RESUMEN
BACKGROUND: The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease. METHODS: We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality. RESULTS: No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively). CONCLUSIONS: In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).
Asunto(s)
Angioplastia de Balón , Stents Liberadores de Fármacos/efectos adversos , Paclitaxel/administración & dosificación , Enfermedad Arterial Periférica/terapia , Anciano , Anciano de 80 o más Años , Angioplastia de Balón/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Isquemia/terapia , Masculino , Paclitaxel/efectos adversos , Enfermedad Arterial Periférica/mortalidad , Modelos de Riesgos Proporcionales , Stents/efectos adversosRESUMEN
The aim of this study is to identify how managers of micro-sized enterprises experience the impact of the Covid-19 pandemic on their business operations, work-life balance and well-being. Further, the study aims to make comparisons between managers of micro-sized businesses and managers of small-sized businesses. This mixed-method study is based on qualitative interviews with ten managers of micro-sized enterprises and a questionnaire answered by 95 managers of micro-sized and small-sized enterprises in regions in the north of Sweden. Managers of micro-sized enterprises reported significantly worse scores for mental well-being, job satisfaction and life satisfaction in comparison with managers of small-sized enterprises. Three themes emerged from the qualitative analysis: Changed leadership role, Impact on private life and Impact on well-being. In the interviews, the managers of micro-sized enterprises reported that the pandemic had increased their workload and forced them to mobilise strategies for enterprise survival. This study indicates that managers of micro-sized enterprises had changed their leadership role and increased their workload and number of work tasks, including supporting the employees, developing strategies for business survival and applying for governmental support. However, the managers demonstrated creativity in finding new solutions for their enterprises.
Asunto(s)
Personal Administrativo/psicología , COVID-19/prevención & control , Emprendimiento/estadística & datos numéricos , Pequeña Empresa/organización & administración , Equilibrio entre Vida Personal y Laboral , Carga de Trabajo/estadística & datos numéricos , COVID-19/epidemiología , Humanos , Salud Laboral/estadística & datos numéricos , Servicios de Salud del Trabajador/organización & administración , SueciaRESUMEN
OBJECTIVES: This study presents the results of catheter-directed foam sclerotherapy (CDS) for chronic venous ulcer refractory to compression treatment, four weeks and one year after treatment. METHODS: In sum, 31 patients (32 limbs) with refractory chronic venous ulcer and duplex-verified superficial insufficiency were offered CDS. CDS was conducted with 10 ml of sclerosant foam of 3% polidocanol. Four weeks and one year after treatment, the patients were evaluated regarding ulcer healing and ultrasound appearance of the saphenous trunk. RESULTS: CDS was successfully performed in all patients. After one year, 65% of the ulcers were healed. Only two (6%) recurred. 86% of the treated saphenous trunk were completely occluded, 3% was partly occluded and 10% were recanalised. No serious side effects occurred. CONCLUSIONS: CDS is one alternative of eliminating superficial venous reflux when treating refractory venous leg ulcers. This study suggests that the treatment is safe and induce a quick ulcer healing.
Asunto(s)
Soluciones Esclerosantes/uso terapéutico , Escleroterapia/métodos , Úlcera Varicosa/terapia , Adulto , Anciano , Anciano de 80 o más Años , Cateterismo , Enfermedad Crónica , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Recurrencia , Vena Safena/diagnóstico por imagen , Soluciones Esclerosantes/administración & dosificación , Escleroterapia/instrumentación , Resultado del Tratamiento , Ultrasonografía , Úlcera Varicosa/diagnóstico por imagen , Insuficiencia Venosa/diagnóstico por imagenRESUMEN
The objective was to determine the activation of white blood cells (WBCs) and endothelial cells in patients with healed venous ulcer and the influence of the standing position and of treatment with flavonoids. Ten patients with a healed venous ulcer were treated with flavonoid substance (90% diosmin), 1000 mg three times daily for 30 days. Blood samples were taken from arm and dorsal foot veins before and after standing for 30 minutes. Blood sampling was performed before treatment, after three days, one month and three months. The activation of WBCs was determined by measuring adhesion molecule CD11b and CD18 expression on the surface of granulocytes and monocytes. In addition, interleukin 6 (IL-6), IL-8, soluble E-selectin (sE-selectin), sL-selectin and sICAM-1 levels in serum were quantified. The results showed that standing did not influence any of the measured parameters significantly. Expression of CD11b adhesion molecules on granulocytes was significantly up-regulated (p = 0.044) after treatment with flavonoids for one month, but this increase was not significant (p = 0.056) two months after the treatment period compared with the baseline level. The expression of CD18 remained unchanged. Baseline expression of CD11b or CD18 on monocytes did not change significantly during the study period. Neither was any significant change observed in the levels of IL-6, IL-8 or the soluble adhesion molecules. It was concluded that flavonoid treatment for 30 days increased the expression of CD11b adhesion molecules on circulating granulocytes. No general effect on the inflammatory process could be observed as assessed by levels of cytokines and soluble adhesion molecules. Possible explanations for these findings could be that a decreased number of primed granulocytes leave the circulation due to a changed WBC/endothelial cell interaction or that flavonoids have a direct effect on granulocytes. Further studies are needed to clarify the mode of action of flavonoids in chronic venous disease.
Asunto(s)
Diosmina/uso terapéutico , Endotelio Vascular/efectos de los fármacos , Neutrófilos/efectos de los fármacos , Úlcera Varicosa/sangre , Adulto , Anciano , Antígenos CD18/sangre , Selectina E/sangre , Femenino , Citometría de Flujo , Humanos , Molécula 1 de Adhesión Intercelular/sangre , Interleucina-6/sangre , Interleucina-8/sangre , Selectina L/sangre , Masculino , Microcirculación/efectos de los fármacos , Persona de Mediana Edad , Estadísticas no ParamétricasRESUMEN
OBJECTIVE: To find out whether intraoperative angioscopic assistance has any effect on graft outcome in patients with critical leg ischemia. MATERIAL AND METHODS: One hundred one patients requiring a below-knee bypass were assigned to undergo in situ saphenous vein bypass with or without intraoperative angioscopic assistance; otherwise treated similarly including preoperative duplex vein mapping, intraoperative graft flow measurements, and angiography. Data on operative details, morbidity, hospital stay, and graft patency were collected prospectively and compared. All patients were followed up for 12 months. RESULTS: The group that underwent angioscopy (A) and the control group (B) were similar in all respects, except for the number of patients enrolled in the groups (32 and 69, respectively). Angioscopy revealed incompletely destructed valves in 34 patients (range, 0 to 5; mean 1), undiagnosed vein branches in 111 patients (mean 4.3), and partly occluding thrombus in 5 patients. The number of postoperative arteriovenous fistulas with signs of failing graft and a need for angiographic or surgical reintervention were significantly higher in group B (P <.0001). The 1-year primary patency rate was significantly better in group A (P <.01), but the primary assisted and secondary patency rates did not differ between the groups. CONCLUSIONS: Angioscopic assistance has an impact on primary graft patency, minimizes the risk for graft failure and thus reduces the need for reintervention by allowing identification of persistent saphenous vein branches, incomplete valve destruction, and partly occluding graft thrombus without adding extra operative time.