JACC. Clinical electrophysiology · 2026
Accuracy of Implantable Loop Recorders: Multicenter, Multidevice Comparison.
СтатьяМногоцентровое исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Kamsani Suraya H, Middeldorp Melissa E, Evans Shaun, Russo Andrea M, Jayakumar Mohanaraj, Deering Thomas F, Shahmohamadi Elnaz, Baykaner Tina, Fitzgerald John L, Gopinathannair Rakesh, Abbas Mohamed, Varma Niraj, Freeman James V, Mittal Suneet, Sanders Prashanthan
Аннотация
BACKGROUND: Implantable loop recorders (ILRs) frequently generate false-positive alert transmissions, increasing clinical burden.
OBJECTIVES: This study sought to evaluate and compare arrhythmia detection accuracy among currently used ILRs: Medtronic (MDT) LINQ II with AccuRhythm AI, Boston Scientific (BSX) LUX-Dx with a Dual-Stage Algorithm, Biotronik (BIO) Biomonitor III with RhythmCheck, and Abbott (ABT) Confirm Rx (SharpSense).
METHODS: A multicenter, multivendor database of 437,351 electrocardiogram-verified episodes from 6,756 patients (January 2022 to March 2023, across 25 centers) was used. A random sample of 1,140 patients (∼283 per device) was selected based on a prospectively determined power analysis. All alerts were independently adjudicated by trained physicians.
RESULTS: The study cohort (median age: 69.5 years [IQR: 60.1-77.0]; 39% women) generated 25,826 total alerts, with a median of 5 alerts (IQR: 2-14) per patient. Indications for ILR implant included cryptogenic stroke (21.0%), suspected atrial fibrillation (AF) (11.3%), AF management (23.6%), syncope (23.2%), palpitations (14.9%), ventricular tachycardia (2.1%), and unknown (3.8%). Alerts for atrial tachycardia/AF were most frequent (BIO: 70.8%; MDT: 68.0%; ABT: 55.7%; BSX: 35.7%). After adjudication, BSX had the highest positive predictive values (PPVs), followed by ABT and MDT, which had similar and moderate PPVs, whereas BIO had the lowest (BSX: 0.73; MDT: 0.56; ABT: 0.51; BIO: 0.23). False-positive atrial tachycardia/AF alerts with BIO devices were due to ectopy (75.8%), combined ectopy with oversensing/noise (5.3%), isolated oversensing (5.2%), sinus arrhythmias (3.9%), indeterminate reason (3.7%), noise (3.6%), and bradycardia (2.5%). For bradycardia detection, BSX demonstrated the highest PPV (0.96), whereas MDT had the lowest PPV (0.36; primarily due to undersensing). Pause detection accuracy was lowest for ABT (PPV: 0.01; 79.8% due to undersensing) and highest for BSX (PPV: 0.70). Tachycardia alerts had moderate PPVs for BIO (0.62) and BSX (0.61), with substantially lower PPVs for MDT (0.29) and ABT (0.27).
CONCLUSIONS: ILRs demonstrate variable accuracy in arrhythmia detection, with a substantial burden of false-positive alerts across all vendors despite artificial intelligence-based and other algorithmic enhancements. Further improvement of alert algorithms to reduce clinic burdens is needed.
OBJECTIVES: This study sought to evaluate and compare arrhythmia detection accuracy among currently used ILRs: Medtronic (MDT) LINQ II with AccuRhythm AI, Boston Scientific (BSX) LUX-Dx with a Dual-Stage Algorithm, Biotronik (BIO) Biomonitor III with RhythmCheck, and Abbott (ABT) Confirm Rx (SharpSense).
METHODS: A multicenter, multivendor database of 437,351 electrocardiogram-verified episodes from 6,756 patients (January 2022 to March 2023, across 25 centers) was used. A random sample of 1,140 patients (∼283 per device) was selected based on a prospectively determined power analysis. All alerts were independently adjudicated by trained physicians.
RESULTS: The study cohort (median age: 69.5 years [IQR: 60.1-77.0]; 39% women) generated 25,826 total alerts, with a median of 5 alerts (IQR: 2-14) per patient. Indications for ILR implant included cryptogenic stroke (21.0%), suspected atrial fibrillation (AF) (11.3%), AF management (23.6%), syncope (23.2%), palpitations (14.9%), ventricular tachycardia (2.1%), and unknown (3.8%). Alerts for atrial tachycardia/AF were most frequent (BIO: 70.8%; MDT: 68.0%; ABT: 55.7%; BSX: 35.7%). After adjudication, BSX had the highest positive predictive values (PPVs), followed by ABT and MDT, which had similar and moderate PPVs, whereas BIO had the lowest (BSX: 0.73; MDT: 0.56; ABT: 0.51; BIO: 0.23). False-positive atrial tachycardia/AF alerts with BIO devices were due to ectopy (75.8%), combined ectopy with oversensing/noise (5.3%), isolated oversensing (5.2%), sinus arrhythmias (3.9%), indeterminate reason (3.7%), noise (3.6%), and bradycardia (2.5%). For bradycardia detection, BSX demonstrated the highest PPV (0.96), whereas MDT had the lowest PPV (0.36; primarily due to undersensing). Pause detection accuracy was lowest for ABT (PPV: 0.01; 79.8% due to undersensing) and highest for BSX (PPV: 0.70). Tachycardia alerts had moderate PPVs for BIO (0.62) and BSX (0.61), with substantially lower PPVs for MDT (0.29) and ABT (0.27).
CONCLUSIONS: ILRs demonstrate variable accuracy in arrhythmia detection, with a substantial burden of false-positive alerts across all vendors despite artificial intelligence-based and other algorithmic enhancements. Further improvement of alert algorithms to reduce clinic burdens is needed.