RESUMO
BACKGROUND: Leadless pacemakers were developed to reduce complications associated with transvenous pacemaker implantation and long-term follow-up. Existing international guidelines lack detailed instructions on patients suitable for leadless pacemaker implantation. Our aim was to develop a consensus document that provides medical guidance for all health professionals involved in the indication and implantation of Transcatheter Pacing System single-chamber device (VR leadless) pacemakers for patients with atrial fibrillation or in sinus rhythm. METHODS: A panel of experts, including interventional and non-interventional cardiologists, used the Research ANd Development/University of California at Los Angeles (RAND/UCLA) method to rate the appropriateness of leadless pacemaker implantation for 64 scenarios in patients with atrial fibrillation and 192 scenarios in sinus rhythm. The scenarios were rated individually and again during a moderated group session. Median ratings and level of agreement were calculated to classify each scenario as appropriate, inappropriate, or questionable. RESULTS: This consensus statement, based on available literature and the experts' opinions, summarizes recommendations for standardizing and optimizing leadless pacemaker implantation. The limitation for vascular access via the superior vena cava was the most influential variable when indicating leadless pacemaker implantation in both patients with atrial fibrillation and patients in sinus rhythm. CONCLUSIONS: Life expectancy, risk of infection, prosthetic valve, left ventricular ejection fraction (LVEF), limitation for vascular access via the superior vena cava, and mobility and exercise capacity determine who is advised to undergo VR leadless pacemaker implantation. More prospective studies are needed to optimize existing recommendations.
Assuntos
Fibrilação Atrial , Marca-Passo Artificial , Realidade Virtual , Humanos , Fibrilação Atrial/terapia , Volume Sistólico , Veia Cava Superior , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
Objetivos: Evaluar sistemáticamente la evidencia publicada en relación con la utilidad de la ecografía y de la resonancia magnética nuclear (RMN) en la evaluación de la respuesta al tratamiento en pacientes con artritis por depósito de cristales de urato monosódico. Métodos: Revisión sistemática. Se definió una estrategia de búsqueda bibliográfica sensible en MEDLINE (desde 1960), EMBASE (desde 1980) y Cochrane Library (Central) y búsqueda manual en lo publicado en congresos internacionales (EULAR, ACR), seleccionando estudios que evaluasen la respuesta al tratamiento de los pacientes con gota (AINE, hipouricemiantes, etc., independientemente del tipo, de la dosis y de la duración del tratamiento e independientemente del criterio seleccionado para el diagnóstico, el tipo y el número de articulaciones afectadas) mediante pruebas de imagen (ecografía y/o RMN). Se seleccionaron metaanálisis, revisiones sistemáticas, ensayos clínicos, cohortes de calidad y estudios de validación. Resultados: Los estudios incluid fueron 3 series de casos, de diseno prospectivo, en los que se analizó un total de 36 pacientes con artritis gotosa y en los que se evaluó la respuesta al tratamiento hipouricemiante mediante ecografía. No hubo ningún estudio que analizara la respuesta al tratamiento hipouricemiante con RMN. Todos los pacientes incluidos tenían valores basales de uricemia por encima de las recomendaciones EULAR. La mejoría en los hallazgos ecográficos se correlacionó con la reducción de los valores séricos de ácido úrico en todos los estudios. Conclusiones: El uso de la ecografía parece útil en la evaluación de la respuesta al tratamiento hipouricemiante en los pacientes con artritis gotosa (nivel de evidencia 3a; grado de recomendación B). Actualmente no se dispone de ninguna evidencia para analizar la utilidad de la RMN en la evaluación del tratamiento de los pacientes con artritis gotosa (AU)
Background: Imaging may be useful for monitoring response to therapy. Within the OMERACT proposal for the core set domains for outcome measures in chronic gout, serum urate levels, recurrence of gouty flares, tophus regression, and joint damage imaging have been included, among other proposed issues. Objectives: To perform a systematic literature review of the usefulness of magnetic resonance imaging (MRI) and ultrasound (US) on assessment of treatment response in patients with gout. Methods: MEDLINE, EMBASE, Cochrane Library (up to February 2012), and abstracts presented at the 2010 and 2011 meetings of the American College of Rheumatology and European League Against Rheumatism, were searched for treatment studies of any duration and therapeutic options, examining the ability of MRI/US to assess treatment response in gouty patients. Meta-analyses, systematic reviews, randomized clinical trials, cohort and case-control studies and validation studies were included. Quality was appraised using validated scales. Results: There were only 3 US published studies in the literature that analysed US utility on assessment of response to treatment in patients with gout. All of them were prospective case studies with a small number of patients and they were reviewed in detailed. A total of 36 patients with gout were examined with US. All of them had a baseline serum urate > 6 mg/dL. US features of gout (double contour sign, hyperechoic spots in synovial fluid, hyperechoic cloudy areas, tophus diameter and volume) achieved significant reduction in patients who reached the objective of uricemia ≤ 6 mg/dL in all the studies; however, patients in whom levels did not drop below 6 mg/dL had no change of US features of gout. Other parameters evaluated in one study included ESR, CRP, number of tender joints (TRN), number of swollen joints, and pain score (SP). All of them decreased with uricemia reduction, but only TRN and SP were statistically significant. No data was found on the value of MRI on treatment response assessment in patients with gout. Conclusions: The improvement in ultrasound features shows concurrent validity with uric acid reduction. ccording to the published evidence, US can be a useful tool for monitoring treatment of gouty patients, although more research is needed. The value of MRI on treatment response assessment in patients with gout remains to be determined (AU)
Assuntos
Humanos , Gota/epidemiologia , Espectroscopia de Ressonância Magnética , Ultrassonografia , Supressores da Gota/uso terapêutico , Resultado do Tratamento , Hiperuricemia/tratamento farmacológico , Anti-Inflamatórios não Esteroides/uso terapêuticoRESUMO
Objetivo. Determinar la eficacia y la seguridad de denosumab en la osteoporosis. Métodos. Se realizó una búsqueda sistemática en MEDLINE, EMBASE y el Registro Central Cochrane de ensayos controlados (de 1950 a Julio de 2010), resúmenes de congresos (2009-2010), registros de ensayos y listas de referencias. Los criterios de selección fueron los siguientes: (población) pacientes con osteoporosis de cualquier edad; (intervención) tratamiento con denosumab; (desenlace) eficacia y seguridad; (diseño del estudio) ensayos clínicos con selección aleatoria; sin restricciones de idioma. Dos revisores independientes revisaron títulos y resúmenes y posteriormente extrajeron los datos de los estudios seleccionados, incluyendo elementos de calidad y desenlaces de interés. Se realizó un metanaálisis con los datos de seguridad. Resultados. Se incluyeron 25 estudios. El denosumab reduce el riesgo de fracturas radiográficas nuevas en un 68% en comparación con el placebo (p<0,001); incrementa la de densidad mineral ósea (DMO) en la columna lumbar, la cadera total y el tercio distal del radio, más que el alendronato y el placebo. Una dosis subcutánea única de denosumab provocó una disminución rápida, profunda, sostenida y dosis-dependiente de los marcadores de remodelado óseo (MRO). El denosumab fue bien tolerado en general. El metananálisis mostró un aumento en la incidencia de infecciones urinarias (p=0,012) y eczema (p<0,001) en los pacientes tratados con denosumab. No se pudo realizar metaanálisis de eficacia debido a la heterogeneidad de los estudios. Conclusiones. El denosumab administrado por vía subcutánea, 2 veces al año, se asocia con una reducción en el riesgo de fracturas vertebrales, no vertebrales y de cadera, en mujeres con osteoporosis. El denosumab se asocia con un incremento mayor y sostenido en la DMO, y una reducción en los MRO, en comparación con el placebo y el alendronato, así como con un riesgo aumentado de infecciones urinarias y eczema (AU)
Purpose: To determine the efficacy and safety of denosumab in osteoporosis. Methods: A systematic search was performed in MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (1950 to July 2010), meeting abstracts (20092010), trial registries, and reference lists. The selection criteria were as follows: (population) osteoporosis patients of any age; (intervention) treatment with denosumab; (outcome) efficacy and safety; (study design) randomized clinical trials (RCTs); no language restrictions. Two reviewers independently screened titles and abstracts and subsequently extracted data from the selected studies including quality items, and on outcomes of interest. A meta-analysis was performed for safety issues. Results: A total of 25 studies were included. Denosumab reduces the risk of new radiographic vertebral fracture in a 68% compared with placebo (p < 0.001) and increases bone mineral density (BMD) at lumbar spine, total hip, and one-third radius more than alendronate and placebo. A single subcutaneous dose of denosumab resulted in a dose-dependent, rapid, profound, and sustained decrease bone turnover markers (BTMs). Denosumab was in general well tolerated. A meta-analysis has shown an increase in the incidence of urinary infections (p = 0.012) and eczema (p < 0.001) in the patients treated with denosumab. Meta-analysis of efficacy was complicated due to the study features. Conclusions: Denosumab given subcutaneously twice yearly is associated with a reduction in the risk of vertebral, nonvertebral, and hip fractures in women with osteoporosis. Denosumab is associated with greater and sustained increases in BMD and reductions in BTMs compared with placebo and/or alendronate and with a risk of urinary infections and eczema (AU)
