A randomized study of remote follow-up of implantable cardioverter defibrillators: Safety and efficacy report of the ECOST trial

European Heart Journal

Volumn 34, Issue 8, 2013, Pages 605-614

  Guédon Moreau, Laurence ^a   Lacroix, Dominique ^a   Sadoul, Nicolas ^b   Clémenty, Jacques ^c   Kouakam, Claude ^a   Hermida, Jean Sylvain ^d   Aliot, Etienne ^b   Boursier, Michel ^e   Bizeau, Olivier ^f   Kacet, Salem ^a  

^a LILLE UNIVERSITY HOSPITAL   (France)

^b CHU NANCY BRABOIS   (France)

^c BORDEAUX UNIVERSITY HOSPITAL   (France)

^d AMIENS UNIVERSITY HOSPITAL   (France)

^e Centre Hospitalier Régional Bon Secours   (France)

^f Centre Hospitalier Régional la Source   (France)

Author keywords

Implantable cardioverter defibrillator; Remote monitoring; Telemedicine

Indexed keywords

AMBULATORY MONITORING; ARTICLE; CAUSE OF DEATH; CONTROL GROUP; CONTROLLED STUDY; DEATH; DEVICES; FOLLOW UP; HEART ARRHYTHMIA; HOME MONITORING; HUMAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; LONGEVITY; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SAFETY; SHOCK; SURVIVAL;

AMBULATORY CARE; ARRHYTHMIAS, CARDIAC; CAUSE OF DEATH; DEFIBRILLATORS, IMPLANTABLE; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; MONITORING, AMBULATORY; PROSPECTIVE STUDIES; REMOTE CONSULTATION; TREATMENT OUTCOME;

EID: 84874478830     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehs425     Document Type: Article

References (24)

1. ICT for better healthcare in Europe. http://ec.europa.eu/information- society/activities/health/index-en.htm (18 June 2012).
2. Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA III, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, Schoenfeld MH, Silka MJ, Stevenson LW, Sweeney MO, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Faxon DP, Halperin JL, Hiratzka LF, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Ornato JP, Page RL, Riegel B, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Anti-arrhythmia Devices); American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation 2008;117:2820-2840.
3. Brugada P. What evidence do we have to replace in-hospital implantable cardio-verter defibrillator follow-up? Clin Res Cardiol 2006;95(Suppl. 3):III/3-9.
4. Heidbüchel H, Lioen P, Foulon S, Huybrechts W, Ector J, Willems R, Ector H. Potential role of remote monitoring for scheduled and unscheduled evaluations of patients with an implantable defibrillator. Europace 2008;10:351-357.
5. Nielsen JC, Kottkamp H, Zabel M, Aliot E, Kreutzer U, Bauer A, Schuchert A, Neuser H, Schumacher B, Schmidinger H, Stix G, Clémenty J, Danilovic D, Hindricks G. Automatic home monitoring of implantable cardioverter defibrilla-tors. Europace 2008;10:729-735.
6. Lazarus A. Remote, wireless, ambulatory monitoring of implantable pacemakers, cardioverter defibrillators, and cardiac resynchronization therapy systems: analysis of a worldwide database. Pacing Clin Electrophysiol 2007;30(Suppl. 1):S2-S12.
7. 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: 164-170.
8. Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH; CONNECT Investigators. 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;57:1181-1189.
9. Spencker S, Coban N, Koch L, Schirdewan A, Müller D. Potential role of home monitoring to reduce inappropriate shocks in implantable cardioverter-defibrillator patients due to lead failure. Europace 2009;11:483-488.
10. Sacher F, Probst V, Bessouet M, Wright M, Maluski A, Abbey S, Bordachar P, Deplagne A, Ploux S, Lande G, Jäis P, Hocini M, Häissaguerre M, Le Marec H, Clémenty J. Remote implantable cardioverter defibrillator monitoring in a Brugada syndrome population. Europace 2009;11:489-494.
11. Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; TRUST Investigators. 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;122:325-332.
12. Guédon-Moreau L, Chevalier P, Marquié C, Kouakam C, Klug D, Lacroix D, Brigadeau F, Kacet S. Contributions of remote monitoring to the follow-up of implantable cardioverter-defibrillator leads under advisory. Eur Heart J 2010;31: 2246-2252.
13. Alter P, Waldhans S, Plachta E, Moosdorf R, Grimm W. Complications of implan-table cardioverter defibrillator therapy in 440 consecutive patients. Pacing Clin Electrophysiol 2005;28:926-932.
14. Groves R. Urgent medical device information: Sprint Fidelisw lead patient management recommendations. October 15, 2007 Letter to physicians. http://www. medtronic.com/product-advisories/physician/sprint-fidelis/PROD-ADV-PHYS-OCT (17 July 2012).
15. Schron EB, Exner DV, Yao Q, Yao Q, Jenkins LS, Steinberg JS, Cook JR, Kutalek SP, Friedman PL, Bubien RS, Page RL, Powell J. Quality of life in the Anti-arrhythmics Versus Implantable Defibrillators trial: impact of therapy and influence of adverse symptoms and defibrillator shocks. Circulation 2002;105: 589-594.
16. van Rees JB, Borleffs CJ, de Bie MK, Stijnen T, van Erven L, Bax JJ, Schalij MJ. Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality. J Am Coll Cardiol 2011;57:556-562.
17. Klug D, Balde M, Pavin D, Hidden-Lucet F, Clémenty J, Sadoul N, Rey JL, Lande G, Lazarus A, Victor J, Barnay C, Grandbastien B, Kacet S; PEOPLE Study Group. Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study. Circulation 2007;116:1349-1355.
18. Poole JE, Gleva MJ, Mela T, Chung MK, Uslan DZ, Borge R, Gottipaty V, Shinn T, Dan D, Feldman LA, Seide H, Winston SA, Gallagher JJ, Langberg JJ, Mitchell K, Holcomb R; for the REPLACE Registry Investigators. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation 2010;122:1553-1561.
19. Wilkoff BL, Auricchio A, Brugada J, Cowie M, Ellenbogen KA, Gillis AM, Hayes DL, Howlett JG, Kautzner J, Love CJ, Morgan JM, Priori SG, Reynolds DW, Schoenfeld MH, Vardas PE. HRS/EHRA expert consensuson the monitoring of cardiovascular implantable electronic devices(CIEDs): description of techniques, indications, personnel, frequencyand ethical considerations. Euro-pace 2008;10:707-725.
20. Daubert JP, Zareba W, Cannom D, McNitt S, Rosero SZ, Wang P, Schuger C, Steinberg JS, Higgins SL, Wilber DJ, Klein H, Andrews ML, Hall WJ, Moss AJ; MADIT II investigators. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol 2008;51:1357-1365.
21. Saxon LA, Hayes DL, Gilliam FR, Heidenreich PA, Day J, Seth M, Meyer TE, Jones PW, Boehmer JP. Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study. Circulation 2010;122:2359-2367.
22. Mabo P, Defaye P, Sadoul N, Davy J-M, Deharo J-C, Kacet S, Bellissant E, Daubert J-C. EVATEL: Remote follow-up of patients implanted with an ICD: the prospective randomized EVATEL study. ESC Congress report. Hot Line II-Frontiers in interventional and device treatments. http://www.escardio.org/congresses/esc- 2011/congress-reports/Pages/707-1-EVATEL.aspx (last accessed 17 July 2012).
23. Papavasileiou LP, Forleo GB, Panattoni G, Schirripa V, Minni V, Magliano G, Bellos K, Santini L, Romeo F. Work burden with remote monitoring of implanta-ble cardioverter defibrillator: is it time for reimbursement policies? J Cardiovasc Med (Hagerstown) 2012 (24 May 2012).
24. Auricchio A, Moccetti T. Electronic cardiac medicine: present and future opportunities. Swiss Med Wkly 2010;140:w13052.