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Europace Advance Access originally published online on March 16, 2006
Europace 2006 8(4):288-292; doi:10.1093/europace/eul009
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

ICD

The RIONI study rationale and design: validation of the first stored electrograms transmitted via home monitoring in patients with implantable defibrillators

C. Perings1,*, G. Klein2, E. Toft3,4, C. Moro5, D. Klug6, D. Böcker7, H.J. Trappe1, T. Korte2 on behalf of the RIONI Investigators

1 Department of CardiologyUniversity of BochumBochum Germany; 2 Department of Cardiology and AngiologyMedical School HannoverCarl-Neuberg-Street 1, D-30625 Hannover Germany; 3 Institute of Health Science and TechnologyAalborg UniversityAalborg Denmark; 4 Department of Cardiology, Aalborg SygehusÅrhus Universitu Hospitals Aalborg Denmark; 5 Department of CardiologyHospital Ramón y CajalMadrid Spain; 6 Department of CardiologyCentre Hospitalier Régional Universitaire LilleLille France; 7 Department of Cardiology, Medizinische Klinik und Poliklinik CUniv.-Klinikum MünsterMünster Germany

Manuscript submitted 30 August 2005. Accepted after revision 22 January 2006.

* Corresponding author. Tel: +49 2323 4991601; fax: +49 2323 499301. E-mail address: christian.perings{at}marienhospital-herne.de


   Abstract
Top
 Abstract
Introduction
 Concept of home monitoring
 Objectives of RIONI
 Discussion
 Conclusion
 Appendix
 References
 
Appropriate and inappropriate therapies of implantable cardioverter defibrillators (ICDs) have a major impact on morbidity and quality of life in ICD recipients. The recently introduced home monitoring of ICD devices is a promising new technique which remotely offers information about the status of the system. Stored intracardiac electrograms (IEGMs), which are essential for correct classification of appropriate and inappropriate ICD discharges, have until now not been available with ICD home monitoring on a day-by-day basis because of limitations of transferable data. We demonstrate the first compressed IEGMs daily transferable via home monitoring (IEGM-online). Validation of these electrograms will be performed in the Reliability of IEGM-Online Interpretation (RIONI) study. A total of 210 episodes of stored IEGMs will be collected by at least 12 European centres. The primary endpoint of this study is to investigate whether the IEGM-online based evaluation of the appropriateness of the ICDs therapeutic decision following episode detection is equivalent to the evaluation based on the complete ICD episode Holter extracted from the IEGM stored. The evaluation is independently done by an expert board of three experienced ICD investigators. The equivalence of the two methods is accepted if the evaluations yield a different conclusion for <10% of all evaluated IEGMs. The conclusion of the study is expected at the beginning of 2007. If RIONI successfully validates IEGMs transmitted via home monitoring, a strong basis for the use of this promising technique will be established.

Key Words: Implantable defibrillator, Home monitoring, Stored intracardiac electrogram


   Introduction
Top
 Abstract
 Introduction
Concept of home monitoring
 Objectives of RIONI
 Discussion
 Conclusion
 Appendix
 References
 
The implantable cardioverter/defibrillator (ICD) has been shown to be remarkably effective in preventing sudden cardiac death and total mortality in both adults and children with life threatening ventricular tachyarrhythmia.1Go–3Go Recent studies have shown favourable results for defibrillators implanted in high-risk patients with prophylactic indication.4Go–6Go The benefit of defibrillator therapy now has to be characterized focusing on softer endpoints such as cardiac morbidity and quality of life. Recent studies have shown that the morbidity of ICD patients is closely related to the incidence of appropriate and inappropriate ICD therapies and hardware problems of the device.7Go–9Go The early diagnosis and treatment of these adverse events might significantly decrease the morbidity in ICD patients. In this context, the recently introduced home monitoring of ICD devices is a promising new technique which offers information about the status of the device and ICD therapies for ventricular and supraventricular arrhythmias on a day-by-day basis without direct contact between patient and physician.10Go

Stored intracardiac electrograms (IEGMs), which have been shown to be essential for the differential diagnosis of appropriate and inappropriate ICD discharges,7Go–9Go have until now not been available with ICD home monitoring due to limitations of transferable data. We demonstrate the first compressed IEGMs transferred via home monitoring (IEGM-online) and outline the rational and design of the ‘Reliability of IEGM-Online Interpretation (RIONI)’ study for the validation of these IEGMs.


   Concept of home monitoring
Top
 Abstract
 Introduction
 Concept of home monitoring
Objectives of RIONI
 Discussion
 Conclusion
 Appendix
 References
 
The home monitoring concept is illustrated in Figure 1. Long-range implant telemetry is integrated into single and dual chamber ICDs and ICDs with cardiac resynchronization therapy (CRT-D). It is a technology that enables data to be automatically transmitted over a distance of several metres to a patient device, from where the data are sent to a service centre. The service centre processes the data immediately and makes them available to the physician via fax or the Internet. Until recently, data transferable via home monitoring were battery status, event counters and cycle lengths of recent ICD therapies, sensed signals in ventricle and atrium, and pacing and shock impedance.10Go


Figure 0091
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  		Figure 1 Home monitoring: scheme of data transferral.

 
Stored IEGM recording via home monitoring
The latest extension of the home monitoring capabilities comprises the integration of IEGM transmission. Hence, the physician should now be enabled remotely to evaluate the ICDs therapeutic decisions. IEGM-online messages are transmitted separately from standard counter messages (trend and event counter messages). An IEGM-online is triggered after detection of an episode classified into VT1-, VT2-, or VF-zone and directly sent after termination of the episode without the patients' involvement. These IEGM-online transmissions are always associated with an event counter message. An IEGM-online is also triggered after detection of an episode classified as supraventricular tachycardia, which is sent following the next periodic trend message.

The technology is integrated in single and dual chamber ICDs and CRT-Ds (Lumos VR-T®, Lumos DR-T®, Kronos LV-T®, Biotronik Inc., Berlin, Germany) which are used in this study in combination with an external patient device for data transferral (RUC 1000-A, CardioMessenger®, Biotronik Inc.). The function of the ICD and CRT-D devices used is identical to corresponding standard models without transferable IEGM-online with regard to sensing, pacing, shock delivery, and test and memory function.

The IEGM-online comprises the following data.

  1. Episode number.
  2. Time of episode detection, termination, and episode duration.
  3. Zone of initial detection, number of redetections in VT1-, VT2-, and VF-zone.
  4. IEGM (bipolar, near-field) from the ventricular chamber for the initial episode detection. The IEGMs length varies according to the rhythm: the higher the ventricular rate, the shorter the transmitted IEGM. The maximum length is 12 s. First tests have mainly shown a duration of 8 s (slow VT) to 3 s (VF).
  5. Rhythm marker information associated with the transmitted IEGM for the atrial and the ventricular chamber, respectively. Atrial markers displayed are ‘As’, ‘Ap’, ventricular markers ‘Vs’, ‘Vp’, ‘VT1’, ‘VT2’, ‘VF’. Together with the markers, the associated cycle lengths in ms are presented.
  6. Number of applied ATP therapies.
  7. Number of shock therapies.
  8. Details of the ICDs classification, including the use of single and dual chamber detection algorithms.
An example of the first IEGMs transferred via home monitoring is illustrated in Figure 2A and B.


Figure 0092
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  		Figure 2 (A) Compressed, virtual, stored electrogram via home monitoring before fulfilled detection criterion; 4 s storage time. (B) Regular stored electrogram of the same ICD episode; 19 s storage time. A, atrium; V, ventricle; As, atrial sensing; Vs, ventricular sensing; VF, ventricular fibrillation.

 

   Objectives of RIONI
Top
 Abstract
 Introduction
 Concept of home monitoring
 Objectives of RIONI
Discussion
 Conclusion
 Appendix
 References
 
Primary endpoint
The primary endpoint of this study is to investigate whether the IEGM-online based evaluation of the appropriateness of the ICDs therapeutic decision following episode detection is equivalent to the evaluation based on the complete ICD episode extracted from the stored IEGM. The evaluation is independently done by an expert board of three experienced ICD investigators. The equivalence of the two methods is accepted, if the evaluations yield a different conclusion for <10% of all evaluated IEGMs.

Secondary endpoints
The secondary endpoints aim at a more detailed analysis of the IEGM-online reliability and usefulness:

  1. Comparison of reduced and full-length IEGM with IEGM-online: The Expert Board members' IEGM-online based evaluation of the appropriateness of the ICDs reaction to an episode is compared with the evaluation based on an ICD record of reduced length, i.e. an IEGM artificially adapted to the IEGM-online appearance. The attending physicians' IEGM-online based evaluation of the appropriateness of the ICDs reaction to an episode is compared with the evaluation based on the full-length ICD record.
  2. Rhythm classification: The reliability of the rhythm classifications using the IEGM-online and the shortened stored IEGM is evaluated, with the rhythm classification based on the full-length IEGM from the ICD memory as the reference. The following classes of episodes are distinguished:
    1. ventricular tachycardia
    2. ventricular fibrillation
    3. atrial fibrillation
    4. other forms of supraventricular tachycardia
    5. oversensing due to lead failure/fracture
    6. T-wave oversensing
    7. other classifications
    The comparison is performed as an intra-observer comparison for the classification by the Expert Board members and by the attending physicians, as well as an inter-observer comparison between the Expert Board's and the physicians' classifications.
  3. Patients with correctly classified episodes: The rate of patients whose arrhythmia episodes are predominantly, correctly classified by the Expert Board based on the IEGM-online is determined. Predominantly correct means that not more than one episode is misclassified, if the patient has less than 10 episodes or not >15% of the episodes, if the patient has 10 or more than 10 episodes. A maximum of 15% of incorrectly evaluated episodes in patients with 10 or more episodes was defined to be clinically acceptable.

Therapy implications of the IEGM-online
The conclusions the attending physician would like to draw from the IEGM-online and the home monitoring data in general with respect to changes in ICD and arrhythmia-related drug therapy are compared with the conclusions drawn during a follow-up visit.

Data collection and analysis
The study will be conducted as an international, multicentre, prospective, open study in at least 12 European clinical centres. The number of episodes considered for evaluation will be restricted to five per patient and type of episode. Types of episodes have been defined earlier.

The study will enrol patients with indication for ICD implantation according to their physician, with or without additional indication for cardiac resynchronization. Home monitoring will be activated on patient's hospital discharge and the patient will be registered for home monitoring service in the implanting hospital's user group. Patient management is left to the attending physician's own discretion. IEGM-online episodes have to be evaluated by the attending physician within 2 working days of notification. The Expert Board members receive 10 episodes per evaluation.

A total of 210 episodes have to be analysed. Following the sequential group method of Pocock, interim analyses on an adjusted level of significance will be performed after 70 and 140 episodes. It is estimated that 210 episodes require about 2880 patient months of follow-up. Hence, 240 patients will be enrolled and followed for about 12 months.

The examinations will be conducted with regard to the tenets of ‘Good Clinical Practice’ and the Declaration of Helsinki and in accordance with the Medical Product Law. Ethical board approval has been obtained for the study.

Statistical analysis
The hypothesis of the primary endpoint is as follows.

Hypothesis H0: The IEGM-online based evaluation of the ICD therapy appropriateness by the Expert Board deviates from the evaluation based on a stored IEGM for more than or equal to 10% of determinable episodes.

Alternative hypothesis H1: The IEGM-online based evaluation of the ICD therapy appropriateness by the Expert Board deviates from the evaluation based on a stored IEGM for <10% of determinable episodes.

The trial is powered to prove that the reliability of IEGM-online is better than 90% with the level of significance alpha=5% and the power 1-beta=80%, assuming a true reliability of 96%. For the metric data, mean values, standard deviations, medians, maxima, and minima will be calculated. The statistical significance of all endpoints will be analysed using SPSS and the binomial test statistics. The main analysis of the study will be fully specified in a blinded statistical analysis plan approved by the steering committee before the end of the trial.


   Discussion
Top
 Abstract
 Introduction
 Concept of home monitoring
 Objectives of RIONI
 Discussion
Conclusion
 Appendix
 References
 
IEGMs in home monitoring of ICD patients
Currently, ambulatory follow-up of patients with ICDs are performed at 3–6 months intervals. Additional follow-ups are most often performed following ICD therapies. A main objective for device interrogation is the analysis of delivered ATP or shocks and to differentiate appropriate and inappropriate device interventions. It has well been shown that the most important data source for this analysis is the IEGMs stored in the ICDs memory.7Go–9Go,11Go–15Go Until recently, IEGMs have not been integrated in home monitoring systems due to the large amount of data transferred.

The latest extension of the home monitoring capabilities comprises the integration of IEGM transmission, the IEGM-online. Systems of other manufacturers with remote ICD monitoring via standard telephone line have shown the worth of available, integrated, stored electrogram transmission.16Go The home monitoring system investigated in RIONI, will, for the first time, be able remotely to evaluate the ICDs therapeutic decisions via IEGM-online on a day-by-day basis.

Key issues of RIONI
This study will investigate whether the remote evaluation of the ICDs therapeutic decisions by the physician using the IEGM-online is safe and reliable. The IEGM-online evaluations are compared with the decisions drawn from a stored full-length IEGM and from an IEGM artificially adapted to the length of the IEGM-online. With this approach, the source of potential misinterpretations by compression, transmission, and shortening of the IEGM-online can be well identified. Furthermore, the reliability of the rhythm classifications using the IEGM-online will be evaluated, with the rhythm classification based on the full-length IEGM from the ICD memory as the reference. As further secondary endpoints, the percentage of patients whose episodes are correctly classified on the basis of the IEGM-online will be determined, and the conclusions the attending physician draws from the IEGM-online and the home monitoring data with respect to changes in ICD programming and additional arrhythmia management will be compared with the conclusions drawn during a regular follow-up visit.

Potential benefits of telemedicine-assisted care of ICD patients
Recent studies have shown favourable results for defibrillators implanted in high-risk patients with prophylactic indications.4Go–6Go As a consequence, the annual European and US implant rates are expected to rise dramatically and thus the device follow-up burden will also significantly increase.17Go–19Go Remote follow-up, offered by home monitoring technique, offers an alternative for overcrowded clinics and convenience for patients. Particularly, in patients with low event rates during follow-up and in patients with early battery depletion, home monitoring might significantly lower the need for ambulatory ICD controls.

Recent studies have shown that the morbidity of ICD patients is closely related to the incidence of appropriate and inappropriate ICD therapies and hardware problems of the device.7Go–9Go The early diagnosis and treatment of these adverse events might significantly decrease morbidity in ICD patients. Correct differential diagnosis of ICD therapies (appropriate, inappropriate, atrial fibrillation/atrial flutter, electrode failure) transferred in patients with home monitoring devices is crucial for the success of this technique. If RIONI successfully validates IEGMs transmitted via home monitoring, this technique may become established. If IEGMs are successfully integrated in the system, further studies will have to show prospectively, if this technology can reduce adverse events, lower morbidity and improve quality of life in ICD patients, reduce ambulatory visits of ICD patients and lower costs during follow-up.

Potential limitations of home monitoring technique
Remote monitoring of ICD patients will lead to data transferral to the physician on a day-by-day basis. The physician has to screen the data and react in the case of potential problems. This might result in an additional burden to the physician, nursing and technical personnel. Further developments of the technique have to focus on tools to make management of transferred data as quick and easy as possible. Furthermore, more and earlier information about ICD therapies might be a burden to the patients who are confronted with the remote monitoring information. Another risk might be the development of different remote monitoring systems by the various companies. As we live in an era of evolving electronic medical records, efforts should be made to establish common approaches to transmission and storage of data generated by ICDs of different manufacturers.


   Conclusion
Top
 Abstract
 Introduction
 Concept of home monitoring
 Objectives of RIONI
 Discussion
 Conclusion
Appendix
 References
 
We demonstrate the first compressed virtual IEGMs transferred via home monitoring on a day-by-day basis. The RIONI study will validate stored IEGMs transmitted via home monitoring in comparison with stored IEGMs gained by regular ICD interrogation. The results of this study will provide a basis for this promising technology.


   Appendix
Top
 Abstract
 Introduction
 Concept of home monitoring
 Objectives of RIONI
 Discussion
 Conclusion
 Appendix
References
 
RIONI Participating Investigators: W. Bauer, Würzburg, Germany; D. Böcker, Münster, Germany; P. Broadhurst, Aberdeen, UK; T. Cripps, Bristol, UK; W. Duckeck, Bremen, Germany; P. Geelen, Aalst, Belgium; J.C. Geller, Bad Berka, Germany; B.-D. Gonska, Karlsruhe, Germany; A. Hartmann, Leipzig, Germany; F. Hintringer, Innsbruck, Austria; E. Hoffmann, München, Germany; M. James, Taunton, UK; D. Klug, Lille, France; T. Korte, Hannover, Germany; M. Mason, Harefield, UK; G. Mentz, Wiesbaden, Germany; C. Mewis, Homburg/Saar, Germany; C. Moro, Madrid, Spain; H. Nägele, Hamburg, Germany; V. Paul, Chertsey, UK; C. Perings, Herne, Germany; A.J. Rouwen, Berlin, Germany; R. Sadowski, Schwedt, Germany; A. Schuchert, Hamburg, Germany; J.O. Schwab, Bonn, Germany; H. Schwacke, Hamburg, Germany; A. Tiroke, Kiel, Germany; E. Toft, Aalborg, Denmark; C. Wacker, Rothenburg o.d. Tauber, Germany; C. Weiß, Mainz, Germany; C. Wende, Saarlouis, Germany (additional centres are currently selected).

Expert Board Members: D. Bänsch, Allgemeines Krankenhaus St Georg, Hamburg, Germany; P. Brugada, Cardiovascular Centre, O.L.V. Hospital, Aalst, Belgium; G. Stix, Department of Cardiology, University Clinic Wien, Austria.


   References
Top
 Abstract
 Introduction
 Concept of home monitoring
 Objectives of RIONI
 Discussion
 Conclusion
 Appendix
 References
 
[1] Winkle RA, Mead RH, Ruder MA, Gaudiani VA, Smith NA, Buch WS, et al. Long-term-outcome with the automatic implantable cardioverter-defibrillator. J Am Coll Cardiol 1989; 13: 1353–61.[Abstract]

[2] . The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med 1997; 337: 1576–83.[Abstract/Free Full Text]

[3] Moss AJ, Hall WJ, Cannom DS, et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. N Engl J Med 1996; 335: 1933–40.[Abstract/Free Full Text]

[4] Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002; 346: 877–83.[Abstract/Free Full Text]

[5] Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005; 352: 225–37.[Abstract/Free Full Text]

[6] Cleland JGF, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005; 352: 1539–49.[Abstract/Free Full Text]

[7] Korte T, Jung W, Ostermann G, Wolpert C, Spehl S, Esmailzadeh B, et al. Hospital readmission after transvenous cardioverter/defibrillator implantation: a single centre study. Eur Heart J 2000; 21: 1186–96.[Abstract/Free Full Text]

[8] Marchlinski FE, Callans DJ, Gottlieb CD, Schwatzman D, Preminger M. Benefits and lessons learned from stored electrogram information in implantable defibrillators. J Cardiovasc Electrophysiol 1995; 6: 832–51.[ISI][Medline]

[9] Auricchio A, Hartung W, Geller C, Klein H. Clinical relevance of stored electrograms for implantable cardioverter-defibrillators (ICD) troubleshooting and understanding of mechanisms for ventricular tachyarrhythmias. Am J Cardiol 1996; 78: 33–41.[CrossRef][ISI][Medline]

[10] Theuns DA, Res JC, Jordaens LJ. Feasibility of home monitoring in ICD therapy: future perspectives. Europace 2003; 5: 139–42.[Abstract/Free Full Text]

[11] Bänsch D, Steffgen F, Grönefeld G, Wolpert C, Böcker D, Mletzko RU, et al. The 1+1 trail: a prospective trial of a dual- versus a single-chamber implantable defibrillator in patients with slow ventricular tachycardias. Circulation 2004; 110: 1022–9.[Abstract/Free Full Text]

[12] ASTRID Investigators.Dorian P, Philippon F, Thibault B, Kimber S, Sterns L, Greene M, et al. Randomized controlled study of the detection enhancements versus rate-only detection to prevent inappropriate therapy in a dual chamber implantable cardioverter-defibrillator. Heart Rhythm 2004; 1: 540–7.[CrossRef][ISI][Medline]

[13] Theuns DA, Klootwijk AP, Goedhart DM, Jordaens LJ. Prevention of inappropriate therapy in implantable cardioverter-defibrillators: results of a prospective, randomized study of tachyarrhythmia detection algorithms. J Am Coll Cardiol 2004; 44: 2362–7.[Abstract/Free Full Text]

[14] Glikson M, Swerdlow CD, Gurevitz OT, Daoud E, Shivkumar K, Wilkoff B, et al. Optimal combination of discriminators for differentiating ventricular from supraventricular tachycardia by dual-chamber defibrillators. J Cardiovasc Electrophysiol 2005; 16: 732–9.[CrossRef][ISI][Medline]

[15] Wolpert C, Kuschyk J, Aramin N, Spehl S, Streitner F, Suselbeck T, et al. Incidence and electrophysiological characteristics of spontaneous ventricular tachyarrhythmias in high risk coronary patients and prophylactic implantation of a defibrillator. Heart 2004; 90: 667–71.[Abstract/Free Full Text]

[16] Schoenfeld MH, Compton SJ, Mead RH, Weiss DN, Sherfesee L, et al. Remote monitoring of implantable cardioverter defibrillators: a prospective analysis. Pacing Clin Electrophysiol 2004; 27: 757–63.[CrossRef][Medline]

[17] Winter SL, Packer DL, Marchlinski FE, et al. Consensus statement on indications, guidelines for use, and recommendations for follow-up of implantable cardioverter defibrillators. Pacing Clin Electrophysiol 2001; 24: 262–9.[CrossRef][Medline]

[18] In:McGrory-Usset ME and Stanton MS. Use of implantable cardioverter defibrillator (ICD) Therapy: ICD guidelines around the world. In Ovyshcher IE (Ed.). New Development in Cardiac Pacing and Electrophysiology 2002; Armonk, NY Futura Publishing Company Inc. pp. 81–90.

[19] Frye WB. Cardiology workforce: there's already a shortage, and its getting worse!. J Am Coll Cardiol 2002; 39: 2077–9.[Free Full Text]


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