Results from the IN-TIME study have shown a significant reduction in all-cause mortality in heart failure patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchonisation therapy defibrillators (CRT-Ds) fitted with remote monitoring compared to standard care therapy.
Gerhard Hindricks, Heart Center, University Leipzig, Germany, study co-ordinator presented these first results of the study at the European Society of Cardiology congress (ESC, 31 August–4 September, Amsterdam, The Netherlands).
Hindricks told delegates: “IN-TIME is the first implant-based remote monitoring randomised, controlled trial demonstrating significant benefits of implant-based home monitoring for patients with advanced heart failure.” The study results demonstrated a significant reduction in all-cause mortality in patients with severely depressed left ventricular-function and NYHA II/III supported by implant-based remote monitoring (Home Monitoring/Biotronik), as compared to standard care. At one-year follow-up, significantly more patients in the control group as compared to the remote monitoring group worsened according to the modified Packer score (27.5% vs. 18.9%).
The prospective, randomised, controlled, multicentre (36 sites) trial analysed 664 patients (mean age 66±9 years) with chronic heart failure lasting for three months or more. All patients were fitted with implanted devices that had a remote monitoring function (58% receiving CRT-D and 42% ICD therapy). Three hundred and thirty three patients were studied in the remote monitoring arm and 331 in the standard care arm. In the second group, remote monitoring data were still collected but were not accessible to the central monitoring unit (Heart Centre, Leipzig, Germany) or treating physicians until the end of the study. For these patients all treatment interventions were either patient-initiated or triggered by in-office follow-ups.
“The occurrence of atrial or ventricular arrhythmias or specific trends in certain clinical parameters can often be the first sign of worsening heart failure that leads to hospitalisation or death,” said Hindricks. “Biotronik Home Monitoring allows physicians to facilitate early detection of clinically relevant events or crucial trends in cardiac device patients. They then have enough notice to intervene in time, thereby preventing serious or even fatal events and effectively supporting the management of heart failure patients.”
Hindricks also told delegates that a detailed analysis of events, triggers, medical actions and time lines is currently underway to further explore the mechanisms underlying the significant effects observed in the heart failure patients supported by home monitoring.