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  • Acticor_7_VR_T_DX__Plexa_S_DX
  • Plexa_S_DX
  • VR_T_DX_Plexa_S_DX
  • Acticor_7_VR_T_DX__Plexa_S_DX
  • Plexa_S_DX

    DX Technology

    ADVANCED DIAGNOSTICS. OPTIMIZED CARE.

    Atrial Fibrillation Management Solution for Single-Chamber ICD Patients

    Atrial fibrillation (AF) is a widespread, often silent problem for implantable cardioverter-defibrillator (ICD) patients, occurring at an annual incidence of nearly 21%.1 Unfortunately, it is difficult or even impossible to detect with a standard, single-chamber ICD.1 If AF remains untreated, a patient’s clinical condition may worsen, potentially resulting in severe outcomes. 

    This is where DX Technology comes in. By providing atrial sensing capabilities, DX Technology addresses the shortcomings of single-chamber ICDs. It is the only single-lead ICD system able to provide AF management diagnostic data originating directly from the atrium – and this is what makes it truly unique.

    Category

    Tachycardia ICD

    Product Highlights

    Icon DX Technologie

    Detect AF Early

    DX ICDs increase the likelihood of detecting atrial arrhythmias early, helping you to identify patients at risk and ensure prompt, appropriate patient management

    DX Technology - AF Management Solution; Monitor AF Burden Reliably

    Monitor AF Burden Reliably

    The DX ICD system helps you monitor AF burden over time3 so that you can intervene when needed, react to changes in patient status and optimize treatment

    DX Technology - AF Management Solution; Improve Outcomes Effectively 

    Improve Outcomes Effectively

    Once AF is detected and its burden monitored, appropriate therapy, when needed, can be initiated in a timely manner for improved clinical outcomes9

    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

    Clinical Evidence

    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

    Key Studies

    More Than a Decade of Clinical Experience

    DX Technology Related Information

    More Than a Decade of Clinical Experience

    DX Technology boasts a long-standing history of clinical experience and a vast body of clinical evidence. Since 2009, over 100,000 implantations¹⁴ have been performed in more than 80 countries¹⁴, supported by over 20 clinical studies involving more than 4,000 patients.¹⁵

    This strong foundation of clinical evidence has recently been enriched by the MATRIX study results, the largest clinical evaluation of DX Technology to date.³
    >20
    clinical studies
    >4,000
    study patients
    >100,000
    devices implanted

    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

    Media

    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.

    Related Information

    Downloads & Related Links

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

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    References

    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, Volume 2018, 14 August 2018, Article ID 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, Volume 31, Issue 4, April 2020, Pages 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, Volume 25, Issue 5, May 2023, Pages 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, Volume 29, Issue 12, December 2018, Pages 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, Volume 336, 1 August 2021, Pages 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. Volume 38, Issue 2, 15 January 2022, Pages 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, Volume 30, Issue 10, October 2019, Pages 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, Volume 50, Issue 5, November 2016, Pages 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, Volume 42, Issue 5, 1 February 2020, Pages 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, Volume 383, Volume 14, 1 October 2020, Pages 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, Volume 36, Issue 3, 14 January 2015, Pages 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, Volume 7, Issue 8, August 2021, Pages 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, Volume 23, Issue 3, 9 March 2021, Pages 329–344.; 14. Data on file, status January 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. Contoured housing; Acticor/Rivacor VR: 60x61.5x10 mm; 30 ccm.

    * Estimated cost difference: 228€ per year per patient.