Heart failure patients with cardiac implantable electronic devices may not experience improved outcomes compared to usual care, according to a new study set to be published in JAMA.
Data from the REM-HF trial indicated that remote monitoring of CIED patients was not associated with either reduced mortality or fewer cardiovascular hospitalizations when compared to the usual care for the devices.
“Results from this trial, in a setting intended to maximize the benefit of remote monitoring, do not support its routine use in the management of patients with CIEDs. The assumption that ‘more data improves outcomes’ is not true. If patients are well-treated already, and have well-controlled symptoms, looking at remotely collected data weekly is no better than usual care,” co-principal investigator Dr. Martin Cowie of Imperial College London said in a press release.
The study included 1,650 heart failure patients with either a cardiac resynchronization therapy device with a pacemaker, CRT with a defibrillator function or an implantable cardioverter-defibrillator, with random assignment to either remote monitoring or usual care.
Patients in the remote monitoring cohort had data from their devices automatically downloaded on a weekly basis and transmitted to their managing healthcare professional where the data was used to advise on medication and lifestyle and general care. The standard-care cohort had usual remote monitoring for 3-6 months but did not have any automatic downloads.
“Although some studies investigating a range of remote monitoring strategies have suggested potential benefit, and adoption of remote monitoring is quite widespread, results of the REM-HF trial offer a new perspective that has the potential to change clinical practice. Our trial is distinct in its design, comprising multiple manufacturers’ devices, with monitoring occurring in the patients’ usual care centres, and with potentially pre-emptive care interventions driven by observation of trends seen over the course of routine weekly downloads of multiple diagnostic variables,” study co-principal investigator Dr. John Morgan said in prepared remarks.
The primary endpoint for the study was the 1st event of death from any cause or unplanned hospitalizations for cardiovascular reasons, with secondary endpoints including all-cause death, cardiovascular deaths and unplanned hospitalizations.
After a median follow-up period of 2.8 years, no significant difference was seen between groups for the primary endpoint, with the RM group reporting a 42.4% rate versus a 40.8% rate for those receiving usual care. Secondary endpoints were also similar, authors wrote.
“Despite a large number of patients, considerable follow-up time, acceptable patient adherence to weekly downloads, and additional contacts with patients driven by the remotely collected data, we did not demonstrate any improvement in outcome for patients randomized to remote monitoring compared to usual care in nine English hospitals. It is possible that an effect could be demonstrated in health care systems with less well developed usual care, where patients are less-well treated and have more severe symptoms,” Dr. Cowie said in a prepared statement.
A more focused study on patients with CRT-D devices indicated that the remote monitoring could be associated with cost savings.
Data came from the MORE-CARE study which was terminated early due to slow recruitment, making it underpowered to evaluate its primary endpoint of mortality and hospitalizations for cardiovascular or device related reasons.
Secondary outcomes were still analyzed, reporting cost savings due to a 41% reduction in in-office visits.
“Healthcare resource utilization for cardiovascular reasons was 38% lower in the remote versus the standard arm, and there was an estimated cost-saving that went along with that – both from the perspective of the healthcare system, but also in terms of personal patient travel costs,” lead investigator Giuseppe Boriani of Italy’s University of Modena and Reggio Emilia said in a prepared statement.
Use of remote monitoring for CRT-D patients resulted in savings of $3242 (EU €2,899) per 100 patients at 2 years, almost entirely through the reduction of scheduled office visits. A