IN-TIME, in Print: Telemonitoring for HF Boosts Outcomes

Shelley Wood

August 14, 2014

LONDON, UK — Results of the IN-TIME implant-based telemonitoring study, first reported at the European Society of Cardiology 2013 meeting last September, have now been published in the August 16, 2014 issue of the Lancet[1]. The study, led by Dr Gerhard Hindricks (University of Leipzig, Germany), showed that patients randomized to wireless monitoring of their implanted devices had improved heart-failure outcomes vs patients receiving standard care.

The published data are very similar to what was first unveiled last year. As previously reported by heartwire , the study was funded by Biotronik and used its devices, both defibrillating cardiac resynchronization therapy devices (CRT-Ds) (58.7% of patients) and implantable cardioverter defibrillators (ICDs) (41.3% of patients).

Patients in the telemonitoring arm were also equipped with "Cardio Messenger" systems for their homes that automatically relayed the data from their implants to a central monitoring location. Both patients and physicians were aware of which group the patient had been allocated to. At baseline, patients had a mean ejection fraction of 26%, and more than half were in NYHA class 3.

At 12 months, significantly fewer patients in the home-monitoring group (n=333) as compared with the standard-care group (n=331) had reached the primary end point, defined as a worsening score made up of mortality, overnight hospitalization for deteriorating HF, and NYHA class global self-assessment (18.9% vs 27.2%). As well, fewer home-monitoring patients died of any cause over the study period (10 vs 27 patients). Of those deaths, eight were cardiovascular in the telemonitoring group vs 21 in the control group, including six vs 15 from worsening heart failure, the authors note.

Possible Explanations

In the paper, Hindricks et al offer some possible explanations for their results, saying that were three likely factors. The first is early detection of onset or progression of ventricular and atrial tachycardias, the latter being the more commonly observed arrhythmia in IN-TIME. Early detection of atrial tachyarrhythmias, followed by appropriate treatment, has previously been shown to suppress "irregular, rapid ventricular response that might otherwise trigger hemodynamic instability and worsen congestive heart failure," they write. Those findings are supported by the fact that patients with a history of atrial fibrillation were also more likely to benefit from telemonitoring in IN-TIME.

Other likely contributors to the telemonitoring benefit are early recognition of suboptimal device function, as well as increased patient-physician contact prompted by activity detected on telemonitoring. That kind of contact "raised patients' awareness of relevant developments and encouraged them to take more responsibility for their own health, including adherence to prescribed treatments," the authors write.

Acknowledging that the lack of blinding to treatment group was a limitation of the study, the authors point out the "subjective components" of the composite end point ultimately had little impact on the results, particularly in light of the mortality difference.

The authors conclude that telemonitoring as used in IN-TIME is feasible and "should be used in clinical practice."

Data Dump?

That may be easier said than done, cautions Dr Martin Cowie (Royal Brompton Hospital, London, UK) in an accompanying editorial that points to the range of other negative or neutral trials conducted in the telemonitoring space[2]. Remote monitoring, he agrees, is "technically feasible but requires services to be redesigned at a time when reimbursement for such an approach is not universal."

In IN-TIME, he points out, there was a central monitoring unit that alerted participating sites to events that occurred, and those reviewing the data needed support to handle the volume.

"Remote monitoring shows much promise, but how such services should be set up, and with which technologies, is still unclear."

Hindricks disclosed being a member of the advisory board/consultant for Biotronik, Biosense, St Jude Medical, Sterotaxis, and Cyberheart and having received lecture fees from these companies (with the exception of Cyberheart). Disclosures for the coauthors are listed in the article. Cowie disclosed consulting for and receiving speaking fees or research funding from Medtronic, Boston Scientific, and St Jude Medical.

 

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