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

. 2019 Oct ; 108 (10) : 1117-1127. [epub] 20190314

Jazyk angličtina Země Německo Médium print-electronic

Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/pmid30874886
Odkazy

PubMed 30874886
PubMed Central PMC6753058
DOI 10.1007/s00392-019-01447-5
PII: 10.1007/s00392-019-01447-5
Knihovny.cz E-zdroje

AIMS: In the IN-TIME trial, automatic daily implant-based multiparameter telemonitoring significantly improved clinical outcomes in patients with chronic systolic heart failure and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). We compared IN-TIME results for ICD and CRT-D subgroups. METHODS: Patients with LVEF ≤ 35%, NYHA class II/III, optimized drug treatment, no permanent atrial fibrillation, and a dual-chamber ICD (n = 274) or CRT-D (n = 390) were randomized 1:1 to telemonitoring or no telemonitoring for 12 months. Primary outcome measure was a composite clinical score, classified as worsened if the patient died or had heart failure-related hospitalization, worse NYHA class, or a worse self-reported overall condition. RESULTS: The prevalence of worsened score at study end was higher in CRT-D than ICD patients (26.4% vs. 18.2%; P = 0.014), as was mortality (7.4% vs. 4.1%; P = 0.069). With telemonitoring, odds ratios (OR) for worsened score and hazard ratios (HR) for mortality were similar in the ICD [OR = 0.55 (P = 0.058), HR = 0.39 (P = 0.17)] and CRT-D [OR = 0.68 (P = 0.10), HR = 0.35 (P = 0.018)] subgroups (insignificant interaction, P = 0.58-0.91). CONCLUSION: Daily multiparameter telemonitoring has a potential to reduce clinical endpoints in patients with chronic systolic heart failure both in ICD and CRT-D subgroups. The absolute benefit seems to be higher in higher-risk populations with worse prognosis.

2 Department of Medicine Cardiology Angiology and Intensive Care Medicine Universitätsklinikum Schleswig Holstein Lübeck Germany

Arrhythmia and Invasive Electrophysiology Section Division of Cardiology Zentralklinik Bad Berka Bad Berka Germany

Center for Clinical Research Biotronik SE and Co KG Berlin Germany

Clinic for Cardiology and Angiology Hannover Medical School Hannover Germany

Clinic for Cardiology and Internistic Intensive Care Medicine Bielefeld Clinical Center Bielefeld Germany

Department of Cardiology and Internistic Intensive Care Medicine Munich State Hospital Bogenhausen Munich Germany

Department of Cardiology Hospital Munich Thalkirchen Peter Osypka Heart Center Munich Germany

Department of Cardiology Sana Kliniken Ostholstein Klinik Oldenburg Oldenburg Germany

Department of Cardiology University Hospital Gentofte Hellerup Denmark

Department of Clinical Medicine Århus University Åarhus Denmark

Department of Electrophysiology University of Leipzig Heart Center Leipzig Germany

Department of Internal Medicine 1 Cardiology Faculty of Medicine and Dentistry Olomouc Czech Republic

Department of Medicine 1 Cardiology Klinikum Großhadern Munich Germany

Division of Cardiology Vascular Medicine Pneumology and Intensive Care Medicine HELIOS Klinikum Pirna GmbH Pirna Germany

Medical Center for Cardiology Munich Germany

Na Homolce Prague Czech Republic

Otto von Guericke University School of Medicine Magdeburg Germany

Sydney Adventist Hospital Sydney Australia

University Hospital Bonn Bonn Germany

Zobrazit více v PubMed

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, et al. 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur J Heart Fail. 2016;18:891–975. doi: 10.1002/ejhf.592. PubMed DOI

Dagres N, Hindricks G. Risk stratification after myocardial infarction: is left ventricular ejection fraction enough to prevent sudden cardiac death? Eur Heart J. 2013;34:1964–1971. doi: 10.1093/eurheartj/eht109. PubMed DOI

Wolff G, Lin Y, Karathanos A, Brockmeyer M, Wolters S, Nowak B, et al. Implantable cardioverter/defibrillators for primary prevention in dilated cardiomyopathy post-DANISH: an updated meta-analysis and systematic review of randomized controlled trials. Clin Res Cardiol. 2017;106:501–513. doi: 10.1007/s00392-017-1079-0. PubMed DOI

Varma N, Wilkoff B. Device features for managing patients with heart failure. Heart Fail Clin. 2011;7:215–225. doi: 10.1016/j.hfc.2010.12.005. PubMed DOI

Hasan A, Paul V. Telemonitoring in chronic heart failure. Eur Heart J. 2011;32:1457–1464. doi: 10.1093/eurheartj/ehr005. PubMed DOI

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. doi: 10.1007/s10840-008-9311-5. PubMed DOI

Burri H, Senouf D. Remote monitoring and follow-up of pacemakers and implantable cardioverter defibrillators. Europace. 2009;11:701–709. doi: 10.1093/europace/eup110. PubMed DOI PMC

Saxon LA, Hayes DL, Gilliam FR, Heidenreich PA, Day J, Seth M, et al. Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study. Circulation. 2010;122:2359–2367. doi: 10.1161/CIRCULATIONAHA.110.960633. PubMed DOI

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;384:583–590. doi: 10.1016/S0140-6736(14)61176-4. PubMed DOI

Slotwiner D, Varma N, Akar JG, Annas G, Beardsall M, Fogel RI, et al. HRS expert consensus statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. Heart Rhythm. 2015;12:e69–e100. doi: 10.1016/j.hrthm.2015.05.008. PubMed DOI

Hawkins NM, Virani SA, Sperrin M, Buchan IE, McMurray JJ, Krahn AD. Predicting heart failure decompensation using cardiac implantable electronic devices: a review of practices and challenges. Eur J Heart Fail. 2016;18:977–986. doi: 10.1002/ejhf.458. PubMed DOI

Boriani G, Da Costa A, Quesada A, Ricci RP, Favale S, Boscolo G, et al. 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. doi: 10.1002/ejhf.626. PubMed DOI

Morgan JM, Kitt S, Gill J, McComb JM, Ng GA, Raftery J, et al. Remote management of heart failure using implantable electronic devices. Eur Heart J. 2017;38:2352–2360. doi: 10.1093/eurheartj/ehx227. PubMed DOI PMC

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. doi: 10.1054/jcaf.2001.25652. PubMed DOI

Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, et al. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator. The dual chamber and VVI implantable defibrillator (DAVID) trial. JAMA. 2002;288:3115–3123. doi: 10.1001/jama.288.24.3115. PubMed DOI

Nahlawi M, Waligora M, Spies SM, Bonow RO, Kadish AH, Goldberger JJ. Left ventricular function during and after right ventricular pacing. J Am Coll Cardiol. 2004;44:1883–1888. doi: 10.1016/j.jacc.2004.06.074. PubMed DOI

Sweeney MO, Bank AJ, Nsah E, Koullick M, Zeng QC, Hettrick D, et al. Minimizing ventricular pacing to reduce atrial fibrillation in sinus-node disease. N Engl J Med. 2007;357:1000–1008. doi: 10.1056/NEJMoa071880. PubMed DOI

Ruwald AC, Kutyifa V, Ruwald MH, Solomon S, Daubert JP, Jons C, et al. The association between biventricular pacing and cardiac resynchronization therapy-defibrillator efficacy when compared with implantable cardioverter defibrillator on outcomes and reverse remodelling. Eur Heart J. 2015;36:440–448. doi: 10.1093/eurheartj/ehu294. PubMed DOI

Linde C, Abraham WT, Gold MR, St John Sutton M, Ghio S, Daubert C. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008;52:1834–1843. doi: 10.1016/j.jacc.2008.08.027. PubMed DOI

Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, et al. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008;117:2608–2616. doi: 10.1161/CIRCULATIONAHA.107.743120. PubMed DOI

Martin DO, Day JD, Lai PY, Murphy AL, Nayak HM, Villareal RP, et al. Atrial support pacing in heart failure: results from the multicenter PEGASUS CRT trial. J Cardiovasc Electrophysiol. 2012;23:1317–1325. doi: 10.1111/j.1540-8167.2012.02402.x. PubMed DOI

Varma N, Piccini JP, Snell J, Fischer A, Dalal N, Mittal S. 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. doi: 10.1016/j.jacc.2015.04.033. PubMed DOI

Bohm M, Drexler H, Oswald H, Rybak K, Bosch R, Butter C, et al. Fluid status telemedicine alerts for heart failure: a randomized controlled trial. Eur Heart J. 2016;37:3154–3163. doi: 10.1093/eurheartj/ehw099. PubMed DOI

Parthiban N, Esterman A, Mahajan R, Twomey DJ, Pathak RK, Lau DH, et al. Remote monitoring of implantable cardioverter-defibrillators: a systematic review and meta-analysis of clinical outcomes. J Am Coll Cardiol. 2015;65:2591–2600. doi: 10.1016/j.jacc.2015.04.029. PubMed DOI

Klersy C, Boriani G, De Silvestri A, Mairesse GH, Braunschweig F, Scotti V, et al. 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. doi: 10.1002/ejhf.470. PubMed DOI

Hindricks G, Varma N. Remote monitoring and heart failure: monitoring parameters, technology, and workflow. Eur Heart J. 2016;37:3164–3166. doi: 10.1093/eurheartj/ehw201. PubMed DOI

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. doi: 10.1161/CIRCULATIONAHA.110.937409. PubMed DOI

Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, et al. 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. doi: 10.1093/eurheartj/ehs425. PubMed DOI 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;57:1181–1189. doi: 10.1016/j.jacc.2010.12.012. PubMed DOI

De Simone A, Leoni L, Luzi M, Amellone C, Stabile G, La Rocca V, et al. Remote monitoring improves outcome after ICD implantation: the clinical efficacy in the management of heart failure (EFFECT) study. Europace. 2015;17:1267–1275. doi: 10.1093/europace/euu318. PubMed DOI

Abraham WT, Adamson PB, Bourge RC, Aaron MF, Costanzo MR, Stevenson LW, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011;377:658–666. doi: 10.1016/S0140-6736(11)60101-3. PubMed DOI

Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet. 2016;387:453–461. doi: 10.1016/S0140-6736(15)00723-0. PubMed DOI

Angermann CE, Assmus B, Anker SD, Brachmann J, Ertl G, Köhler F, et al. Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective cardioMEMS monitoring study for heart failure (MEMS-HF) Clin Res Cardiol. 2018;107:991–1002. doi: 10.1007/s00392-018-1281-8. PubMed DOI

Hindricks G, Varma N, Kacet S, Lewalter T, Sogaard P, Guedon-Moreau L, et al. Daily remote monitoring of implantable cardioverter-defibrillators: insights from the pooled patient-level data from three randomized controlled trials (IN-TIME, ECOST, TRUST) Eur Heart J. 2017;38:1749–1755. doi: 10.1093/eurheartj/ehx015. PubMed DOI PMC

Akar JG, Bao H, Jones P, Wang Y, Chaudhry SI, Varosy P, et al. Use of remote monitoring of newly implanted cardioverter-defibrillators: insights from the patient related determinants of ICD remote monitoring (PREDICT RM) study. Circulation. 2013;128:2372–2383. doi: 10.1161/CIRCULATIONAHA.113.002481. PubMed DOI

Ono M, Varma N. Remote monitoring to Improve long-term prognosis in heart failure patients with implantable cardioverter-defibrillators. Expert Rev Med Devices. 2017;14:335–342. doi: 10.1080/17434440.2017.1306438. PubMed DOI

Ploux S, Varma N, Strik M, Lazarus A, Bordachar P. Optimizing implantable cardioverter-defibrillator remote monitoring: a practical guide. JACC Clin Electrophysiol. 2017;3:315–328. doi: 10.1016/j.jacep.2017.02.007. PubMed DOI

Burri H. Is there a future for remote cardiac implantable electronic device management? Arrhythm Electrophysiol Rev. 2017;6:109–110. doi: 10.15420/aer.2017:10:1. PubMed DOI PMC

Dagres N, Hindricks G. Pulmonary pressure, telemedicine, and heart failure therapy. Lancet. 2015;387:408–410. doi: 10.1016/S0140-6736(15)00808-9. PubMed DOI

Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan BA. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018;392:1047–1057. doi: 10.1016/S0140-6736(18)31880-4. PubMed DOI

Husser D, Geller JC, Taborsky M, Schomburg R, Bode F, Nielsen JC. Remote monitoring and clinical outcomes: details on information flow and workflow in the IN-TIME study. Eur Heart J Qual Care Clin Outcomes. 2019 PubMed PMC

Nejnovějších 20 citací...

Zobrazit více v
Medvik | PubMed

Arrhythmia monitoring and outcome after myocardial infarction (BIO|GUARD-MI): a randomized trial

. 2024 ; 11 () : 1300074. [epub] 20240513

Najít záznam

Citační ukazatele

Nahrávání dat ...

Možnosti archivace

Nahrávání dat ...