLUSION: Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths. CLINICAL TRIAL REGISTRATION: The trial is registered with ClinicalTrials.gov (NCT02701543).
Assuntos
Angioplastia com Balão , Fármacos Cardiovasculares , Doença Arterial Periférica , Preparações Farmacêuticas , Materiais Revestidos Biocompatíveis , Artéria Femoral , Humanos , Paclitaxel , Doença Arterial Periférica/terapia , Artéria Poplítea , Estudos Prospectivos , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
BACKGROUND: Allergic upper airway disease involves pro-inflammatory type-2 cytokines such as IL-5 and regulatory tissue repair mediators, in particular transforming growth factor (TGF)-ß1. The TGF-ß-superfamily member activin-A displays multiple biological functions and shares certain signalling pathways with TGF-ß1. We aimed to examine the coregulation of mucosal activin-A and TGF-ß1 in acute allergic and chronic Th2-driven upper airway disease. METHODS: We investigated mucosal cytokine expression profiles and kinetics using RT-PCR after nasal allergen challenges in patients with seasonal allergic rhinitis. Furthermore, we analysed mucosal specimens from patients with chronic upper airway disease with nasal polyps using ELISPOTs and confocal microscopy. In addition, we stimulated nasal mucosa ex vivo from patients with nasal polyps as well as primary nasal cell cultures from healthy donors. RESULTS: Mucosal activin-A expression revealed increasing correlation with IL-5 and TGF-ß1 at 0.25, 6, and 24 h, respectively, and was significantly upregulated at 6 h after allergen challenge. The correlated expression was found to be more pronounced in chronic disease with nasal polyps, showing substantially (48-fold) increased activin-A-producing cells in nasal polyps by ELISPOT, while submucosal downstream signalling as determined by confocal microscopy was decreased. Ex vivo stimulations of nasal tissue suggested that activin-A and TGF-ß1 mutually regulate each other's expression at the mRNA level and, when combined, enhance IL-5 expression. CONCLUSION: Activin-A in allergic upper airway disease acts as a pro-inflammatory mediator and TGF-ß1 modifier. Our data in the upper airways oppose the view of potentially anti-inflammatory properties in contrast to lymphatic compartments.
Assuntos
Ativinas/imunologia , Alérgenos/imunologia , Rinite Alérgica/imunologia , Fator de Crescimento Transformador beta1/imunologia , Doença Aguda , Adulto , Biomarcadores , Estudos de Casos e Controles , Células Cultivadas , Doença Crônica , ELISPOT , Feminino , Humanos , Interleucina-5/imunologia , Masculino , Microscopia Confocal , Pessoa de Meia-Idade , Mucosa Nasal , Pólipos Nasais/imunologia , Testes de Provocação Nasal , Reação em Cadeia da Polimerase Via Transcriptase ReversaRESUMO
BACKGROUND: To report our preliminary experience with endovascular revascularization of patients with acute mesenteric ischemia (AMI), using thrombectomy devices. METHODS: It is a retrospective analysis of patients admitted to our hospital due to AMI and who were subjected to concomitant or exclusive endovascular treatment, from January 2011 to January 2016. Patients were admitted at the emergency department, underwent imaging investigation, and were referred to the endovascular specialist. Endovascular treatment was performed through left brachial artery access and selective catheterization and thrombectomy with a 6F Rotarex Debulking Device (Straub Medical, Wangs, Switzerland). Laparotomy was performed based on clinical and radiologic sings and at the discretion of the surgeon. Demographic, clinical/periprocedural, postoperative, complication, and adjunct intervention data were reviewed. Technical success was defined as recanalization of the Riolan's arcade on angiographic control. RESULTS: Twenty patients (mean age: 69.8 ± 11.3 years) underwent endovascular revascularization for AMI using thrombectomy devices, during the period of the study. Abdominal pain was the most common complain on admission (65%), with ileus (35%), sepsis (25%), and myocardial infarction as the main clinical referral presentation at admission. Fifteen patients (75%) had suggestive computer tomography (CT) signs of AMI on admission. Endovascular revascularization was successfully performed in all patients through the left brachial artery with a mean procedural time of 28 ± 17 min. Superior mesenteric artery (SMA) was the main vessel involved in 75% on a solely basis. The majority of the SMA occlusions were in the periosteal (30%) and proximal to middle colic artery offspring (35%). Primary use of thrombectomy devices was performed in all patients, associated with balloon angioplasty (7/20; 50%), stent deployment (5/20; 25%), intraoperative selective thrombolysis (4/20; 20%) and catheter-assisted aspiration in 10% (2/20) of patients. Average time between admission and computed tomography angiography was 1.5 ± 0.5 hr, between admission and angiographic procedure was 2.5 ± 1 hr, and between admission and surgery was 9 ± 5 hr. Following recanalization, 14 patients (70%) underwent open surgery. Laparotomy with intestinal resection (enterectomy, colectomy) and transit deviation was the most common procedure. Complications directly related to the endovascular procedure occurred in 2 patients, represented by self-limited small perforations. Overall 30-day mortality was 40% (n = 8). During the period of this study, no patient died as a result of complications related to the use of rotational thrombectomy. CONCLUSIONS: Endovascular treatment of the AMI with the use of thrombectomy devices proved to be technically feasible and reasonably fast procedure. Early diagnosis and adequate treatment remains the cornerstone of the treatment. Early surgical evaluation and close integration between surgical and endovascular specialists are crucial to faster treatment and consequently lower extensive surgical resections and mortality. Further studies are necessary on this field to confirm these findings.
Assuntos
Procedimentos Endovasculares/instrumentação , Artéria Mesentérica Superior/cirurgia , Isquemia Mesentérica/cirurgia , Oclusão Vascular Mesentérica/cirurgia , Trombectomia/instrumentação , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/instrumentação , Angiografia por Tomografia Computadorizada , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Alemanha , Humanos , Masculino , Artéria Mesentérica Superior/diagnóstico por imagem , Artéria Mesentérica Superior/fisiopatologia , Isquemia Mesentérica/diagnóstico por imagem , Isquemia Mesentérica/mortalidade , Isquemia Mesentérica/fisiopatologia , Oclusão Vascular Mesentérica/diagnóstico por imagem , Oclusão Vascular Mesentérica/mortalidade , Oclusão Vascular Mesentérica/fisiopatologia , Pessoa de Meia-Idade , Duração da Cirurgia , Dados Preliminares , Estudos Retrospectivos , Fatores de Risco , Stents , Trombectomia/efeitos adversos , Trombectomia/mortalidade , Terapia Trombolítica , Fatores de Tempo , Resultado do TratamentoRESUMO
INTRODUCTION: Data regarding the effectiveness and safety of percutaneous mechanical thrombectomy (PMT) in contemporary routine care are scarce. MATERIALS AND METHODS: Consecutive patients undergoing PMT of native lower limb acutely/subacutely occluded arteries were included. RESULTS: In all, 525 consecutive patients were available for analysis with a mean age of 66.7 ± 10.7 years. Almost two-third (n = 324; 61.7%) were men with acutely (n = 211; 40.2%) or subacutely (n = 314; 59.8%) occluded lesions presenting mostly in Rutherford-Becker category (RBC): 3 (30.3%) and 4 (47.6%). Mean lesion length was 159 mm (range 22-279 mm), with moderate and severe calcification in 119 (23.3%) lesions. PMT was performed solely in 161(27.2%), PMT + balloon angioplasty in 232 (39.1%), provisional stenting in 169 (28.4%), and thrombolysis in 77 (13.9%) interventions. Procedural technical success rate was 97.7%, with improvement in RBC persisting in 74.1% of patients after 12 ± 2.4 months mean time follow-up. Overall 30 days major adverse events (MAEs) was 6.9% with a mortality rate of 1.1%. No death was directly related to the device. After 12 months, a promising overall target lesion revascularization (TLR; 10.1%), non-TLR (6.6%), and major amputation rates (2.3%) were found. One-year mortality was 8%. CONCLUSION: Treatment with PMT resulted in clinic and hemodynamic improvement in the majority of patients, thereby reducing the need for thrombolysis in a significant proportion of patients. Prospective studies in this issue are recommended.
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Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/cirurgia , Trombectomia/métodos , Doença Aguda , Idoso , Amputação Cirúrgica , Progressão da Doença , Feminino , Humanos , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Recuperação de Função Fisiológica , Estudos Retrospectivos , Fatores de Risco , Trombectomia/efeitos adversos , Trombectomia/mortalidade , Terapia Trombolítica , Fatores de Tempo , Resultado do TratamentoRESUMO
PURPOSE: To examine patient outcomes following the use of the Lutonix drug-coated balloon (DCB) in patients undergoing endovascular intervention in below-the-knee (BTK) arteries. METHODS: A retrospective chart review identified 248 patients who were treated for symptomatic peripheral artery disease with the Lutonix DCB between May 2013 and October 2014. Forty patients were lost to follow-up, leaving 208 patients (mean age 74.1±9.7 years; 138 men) with evaluable data for outcome analysis. The patient cohort suffered from either severe claudication (38.6%) or critical limb ischemia (CLI; 61.4%) in 220 limbs. Almost two-thirds (140, 63.6%) of the 220 target lesions were total occlusions, and 37 (17.8%) of all patients had occlusion of all 3 BTK vessels before intervention. RESULTS: Over a median 9-month follow-up, target lesion revascularization occurred in 15.9% of patients with an average time to first reintervention of 8 months. In total, 39 amputations were performed in 31 limbs. However, 17 of these amputations were preplanned minor amputations below the ankle; only 9 (4.1%) major amputations occurred corresponding to 6.6% of the CLI cohort. Freedom from the composite of death or major amputation was estimated as 92% and 85% at 6 and 12 months, respectively, by Kaplan-Meier analysis. In the full cohort, improvement of at least 1 Rutherford category was seen in 130 (59.1%) limbs after 1 year or at the last follow-up, with 104 (80.0%) of those limbs showing an improvement of ≥2 categories. CONCLUSION: From this single-center experience, the Lutonix DCB shows therapeutic promise in a disease state where new treatment options are needed.
Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Claudicação Intermitente/terapia , Isquemia/terapia , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Dispositivos de Acesso Vascular , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Constrição Patológica , Feminino , Alemanha , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/mortalidade , Claudicação Intermitente/fisiopatologia , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Estimativa de Kaplan-Meier , Salvamento de Membro , Masculino , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Recidiva , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
PURPOSE: To evaluate the safety and efficacy of the Igaki-Tamai biodegradable scaffold after drug-eluting balloon (DEB) angioplasty in patients with occlusive superficial femoral artery (SFA) disease. METHODS: A prospective, single-center, nonrandomized study enrolled 20 patients (mean age 66.7±11.6 years; 14 men) with symptomatic de novo SFA lesions undergoing angioplasty with the In.Pact Admiral paclitaxel-coated balloon and subsequent implantation of the Igaki-Tamai bioresorbable scaffold. All patients were claudicants. The average diameter stenosis was 89.7%, and the mean length was 43.6 mm. Clinical examinations with duplex sonography were performed after 1, 6, 9, and 12 months. The main study outcomes were technical success, restenosis, target lesion revascularization (TLR), ankle-brachial index (ABI) improvement, and changes in quality of life evaluated with the walking impairment questionnaire. Safety was assessed by monitoring the occurrence of adverse events. RESULTS: Angioplasty with a paclitaxel-coated balloon was performed in all patients, resulting in an average diameter stenosis of 24%. Subsequent implantation of the Igaki-Tamai scaffold reduced the average diameter stenosis to 3.5%. In the first 6 months, 2 cases of restenosis were reported, with no TLRs within that period. However, by the 12-month follow-up in 19 patients, 11 patients had lost in-stent patency. Among these patients, 8 had TLRs, which were the only adverse events recorded that were referable to the procedure. Quality-of-life assessments showed improvement in the majority of patients. CONCLUSION: The GAIA-DEB study shows that DEB treatment of the femoral artery prior to the implantation of the biodegradable Igaki-Tamai scaffold is safe. However, the antiproliferative actions of paclitaxel in the vessel wall were not effective in preventing restenosis. In-stent restenosis occurred predominantly after 6 months.
Assuntos
Implantes Absorvíveis , Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Artéria Femoral , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Dispositivos de Acesso Vascular , Idoso , Angioplastia com Balão/efeitos adversos , Índice Tornozelo-Braço , Constrição Patológica , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Projetos Piloto , Estudos Prospectivos , Recidiva , Retratamento , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Dupla , Grau de Desobstrução VascularRESUMO
AIMS: To examine the efficacy and durability of an interwoven self-expanding nitinol stent in the treatment of complex femoropopliteal artery lesions in unselected patients. METHODS AND RESULTS: Five hundred and twenty-seven limbs in 470 patients with femoropopliteal arterial disease were treated with SUPERA stents. Follow-up data were prospectively collected in a single-centre registry and were available for 439 patients (492 limbs). The patients were followed by Doppler ultrasound, stent roentgenograms, estimation of Rutherford-Becker class (RBC) and ankle-brachial index (ABI). Total occlusions were present in 277 limbs (52.6%) and 52.4% had either moderate or severe calcification. The mean lesion length was 126.4 mm. The primary patency (PP) rates were 83.3% after 12 months and 72.8% at two years. The secondary patency rates were 98.1% after 12 months and 92.0% at two years. Patency rates did not differ between superficial femoral artery (SFA) and popliteal lesions. Between baseline and a mean of 21 months of follow-up, mean ABI increased from 0.53 to 0.91, and mean RBC decreased from 3.0 to 1.9 (p<0.001 for both comparisons). Radiographs performed on 229 patients at a mean of 16.6 months confirmed the absence of stent fractures in all patients. CONCLUSIONS: Over a two-year surveillance period, the patency rate and fracture resistance of SUPERA stents implanted for complex femoropopliteal artery disease were high.
Assuntos
Aterosclerose/terapia , Artéria Femoral , Doença Arterial Periférica/terapia , Artéria Poplítea , Stents , Idoso , Índice Tornozelo-Braço , Feminino , Artéria Femoral/diagnóstico por imagem , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Artéria Poplítea/diagnóstico por imagem , Radiografia , Sistema de RegistrosRESUMO
BACKGROUND: Docetaxel plus prednisone is a standard treatment for castration-resistant prostate cancer. Cyclophosphamide may be an effective combination partner. METHODS: This randomised, multicentre, phase II trial compared the combination therapy of docetaxel plus prednisone plus cyclophosphamide with the standard therapy of docetaxel plus prednisone. RESULTS: Thirty-three patients received six 3-week treatment cycles (in total 171 cycles). During treatment, an adequate decline in prostate-specific antigen was seen in both groups (p = 0.068) without between-group differences (p = 0.683). No relevant differences between within-group changes were observed for blood pressure, weight, pain score, laboratory variables or quality of life. There were no serious side effects apart from leucopenia requiring treatment (docetaxel + prednisone + cyclophosphamide arm) and no drug-related withdrawals; all three fatalities were considered to be cancer related. CONCLUSIONS: The oncological effectiveness and tolerability of docetaxel plus prednisone were supported; an additional effect of cyclophosphamide was not detected. However, the small number of patients and short observation period restrict the generalisability of the results.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Neoplasias de Próstata Resistentes à Castração/diagnóstico , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Ciclofosfamida/administração & dosagem , Docetaxel , Humanos , Masculino , Pessoa de Meia-Idade , Prednisona/administração & dosagem , Taxoides/administração & dosagem , Resultado do TratamentoRESUMO
PURPOSE: To determine the time course of enhancement patterns in the aorta and endoleaks at dynamic computed tomographic (CT) angiography as well as their effect on the endoleak detection rate in patients who have undergone abdominal aortic endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: This retrospective study was approved by the local ethics committee and compliant with the Declaration of Helsinki. All patients gave written informed consent for the scientific analysis of their data. Seventy-one patients (mean age, 72 years ± 8 [standard deviation]) were retrospectively included after EVAR of the abdominal aorta. All patients underwent dynamic CT angiography with 10 unidirectional scan phases, followed by a venous phase. Endoleaks were detected visually in all scan phases; the magnitude of enhancement was assessed by using region-of-interest measurements in the aorta and the detectable endoleaks. Statistical analysis was performed with the χ(2) test, the paired t test, and analysis of variance with repeated measurements. RESULTS: The highest mean aortic enhancement was achieved 12 seconds after the bolus-tracking threshold, and the highest mean endoleak enhancement was achieved 22 seconds after the bolus-tracking threshold. In total, 44 endoleaks were detected. The detection rates differed significantly in between the dynamic CT angiography phases (minimum, seven endoleaks at 2 seconds after the bolus-tracking threshold; maximum, 44 endoleaks at 27 seconds after the bolus-tracking threshold; P = .001). The highest detection rate was achieved when the contrast between aortic and endoleak enhancement reached its maximum. CONCLUSION: Dynamic CT angiography revealed that the peak enhancement of endoleaks is significantly different than that of the aorta and that endoleaks may not be adequately evaluated with conventional biphasic CT protocols. The use of dynamic CT angiography is associated with a significantly increased detection rate of endoleaks compared with the detection rates at the time points of conventional biphasic CT.
Assuntos
Angiografia/métodos , Aneurisma da Aorta Abdominal/complicações , Aneurisma da Aorta Abdominal/cirurgia , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Iopamidol/análogos & derivados , Tomografia Computadorizada por Raios X/métodos , Idoso , Idoso de 80 Anos ou mais , Meios de Contraste/administração & dosagem , Feminino , Humanos , Iopamidol/administração & dosagem , Masculino , Pessoa de Meia-Idade , Intensificação de Imagem Radiográfica/métodos , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e Especificidade , Resultado do TratamentoRESUMO
OBJECTIVES: To report on the efficacy of drug eluting stents (DES) in below the knee lesions involving arterial bifurcations after failed angioplasty. BACKGROUND: DES have become a mainstay in the treatment of below the knee lesions. However, little is known about the efficacy of DES in infrapopliteal lesions involving the arterial bifurcations. This is the first report on the endovascular treatment of below-the knee bifurcations. METHODS: 11 patients with critical lower limb ischemia and complex infrapopliteal atherosclerotic disease underwent provisional DES placement in infrapopliteal bifurcation lesions. Clinical and angiographic follow-up data were prospectively collected in all patients. RESULTS: Technical success was achieved in all cases. After 6 months, the two vessel primary patency (2VPP) rate was 54.5% and the 1VPP rate was 81.8%. Between baseline and the follow-up, mean ankle-brachial index increased from 0.31 ± 0.10 to 0.68 ± 0.16, and mean Rutherford-Becker class decreased from 4.73 ± 0.20 to 3.00 ± 1.41 (P < 0.001 for both comparisons). CONCLUSIONS: Bifurcation stenting techniques, that are described for the coronary arteries can be also performed in the infrapopliteal arteries. However, early reocclusion was frequent in this case series, when stenting was performed in a bail-out setting. If balloon angioplasty alone leads to no sufficient results in bifurcation lesions, a single stent strategy could also be considered.
Assuntos
Angioplastia com Balão/instrumentação , Stents Farmacológicos , Isquemia/terapia , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Angioplastia com Balão/efeitos adversos , Índice Tornozelo-Braço , Estado Terminal , Feminino , Humanos , Isquemia/diagnóstico , Isquemia/fisiopatologia , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Desenho de Prótese , Radiografia , Retratamento , Terapia de Salvação , Fatores de Tempo , Falha de Tratamento , Grau de Desobstrução VascularRESUMO
OBJECTIVES: We examined the efficacy and durability of a new interwoven self-expanding nitinol stent system in the treatment of complex popliteal artery lesions in unselected patients. BACKGROUND: The optimal endovascular treatment strategy for atherosclerotic popliteal artery disease is not known. METHODS: We retrospectively analyzed the data gathered in 101 consecutive patients presenting with atherosclerotic, popliteal arterial disease, who underwent implantation of 125 stents. The patients were followed for 12 months by Doppler ultrasound examinations, stent roentgenograms, and estimation of Rutherford-Becker class (RBC) and ankle-brachial index (ABI). RESULTS: The mean age of the patients was 73.1 years, and 52.5% were men. Total occlusions were present in 48 patients (47.5%). The mean stent length was 84.3 ± 45.1 mm (range 40 to 240 mm). A <30% residual stenosis was achieved in 98.0% of procedures. The 6- and 12-month primary patency rates were 94.6 ± 2.3% and 87.7 ± 3.7%, respectively, and the secondary patency rates 97.9 ± 1.5% and 96.5 ± 2.0%, respectively. Between baseline and 12 months of follow-up, mean ABI increased from 0.58 ± 0.15 to 0.97 ± 0.18, and mean RBC decreased from 3.1 ± 0.9 to 1.4 ± 0.8 (p < 0.001 for both comparisons). Radiographs performed on 51 patients, at a mean of 15.2 months, confirmed the absence of stent fractures in 100% of examinations. CONCLUSIONS: Over a 12-month observation period, the patency rate and durability of SUPERA stents implanted for severe popliteal artery disease were high.
Assuntos
Ligas , Angioplastia/instrumentação , Doença Arterial Periférica/terapia , Artéria Poplítea , Stents , Idoso , Idoso de 80 Anos ou mais , Angioplastia/efeitos adversos , Angioplastia/mortalidade , Índice Tornozelo-Braço , Constrição Patológica , Feminino , Alemanha , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Valor Preditivo dos Testes , Desenho de Prótese , Radiografia , Sistema de Registros , Estudos Retrospectivos , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler , Grau de Desobstrução VascularRESUMO
AIMS: Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy in the treatment of carotid artery disease. The use of an embolic protection device (EPD) can reduce the frequency of embolic events during CAS. Difficult vascular anatomy may complicate current generation EPD placement. This problem is addressed by a new EPD, the GARDEX System. The aim of this study was to assess the safety and performance of the GARDEX EPD during CAS. METHODS AND RESULTS: Thirty-eight patients underwent CAS with the GARDEX EPD in two medical centres. All patients were prospectively followed up for 30 days. Device performance and procedural details were collected and analysed prospectively. Vessel anatomy and lesion morphology were evaluated and stratified into a scoring system for anatomic difficulty. More than a third of the patients were considered to have difficult vascular anatomy for CAS. All enrolled patients were successfully treated. There was one (2.6%) minor periprocedural stroke and there were two (5.3%) periprocedural TIAs which resolved within 24 hours. No additional complications were noted during the 30-day follow-up period. CONCLUSIONS: In this first experience, CAS under cerebral protection with the GARDEX EPD was safe and feasible. Our data suggest that the use of the GARDEX EPD is simple and shows high success rates even in challenging anatomies. The role of this new device in CAS needs to be further confirmed in a larger patient population.
Assuntos
Angioplastia/instrumentação , Estenose das Carótidas/terapia , Dispositivos de Proteção Embólica , Embolia/prevenção & controle , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Angiografia , Angioplastia/métodos , Cateteres Cardíacos , Embolia/complicações , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do TratamentoRESUMO
PURPOSE: To evaluate the efficacy and safety of endovascular brachytherapy with liquid beta-emitting rhenium-188 (Re-188) in patients with long-segment in-stent stenosis in the femoropopliteal segment. METHODS: From July 2009 to April 2011, 90 consecutive patients (59 men; mean age 68.3±10.3 years, range 43-86) with symptomatic in-stent stenosis/occlusion (24.6-cm mean lesion length) of the femoropopliteal segment underwent angioplasty and subsequent endovascular brachytherapy. The liquid beta-emitting Re-188 was applied to the target lesion within an angioplasty balloon using a dose of 13 Gy at a depth of 2 mm into the vessel wall. Clinical and angiographic follow-up data were collected up to 2 years. The main study endpoints were the 6- and 12-month primary patency rates defined as <50% in-stent stenosis as detected by duplex ultrasound. Clinical endpoints were the cumulative rates of death, amputation, and bypass surgery, as well as improvement in the Rutherford category and the ankle-brachial index. Results were correlated with patient and lesion characteristics. RESULTS: Primary technical success was achieved in all patients, with 1 early stent thrombosis, but no other complications related to the irradiation. Eighty-eight patients reached the 6-month and 82 the 12-month examinations; the primary patency was 95.2% and 79.8%, respectively. In-stent stenosis occurred in 9 patients, while 10 patients had reocclusion of the treated segment. During follow-up, there were 2 late acute thrombotic occlusions, both after discontinuation of clopidogrel. The clinical status improved in 67.0% and 62.2% of the patients after 6 and 12 months, respectively. No patient, lesion, or procedure variables were predictive of restenosis after EVBT. CONCLUSION: EVBT with liquid beta-emitting Re-188 was safe and effective in preventing restenosis in long-segment femoropopliteal ISS.
Assuntos
Angioplastia com Balão/instrumentação , Arteriopatias Oclusivas/terapia , Braquiterapia/métodos , Artéria Femoral , Artéria Poplítea , Radioisótopos/uso terapêutico , Rênio/uso terapêutico , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Arteriopatias Oclusivas/diagnóstico , Arteriopatias Oclusivas/fisiopatologia , Arteriopatias Oclusivas/radioterapia , Braquiterapia/efeitos adversos , Distribuição de Qui-Quadrado , Constrição Patológica , Intervalo Livre de Doença , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Alemanha , Humanos , Estimativa de Kaplan-Meier , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Valor Preditivo dos Testes , Radiografia , Radioisótopos/efeitos adversos , Recidiva , Estudos Retrospectivos , Rênio/efeitos adversos , Medição de Risco , Fatores de Risco , Trombose/etiologia , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia Doppler Dupla , Grau de Desobstrução VascularRESUMO
OBJECTIVES: This study was conducted to identify patient-related variables that are associated with a higher rate of neurological adverse events during carotid artery stenting (CAS). BACKGROUND: CAS is considered as an alternative treatment for patients with carotid artery stenosis. Despite technical advancements and increase of operator experience, periprocedural neurologic complications cannot completely be prevented. Case selection based on anatomical criteria and other patient characteristics could improve the outcome after CAS. METHODS: Between 2006 and 2009, 833 CAS procedures were performed in 751 consecutive patients under cerebral protection. The influence of patient characteristics, procedural details, and the anatomy of the supraaortic vessels on the incidence of major in-hospital adverse events was assessed. RESULTS: Successful CAS was performed in 99.2% of the procedures. The in-hospital death and stroke rate was 2.0% (1 major stroke, 10 minor strokes, and 7 deaths). Octogenarians had a fourfold higher death and stroke rate than patients younger than 80 years old. There was an increased risk of stroke and death in patients with critical aortic stenosis. Presence of a bovine arch, tortous common carotid artery (CCA) and angulated distal internal carotid artery were associated with a higher risk of stroke and transient ischemic attack. A recently developed scoring system for anatomic suitability correlates well with the periprocedural neurological outcome in this case series. CONCLUSIONS: Anatomical conditions and octogenarian age were associated with an increased rate of neurologic adverse events during CAS. Our findings support a newly proposed scoring system for anatomic suitability to identify patients at high risk for CAS.
Assuntos
Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Artérias Carótidas/anormalidades , Estenose das Carótidas/terapia , Ataque Isquêmico Transitório/epidemiologia , Stents , Acidente Vascular Cerebral/epidemiologia , Malformações Vasculares/epidemiologia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/mortalidade , Aorta Torácica/anormalidades , Estenose das Carótidas/diagnóstico , Estenose das Carótidas/epidemiologia , Estenose das Carótidas/mortalidade , Distribuição de Qui-Quadrado , Feminino , Alemanha , Mortalidade Hospitalar , Humanos , Ataque Isquêmico Transitório/diagnóstico , Ataque Isquêmico Transitório/mortalidade , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/mortalidade , Fatores de Tempo , Resultado do Tratamento , Malformações Vasculares/diagnóstico , Malformações Vasculares/mortalidadeRESUMO
PURPOSE: To present the 5-year angiographic and clinical results of a retrospective registry assessing the performance of sirolimus-eluting stents (SES) in the treatment of infrapopliteal atherosclerotic disease. METHODS: From 2004 to 2009, 158 patients (95 men; mean age 71.9 years) with chronic lower limb ischemia (Rutherford categories 3-6) underwent primary SES placement in focal infrapopliteal lesions. The angiographic endpoint was patency, defined as freedom from in-stent stenosis (ISS) >50%. Clinical endpoints were death, amputation, and bypass surgery. Results were correlated with patient and lesion characteristics and cumulative outcomes were assessed with Kaplan-Meier analysis. RESULTS: Technical success was achieved in all cases. The primary patency rates were 97.0% after 6 months, 87.0% after 12 months, and 83.8% at 60 months. In-stent stenosis was predominantly observed in the first year after stent placement. Female gender was associated with a higher rate of ISS. During clinical follow-up of 144 (91%) patients over a mean 31.1±20.3 months, there were 27 (18.8%) deaths, 4 (2.8%) amputations, and no bypass surgery. Clinical status improved in 92% of the patients with critical limb ischemia (CLI) and 77% of the patients suffering from claudication (p=0.022). CONCLUSION: Treatment of focal infrapopliteal lesions with SES showed encouraging long-term angiographic results in this registry. Clinical improvement was evident, but more pronounced in CLI patients than in patients suffering from claudication. Further studies are needed to evaluate the potential clinical benefit of SES as compared to balloon angioplasty or bare metal stents in the treatment of infrapopliteal lesions.
Assuntos
Angioplastia com Balão/instrumentação , Aterosclerose/terapia , Fármacos Cardiovasculares/administração & dosagem , Stents Farmacológicos , Isquemia/terapia , Extremidade Inferior/irrigação sanguínea , Artéria Poplítea , Sirolimo/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Aterosclerose/complicações , Aterosclerose/diagnóstico por imagem , Aterosclerose/mortalidade , Aterosclerose/fisiopatologia , Distribuição de Qui-Quadrado , Doença Crônica , Constrição Patológica , Feminino , Alemanha , Humanos , Isquemia/diagnóstico por imagem , Isquemia/etiologia , Isquemia/mortalidade , Isquemia/fisiopatologia , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Modelos de Riscos Proporcionais , Desenho de Prótese , Radiografia , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular , Procedimentos Cirúrgicos VascularesRESUMO
PURPOSE: To describe a technique to approach chronic total occlusions (CTOs) of the superficial femoral artery (SFA) after failed antegrade recanalization as an alternative to a conventional transpopliteal approach. METHODS: A retrospective analysis was undertaken of 50 patients (37 men; mean age 71 years) who underwent retrograde recanalization via a distal SFA access after failed antegrade recanalization of SFA CTOs that were not beyond the adductor canal. Antegrade recanalization failed due to flush SFA occlusion, occluded stents, wire perforation, and re-entry failure. Retrograde SFA access required introduction of a 7- to 15-cm, 21-G needle distal to the occlusion. A 0.018-inch guidewire was inserted through the needle followed by a 4- or 6-F, 10-cm sheath or dedicated support catheter only. All retrograde SFA punctures were performed with the patient in the supine position. Once retrograde passage of the occlusion was successful, oftentimes requiring a "double-balloon" technique to disrupt the dissection membrane with abutting balloons delivered from both access sites, balloon angioplasty and/or stenting could be performed from either direction. RESULTS: Retrograde puncture of the distal SFA was successful in all cases. Retrograde recanalization involved insertion of a 6-F sheath in 3 (6%) cases, a 4-F sheath in 32 (64%), and a sheathless approach in 15 (30%). The "double-balloon" technique was necessary to achieve guidewire passage in 12 cases. Recanalization was successful in 48 (96%) cases. Hemostasis time at the distal puncture site was 9.2 minutes (range 3-30). Perioperative complications included 4 pseudoaneurysms (2 groins, 2 distal), 1 peripheral embolization, and 1 small arteriovenous fistula at the distal puncture site. CONCLUSION: For failure of antegrade recanalization of SFA occlusions, the retrograde SFA puncture distal to the adductor canal with the patient remaining supine is a safe and successful technique that represents a convenient alternative to the conventional transpopliteal approach.
Assuntos
Angioplastia com Balão , Angioplastia , Arteriopatias Oclusivas/terapia , Cateterismo Periférico , Artéria Femoral , Idoso , Idoso de 80 Anos ou mais , Angioplastia/efeitos adversos , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Arteriopatias Oclusivas/diagnóstico por imagem , Cateterismo Periférico/efeitos adversos , Doença Crônica , Constrição Patológica , Feminino , Artéria Femoral/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , New South Wales , Posicionamento do Paciente , Punções , Radiografia , Estudos Retrospectivos , Stents , Decúbito Dorsal , Falha de TratamentoRESUMO
PURPOSE: The nonthermal irreversible electroporation (NTIRE) is a novel nonthermal tissue ablation technique by local application of high-voltage current within microseconds leading to a delayed apoptosis. The purpose of this experimental study was the first angiographic evaluation of the acute damage of renal vascular structure in NTIRE. METHODS: Results of conventional dynamic digital substraction angiography (DSA) and visualization of the terminal vascular bed of renal parenchyma by high-resolution X-ray in mammography technique were evaluated before, during, and after NTIRE of three isolated perfused porcine ex vivo kidneys. RESULTS: In the dedicated investigation, no acute vascular destruction of the renal parenchyma and no dysfunction of the kidney perfusion model were observed during or after NTIRE. Conspicuous were concentric wave-like fluctuations of the DSA contrast agent simultaneous to the NTIRE pulses resulting from NTIRE pulse shock wave. CONCLUSION: The NTIRE offers an ablation method with no acute collateral vascular damage in angiographic evaluation.
Assuntos
Eletroporação/métodos , Rim/irrigação sanguínea , Rim/diagnóstico por imagem , Angiografia Digital , Animais , Técnicas In Vitro , Perfusão , SuínosRESUMO
PURPOSE: To examine the efficacy and integrity of a novel interwoven self-expanding nitinol stent system for the treatment of complex femoropopliteal lesions in a "real world" medical practice. METHODS: This retrospective analysis included 107 consecutive patients (77 men; mean age 68.9 years) with atherosclerotic femoropopliteal lesions (occlusions in 31%) who underwent implantation of 137 SUPERA stents. The patients were followed for up to 24 months by Doppler ultrasound examinations, radiography of the stent, and assessments of Rutherford-Becker class and ankle-brachial index (ABI). RESULTS: The mean implanted stent length was 111±50 mm (range 40-270). Procedure success (residual stenosis <30%) was achieved in 99% of procedures. The 6-, 12-, and 24-month cumulative primary patency rates (± standard error) were 93.1%±2.5%, 84.7%±3.6%, and 76.1%±4.5%, respectively, and the secondary patency rates were 99.0%±0.1%, 94.8%±0.2% and 91.9%±0.3%, respectively. Between baseline and 24 months, mean ABI increased from 0.68±0.14 to 0.87±0.10 and the mean Rutherford-Becker class decreased from 3.3±0.7 to 2.0±1.0 (p<0.0001 for both). Radiographs performed in 91 patients at a mean of 16.8±7.0 months found no stent fractures. CONCLUSION: Over a 2-year surveillance period, excellent durability without stent fractures was documented after implantation of the SUPERA stent in complex femoropopliteal lesions. In addition, significant improvements were observed in symptom classification and hemodynamics.
Assuntos
Artéria Femoral/patologia , Doença Arterial Periférica/terapia , Artéria Poplítea/patologia , Stents , Adulto , Idoso , Idoso de 80 Anos ou mais , Ligas , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Estudos Retrospectivos , Resultado do TratamentoRESUMO
The reaction of a solution of B(C6F4H)3 and either iPr3P or tBu3P with CO2 afforded the species R3P(CO2)B(C6F4H)3 (R=iPr (1), tBu (2)). In a similar fashion the boranes, RB(C6F5)2 (R=hexyl, cyclohexyl (Cy), norbornyl), ClB(C6F5)2, or PhB(C6F5)2 were combined with tBu3P and CO2 to give the species tBu3P(CO2)BR(C6F5)2 (R=hexyl (3), Cy (4), norbornyl (5), Cl (6), Ph (7)). Similarly, the compounds [tBu3PH][RBH(C6F5)2] (R= hexyl (8), Cy (9), norbornyl (10)) were prepared by reaction of the precursor frustrated Lewis pair (FLP) with H2. Subsequent reactions of 9 and 10 with CO2 afforded the species [((C6F5)2BR)2(µ-HCO2)][tBu3PH] (R= Cy (11), norbornyl (12)). In related chemistry, combinations of the boranes RBG(C6F5)2 (R=hexyl, Cy, norbornyl) with tBu3P treated with an equivalent of formic acid gave [(C6F5)2BR(HCO2)][tBu3PH] (R=hexyl (13), Cy (14), norbornyl (15)). Subsequent addition of an additional equivalent of borane provides a second synthetic route to 11 and 12. Crystallographic studies of compounds 2-6 and 8-14 are reported and discussed. Further understanding of the FLP complexation and activation of CO2 is provided by computational studies.
RESUMO
OBJECTIVES: The purpose of this study was to investigate the efficacy of drug-eluting balloons (DEBs) in the treatment of long infrapopliteal lesions with regard to the short-term restenosis rate and midterm clinical result. BACKGROUND: Restenosis rates of long-segment tibial artery disease are very high. Recently, a restenosis rate of 69% at 3 months after standard balloon angioplasty was demonstrated. METHODS: Infrapopliteal angioplasty was performed with a paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic, Minneapolis, Minnesota). Clinical and angiographic follow-up was performed at 3 months to detect binary restenosis, and further clinical assessment was performed over a 12-month period thereafter. RESULTS: In 104 patients, 109 limbs were treated for critical limb ischemia (82.6%) or severe claudication (17.4%). Mean lesion length of the arteries treated was 176 ± 88 mm. Angiography studied in 84 treated arteries at 3 months showed a restenosis in 27.4% (19.1% had restenosis of more than 50%, and 8.3% were totally occluded) and usually occurred focally. Only in 9.5% of all angiographically followed up arteries was the entire treated segment restenosed or reoccluded. During a follow-up period of 378 ± 65 days, 1 patient was lost and 17 died. Of the 91 limbs remaining in the analysis, clinical improvement was present in 83 (91.2%). Complete wound healing occurred in 74.2%, whereas major amputation occurred in 4 patients, resulting in limb salvage of 95.6% for patients with critical limb ischemia. CONCLUSIONS: The early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with DEBs compared with historical data using uncoated balloons. Randomized trials are required to show whether this difference will lead to improvement in clinical outcomes.