Study protocol of a prospective single-arm multicenter clinical study to assess the safety and performance of the aXess hemodialysis graft: The pivotal study.

BACKGROUND: Arteriovenous grafts (AVGs) are used for patients deemed unsuitable for the creation of an autogenous arteriovenous fistula (AVF) or unable to await maturation of the AVF before starting hemodialysis. However, AVGs are prone to infection and thrombosis resulting in low long-term patency rates. The novel aXess Hemodialysis Graft consists of porous polymeric biomaterial allowing the infiltration by cells and the growth of neotissue, while the graft itself is gradually absorbed, ultimately resulting in a fully functional natural blood vessel. The Pivotal Study will examine the long-term effectiveness and safety of the aXess Hemodialysis Graft. METHODS: The Pivotal Study is a prospective, single-arm, multicenter study that will be conducted in 110 subjects with end-stage renal disease who are not deemed suitable for the creation of an autogenous vascular access. The primary efficacy endpoint will be the primary patency rate at 6 months. The primary safety endpoint will be the freedom from device-related serious adverse events at 6 months. The secondary endpoints will include the procedural success rate, time to first cannulation, patency rates, the rate of access-related interventions to maintain patency, the freedom from device-related serious adverse events and the rate of access site infections. Patients will be followed for 60 months. An exploratory Health Economic and Outcomes Research sub-study will determine potential additional benefits of the aXess graft to patients, health care institutions, and reimbursement programs. DISCUSSION: The Pivotal study will examine the long-term performance and safety of the aXess Hemodialysis Graft and compare the outcome measures with historical data obtained with other graft types and autogenous AVFs. Potential advantages may include superior long-term patency rates and lower infection rates versus currently available AVGs and a shorter time to first cannulation compared to an autologous AVF. As such, the aXess Hemodialysis Graft may fulfill an unmet clinical need in the field of hemodialysis access.

Mal-positioning of a dialysis catheter: One lumen with arterial blood and the other with venous blood?

Partial anomalous pulmonary vein drainage is a rare congenital defect, where the pulmonary vein drains into a systemic vein instead of draining into the left atrium. We present a case of a 63-year-old woman on hemodialysis who was found to have a right pulmonary vein with anomalous drainage to the superior vena cava after mal-positioning of a dialysis catheter, which demonstrated unexpected blood results from the different lumina of the catheter. Multiple imaging techniques were used to deal with this rare clinical situation. This is the first case reporting a mal-positioning of a left-side internal jugular vein tunneled catheter into a right-side pulmonary vein.

Patient-Centered Care for Patients with Depression or Anxiety Disorder: An Integrative Review.

People have specific and unique individual and contextual characteristics, so healthcare should increasingly opt for person-centered care models. Thus, this review aimed to identify and synthesize the indicators for the care process of the person with depression and/or anxiety disorders, based on patient-centered care, going through the stages of diagnostic assessment and care planning, including intervention. An integrative literature review with research in seven scientific databases and a narrative analysis were carried out. Twenty articles were included, with indicators for diagnostic evaluation and care/intervention planning being extracted. Care planning focused on people with depression and/or anxiety disorder must be individualized, dynamic, flexible, andparticipatory. It must respond to the specific needs of the person, contemplating the identification of problems, the establishment of individual objectives, shared decision making, information and education, systematic feedback, and case management, and it should meet the patient's preferences and satisfaction with care and involve the family and therapeutic management in care. The existence of comorbidities reinforces the importance of flexible and individualized care planning in order to respond to the specific health conditions of each person.

Detection of amastigotes and histopathological alterations in the thymus of Leishmania infantum-infected dogs.

INTRODUCTION: In canine visceral leishmaniasis (CVL), lymphopenia, and the disorganization of lymphoid organs such as spleen and lymph nodes have been demonstrated. However, the involvement of thymus in CVL has not been evaluated so far. Herein, we investigated whether the thymus can be colonized by Leishmania infantum in naturally infected dogs. METHODS: Thymus were obtained from 16 of 58 dogs and samples of this organ were submitted to immunohistochemistry for laminin and fibronectin detection, histopathology, in situ hybridization and polymerase chain reaction (PCR) targeting the gene ITS-1 for Leishmania and sequenced. Samples of spleen, skin and popliteal lymph nodes were collected and submitted to immunohistochemistry and parasitological culture followed by multilocus enzyme electrophoresis. RESULTS: L. infantum was identified in all dogs. DNA and amastigote forms of Leishmania were detected in the thymus from 16 dogs by PCR and in eight by immunohistochemistry. Besides thymus, parasites were detected in spleen, lymph nodes, and skin. A granulomatous or pyogranulomatous thymitis was observed in eight dogs associated to intact amastigotes forms of this parasite. Fibronectin deposition in thymus was higher in dogs with more clinical signs. CONCLUSIONS: These results demonstrate that the thymus of dogs can be parasitized by L. infantum, which may generate inflammatory reactions leading to alterations in thymic microarchitecture.

Tubulointerstitial nephritis and uveitis syndrome in a female adult.

Tubulointerstitial nephritis and uveitis (TINU) syndrome is a rare disease characterised by the association of acutetubulointerstitial nephritis and uveitis. It affects mainly children and young women. Drugs and infections may be precipitating factors. It is a diagnosis of exclusion. The mainstays of treatment are topical and systemic corticosteroids. Prognosis is usually favourable. We report a case of TINU which occurred in our unit. A 37-year-old woman presented with an influenza-like illness, bilateral ocular pain and blurred vision. Ophthalmological evaluation revealed bilateral anterior uveitis and later renal involvement was seen as acute tubulointerstitial nephritis. A diagnosis of TINU was assumed after exclusion of other systemic diseases. She was treated with topical corticosteroids for the uveitis and evolved favourably, with resolution of ocular symptoms and normalisation of serum creatinine and proteinuria. This case highlights the importance of a high degree of clinical suspicion to make the diagnosis of TINU syndrome.

Performance of Alere™ immunochromathographic test for the diagnosis of canine visceral leishmaniasis.

The diagnosis and control of canine visceral leishmaniasis (CVL) has fundamental importance in the control of human visceral leishmaniasis. In this context, the immunochromathographic test (ICT) has emerged as a valuable diagnostic tool. Currently, in Brazil, the algorithm for the diagnosis of CVL uses Dual Path Platform (DPP) ICT as a screening test and ELISA as a confirmatory test. However, the DPP(®) ICT has been facing a problem of insufficient production to meet the national demand. Here, the Alere™ canine visceral leishmaniasis ICT was tested with serum samples from 159 dogs, including symptomatic, asymptomatic and healthy dogs, characterized by DPP(®) ICT and ELISA (panel A), or ELISA and Indirect Immunofluorescence Assay (IFA) (panel B), and parasitological examination as gold standard. In this study, the Alere™ ICT obtained 0.974 sensitivity for panel A and 0.854 sensitivity for panel B. The specificity was 1.0 for both panels. Thus, the Alere™ ICT has potential to be used for the serological diagnosis of CVL.

O uso do Miniex como ferramenta de feedback continuado para residente de medicina de família e comunidade em estágio na atenção primária à saúde / The use of Miniex as a continuous feedback tool for a family and community medicine resident in internship at primary health care / El uso de Miniex como herramienta de feedback continuado para residente de medicina de familia y comunidad en práctica en la atención primaria a la salud

Introdução: A consulta é central no trabalho do médico de família e comunidade. A avaliação da performance do residente e discussões acerca da adequada condução deve ser estimulada. Objetivo: Discutir sobre o uso do Miniex para avaliação sequenciada de performance do residente durante consultas. Métodos: Explanação sobre as discussões teóricas acerca do desenvolvimento de consulta médica seguidas de aplicação do Miniex com avaliação focada nas competências esperadas do médico de família e comunidade. Discussão: Manuais de programas de residências e associações relacionadas têm por vezes citado o Miniex como possibilidade de avaliação do residente, mas não orientam seu uso sistematizado, o que poderia deixar pouco eficiente e descolada sua aplicação. Ademais, pouca discussão existe sobre a interpretação dos componentes do método e o modelo esperado de consulta ideal nas diferentes especialidades. Conclusão: O Miniex é potente instrumento de mudança, mas seu uso deve apontar para um modelo profissional e ser estimulado ao longo de todo o programa de residência.

Introduction: The consultation is central in the work of the family doctor. The assessment of the resident's performance and discussions about right guidance should be encouraged. Objective: To discuss the use of Miniex to evaluate the resident's sequenced performance during consultations. Methods: Explanation about the theoretical discussions about the development of medical consultation followed by application of Miniex with evaluation focused on the expected competencies of the family and community doctor. Discussion: Manuals of residential programs and related associations have sometimes cited the Miniex as a possibility of evaluation of the resident but do not guide their systematic use, which could leave little efficient and detached its application. In addition, little discussion exists on the interpretation of the components of the method and the expected model of ideal consultation in the different specialties. Conclusion: Miniex is a powerful tool for change but its use should point to a professional model and be stimulated throughout the residency program.

Introducción: La consulta es central en el trabajo del médico de familia y comunidad. La evaluación del desempeño del residente y las discusiones sobre la adecuada conducción debe ser estimulada. Objetivo: Discutir sobre el uso de Miniex para la evaluación secuenciada de desempeño del residente durante las consultas. Métodos: Explanación sobre las discusiones teóricas sobre el desarrollo de consulta médica seguida de aplicación del Miniex con evaluación enfocada en las competencias esperadas del médico de familia y comunidad. Discusión: Los manuales de programas de residencias y asociaciones relacionadas tiene a veces citado el Miniex como posibilidad de evaluación del residente, pero no orientan su uso sistematizado, lo que podría dejar poco eficiente y despegado su aplicación. Además, poca discusión existe sobre la interpretación de los componentes del método y el modelo esperado de consulta ideal en las diferentes especialidades. Conclusión: Miniex es un potente instrumento de cambio pero su uso debe apuntar a un modelo profesional y ser estimulado a lo largo de todo el programa de residencia.

Visitas domiciliares pela equipe de Saúde da Família: reflexões para um olhar ampliado do profissional / Home Visits by the Family Health Team: thoughts about the need for a broader professional view

As visitas domiciliares assumem papel fundamental na organização do trabalho das equipes do Programa de Saúde da Família (PSF). Contudo, romper com o paradigma biomédico exige uma vigilância nem sempre fácil ou simples, com o objetivo de ampliar o olhar do profissional. Pensando em resolver essa questão, a Equipe Laranja do Centro de Saúde Jardim Montanhês desenvolveu ficha de visita domiciliar, apresentada neste artigo, visando facilitar o planejamento do cuidado do paciente e atentar para questões que fujam à simples intervenção sobre o corpo doente.

Home visits play an essential role in the work of the Family Health Teams. However, breaking the biomedical model and gaining a more comprehensive view of the patients' needs is not always easy or simple. In an attempt to solve this question, the Orange Team of the Health Center Jardim Montanhês created a home visit record form, presented in this paper. This form is aimed at providing information necessary for planning the patient's care and allows taking knowledge of questions that reach beyond the simple treatment of the diseased body.