title: Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study.
abstract: 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.
  
  
  
  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.
  
  
  
  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%.
  
  
  
  The SJM Confirm DM2102 can accurately and repeatedly detect paroxysmal AF episodes of at least 2 minutes in length.
authors: Herz- und Diabeteszentrum Nordrhein-Westfalen - Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
authors: Georg
authors: G
authors: Nölker
authors: Herzzentrum Dresden, Dresden, Germany.
authors: Julia
authors: J
authors: Mayer
authors: Charité - Universitätsmedizin Berlin Campus Virchow Klinikum, Berlin, Germany.
authors: Leif-Hendrik
authors: LH
authors: Boldt
authors: Klinikum Ingolstadt, Ingolstadt, Germany.
authors: Karlheinz
authors: K
authors: Seidl
authors: Haga Ziekenhuis, Leyenburg, The Netherlands.
authors: Vincent
authors: V
authors: VAN Driel
authors: Klinikum Frankfurt Hoechst, Frankfurt, Germany.
authors: Thomas
authors: T
authors: Massa
authors: Hegau-Bodensee-Klinikum Singen, Singen, Germany.
authors: Marc
authors: M
authors: Kollum
authors: Klinikum Coburg, Coburg, Germany.
authors: Johannes
authors: J
authors: Brachmann
authors: Rhön-Klinikum Bad Neustadt, Bad Neustadt, Germany.
authors: Thomas
authors: T
authors: Deneke
authors: Herzzentrum Leipzig, Leipzig, Germany.
authors: Gerhard
authors: G
authors: Hindricks
authors: Schwarzwald Baar Klinikum, Villingen-Schwenningen, Germany.
authors: Werner
authors: W
authors: Jung
authors: St. Jude Medical, St. Paul, USA.
authors: Kyle J
authors: KJ
authors: Brunner
authors: NAMSA, Golden Valley, Minnesota, USA.
authors: Stacia
authors: S
authors: Kraus
authors: St. Jude Medical, Eschborn, Germany.
authors: Alexander
authors: A
authors: Hümmer
authors: Isar Herzzentrum, München, Germany.
authors: Thorsten
authors: T
authors: Lewalter
mesh_terms: D000200:Action Potentials; D000368:Aged; D001281:Atrial Fibrillation / Q000175:diagnosis* / Q000503:physiopathology; D015716:Electrocardiography, Ambulatory / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005858:Germany; D006329:Heart Conduction System / Q000503:physiopathology*; D006339:Heart Rate; D006801:Humans; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D009426:Netherlands; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015203:Reproducibility of Results; D012815:Signal Processing, Computer-Assisted; D014159:Transducers
keywords: atrial fibrillation; diagnosis; implantable cardiac monitor; monitoring