DX Technology Demonstrates High Detection Accuracy for Atrial Fibrillation (AF) in Single-Chamber ICD Patients

Large-scale study shows that DX-ICD systems together with Home Monitoring allow for reliable guideline-recommended monitoring of subclinical AF

BERLIN, April 14, 2023 /PRNewswire/ -- Results from the MATRIX study show that the high detection accuracy of DX single-lead ICD systems for AF episodes (99.7% for ≥ 1h episodes) in combination with the strong transmission performance of BIOTRONIK Home Monitoring^® allows for reliable guideline-recommended remote monitoring of subclinical AF. The findings were published in Europace earlier this week.¹

MATRIX evaluated the utility of the DX-ICD system (atrial signal detection via a floating dipole integrated in the ICD lead) for remotely monitoring atrial high-rate episodes (AHRE) and their duration progression. In addition, the study analyzed the clinical implications of AHRE detection and progression. The outcome of the study should be interpreted in the context of the 2020 European Society of Cardiology's guidelines on AF which recommend remote monitoring of device-detected AHRE and provide further guidance depending on the AF burden along pre-specified duration strata.

The study was led by Prof. Dr. Gerhard Hindricks, Deutsches Herzzentrum der Charité, and Prof. Dr. Dr. Andreas Bollmann, Heart Center Leipzig at the University of Leipzig and Helios Health Institute, Germany, as coordinating investigators, and sponsored by BIOTRONIK. The international, multicenter registry enrolled 2,054 DX-ICD patients in 119 sites across 24 countries. Patients were followed for 24 months under real-life conditions, i.e., participating centers followed their routine follow-up scheme.

"We know that atrial fibrillation is associated with an up to 5-fold increase in the risk of stroke, an up to 3.5-fold higher all-cause mortality and that the timely initiation of anticoagulation therapy helps to prevent stroke. Yet, the often-asymptomatic nature of atrial fibrillation hampers the diagnosis and treatment of AF," commented Prof. Dr. Gerhard Hindricks of Deutsches Herzzentrum der Charité, Berlin, Germany. "Our analysis shows that you can detect and monitor AHRE with high accuracy in single-chamber ICD patients using DX Technology. Together with the proven transmission reliability of Home Monitoring, this supports a reliable AHRE burden monitoring, as recommended by current guidelines."

In addition, MATRIX underlined the clinical relevance of continuous AHRE monitoring. "New-onset AHRE is not rare and the need for clinical action increases with longer episodes. In our study, 69% of the patients that presented with new-onset AHRE had episodes of one hour or longer by the end of follow-up," said Prof. Dr. Dr. Andreas Bollmann, Heart Centre Leipzig and Helios Health Institute, Germany. "Given that those patients mostly have a mid-to-high CHA₂DS₂-VASc stroke risk, they could profit from a timely prescription of anticoagulants if a net clinical benefit can be anticipated."

"As the largest clinical evaluation of the DX Technology to date, the MATRIX study has clearly proven, under real-world conditions, that DX-ICDs together with BIOTRONIK Home Monitoring can provide clinically-relevant benefits that support physicians in making the right decisions for their single-chamber ICD patients – timely, and consistent with current medical guidelines," added Dr. David Hayes, Chief Medical Officer, BIOTRONIK, Inc.

References:

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

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