Clinical evidence
reduction in mortality associated with Implicity vs. conventional manufacturer-specific remote monitoring in ICD patients.2
fewer false-positive ILR episodes while maintaining high sensitivity, with our FDA-cleared ILR ECG Analyzer†.4–6
average advance alert before a heart failure hospitalization, with 60% sensitivity, from FDA-cleared SignalHF‡.1,6
hours saved per year at 200 patients, the equivalent of about eight weeks of work.7
N. Varma et al., “Impact of a universal monitoring system (‘third party’) on outcomes of ICD patients: A nationwide study,” Heart Rhythm, 2024.
Read MoreE. Marijon¹, E. Vicaut², A. Abraham³, I. Ibnouhsein³, C. Henry³, G. Faedda³, A. Rosier³, N. Varma⁴
(¹) Hôpital Européen Georges Pompidou, Paris, France (²) Hôpital Lariboisière, Paris, France (3) Implicity, Paris, France (⁴) Cleveland Clinic, USA
N. Varma, S. Boveda, I. Ibnouhsein, G. Faedda, A. Rosier, and J. Singh, “Heart failure events prediction algorithm for patients implanted with multi-brand CIED,” Europace, vol. 26, no. Supplement_1, 2024.
Read MoreJ. Durand, J.-L. Bonnet, A. Lazarus, J. Taieb, A. Rosier, and S. Mittal, “Using technology to improve reconnection to remote monitoring in cardiac implantable electronic device patients,” Cardiovasc. Digit. Health J., vol. 5, no. 1, pp. 1–7, 2024.
Read MoreC. Dorra, M. Cassiau, G. Faedda, A. Vinas, C. Henry, A. Rosier, December 2023.
Read MoreE. Crespin et al., “Improved diagnostic performance of insertable cardiac monitors by an artificial intelligence-based algorithm,” Europace, vol. 26, no. 1, 2023.
Read MoreA. Lazarus et al., “Filtering of remote monitoring alerts transmitted by cardiac implantable electronic devices and reclassification of atrial fibrillation events by a new algorithm,” Cardiovasc. Digit. Health J., vol. 4, no. 5, pp. 149–154, 2023.
Read MoreE. Crespin et al., “Po-03-083 Real-world performance and agreement rates with healthcare professionals of a novel AI algorithm reclassifying ILR episodes,” Heart Rhythm, vol. 20, no. 5, pp. S496–S497, 2023.
Read MoreA. Rosier et al., “A novel machine learning algorithm has the potential to reduce by 1/3 the quantity of ILR episodes needing review,” Eur. Heart J., vol. 42, no. Supplement_1, 2021.
Read MoreA. Rosier et al., “Personalized and automated remote monitoring of atrial fibrillation,” Europace, vol. 18, no. 3, pp. 347–352, 2015.
Read MoreRead more on the latest perspective for advancing workflows for CIED remote monitoring.
D. J. Slotwiner et al., “2024 HRS perspective on advancing workflows for CIED remote monitoring,” Heart Rhythm O2, vol. 5, no. 12, pp. 845–853, 2024.
Learn about the new recommendations on Practical Management of the Remote Device Clinic.
A. M. Ferrick et al., “2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic,” Heart Rhythm, vol. 20, no. 9, pp. e92–e144, 2023.
An underlying impediment to worldwide adoption of RM is the irregular availability of reimbursement. This international consensus document delivers a strong message to health care payors to provide adequate reimbursement, according to the country or regional health system, for costs of the RM system itself (hardware, software, and industry service); physician interpretation and effort of allied health professionals; and administrative and nonclinical personnel.
N. Varma, “Highlights from the 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic,” Heart Rhythm O2, vol. 4, no. 9, pp. 526–527, 2023.
A 2023 study led by Professor Niraj Varma explores the evolution of remote monitoring in managing Cardiac Implantable Electronic Devices (CIEDs). The findings highlight a shift from periodic in-office appointments to continuous, personalized remote monitoring, suggesting more efficient and patient-specific care. This change could extend in-office visits to every 24 months for stable patients, impacting healthcare workflow, reimbursement, and data management.
N. Varma et al., “Remote monitoring of cardiac implantable electronic devices and disease management,” Europace, vol. 25, no. 9, p. euad233, 2023.
Alert-driven remote patient monitoring (RPM) or fully virtual care without routine evaluations may reduce clinic workload and promote more efficient resource allocation, principally by diminishing nonactionable patient encounters.
D. S. Chew, J. P. Piccini, F. Au, C. G. Frazier-Mills, J. Michalski, and N. Varma, “Alert-driven vs scheduled remote monitoring of implantable cardiac defibrillators: A cost–consequence analysis from the TRUST trial,” Heart Rhythm, vol. 20, no. 3, pp. 440–447, 2023.
The present study investigated clinicians’ frequency of use of CIED data in clinical practice and revealed preferences and challenges with using CIED reports in clinical decision-making. The survey findings suggest that CIED data reports are comprehensive, providing an abundance of important information. However, improvements can be made to organize reports better to enhance the use of actionable data in clinical practice.
C. Daley et al., “Clinician use of data elements from cardiovascular implantable electronic devices in clinical practice,” Cardiovasc. Digit. Health J., vol. 4, no. 1, pp. 29–38, 2023.
The review summarizes some of the recent research in the field of remote monitoring of cardiac devices. Specifically highlighting major follow-up improvements regarding safety, economic, and patient satisfaction.
K. T. Lappegård and F. Moe, “Remote monitoring of CIEDs—for both safety, economy and convenience?,” Int. J. Environ. Res. Public Health, vol. 19, no. 1, p. 312, 2021.
This study sought to determine the remote monitoring (RM) alert burden in a multicenter cohort of patients with a cardiac implantable electronic device (CIED).
C. J. O’Shea et al., “Remote monitoring alert burden,” JACC Clin. Electrophysiol., vol. 7, no. 2, pp. 226–234, 2021.
The Covid-19 crisis has accelerated the use of remote patient management in various medical fields, especially among professionals dealing with heart rhythm issues. Catalyzed by the pandemic, the practice of cardiac remote monitoring is here to stay.
N. Varma et al., “HRS/EHRA/APHRS/LAHRS/ACC/AHA worldwide practice update for telehealth and arrhythmia monitoring during and after a pandemic,” J. Am. Coll. Cardiol., vol. 76, no. 11, pp. 1363–1374, 2020.
The retrospective, national, observational cohort study highlights that initiating remote monitoring within 90 days of CIED implantation, compared to delayed initiation, was associated with a lower patient mortality rate. This advantage was observed across all CIED device types.
S. Mittal, J. P. Piccini, J. Snell, J. B. Prillinger, N. Dalal, and N. Varma, “Improved survival in patients enrolled promptly into remote monitoring following cardiac implantable electronic device implantation,” J. Interv. Card. Electrophysiol., vol. 46, no. 2, pp. 129–136, 2016.
With increasing indications and access to cardiac implantable electronic devices (CIEDs) worldwide, the number of patients needing CIED follow-up continues to rise. In parallel, the technology available for managing these devices has advanced considerably. In this setting, remote monitoring (RM) has emerged as a complement to routine in-office care. Rigorous studies, randomized and otherwise, have demonstrated advantages to patients with CIED management systems which incorporates RM resulting in authoritative guidelines from relevant professional societies recommending RM for all eligible patients. In addition to clinical benefits, CIED management programs that include RM have been shown to be cost-effective and associated with high patient satisfaction.
E. P. Zeitler and J. P. Piccini, “Remote monitoring of cardiac implantable electronic devices (CIED),” Trends Cardiovasc. Med., vol. 26, no. 6, pp. 568–577, 2016.
The study was conducted to examine the association between the use of remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICD) and all-cause mortality and rehospitalization among patients undergoing initial ICD implant. Upon completion, it was determined that using RPM on patients undergoing first-time ICD implantation is at risk of significantly lower risk of adverse outcomes.
J. G. Akar et al., “Use of remote monitoring is associated with lower risk of adverse outcomes among patients with implanted cardiac defibrillators,” Circ. Arrhythm. Electrophysiol., vol. 8, no. 5, pp. 1173–1180, 2015.
Cardiovascular implantable electronic devices (CIEDs) have evolved significantly since the publication of the 2008 Heart Rhythm Society (HRS) consensus statement1 outlining recommended monitoring strategies. Novel embedded technologies have created the ability of the devices to monitor their own function, record arrhythmias and other physiological parameters, and communicate this information to health care providers without the active participation of the patient. CIEDs with wireless remote monitoring (RM) capabilities stand at the forefront of a new class of medical devices that will unobtrusively acquire vital data beyond the walls of health care facilities and seamlessly transmit the information back to health care providers. This document focuses on implantable devices for managing heart rhythm disorders.
D. Slotwiner et al., “HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices,” Heart Rhythm, vol. 12, no. 7, pp. e69–e100, 2015.
Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial.
M. Zabel et al., “Rationale and design of the MONITOR-ICD study: A randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators,” Am. Heart J., vol. 168, no. 4, pp. 430–437, 2014.
Remote monitoring (RM) is a form of telemedicine technology that permits implanted pacemakers and implantable cardioverter-defibrillators to transmit diagnostic information for review by health care professionals without patients needing to visit the device follow-up clinic. A bedside transmitter in the patient’s home conveys the device data using standard telecommunication protocol to a protected internet-accessible RM data server, which authorized health care professionals can access at any time using standard web browser software. Evidence indicates it can accelerate identification of clinical events and potential device problems.
R. Yee, A. Verma, M. Beardsall, J. Fraser, F. Philippon, and D. V. Exner, “Canadian cardiovascular society/Canadian heart rhythm society joint position statement on the use of remote monitoring for cardiovascular implantable electronic device follow-up,” Can. J. Cardiol., vol. 29, no. 6, pp. 644–651, 2013.
Expanding indications for cardiovascular implantable electronic devices are accompanied by an increasing burden of device clinic follow-up. Remote monitoring (RM) may be less time-consuming compared to in-office follow-up; however, its effect on the device clinic workflow has not been clarified.
E. M. Cronin, E. A. Ching, N. Varma, D. O. Martin, B. L. Wilkoff, and B. D. Lindsay, “Remote monitoring of cardiovascular devices: a time and activity analysis,” Heart Rhythm, vol. 9, no. 12, pp. 1947–1951, 2012.
This study aimed to evaluate remote pacemaker interrogation for the earlier diagnosis of clinically actionable events compared with traditional transtelephonic monitoring and routine in-person evaluation.
G. H. Crossley et al., “Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers,” J. Am. Coll. Cardiol., vol. 54, no. 22, pp. 2012–2019, 2009.
Monitoring implantable cardiac device function and patient condition is important. The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) trial tested the hypothesis that remote home monitoring with automatic daily surveillance (HM) is safe and effective for implantable cardioverter-defibrillator follow-up for one year and enables rapid physician evaluation of significant events.
N. Varma, A. E. Epstein, A. Irimpen, R. Schweikert, and C. Love, “Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: The Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial,” Circulation, vol. 122, no. 4, pp. 325–332, 2010.
This document represents expert consensus concerning the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs).
B. L. Wilkoff et al., “HRS/EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): Description of techniques, indications, personnel, frequency and ethical considerations,” Heart Rhythm, vol. 5, no. 6, pp. 907–925, 2008.
The Implicity platform is a clinical decision support device and is in no way intended to replace the responsibility or clinical judgment of the practitioner. It is designed to optimize data workflows and support medical expertise in patient management.
