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BACKGROUND: Hemostasis control after percutaneous endovascular procedures through the femoral approach remains challenging for catheterization laboratory nurses, given method variability. OBJECTIVE: To summarize the available evidence on vascular devices efficacy dedicated to hemostasis control compared to the extrinsic compression after percutaneous procedures in the femoral vein or artery. METHODS: A systematic review with meta-analysis of randomized clinical trials was conducted. We compared different hemostasis methods in adult patients who underwent diagnostic and/or therapeutic procedures through femoral access. The databases searched were PubMed, Embase, CINAHL and Cochrane CENTRAL, and updated on 03/2022. The outcomes included hematoma, pseudoaneurysm, bleeding, minor and major vascular complication, time to hemostasis, device failure, and manual compression repetition. The risk of bias was assessed using the Cochrane Risk of Bias Tool 1.0. Pooled effect sizes on continuous, categorical and proportion variables were estimated with the random effects model. The continuous variables were summarized as the difference between means weighted by the inverse of variance (WMD), and the categorical ones by the summary of relative risks (RR), estimated by the DerSimonian and Laird method. The Freeman-Tukey method was used to estimate the summary effect of proportions. RESULTS: Fifty articles were included in the systematic review. When compared to extrinsic compression, vascular closure devices resulted in a relative risk reduction (RRR) for hematoma: RR 0.82 [95%CI 0.72 to 0.94] and in shorter time to hemostasis WMD -15.06 min [95%CI -17.56 to -12.56]; no association was observed between interventions with vascular closure devices and extrinsic compression for pseudoaneurysm, bleeding, minor and major vascular complications. Compared to extrinsic compression, sealant or gel type devices were compatible with a RRR for hematoma: RR 0.73 [95%CI 0.59 to 0.90]; and metal clip or staple type devices for pseudoaneurysm: RR 0.48 [95%CI 0.25 to 0.90]; and major vascular complication: RR 0.33 [95%CI 0.17 to 0.64]. For each 100 observations, the device failure rate for metal clip or staple was 3.28% [95%CI 1.69 to 6.27]; for suture 6.84% [95%CI 4.93 to 9.41]; for collagen 3.15% [95%CI 2.24 to 4.41]; and for sealant or gel 7.22% [95% CI 5.49 to 9.45]. CONCLUSIONS: Vascular closure devices performed better in hemostasis control. The certainty of the evidence was rated as very low to moderate. REGISTRATION: PROSPERO CRD42019140794.

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OBJECTIVES: To develop a nursing outcome, consistent with the standardized format of outcomes within the nursing Outcomes Classification (NOC). This outcome will include an outcome label, an outcome definition, and clinical indicators. The proposed use for this outcome is to evaluate the access site of a percutaneous procedure. METHODS: Concept analysis with a scoping review. Initially, content experts were recruited to validate the indicators of the proposed outcome in order to complete a consensus validation. After consensus validation, a review of the proposed outcome and its indicators was completed by two of the editors of the NOC team to confirm that the outcome label, definition, and indicators were consistent with the NOC taxonomy. During this review, edits were made on the label name and definition. FINDINGS: After a series of reviews, the initial outcome of Vascular Status: Percutaneous Procedure Access was changed to Tissue Injury Severity: Percutaneous Procedure. In addition, the original definition of the condition of an access site for percutaneous procedure by venous or arterial puncture and health of surrounding tissues was edited to: Severity of complications from a needle-puncture access through the skin and into deeper tissues. The outcome has 11 indicators to be used to formulate a target rating for use in the clinical setting. The indicators were not edited over the course of the reviews. CONCLUSION: The proposed outcome will assist nurses in evaluating the access site of percutaneous procedures and in identifying possible complications. IMPLICATIONS FOR THE NURSING PRACTICE: This research contributes to the refinement of the NOC taxonomy by having a new outcome that meets clinical practice needs.

OBJETIVOS: Desenvolver um resultado de enfermagem, consistente com o formato padronizado de resultados da Classificação dos Resultados de Enfermagem (NOC). Este resultado incluirá um título de resultado, uma definição de resultado e indicadores clínicos. O uso proposto para esse resultado é avaliar o local de acesso de um procedimento percutâneo. MÉTODOS: Análise de conceito com revisão de escopo. Inicialmente, especialistas de conteúdo foram utilizados para validar os indicadores do resultado proposto em uma validação por consenso. Após a validação por consenso, uma revisão do resultado proposto e de seus indicadores foi realizada por dois editores da equipe da Classificação dos Resultados de Enfermagem para confirmar o título do resultado, definição e indicadores para serem consistentes com a taxonomia NOC. Durante esta revisão, foram feitas edições no título e na definição. RESULTADOS: Após uma série de revisões, o resultado denominado inicialmente de Estado Vascular: Acesso Procedimento Percutâneo foi alterado para Gravidade da Lesão Tecidual: Procedimento Percutâneo. Além disso, a definição original de condição de um local de acesso de procedimento percutâneo por punção venosa ou arterial e saúde dos tecidos adjacentes foi editada para - Gravidade das complicações de um acesso por punção com agulha através da pele e em tecidos mais profundos. O resultado tem 11 indicadores a serem usados para formular uma classificação-alvo para uso no ambiente clínico. Os indicadores não foram editados ao longo das revisões. CONCLUSÃO: O resultado proposto auxiliará o enfermeiro a avaliar o local de acesso dos procedimentos percutâneos e identificar possíveis complicações. IMPLICAÇÕES PARA A PRÁTICA DE ENFERMAGEM: Esta pesquisa contribui para o refinamento da taxonomia NOC por ter um novo resultado que atende às necessidades da prática clínica.

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Introdução: Procedimentos percutâneos estão em ascensão e de forma expressiva o acesso femoral ainda é utilizado por muitas especialidades de laboratórios de cateterismo. A despeito do aprimoramento da técnica de punção e dos diferentes métodos de hemostasia, seu controle ainda é um desafio para as equipes dos laboratórios, principalmente pelos diferentes mecanismos de ação. Neste contexto, sumarizar as evidências para identificar as diferenças na eficácia e segurança seriam muito importantes para estas equipes. Objetivo: Conduzir uma revisão sistemática com metanálise comparando métodos de controle da hemostasia para o acesso femoral em pacientes submetidos a procedimento percutâneo. Métodos: Realizou-se uma revisão sistemática com metanálise de ensaios clínicos randomizados que compararam dispositivos de fechamento vascular e compressão extrínseca. A busca foi realizada no PubMed/MEDLINE, Embase, CINAHL e CENTRAL, sem delimitar início e com atualização em março de 2021. O risco de viés foi avaliado utilizando a ferramenta Cochrane Risk of Bias Tool (RoB) 1.0. Os parâmetros para dados contínuos, categóricos e de proporção de eventos foram estimados a partir do modelo de efeitos aleatórios. O nível de significância adotado foi de 0,05 e intervalo de confiança (IC) de 95%. Os dados contínuos foram apresentados como diferença entre médias ponderadas pelo inverso da variância (WMD), e parâmetros para riscos relativos (RR) foram estimados pelo método de DerSimonian and Laird. Para estimar a proporção de eventos de falha foi utilizado o método de Freeman-Tukey. Resultados: Foram incluídos 46 artigos para síntese qualitativa e 44 para quantitativa. Dispositivos de fechamento vascular comparados à compressão extrínseca resultaram em risco reduzido de hematoma: RR 0,82 [95% IC 0,72 a 0,94; P=0,005] e menor tempo de hemostasia: WMD -15,06 min [95% IC -17,56 a -12,56; P<0,00001]. Não houve diferença para pseudoaneurisma RR 0,84 [95% IC 0,54 a 1,30; P=0,44], sangramento RR 0,96 [95% IC 0,55 a 1,67; P=0,88], complicação vascular menor RR 0,80 [95% IC 0,60 a 1,06; P=0,12] e complicação vascular maior [0,69 (0,39 a 1,22); P=0,20]. Os dispositivos do tipo selante ou gel foram compatíveis com risco reduzido de hematoma RR 0,73 [95% IC 0,59 a 0,90; P=0,004] e dispositivos do tipo clip de metal/grampo com risco reduzido de pseudoaneurisma RR 0,48 [95% IC 0,25 a 0,90; P=0,02] e complicação vascular maior RR 0,33 [95% IC 0,17 a 0,64; P=0,001], quando comparados à compressão extrínseca. A taxa de falha do dispositivo foi de 3,28% (95% IC 1,69 a 6,27) para clip de metal/grampo, 7,09% (95% IC 4,91 a 10,15) para sutura, 3,04% (95% IC 2,10 a 4,37) para colágeno e 7,21% (95% IC 5,21% a 8,89%) para selante ou gel. Conclusões: Os dispositivos de fechamento vascular reduzem o risco de formação de hematoma e do tempo de hemostasia em comparação à compressão extrínseca. Os dispositivos do tipo selante ou gel e do tipo clip de metal ou grampo apresentaram melhor desempenho no controle da hemostasia em relação à compressão extrínseca, e os dispositivos do tipo colágeno tendem a menor proporção de eventos de falha entre os dispositivos. Um viés médio e um baixo grau de confiança foram observados nas estimativas de evidências.

Introduction: Percutaneous procedures are on the rise and femoral access is still significantly used by many specialties in catheterization laboratories. Despite the improvement of the puncture technique and the different hemostasis methods, its control is still a challenge for the laboratory teams, mainly due to the different mechanisms of action. In this context, summarizing the evidence to identify differences in efficacy and safety would be very important for these workers. Objective: To conduct a systematic review with meta-analysis comparing hemostasis control methods for femoral access in patients undergoing percutaneous procedure. Methods: A systematic review was carried out with a meta-analysis of randomized clinical trials that compared vascular closure devices and extrinsic compression. The search was carried out in PubMed/MEDLINE, Embase, CINAHL and CENTRAL, without delimiting the beginning and updated in March 2021. The risk of bias was assessed using the Cochrane Risk of Bias Tool (RoB) 1.0. The parameters for continuous, categorical and event proportion data were estimated from the random effects model. The level of significance adopted was 0.05 and the confidence interval (CI) was 95%. Continuous data were presented as a difference between averages weighted by the inverse of variance (WMD), and parameters for relative risks (RR) were estimated using the DerSimonian and Laird method. To estimate the proportion of failure events, the Freeman-Tukey method was used. Results: 46 articles were included for qualitative synthesis and 44 for quantitative. Vascular closure devices compared to extrinsic compression resulted in reduced risk of hematoma: RR 0.82 [95% CI 0.72 to 0.94; P = 0.005] and shorter hemostasis time: WMD -15.06 min [95% CI -17.56 to -12.56; P <0.00001]. There was no difference for RR pseudoaneurysm 0.84 [95% CI 0.54 to 1.30; P = 0.44], bleeding RR 0.96 [95% CI 0.55 to 1.67; P = 0.88], minor vascular complication RR 0.80 [95% CI 0.60 to 1.06; P = 0.12] and major vascular complication [0.69 (0.39 to 1.22); P = 0.20]. Sealant or gel type devices were compatible with reduced risk of hematoma RR 0.73 [95% CI 0.59 to 0.90; P = 0.004] and metal clip/staple type devices with reduced risk of pseudoaneurysm RR 0.48 [95% CI 0.25 to 0.90; P = 0.02] and major vascular complication RR 0.33 [95% CI 0.17 to 0.64; P = 0.001], when compared to extrinsic compression. The failure rate of the device was 3.28% (95% CI 1.69 to 6.27) for metal clip/staple, 7.09% (95% CI 4.91 to 10.15) for suture, 3.04% (95% CI 2.10 to 4.37) for collagen and 7.21% (95% IC 5.21% a 8.89%) for sealant or gel. Conclusions: Vascular closure devices reduce the risk of hematoma formation and hemostasis time compared to extrinsic compression. Sealant or gel and metal clip or staple devices performed better in controlling hemostasis in relation to extrinsic compression, and collagen type devices tend to have a lower proportion of failure events among devices. A medium bias and a low degree of confidence were observed in the evidence estimates.

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OBJECTIVE: To describe the implantation of a care quality indicator associated to the nursing diagnosis of patients at high risk of bleeding, based on the alarming results of prothrombin time (PT), partially activated thromboplastin time (aPTT) and platelets. METHODS: Retrospective experience report of multidisciplinary actions developed in a university hospital. The stages of the study involved team meetings, search for effective communication strategies and creation of a new indicator of quality of care. RESULTS: The indicator was called "Compliance of Nursing Diagnosis Risk for bleeding", monitored monthly since June 2016. The technical file includes the characteristics and attributes of the indicator. Based on the analyzes of the indicator, action plans are established for its qualification. CONCLUSION: The implementation of the quality of care indicator associated to the nursing diagnosis improved the communication process, the monitoring and the nursing care to patients at risk of bleeding.

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OBJECTIVE: To describe the process of implanting the surgical safety checklist in a catheterization laboratory (CL). METHOD: Descriptive case report study about the safety strategies developed in the last six years in a university hospital in the southern region of Brazil. RESULTS: The six international patient safety goals (IPSG) were incorporated into the care practice in accordance with the hospital's Joint Comission International (JCI) accreditation program, through a continuous process of educational nature. The checklist was adapted considering the characteristics of the unit and the procedures performed. CONCLUSION: The implementation of the checklist provided the promotion of patient safety, greater staff integration, advances in communication among professionals and the recording of in-room care information.

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Resumo OBJETIVO Descrever a implantação de um indicador de qualidade assistencial associado ao diagnóstico de enfermagem de pacientes com alto risco de sangramento, com base nos resultados alarmantes de tempo de protombina (TP), tempo de tromboplastina parcialmente ativada (TTPa) e plaquetas. MÉTODOS Relato de experiência retrospectivo de ações multidisciplinares desenvolvidas em um hospital universitário. As etapas do estudo envolveram reuniões de equipes, busca de estratégias de comunicação efetiva e criação de um novo indicador de qualidade assistencial. RESULTADOS O indicador foi denominado "Conformidade do Diagnóstico de Enfermagem Risco de Sangramento", monitorado mensalmente desde junho de 2016. A ficha técnica contempla as características e atributos do indicador. Com base nas suas análises são estabelecidos planos de ações para sua qualificação. CONCLUSÃO A implantação do indicador de qualidade assistencial associado ao diagnóstico de enfermagem aprimorou o processo de comunicação, monitoramento e cuidado de enfermagem a pacientes com risco de sangramento.

Resumen OBJETIVO Describir la implementación de un indicador de calidad asistencial asociado al diagnóstico de enfermería de pacientes con alto riesgo de sangrado, con base en los resultados alarmantes de tiempo de protombina (Tp), tiempo de tromboplastina parcialmente activada (TTPa) y plaquetas. MÉTODO Relato de experiencia retrospectiva de acciones multidisciplinares desarrolladas en un hospital universitario. Las etapas del estudio involucraron reuniones de equipos, búsqueda de estrategias de comunicación efectiva y creación de un nuevo indicador de calidad asistencial. RESULTADOS El indicador se denominó "Conformidad del Diagnóstico de Enfermería Riesgo de Sangrado", y se monitoreó mensualmente desde junio de 2016. La ficha técnica contempla las características y atributos del indicador. Con base en los análisis del indicador se establecen planes de acción para su cualificación. CONCLUSIÓN La implementación del indicador de calidad asistencial asociado al diagnóstico de enfermería mejoró el proceso de comunicación, el monitoreo y el cuidado de enfermería a pacientes con riesgo de sangrado.

Abstract OBJECTIVE To describe the implantation of a care quality indicator associated to the nursing diagnosis of patients at high risk of bleeding, based on the alarming results of prothrombin time (PT), partially activated thromboplastin time (aPTT) and platelets. METHODS Retrospective experience report of multidisciplinary actions developed in a university hospital. The stages of the study involved team meetings, search for effective communication strategies and creation of a new indicator of quality of care. RESULTS The indicator was called "Compliance of Nursing Diagnosis Risk for bleeding", monitored monthly since June 2016. The technical file includes the characteristics and attributes of the indicator. Based on the analyzes of the indicator, action plans are established for its qualification. CONCLUSION The implementation of the quality of care indicator associated to the nursing diagnosis improved the communication process, the monitoring and the nursing care to patients at risk of bleeding.

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Resumo OBJETIVO Descrever o processo de implantação da lista de verificação de segurança cirúrgica em laboratório de cateterismo (LC). MÉTODO Estudo descritivo do tipo relato de experiência das estratégias de segurança desenvolvidas nos últimos seis anos em hospital universitário da região Sul do Brasil. RESULTADOS Foram incorporadas na prática assistencial as seis metas internacionais de segurança do paciente (MISP) em consonância com o programa de acreditação hospitalar pela Joint Comission International (JCI), por meio de um processo contínuo com caráter educativo. A lista de verificação foi adaptada considerando as características da unidade e os procedimentos realizados. CONCLUSÕES A implantação da lista de verificação proporcionou a promoção da segurança do paciente, maior integração da equipe, avanços na comunicação entre os profissionais e no registro das informações da assistência em sala.

Resumen OBJETIVO Describir el proceso de implantación de la lista de verificación de seguridad quirúrgica en un laboratorio de cateterismo (LC). MÉTODO Estudio descriptivo del tipo relato de experiencia sobre las estrategias de seguridad desarrolladas en los últimos seis años en un hospital universitario de la región Sur de Brasil. RESULTADOS Se incorporaron en la práctica asistencial las seis metas internacionales de seguridad del paciente (MISP) en consonancia con el programa de acreditación hospitalaria por la Joint Comission International (JCI), a través de un proceso continuo con carácter educativo. La lista de verificación fue adaptada considerando las características de la unidad y los procedimientos realizados. Conclusión: La implantación de la lista de verificación proporcionó la promoción de la seguridad del paciente, una mayor integración del equipo, avances en la comunicación entre los profesionales y en el registro de las informaciones de la asistencia en sala.

Abstract OBJECTIVE To describe the process of implanting the surgical safety checklist in a catheterization laboratory (CL). METHOD Descriptive case report study about the safety strategies developed in the last six years in a university hospital in the southern region of Brazil. RESULTS The six international patient safety goals (IPSG) were incorporated into the care practice in accordance with the hospital's Joint Comission International (JCI) accreditation program, through a continuous process of educational nature. The checklist was adapted considering the characteristics of the unit and the procedures performed. CONCLUSION The implementation of the checklist provided the promotion of patient safety, greater staff integration, advances in communication among professionals and the recording of in-room care information.

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OBJECTIVE: To map the production of knowledge on vascular access complications in patients undergoing percutaneous procedures in hemodynamic laboratories. METHODS: Scoping review study. The search strategy was developed in three stages, considering the period from July 2005 to July 2015 in the PubMed, CINAHL, Scopus, and LILACS databases. The collected data were analyzed and summarized in a narrative form. RESULTS: One-hundred twenty-eight publications that made it possible to map the contexts of study of complications, occurrence according to access routes, as well as an understanding of diagnosis and clinical management, were included. Three theme categories were identified: complications; predictive factors; and diagnosis/treatment. CONCLUSION: Vascular access site complications range according to the access route used. Knowledge of factors that permeate the occurrence of these events may contribute to early detection, planning, and monitoring of the care implemented.

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BACKGROUND: Interleukin-6 (IL-6) plays a central role in atherosclerosis and inflammation. It may improve risk prediction in patients at intermediate cardiovascular risk. OBJECTIVE: To analyze the impact of serum IL-6 in predicting early angiographic coronary artery disease in patients at intermediate cardiovascular risk with chest pain. METHODS: In a cross-sectional study, patients referred for coronary angiography due to suspected coronary artery disease (CAD) were included. Coronary artery disease was defined as the presence of at least 30% stenosis in one or more coronary artery. Severity of CAD was classified by the anatomic burden score. Performance of serum IL-6 assay was compared with ACC/AHA atherosclerotic cardiovascular disease (ASCVD) risk score and hs-CRP through receiver operating characteristic (ROC) curves. RESULTS: We have included 48 patients with a mean 10-year ASCVD risk of 10.0 ± 6.8%. The prevalence of CAD was 72.9%. The presence of CAD was associated with higher mean levels of IL-6 (p = 0.025). Patients with CAD had significantly more overweight than subjects without CAD. In 27% of patients, IL-6 was >1.0 pg/mL and 100% of these patients had CAD, while only 64% in those with IL-6 <1.0 pg/mL, corresponding to a positive predictive value of 100% (p = 0.015). The area under the receiver operating characteristic (ROC) curve of IL-6, hs-CRP and ASCVD were respectively 0.72, 0.60 and 0.54. Intermediate risk patients with IL-6 >1.0 pg/mL were further reclassified into ASCVD high risk due to the presence of coronary lesions. CONCLUSION: In intermediate risk patients referred for coronary angiography, a serum IL-6 level above 1 pg/mL is predictive of significant CAD. IL-6 determination may be useful to reclassify ASCVD intermediate risk patients into higher risk categories.

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Resumo OBJETIVO Mapear a produção de conhecimento acerca das complicações do acesso vascular em pacientes submetidos a procedimentos percutâneos em Laboratório de Hemodinâmica. MÉTODOS Estudo do tipo revisão de escopo. Elaborou-se estratégia de busca em três etapas, considerando o período entre julho de 2005 e 2015, nas bases de dados PubMed, CINAHL, Scopus e LILACS. Os dados extraídos foram analisados e sintetizados de forma narrativa. RESULTADOS Foram incluídas 128 publicações que permitiram mapear os contextos de estudo das complicações, a ocorrência de acordo com as vias, bem como a compreensão do diagnóstico e manejo clínico. Como síntese da análise identificou-se três categorias temáticas: Complicações; Fatores preditores; e Diagnóstico/tratamento. CONCLUSÃO As complicações no local do acesso vascular são de ocorrência variável conforme a via de acesso utilizada. O conhecimento dos fatores que permeiam a ocorrência destes eventos podem auxiliar no reconhecimento precoce, planejamento e monitorização dos cuidados implementados.

Resumen OBJETIVO Mapear la producción de conocimiento acerca de las complicaciones del acceso vascular en pacientes sometidos a procedimientos percutâneos en el Laboratorio de Hemodinamia. MÉTODOS Estudio de tipo revisión de escopo. Se elaboró la estrategia de búsqueda en tres etapas, considerando el período comprendido entre julio 2005 y 2015, en las bases PubMed, CINAHL, Scopus y LILACS. Los datos extraídos fueron analizados y sintetizados de forma narrativa. RESULTADOS Fueron incluidas 128 publicaciones que permitieron mapear los contextos de estudio de las complicaciones, la ocurrencia de acuerdo con las vías, así como la comprensión del diagnóstico y manejo clínico. Como síntesis del análisis se identificó tres categorías temáticas: Complicaciones, Factores predictores y Diagnóstico/tratamiento. CONCLUSIÓN Las complicaciones en el sitio del acceso vascular son de ocurrencia variable de acuerdo con la vía de acceso utilizada. El conocimiento de los factores que están presentes en la ocurrencia de estos eventos puede auxiliar en el reconocimiento temprano, planeamiento y control de la atención implementados.

Abstract OBJECTIVE To map the production of knowledge on vascular access complications in patients undergoing percutaneous procedures in hemodynamic laboratories. METHODS Scoping review study. The search strategy was developed in three stages, considering the period from July 2005 to July 2015 in the PubMed, CINAHL, Scopus, and LILACS databases. The collected data were analyzed and summarized in a narrative form. RESULTS One-hundred twenty-eight publications that made it possible to map the contexts of study of complications, occurrence according to access routes, as well as an understanding of diagnosis and clinical management, were included. Three theme categories were identified: complications; predictive factors; and diagnosis/treatment. CONCLUSION Vascular access site complications range according to the access route used. Knowledge of factors that permeate the occurrence of these events may contribute to early detection, planning, and monitoring of the care implemented.

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