| Literature DB >> 33959819 |
Jacopo Francesco Imberti1, Alberto Tosetti1, Davide Antonio Mei1, Anna Maisano1, Giuseppe Boriani2.
Abstract
PURPOSE OF REVIEW: Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) is recommended as part of the individualized multidisciplinary follow-up of heart failure (HF) patients. Aim of this article is to critically review recent findings on RM, highlighting potential benefits and barriers to its implementation. RECENTEntities:
Keywords: Cardiac resynchronization device; Heart failure; Implantable cardioverter defibrillator; Remote monitoring; Telemedicine; pacemaker
Mesh:
Year: 2021 PMID: 33959819 PMCID: PMC8102149 DOI: 10.1007/s11886-021-01487-2
Source DB: PubMed Journal: Curr Cardiol Rep ISSN: 1523-3782 Impact factor: 2.931
Fig. 1.Remote monitoring as part the multidisciplinary approach to the treatment of heart failure patients. CIEDs cardiac implantable electronic devices, EP electrophysiology, HF heart failure
Randomized clinical trials (RCTs) comparing remote monitoring (RM) versus in-office only follow-up
| Study | RM system | Sample size ( | Average follow-upa(months) | Device type | Primary endpoint | Results |
|---|---|---|---|---|---|---|
| PREFER, 2009 [ | CLN | 897 (14% HF) | 12 | PM | • Mean time to first diagnosis of clinically actionable events | • 5.7 (RM) vs. 7.7 (CG) months ( |
| Al-Khatib et al., 2010 [ | CLN | 151 | 12 | ICD, CRTD | • Composite of CV hospitalization, emergency room visit for cardiac cause and unscheduled visit to the electrophysiology clinic for a device-related issue | • 32% (RM) vs. 34% (CG) ( |
| ECOST substudy, 2010b [ | HM | 40 | 22 | ICD | • Monitoring of device status and leads function in recipients of high-voltage ICD leads under advisory | • 3/18 (RM) vs. 0/18 (CG) lead fracture detection |
| TRUST, 2010b [ | HM | 1339 | 12 | ICD | • Number of total in-hospital device evaluations • Adverse event (deaths, stroke, surgical intervention) rate • Time from arrhythmic event to physician evaluation • Detection of device-related complications | • 2.1 (RM) vs. 3.8 ppy ( • 10.4% in both groups ( • 1 (RM) vs. 36 (CG) days ( • 4.4% (RM) vs. 1.4% (CG) ( |
| CONNECT, 2011 [ | HM | 1997 | 15 | ICD, CRTD | • Time from clinical event (arrhythmias, CV disease progression and device issues) to clinical decision • Mean length of CV hospitalization | • 4.6 (RM) vs. 22 (CG) days ( • 3.3 (RM) vs. 4 (CG) days ( |
| DOT-HF, 2011 [ | OV (CLN) | 335 | 14.9 | ICD, CRTD | • Composite of all-cause mortality and HF hospitalizations | • 29% (RM) vs. 20% (CG) ( |
| COMPAS, 2012b [ | HM | 538 | 18.3 | PM | • Composite of all-cause death and hospitalizations for device-related or CV adverse events | • 17.3% (RM) vs. 19.1% (CG) ( |
| EVATEL, 2012 [ | NA | 1501 | 12 | ICD | • Composite of death, CV hospitalization, and ineffective or inappropriate device therapy | • 30.1% (RM) vs. 28.5% (CG) ( |
| EVOLVO, 2012 [ | CLN | 200 | 16 | ICD, CRTD | • Rate of emergency department or urgent in-office visits for HF, arrhythmias, or ICD-related events | • 75 vs. 117 visits, 35% reduction ( |
| ECOST, 2013b [ | HM | 433 | 24.2 | ICD | • Proportion of patients with ≥ 1 MAE (deaths and CV/procedure/device-related MAE) | • 38.5% (RM) vs. 41.5% (CG) ( |
| SAVE-HM, 2013 [ | HM | 115 PM 36 ICD | 17.1 26.3 | PM, ICD | • Number of outpatient follow-ups • Number of adverse events | • 57.8% reduction in RM group • No difference between groups |
| IN-TIME, 2014b [ | HM | 664 | 12 | ICD, CRTD | • Worsened composite score of all-cause death, hospital admission for HF, change in NYHA class and in patient global self-assessment | • 18.9% (RM) vs. 27.2% (CG) ( |
| EuroEco, 2015b [ | HM | 303 | 24 | ICD | • Total follow-up-related cost for providers | • 204€ (RM) vs. 213€ (CG) ( |
| IMPACT, 2015b [ | HM | 2718 | 24 | ICD, CRTD | • Composite of stroke, systemic embolism and major bleeding | • 2.4 (RM) vs. 2.3 (CG) p100-py, HR 1.06 (95% CI 0.75-1.51) |
| LIMIT-CHF, 2015 [ | CLN, MER | 80 | 12 | ICD, CRTD | • Number of hospital readmission per patient | • 0.3 (RM) vs. 0.2 (CG) ( |
| OptiLink HF, 2016 [ | CLN | 1002 | 23 | ICD, CRTD | • Composite of death and CV hospitalization | • 45% (RM) vs. 48.1% (CG), HR 0.87 (95% CI 0.72-1.04) |
| MORE-CARE, 2017 [ | CLN | 865 | 24 | CRTD | • Composite of death, CV hospitalization and device related hospitalization | • 29.7 (RM) vs. 28.7 (CG), HR: 1.02 (95% CI 0.80-1.30) |
| REM-HF, 2017 [ | CLN, LAT, MER | 1650 | 33.6 | ICD, CRTD/P | • Composite of death and CV hospitalization | • 42.4 (RM) vs. 40.8 (CG), HR 1.01 (95% CI 0.87-1.18) |
| REMOTE-CIED, 2019 [ | LAT | 595 | 24 | ICD | • Effects of RM on health status • Effects of RM ICD acceptance | • No effect on KCCQ total score • No effect on FPAS total score |
| At-Home, 2020b [ | HM | 1274 (25% HF) | 24 | PM | • Composite of death, stroke, or cardiovascular events requiring surgery | • 10.9% (RM) vs. 11.8% (CG) ( |
Table 1 shows pivotal RCTs comparing RM vs. in-office only follow-up in heart failure patients implanted with CIEDs in terms of mortality, hospitalizations, and other potential RM benefits
CI confidence interval, CLN CareLink Network (Medtronic Inc.; Minneapolis and Tempe, USA); CG control group, CRT-D cardiac resynchronization therapy defibrillator, CRT-P cardiac resynchronization therapy pacing (no defibrillator), CV cardiovascular, FPAS Florida Patient Acceptance Survey, HF heart failure, HM Home Monitoring (Biotronik SE & Co. KG; Berlin, Germany), HR hazard ratio, ICD implantable cardioverter-defibrillator, KCCQ Kansas City Cardiomyopathy Questionnaire, LAT Latitude Patient Management System (Boston Scientific; St Paul, USA), MAE major adverse event, MER Merlin.net (St. Jude Medical; Sylmar, USA), NA not available, NYHA New York Heart Association class, NS nonsignificant, OR odds ratio, OV OptiVol (pulmonary congestion) algorithm, PM pacemaker, ppy per patient-year, RM remote monitoring, RR relative risk
aMean or median, whatever provided in the original publication.
bDaily RM transmissions.
Meta-analysis of randomized clinical trials on remote monitoring of cardiac implantable electronic devices from various device manufacturers: effects on mortality, hospitalizations, and visits
| Meta-analysis | RM system | Sample size ( | Average | No of studies included | Primary endpoint | Results |
|---|---|---|---|---|---|---|
| Parthiban et al. (2015) [ | HM, CLN | 4932 5372 | 14.4 NA | 7 7 | • All-cause mortality (RM vs. CG) • Hospitalizations (RM vs. CG) | • OR 0.83 (95% CI 0.58-1.17) • OR 0.83 (95% CI 0.63-1.10) |
| Klersy et al., (2016) [ | HM, CLN | 5702 | 12-36 | 11 | • Reduction in total number of visits (RM vs. CG) • Cardiac hospitalizations (RM vs. CG) • Composite of emergency room, unplanned hospital visits, or hospitalizations (RM vs. CG) | • RR 0.56 (95% CI 0.43-0.73) • RR 0.96 (95% CI 0.82-1.12) • RR 0.99 (95% CI 0.68-1.43) |
CI confidence interval, CLN CareLink Network (Medtronic Inc.; Minneapolis and Tempe, USA), CG control group, HM Home Monitoring (Biotronik SE & Co. KG; Berlin, Germany), No number, NA not available, OR odds ratio, RM, remote monitoring, RR, relative risk
aMean or median, whatever provided in the original publication