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IN-TIME: Implant-based telemonitoring improved outcomes for patients with HF
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Patients with HF who received an implantable cardioverter defibrillator or cardiac resynchronization defibrillator had improved clinical outcomes if they also received daily, automatic, implant-based telemonitoring, according to new data from the IN-TIME trial.
The randomized controlled trial was conducted at 36 centers in Australia, Europe and Israel. In total, 664 patients were randomly assigned standard care plus telemonitoring (n=333) or standard care without telemonitoring (n=331). The characteristics of the patients were as follows: chronic HF, NYHA class II/III symptoms, ejection fraction ≤35%, optimal drug therapy, no atrial fibrillation and recent ICD or CRT-D implant (Biotronik) equipped with a Biotronik Home Monitoring function, according to the study.
The devices transmitted daily at a scheduled time or upon tachycardia detection to a small portable patient device. The data were then automatically relayed using mobile telephone links to the Biotronik Home Monitoring Service Center in Berlin, Germany, and were subsequently processed and sent to a secure website to which the patients’ physicians had access. Patients assigned to the telemonitoring group had their data reviewed by the investigators, nurses and physicians, whereas patients assigned standard care only had no data accessible until study completion and were treated according to European guidelines.
The primary outcome was a composite score incorporating all-cause mortality, overnight admission for HF, change in NYHA class and change in global self-assessment. At 1 year, 18.9% of patients assigned telemonitoring and 27.2% assigned standard care alone had a worsened composite score (OR=0.63; 95% CI, 0.43-0.9). According to the researchers, the difference in clinical outcome between the two groups was driven by lower mortality among patients assigned telemonitoring (10 deaths vs. 27 deaths). Eight CV-related deaths were reported in the telemonitoring group vs. 21 in the standard care group.
The telemonitoring and standard care groups had a similar number of hospital admissions for worsening HF (44 vs. 47; P=.38) and median length of stay (8 days vs. 7 days; P=.21).
The researchers also assessed the primary outcome within subgroups in a post-hoc exploratory analysis. The data revealed no significant interaction between subgroups, except for patients with a history of AF, who were more likely to benefit from telemonitoring compared with patients without a history of AF.
Based on the telemonitoring data, the researchers contacted 238 patients (71%), for an average of 2.1 contacts per patient-year.
“The favorable effect of telemonitoring seemed to arise from careful attention to various kinds of remote data without a single, typical scenario,” Gerhard Hindricks, MD, PhD, from the Heart Center Leipzig, Germany, and colleagues wrote. The researchers said three mechanisms appear to have contributed to the improved clinical outcomes among patients assigned telemonitoring: early detection of the onset/progression of tachyarrhythmias; early recognition of suboptimal device function; and patient interviews prompted by monitoring.
“The telemonitoring technique … is feasible and should be used in clinical practice for patients with [HF] and an indication for an ICD or CRT-D treatment,” the researchers concluded.
Disclosure: See the full study for a list of relevant financial disclosures.
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