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    DX-Technologie

    ERWEITERTE DIAGNOSTIK. OPTIMIERTE VERSORGUNG.

    Lösung zum Management von Vorhofflimmern bei Einkammer-ICD-Patienten

    Vorhofflimmern („Atrial Fibrillation“, AF) ist ein weit verbreitetes, oft asymptomatisches Krankheitsbild bei Patienten mit implantierbarem Kardioverter-Defibrillator (ICD) und tritt jährlich in fast 21 % der Fälle auf.1 Leider ist es mit einem Standard-Einkammer-ICD schwer oder sogar gar nicht zu erkennen.1 Bleibt Vorhofflimmern unbehandelt, kann sich der klinische Zustand des Patienten verschlechtern, was schwerwiegende Folgen haben kann. 

    An dieser Stelle kommt die DX-Technologie ins Spiel. Durch die Möglichkeit, Signale im Atrium zu detektieren, behebt die DX-Technologie Unzulänglichkeiten von Einkammer-ICDs. Es ist das einzige Single-Lead-ICD-System, das diagnostische Daten zum Vorhofflimmern direkt aus dem Atrium liefert – und das macht es wirklich einzigartig.

    Category

    Tachycardia ICD

    Produkt-Highlights

    Icon DX Technologie

    Vorhofflimmern frühzeitig erkennen

    DX-ICDs erhöhen die Wahrscheinlichkeit, atriale Arrhythmien frühzeitig zu erkennen, und helfen Ihnen so, Risikopatienten zu identifizieren und ein schnelles, angemessenes Patientenmanagement sicherzustellen.

    DX Technology - AF Management Solution; Monitor AF Burden Reliably

    AF-Last zuverlässig überwachen

    Das DX-ICD-System hilft Ihnen, die AF-Last im Laufe der Zeit zu überwachen3, so dass Sie bei Bedarf eingreifen, auf Veränderungen im Patientenstatus reagieren und die Behandlung optimieren können.

    DX Technology - AF Management Solution; Improve Outcomes Effectively 

    Ergebnisse effektiv verbessern

    Sobald Vorhofflimmern erkannt und die AF-Last überwacht wird, kann bei Bedarf rechtzeitig eine geeignete Therapie eingeleitet werden, um die klinischen Ergebnisse zu verbessern.9

    The Power of Diagnostics: DX ICD Technology and its implications

    Take the opportunity and watch our latest webinar on the shared experiences with our DX Technology and its implications on patient selection and clinical practice with Dr. Biffi (Italy) and Dr. Matthews (UK). 

    In this webinar, you will:

    • Explore why DX Technology is superior to single-camber ICDs in the detection of atrial fibrillation.​​​​​​
    • Learn how DX enables faster and more effective intervention.
    • Discover how DX can improve patient outcome.
    Watch now

    Unparalleled Single-Lead ICD Technology

    Available as a unique, single-lead ICD system equipped with a floating atrial dipole, DX ICDs offer reliable, timely information about atrial arrhythmias and detect AF early.2, 3, 4, 5, 6 After detection, the system helps you monitor AF burden over time.3

    It can be paired with the proven BIOTRONIK Home Monitoring® platform, and complemented with the BIOTRONIK Patient App. In combination, this AF management solution offers a comprehensive assessment of ICD patients and enables earlier, well-informed decision-making.3 

    Acticor 7 VR T DX Plexa S DX

    Klinische Evidenz

    Detect AF Early

    • Direct, true atrial signal thanks to the DX tachycardia lead enhanced with a floating atrial dipole.
    • Long-term, stable atrial sensing (24-month follow-up).2, 3, 4
    • It is almost four times more likely to detect atrial tachyarrhythmia (AT)/AF with DX ICD than with a standard single-chamber ICD in patients without a history of atrial arrhythmias at implant.2, 6, 7
    • Reliable detection and transmission of atrial high-rate episodes (AHREs) with clinically relevant duration (for AHRE ≥1 hour, positive predictive value (PPV) >99.7%).3
    • Real-world data for DX ICD patients over a two-year follow-up period shows Home Monitoring messages are transmitted for 90.2% of patients.3 Among these, messages are transmitted on 92.5% of days (median value).3
    Detect AF Early

    Monitor AF Burden Reliably

    • DX ICD allows correct estimation of AF burden with reliable classification of AHRE episodes by their duration (6min–1h, 1h–24h, and ≥24h).3
    • DX ICD helps clinicians adhere to the AF European guidelines on AHRE monitoring and initiate oral anticoagulant (OAC) treatment for stroke prevention in a timely manner.9
    • DX ICD offers decision support for therapeutic interventions such as initiation of antiarrhythmic drugs or AF ablation, proven to reduce symptoms and improve cardiovascular outcomes.9,10
    Monitor AF Burden Reliably

    Improve Outcomes Effectively

    • Incidence of OAC prescription onset tends to be higher with DX ICDs compared to standard single-chamber ICDs.2
    • Associated with lower stroke incidence compared to single-chamber ICDs, DX ICDs have been shown to help avoid 4.6 strokes per year per 1,000 patients.1
    • By helping to avoid strokes, DX ICDs save costs compared to single-chamber ICDs in patients with a CHA2DS2-VASc score >5, with the highest savings for patients with a CHA2DS2-VASc score of 9.1,*
    • An 81% reduction of nonactionable clinic visits12 and a 21% reduction in the number of hospitalizations11 can be achieved by incorporating BIOTRONIK Home Monitoring into the AF management workflow.
    • The BIOTRONIK Patient App allows patients to be more engaged in their care and integrates them into their disease management, an approach that can foster improved health awareness and behavior.13
    • Furthermore, it adds patient-reported data to enable joint rhythm and symptom evaluation and provides faster notification of patient symptoms for quicker reaction to changes in a patient’s condition.
    Improve Outcomes Effectively

    Wichtige Studien

    Mehr als ein Jahrzehnt klinischer Erfahrung

    DX Technology Related Information

    Mehr als ein Jahrzehnt klinischer Erfahrung

    Die DX-Technologie kann auf eine langjährige klinische Erfahrung und eine Vielzahl von klinischen Studien zurückblicken. Seit 2009 wurden über 100.000 Implantationen¹⁴ in mehr als 80 Ländern¹⁴ durchgeführt, unterstützt durch über 20 klinische Studien mit mehr als 4.000 Patienten.¹⁵

    Diese solide Grundlage klinischer Evidenz wurde vor kurzem durch die Ergebnisse der MATRIX-Studie, der bisher grössten klinischen Evaluierung der DX-Technologie, ergänzt.³
    >20
    klinische Studien
    >4.000
    Studienpatienten
    >100.000
    Implantationen

    MATRIX

    • In an unselected, real-life setting, the study results confirm that DX Technology, combined with BIOTRONIK Home Monitoring, allows for reliable, guideline-recommended remote monitoring of subclinical AF.3
    • The clinical relevance of AHRE monitoring is underlined by the fact that patients with new-onset AHRE often experience AHRE progression and are at substantial risk of thromboembolic events, while most of them are not on OAC.3
    FIND OUT MORE
    Adjudication Outcome for the First AHRE

    THINGS

    • The THINGS registry results show that DX systems are associated with an almost fourfold likelihood of detecting AT/AF compared to a standard, single-chamber ICDs.2
    • The diagnosis of AT/AF often leads to clinical interventions, mainly represented by OAC onset.2
    FIND OUT MORE
    THINGS

    SENSE

    • The SENSE study results show that the DX ICD system may offer significant benefits for AHRE detection in ICD patients who do not have an atrial pacing indication, but are at high risk of developing subclinical AF.7
    FIND OUT MORE
    AHRE Detection

    Medien

    Dr. George Thomas, Principal Investigator of the SENSE study, on DX Technology and AHRE detection.
    Selecting the Right ICD - To aid in the selection of the ICD device type to be implanted, Dr. Mate Vamos from the University of Szeged, Hungary, together with a panel of experts, recently introduced a helpful ICD selection flowchart.

    Weitere Informationen

    Downloads und weitere Links

    DOWNLOAD MATRIX STUDY LEAFLET DOWNLOAD THINGS STUDY LEAFLET DOWNLOAD SENSE STUDY LEAFLET

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    Referenzen

    1. Reinhold T, Belke R, Hauser T, et al. Cost Saving Potential of an Early Detection of Atrial Fibrillation in Patients after ICD Implantation. BioMed Research International, Band 2018, 14. August 2018, Artikel 3417643. 2. Biffi M, Iori M, De Maria E, et al. The role of atrial sensing for new-onset atrial arrhythmias diagnosis and management in single-chamber implantable cardioverter-defibrillator recipients: Results from the THINGS registry. Journal of Cardiovascular Electrophysiology, Band 31, Ausgabe 4, April 2020, Seiten 846–853. 3. Hindricks G, Theuns DA, 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, Band 25, Ausgabe 5, Mai 2023, Seiten 1-10, euad061. 4. Kurt M, Jathanna N, Babady M, et al. Avoiding inappropriate therapy of single-lead implantable cardioverter-defibrillator by using atrial-sensing electrodes. Journal of Cardiovasc Electrophysiology, Band 29, Ausgabe 12, Dezember 2018, Seiten 1682–1689. 5. Gwag HB, Lee SH, Kim JS, et al. Long-term evaluation of sensing variability of a floating atrial dipole in a single-lead defibrillator: The mechanistic basis of long-term stability of amplified atrial electrogram. International Journal of Cardiology, Band 336, 1. August 2021, Seiten 67–72. 6. Pung X, Hong DZ, Ho TY, et al. The utilization of atrial sensing dipole in single lead implantable cardioverter defibrillator for detection of new-onset atrial high-rate episodes or subclinical atrial fibrillation: A systematic review and meta-analysis. Journal of Arrhythmia. Band 38, Ausgabe 2, 15. Januar 2022, Seiten 177–186. 7. Thomas G, Choi DY, Doppalapudi H, et al. Subclinical atrial fibrillation detection with a floating atrial sensing dipole in single lead implantable cardioverter-defibrillator systems: Results of the SENSE trial. Journal of Cardiovascular Electrophysiology, Band 30, Ausgabe 10, Oktober 2019, Seiten 1994–2001. 8. Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. European Journal of Cardio-Thoracic Surgery, Band 50, Ausgabe 5, November 2016, Seiten e1–e88. 9. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal, Band 42, Ausgabe 5, 1. Februar 2020, Seiten 373–498. 10. Kirchhof P, Camm AJ, Goette A, et al. EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. The New England Journal of Medicine, Band 383, Ausgabe 14, 1. Oktober 2020, Seiten 1305–1316. 11. Heidbuchel H, Hindricks G, Broadhurst P, et al. EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): A provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring. European Heart Journal, Band 36, Ausgabe 3, 14. Januar 2015, Seiten 158–169. 12. Varma N, Love CJ, Michalski J, et al. Alert-Based ICD Follow-Up: A Model of Digitally Driven Remote Patient Monitoring. JACC: Clinical Electrophysiology, Band 7, Ausgabe 8, August 2021, Seiten 976–987. 13. Fabritz L, Crijns HJGM, Guasch E, et al. Dynamic risk assessment to improve quality of care in patients with atrial fibrillation: the 7th AFNET/EHRA Consensus Conference. EP Europace, Band 23, Ausgabe 3, 9. März 2021, Seiten 329–344. 14. Status Januar 2024. 15. Based on completed studies with a focus on evaluating DX Technology. Further DX recipients are included in ongoing studies or studies with broader scope.  16. Vamos M, Nemeth M, Balazs T, Zima E, Duray GZ. Rationale and feasibility of the atrioventricular single-lead ICD systems with a floating atrial dipole (DX) in clinical practice. Trends Cardiovasc Med. 2022;32(2):84-89. 17. Konturiertes Gehäuse; Acticor/Rivacor VR: 60x61,5x10 mm; 30 cm3.

    * Geschätzter Kostenunterschied: 228 € pro Jahr und Patient.