TY - JOUR
T1 - Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME)
T2 - A randomised controlled trial
AU - Hindricks, Gerhard
AU - Taborsky, Milos
AU - Glikson, Michael
AU - Heinrich, Ullus
AU - Schumacher, Burghard
AU - Katz, Amos
AU - Brachmann, Johannes
AU - Lewalter, Thorsten
AU - Goette, Andreas
AU - Block, Michael
AU - Kautzner, Josef
AU - Sack, Stefan
AU - Husser, Daniela
AU - Piorkowski, Christopher
AU - Søgaard, Peter
N1 - Funding Information:
The study was sponsored by Biotronik SE & Co. KG, Berlin, Germany. We thank Prof Walter Lehmacher from the Institute of Medical Statistics, Informatics, and Epidemiology (University of Cologne, Germany) for verifying all statistical evaluations as external academic biostatistician; to the endpoint committee ( appendix ); Jochen Proff for contributions to study design, study coordination, data analysis, and scientific input; Heinrich Beilmann for contributions to study design and study management; Valeria Marquard-Handreck for study management; Jürgen Schrader for data analysis and scientific input; Dejan Danilovic for data analysis, scientific input, and checking the Article's language and style; and Bernd Brüsehaber for statistical calculations.
Funding Information:
GH is a member of the advisory board or consultant in Biotronik, Biosense, St Jude Medical, Stereotaxis, and Cyberheart, and has received honoraria for lectures from these companies except for Cyberheart. JK is a member of the advisory board or consultant in Boston Scientific, Biosense Webster, GE Healthcare, Siemens Healthcare, and St Jude Medical. He has received honoraria for lectures from Biotronik, Boston Scientific, Biosense Webster, Hansen Medical, Medtronic, and St Jude Medical. PS is a consultant for Biotronik and has received equipment from GE Health Care and from EBR Systems. CP has received personal fees and grants from Biotronik and SJM. The other authors declare no competing interests.
PY - 2014
Y1 - 2014
N2 - Background An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial. Methods We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II-III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1:1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT00538356. Findings We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65·5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58·7%). At 1 year, 63 (18·9%) of 333 patients in the telemonitoring group versus 90 (27·2%) of 331 in the control group (p=0·013) had worsened composite score (odds ratio 0·63, 95% CI 0·43-0·90). Ten versus 27 patients died during follow-up. Interpretation Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure. Such telemonitoring is feasible and should be used in clinical practice. Funding Biotronik SE & Co. KG.
AB - Background An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial. Methods We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II-III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1:1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT00538356. Findings We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65·5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58·7%). At 1 year, 63 (18·9%) of 333 patients in the telemonitoring group versus 90 (27·2%) of 331 in the control group (p=0·013) had worsened composite score (odds ratio 0·63, 95% CI 0·43-0·90). Ten versus 27 patients died during follow-up. Interpretation Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure. Such telemonitoring is feasible and should be used in clinical practice. Funding Biotronik SE & Co. KG.
UR - http://www.scopus.com/inward/record.url?scp=84906277392&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(14)61176-4
DO - 10.1016/S0140-6736(14)61176-4
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AN - SCOPUS:84906277392
SN - 0140-6736
VL - 384
SP - 583
EP - 590
JO - The Lancet
JF - The Lancet
IS - 9943
ER -