Problema de Salud AUGE N°37
Ataque Cerebrovascular Isquémico en personas de 15 años y más
Recomendación de tratamiento – Juicio del Panel y Evidencia
En personas de 15 años y más con Ataque Cerebrovascular isquémico agudo con foramen oval permeable, el Ministerio de Salud SUGIERE realizar cierre del foramen oval permeable en adición al tratamiento antitrombótico, por sobre realizar sólo tratamiento antitrombótico.
Comentarios del panel de expertos
►El balance entre los potenciales beneficios y riesgos es variable en distintas personas. Por lo cual es importante considerar factores que condicionan la respuesta (edad, tamaño del foramen oval, presencia de aneurisma del septum inter auricular, reglas de predicción clínica como la escala de RoPE*) y los valores y preferencias de las personas, lo cual debe ser evaluado caso a caso.
*Risk of Paradoxical Embolism Score
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 | 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.
2.- ¿Qué tan significativos son los efectos deseables anticipados?
| Trivial | Pequeño | Moderado | Grande | Varía | No lo sé |
|---|
Moderados: El equipo elaborador de la Guía estimó que los efectos deseables de «realizar cierre del foramen oval permeable más tratamiento antitrombótico» en comparación a » realizar sólo tratamiento antitrombótico» son moderados, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.
Evidencia de investigación
Tabla de Resumen de Resultados (Summary of Findings)
|
Cierre del foramen oval permeable para ataque cerebrovascular isquémico agudo |
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|
Población |
Personas mayores de 15 años con ataque cerebrovascular (ACV) isquémico agudo. |
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|
Intervención |
Realizar cierre del foramen oval permeable más tratamiento antitrombótico. |
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|
Comparación |
Realizar sólo tratamiento antitrombótico. |
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|
Desenlaces |
Efecto relativo (IC 95%) — Estudios/ pacientes |
Efecto absoluto estimado* |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
||
|
antitrombóticos |
Cierre + antitrombóticos |
Diferencia (IC 95%) |
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|
Accidente cerebrovascular |
RR 0,43 (0,21 a 0,90) — 5 ensayos / 3340 Personas [50-54] |
45 por 1000 |
19 por 1000 |
Diferencia: 26 menos (4 a 35 menos) |
⊕⊕◯◯1,2 Baja |
Realizar cierre del foramen oval permeable más tratamiento antitrombótico comparado con sólo tratamiento antitrombótico podría disminuir el riesgo de accidente cerebrovascular, pero la certeza de la evidencia es baja. |
|
Fibrilación o flutter auricular |
RR 4,53 (2,21 a 9,29) — 5 ensayos / 3340 Personas [50-54] |
7 por 1000 |
34 por 1000 |
Diferencia: 27 más (9 a 62 más) |
⊕⊕⊕⊕1 Alta |
Realizar cierre del foramen oval permeable más tratamiento antitrombótico comparado con sólo tratamiento antitrombótico aumenta el riesgo de fibrilación o flutter auricular. |
|
Sangrado mayor |
RR 0,97 (0,42 a 2,26) — 5 ensayos / 3440 Personas [50-54] |
12 por 1000 |
12 por 1000 |
Diferencia: 0 (7 menos a 15 más) |
⊕⊕◯◯1,3 Baja |
Realizar cierre del foramen oval permeable más tratamiento antitrombótico comparado con sólo tratamiento antitrombótico podría disminuir los sangrados mayores, 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 CON antitrombóticos está basado en el riesgo del grupo control en los estudios. El riesgo CON cierre + antitrombóticos (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 ningún ensayo fue ciego. No se disminuyó por este factor para el desenlace fibrilación auricular, ya que el sesgo probablemente reforzaría esta conclusión.
2 Se disminuyó un nivel de certeza de evidencia por inconsistencia (I2 50%)
3 Se disminuyó un nivel de certeza de evidencia por imprecisión ya que cada extremo del intervalo de confianza conlleva una decisión diferente
Fecha de elaboración de la tabla: Octubre, 2018.
Referencias
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118. Spies C, Khandelwal A, Timmemanns I, Kavinsky CJ, Schräder R, Hijazi ZM. Recurrent events following patent foramen ovale closure in patients above 55 years of age with presumed paradoxical embolism. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2008;72(7):966-70.
119. Spies C, Timmermanns I, Reissmann U, van Essen J, Schräder R. Patent foramen ovale closure with the Intrasept occluder: Complete 6-56 months follow-up of 247 patients after presumed paradoxical embolism. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2008;71(3):390-5.
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
3.- ¿Qué tan significativos son los efectos indeseables anticipados?
| Grande | Moderado | Pequeño | Trivial | Varía | No lo sé |
|---|
Pequeños: El equipo elaborador de la Guía estimó que los efectos indeseables de «realizar cierre del foramen oval permeable más tratamiento antitrombótico» en comparación a » realizar sólo tratamiento antitrombótico» son pequeños, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud.
Evidencia de investigación
Tabla de Resumen de Resultados (Summary of Findings)
|
Cierre del foramen oval permeable para ataque cerebrovascular isquémico agudo |
||||||
|
Población |
Personas mayores de 15 años con ataque cerebrovascular (ACV) isquémico agudo. |
|||||
|
Intervención |
Realizar cierre del foramen oval permeable más tratamiento antitrombótico. |
|||||
|
Comparación |
Realizar sólo tratamiento antitrombótico. |
|||||
|
Desenlaces |
Efecto relativo (IC 95%) — Estudios/ pacientes |
Efecto absoluto estimado* |
Certeza de la evidencia (GRADE) |
Mensajes clave en términos sencillos |
||
|
antitrombóticos |
Cierre + antitrombóticos |
Diferencia (IC 95%) |
||||
|
Accidente cerebrovascular |
RR 0,43 (0,21 a 0,90) — 5 ensayos / 3340 Personas [50-54] |
45 por 1000 |
19 por 1000 |
Diferencia: 26 menos (4 a 35 menos) |
⊕⊕◯◯1,2 Baja |
Realizar cierre del foramen oval permeable más tratamiento antitrombótico comparado con sólo tratamiento antitrombótico podría disminuir el riesgo de accidente cerebrovascular, pero la certeza de la evidencia es baja. |
|
Fibrilación o flutter auricular |
RR 4,53 (2,21 a 9,29) — 5 ensayos / 3340 Personas [50-54] |
7 por 1000 |
34 por 1000 |
Diferencia: 27 más (9 a 62 más) |
⊕⊕⊕⊕1 Alta |
Realizar cierre del foramen oval permeable más tratamiento antitrombótico comparado con sólo tratamiento antitrombótico aumenta el riesgo de fibrilación o flutter auricular. |
|
Sangrado mayor |
RR 0,97 (0,42 a 2,26) — 5 ensayos / 3440 Personas [50-54] |
12 por 1000 |
12 por 1000 |
Diferencia: 0 (7 menos a 15 más) |
⊕⊕◯◯1,3 Baja |
Realizar cierre del foramen oval permeable más tratamiento antitrombótico comparado con sólo tratamiento antitrombótico podría disminuir los sangrados mayores, 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 CON antitrombóticos está basado en el riesgo del grupo control en los estudios. El riesgo CON cierre + antitrombóticos (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 ningún ensayo fue ciego. No se disminuyó por este factor para el desenlace fibrilación auricular, ya que el sesgo probablemente reforzaría esta conclusión.
2 Se disminuyó un nivel de certeza de evidencia por inconsistencia (I2 50%)
3 Se disminuyó un nivel de certeza de evidencia por imprecisión ya que cada extremo del intervalo de confianza conlleva una decisión diferente
Fecha de elaboración de la tabla: Octubre, 2018.
Referencias
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107. Papa M, Gaspardone A, Fragasso G, Fracasso G, Ajello S, Gioffrè G, Iamele M, Iani C, Margonato A. Usefulness of transcatheter patent foramen ovale closure in migraineurs with moderate to large right-to-left shunt and instrumental evidence of cerebrovascular damage. The American journal of cardiology. 2009;104(3):434-9.
108. Pezzini A, Grassi M, Lodigiani C, Patella R, Gandolfo C, Zini A, DeLodovici ML, Paciaroni M, Del Sette M, Toriello A, Musolino R, Calabrò RS, Bovi P, Adami A, Silvestrelli G, Sessa M, Cavallini A, Marcheselli S, Marco Bonifati D, Checcarelli N, Tancredi L, Chiti A, Del Zotto E, Tomelleri G, Spalloni A, Giorli E, Costa P, Giacalone G, Ferrazzi P, Poli L, Morotti A, Piras V, Rasura M, Simone AM, Gamba M, Cerrato P, Zedde ML, Micieli G, Melis M, Massucco D, Guido D, De Giuli V, Bonaiti S, D’Amore C, La Starza S, Iacoviello L, Padovani A, Italian Project on Stroke in Young Adults (IPSYS) Investigators. Propensity Score-Based Analysis of Percutaneous Closure Versus Medical Therapy in Patients With Cryptogenic Stroke and Patent Foramen Ovale: The IPSYS Registry (Italian Project on Stroke in Young Adults). Circulation. Cardiovascular interventions. 2016;9(9).
109. Post MC, Van Deyk K, Budts W. Percutaneous closure of a patent foramen ovale: single-centre experience using different types of devices and mid-term outcome. Acta cardiologica. 2005;60(5):515-9.
110. Presbitero P, Lanzone AM, Albiero R, Lisignoli V, Zavalloni Parenti D, Gasparini GL, Lodigiani C, Barbaro C, Fappani A, Barberis G, Rossi ML, Pagnotta P. Anatomical patterns of patent foramen ovale (PFO): do they matter for percutaneous closure?. Minerva cardioangiologica. 2009;57(3):275-84.
111. Rigatelli G, Dell’Avvocata F, Giordan M, Ronco F, Braggion G, Schenal N, Aggio S, Cardaioli P. Transcatheter patent foramen ovale closure in spite of interatrial septum hypertrophy or lipomatosis: a case series. Journal of cardiovascular medicine (Hagerstown, Md.). 2010;11(2):91-5.
112. Schuchlenz HW, Weihs W, Berghold A, Lechner A, Schmidt R. Secondary prevention after cryptogenic cerebrovascular events in patients with patent foramen ovale. International journal of cardiology. 2005;101(1):77-82.
113. Serena J, Marti-Fàbregas J, Santamarina E, Rodríguez JJ, Perez-Ayuso MJ, Masjuan J, Segura T, Gállego J, Dávalos A, CODICIA, Right-to-Left Shunt in Cryptogenic Stroke Study, Stroke Project of the Cerebrovascular Diseases Study Group, Spanish Society of Neurology. Recurrent stroke and massive right-to-left shunt: results from the prospective Spanish multicenter (CODICIA) study. Stroke; a journal of cerebral circulation. 2008;39(12):3131-6.
114. Shafi NA, McKay RG, Kiernan FJ, Silverman IE, Ahlquist M, Silverman DI. Determinants and clinical significance of persistent residual shunting in patients with percutaneous patent foramen ovale closure devices. International journal of cardiology. 2009;137(3):314-6.
115. Sievert H, Horvath K, Zadan E, Krumsdorf U, Fach A, Merle H, Scherer D, Schräder R, Spies H, Nowak B, Lissmann-Jensen H. Patent foramen ovale closure in patients with transient ischemia attack/stroke. Journal of interventional cardiology. 2001;14(2):261-6.
116. Sievert H, Ruygrok P, Salkeld M, Baumgartner H, Meier B, Windecker S, Juliard JM, Aubry P, Tiefenbacher C, Krumsdorf U, Vermeersch P, Ewert P, Piéchaud JF. Transcatheter closure of patent foramen ovale with radiofrequency: acute and intermediate term results in 144 patients. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2009;73(3):368-73.
117. Slavin L, Tobis JM, Rangarajan K, Dao C, Krivokapich J, Liebeskind DS. Five-year experience with percutaneous closure of patent foramen ovale. The American journal of cardiology. 2007;99(9):1316-20.
118. Spies C, Khandelwal A, Timmemanns I, Kavinsky CJ, Schräder R, Hijazi ZM. Recurrent events following patent foramen ovale closure in patients above 55 years of age with presumed paradoxical embolism. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2008;72(7):966-70.
119. Spies C, Timmermanns I, Reissmann U, van Essen J, Schräder R. Patent foramen ovale closure with the Intrasept occluder: Complete 6-56 months follow-up of 247 patients after presumed paradoxical embolism. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2008;71(3):390-5.
120. Taaffe M, Fischer E, Baranowski A, Majunke N, Heinisch C, Leetz M, Hein R, Bayard Y, Büscheck F, Reschke M, Hoffmann I, Wunderlich N, Wilson N, Sievert H. Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder). The American journal of cardiology. 2008;101(9):1353-8.
121. Thaman R, Faganello G, Gimeno JR, Szantho GV, Nelson M, Curtis S, Martin RP, Turner MS. Efficacy of percutaneous closure of patent foramen ovale: comparison among three commonly used occluders. Heart (British Cardiac Society). 2011;97(5):394-9.
122. Thanopoulos BV, Dardas PD, Karanasios E, Mezilis N. Transcatheter closure versus medical therapy of patent foramen ovale and cryptogenic stroke. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2006;68(5):741-6.
123. Varma C, Benson LN, Warr MR, Yeo E, Yip J, Jaigobin CS, Webb G, McLaughlin PR. Clinical outcomes of patent foramen ovale closure for paradoxical emboli without echocardiographic guidance. Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2004;62(4):519-25.
124. Vigna C, Inchingolo V, Giannatempo G, Pacilli MA, Di Viesti P, Fusilli S, Amico CM, Santoro T, Lanna P, Fanelli R, Simone P, Loperfido F. Clinical and brain magnetic resonance imaging follow-up after percutaneous closure of patent foramen ovale in patients with cryptogenic stroke. The American journal of cardiology. 2008;101(7):1051-5.
125. Wahl A, Jüni P, Mono ML, Kalesan B, Praz F, Geister L, Räber L, Nedeltchev K, Mattle HP, Windecker S, Meier B. Long-term propensity score-matched comparison of percutaneous closure of patent foramen ovale with medical treatment after paradoxical embolism. Circulation. 2012;125(6):803-12.
126. Wahl A, Kunz M, Moschovitis A, Nageh T, Schwerzmann M, Seiler C, Mattle HP, Windecker S, Meier B. Long-term results after fluoroscopy-guided closure of patent foramen ovale for secondary prevention of paradoxical embolism. Heart (British Cardiac Society). 2008;94(3):336-41.
127. Wahl A, Praz F, Tai T, Findling O, Walpoth N, Nedeltchev K, Schwerzmann M, Windecker S, Mattle HP, Meier B. Improvement of migraine headaches after percutaneous closure of patent foramen ovale for secondary prevention of paradoxical embolism. Heart (British Cardiac Society). 2010;96(12):967-73.
128. Wahl A, Tai T, Praz F, Schwerzmann M, Seiler C, Nedeltchev K, Windecker S, Mattle HP, Meier B. Late results after percutaneous closure of patent foramen ovale for secondary prevention of paradoxical embolism using the amplatzer PFO occluder without intraprocedural echocardiography: effect of device size. JACC. Cardiovascular interventions. 2009;2(2):116-23.
129. Weimar C, Holle DN, Benemann J, Schmid E, Schminke U, Haberl RL, Diener HC, Goertler M, German Stroke Study Collaboration. Current management and risk of recurrent stroke in cerebrovascular patients with right-to-left cardiac shunt. Cerebrovascular diseases (Basel, Switzerland). 2009;28(4):349-56.
130. Windecker S, Wahl A, Nedeltchev K, Arnold M, Schwerzmann M, Seiler C, Mattle HP, Meier B. Comparison of medical treatment with percutaneous closure of patent foramen ovale in patients with cryptogenic stroke. Journal of the American College of Cardiology. 2004;44(4):750-8.
131. Zanchetta M, Pedon L, Olivieri A, Benacchio L. Randomized study comparing mechanical with electronic 2-dimensional intracardiac ultrasound monitoring (MEDIUM) during percutaneous closure of patent foramen ovale in adult patients with cryptogenic stroke. Echocardiography (Mount Kisco, N.Y.). 2008;25(5):496-503.
132. Zhang CJ, Huang YG, Huang XS, Huang T, Huang WH, Shen JJ, Xun ZR. Transcatheter closure of patent foramen ovale with the Spider patent foramen ovale occluder: a prospective, single-center trial. Chinese medical journal. 2010;123(7):834-7.
133. van de Wyngaert F, Kefer J, Hermans C, Ovaert C, Pasquet A, Beguin C, Sindic C, Sluysmans T. Absence of recurrent stroke after percutaneous closure of patent foramen ovale despite residual right-to-left cardiac shunt assessed by transcranial Doppler. Archives of cardiovascular diseases. 2008;101(7-8):435-41.
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
4.- ¿Cuál es la certeza general de la evidencia sobre efectos?
| Muy baja | Baja | Moderada | Alta | Ningún estudio incluido |
|---|
Baja: Existe cierta incertidumbre respecto del efecto de «realizar cierre del foramen oval permeable más tratamiento antitrombótico» en comparación a » realizar sólo tratamiento antitrombótico».
Evidencia de investigación
|
Desenlaces |
Importancia |
Certeza de la Evidencia |
|
Accidente cerebrovascular |
CRÍTICO |
⨁⨁◯◯ |
|
Fibrilación o flutter auricular |
IMPORTANTE |
⨁⨁⨁◯ |
|
Sangrado mayor |
CRÍTICO |
⨁⨁◯◯ |
a. Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo, ya que ningún ensayo fue ciego
b. Se disminuyó un nivel de certeza de evidencia por inconsistencia (I2 50%)
c. Se disminuyó un nivel de certeza de evidencia por imprecisión ya que cada extremo del intervalo de confianza conlleva una decisión diferente
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 «realizar cierre del foramen oval permeable más tratamiento antitrombótico» y » realizar sólo tratamiento antitrombótico».
Evidencia de investigación
Se identificó una revisión sistemática relacionada con valores y preferencias de pacientes sobre tratamiento a antitrombótico.
En la revisión (1) se incluyeron estudios que examinaron preferencias de pacientes sobre terapia antitrombótica y estudios que examinaron (en el contexto de profilaxis antitrombótica o tratamiento antitrombótico) cómo los pacientes valoran los estados de salud alternativos y las experiencias con el tratamiento.
Los autores identificaron 48 estudios relacionados con fibrilación auricular, trombosis venosa, ataque cerebrovascular o profilaxis de infarto de miocardio, trombólisis en accidente cerebrovascular agudo o infarto de miocardio y tratamiento antitrombótico 1.
De los estudios de trombólisis en accidente cerebrovascular los autores mencionan un estudio en que el 79% de las mujeres y el 86% de los hombres estarían de acuerdo con el tratamiento trombolítico para aumentar la probabilidad de recuperación del accidente cerebrovascular de un 38% a 50% frente a un 6 % de riesgo de otro ataque cerebrovascular o muerte en el primer día después de tomar el medicamento. Las mujeres tenían menos confianza en sus decisiones y eran más reacias al riesgo.
Otro estudio citado en esta categoría (en once personas con ataque cerebrovascular en que se realizaron entrevistas semi estructuradas) realizado para evaluar voluntad de aceptar y conciencia de riesgos y beneficios del tratamiento trombolítico, describe que la percepción del riesgo entre los pacientes varió sustancialmente. Algunos perciben el riesgo como irrelevante o incluso inexistente. Otros percibieron el riesgo de morir como una amenaza abrumadora.
En la misma categoría de tratamiento trombolítico en ataque cerebrovascular, los autores citan otro estudio realizado en 150 sobrevivientes de ataque cerebrovascular en que realizan un análisis de decisión sobre preferencia de tratamiento trombolítico concluye que el 100% los participantes habrían aceptado el tratamiento para evitar un accidente cerebrovascular grave, y el 13% habría aceptado el tratamiento para evitar ataque cerebrovascular leve. La edad avanzada y vivir solo tuvieron impacto en la voluntad de aceptar el tratamiento y la razón más importante para aceptarlo fue el deseo de mantener la independencia funcional.
Los autores concluyen que los valores y preferencias de pacientes con respecto a tratamiento trombolítico o trombo profilaxis parecen ser muy variables. Las respuestas de las personas pueden
depender de su experiencia previa con los tratamientos o de los resultados de salud considerados, así como de los métodos utilizados para la obtención de preferencias y que debe ser una práctica estándar en la elaboración de guías de práctica clínica realizar revisiones sistemáticas sobre valores y preferencias de pacientes en áreas de contenidos específicos.
Referencia
1. MacLean S, Mulla S, Akl EA, Jankowski M, Vandvik PO, Ebrahim S, McLeod S, Bhatnagar N, Guyatt GH. Patient values and preferences in decision making for antithrombotic therapy: a systematic review: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e1S-e23S. doi: 10.1378/chest.11-2290. Review. PubMed PMID: 22315262; PubMed Central PMCID: PMC3278050.
Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de valores y preferencias de los pacientes
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 |
|---|
Probablemente favorece la intervención: Considerando que la intervención es «realizar cierre del foramen oval permeable más tratamiento antitrombótico» y la comparación es » realizar sólo tratamiento antitrombótico», el equipo elaborador de la Guía opinó que el balance entre efectos deseables e indeseables probablemente favorece «realizar cierre del foramen oval permeable más tratamiento antitrombótico».
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 moderados: El equipo elaborador de la Guía consideró que los costos de «realizar cierre del foramen oval permeable más tratamiento antitrombótico» son moderados si se compara con los costos de » realizar sólo tratamiento antitrombótico», en función de los antecedentes, experiencia clínica, conocimiento de gestión o experiencia de los pacientes.
Evidencia de investigación
Tabla. Precios referenciales*
|
Ítem |
Cierre del foramen oval permeable MÁS tratamiento antitrombótico |
Tratamiento antitrombótico |
|
|
Cirugía-de complejidad menor: incluye comunicación interauricular simple, estenosis pulmonar valvular, estenosis mitral o similar
Dispositivo Amplazter |
$1.395.5202
$ 340.0003 |
—– |
|
|
Tratamiento antitrombótico**:
Ácido acetilsalicílico 100 mg1 Clopidogrel 75 mg3 |
$ 10,711 $ 123,763 |
$ 10,711 $ 123,763
|
|
|
Total
|
Variable según medicamento utilizado y duración del tratamiento |
Variable según medicamento utilizado y duración del tratamiento |
|
*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.
** Precio por comprimido o por ampolla.
Referencias
1. Precio CENEBAST.
2. Arancel MAI
3. Mercado público
2. Arancel MAI
3. Mercado público
Búsqueda y Síntesis de Evidencia
Búsqueda de costos
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 |
|---|
Ningún estudio incluido
Evidencia de investigación
No se realizó la búsqueda de estudios que abordaran la costo-efectividad de esta intervención ya que no fuer considerado un tratamiento de alto costo (1).
Referencia
1. Anual $2.418.399 y Mensual $201.533. 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.
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 «realizar cierre del foramen oval permeable más tratamiento antitrombótico», 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 | Sí | Varía | No lo sé |
|---|
Probablemente sí: El equipo elaborador de la Guía consideró que «realizar cierre del foramen oval permeable más tratamiento antitrombótico» probablemente 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 | Sí | Varía | No lo sé |
|---|
Probablemente sí: El equipo elaborador de la Guía consideró que «realizar cierre del foramen oval permeable más tratamiento antitrombótico» probablemente SÍ es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.