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Problema de salud AUGE N°01

Hemodiálisis

Recomendación de Tratamiento – Juicio del Panel y Evidencia

En personas con enfermedad renal crónica etapa 5 que inician hemodiálisis, el Ministerio de Salud sugiere el uso de fístula arterio-venosa (AV) por sobre catéter permanente como acceso vascular
Comentarios del panel:
►Para poder aplicar esta recomendación es necesario preparar a la persona y a sus cuidadores previo al inicio de diálisis, lo que implica un diagnóstico precoz, oportuno y un seguimiento cercano.
►La implementación de fístulas AV puede verse limitada en la actualidad por la carencia de cirujanos vasculares que confeccionen fístulas y por falta de información apropiada a las personas en tratamiento.
►Personas mayores de 80 años o con una falla cardíaca avanzada podrían experimentar efectos adversos derivados del aumento del flujo sanguíneo por la fístula. Este grupo de personas que pudieran beneficiarse de acceder a diálisis mediante un catéter permanente.

El Panel de Expertos analizó y debatió cada uno de las preguntas de la “Tabla de la evidencia a la decisión”, considerando tanto la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de los pacientes. Una vez consensuada la postura del panel respecto a las preguntas, emitieron un juicio seleccionando la opción de respuesta que mejor representaba la opinión del conjunto (destacada con color). Finalmente cuando el panel emitió su juicio sobre todas las preguntas, se emitió la recomendación.

A continuación se presenta la “Tabla de la evidencia a la decisión” con el resumen de los juicios, la evidencia de investigación evaluada, consideraciones adicionales y comentarios planteados por el panel.

 1.- ¿El problema es una prioridad?
No Probablemente no Probablemente sí Varía No lo sé

El problema ha sido definido como prioritario en el marco de las Garantías Explícitas en Salud (GES), régimen integral de salud que prioriza un grupo de patologías o problemas de salud, garantizando el acceso a tratamiento oportuno y de calidad.

 2.- ¿Qué tan significativos son los efectos deseables anticipados?
Trivial Pequeño Moderado Grande Varía No lo sé

Grandes: El equipo elaborador de la Guía estimó que los efectos deseables de «usar fístula arterio-venosa » en comparación a «catéter permanente» son grandes, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.

Consideraciones Adicionales

El panel considera que los beneficios de usar diálisis precoz son nulos.

Evidencia de investigación

Tabla de Resumen de Resultados (Summary of Findings)

Fístula comparado con catéter permanente para personas con enfermedad renal crónica etapa que inician hemodiálisis

 

Pacientes

Personas con enfermedad renal crónica etapa que inician hemodiálisis

 

Intervención

Fístula.

 

Comparación

Catéter permanente.

 

Desenlaces

Efecto

Certeza de la evidencia

(GRADE)

Mensajes clave en términos sencillos

 
 

Mortalidad

El grupo con catéter presentó una mortalidad de 25,6% (IC 95% 20,3 a 32,3) comparado con el grupo con fístula que presentó una mortalidad de 15,3% (IC 95% 12,5 a 18,7).

◯◯◯1,2

Muy baja

El uso de fístula comparado con catéter permanente podría disminuir la mortalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

 

Permeabilidad del acceso a 2 años

La permeabilidad en el grupo con catéter fue de 49,9% (IC 95% 40,8 a 60,9). En cambio, en el grupo con fístula arteriovenosa fue de 54,8% (IC 95% 52,2 a 57,6%).

◯◯◯1,2

Muy baja

El uso de fístula comparado con catéter permanente podría conllevar una mayor probabilidad de permeabilidad a 2 años. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

 

Infecciones

La tasa de infecciones fue un 16% (IC 95% 7,8 a 34,4) en el grupo con catéter comparado con un 2,1% (IC 95% 0,1 a 4,3) en el grupo con fístula.

◯◯◯1,2

Muy baja

El uso de fístula comparado con catéter permanente podría disminuir el riesgo de infecciones. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

 

IC 95%: Intervalo de confianza del 95%.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
1 Diseño observacional.
2 Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo, ya que algunos ensayos no ajustaron por factores confundentes.
Fecha de elaboración de la tabla: Octubre, 2018.

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Búsqueda y Síntesis de Evidencia

 3.- ¿Qué tan significativos son los efectos indeseables anticipados?
Grande Moderado Pequeño Trivial Varía No lo sé

Triviales: El equipo elaborador de la Guía estimó que los efectos indeseables de «usar fístula arterio-venosa » en comparación a «catéter permanente» son triviales o no relevantes, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.

Consideraciones Adicionales

El panel de expertos considera que el efecto adverso es que esta intervención puede generar alto flujo sanguíneo.

Evidencia de investigación

Tabla de Resumen de Resultados (Summary of Findings)

Fístula comparado con catéter permanente para personas con enfermedad renal crónica etapa que inician hemodiálisis

 

Pacientes

Personas con enfermedad renal crónica etapa que inician hemodiálisis

 

Intervención

Fístula.

 

Comparación

Catéter permanente.

 

Desenlaces

Efecto

Certeza de la evidencia

(GRADE)

Mensajes clave en términos sencillos

 
 

Mortalidad

El grupo con catéter presentó una mortalidad de 25,6% (IC 95% 20,3 a 32,3) comparado con el grupo con fístula que presentó una mortalidad de 15,3% (IC 95% 12,5 a 18,7).

◯◯◯1,2

Muy baja

El uso de fístula comparado con catéter permanente podría disminuir la mortalidad. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

 

Permeabilidad del acceso a 2 años

La permeabilidad en el grupo con catéter fue de 49,9% (IC 95% 40,8 a 60,9). En cambio, en el grupo con fístula arteriovenosa fue de 54,8% (IC 95% 52,2 a 57,6%).

◯◯◯1,2

Muy baja

El uso de fístula comparado con catéter permanente podría conllevar una mayor probabilidad de permeabilidad a 2 años. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

 

Infecciones

La tasa de infecciones fue un 16% (IC 95% 7,8 a 34,4) en el grupo con catéter comparado con un 2,1% (IC 95% 0,1 a 4,3) en el grupo con fístula.

◯◯◯1,2

Muy baja

El uso de fístula comparado con catéter permanente podría disminuir el riesgo de infecciones. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

 

IC 95%: Intervalo de confianza del 95%.
GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
1 Diseño observacional.
2 Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo, ya que algunos ensayos no ajustaron por factores confundentes.
Fecha de elaboración de la tabla: Octubre, 2018.

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Investigators. Comparative effectiveness of early versus conventional timing of dialysis initiation in advanced CKD. American journal of kidney diseases : the official journal of the National Kidney Foundation. 2014;63(5):806-15.

Búsqueda y Síntesis de Evidencia

 4.- ¿Cuál es la certeza general de la evidencia sobre efectos?
Muy baja Baja Moderada Alta Ningún estudio incluido

Muy Baja: Existe considerable incertidumbre respecto del efecto de «usar fístula arterio-venosa » en comparación a «catéter permanente».

Evidencia de investigación

Desenlaces

Importancia

Certainty of the evidence
(GRADE)

Mortalidad

CRÍTICO

◯◯◯
MUY BAJA
a

Permeabilidad del acceso a 2 años

IMPORTANTE

◯◯◯
MUY BAJA
a

Infecciones

CRÍTICO

◯◯◯
MUY BAJA
a

a. Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo, ya que algunos ensayos no ajustaron por factores confundentes.

 5.- ¿Hay incertidumbre importante o variabilidad sobre qué tanto valora la gente los desenlaces principales?
Incertidumbre o variabilidad importantes Posiblemente hay incertidumbre o variabilidad importantes Probablemente no hay incertidumbre ni variabilidad importantes No hay variabilidad o incertidumbre importante

Posiblemente hay incertidumbre o variabilidad importantes: En función de la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud, el equipo elaborador de la Guía consideró que posiblemente existe incertidumbre o variabilidad importante respecto a lo que escogería una persona informada de los efectos deseables e indeseables de «usar fístula arterio-venosa » y «catéter permanente».

Evidencia de investigación

Estudio descriptivo, desarrollado en clínica de hemodiálisis en Fortaleza, estado de Ceará, entre octubre y noviembre de 2014, con 28 pacientes en tratamiento de hemodiálisis.(1)
Los resultados de este estudio informan que en los testimonios recolectados, se observa una preocupación mayor con la permanencia y el mantenimiento del acceso, que demandan muchos cuidados domiciliarios, con modificación significativa de los hábitos de vida
“Busco no mojar el catéter. Nunca me siento, siempre pongo una toallita, encima, o coloco una película de plástico, y luego coloco el micropore (cinta adhesiva) en el lado en que esta el catéter para intentar bañarme tranquilamente, pero no consigo porque no lo puedo mojar. La única manera que tengo es intentar prevenir el máximo que se moje.
“yo no duermo del lado donde esta puesta la fístula [FAV], siempre la protejo, hago ejercicio con la bolita, y cuando tiene hematoma, paso hielo y agua caliente…….»

Una revisión sistemática de estudios cualitativos es describió las percepciones de los pacientes sobre el acceso vascular al inicio y en el mantenimiento en hemodiálisis.(2)
Se incluyeron 46 estudios con 1.034 pacientes y se utilizó síntesis temática para analizar los hallazgos.
Se informan los siguientes resultados:
Apariencia física
Los pacientes se preocupan por mantener una apariencia normal y se esfuerzan por evitar la desfiguración visible del cuerpo .Este rechazo subyacente de la hemodiálisis o creación de FAV
Para algunos pacientes, examinar la fístula constantemente por temor al mal funcionamiento se convirtió en un trabajo diario » mientras que para otros, limpiar el catéter fue un componente crucial del mantenimiento continuo

Referencia
1. Flávia Lidyane Lima, Larissa Rodrigues. Percepção do paciente renal crônico acerca dos cuidados com acessos para hemodiálise. Cogitare Enferm. 2016;3(21):01–7.
2. Casey JR, Hanson CS, Winkelmayer WC, Craig JC, Palmer S, Strippoli GFM, et al. Patients’ perspectives on hemodialysis vascular access: a systematic review of qualitative studies. Am J Kidney Dis Off J Natl Kidney Found. 2014 Dec;64(6):937–53.

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 6.- El balance entre efectos deseables e indeseables favorece la intervención o la comparación?
Favorece la comparación Probablemente favorece la comparación No favorece la intervención ni la comparación Probablemente favorece la intervención Favorece la intervención Varía No lo sé

Favorece la intervención: Considerando que la intervención es «usar fístula arterio-venosa » y la comparación es «catéter permanente», el equipo elaborador de la Guía opinó que el balance entre efectos deseables e indeseables claramente favorece «usar fístula arterio-venosa «.

 7.- ¿Qué tan grandes son los recursos necesarios (costos)?
Costos extensos Costos moderados Costos y ahorros despreciables Ahorros moderados Ahorros extensos Varía No lo sé

Costos y ahorros despreciables: El equipo elaborador de la Guía consideró que los costos y ahorros de «usar fístula arterio-venosa » son despreciables si se compara con «catéter permanente», en función de los antecedentes, experiencia clínica, conocimiento de gestión o experiencia de los pacientes.

Consideraciones Adicionales

El panel de expertos considera que se deben incluir los costos de las imágenes, hospitalización, catéter e insumos.
El panel de expertos considera que los valores de la instalación de fístulas son más bajos.

Evidencia de investigación

A continuación se muestran los costos referenciales, es preciso considerar que estos costos fueron recogidos con el único objetivo de constituir un antecedente aproximado del usar catéter permanente y usar fístula de modo que el equipo elaborador de la Guía se pudiese pronunciar al respecto.

Procedimiento

Precios en Convenio Marco

Acceso Vascular Autólogo en brazo o antebrazo

$813.850

Acceso Vascular Autólogo de alta complejidad

$1.087.290

Acceso Vascular con Prótesis en extremidad superior

$983.390

Promedio Simple Precio de Mercado(clínicas privadas)

Instalación de catéter tunelizado de hemodiálisis por técnica percutánea

$608.1501

Referencias:
1. Programade prestaciones valoradas (PPV 2018)

Búsqueda y Síntesis de Evidencia

 8.- ¿La costo-efectividad de la intervención beneficia la intervención o la comparación?
Favorece la comparación Probablemente favorece la comparación No favorece la intervención ni la comparación Probablemente favorece la intervención Favorece la intervención Varía Ningún estudio incluido

Probablemente favorece la intervención: Considerando que la intervención es «usar fístula arterio-venosa » y la comparación es «catéter permanente», el equipo elaborador de la Guía opinó que probablemente la alternativa más costo-efectiva es «usar fístula arterio-venosa «.

Evidencia de investigación

Autor País

(Año)

Rosas, EE.UU

2012(1)

Moneda, año

Dólar americano, 2004

Población

Pacientes con insuficiencia renal crónica terminal que inician hemodiálisis

Intervención/Comparador

FAV y colocar un acceso vascular sintético, en el caso de que FAV esté inmadura (FAV1) vs acceso vascular sintético como acceso inicial (AVS)

Perspectiva

 

Tercer pagador

Modelo/

Horizonte temporal

Modelo de Markov. Horizonte temporal 5 años

Costo del tratamiento

Instalación FAV USD 762,70

Instalación SVA USD 703,03

Los autores presentan los costos directos de hospitalización, revisión, septicemia, anestesia, etc. No incluidos en este resumen

RCEI

(USD 9389)

CLP /AVAC para AVF1 comparado con AVS.

AVF1 fue la estrategia dominante cuando su maduración fue de un 60% o más.

FAV 1 arrojó 2,19 AVAC vs 2,06 AVAC con AVS.

Análisis de sensibilidad

Determinístico de 1 y 2 vías para las siguientes variables: tasa de maduración de FAV, costos de FAV, tasa de complicación de catéteres venosos centrales

Financiamiento

No se reporta

Umbral de pago del país

USD 50.000 por AVAC

Conclusiones del estudio

Las estrategias fueron menor al umbral de pago siempre que la probabilidad de maduración de la FAV fuera de un 36% o más.

Autor País

(Año)

Shechter Canadá 2017(2)

 

Moneda, año

Dólar americano 2014

Población

Pacientes con enfermedad renal crónica que inician hemodiálisis

Intervención/Comparador

Catéter venoso central (CVC) vs FAV vs Injerto (AVG)

Perspectiva

 

Tercer pagador

Modelo/

Horizonte temporal

Modelo de simulación de Monte Carlo.

 

Horizonte temporal de toda la vida

Costo del tratamiento

Instalación:

 CVC USD 319

FAV USD 888

AVG USD 643

Remover CVC USD 154

RCEI

La referencia de ICER de FAV (AVG) dentro de los 12 (3) meses posteriores a la iniciación de HD en comparación al CVC es de USD 105mil/QALY (USD 101mil/QALY) a nivel poblacional incluidos los costos de hemodiálisis incluidos.

Análisis de sensibilidad

Análisis de sensibilidad determinístico de 1 vía y análisis probabilístico

Financiamiento

No se reporta

Umbral de pago del país

CAD

30.000

Conclusiones del estudio

La rentabilidad del acceso vascular se deben en gran medida a los costos anuales de hemodiálisis.

Referencia
1. Rosas SE, Feldman HI. Synthetic Vascular Hemodialysis Access Versus Native Arteriovenous Fístula. Ann Surg [Internet]. 2012 Jan;255(1):181–6. Available from: https://insights.ovid.com/crossref?an=00000658-201201000-00028 [Internet]. 2016 Apr 21;14(2):185–93. Available from: http://link.springer.com/10.1007/s40258-015-0212-3
2. Shechter SM, Chandler T, Skandari MR, Zalunardo N. Cost-effectiveness Analysis of Vascular Access Referral Policies in CKD. Am J Kidney Dis [Internet]. 2017 Sep;70(3):368–76. Available from: http://www.ncbi.nlm.nih.gov/pubmed/28599902

Búsqueda y Síntesis de Evidencia

 9.- ¿Cuál sería el impacto en equidad en salud?
Reducido Probablemente reducido Probablemente ningún impacto Probablemente aumentado Aumentado Varía No lo sé

Reducida: El equipo elaborador de la Guía consideró que la equidad en salud se reduciría si se recomendase «usar fístula arterio-venosa «, dado que identificó grupos o contextos que actualmente tiene barreras de acceso importantes, ya sea en términos económicos, geográficos u otros.

 10.- ¿La intervención es aceptable para las partes interesadas?
No Probablemente no Probablemente sí Varía No lo sé

Sí: El equipo elaborador de la Guía consideró que «usar fístula arterio-venosa » SÍ es aceptable para las partes interesadas (profesionales de la salud, gestores de centros de salud, directivos de centros de salud, pacientes, cuidadores, seguros de salud, otros).

 11.- ¿Es factible implementar la intervención?
No Probablemente no Probablemente sí Varía No lo sé

Probablemente no: El equipo elaborador de la Guía consideró que «usar fístula arterio-venosa » probablemente NO es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.