Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial

European Journal of Heart Failure

Volumn 19, Issue 3, 2017, Pages 416-425

  Boriani, Giuseppe ^a,b   Da Costa, Antoine ^c   Quesada, Aurelio ^d   Ricci, Renato Pietro ^e   Favale, Stefano ^f   Boscolo, Gabriele ^g   Clementy, Nicolas ^h   Amori, Valentina ⁱ   Mangoni di S Stefano, Lorenza ⁱ   Burri, Haran ^j  

^a UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^b UNIVERSITY OF BOLOGNA   (Italy)

^c UNIVERSITY HOSPITAL OF SAINT ETIENNE   (France)

^d HOSPITAL GENERAL UNIVERSITARIO DE VALENCIA   (Spain)

^e SAN FILIPPO NERI HOSPITAL   (Italy)

^f POLICLINICO   (Italy)

^g Chioggia ULSS 14   (Italy)

^h UNIVERSITÉ DE TOURS   (France)

ⁱ Medtronic Italia   (Italy)

^j GENEVA UNIVERSITY HOSPITALS   (Switzerland)

more..

Author keywords

Cardiac resynchronization therapy; Costs; Healthcare; Heart failure; Outcome; Remote monitoring

Indexed keywords

AGED; ARTICLE; CARDIAC RESYNCHRONIZATION THERAPY; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CLINICAL OUTCOME; CONTROLLED STUDY; EMERGENCY WARD; FEMALE; FOLLOW UP; HEALTH CARE UTILIZATION; HEART FAILURE; HOSPITAL ADMISSION; HOSPITALIZATION; HUMAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL (TOPIC); TELEMONITORING; AFTERCARE; AMBULATORY MONITORING; CARDIAC RESYNCHRONIZATION THERAPY DEVICE; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; HOSPITAL EMERGENCY SERVICE; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PROCEDURES; RANDOMIZED CONTROLLED TRIAL; STATISTICS AND NUMERICAL DATA; TELEMEDICINE; UTILIZATION;

AFTERCARE; AGED; CARDIAC RESYNCHRONIZATION THERAPY; CARDIAC RESYNCHRONIZATION THERAPY DEVICES; CARDIOVASCULAR DISEASES; EMERGENCY SERVICE, HOSPITAL; FEMALE; HEART FAILURE; HOSPITALIZATION; HUMANS; MALE; MIDDLE AGED; MONITORING, AMBULATORY; MORTALITY; PROSPECTIVE STUDIES; TELEMEDICINE;

EID: 84994071225     PISSN: 13889842     EISSN: 18790844     Source Type: Journal    
DOI: 10.1002/ejhf.626     Document Type: Article

References (32)

1. Maggioni AP, Dahlström U, Filippatos G, Chioncel O, Leiro MC, Drozdz J, Fruhwald F, Gullestad L, Logeart D, Metra M, Parissis J, Persson H, Ponikowski P, Rauchhaus M, Voors A, Nielsen OW, Zannad F, Tavazzi L. EURObservational research programme: the Heart Failure Pilot survey (ESC-HF Pilot). Eur J Heart Fail 2010;12:1076–1084.
2. Khan H, Greene SJ, Fonarow GC, Kalogeropoulos AP, Ambrosy AP, Maggioni AP, Zannad F, Konstam MA, Swedberg K, Yancy CW, Gheorghiade M, Butler J; EVEREST Trial Investigators. Length of hospital stay and 30-day readmission following heart failure hospitalization: insights from the EVEREST trial. Eur J Heart Fail 2015;17:1022–1031.
3. Greene SJ, Fonarow GC, Solomon SD, Subacius H, Maggioni AP, Bohm M, Lewis EF, Zannad F, Gheorghiade M; ASTRONAUT Investigators and Coordinators. Global variation in clinical profile, management, and post-discharge outcomes among patients hospitalized for worsening chronic heart failure: Findings from the ASTRONAUT trial. Eur J Heart Fail 2015;17:591–600.
4. Bristow MR, Saxon L a, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004;350:2140–2150.
5. Cleland J, Daubert J, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005;352:1539–1549.
6. Boriani G, Berti E, Maria L, Belotti B, Biffi M, Palma R De, Malavasi VL, Bottoni N, Rossi L, De Maria E, Mantovan R, Zardini M, Casali E, Marconi M, Bandini A, Tomasi C, Boggian G, Barbato G, Toselli T, Zennaro M, Sassone B, Romagna E; RERAI (Registry of Emilia Romagna on Arrhythmia Interventions) Investigators. Cardiac device therapy in patients with left ventricular dysfunction and heart failure: ‘real-world’ data on long-term outcomes (mortality, hospitalizations, days alive and out of hospital). Eur J Heart Fail 2016; 18:693–702.
7. 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.
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. Landolina M, Perego GB, Lunati M, Curnis A, Guenzati G, Vicentini A, Parati G, Borghi G, Zanaboni P, Valsecchi S, Marzegalli M. 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;125:2985–2992.
10. Burri H, Quesada A, Ricci RP, Boriani G, Davinelli M, Favale S, Da Costa A, Kautzner J, Moser R, Navarro X, Santini M. The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) study: rationale and design. Am Heart J 2010;160:42–48.
11. Boriani G, Da Costa A, Ricci RP, Quesada A, Favale S, Iacopino S, Romeo F, Risi A, Mangoni di S Stefano L, Navarro X, Biffi M, Santini M, Burri H; MORE-CARE Investigators. The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) randomized controlled trial: phase 1 results on dynamics of early intervention with remote monitoring. J Med Internet Res 2013;15:e167.
12. Hindricks G, Elsner C, Piorkowski C, Taborsky M, Geller JC, Schumacher B, Bytesnik J, Kottkamp H. 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.
13. Guédon-Moreau L, Lacroix D, Sadoul N, Clémenty J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S; ECOST Trial Investigators. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J 2013;34:605–614.
14. Boriani G, Diemberger I, Martignani C, Biffi M, Valzania C, Bertini M, Domenichini G, Saporito D, Ziacchi M, Branzi A. Telecardiology and remote monitoring of implanted electrical devices: the potential for fresh clinical care perspectives. J Gen Intern Med 2008;23:73–77.
15. Klersy C, Boriani G, Silvestri A De, Mairesse GH, Braunschweig F, Scotti V, Balduini A, Cowie MR, Leyva F; Health Economics Committee of the European Heart Rhythm Association. Effect of telemonitoring of cardiac implantable electronic devices on healthcare utilization: a meta-analysis of randomized, controlled trials in patients with heart failure. Eur J Heart Fail 2016;18:195–204.
16. Böhm M, Drexler H, Oswald H, Rybak K, Bosch R, Butter C, Klein G, Gerritse B, Monteiro J, Israel C, Bimmel D, Käab S, Huegl B, Brachmann J; OptiLink HF Study Investigators. Fluid status telemedicine alerts for heart failure: a randomized controlled trial. Eur Heart J 2016 Mar 16. pii: ehw099 [Epub ahead of print].
17. Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, Brachmann J, Lewalter T, Goette A, Block M, Kautzner J, Sack S, Husser D, Piorkowski C, Søgaard P; IN-TIME Study Group. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet 2014;384:583–590.
18. van Deursen VM, Urso R, Laroche C, Damman K, Dahlström U, Tavazzi L, Maggioni AP, Voors AA. Co-morbidities in patients with heart failure: an analysis of the European Heart Failure Pilot Survey. Eur J Heart Fail 2013;16:103–111.
19. Van Veldhuisen DJ, Braunschweig F, Conraads V, Ford I, Cowie MR, Jondeau G, Kautzner J, Aguilera RM, Lunati M, Yu CM, Gerritse B, Borggrefe M; DOT-HF Investigators. Intrathoracic impedance monitoring, audible patient alerts, and outcome in patients with heart failure. Circulation 2011;124:1719–1726.
20. Boriani G, Maniadakis N, Auricchio A, Müller-Riemenschneider F, Fattore G, Leyva F, Mantovani L, Siebert M, Willich SN, Vardas P, Kirchhof P. Health technology assessment in interventional electrophysiology and device therapy: a position paper of the European Heart Rhythm Association. Eur Heart J 2013;34:1869–1874.
21. Boriani G, Auricchio A, Klersy C, Kirchhof P, Brugada J, Morgan J, Vardas P. Healthcare personnel resource burden related to in-clinic follow-up of cardiovascular implantable electronic devices: a European Heart Rhythm Association and Eucomed joint survey. Europace 2011;13:1166–1173.
22. Heidbuchel H, Hindricks G, Broadhurst P, Van Erven L, Fernandez-Lozano I, Rivero-Ayerza M, Malinowski K, Marek A, Garrido RFR, Loscher S, Beeton I, Garcia E, Cross S, Vijgen J, Koivisto U-M, Peinado R, Smala A, Annemans L. EuroEco (European Health Economic Trial on Home Monitoring in ICD Patients): a provider perspective in five European countries on costs and net financial impact of follow-up with or without remote monitoring. Eur Heart J 2015;36:158–169.
23. Raatikainen MJ, Uusimaa P, Van Ginneken MM, Janssen JP, Linnaluoto M. Remote monitoring of implantable cardioverter defibrillator patients: a safe, time-saving, and cost-effective means for follow-up. Europace 2008;10:1145–1151.
24. Zanaboni P, Landolina M, Marzegalli M, Lunati M, Perego GB, Guenzati G, Curnis A, Valsecchi S, Borghetti F, Borghi G, Masella C. Cost–utility analysis of the EVOLVO study on remote monitoring for heart failure patients with implantable defibrillators: randomized controlled trial. J Med Internet Res 2013;15:e106.
25. Fauchier L, Sadoul N, Kouakam C, Briand F, Chauvin M, Babuty D, Clementy J. Potential cost savings by telemedicine-assisted long-term care of implantable cardioverter defibrillator recipients. Pacing Clin Electrophysiol 2005;28 Suppl 1:S255–S259.
26. Guédon-Moreau L, Lacroix D, Sadoul N, Clémenty J, Kouakam C, Hermida JS, Aliot E, Kacet S; ECOST Trial Investigators. Costs of remote monitoring vs. ambulatory follow-ups of implanted cardioverter defibrillators in the randomized ECOST study. Europace 2014;16:1181–1188.
27. Al-Khatib SM, Piccini JP, Knight D, Stewart M, Clapp-Channing N, Sanders GD. Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial. J Cardiovasc Electrophysiol 2010;21:545–550.
28. Burri H, Sticherling C, Wright D, Makino K, Smala A, Tilden D. Cost–consequence analysis of daily continuous remote monitoring of implantable cardiac defibrillator and resynchronization devices in the UK. Europace 2013;15:1601–1608.
29. Elsner CH, Sommer P, Piorkowski C, Taborsky M, Neuser H, Bytesnik J, Geller JC, Kottkamp H, Wiesmeth H, Hindricks G. A prospective multicenter comparison trial of Home Monitoring against regular follow-up in MADIT II patients: additional visits and cost impact. Comput Cardiol 2006;33:241–244.
30. Morgan JM, Dimitrov BD, Gill J, Kitt S, Andre Ng G, McComb JM, Raftery J, Roderick P, Seed A, Williams SG, Witte KK, Jay Wright D, Yao GL, Cowie MR. Rationale and study design of the REM-HF study: remote management of heart failure using implanted devices and formalized follow-up procedures. Eur J Heart Fail 2014;16:1039–1045.
31. Whellan DJ, Ousdigian KT, Al-Khatib SM, Pu W, Sarkar S, Porter CB, Pavri BB, O'Connor CM; PARTNERS Study Investigators. Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations. Results From PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study. J Am Coll Cardiol 2010;55:1803–1810.
32. Boriani G. Remote monitoring of cardiac implantable electrical devices in Europe: Quo vadis? Europace 2015;17:674–676.