Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study

• Published in: Journal of cardiovascular electrophysiology Vol. 27; no. 12; pp. 1403 - 1410
• Main Authors: NÖLKER, GEORG, MAYER, JULIA, BOLDT, LEIF-HENDRIK, SEIDL, KARLHEINZ, VAN DRIEL, VINCENT, MASSA, THOMAS, KOLLUM, MARC, BRACHMANN, JOHANNES, DENEKE, THOMAS, HINDRICKS, GERHARD, JUNG, WERNER, BRUNNER, KYLE J., KRAUS, STACIA, HÜMMER, ALEXANDER, LEWALTER, THORSTEN
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01.12.2016; Wiley Subscription Services, Inc
• Subjects: Action Potentials; Aged; atrial fibrillation; Atrial Fibrillation - diagnosis; Atrial Fibrillation - physiopathology; Cardiac arrhythmia; Data processing; Decision making; diagnosis; Electrocardiography, Ambulatory - instrumentation; Equipment Design; Female; Fibrillation; Germany; Heart; Heart Conduction System - physiopathology; Heart diseases; Heart Rate; Humans; implantable cardiac monitor; Male; Materials Testing; Middle Aged; monitoring; Netherlands; Predictive Value of Tests; Prospective Studies; Reproducibility of Results; Signal Processing, Computer-Assisted; Transducers; diagnosis; atrial fibrillation; monitoring; implantable cardiac monitor
• ISSN: 1045-3873; 1540-8167
• DOI: 10.1111/jce.13089

DETECT AF Study Results Introduction Reliable detection and monitoring of atrial fibrillation (AF) is essential for accurate clinical decision making, which can now be done continuously with the introduction of implantable cardiac monitors (ICM) The DETECT AF study evaluated the performance of the Confirm DM2102 ICM (St. Jude Medical, St. Paul, MN, USA) to accurately detect and monitor AF. Methods Ninety patients previously implanted with the ICM and with either suspected or known paroxysmal AF were enrolled at 12 centers in Germany and The Netherlands. At least 2 weeks after ICM implant, patients wore a Holter monitor for 4 days, while the ICM monitored for AF episodes lasting at least 2 minutes. Holter monitor data was analyzed by a blinded, independent core laboratory and compared to the ICM AF detections. Patient and episode sensitivity (SE), specificity (SP), positive predictive value (PPV), and negative predictive (NPV) were calculated using standard analysis and a generalized estimation equation method where appropriate. Results A total of 79/90 subjects (61% male, 65.7 ± 9.6 years old) were included in the analysis, totaling 6,894 hours of Holter monitoring. Using a per patient analysis SE was 100%, PPV was 64.0%, SP was 85.7%, and NPV was 100%. Using a per episode analysis, SE was 94.0% and PPV was 64.0%. With an AF duration analysis, the SE was 83.9%, PPV was 97.3%, SP was 99.4% with an NPV of 98.5%. Conclusion The SJM Confirm DM2102 can accurately and repeatedly detect paroxysmal AF episodes of at least 2 minutes in length.