CardioExchange Archive

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Following in the wake of studies that failed to find benefits associated with remote wireless monitoring of heart failure (HF) patients, the In-Time trial, presented at the European Society of Cardiology meeting in Amsterdam, is the first trial to show that home monitoring of HF patients may be beneficial.

Gerhard Hindricks, the coordinating investigator of the trial, said that In-Time was designed to test whether automatic remote home monitoring can detect events that precede clinical events and thereby spark interventions to help reduce hospitalizations for HF. In the trial, 664 chronic HF patients with an indication for an ICD were randomized to home monitoring plus standard care or standard care alone.

The primary endpoint was a modified Packer Score by which each patient was classified at the end of the study as worsened, unchanged, or improved based on the following factors: death; overnight hospitalization for worsening heart failure; favorable, unfavorable, or no change in NYHA class; and improvement, deterioration, or no change in the patient’s global self-assessment score.

• After 12 months, 18.9% of patients in the home-monitoring arm had worsened, compared to 27.5% in the control arm (p<0.05).
• There were 10 deaths in the home-monitoring arm versus 27 deaths in the control arm (p=0.004).
• Cardiovascular mortality was reduced from 21 deaths in the control arm to 8 deaths in the home-monitoring arm (p=0.012)
• Home monitoring was a significant prognostic factor for death in both a univariate and a multivariate analysis

The investigators have not fully analyzed the events detected by the home monitors, but an initial examination showed that most of the clinical events were related to atrial fibrillation, CRT performance, lead parameters, VT/VF shock, and premature ventricular contractions. As a result of home monitoring, there were 696 patient contacts, which worked out to 2.27 per patient per year. Of these contacts, 13% revealed drug incompliance; 16% triggered a visit to the physician.

At an ESC news conference, Hindrick speculated that the trial may have succeeded because it did not rely on patient activity. Data from the device was automatically sent to a central monitoring unit where alerts were monitored by a team of trained nurses who contacted patients and intervened as necessary.

Hindrick concluded that “In-Time is the first implant-based remote monitoring randomized controlled trial demonstrating significant benefits of implant-based home monitoring for patients with advanced heart failure…. Home-monitoring-based detection of changes in clinical status or technical events can trigger medical action that prevents worsening of heart failure.”

In-Time was sponsored by Biotronik.