Is There a Future for Remote Cardiac Implantable Electronic Device Management?

Abstract

Remote follow-up and monitoring of patients implanted with cardiac implantable electronic devices (CIEDs) has been introduced over a decade ago, and is now indicated according to European (class IIa indication 1 ) and American (class I indication 2 ) guidelines. There have been high expectations that this technology will improve patient outcome, as it significantly shortens response to actionable events (e.g. AF) compared with standard in-office follow-up. 3,4 However, several randomised trials have failed to meet this promise. 5,6The remote management of heart failure using implanted devices and formalised follow-up procedures (REM-HF) study has been published recently. 7 This trial, conducted at nine centres in England, randomised 1650 patients implanted with an ICD, cardiac resynchronisation therapy defibrillator or cardiac resynchronisation therapy pacemaker to either remote management with weekly transmissions or to usual care.After a median follow-up of 2.8 years, there were no differences in the primary outcome of mortality or cardiovascular admissions, nor in any of the secondary endpoints (although there was a trend in reduced mortality). This study is remarkable in that it is -as yet -the largest study in this field, with the longest follow-up, few exclusion criteria (e.g. AF was admissible and there was no age limit), and included devices from three major manufacturers. The results were disappointing: there were no differences in the primary endpoint of total mortality or cardiovascular hospitalisation, nor in any of the secondary endpoints. However, there are a number of points that need to be discussed.First, the study was performed in tertiary expert centres where specialised heart failure clinics already manage these complex patients to a high level of quality of care. Therefore, incremental benefit of any intervention is likely to be more difficult to achieve, and results may not be extrapolated to other less specialised settings.Second, this was not a study randomising remote device management with standard in-office care, as patients in the control group could be remotely monitored (except to manage heart failure). Third, the active group required weekly transmissions to be actively performed by the patients, with almost 40 % of patients transmitting <75 % of the time at 2 years. This is in contrast to automatic pre-defined alerts, which are the usual form of remote management, and that achieve successful transmissions in >90 % of the time. In any process aiming to improve patient outcome, three fundamental factors are implicated: 1) availability of good data, 2) proper interpretation of these data and 3) generation of meaningful action.In the case of REM-HF, there was most probably data overload, with parameters that are sometimes difficult to interpret individually (e.g. transthoracic impedance, heart rate variability etc.). This is probably one of the reasons why so little action was taken. For the reasons detailed above, it is not surprising that the study was negative.The key to improving ...

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial

“…Debates on the optimal telemonitoring technology (parameters to be monitored, frequency of data transmission) and clinical response system continue [11, 26, 36–38]. Both randomized trials of implant-based telemonitoring with positive outcomes, IN-TIME [9] and CHAMPION [31, 32], were characterized by largely successful daily data transmission and a well-designed response system to device-mediated alerts [26, 39].…”

Remote monitoring of implantable cardioverter-defibrillators and resynchronization devices to improve patient outcomes: dead end or way ahead?

“…In a subgroup analysis, device type and essential patient characteristics did not interact with the overall neutral result. It was concluded that in developed healthcare systems with high quality HF services, using data from weekly RM of CIEDs is unlikely to improve patient outcomes 34 , 60 …”

“…To better understand why overall results differed between Truecoin and the REM-HF trial, 34 we compared operational details. Five major differences emerge: (i) Truecoin included only daily RM, while REM-HF excluded this approach; (ii) in REM-HF, there was no true control group with IPE alone, because control patients were permitted to continue with alert-based RM if this was already in place 60 ; (iii) REM-HF required weekly RM transmissions to be actively performed by the patients and almost 40% of patients transmitted data for <75% of weeks 60 ; this attrition in compliance degraded connectivity, i.e. the foundation for RM, in contrast to successful transmission on >85% of days in Truecoin consistently during follow-up 8 , 9 , 23 , 31–33 , 39 .…”

“…the foundation for RM, in contrast to successful transmission on >85% of days in Truecoin consistently during follow-up 8 , 9 , 23 , 31–33 , 39 . (iv) REM-HF investigational sites were overloaded with unfiltered data—the nine sites received 79 325 RM transmissions over 2 years (10–15 transmissions/day per site); consequently, the attending physicians initiated medication change or advised the patient to seek medical attention in only 226 (<0.3%) and 910 (<1.2%) of transmissions, respectively 34 , 60 ; (v) parameters followed were different, e.g. thoracic impedance was not used in IN-TIME but was included in REM-HF.…”

Performance of alert transmissions from cardiac implantable electronic devices to the CareLink network: A retrospective analysis

“… 1 , 2 Despite these advancements, remote follow-up still follows a calendar-based schedule, imparting significant review burden on staff and resulting in few meaningful actions. 3 , 4 To further improve patient outcomes, many CIED systems now provide exception-based remote monitoring approaches, using alerts to notify physicians of significant clinical changes sensed by the device or of CIED performance issues. 5 However, device connectivity is critical for the operation of the alert-based system and thus remains as a substantial barrier to unlocking its full effectiveness.…”