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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
JC. Geller, T. Lewalter, NE. Bruun, M. Taborsky, F. Bode, JC. Nielsen, C. Stellbrink, S. Schön, H. Mühling, H. Oswald, S. Reif, S. Kääb, P. Illes, J. Proff, N. Dagres, G. Hindricks, IN-TIME Study Group,
Language English Country Germany
Document type Journal Article, Multicenter Study, Randomized Controlled Trial
NLK
ProQuest Central
from 2005-01-01 to 1 year ago
Medline Complete (EBSCOhost)
from 2000-08-01 to 1 year ago
Health & Medicine (ProQuest)
from 2005-01-01 to 1 year ago
- MeSH
- Defibrillators, Implantable * MeSH
- Middle Aged MeSH
- Humans MeSH
- Survival Rate trends MeSH
- Follow-Up Studies MeSH
- Cause of Death trends MeSH
- Prospective Studies MeSH
- Risk Factors MeSH
- Aged MeSH
- Cardiac Resynchronization Therapy methods MeSH
- Heart Failure, Systolic mortality physiopathology therapy MeSH
- Telemedicine methods MeSH
- Stroke Volume physiology MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Geographicals
- Germany MeSH
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.
Center for Clinical Research Biotronik SE and Co KG Berlin Germany
Clinic for Cardiology and Angiology Hannover Medical School Hannover 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 Medicine 1 Cardiology Klinikum Großhadern Munich Germany
Medical Center for Cardiology Munich Germany
References provided by Crossref.org
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- $a Geller, Johann Christoph $u Arrhythmia and Invasive Electrophysiology Section, Division of Cardiology, Zentralklinik Bad Berka, Bad Berka, Germany. christoph.geller@zentralklinik.de. Otto-von-Guericke University School of Medicine, Magdeburg, Germany. christoph.geller@zentralklinik.de.
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- $a 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 / $c JC. Geller, T. Lewalter, NE. Bruun, M. Taborsky, F. Bode, JC. Nielsen, C. Stellbrink, S. Schön, H. Mühling, H. Oswald, S. Reif, S. Kääb, P. Illes, J. Proff, N. Dagres, G. Hindricks, IN-TIME Study Group,
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- $a 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.
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