Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole
The 2020 ESC Guidelines for Diagnosis and Management of Atrial Fibrillation (AF)2 recommend remote monitoring (RM) of device-detected atrial high rate episodes (AHRE) and propose options for managing AHRE along pre-specified strata (6min…<1h, 1h…<24h, ≥24h)3 . DX Technology is unique in that it offers true atrial sensing in single-chamber ICD systems. This analysis aimed to assess the DX-ICD system’s capability to follow this recommendation, and to evaluate findings on AHRE detection and progression regarding their clinical implications based on real-life MATRIX registry data. MATRIX is the largest trial involving DX-ICD systems to date, enrolling 2,054 patients in 119 centers worldwide.
The study found that the DX-ICD system demonstrates a high detection accuracy for AHRE throughout 2 years of follow-up. Combined with the high transmission rate of BIOTRONIK Home Monitoring (HM), this allows reliable, guideline-recommended screening for subclinical AF and monitoring of AHRE duration progression.
Furthermore, the clinical relevance of new-onset AHRE detection and burden monitoring was underlined by MATRIX results, as new-onset AHRE was not rare, and progression shown to be common in these patients. In fact, the majority of patients with new-onset AHRE (69.5%) presented with AHRE of longer duration (i.e., 1 hour or more) during follow-up. More importantly, 80% of patients with new-onset AHRE had a substantial risk of thromboembolic events (i.e. a high CHA2DS2-VASc score) - and in most of these cases (69.5%), patients were not on oral anticoagulation (OAC) at baseline.
Read more about the study design, key results, and clinical relevance below.
Two objectives
Adjudication of Device-Detected AHRE Shows High Positive Predictive Value
Analyzing the detection accuracy of DX-ICD systems for different AHRE durations, the first occurring AHRE per duration stratum was adjudicated, revealing a positive predictive value (PPV) of >99.7% for AHRE durations ≥1h.
Investigators Value the System’s Atrial Signal Detection Quality
DX-ICD systems including Home Monitoring (HM) delivered a high real-life transmission performance: In patients with active HM (n=1,841)ii, the median daily transmission rate (i.e., % of days with transmissions) was 92.5%.iii
The system's high transmission rate, combined with its high AHRE detection accuracy, allows for reliable, guideline -recommended remote monitoring of subclinical AF.
New-Onset AHRE Is Not Rare
In patients with no AF history (n = 1,451), new-onset AHRE occurred in 119 patients (8.2%) during the 2 years of follow-up.
Progression Is Common
Progression to a stratum of longer duration was rather frequent (31.1%)
Episode Duration Often Exceeded 1h
By end of follow-up, AHRE duration reached or exceeded 1h in approx. 7 out of 10 patients (82/119, 69%) with new onset AHRE.
Many New-Onset AHRE Patients Were at High Risk of Thromboembolic Events
79.8% of patients with new-onset AHRE had a high CHA2DS2-VASc stroke risk (95/119).
Most of these were not on OAC therapy at baseline (66/95, 69.5%).
To explore the impact of enhanced features and capabilities of the BIOTRONIK DX system on detection and management of AF in an unselected real-life setting.
i AHRE lasting ≥ 6 minutes were included in the analysis.
ii "Active": at least 1 HM transmission was received during the 24 months of follow-up.
iii transmission rate = % of days with transmissions
1 Management and Detection of Atrial Tachyarrhythmias in Patients Implanted with BIOTRONIK DX Systems
2 Here used short term for “2020 European Society of Cardiology Guidelines for the diagnosis and management of atrial fibrillation”
3 Hindricks G, Potpara T, Dagres N et al. Eur Heart J 2021;42(5):373-498. DOI: 10.1093/eurheartj/ehaa612
