ArticlePacing and clinical electrophysiology : PACE2019
Clinical evaluation of a small implantable cardiac monitor with a long sensing vector.
Article in Pacing and clinical electrophysiology : PACE, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed.
- Subdermal Insertable Sensors for Health Monitoring: Applications, Challenges, and Emerging Technologies.Annals of biomedical engineering · 2026Review
- Safety, performance, and remote programming utilization of an insertable cardiac monitor: The LUX-Dx PERFORM study.Heart rhythm O2 · 2026Article
- Algorithm Improvements in an Insertable Cardiac Monitor Reduce False Positives and Episode Review Burden.Pacing and clinical electrophysiology : PACE · 2025Article
- Subcutaneous sensors for monitoring congestion and to reduce heart failure hospitalizations-a viable middle ground between deep implantable intravascular monitoring devices and wearable technologies?Heart failure reviews · 2025Review
- Advances in Cardiovascular Wearable Devices.Biosensors · 2024Review
- Monitoring of Remotely Reprogrammable Implantable Loop Recorders With Algorithms to Reduce False-Positive Alerts.Journal of the American Heart Association · 2024Article
- Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial.Frontiers in cardiovascular medicine · 2024Article
- Preliminary results from the LUX-Dx insertable cardiac monitor remote programming and performance (LUX-Dx PERFORM) study.Clinical cardiology · 2023Observational
- ESC Working Group on e-Cardiology Position Paper: accuracy and reliability of electrocardiogram monitoring in the detection of atrial fibrillation in cryptogenic stroke patientsEuropean heart journal. Digital health · 2022Review
- Accuracy of atrial fibrillation detection by an insertable cardiac monitor in patients undergoing catheter ablation: Results of the BioVAD study.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2022Article
- Programming Optimization in Implantable Cardiac Monitors to Reduce False-Positive Arrhythmia Alerts: A Call for Research.Diagnostics (Basel, Switzerland) · 2022Article
- Effectiveness of SharpSense™ algorithms in reducing bradycardia and pause detection: real-world performance in Confirm Rx™ insertable cardiac monitor.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2022Article
- The BIOMONITOR III Injectable Cardiac Monitor: Clinical Experience with a Novel Injectable Cardiac Monitor.Journal of clinical medicine · 2022Article
- Factors affecting signal quality in implantable cardiac monitors with long sensing vector.Journal of arrhythmia · 2021Article
- Article
- Clinical evaluation of a small implantable cardiac monitor with a long sensing vector.Pacing and clinical electrophysiology : PACE · 2019Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionWe conducted this study to show the safety and efficacy of a new implantable cardiac monitor (ICM), the BioMonitor 2 (Biotronik SE & Co. KG; Berlin, Germany), and to describe the arrhythmia detection performance.
methodsThe BioMonitor 2 has an extended sensing vector and is implanted close to the heart. It can transmit up to six subcutaneous electrocardiogram strips by Home Monitoring each day. We enrolled 92 patients with a standard device indication for an ICM in a single-arm, multicenter prospective trial. Patients were followed for 3 months, and 48-h Holter recordings were used to evaluate the arrhythmia detection performance.
resultsOne patient withdrew consent and in one patient, the implantation failed. Two study device-related serious adverse events were reported, satisfying the primary safety hypothesis. Implantations took 7.4 ± 4.4 min from skin cut to suture. At 1 week, the R-wave amplitude was 0.75 ± 0.53 mV. In the 82 patients with completed Holter recordings, all patients with arrhythmias were correctly identified. False positive detections of arrhythmia were mostly irregular rhythms wrongly detected as atrial fibrillation (episode-based positive predictive value 72.5%). Daily Home Monitoring transmission was 94.9% successful.
conclusionSafety and efficacy of the new device has been demonstrated. The detected R-wave amplitudes are large, leading to a low level of inappropriate detections due to over- or undersensing.
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