Safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery: prospective and multicentric trial.

BACKGROUND: The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA). METHODS: From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were: initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months. RESULTS: Most patients (56.6%) were men and the mean age was 68.59 (33.1-99.15) years. 25.3% of the total population had intermittent claudication and 73.5% presented with critical limb ischemia. Most lesions were total occlusions (75.9%) and the mean lesion length was 71.16 mm. Contralateral femoral access was performed in 26.5%cases, and ipsilateral femoral approach was used for the remaining 73.5% patients. Technical and arteriographic success was obtained in all 83 (100.00%) patients. Duplex controlled primary patency rate at 6 and 12 months was 95.8% and 76.1%, respectively. The freedom from target lesion revascularization rate was 98.7% and 92.6% at 6 and 12 months, respectively. No stent fractures were observed in this study. Major adverse event rate at 1 year (clinically driven TLR, major amputation, and all-cause mortality) was 15.7%: two target lesion revascularizations (2.4%), one major amputation (1.2%) and ten deaths not related to the procedure (12%). CONCLUSIONS: In conclusion, this study demonstrates the safety and efficacy of the EPIC™ Nitinol Vascular Stent System for the treatment of SFA lesions.

Safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery: prospective and multicentric trial

BACKGROUND: The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA).METHODS: From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were: initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months.

Vivência de mães no alojamento conjunto frente ao Método Mãe-canguru / Mothers´lived experience in the rooming-in facing the Kangaroo-mother Method / La vivencia de madres en el alojamiento conjunto frente al Método Madre-Canguro

Objetivos: descrever a vivência de mães frente ao Método Mãe Canguru (MM-C) no alojamento conjunto e identificar o envolvimento da família nesse processo. Método: estudo descritivo qualitativo utilizando como técnica de coleta o grupo focal com entrevistas gravadas em dois grupos de puérperas mães-canguru no alojamento conjunto de uma maternidade pública em Natal/RN, no período de uma semana, a partir de um roteiro temático: vivência de mães frente ao MM-C em alojamento conjunto e o envolvimento da família nesse processo. O estudo foi aprovado pelo Comitê de Ética em Pesquisada UFRN com Parecer Consubstanciado Prot. Nº 84/03 CEP-UFRN. Resultados: emergiram três núcleos temáticos: Ajudando o filho no desenvolvimento lento, passo a passo; Favorecendo o contato com o bebê que deveria ainda estar no útero e Expectando a cada dia o aumento e a adaptação do bebê. Conclusões: apesar das dificuldades em se manter esse método pelas dificuldades institucionais na atualidade, ainda é um método eficiente. Essas dificuldades podem ser minimizadas pelas políticas perinatais vigentes, visando prevenção de danos à saúde de bebês prematuros, gerando tranquilidade para toda equipe neonatal e familiar.(AU)

Objective: to describe the experience of mothers facing the Kangaroo-Mother Method (KMM) in rooming-in and identify the family involvement in this process. Method: qualitative and descriptive study using as a data-collection technique the focus group with recorded interviews, in two groups of kangaroo-mothers puerperas in a rooming-in of a public maternity on Natal/RN, in the period of one week, from the research thematic entitled: experience of mothers facing the KMM in rooming-in and the family involvement in this process. The study was approved by the Ethics in Research Committe of UFRN, under Embodied Opinion Prot. No. 84/03 CEP-UFRN Results: it emerged three thematic points: Helping child in developing slowly, step by step; Promoting contact with the baby that should still be in the womb; and expecting every day for the baby's growing and adjustment. Conclusion: despite the difficulties in keeping this method by institutional problems nowadays, it is still an efficient method. These difficulties can be minimized by existing perinatal policies, aimed at preventing damage to the health of premature babies, creating peacefulness for the neonatal healthcare team and the whole family.(AU)

Objetivos: describir la vivencia de madres frente al Método Madre-Canguro (MM-C) en el alojamiento conjunto, e identificar el envolvimiento de la familia en ese proceso. Método: estudio descriptivo y cualitativo utilizando como técnica de colecta el grupo focal con entrevistas grabadas en dos grupos de puérperas madres-canguro en el alojamiento conjunto de una maternidad pública en Natal/RN, en el período de una semana. A partir de un rotero temático: vivencia de Madres frente al MM-C en alojamiento conjunto y el envolvimiento de la familia en ese proceso. El estudio fue aprobado por el Comité de Ética en Pesquisa de la UFRN con parecer justificado a través del registro número 84/03 CEPUFRN. Resultados: emergieron tres núcleos temáticos: Ayudando al hijo en el proceso de desarrollo lento, paso a paso; Favoreciendo el contacto con el bebe que debería estar todavía en el útero; Observando a cada día el aumento y la adaptación del bebe. Conclusiones: a pesar de las dificultades en mantenerse ese método por las dificultades institucionales en la actualidad todavía es un método eficiente. Esas dificultades pueden ser minimizadas por las políticas perinatales vigentes visualizando la prevención de daños a la salud de bebes prematuros, generando tranquilidad para todo el equipo neonatal y familiar.(AU)