Georg Nölker1, Julia Mayer2, Leif-Hendrik Boldt3, Karlheinz Seidl4, Vincent VAN Driel5, Thomas Massa6, Marc Kollum7, Johannes Brachmann8, Thomas Deneke9, Gerhard Hindricks10, Werner Jung11, Kyle J Brunner12, Stacia Kraus13, Alexander Hümmer14, Thorsten Lewalter15. 1. Herz- und Diabeteszentrum Nordrhein-Westfalen - Ruhr-Universität Bochum, Bad Oeynhausen, Germany. 2. Herzzentrum Dresden, Dresden, Germany. 3. Charité - Universitätsmedizin Berlin Campus Virchow Klinikum, Berlin, Germany. 4. Klinikum Ingolstadt, Ingolstadt, Germany. 5. Haga Ziekenhuis, Leyenburg, The Netherlands. 6. Klinikum Frankfurt Hoechst, Frankfurt, Germany. 7. Hegau-Bodensee-Klinikum Singen, Singen, Germany. 8. Klinikum Coburg, Coburg, Germany. 9. Rhön-Klinikum Bad Neustadt, Bad Neustadt, Germany. 10. Herzzentrum Leipzig, Leipzig, Germany. 11. Schwarzwald Baar Klinikum, Villingen-Schwenningen, Germany. 12. St. Jude Medical, St. Paul, USA. 13. NAMSA, Golden Valley, Minnesota, USA. 14. St. Jude Medical, Eschborn, Germany. 15. Isar Herzzentrum, München, Germany.
Abstract
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.
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.
Authors: Niraj Varma; Iwona Cygankiewicz; Mintu P Turakhia; Hein Heidbuchel; Yu-Feng Hu; Lin Yee Chen; Jean-Philippe Couderc; Edmond M Cronin; Jerry D Estep; Lars Grieten; Deirdre A Lane; Reena Mehra; Alex Page; Rod Passman; Jonathan P Piccini; Ewa Piotrowicz; Ryszard Piotrowicz; Pyotr G Platonov; Antonio Luiz Ribeiro; Robert E Rich; Andrea M Russo; David Slotwiner; Jonathan S Steinberg; Emma Svennberg Journal: Circ Arrhythm Electrophysiol Date: 2021-02-12
Authors: Niraj Varma; Iwona Cygankiewicz; Mintu P Turakhia; Hein Heidbuchel; Yufeng Hu; Lin Yee Chen; Jean-Philippe Couderc; Edmond M Cronin; Jerry D Estep; Lars Grieten; Deirdre A Lane; Reena Mehra; Alex Page; Rod Passman; Jonathan P Piccini; Ewa Piotrowicz; Ryszard Piotrowicz; Pyotr G Platonov; Antonio Luiz Ribeiro; Robert E Rich; Andrea M Russo; David Slotwiner; Jonathan S Steinberg; Emma Svennberg Journal: Cardiovasc Digit Health J Date: 2021-01-29
Authors: Ben Freedman; Giuseppe Boriani; Taya V Glotzer; Jeff S Healey; Paulus Kirchhof; Tatjana S Potpara Journal: Nat Rev Cardiol Date: 2017-07-06 Impact factor: 32.419
Authors: Simon Wechselberger; Mads Kronborg; Yan Huo; Judith Piorkowski; Sebastian Neudeck; Ellen Päßler; Ali El-Armouche; Utz Richter; Julia Mayer; Stefan Ulbrich; Liying Pu; Bettina Kirstein; Thomas Gaspar; Christopher Piorkowski Journal: Europace Date: 2018-11-01 Impact factor: 5.214
Authors: Emanuele Bertaglia; Benjamin Blank; Carina Blomström-Lundqvist; Axel Brandes; Nuno Cabanelas; G-Andrei Dan; Wolfgang Dichtl; Andreas Goette; Joris R de Groot; Andrzej Lubinski; Eloi Marijon; Béla Merkely; Lluis Mont; Christopher Piorkowski; Andrea Sarkozy; Neil Sulke; Panos Vardas; Vasil Velchev; Dan Wichterle; Paulus Kirchhof Journal: Europace Date: 2019-10-01 Impact factor: 5.214