Guía de Práctica Clínica - Problema de Salud AUGE N°05
Infarto agudo del miocardio
Recomendación T4 – Juicio del Panel y Evidencia
T.4 En personas con infarto agudo al miocardio con supradesnivel del segmento ST (SDST) reciente en post tratamiento que reciben prevención secundaria habitual, el Ministerio de Salud SUGIERE realizar rehabilitación cardíaca por sobre no realizarla. (recomendación condicional, basada en certeza baja de los efectos)
Comentarios del Panel de Expertos:
►Es importante que la rehabilitación cardiaca se inicie con una evaluación al inicio de la terapia para definir la modalidad, intensidad y gradualidad del ejercicio, y ésta sea realizada siguiendo protocolos definidos.
►Pacientes de alto riesgo (por ejemplo, con disfunción ventricular importante) podrían beneficiarse de monitorización y controles más frecuente para evaluar la respuesta al tratamiento.
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.
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
El problemade salud ha sido definido como prioritario de abordar a través de una Guía de Práctica Clínica por la División de Prevención y Control de Enfermedades del Ministerio de Salud. La pregunta ha sido priorizada por el equipo de esta Guía, ya sea porque existía variabilidad o incertidumbre.
| Trivial | Pequeño | Moderado | Grande | Varía | No lo sé |
|---|
Moderados: El equipo elaborador de la Guía estimó que los efectos deseables de «realizar rehabilitación cardíaca» en comparación a «no realizar rehabilitación cardíaca» son moderados, 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 la rehabilitación cardiaca tendría efectos mayores a lo presentado por la evidencia. Además, tendría efecto en la calidad de vida y en la conciencia de enfermedad crónica permitiendo mayor adherencia al tratamiento.
Evidencia de investigación
|
Rehabilitación cardiaca para la enfermedad coronaria. |
||||||
|
Población |
Personas con infarto agudo al miocardio con supradesnivel del segmento ST (SDST) reciente en post tratamiento que reciben prevención secundaria habitual. |
|||||
|
Intervención |
Rehabilitación cardíaca. |
|||||
|
Comparación |
No realizar rehabilitación. |
|||||
|
Desenlaces |
Efecto relativo (IC 95%) — Estudios/ pacientes |
Efecto absoluto estimado* |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
||
|
SIN rehabilitación cardiaca |
CON Rehabilitación cardiaca |
Diferencia (IC 95%) |
||||
|
Mortalidad (seguimiento de 12 a 36 meses) |
RR 0,89 (0,78 a 1,01) — 13 ensayos/ 5644 pacientes de una revisión sistemática [3] |
125 por 1000 |
112 por 1000 |
Diferencia: 13 menos |
⊕⊕◯◯1,2,3Baja |
La rehabilitación cardiaca podría disminuir la mortalidad, pero la certeza de la evidencia es baja. |
|
Hospitalizaciones (seguimiento de 12 a 36 meses) |
RR 0,95 (0,84 a 1,07) — 6 ensayos/ 1855 pacientes de una revisión sistemática [3] |
354 por 1000 |
336 por 1000 |
Diferencia: 18 menos (57 menos a 25 más) |
⊕⊕◯◯1,2 Baja |
Rehabilitación cardiaca podría disminuir las hospitalizaciones, pero la certeza de la evidencia es baja. |
|
Infarto agudo al miocardio (seguimiento de 12 a 36 meses) |
RR 1,09 (0,91 a 1,29) — 11 ensayos/ 2989 pacientes de una revisión sistemática [3] |
80 por 1000 |
87 por 1000 |
Diferencia: 7 más (65 menos a 23 más) |
⊕⊕◯◯1,2 Baja |
Rehabilitación cardiaca podría aumentar los infartos agudos al miocardio, pero la certeza de la evidencia es baja. |
IC 95%: Intervalo de confianza del 95% // RR: Riesgo relativo // GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
* El riesgo no realizar rehabilitación está basado en el riesgo del grupo control en los estudios. El riesgo rehabilitación cardíaca (y su intervalo de confianza) está calculado a partir del efecto relativo (y su intervalo de confianza).
1 Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo ya que en la mayoría de los ensayos incluidos no está clara la generación de secuencia de aleatorización y ocultamiento de ésta. Además, el ensayo no fue ciego.
2 Se disminuyó un nivel de certeza de la evidencia por imprecisión puesto que a ambos extremos del estimador puntual se tomarían diferentes decisiones.
Fecha de elaboración de la tabla: Diciembre, 2018.
Referencia
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
| Grande | Moderado | Pequeño | Trivial | Varía | No lo sé |
|---|
Pequeños: El equipo elaborador de la Guía estimó que los efectos indeseables de «realizar rehabilitación cardíaca» en comparación a «no realizar rehabilitación cardíaca» son pequeños, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.
Consideraciones Adicionales
Considerando que la intervención se realiza por equipos especializados, experimentados y con protocolos definidos, los efectos indeseables graves son poco frecuentes.
Los efectos indeseables menos graves son más frecuentes.
Evidencia de investigación
|
Rehabilitación cardiaca para la enfermedad coronaria. |
||||||
|
Población |
Personas con infarto agudo al miocardio con supradesnivel del segmento ST (SDST) reciente en post tratamiento que reciben prevención secundaria habitual. |
|||||
|
Intervención |
Rehabilitación cardíaca. |
|||||
|
Comparación |
No realizar rehabilitación. |
|||||
|
Desenlaces |
Efecto relativo (IC 95%) — Estudios/ pacientes |
Efecto absoluto estimado* |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
||
|
SIN rehabilitación cardiaca |
CON Rehabilitación cardiaca |
Diferencia (IC 95%) |
||||
|
Mortalidad (seguimiento de 12 a 36 meses) |
RR 0,89 (0,78 a 1,01) — 13 ensayos/ 5644 pacientes de una revisión sistemática [3] |
125 por 1000 |
112 por 1000 |
Diferencia: 13 menos |
⊕⊕◯◯1,2,3Baja |
La rehabilitación cardiaca podría disminuir la mortalidad, pero la certeza de la evidencia es baja. |
|
Hospitalizaciones (seguimiento de 12 a 36 meses) |
RR 0,95 (0,84 a 1,07) — 6 ensayos/ 1855 pacientes de una revisión sistemática [3] |
354 por 1000 |
336 por 1000 |
Diferencia: 18 menos (57 menos a 25 más) |
⊕⊕◯◯1,2 Baja |
Rehabilitación cardiaca podría disminuir las hospitalizaciones, pero la certeza de la evidencia es baja. |
|
Infarto agudo al miocardio (seguimiento de 12 a 36 meses) |
RR 1,09 (0,91 a 1,29) — 11 ensayos/ 2989 pacientes de una revisión sistemática [3] |
80 por 1000 |
87 por 1000 |
Diferencia: 7 más (65 menos a 23 más) |
⊕⊕◯◯1,2 Baja |
Rehabilitación cardiaca podría aumentar los infartos agudos al miocardio, pero la certeza de la evidencia es baja. |
IC 95%: Intervalo de confianza del 95% // RR: Riesgo relativo // GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
* El riesgo no realizar rehabilitación está basado en el riesgo del grupo control en los estudios. El riesgo rehabilitación cardíaca (y su intervalo de confianza) está calculado a partir del efecto relativo (y su intervalo de confianza).
1 Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo ya que en la mayoría de los ensayos incluidos no está clara la generación de secuencia de aleatorización y ocultamiento de ésta. Además, el ensayo no fue ciego.
2 Se disminuyó un nivel de certeza de la evidencia por imprecisión puesto que a ambos extremos del estimador puntual se tomarían diferentes decisiones.
Fecha de elaboración de la tabla: Diciembre, 2018.
Referencia
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
| Muy baja | Baja | Moderada | Alta | Ningún estudio incluido |
|---|
Baja: Existe cierta incertidumbre respecto del efecto de «realizar rehabilitación cardíaca» en comparación a «no realizar rehabilitación cardíaca».
Evidencia de investigación
|
Desenlaces |
Certainty of the evidence |
|
Mortalidad |
⨁⨁◯◯ |
|
Ingreso hospitalario |
⨁⨁◯◯ |
|
Infarto agudo al miocardio |
⨁⨁◯◯ |
a. Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo ya que en la mayoría de los ensayos incluidos no está clara la generación de secuencia de aleatorización y ocultamiento de ésta. Además, el ensayo no fue ciego.
b. Se disminuyó un nivel de certeza de la evidencia por imprecisión puesto que a ambos extremos del estimador puntual se tomarían diferentes decisiones.
| Incertidumbre o variabilidad importantes | Posiblemente hay incertidumbre o variabilidad importantes | Probablemente no hay incertidumbre ni variabilidad importantes | No hay variabilidad o incertidumbre importante |
|---|
No hay variabilidad o incertidumbre importante: 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 no existe incertidumbre o variabilidad importante respecto a lo que escogería una persona informada de los efectos deseables e indeseables de «realizar rehabilitación cardíaca» y «no realizar rehabilitación cardíaca». Todas o casi todas las personas escogerían realizar rehabilitación cardíaca.
Evidencia de investigación
Se identificó un estudio sobre percepciones y creencias de pacientes tras acudir a un programa de rehabilitación cardíaca.
Un estudio cualitativo fenomenológico en 27 personas que habían sufrido un primer Infarto Agudo de Miocardio (IAM), exploró las consecuencias de acudir o no acudir a Rehabilitación Cardiaca en las percepciones y creencias de los pacientes tras un IAM (1).
Se crearon 4 perfiles en función de la edad, sexo y participación o no en rehabilitación cardíaca. Se realizaron 4 grupos focales y 7 entrevistas semi-estructuradas, hasta saturación del discurso (1).
Los autores concluyen que la rehabilitación cardíaca modifica las percepciones y creencias del paciente. Aumenta y mejora la información recibida, proporcionando al paciente mayores conocimientos sobre su enfermedad y sobre los cambios a adoptar. El paciente experimenta mayor seguridad y apoyo social, lo que mejora su implicación en la prevención secundaria. Mejora las expectativas percibidas de futuro, reduciendo el miedo y la ansiedad. Por el contrario, los no participantes presentaron mayor desconocimiento sobre la enfermedad y menor implicación en el proceso rehabilitador. Por lo tanto, la rehabilitación cardiaca proporciona el conocimiento y apoyo necesario para la adaptación al nuevo estilo de vida, debido a que los asistentes a rehabilitación cardiaca están mejor preparados y más motivados para llevar a cabo la prevención secundaria con respecto a aquellos que no asisten (1).
Referencias
Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de valores y preferencias de los pacientes
| 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 «realizar rehabilitación cardíaca» y la comparación es «no realizar rehabilitación cardíaca», el equipo elaborador de la Guía opinó que el balance entre efectos deseables e indeseables claramente favorece «realizar rehabilitación cardíaca».
| Costos extensos | Costos moderados | Costos y ahorros despreciables | Ahorros moderados | Ahorros extensos | Varía | No lo sé |
|---|
Costos moderados: El equipo elaborador de la Guía consideró que los costos de «realizar rehabilitación cardíaca» son moderados si se compara con los costos de «no realizar rehabilitación cardíaca», en función de los antecedentes, experiencia clínica, conocimiento de gestión o experiencia de los pacientes.
Evidencia de investigación
|
Ítems |
Rehabilitación cardíaca |
No realizar rehabilitación cardíaca |
||
|
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· Programa de RC Modelo Estándar o Intermedio. Se basa en el programa entregado por uno de los centros de la red pública de salud en Chile que dispone de este servicio, el Complejo Hospitalario San José (15 sesiones 2 a 3 veces por semana)
|
$ 67.8743
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· Consulta integral de especialidades (para derivación a RC) |
$48.1543 |
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· Educación de grupo por enfermera, matrona o nutricionista (Pre RC)
|
$ 8.0543
|
—– |
||
|
· Kinesiólogo (Pre RC) |
$ 10.3243 |
—–
|
||
|
Total, rehabilitación cardíaca |
$ 134.406 |
—– |
||
|
|
|
||
|
Medicamentos 2: |
Día |
Mes |
Día |
Mes |
|
Ácido acetilsalicílico 100 mg – cm |
$ 10,71 |
$ 321 |
$ 10,71 |
$ 321 |
|
Amiodarona 200 mg – cm |
$ 18,45 |
$ 553 |
$ 18,45 |
$ 553 |
|
Atorvastatina 20 mg – cm |
$ 20,50 |
$ 615 |
$ 20,50 |
$ 615 |
|
Carvedilol 12,5 mg – cm |
$ 32,13 |
$ 964 |
$ 32,13 |
$ 964 |
|
Clopidogrel 75 mg – cm |
$ 154,70 |
$ 4.641 |
$ 154,70 |
$ 4.641 |
|
Espironolactona 25 mg – cm |
$ 24,51 |
$ 735 |
$ 24,51 |
$ 735 |
|
Famotidina 40 mg – cm |
$ 19,04 |
$ 571 |
$ 19,04 |
$ 571 |
|
Furosemida 40 mg – cm |
$ 10,12 |
$ 303 |
$ 10,12 |
$ 303 |
|
Propanolol 10 mg – cm |
$ 9,52 |
$ 286 |
$ 9,52 |
$ 286 |
|
Enalapril 10 mg – cm |
$ 4,11 |
$ 123 |
$ 4,11 |
$ 123 |
|
Total medicamentos (mes) |
$9.113 |
$9.113 |
||
|
Consultas, exámenes y otros 3: Consulta integral de especialidades en medicina interna y subespecialidades (en hospitales tipo 1 y 2)2 |
$48.154 |
48154 |
||
|
Educación de grupo por enfermera, matrona o nutricionista2 |
$5.054 |
$5.054 |
||
|
Creatinquinasa ck – mb miocárdica 2 |
$1.346 |
$1.346 |
||
|
Ecocardiograma doppler, con registro (incluye cód. 17.01.008) 2 |
$ 17. 032 |
$ 17. 032 |
||
|
Ergometría (incluye e.c.g. antes, durante y después del ejercicio con monitoreo continuo y medición de la intensidad del esfuerzo) 2 |
$23.266 |
$23.266 |
||
|
Perfil hepático (incluye tiempo de protrombina, bilirrubina total y conjugada, fosfatasas alcalinas totales, ggt, transaminasas got/ast y gpt/alt) 2 |
$15.435 |
$15.435 |
||
|
Perfil lipídico (incluye: colesterol total, hdl, ldl, vldl y triglicéridos) 2 |
$8.737 |
$8.737 |
||
|
Total, consultas, exámenes y otros |
$101.992 |
$101.992 |
||
|
TOTAL (estimado): $ 236.398 |
TOTAL (estimado): $ 111.105 |
|||
*El porcentaje de cobertura del seguro de salud sobre el precio de la(s) prestación (es) sanitaria(s), dependerá del tipo de seguro de cada paciente.
**El costo de implementación de Programa de RC es de $38.371 y $ 323.477 para Modelo Bajos Recursos y Modelo Sudamericano, respectivamente.
***Costos estimados (no todos los pacientes reciben todos los medicamentos incluidos en la canasta). Se consideró costo mensual para medicamentos. Para el resto de prestaciones se consideró costo por “una vez”. Para Programa RC, se consideró el costo de 15 sesiones.
Referencia
1. Proyecto FONIS Código: SA14ID0005. Evaluación de costo-utilidad de la Rehabilitación Cardíaca en Chile, 2018. Pamela Serón. (Aún no publicado).
2. Precio CENABAST.
3. Precio obtenido de la base de datos del Estudio de Verificación de Costos 2015 MINSAL. El precio fue actualizado utilizando la UF al 1 de julio 2018. Costos por “una vez” o por “1 comprimido”
Búsqueda y Síntesis de Evidencia
Búsqueda de costos
| 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 «realizar rehabilitación cardíaca» y la comparación es «no realizar rehabilitación cardíaca», el equipo elaborador de la Guía opinó que probablemente la alternativa más costo-efectiva es «realizar rehabilitación cardíaca».
Evidencia de investigación
Ningún estudio incluido No se realizó la búsqueda de estudios que abordaran la costo-efectividad, ya que la intervención evaluada no es considerada de alto costo (Anual $2.418.399 y Mensual $201.533) (1).
Referencia
1. Ministerio de Salud. Decreto 80: Determinar umbral nacional de costo anual al que se refiere el artículo 6° de la Ley 20.850 [Internet]. Santiago; 2015 Nov.
| 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 «realizar rehabilitación cardíaca», dado que identificó grupos o contextos que actualmente tiene barreras de acceso importantes, ya sea en términos económicos, geográficos u otros.
Consideraciones Adicionales
El panel señala que su juicio es debido a que no se encuentra financiada por el estado la rehabilitación cardiaca y a su falta de acceso a nivel nacional.
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
Sí: El equipo elaborador de la Guía consideró que «realizar rehabilitación cardíaca» 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).
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
Probablemente sí: El equipo elaborador de la Guía consideró que «realizar rehabilitación cardíaca» probablemente SÍ es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.
Consideraciones Adicionales
El panel destaca que para la implementación es necesario contar con un equipo de rehabilitación especializado en rehabilitación cardiaca.