AIMS: Randomized clinical trials investigating a possible outcome effect of remote monitoring in patients with implantable defibrillators have shown conflicting results. This study analyses the information flow and workflow details from the IN-TIME study and discusses whether differences of message content, information speed and completeness, and workflow may contribute to the heterogeneous results. METHODS AND RESULTS: IN-TIME randomized 664 patients with an implantable cardioverter/defibrillator indication to daily remote monitoring vs. control. After 12 months, a composite clinical score and all-cause mortality were improved in the remote monitoring arm. Messages were received on 83.1% of out-of-hospital days. Daily transmissions were interrupted 2.3 times per patient-year for more than 3 days. During 1 year, absolute transmission success declined by 3.3%. Information on medical events was available after 1 day (3 days) in 83.1% (94.3%) of the cases. On all working days, a central monitoring unit informed investigators of protocol defined events. Investigators contacted patients with a median delay of 1 day and arranged follow-ups, the majority of which took place within 1 week of the event being available. CONCLUSION: Only limited data on the information flow and workflow have been published from other studies which failed to improve outcome. However, a comparison of those data to IN-TIME suggest that the ability to see a patient early after clinical events may be inferior to the set-up in IN-TIME. These differences may be responsible for the heterogeneity found in clinical effectiveness of remote monitoring concepts.

Aalborg University Hospital Søndre Skovvej 15 Aalborg Denmark

Aarhus University Hospital Palle Juul Jensens Boulevard 99 Aarhus Denmark

Biotronik SE and Co KG Woermannkehre 1 Berlin Germany

Heart Center Leipzig Strümpelstr 39 Leipzig Germany

Klinikum Bielefeld Teutoburger Str 50 Bielefeld Germany

Olomouc University Hospital 1 P Pavlova 6 Olomouc Czech Republic

Peter Osypka Heart Center Am Isarkanal 36 München Germany

Sana Kliniken Ostholstein Mühlenkamp 5 Oldenburg Germany

Segeberger Kliniken Am Kurpark 1 Bad Segeberg Germany

Vivantes Klinikum Neukölln Rudower Straße 48 Berlin Germany

Zentralklinik Bad Berka Robert Koch Allee 9 Bad Berka Germany

Zobrazit více v PubMed

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 Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations: developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA); and in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC), the Heart Failure Association of ESC (HFA), and the Heart Failure Society of America (HFSA). Endorsed by the Heart Rhythm Society, the European Heart Rhythm Association (a registered branch of the ESC), the American College of Cardiology, the American Heart Association. Europace 2008;10:707–725. PubMed

Slotwiner D, Varma N, Akar JG, Annas G, Beardsall M, Fogel RI, Galizio NO, Glotzer TV, Leahy RA, Love CJ, McLean RC, Mittal S, Morichelli L, Patton KK, Raitt MH, Pietro Ricci R, Rickard J, Schoenfeld MH, Serwer GA, Shea J, Varosy P, Verma A, Yu C-M.. HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. Heart Rhythm 2015;12:e69–e100. PubMed

Burri H, Senouf D.. Remote monitoring and follow-up of pacemakers and implantable cardioverter defibrillators. Europace 2009;11:701–709. PubMed PMC

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;122:325–332. PubMed

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. PubMed

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;57:1181–1189. PubMed

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. PubMed

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.. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet 2014;384:583–590. PubMed

Nägele H, Lipoldová J, Oswald H, Klein G, Elvan A, Vester E, Bauer W, Bondke H, Reif S, Daub C, Menzel F, Schrader J, Zach G.. Home monitoring of implantable cardioverter-defibrillators: interpretation reliability of the second-generation “IEGM Online” system. Europace 2015;17:584–590. PubMed PMC

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. PubMed PMC

Arya A, Block M, Kautzner J, Lewalter T, Mörtel H, Sack S, Schumacher B, Søgaard P, Taborsky M, Husser D, Hindricks G.. Influence of Home Monitoring on the clinical status of heart failure patients: design and rationale of the IN-TIME study. Eur J Heart Fail 2008;10:1143–1148. PubMed

Brachmann J, Böhm M, Rybak K, Klein G, Butter C, Klemm H, Schomburg R, Siebermair J, Israel C, Sinha A-M, Drexler H.. Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink). Eur J Heart Fail 2011;13:796–804. PubMed PMC

Morgan JM, Dimitrov BD, Gill J, Kitt S, Ng GA, McComb JM, Raftery J, Roderick P, Seed A, Williams SG, Witte KK, Wright DJ, 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. PubMed

Packer M. Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure. J Card Fail 2001;7:176–182. PubMed

Parthiban N, Esterman A, Mahajan R, Twomey DJ, Pathak RK, Lau DH, Roberts-Thomson KC, Young GD, Sanders P, Ganesan AN.. Remote monitoring of implantable cardioverter-defibrillators: a systematic review and meta-analysis of clinical outcomes. J Am Coll Cardiol 2015;65:2591–2600. PubMed

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.. Fluid status telemedicine alerts for heart failure: a randomized controlled trial. Eur Heart J 2016;37:3154–3163. PubMed

Boriani G, Da Costa A, Quesada A, Ricci RP, Favale S, Boscolo G, Clementy N, Amori V, Mangoni di S. Stefano L, Burri H.. 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. Eur J Heart Fail 2017;19:416–425. PubMed

Morgan JM, Kitt S, Gill J, McComb JM, Ng GA, Raftery J, Roderick P, Seed A, Williams SG, Witte KK, Wright DJ, Harris S, Cowie MR; Results of the REM-HF study. Remote management of heart failure using implantable electronic devices. Eur Heart J 2017;38:2352–2360. PubMed PMC

Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida J-S, Aliot E, Boursier M, Bizeau O, Kacet S.. 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. PubMed PMC

Hindricks G, Varma N, Kacet S, Lewalter T, Søgaard P, Guédon-Moreau L, Proff J, Gerds TA, Anker SD, Torp-Pedersen C.. Daily remote monitoring of implantable cardioverter-defibrillators: insights from the pooled patient-level data from three randomised controlled trials (IN-TIME, ECOST, TRUST). Eur Heart J 2017;38:1749–1755. PubMed PMC

Anker SD, Koehler F, Abraham WT.. Telemedicine and remote management of patients with heart failure. Lancet 2011;378:731–739. PubMed

Marzegalli M, Landolina M, Lunati M, Perego GB, Pappone A, Guenzati G, Campana C, Frigerio M, Parati G, Curnis A, Colangelo I, Valsecchi S.. Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively. Trials 2009;10:42.. PubMed PMC

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. PubMed

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.. 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.. PubMed PMC

Varma N, Piccini JP, Snell J, Fischer A, Dalal N, Mittal S.. The relationship between level of adherence to automatic wireless remote monitoring and survival in pacemaker and defibrillator patients. J Am Coll Cardiol 2015;65:2601–2610. PubMed

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial