Studies Suggest Remote Monitoring Doesn’t Improve Outcomes in HF Patients With CIEDs
Remote monitoring of heart failure (HF) patients with cardiac implantable electronic devices (CIEDs) may not be associated with reduced mortality or fewer cardiovascular hospitalizations compared to usual care, according to results from the REM-HF Trial. Similarly, results from the MORE-CARE study found remote monitoring of HF patients fitted with biventricular defibrillators (CRT-D) may not improve outcomes compared to those whose devices were monitored during in-clinic visits. Both studies were presented Aug. 28 during ESC Congress 2016 in Rome
The REM-HF study looked at 1,650 HF patients (mean age 70 years) from nine British hospitals each of whom had one of three types of CIEDs equipped for remote monitoring:
- Cardiac resynchronization therapy [CRT] device with pacemaker [CRT-P];
- CRT device with defibrillator function [CRT-D];
- or implantable cardioverter-defibrillator [ICD]);
Patients were randomized to receive either usual care (three to six remote monitoring per month, plus usual HF services) or remote monitoring. Those receiving remote monitoring had data automatically downloaded from their device and sent to their health care provider on a weekly basis. Results were used to inform discussions around medication, lifestyle and/or need for additional visits. The study’s primary endpoint was the first event of death from any cause or unplanned hospitalization for cardiovascular reasons. Secondary endpoints included death from any cause, cardiovascular-related death, and unplanned hospitalization. The median follow-up period was 2.8 years.
Overall results showed no significant difference was seen between the groups in the primary end point, which occurred in 42.4 percent of the remote monitoring group and 40.8 percent of the usual care group. Secondary endpoints also occurred at a similar rate in both groups.
“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,” commented Martin R. Cowie, MD, from Imperial College London, UK, co-principal investigator of the study. “The assumption that ‘more data improves outcomes’ is not true,” he added. “If patients are well-treated already, and have well-controlled symptoms, looking at remotely collected data weekly is no better than usual care.”
In the MORE-CARE Trial, 900 HF patients implanted with a CRT-D with wireless transmission capabilities were randomized within eight weeks of device implantation to receive remote monitoring of their device alternating with in-office visits or to have all their checks done in-office. After a median follow-up of 24 months there was no significant difference in the rate of the primary endpoint of mortality and hospitalizations for cardiovascular or device-related reasons (29.7 percent in the remote group and 28.7 percent in the standard care group).
While the study was terminated early due to slow recruitment, the results, which include a secondary finding of cost-savings due to a 41 percent reduction of in-office visits, suggest “there may be a valid reason for implementing remote monitoring despite the lack of impact on hard clinical outcomes,” said lead investigator Giuseppe Boriani, MD, PhD. “Health care resource utilization for cardiovascular reasons was 38 percent lower in the remote versus the standard care arm, and there was an estimated cost-saving that went along with that – both from the perspective of the health care system, but also in terms of personal patient travel costs,” he explains.
Keywords: ESC Congress, Ambulatory Care, Cardiac Resynchronization Therapy, Defibrillators, Implantable, Health Personnel, Heart Failure, Hospitalization, Pacemaker, Artificial, Research Personnel
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