La tecnología DX demuestra una alta precisión en la detección de la fibrilación auricular (FA) en pacientes con DAI monocameral El estudio a gran escala muestra que los sistemas DAI DX en combinación con Home Monitoring permiten la monitorización fiable de la FA subclínica recomendada por las guías
Los resultados del estudio MATRIX muestran que la alta precisión en la detección de los sistemas DAI DX con un solo cable para los episodios de FA (99,7 % para episodios ≥1 h), combinada con el potente rendimiento de transmisión de BIOTRONIK Home Monitoring®, permite la monitorización remota fiable de la FA subclínica recomendada por las guías. Los resultados se publicaron en Europace a principios de esta semana. 1
MATRIX evaluó la utilidad del sistema DAI DX (detección de la señal auricular mediante un dípolo flotante integrado en el cable del DAI) para la monitorización remota de los episodios de alta frecuencia auricular (AHRE) y la evolución de su duración. Además, el estudio analizó las implicaciones clínicas de la detección y la evolución de los AHRE. El resultado del estudio debe interpretarse en el contexto de las directrices sobre la FA de 2020 de la Sociedad Europea de Cardiología, que recomiendan la monitorización remota de los AHRE detectados con dispositivo y proporcionan una guía adicional dependiendo de la carga AF junto con los estratos de duración preespecificados.
El estudio estuvo dirigido por el Prof. Dr. Gerhard Hindricks, Deutsches Herzzentrum der Charité, y el Prof. Dr. Dr. Andreas Bollmann, Centro de Cardiología de Leipzig en la Universidad de Leipzig e Instituto Helios de la Salud, Alemania, como investigadores coordinadores, y contó con el patrocinio de BIOTRONIK. El registro internacional multicéntrico incluyó a 2.054 pacientes DAI DX en 119 centros de 24 países. Los pacientes se sometieron a un seguimiento de 24 meses en condiciones de vida real, es decir, los centros participantes siguieron su esquema de seguimiento habitual.
«Sabemos que la fibrilación auricular multiplica por 5 el riesgo de accidentes cerebrovasculares, y por 3,5 la mortalidad por cualquier causa, y que comenzar a tiempo con la terapia de anticoagulación ayuda a evitar el accidente cerebrovascular. Además, el carácter a menudo asintomático de la fibrilación auricular dificulta su diagnóstico y tratamiento», comentó el Prof. Dr. Gerhard Hindricks, Deutsches Herzzentrum der Charité, Alemania. «Nuestro análisis demuestra que es posible detectar y monitorizar los AHRE con una precisión alta en los pacientes con DAI monocameral usando la tecnología DX. Junto con la fiabilidad probada de la transmisión de Home Monitoring, esto facilita una monitorización fiable de la carga de AHRE, tal y como recomiendan las guías actuales».
Además, MATRIX destaca la relevancia clínica de la monitorización continua de los AHRE.«El AHRE de nueva aparición no es raro, y la necesidad de una actuación clínica aumenta con los episodios más largos. En nuestro estudio, el 69 % de los pacientes que presentaban AHRE de nueva aparición tuvieron episodios de una hora o más al final del seguimiento», explicó el Prof. Dr. Dr. Andreas Bollmann, Centro de Cardiología de Leipzig en la Universidad de Leipzig e Instituto Helios de la Salud, Alemania. «Dado que estos pacientes tienen en su mayoría un riesgo de ACV CHA2DS2-VASc de medio a alto, se podrían beneficiar de una prescripción a tiempo de anticoagulantes si se puede prever un beneficio clínico neto».
«El estudio MATRIX, como la mayor evaluación clínica de la tecnología DX hasta la fecha, ha demostrado claramente y en condiciones de mundo real que los DAI DX junto con BIOTRONIK Home Monitoring pueden proporcionar beneficios clínicamente relevantes, que ayudan a los médicos a tomar a tiempo las decisiones correctas y conformes a las guías médicas actuales para sus pacientes con DAI monocameral», añadió el Dr. David Hayes, director médico de BIOTRONIK, BIOTRONIK, Inc.
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Referencias:
1. Hindricks G., Theuns, D., Bar-Lev D. et al.: Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole, EP Europace, 2023;, euad061, https://doi.org/10.1093/europace/euad061
Acerca de BIOTRONIK:
En BIOTRONIK, el bienestar del paciente es nuestra principal prioridad y lo ha sido durante 60 años. BIOTRONIK es una empresa líder mundial en tecnología médica con productos y servicios que salvan y mejoran la vida de millones de personas con patologías cardíacas y de los vasos sanguíneos, así como dolor crónico. Impulsados por el objetivo de combinar a la perfección la tecnología y el cuerpo humano, trabajamos para desarrollar soluciones cardiovasculares, endovasculares y de neuromodulación innovadoras. BIOTRONIK tiene su sede en Berlín (Alemania) y representación en más de 100 países.
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FDA Breakthrough Device Designation for BIOTRONIK Freesolve™ Below-the-Knee Resorbable Magnesium Scaffold (RMS)
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