HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices.

Abstract

Cardiovascular implantable electronic devices (CIEDs) have evolved significantly since the publication of the 2008 Heart Rhythm Society (HRS) consensus statement1Wilkoff B.L. Auricchio A. Brugada J. et al.HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations: developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA); and in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC), the Heart Failure Association of ESC (HFA), and the Heart Failure Society of America (HFSA). Endorsed by the Heart Rhythm Society, the European Heart Rhythm Association (a registered branch of the ESC), the American College of Cardiology, the American Heart Association.Heart Rhythm. 2008; 5: 907-925Abstract Full Text Full Text PDF PubMed Scopus (225) Google Scholar 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. The 2008 recommendations were, by necessity, consensus driven, without objective evidence to inform clinical practice. The document recognized that contemporary CIED follow-up has been neglected and that many patients were not receiving the recommended follow-up care. This deficiency was subsequently confirmed; patient follow-up has been erratic, with almost a quarter of patients not seen in person in the year following implant.2Al-Khatib S.M. Mi X. Wilkoff B.L. Qualls L.G. Frazier-Mills C. Setoguchi S. Hess P.L. Curtis L.H. Follow-up of patients with new cardiovascular implantable electronic devices: are experts’ recommendations implemented in routine clinical practice?.Circ Arrhythm Electrophysiol. 2013; 6: 108-116Crossref PubMed Scopus (28) Google Scholar The 2008 document advocated for structured follow-up that employs a system of regular in-person evaluations (IPEs). Remote interrogation (RI) and RM technologies (defined below) were developed as complementary tools to replace some of the routine follow-up appointments during the long-term phase of CIED management while maintaining an IPE schedule of at least 6–12 months.3Halimi F. Clementy J. Attuel P. Dessenne X. Amara W. OEDIPE Trial Investigators. Optimized post-operative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial.Europace. 2008; 10: 1392-1399Crossref PubMed Scopus (63) Google Scholar Since 2008, randomized controlled trials have compared IPE and remote management strategies for follow-up care of patients with CIEDs. Various trials have also explored the ability of RM to detect problems early, thereby improving patient outcomes. The trials have employed a variety of proprietary technologies in various health care models and have collectively shown the superiority of RI and RM for achieving the follow-up goals of patient adherence to structured follow-up protocols and improvement in device clinic workflow efficiency. The advent of automatic wireless RM has been critical to these results, a change in paradigm that forms the basis of new recommendations. The present document was developed from the foundations laid by the 2008 HRS consensus statement1Wilkoff B.L. Auricchio A. Brugada J. et al.HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations: developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA); and in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC), the Heart Failure Association of ESC (HFA), and the Heart Failure Society of America (HFSA). Endorsed by the Heart Rhythm Society, the European Heart Rhythm Association (a registered branch of the ESC), the American College of Cardiology, the American Heart Association.Heart Rhythm. 2008; 5: 907-925Abstract Full Text Full Text PDF PubMed Scopus (225) Google Scholar and the 2012 expert consensus statement on remote monitoring of CIEDs by the International Society for Holter and Noninvasive Electrocardiography and the European Heart Rhythm Association.4Dubner S. Auricchio A. Steinberg J.S. et al.ISHNE/EHRA expert consensus on remote monitoring of cardiovascular implantable electronic devices (CIEDs).Ann Noninvasive Electrocardiol. 2012; 17: 36-56Crossref PubMed Scopus (30) Google Scholar The goals for follow-up, hardware definitions, and personnel remain the same and will not be covered in this document, except for cases in which remote technologies and responsibilities have evolved. The present document provides new recommendations based on data published since 2008, endorses the need to maintain consistent follow-up, and outlines the limitations of strictly in-person methods. We focus on the organizational changes required to most effectively implement RI and RM, from the occasional replacement of routine appointments (for patient and clinician convenience) to a system of nearly continuous monitoring, with most IPEs initiated in response to alert notifications communicated by RM, thereby improving the quality and efficiency of patient care. The terms RI and RM are often used interchangeably, with RM being the colloquially accepted term for both. RI and RM, however, refer to different and complementary tools, which we will define below and address separately throughout the text. RI refers to routine, scheduled, remote device interrogations structured to mirror in-office checkups.4Dubner S. Auricchio A. Steinberg J.S. et al.ISHNE/EHRA expert consensus on remote monitoring of cardiovascular implantable electronic devices (CIEDs).Ann Noninvasive Electrocardiol. 2012; 17: 36-56Crossref PubMed Scopus (30) Google Scholar, 5Burri H. Remote follow-up and continuous remote monitoring, distinguished.Europace. 2013; 15: i14-i16Crossref PubMed Scopus (25) Google Scholar Practically all information obtained during an in-office device checkup can now be obtained remotely. An important exception to this is the data for measuring the pacing capture threshold, which is available only for devices capable of automatically measuring the capture threshold. RM refers to the automated transmission of data based on prespecified alerts related to device functionality and clinical events.4Dubner S. Auricchio A. Steinberg J.S. et al.ISHNE/EHRA expert consensus on remote monitoring of cardiovascular implantable electronic devices (CIEDs).Ann Noninvasive Electrocardiol. 2012; 17: 36-56Crossref PubMed Scopus (30) Google Scholar This provides the ability for rapid detection of abnormal device function and/or arrhythmia events.6Varma N. Pavri B.B. Stambler B. Michalski J. TRUST Investigators. Same-day discovery of implantable cardioverter defibrillator dysfunction in the TRUST remote monitoring trial: influence of contrasting messaging systems.Europace. 2013; 15: 697-703Crossref PubMed Scopus (34) Google Scholar, 7Varma N. Stambler B. Chun S. Detection of atrial fibrillation by implanted devices with wireless data transmission capability.Pacing Clin Electrophysiol. 2005; 28: S133-S136Crossref PubMed Scopus (107) Google Scholar The writing group was comprised of content experts representing the following organizations: the HRS, the Latin American Society of Cardiac Pacing and Electrophysiology (SOLAECE), the American College of Cardiology (ACC), The American Heart Association (AHA), the European Heart Rhythm Association (EHRA), the Pediatric and Congenital Electrophysiology Society (PACES), and the Asia Pacific Heart Rhythm Society (APHRS). The members of the writing group performed a comprehensive literature search, developed a series of recommendations, and provided explanations for the reasoning and research used to make each recommendation outlined in the document text. ?>*A review of relevant data was performed including evidence from studies conducted in human subjects and published in English from PubMed, EMBASE, Cochrane, and the Agency for Healthcare Research and Quality Reports. Key search terms included but were not limited to the following: pacemaker, implantable defibrillator, cardiac resynchronization therapy device, remote monitor, remote interrogation, transtelephonic, randomized controlled trial, meta-analysis, registry, and observational trials. The recommendations were voted on, with the vote threshold for inclusion set at 80%. The classification of recommendation and the level of evidence follow the recently updated ACC/AHA standard.8Jacobs A.K. Anderson J.L. Halperin J.L. The evolution and future of ACC/AHA clinical practice guidelines: a 30-year journey: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.J Am Coll Cardiol. 2014; 64: 1373-1384Abstract Full Text Full Text PDF PubMed Scopus (95) Google Scholar Class I is a strong recommendation, denoting a benefit greatly exceeding risk. Class IIa is a somewhat weaker recommendation, with a benefit probably exceeding risk, and class IIb denotes a benefit equivalent to or possibly exceeding risk. Class III is a recommendation against a specific treatment because either there is no net benefit or there is net harm. Level of evidence A denotes the highest level of evidence, usually from multiple randomized controlled trials or from a single randomized clinical trial and a high-quality registry. Level of evidence B indicates a moderate level, either from randomized trials or well-executed nonrandomized trials. Level of evidence C is from weaker studies with significant limitations, and level of evidence E is from consensus opinions in the absence of credible published evidence. The writing committee believes that the problems faced by patients with heart rhythm disorders cannot be addressed if clinicians, scientists, and industry work in isolation and that the value of this document would be enhanced by a structured dialogue with industry to address technical questions and gain an understanding of the challenges faced by industry in advancing this technology. Because of the potential for actual or perceived bias, strict parameters had to be established for information sharing. It is the policy of the HRS that industry may participate in the development of clinical documents in an advisory capacity, but not in its authorship. To this end, manufacturers of cardiac rhythm management devices and related industries were invited to join the writing committee at a forum on emerging technologies. The forum provided a venue for sharing important research and innovation and helped inform the writing committee’s recommendations for future developments in the field. The remote evaluation of CIEDs began with the transtelephonic monitoring (TTM) of pacemakers, which was first introduced in 1971. Soon after its adoption, the supplementation of in-office visits with TTM for pacemaker follow-up became common in North America. TTM is still in use, and its function remains essentially unchanged.1Wilkoff B.L. Auricchio A. Brugada J. et al.HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations: developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA); and in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC), the Heart Failure Association of ESC (HFA), and the Heart Failure Society of America (HFSA). Endorsed by the Heart Rhythm Society, the European Heart Rhythm Association (a registered branch of the ESC), the American College of Cardiology, the American Heart Association.Heart Rhythm. 2008; 5: 907-925Abstract Full Text Full Text PDF PubMed Scopus (225) Google Scholar The technology delivers limited data on pacemaker function via analog transmission over a telephone landline; the information includes sensing, capture, and battery longevity data, as well as a real-time electrocardiogram (Figure 1). TTM requires coordination with the clinical staff to receive and interpret the data. Verbal communication between the patient and the nurse or technician who performs TTM is necessary, allowing real-time assessment of the patient’s clinical status. TTM technology is not capable of retrieving diagnostic data from the device’s memory and can provide only rudimentary data on the pacemaker’s function. RI and RM technologies, which are now incorporated in all CIEDs, are recommended over TTM because of the additional diagnostic data they provide.9Crossley G.H. Chen J. Choucair W. Cohen T.J. Gohn D.C. Johnson W.B. Kennedy E.E. Mongeon L.R. Serwer G.A. Qiao H. Wilkoff B.L. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.J Am Coll Cardiol. 2009; 54: 2012-2019Abstract Full Text Full Text PDF PubMed Scopus (161) Google Scholar Despite its limitations, TTM remains an important tool for places where more advanced technological solutions have not or cannot be instituted. In the late 1990s, inductive technology was incorporated into CIEDs for the purpose of RI (Figure 1).10Schoenfeld M.H. Compton S.J. Mead R.H. Weiss D.N. Sherfesee L. Englund J. Mongeon L.R. Remote monitoring of implantable cardioverter defibrillators: a prospective analysis.Pacing Clin Electrophysiol. 2004; 27: 757-763Crossref PubMed Scopus (171) Google Scholar, 11Al-Khatib S.M. Piccini J.P. Knight D. Stewart M. Clapp-Channing N. Sanders G.D. Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial.J Cardiovasc Electrophysiol. 2010; 21: 545-550Crossref PubMed Scopus (87) Google Scholar These systems use a wand-based radiofrequency platform to transfer data between the patient’s device and a transceiver. The remote inductive interrogation procedure is similar to that performed at a typical IPE. Once the wand is placed over the device, the programmed, stored, and measured data are sent via real-time radiofrequency transmissions from the patient’s device to a home transceiver. The patient receives feedback regarding the success or failure of the transmission. The data are then sent from the transceiver by telephone to a central repository where they are stored and processed securely. Communication between the in-home transceiver and the central storage repository can be conducted using either analog phone lines or a cellular wireless data network. The data are then available via a secure dedicated website for the provider to retrieve and review. Inductive systems can be time-consuming and cumbersome to operate, can create challenges for compliance, and do not automatically transmit asymptomatic events.11Al-Khatib S.M. Piccini J.P. Knight D. Stewart M. Clapp-Channing N. Sanders G.D. Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial.J Cardiovasc Electrophysiol. 2010; 21: 545-550Crossref PubMed Scopus (87) Google Scholar, 12Cronin E.M. Ching E.A. Varma N. Martin D.O. Wilkoff B.L. Lindsay B.D. Remote monitoring of cardiovascular devices: a time and activity analysis.Heart Rhythm. 2012; 9: 1947-1951Abstract Full Text Full Text PDF PubMed Scopus (68) Google Scholar In 2001, the first fully automatic platform for RM was introduced.13Theuns D.A. Res J.C. Jordaens L.J. Home monitoring in ICD therapy: future perspectives.Europace. 2003; 5: 139-142Crossref PubMed Scopus (52) Google Scholar Currently, multiple such platforms are in use. Automatic RM offers the advantage of independence from patient or physician scheduling. Although there are proprietary differences, essentially the implanted device initiates transmissions periodically at set frequencies (ranging from every 3 weeks to daily) and additionally if certain abnormal criteria are detected. Symptomatic patients may also initiate the interrogations. Radiofrequency transmissions are sent wirelessly to a transceiver located close to the patient, typically in the patient’s bedroom (Figure 1). Using either analog landlines or wireless data networks, the transmitted data are sent to the manufacturer’s central repository for storage and retrieval. Physicians or designees typically access the patient data by logging onto a secure, dedicated website. Most large-scale randomized trials of remote follow-up paradigms have employed both RI and RM as complementary tools; however, several important early studies have examined RI alone. RI technology was first implemented for managing patients with implantable cardioverter-defibrillators (ICDs) to reduce the frequency of scheduled in-person follow-up visits. Two prospective studies evaluated the technology from the perspective of the patient and clinician.10Schoenfeld M.H. Compton S.J. Mead R.H. Weiss D.N. Sherfesee L. Englund J. Mongeon L.R. Remote monitoring of implantable cardioverter defibrillators: a prospective analysis.Pacing Clin Electrophysiol. 2004; 27: 757-763Crossref PubMed Scopus (171) Google Scholar, 14Joseph G.K. Wilkoff B.L. Dresing T. Burkhardt J. Khaykin Y. Remote interrogation and monitoring of implantable cardioverter defibrillators.J Interv Card Electrophysiol. 2004; 11: 161-166Crossref PubMed Scopus (87) Google Scholar Patients reported high satisfaction and acceptance of the technology, and clinicians found the data to be reliable and sufficient for evaluating device function and detecting arrhythmias while reducing the frequency of IPEs. The Pacemaker Remote Follow-up Evaluation and Review study examined the hypothesis that frequent scheduled RIs of pacemakers might be superior to routine IPEs by providing early identification of significant findings such as ventricular arrhythmias, atrial fibrillation, device/lead malfunction, and battery voltage elective replacement indicator status (ie, clinically actionable events).9Crossley G.H. Chen J. Choucair W. Cohen T.J. Gohn D.C. Johnson W.B. Kennedy E.E. Mongeon L.R. Serwer G.A. Qiao H. Wilkoff B.L. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.J Am Coll Cardiol. 2009; 54: 2012-2019Abstract Full Text Full Text PDF PubMed Scopus (161) Google Scholar This prospective randomized trial enrolled 980 patients who were assigned in a 2:1 ratio to undergo RI vs a control group assigned to IPE and TTM-based follow-up. Over the 12-month study, clinically actionable events were detected significantly sooner among patients randomized to RI compared to IPE+TTM groups (mean time 5.7 and 7.7 months, respectively; P < .0001). Among patients undergoing RI, 446 of 676 events (66%) were detected as compared with only 3 of 190 events (2%) in patients undergoing IPE+TTM. These early clinical trials of RI validated its safety and effectiveness, as well as patient and clinician satisfaction. The combination of RI and wireless RM allows for nearly continuous monitoring, providing daily self-testing and event notification for out-of-bound parameters, which are not possible for wanded telemetry systems. These complementary follow-up tools form the basis of the clinical trials discussed below. The 2008 transatlantic consensus recommendations advocated a regular calendar-based follow-up system of either IPE or RI, although their comparative efficacy and ideal ratio was unknown at that time.1Wilkoff B.L. Auricchio A. Brugada J. et al.HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations: developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA); and in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC), the Heart Failure Association of ESC (HFA), and the Heart Failure Society of America (HFSA). Endorsed by the Heart Rhythm Society, the European Heart Rhythm Association (a registered branch of the ESC), the American College of Cardiology, the American Heart Association.Heart Rhythm. 2008; 5: 907-925Abstract Full Text Full Text PDF PubMed Scopus (225) Google Scholar Since then, the Lumos-T Safely RedUces RouTine Office Device Follow-up (TRUST) trial in 2010 (Table 1) compared and contrasted the 2 methods, with results showing that RI combined with RM more effectively and durably attained the goals of timely scheduled follow-up and patient retention (Figure 2).15Varma N. Epstein A.E. Irimpen A. Schweikert R. Love C. TRUST Investigators. 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. 2010; 122: 325-332Crossref PubMed Scopus (445) Google Scholar, 16Varma N. Michalski J. Stambler B. Pavri B.B. TRUST Investigators. Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial—testing execution of the recommendations.Eur Heart J. 2014; 35: 1345-1352Crossref PubMed Scopus (71) Google Scholar Moreover, replacement of many IPEs with RI follow-up evaluations resulted in increased efficiency for both patients and clinics”.15Varma N. Epstein A.E. Irimpen A. Schweikert R. Love C. TRUST Investigators. 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. 2010; 122: 325-332Crossref PubMed Scopus (445) Google Scholar, 17Ricci R.P. Morichelli L. D’Onofrio A. Calò L. Vaccari D. Zanotto G. Curnis A. Buja G. Rovai N. Gargaro A. Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry.Europace. 2013; 15: 970-977Crossref PubMed Scopus (42) Google Scholar, 18Ricci R.P. Morichelli L. D’Onofrio A. Calo L. Vaccari D. Zanotto G. Curnis A. Buja G. Rovai N. Gargaro A. Manpower and outpatient clinic workload for remote monitoring of patients with cardiac implantable electronic devices: data from the HomeGuide Registry.J Cardiovasc Electrophysiol. 2014; 25: 1216-1223Crossref PubMed Scopus (43) Google ScholarTable 1Remote Follow-Up: Clinical Evidence*The table summarizes clinical trials discussed in the text.Study Name/AuthorYearStudy TypeStudy Size (No. of Patients)Inclusion CriteriaEnd PointsResultsFindingsRandomized trials—PMsPREFER9Crossley G.H. Chen J. Choucair W. Cohen T.J. Gohn D.C. Johnson W.B. Kennedy E.E. Mongeon L.R. Serwer G.A. Qiao H. Wilkoff B.L. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.J Am Coll Cardiol. 2009; 54: 2012-2019Abstract Full Text Full Text PDF PubMed Scopus (161) Google Scholar2009Randomized, prospective, multicenter897VVI/DDD PMsMean time to first diagnosis of CAE, comparing the RM arm and the control armFU: 375 ± 140 dMean time to first diagnosis of CAE was shorter in the RM armMedtronic CareLink RMMean time to first diagnosis of CAE was 5.7 mo in the RM arm vs 7.7 mo in the control arm P < 0.001COMPAS25Mabo P. Victor F. Bazin P. Ahres S. Babuty D. Da Costa A. Binet D. Daubert J.C. COMPAS Trial Investigators. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial).Eur Heart J. 2012; 33: 1105-1111Crossref PubMed Scopus (243) Google Scholar2011Randomized, multicenter538DDD PMs indications, no PM dependentsMAE: hospitalization for PM-related complications, CV events, and deathFU: 18 moRM was safe and reduced the number of in-office visitsBiotronik HMIncidence of each MAEMAE: 17.3% in the RM arm vs 19.1% in the control arm (P < 0.01 for non-inferiorityRM enabled earlier detection of clinical and device-related adverse eventsRM reduction of in-office visitsHospitalization due to PM complications in the RM arm (0.4%) vs the control arm (2.8%) P < 0.05Mean number of unscheduled FUs per patient per year: 56% lower in the RM arm p<0.001Randomized trials—ICDsTRUST6Varma N. Pavri B.B. Stambler B. Michalski J. TRUST Investigators. Same-day discovery of implantable cardioverter defibrillator dysfunction in the TRUST remote monitoring trial: influence of contrasting messaging systems.Europace. 2013; 15: 697-703Crossref PubMed Scopus (34) Google Scholar, 15Varma N. Epstein A.E. Irimpen A. Schweikert R. Love C. TRUST Investigators. 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. 2010; 122: 325-332Crossref PubMed Scopus (445) Google Scholar, 16Varma N. Michalski J. Stambler B. Pavri B.B. TRUST Investigators. Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial—testing execution of the recommendations.Eur Heart J. 2014; 35: 1345-1352Crossref PubMed Scopus (71) Google Scholar, 26Varma N. Michalski J. Epstein A.E. Schweikert R. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-up (TRUST) Trial.Circ Arrhythm Electrophysiol. 2010; 3: 428-436Crossref PubMed Scopus (131) Google Scholar2010Randomized, prospective, multicenter1,339VVI/DDD ICDs, no PM dependentTotal in-hospital device evaluationsIn-hospital device evaluation was 2.1 per patient per year in the RM arm vs 3.8 per patient per year in the control arm p < 0.001RM was safe in supplanting “routine” in-office visits, enabling early event detection in ICD recipientsBiotronik HMOverall adverse event rateOverall adverse event rate was 10.4% in both groups at 12 mo p = 0.005 for non-inferiorityTime from event onset to physician evaluationRM reduced event detection delay by >30 d p<0.001CONNECT21Crossley G. Boyle A. Vitense H. Chang Y. Mead R.H. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts.J Am Coll Cardiol. 2011; 57: 1181-1189Abstract Full Text Full Text PDF PubMed Scopus (398) Google Scholar2011Randomized, prospective, multicenter.1,997ICDs and CRT-DsTime from a clinical event to a clinical decision22 d (in-office arm) vs 4.6 d (RM arm) p<.001RM reduced the time to a clinical decisionMedtronic Carelink RMEvaluated hospitalization LOSHealth care use for CV reasons: 4 d (in-office arm) vs 3.3 d (RM arm) p<.001RM reduced the mean LOSLOS per hospitalization was 3.2 d in the RM arm vs 4.3 d in the in-office arm p = .002ECOST23Guedon-Moreau L. Lacroix D. Sadoul N. Clementy J. Kouakam C. Hermida J.S. Aliot E. Boursier M. Bizeau O. Kacet S. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial.Eur Heart J. 2012; 34: 605-614Crossref PubMed Scopus (201) Google ScholarClinical aspects2012Randomized, prospective, multicenter433ICDsIncidence of MAE (all-cause and CV death)FU: 24.2 moRM was as safe as standard FUBiotronik HMProcedure-related complications and device-related adverse eventsMAE: 40.3% vs 43.3% in the RM arm vs in the control arm p<0.05 (non inferiority)RM reduces appropriate and inappropriate shocksAppropriate and inappropriate shocks delivered were 71% lower in the RM arm p < 0.05Battery longevity increased in the RM arm p<0.0276% reduction of capacitor chargesEconomic aspects2014310Economic impact of RM on patients with ICDNonhospital costs: RM: €1695 ± 1131 p<0.04RM reduced mean nonhospital costs per patient per yearConventional: €1952 ± 1023RM did not significantly reduce the hospital costs per patient per yearHospital costs:RM: €2829 ± 6382Conventional: €3549 ± 9714 p = .46Savings were increased to €494 by adding the ICD to nonhospital costs or to €315 per patient per year by adding the monitoring systemEVOLVO27Landolina M. Perego G.B. Lunati M. Curnis A. Guenzati G. Vicentini A. Parati G. Borghi G. Zanaboni P. Valsecchi S. Marzegalli M. Remote monitoring reduces healthcare use and improves quality of care in heart failure patients with implantable defibrillators: the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study.Circulation. 2012; 125: 2985-2992Crossref PubMed Scopus (245) Google ScholarClinical aspects2012Randomized, prospective, multicenter200LVEF ≤35%Rate of the emergency department or urgent in-office visits for heart failure, arrhythmias, or ICD-related eventsFU: 16 moRM reduced the number of emergency department or urgent in-office visits and health care useMedtronic ICDs or CRT-Ds with thoracicTotal events: 0.59 vs 0.93 events per patient per year in the RM arm vs in the control arm p = 0.005RM increased the efficiency of health careimpedance measurement capabilities (OptiVol)Number of urgent visits per patient per year for heart failure, arrhythmias, or ICD-related: 4.4 in the RM arm vs 5.7 in the control arm p<0.001Time from ICD alert to review: 1.