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1.
Vascular ; 28(6): 747-755, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33045944

RESUMO

OBJECTIVES: To compare perioperative outcomes related to atherectomy with percutaneous transluminal angioplasty versus percutaneous transluminal angioplasty alone for the treatment of lower extremity chronic limb threatening ischemia using a national patient database. METHODS: Patients with chronic limb threatening ischemia treated with atherectomy and percutaneous transluminal angioplasty or percutaneous transluminal angioplasty alone from 2011 to 2016 in the National Surgical Quality Improvement Program database were identified. Primary outcomes were major adverse limb events (30-day untreated loss of patency, major reintervention, major amputation) and major adverse cardiac events (cardiac arrest, composite outcome of myocardial infarction or stroke). Secondary outcomes included 30-day mortality, length of stay, and any unplanned readmission within 30 days. Multivariate regression analyses were performed to determine independent predictors of outcome. Propensity score matched cohort analysis was performed. A p-value <0.05 was considered statistically significant. Subgroup analyses of femoropopliteal and infrapopliteal interventions were performed. RESULTS: In total, 2636 (77.2%) patients were treated with percutaneous transluminal angioplasty and 778 (22.8%) were treated with atherectomy and percutaneous transluminal angioplasty. Multivariate analyses of the unadjusted cohort revealed no significant differences in major adverse cardiac events or major adverse limb events between the two groups (p-value >0.05). Subgroup analysis of femoropopliteal interventions demonstrated a significantly decreased likelihood of untreated loss of patency in 30 days in the atherectomy group compared to the percutaneous transluminal angioplasty group (1.1% vs. 2.7%, respectively; p-value = 0.034), which persisted on propensity score matched analysis (1.1% vs. 3.1%, respectively; p-value = 0.026). CONCLUSION: Atherectomy with balloon angioplasty of femoropopliteal disease provides a significant decrease in untreated loss of patency compared to balloon angioplasty alone.


Assuntos
Angioplastia com Balão , Aterectomia , Isquemia/terapia , Doença Arterial Periférica/terapia , Idoso , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Aterectomia/efeitos adversos , Aterectomia/mortalidade , Doença Crônica , Bases de Dados Factuais , Feminino , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
4.
Ann Vasc Surg ; 69: 80-84, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32791191

RESUMO

Novel 2019 coronavirus (COVID-19) infection usually causes a respiratory disease that may vary in severity from mild symptoms to severe pneumonia with multiple organ failure. Coagulation abnormalities are frequent, and reports suggest that COVID-19 may predispose to venous and arterial thrombotic complications. We report a case of acute lower limb ischemia and resistance to heparin as the onset of COVID-19 disease, preceding the development of respiratory failure. This case highlights that the shift of coagulation profile toward hypercoagulability was associated with the acute ischemic event and influenced the therapy.


Assuntos
Infecções por Coronavirus/diagnóstico , Isquemia/diagnóstico , Isquemia/terapia , Extremidade Inferior/irrigação sanguínea , Pneumonia Viral/diagnóstico , Doença Aguda , Anticoagulantes/administração & dosagem , Betacoronavirus , Biomarcadores/sangue , Diagnóstico Diferencial , Diagnóstico por Imagem , Heparina/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Trombectomia , Trombofilia/complicações , Trombofilia/tratamento farmacológico
5.
Vasc Health Risk Manag ; 16: 271-284, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32753875

RESUMO

Introduction: Previous studies have suggested that women with chroniclimb-threatening ischemia (CLTI) may have worse outcomes than men. The aim of this study was to determine whether there are sex-related differences in outcomes of patients with CLTI undergoing endovascular treatment with current endovascular technologies. Patients and Methods: Data were derived from the LIBERTY 360 study (NCT01855412). Hazard ratios and the respective 95% confidence intervals were synthesized to examine the association between sex and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE) and major amputation/death up to 3 years of follow-up. Results: A total of 689 patients with CLTI (female: N=252 vs male: N=437) treated with any FDA approved or cleared device were included. The mean lesion length was 126.9±117.3mm and 127.4±113.3mm for the female and male patients, respectively. Although a slightly higher incidence of in-hospital mortality was observed in the female group (1.2% vs 0.0%, p=0.049), there was no difference in female vs male survival rates during follow-up. However, the risk of major amputation at 18 months was higher for the male group (male vs female: HR: 2.36; 95% CI: 1.09-5.12; p=0.030). No difference between the two groups was detected in terms of TVR or MAE during follow-up. Discussion: Data regarding sex-related disparity in outcomes after endovascular therapy of patients with CLTI are conflicting. Gender-related characteristics rather than biological sex characteristics might be the cause of these conflicting findings. Further studies are needed to evaluate the role of sex in revascularization outcomes among this high-risk population.


Assuntos
Angioplastia com Balão , Isquemia/terapia , Doença Arterial Periférica/terapia , Idoso , Idoso de 80 Anos ou mais , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Causas de Morte , Doença Crônica , Feminino , Mortalidade Hospitalar , Humanos , Isquemia/diagnóstico , Isquemia/mortalidade , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento
6.
Eur J Vasc Endovasc Surg ; 60(4): 549-558, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32807674

RESUMO

OBJECTIVE: Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort. METHODS: A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan-Meier method and Cox regression. RESULTS: There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78-0.91), amputation or death (HR 0.87, 95% CI 0.81-0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80-0.92) were observed. CONCLUSION: In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia.


Assuntos
Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Stents Farmacológicos , Procedimentos Endovasculares/instrumentação , Isquemia/terapia , Perna (Membro)/irrigação sanguínea , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Demandas Administrativas em Assistência à Saúde , Idoso , Idoso de 80 Anos ou mais , Amputação , Fármacos Cardiovasculares/efeitos adversos , Doença Crônica , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Alemanha , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Pontuação de Propensão , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
7.
Arterioscler Thromb Vasc Biol ; 40(9): 2322-2331, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32698688

RESUMO

OBJECTIVE: Inflammatory markers, such as hs-CRP (high-sensitivity C-reactive protein), have been reported to be related to peripheral artery disease (PAD). Galectin-3, a biomarker of fibrosis, has been linked to vascular remodeling and atherogenesis. However, its prospective association with incident PAD is unknown; as is the influence of inflammation on the association between galectin-3 and PAD. Approach and Results: In 9851 Atherosclerosis Risk in Communities Study participants free of PAD at baseline (1996-1998), we quantified the association of galactin-3 and hs-CRP with incident PAD (hospitalizations with PAD diagnosis [International Classification of Diseases-Ninth Revision: 440.2-440.4] or leg revascularization [eg, International Classification of Diseases-Ninth Revision: 38.18]) as well as its severe form, critical limb ischemia (PAD cases with resting pain, ulcer, gangrene, or leg amputation) using Cox models. Over a median follow-up of 17.4 years, there were 316 cases of PAD including 119 critical limb ischemia cases. Log-transformed galectin-3 was associated with incident PAD (adjusted hazard ratio, 1.17 [1.05-1.31] per 1 SD increment) and critical limb ischemia (1.25 [1.05-1.49] per 1 SD increment). The association was slightly attenuated after further adjusting for hs-CRP (1.14 [1.02-1.27] and 1.22 [1.02-1.45], respectively). Log-transformed hs-CRP demonstrated robust associations with PAD and critical limb ischemia even after adjusting for galectin-3 (adjusted hazard ratio per 1 SD increment 1.34 [1.18-1.52] and 1.34 [1.09-1.65], respectively). The addition of galectin-3 and hs-CRP to traditional atherosclerotic predictors (C statistic of the base model 0.843 [0.815-0.871]) improved the risk prediction of PAD (ΔC statistics, 0.011 [0.002-0.020]). CONCLUSIONS: Galectin-3 and hs-CRP were independently associated with incident PAD in the general population, supporting the involvement of fibrosis and inflammation in the pathophysiology of PAD.


Assuntos
Proteína C-Reativa/análise , Galectina 3/sangue , Mediadores da Inflamação/sangue , Claudicação Intermitente/sangue , Isquemia/sangue , Doença Arterial Periférica/sangue , Idoso , Biomarcadores/sangue , Estado Terminal , Feminino , Fibrose , Humanos , Incidência , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/epidemiologia , Claudicação Intermitente/terapia , Isquemia/diagnóstico , Isquemia/epidemiologia , Isquemia/terapia , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/epidemiologia , Doença Arterial Periférica/terapia , Prognóstico , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Estados Unidos
8.
J Endovasc Ther ; 27(5): 714-725, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32618486

RESUMO

Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study (ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.


Assuntos
Angioplastia com Balão , Aterectomia , Artéria Femoral , Claudicação Intermitente/terapia , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Idoso de 80 Anos ou mais , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Angioplastia com Balão/mortalidade , Aterectomia/efeitos adversos , Aterectomia/instrumentação , Aterectomia/mortalidade , Doença Crônica , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/mortalidade , Claudicação Intermitente/fisiopatologia , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Grau de Desobstrução Vascular
9.
J Endovasc Ther ; 27(4): 599-607, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32633651

RESUMO

Purpose: To report the outcomes of bypass grafting (BG) vs endovascular therapy (EVT) in patients with non-dialysis-dependent chronic kidney disease (CKD) and chronic limb-threatening ischemia (CLTI). Materials and Methods: The CRITISCH Registry is a prospective, national, interdisciplinary, multicenter registry evaluating the current practice of all available treatment options in 1200 consecutive CLTI patients. For the purposes of this analysis, only the 337 patients with non-dialysis-dependent CKD treated by either BG (n=86; median 78 years, 48 men) or EVT (n=251; median age 80 years, 135 men) were analyzed. The primary composite outcome was amputation-free survival (AFS); secondary outcomes were overall survival (OS) and amputation-free time (AFT). All outcomes were evaluated in Cox proportional hazards models; the results are reported as the hazard ratio (HR) and 95% confidence interval (CI). Results: The Cox regression analysis revealed a significantly greater hazard of amputation or death after BG (HR 1.78, 95% CI 1.05 to 3.03, p=0.028). The models for AFT and overall survival also suggested a higher hazard for BG, but the differences were not significant (AFT: HR 1.66, 95% CI 0.78 to 3.53, p=0.188; OS: HR 1.41, 95% CI 0.80 to 2.47, p=0.348). The absence of runoff vessels (HR 1.73, 95% CI 1.15 to 2.60, p=0.008) was associated with a decreased AFS. The likelihood of amputation was higher in male patients (HR 2.21, 95% CI 1.10 to 4.45, p=0.027) and was associated with a lack of runoff vessels (HR 1.95, 95% CI 0.96 to 3.95, p=0.065) and myocardial infarction (HR 3.74, 95% CI 1.23 to 11.35, p=0.020). Death was more likely in patients without runoff vessels (HR 1.76, 95% CI 1.11 to 2.80, p=0.016) and those with a higher risk score (HR 1.73, 95% CI 1.03 to 2.91, p=0.038). Conclusion: This analysis suggested that BG was associated with poorer AFS than EVT in patients with non-dialysis-dependent CKD and CLTI. Male sex, previous myocardial infarction, and the absence of runoff vessels were additionally identified as predictors of poorer outcomes.


Assuntos
Procedimentos Endovasculares , Isquemia/terapia , Doença Arterial Periférica/terapia , Insuficiência Renal Crônica/terapia , Enxerto Vascular , Idoso , Idoso de 80 Anos ou mais , Amputação , Doença Crônica , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Alemanha/epidemiologia , Humanos , Isquemia/diagnóstico , Isquemia/mortalidade , Salvamento de Membro , Masculino , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/mortalidade , Estudos Prospectivos , Sistema de Registros , Insuficiência Renal Crônica/diagnóstico , Insuficiência Renal Crônica/mortalidade , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Enxerto Vascular/efeitos adversos , Enxerto Vascular/mortalidade
10.
J Endovasc Ther ; 27(5): 683-690, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32666871

RESUMO

Purpose: To evaluate the safety and efficacy of the novel SELUTION sustained-limus-release (SLR) drug-eluting balloon (DEB) in the treatment of femoropopliteal lesions. Materials and Methods: Between October 2016 and May 2017, 50 subjects (mean age 69.6±10.4 years; 29 men) with symptomatic moderate to severe lower limb ischemia (Rutherford categories 2 or 3) were enrolled at 4 German centers for the SELUTION SLR first-in-human trial (ClinicalTrials.gov NCT02941224). The SELUTION SLR utilizes micro-reservoirs (biodegradable polymer spheres containing sirolimus) embedded within an amphipathic membrane coated onto an angioplasty balloon. The biodegradable reservoirs are transferred to the target vessel lumen during brief balloon inflation. The primary trial objective was comparison of angiographic late lumen loss at 6 months against an objective performance criterion (OPC) value of 1.04 mm for uncoated balloon angioplasty. Secondary endpoints included device, procedural, and clinical success; clinical and imaging assessments of primary patency and restenosis; functional assessments including Rutherford category and ankle-brachial index (ABI); and major adverse events [composite of cardiovascular mortality, index limb amputation, target limb thrombosis, and clinically-driven target lesion revascularization (CD-TLR)]. Results: At 6 months, median angiographic late lumen loss following SELUTION SLR treatment was 0.19 mm (range -1.16 to 3.07). Mean angiographic late lumen loss (n=34) was 0.29±0.84 mm (95% CI -0.01 to 0.58), significantly lower than the 1.04-mm OPC value (p<0.001). The rate of primary patency by duplex ultrasound was 88.4%, and freedom from angiographic binary restenosis was 91.2%. Through 6 months, there was significant improvement over baseline in Rutherford categories (p<0.001) and in ABI measurements (p<0.001). A single case (2%) of CD-TLR occurred at 5 months. There were no other major adverse events. Conclusion: Through 6 months, the SELUTION SLR DEB appears to inhibit restenosis effectively and safely, improving outcomes in subjects with symptomatic femoropopliteal disease.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Artéria Femoral , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Sirolimo/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Constrição Patológica , Preparações de Ação Retardada , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Alemanha , Humanos , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Recuperação de Função Fisiológica , Índice de Gravidade de Doença , Sirolimo/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
11.
Proc Natl Acad Sci U S A ; 117(32): 19033-19044, 2020 08 11.
Artigo em Inglês | MEDLINE | ID: mdl-32709748

RESUMO

Therapeutic factors secreted by mesenchymal stem cells (MSCs) promote angiogenesis in vivo. However, delivery of MSCs in the absence of a cytoprotective environment offers limited efficacy due to low cell retention, poor graft survival, and the nonmaintenance of a physiologically relevant dose of growth factors at the injury site. The delivery of stem cells on an extracellular matrix (ECM)-based platform alters cell behavior, including migration, proliferation, and paracrine activity, which are essential for angiogenesis. We demonstrate the biophysical and biochemical effects of preconditioning human MSCs (hMSCs) for 96 h on a three-dimensional (3D) ECM-based microgel platform. By altering the macromolecular concentration surrounding cells in the microgels, the proangiogenic phenotype of hMSCs can be tuned in a controlled manner through cell-driven changes in extracellular stiffness and "outside-in" integrin signaling. The softest microgels were tested at a low cell dose (5 × 104 cells) in a preclinical hindlimb ischemia model showing accelerated formation of new blood vessels with a reduced inflammatory response impeding progression of tissue damage. Molecular analysis revealed that several key mediators of angiogenesis were up-regulated in the low-cell-dose microgel group, providing a mechanistic insight of pathways modulated in vivo. Our research adds to current knowledge in cell-encapsulation strategies by highlighting the importance of preconditioning or priming the capacity of biomaterials through cell-material interactions. Obtaining therapeutic efficacy at a low cell dose in the microgel platform is a promising clinical route that would aid faster tissue repair and reperfusion in "no-option" patients suffering from peripheral arterial diseases, such as critical limb ischemia (CLI).


Assuntos
Células-Tronco Mesenquimais/química , Células-Tronco Mesenquimais/citologia , Microgéis/química , Neovascularização Fisiológica , Animais , Proliferação de Células , Células Imobilizadas/química , Células Imobilizadas/citologia , Células Imobilizadas/metabolismo , Matriz Extracelular/genética , Matriz Extracelular/metabolismo , Membro Posterior/irrigação sanguínea , Membro Posterior/metabolismo , Membro Posterior/cirurgia , Humanos , Integrinas/genética , Integrinas/metabolismo , Isquemia/fisiopatologia , Isquemia/cirurgia , Isquemia/terapia , Transplante de Células-Tronco Mesenquimais , Células-Tronco Mesenquimais/metabolismo , Camundongos , Camundongos Nus
12.
Sichuan Da Xue Xue Bao Yi Xue Ban ; 51(4): 582-586, 2020 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-32691572

RESUMO

History and clinical findings: A 76 year-old woman with 8-year history of diabetes mellitus and hypertension was admitted with gangrene of left great toe, 3rd, 4th and 5th toes. Twenty months ago, She started to receive hemodialysis due to end-stage renal disease. She did not have any history of reactive airway disease nor bradycardia that would contraindicate the use of topical beta-blocker. The X-ray of left lower limb and foot showed calcification of left superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, dorsal foot artery and digital artery, as well as osteolytic destruction at distal end of metatarsal bone, and lateral dislocation of the 4th and 5th toes. Color Doppler ultrasound of bilateral lower extremity arteries showed obvious calcification of bilateral superficial femoral arteries, thrombosis of left popliteal artery, severe stenosis of left anterior tibial artery, occlusion of left posterior tibial artery, right anterior tibial artery and posterior tibial artery. Computed tomographic angiography (CTA) of bilateral lower limb arteries revealed moderate stenosis of left superficial femoral artery, occlusion of left popliteal artery, left posterior tibial artery and dorsal pedal artery, occulusion of right posterior tibial artery, but right dorsal pedal artery was visible. Diagnosis, treatment and follow-up: Diagnosis of diabetic foot (left, grade 4) and diabetic lower extremity arterial occlusion (left, stage 4) was made. Based on multidisciplinary team (MDT) discussion, the patient was unable to undergo vascular bypass surgery, and left lower extermity amputation also was not suitable because of right atrial thrombosis. Therefore, conservative treatment was recommended. The specific scheme used clopidogrel for antiplatelet agglutination, Low Molecular Weight Heparin (Clexane) and warfarin for anticoagulation, lipo-alprostadil for vasodilation, as well as local debridement and ultrasonic debridement. The treatments were given for up to 9 weeks, but with no significant clinical response. So the patient was treated with vacuum-assisted closure and autologous platelet-rich gel therapy for the next 7 weeks, then applied with 1 drop of timolol maleate 0.5% ophthalmic solution per cm 2 wound area every other day for another 6 weeks, the wound rapidly healed and re-epithelialized basically. The follow-up for 5 weeks showed that the wound healed completely without any discomfort. No side effect was found.


Assuntos
Plaquetas , Diabetes Mellitus , Pé Diabético , Géis , Timolol , Antagonistas Adrenérgicos beta/farmacologia , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Artérias/patologia , Pé Diabético/complicações , Pé Diabético/terapia , Feminino , Géis/farmacologia , Géis/uso terapêutico , Humanos , Isquemia/terapia , Timolol/farmacologia , Timolol/uso terapêutico , Resultado do Tratamento , Cicatrização/efeitos dos fármacos
13.
Ann Vasc Surg ; 69: 1-8, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32599114

RESUMO

BACKGROUND: The adverse gender disparities for women after open abdominal aortic aneurysm (AAA) repair have been well documented. The purpose of this study is to review whether these disparities extend to elective endovascular aneurysm repair (EVAR). METHODS: Nonruptured, elective AAA was identified from the American College of Surgeons' National Quality Improvement Program (NSQIP) Targeted Participant Use File for EVAR from 2012 to 2017. The primary outcome was mortality. Secondary outcomes included lower extremity ischemia requiring intervention (LEIRI) and prolonged operative time (>120 min). Multivariable logistic regression models were used to assess the risk of mortality, LEIRI, and prolonged operative time among women compared with men. RESULTS: There were 14,019 EVAR procedures captured. A total of 3,367 were included for analysis after limiting to nonruptured, elective cases for diagnosis of AAA with a Current Procedural Terminology procedure code for EVAR. Of those, 2,764 (82.1%) were performed in men and 603 (17.9%) in women. Female patients were older (median [interquartile range (IQR)] 77 years [70-82] versus 74 years [68-80], P < 0.001), more likely to smoke (35.5% versus 29.6%, P = 0.005), and less likely to have diabetes (12.4% versus 17.8%, P = 0.001). Women had slightly smaller AAA size (median [IQR] 5.4 cm [5.0-5.9] versus 5.5 cm [5.1-6.0], P < 0.001) and were more likely to have prior abdominal operations (35.3% versus 23.1%, P < 0.001). The operative time was longer among women (median 114 min. [85-150] versus 105 min. [82-140], P < 0.001). Postoperatively, mortality was higher in female patients (1.8% versus 0.9%, P = 0.036), LEIRI occurred in higher proportion among female patients (2.7% versus 1.2%, P = 0.009), and their hospital stay was also longer (median 2 days [1-3] versus 1 day [1-2] days, P < 0.001). On multivariable logistic regression analysis, hematocrit level <30 vol% versus ≥30 vol% (odds ratio (OR) 5.5, 95% confidence interval (CI) 2.1-14.5, P < 0.001) was associated with increased mortality. Although not statistically significant, there was also evidence that the odds of mortality were also greater among women (OR 2.0, 95% CI 0.98-4.2, P = 0.06). LEIRI was more likely among women (OR 2.1, 95% CI 1.2-3.9, P = 0.015) and patients with a smoking history (OR 1.8, 95% CI 1.0-3.2, P = 0.044). Finally, odds of prolonged operative time were higher among women (OR 1.4, 95% CI 1.2-1.7, P < 0.001) and patients with chronic obstructive pulmonary disease (OR 1.2, 95% CI 1.0-1.5, P = 0.033) or partial/total dependent functional status (OR 2.2, 95% CI 1.3-3.7, P = 0.003). CONCLUSIONS: Although EVAR has improved overall surgical AAA outcomes, the NSQIP data in elective EVAR demonstrate continued sex disparities in morbidity and mortality after AAA surgical repair to the detriment of female patients.


Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Disparidades nos Níveis de Saúde , Disparidades em Assistência à Saúde , Isquemia/etiologia , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Implante de Prótese Vascular/mortalidade , Bases de Dados Factuais , Procedimentos Cirúrgicos Eletivos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Isquemia/mortalidade , Isquemia/terapia , Masculino , Duração da Cirurgia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
15.
Nat Rev Cardiol ; 17(11): 685-697, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32483304

RESUMO

Extracellular vesicles (EVs) are a heterogeneous group of natural particles that are relevant to the treatment of cardiovascular diseases. These endogenous vesicles have certain properties that allow them to survive in the extracellular space, bypass biological barriers and deliver their biologically active molecular cargo to recipient cells. Moreover, EVs can be bioengineered to increase their stability, bioactivity, presentation to acceptor cells and capacity for on-target binding at both cell-type-specific and tissue-specific levels. Bioengineering of EVs involves the modification of the donor cell before EV isolation or direct modification of the EV properties after isolation. The therapeutic potential of native EVs and bioengineered EVs has been only minimally explored in the context of cardiovascular diseases. Efforts to harness the therapeutic potential of EVs will require innovative approaches and a comprehensive integration of knowledge gathered from decades of research into molecular-compound delivery. In this Review, we outline the endogenous properties of EVs that make them natural delivery agents as well as the features that can be improved by bioengineering. We also discuss the therapeutic applications of native and bioengineered EVs to cardiovascular diseases and examine the opportunities and challenges that need to be addressed to advance this research area, with an emphasis on clinical translation.


Assuntos
Bioengenharia , Doenças Cardiovasculares/terapia , Vesículas Extracelulares/transplante , Isquemia/terapia , Infarto do Miocárdio/terapia , Regeneração , Células-Tronco/metabolismo , Acidente Vascular Cerebral/terapia , Encéfalo/fisiologia , Sobrevivência Celular , Vesículas Extracelulares/metabolismo , Extremidades/irrigação sanguínea , Coração/fisiologia , Humanos , MicroRNAs/metabolismo , MicroRNAs/uso terapêutico , Miócitos Cardíacos , Comunicação Parácrina
16.
Stroke ; 51(7): 2036-2044, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32517584

RESUMO

BACKGROUND AND PURPOSE: As numerous questions remain about the best anesthetic strategy during thrombectomy, we assessed functional and radiological outcomes in stroke patients treated with thrombectomy in presence of general anesthesia (GA) versus conscious sedation (CS) and local anesthesia (LA). METHODS: We conducted a cohort study on prospectively collected data from 4429 patients enrolled in the Italian Registry of Endovascular Treatment in Acute Stroke. RESULTS: GA was used in 2013 patients, CS in 1285 patients, and LA in 1131 patients. The rates of 3-month modified Rankin Scale score of 0-1 were 32.7%, 33.7%, and 38.1% in the GA, CS, and LA groups: GA versus CS: odds ratios after adjustment for unbalanced variables (adjusted odds ratio [aOR]), 0.811 (95% CI, 0.602-1.091); and GA versus LA: aOR, 0.714 (95% CI, 0.515-0.990). The rates of modified Rankin Scale score of 0-2 were 42.5%, 46.6%, and 52.4% in the GA, CS, and LA groups: GA versus CS: aOR, 0.902 (95% CI, 0.689-1.180); and GA versus LA: aOR, 0.769 (95% CI, 0.566-0.998). The rates of 3-month death were 21.5%, 19.7%, and 14.8% in the GA, CS, and LA groups: GA versus CS: aOR, 0.872 (95% CI, 0.644-1.181); and GA versus LA: aOR, 1.235 (95% CI, 0.844-1.807). The rates of parenchymal hematoma were 9%, 12.6%, and 11.3% in the GA, CS, and LA groups: GA versus CS: aOR, 0.380 (95% CI, 0.262-0.551); and GA versus LA: aOR, 0.532 (95% CI, 0.337-0.838). After model of adjustment for predefined variables (age, sex, thrombolysis, National Institutes of Health Stroke Scale, onset-to-groin time, anterior large vessel occlusion, procedure time, prestroke modified Rankin Scale score of <1, antiplatelet, and anticoagulant), differences were found also between GA versus CS as regards modified Rankin Scale score of 0-2 (aOR, 0.659 [95% CI, 0.538-0.807]) and GA versus LA as regards death (aOR, 1.413 [95% CI, 1.095-1.823]). CONCLUSIONS: GA during thrombectomy was associated with worse 3-month functional outcomes, especially when compared with LA. The inclusion of an LA arm in future randomized clinical trials of anesthesia strategy is recommended.


Assuntos
Isquemia Encefálica/terapia , Isquemia/terapia , Acidente Vascular Cerebral/terapia , Trombectomia , Idoso , Idoso de 80 Anos ou mais , Anestesia Geral/efeitos adversos , Procedimentos Endovasculares/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Trombectomia/métodos
17.
J Endovasc Ther ; 27(4): 647-657, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32508220

RESUMO

Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.


Assuntos
Angioplastia com Balão/instrumentação , Materiais Revestidos Biocompatíveis , Artéria Femoral , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/mortalidade , Doença Crônica , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , 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 , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
18.
J Endovasc Ther ; 27(4): 547-564, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32571125

RESUMO

Endovascular revascularization has been increasingly utilized to treat patients with chronic limb-threatening ischemia (CLTI), particularly atherosclerotic disease in the infrapopliteal arteries. Lesions of the infrapopliteal arteries are the result of 2 different etiologies: medial calcification and intimal atheromatous plaque. Although several devices are available for endovascular treatment of infrapopliteal lesions, balloon angioplasty still comprises the mainstay of therapy due to a lack of purpose-built devices. The mechanism of balloon angioplasty consists of adventitial stretching, medial necrosis, and dissection or plaque fracture. In many cases, the diffuse nature of infrapopliteal disease and plaque complexity may lead to dissection, recoil, and early restenosis. Optimal balloon angioplasty requires careful attention to assessment of vessel calcification, appropriate vessel sizing, and the use of long balloons with prolonged inflation times, as outlined in a treatment algorithm based on this systematic review. Further development of specific devices for this arterial segment are warranted, including devices for preventing recoil (eg, dedicated atherectomy devices), treating dissections (eg, tacks, stents), and preventing neointimal hyperplasia (eg, novel drug delivery techniques and drug-eluting stents). Further understanding of infrapopliteal disease, along with the development of new technologies, will help optimize the durability of endovascular interventions and ultimately improve the limb-related outcomes of patients with CLTI.


Assuntos
Algoritmos , Angioplastia com Balão , Técnicas de Apoio para a Decisão , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Amputação , Angioplastia com Balão/efeitos adversos , Angioplastia com Balão/instrumentação , Angioplastia com Balão/mortalidade , Doença Crônica , Tomada de Decisão Clínica , Humanos , Isquemia/diagnóstico por imagem , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Seleção de Pacientes , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Recidiva , Fatores de Risco , Resultado do Tratamento , Grau de Desobstrução Vascular
19.
J Endovasc Ther ; 27(4): 641-646, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32571134

RESUMO

Purpose: To investigate the prognostic impact of infrapopliteal (IP) artery anatomic severity according to the Global Limb Anatomic Staging System (GLASS) on delayed wound healing in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: This study retrospectively analyzed 639 limbs with tissue loss in 484 CLTI patients (mean age 74±10 years; 300 men) presenting IP lesions treated with endovascular therapy between April 2010 and December 2015. Two-thirds of patients had diabetes (323, 67%) and over half were on hemodialysis (255, 53%). More than a third of the limbs (251, 39%) were classified as clinical stage 4 according to the Wound, Ischemia, and foot Infection (WIfI) system. IP anatomic severity was classified based on preprocedural angiography according to the GLASS. Severity of arterial calcification was assessed using high-intensity fluoroscopy and classified into 3 groups: none (grade 0), unilateral (grade 1), and bilateral (grade 2). Poor below-the-ankle (BTA) runoff was defined as the lack of a pedal arch with 0 to 1-vessel runoff within the dorsal pedis artery and the lateral and medial plantar arteries. The outcome measure was 1-year wound healing. The association of anatomic characteristics with delayed wound healing was evaluated using Cox proportional hazards regression analysis. Outcomes are presented as the adjusted hazard ratio (HR) with 95% confidence interval (CI). Results: During a mean follow-up of 22±19 months, the 1-year cumulative wound healing rate was estimated to be 59.0% (95% CI 54.5% to 63.5%). Multivariable analysis demonstrated independent associations between delayed wound healing and IP calcification grade (HR 1.24, 95% CI 1.02 to 1.50, p=0.027) and poor BTA runoff (HR 1.39, 95% CI 1.04 to 1.85, p=0.025) but not the GLASS IP grade (HR 0.92, 95% CI 0.82 to 1.14, p=0.21). Conclusion: The current study revealed that IP arterial calcification and poor BTA runoff were significantly associated with delayed wound healing, whereas the GLASS was not predictive of wound healing.


Assuntos
Regras de Decisão Clínica , Procedimentos Endovasculares , Isquemia/terapia , Doença Arterial Periférica/terapia , Artéria Poplítea , Calcificação Vascular/terapia , Cicatrização , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Feminino , Humanos , Isquemia/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Stents , Fatores de Tempo , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem
20.
J Endovasc Ther ; 27(5): 693-705, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32583749

RESUMO

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Artéria Femoral , Claudicação Intermitente/terapia , Isquemia/terapia , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Idoso , Angioplastia com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Constrição Patológica , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/fisiopatologia , Isquemia/diagnóstico por imagem , Isquemia/fisiopatologia , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Recuperação de Função Fisiológica , Sistema de Registros , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
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