Remote monitoring of heart failure: benefits for therapeutic decision making

Figures & data

Table 1. Major studies demonstrating the role of remote monitoring in management of heart failure.

Study	Number of patients included	Study protocol	Results
1. Structured trans-telephonic support and telemonitoring of HF patients
Tele-HF study	1653 patients	Telemonitoring care (interactive voice-response system) vs. usual care	1. Readmission rates – NS 2. Deaths – NS
TIM-HF study	710 patients	Telemedical care (portable devices transferred encrypted data including electrocardiography, blood pressure and body weight vs. usual care	1. Hospitalization rates – NS
2. Remote monitoring with implanted therapeutic devices: detection of heart rhythm disorders
ASSERT study	2580 patients	Patients with implanted CIEDs, 2.5 years of follow-up. Newly detected AF episodes (with more than 6 min of duration) were counted	Newly detected AF episode have been detected in 34.7% of the involved population
TRENDS trial	1368 patients	Patients with no history of AF were included. Newly detected AF episodes (with more than 5 min of duration) were counted	Newly detected AF episode have been detected in 30% of the involved population
TRUST trial	1339 patients	Remote monitoring vs. standard follow-up	AF detection occurred at 5.5 days in the remote monitoring group compared with 40 days in the standard follow-up group
CONNECT trial	1997 patients	Patients with implanted ICDs were involved	3 vs. 24 days interval between AF episodes detection and clinical response in the remote monitoring vs. standard follow-up groups
COMPAS trial	538 patients	Remote monitoring follow-up vs. standard care (18.3 months of follow-up)	1. 17.3% vs. 19.1% (P < .01 for non-inferiority) patients experienced at least one major adverse event (all-cause death, hospitalizations for device-related or cardiovascular events) in the remote monitoring group and standard care group, respectively 2. Hospitalizations for atrial arrhythmias (6 vs. 18) and strokes (2 vs. 8) were fewer (P < .05) 3. Number of interim ambulatory visits was 56% lower (P < .001) in the remote monitoring than the standard care group
3. Detection and management of system-related complications in patients with implanted CIEDs
ECOST trial	40 patients	Patients with high-voltage leads were involved, with 22 ± 4 months of follow-up after implantation	Lead failure was registered in 7.5% of patients
4. Detection of heart failure worsening in hemodynamics
SENSE-HF trial	501 patients	Intracardiac impedance-derived fluid index measurement	Low sensitivity and positive predictive value in the early period after implantation (6 months), though sensitivity improved within the first 6 months after implantation
DOT-HF study	335 patients	Patients with implanted CIEDs were involved and randomized to have information available to physicians and patients as an audible alert in case of preset threshold crossings (access arm) or not (control arm)	Routine monitoring of intrathoracic impedance was not associated with a better outcome and was associated with an increased likelihood of HF hospitalization
PARTNERS-HF trial	694 patients	Patients with implanted CRTDs were involved and followed-up for 11.7 ± 2 months	Reduced impedance (or increased fluid index) has been demonstrated to be the most sensitive parameter to predict HF hospitalizations
IN-TIME trial	664 patients	Patients with NYHA class II and III and implanted ICDs and CRTDs were enrolled and randomized to standard vs. remote monitoring (in response to telemonitoring observations the investigators did a standardized telephone interview to establish whether patient’s overall condition or symptoms had worsened or not, whether there was a sudden increase in body weight (>2 kg within the preceding 3 days) or scheduled visit to family doctor) arms	1. 63 patients (18.9%) with worsened composite clinical score in the telemonitoring group vs. 90 patients (27.2%) in the control group (P = .013) 2. Mortality was lower in the telemonitoring group compared to the control group (n = 10 vs. 27) 3. No significant differences in hospitalization among these groups was demonstrated
REM-HF trial	1650 patients	Patients with implanted CIEDs (ICD, CRTP, and CRTD) with remote monitoring were enrolled in the study and randomized to usual care or remote monitoring, with 2.8 years of median follow-up. Management of patients with remote monitoring was based on the data healthcare professional has received on a weekly basis from the device. Patients in usual care group had a usual care from heart failure service and remote monitoring of the device (once per 3–6 months)	No significant differences in the primary (death from any cause or unplanned hospitalization for cardiovascular reasons) and secondary (death from any cause, death from cardiovascular reasons, unplanned hospitalization) end points were demonstrated
MORE-CARE trial	865 patients	Patients with implanted CRTDs were enrolled and randomized into remote and standard follow-up arms	1. No significant differences in the composite of death and hospitalization due to cardiovascular and device-related reasons between these two groups were demonstrated 2. A significant 38% reduction in healthcare resources utilization in the remote arm (2-year rates of cardiovascular hospitalizations, cardiovascular emergency department admissions, and cardiovascular in-office follow-ups) as compared with the standard arm was demonstrated
5. Detection of sleep disorders: the potential implementation of remote monitoring
DREAM study	40 patients	Patients with implanted CIEDs and incorporated Sleep Apnea Monitoring (SAM algorithm) were enrolled. Sleep apnea diagnosis was confirmed by polysomnography as a gold standard diagnostic technique and compared with the respiratory disturbances index evaluated by the SAM algorithm	1. 88.9% sensitivity (95% CI 65.3–98.6%) 2. 88.9% positive predictive value (95% CI 65.3–98.6%) 3. 84.6% specificity (95% CI 54.6–98.1%)
6. Remote monitoring with implanted monitoring-only devices
COMPASS-HF	274 patients	Patients were randomized into Chronicle device and standard groups	1. Reduction in HF admissions or urgent follow-up visits in Chronicle group by 21% (P = .33) – NS 2. Retrospective analysis has demonstrated a statistically significant 36% reduction in relative risk of the time to first hospitalization in the Chronicle group
REDUCEhf trial	1300 patients (designed to enroll); 400 patients enrolled	Patients with an indication of ICD implantation was enrolled (ICD implantation with an RV pressure monitoring)	1. The trial was prematurely terminated due to technical complications after enrolment 2. No benefit from hemodynamics monitoring has been demonstrated
CHAMPION trial	550 patients	Patients with NYHA Class II were included and randomized into the CardioMEMs and usual monitoring groups	1. Statistically significant reduction in HF hospitalization (regardless of LV ejection fraction) by 28% and 37% in the CardioMEMS group over 6- and 15-months of follow-up, respectively 2. Rates of non-HF-related hospitalizations were similar in both groups 3. Patients included in the CardioMEMS group had a significant reduction in the mean pulmonary artery pressure and better quality of life during the 6-month of follow-up based on the Minnesota Living with Heart Failure Questionnaire
HOMEOSTASIS study	40 patients	Patients with NYHA class III-IV HF were enrolled to receive a HeartPOD device to directly measure LA pressure. The follow-up period was divided into the first blinded (3 months), the second titration (3 months) and the third stability periods (19 months)	HeartPOD group had statistically significant: 1. Improved control of LA pressure 2. Improvement in NYHA class 3. More optimal neurohormonal antagonist dosing 4. 59% reduction of clinical events in the titration and stability period as compared with observation period

NS: nonsignificant; HF: heart failure; AF: atrial fibrillation; RV: right ventricle; LA: left atria, CIED: cardiac implantable electronic device; ICD: implantable cardioverter defibrillator; CRTP: cardiac resynchronization therapy; CRTD: cardiac resynchronization therapy with ICD function.