IN-TIME Sees Better Results, Fewer Deaths, With HF Home Monitoring

Shelley Wood

September 01, 2013

AMSTERDAM — Succeeding where others have failed, the IN-TIME trial has demonstrated that wireless monitoring of implanted devices can improve heart-failure outcomes.

Dr Gerhard Hindricks (University of Leipzig, Germany) presented IN-TIME to the press here at the European Society of Cardiology (ESC) 2013 Congress in advance of a hot-line session later today.

"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," Hindricks said.

Indeed, other small studies of heart-failure monitoring have been mixed, and in two major randomized trials of HF telemedicine came up empty-handed, prompting one expert to suggest these efforts should be abandoned.

Just in Time?

All of the devices studied in IN-TIME were made by Biotronik and included defibrillating cardiac resynchronization therapy (CRT-Ds) devices (58% of patients) and implantable cardioverter defibrillators (ICDs) (42% of patients). Patients were also equipped with "Cardio Messenger" systems for their homes that relayed the data from their implants to a central monitoring location.

A total of 716 patients were randomized to either home monitoring or a control group with standard HF care; 82 patients (30 in the home-monitoring group) terminated the study early due to deaths, withdrawal of consent, loss to follow-up, or other reasons.

At 12 months, significantly fewer patients in the home-monitoring group had reached the primary end point, worsening by modified Packer score (a composite of mortality, overnight hospitalization for worsened HF, and NYHA class global self-assessment). Moreover, fewer home-monitoring patients died of any cause over the study period.

Outcomes With Home Monitoring vs Standard Care

End point Home monitoring (%) Standard care (%) p
Worsened HF, by modified Packer score 18.9 27.5 <0.05
All-cause mortality 3.4 8.7 <0.012

 

Asked why his study succeeded where others have not, Hindricks called the Biotronik system "the most advanced implant-based telemonitoring platform," with studies showing that the "chain of information with this platform works very, very well.

"All the patient has to do after the implant has been done is plug in the Cardio Messenger, and from that moment on--and this is really important--everything works very automatically. Automatic detection of the signals, automatic transmission--the patient does nothing. This is one of the differences with other telemonitoring applications. Whenever you involve patients, the likelihood that the chain of information, which is crucial, doesn't work appropriately is very, very high."

Commenting on the study for heartwire , Dr Mariell Jessup (University of Pennsylvania, Philadelphia) also highlighted the lack of patient involvement.

"I think probably the difference in this trial is that the patients didn't have to do anything special," she said. "They were having ongoing monitoring, whether they wanted it or not. And we'll have to understand more what components of that really translated into being such a beneficial outcome, what kinds of interventions were made, did this make people feel better, were there more trips to the hospital? We don't have all that data."

To heartwire , Hindricks said that the results from IN-TIME would be easy to translate to individual clinics, because of the highly automated nature of the process. "We have more than 1000 patients at Heart Center Leipzig using home monitoring, we have specially trained nursing staff who go to the website and analyze the patients, the patients are in electronic files, you don't see the patients without events, and you set the event triggers according to study protocol or according to the individual needs or requirements of the patients."

When a patient has an event that warrants further investigation, these are flagged in the morning, and the physician can instigate follow-up. "It is not that difficult. . . . It can be easily copied."

Hindricks disclosed receiving study grants, educational grants, and honoraria from Biotronik.

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