Home monitoring of implantable cardioverter-defibrillators: interpretation reliability of the second-generation "IEGM Online" system
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't
PubMed
25567067
PubMed Central
PMC4381835
DOI
10.1093/europace/euu349
PII: euu349
Knihovny.cz E-resources
- Keywords
- Arrhythmia detection, Home monitoring, Implantable cardioverter-defibrillator, Intracardiac electrogram, Remote monitoring, Telemedicine,
- MeSH
- Defibrillators, Implantable * MeSH
- Electrocardiography methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Observer Variation MeSH
- Online Systems MeSH
- Reproducibility of Results MeSH
- Sensitivity and Specificity MeSH
- Arrhythmias, Cardiac diagnosis therapy MeSH
- Telemedicine methods MeSH
- User-Computer Interface MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Research Support, Non-U.S. Gov't MeSH
AIMS: Intracardiac electrograms (IEGMs) are essential for the assessment of implantable cardioverter-defibrillator (ICD) function. The Biotronik Home Monitoring systems transmit an 'IEGM Online' that is shorter than the full-length programmer IEGM due to technical constrains. The aim of this study was to evaluate the accuracy of the physician's classification of the underlying rhythm based on the second-generation IEGM Online. METHODS AND RESULTS: In total, 1533 patients treated with single- and dual-chamber ICDs and cardiac resynchronization therapy defibrillators were enrolled at 67 investigational sites and followed for 15 months. The investigators classified the rhythm shown in IEGM Online as ventricular tachycardia, ventricular fibrillation, atrial fibrillation, other supraventricular tachyarrhythmia, oversensing due to lead failure, T-wave oversensing, or other rhythm. At the next in-office follow-up, the investigators classified independently the rhythm seen in the corresponding programmer IEGM. The two rhythm classifications were compared thereafter. Both IEGM Online and programmer IEGM were available in 2099 arrhythmic or oversensing events, of which 146 (7.0%) were classified as other rhythm or artefacts and were excluded as inconclusive or atypical. The remaining 1953 events, affecting 352 patients (23.0%), were classified correctly in 1803 cases (92.3%). The accuracy of rough rhythm classification as ventricular, supraventricular, or oversensing was 97.2%. CONCLUSION: The Lumax and IEGM Online HD Evaluation study demonstrates that remote IEGM analysis is reasonably accurate in a remote monitoring system that transmits shorter IEGM than the full-length programmer IEGM for the sake of frequent, fully automatic data transmission.
Biotronik SE and Co KG Berlin Germany
Charité University Medicine Berlin Campus Charité Mitte Berlin Germany
Department of Cardiology Isala Klinieken Zwolle The Netherlands
Department of Cardiology Städtisches Klinikum München Bogenhausen Munich Germany
Department of Internal Medicine LKH Bruck an der Mur Bruck an der Mur Austria
Elisabeth Krankenhaus Recklinghausen Germany
Evangelisches Krankenhaus Düsseldorf Germany
Hannover Medical School Hannover Germany
Medical Clinic Hospital Reinbek St Adolf Stift Reinbek Germany
St Anne's University Hospital and International Clinical Research Center Brno Czech Republic
See more in PubMed
Auricchio A, Hartung W, Geller C, Klein H. Clinical relevance of stored electrograms for implantable cardioverter-defibrillator (ICD) troubleshooting and understanding of mechanisms for ventricular tachyarrhythmias. Am J Cardiol 1996;78(5A):33–41. PubMed
Dubner S, Auricchio A, Steinberg JS, Vardas P, Stone P, Brugada J, et al. ISHNE/EHRA expert consensus on remote monitoring of cardiovascular implantable electronic devices (CIEDs). Europace 2012;14:278–93. PubMed
Wilkoff BL, Auricchio A, Brugada J, Cowie M, Ellenbogen KA, Gillis AM, et al. HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations. Europace 2008;10:707–25. PubMed
Halimi F, Cantu F. Remote monitoring for active cardiovascular implantable electronic devices: a European survey. Europace 2010;12:1778–80. PubMed
Ritter O, Bauer WR. Use of “IEGM Online” in ICD patients - early detection of inappropriate classified ventricular tachycardia via Home Monitoring. Clin Res Cardiol 2006;95:368–72. PubMed
Jung W, Rillig A, Birkemeyer R, Miljak T, Meyerfeldt U. Advances in remote monitoring of implantable pacemakers, cardioverter defibrillators and cardiac resynchronization therapy systems. J Interv Card Electrophysiol 2008;23:73–85. PubMed
Burri H, Senouf D. Remote monitoring and follow-up of pacemakers and implantable cardioverter defibrillators. Europace 2009;11:701–9. PubMed PMC
Perings C, Bauer WR, Bondke HJ, Mewis C, James M, Bocker D, et al. Remote monitoring of implantable-cardioverter defibrillators: results from the Reliability of IEGM Online Interpretation (RIONI) study. Europace 2011;13:221–9. PubMed
Ricci RP, Morichelli L, Santini M. Home monitoring remote control of pacemaker and implantable cardioverter defibrillator patients in clinical practice: impact on medical management and health-care resource utilization. Europace 2008;10:164–70. PubMed
Varma N, Epstein AE, Irimpen A, Schweikert R, Love C. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation 2010;122:325–32. PubMed
Varma N, Michalski J, Epstein AE, Schweikert R. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol 2010;3:428–36. PubMed
Guedon-Moreau L, Chevalier P, Marquie C, Kouakam C, Klug D, Lacroix D, et al. Contributions of remote monitoring to the follow-up of implantable cardioverter-defibrillator leads under advisory. Eur Heart J 2010;31:2246–52. PubMed PMC
Hindricks G, Elsner C, Piorkowski C, Taborsky M, Geller JC, Schumacher B, et al. Quarterly vs. yearly clinical follow-up of remotely monitored recipients of prophylactic implantable cardioverter-defibrillators: results of the REFORM trial. Eur Heart J 2014;35:98–105. PubMed PMC
Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. J Am Coll Cardiol 2011;57:1181–9. PubMed
Brugada P. What evidence do we have to replace in-hospital implantable cardioverter defibrillator follow-up? Clin Res Cardiol 2006;95(Suppl 3):iii3–9. PubMed
Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, et al. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study. Circulation 2012;125:2985–92. PubMed
Muller A, Goette A, Perings C, Nagele H, Konorza T, Spitzer W, et al. Potential role of telemedical service centers in managing remote monitoring data transmitted daily by cardiac implantable electronic devices: results of the early detection of cardiovascular events in device patients with heart failure (detecT-Pilot) study. Telemed J E Health 2013;19:460–6. PubMed
Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, et al. A randomized trial of long-term remote monitoring of pacemaker recipients (The COMPAS trial). Eur Heart J 2012;33:1105–11. PubMed PMC
Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, et al. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet 2014;384:583–90. PubMed