Top

Current Cardiology Reports

Published in:

26-09-2023 | Pacemaker | Invasive Electrophysiology and Pacing (EK Heist, Section Editor)

Long-Term Remote vs. Conventional Monitoring of Pacemakers: Systematic Review and Meta-Analysis of Randomized Controlled Trials

Authors: Antônio Silva Menezes Junior, André Rivera, Isabele Ayumi Miyawaki, Douglas Mesadri Gewehr, Bárbara Nascimento

Published in: Current Cardiology Reports | Issue 11/2023

Abstract

Purpose of Review

Remote monitoring (RM) is the standard of care for patients with cardiac implantable electronic devices (CIEDs), particularly pacemakers. However, the long-term outcomes of RM versus conventional monitoring (CM) of pacemakers and its effectiveness in reducing in-office (IO) visits for device reprogramming require elucidation. This systematic review and meta-analysis aimed to compare the RM and CM of pacemakers over a long-term follow-up.

Recent Findings

We systematically searched the PubMed/MEDLINE, Embase, Cochrane, and ClinicalTrials.gov databases for randomized controlled trials (RCTs) comparing RM and CM of pacemakers with at least 12 months of follow-up. Binary endpoints were pooled with risk ratios (RRs), whereas continuous outcomes were computed using mean differences (MDs) or standardized MDs (SMDs). Heterogeneity was assessed using I² statistics. Among the eight included RCTs, 2159 (48.9%) of 4063 patients underwent RM. Follow-up periods ranged from 12 to 24 months. There were no significant between-group differences in all-cause mortality (RR = 1.19; 95% confidence interval [CI], 0.90–1.57; p = 0.22; I² = 0%), stroke (RR = 0.90; 95% CI, 0.43–1.91; p = 0.79; I² = 23%), hospitalizations for cardiovascular and/or device-related adverse events (RR = 0.95; 95% CI, 0.75–1.21; p = 0.70; I² = 0%), and quality of life (SMD = – 0.06; 95% CI, – 0.22 to 0.10; p = 0.473; I² = 0%). RM was associated with fewer IO visits/patient/year (MD = 0.98; 95% CI, – 1.64 to – 0.33; p = 0.08; I² = 98%) and higher rates of atrial tachyarrhythmia (ATA) detection (RR = 1.22; 95% CI, 1.01–1.48; p = 0.04; I² = 0%) than was CM.

Summary

This meta-analysis suggests that RM of pacemakers leads to higher rates of ATA detection and fewer IO visits/patient/year, without compromising patient safety.

Available only for authorised users

• Abraham WT, Gras D, Yu CM, Guzzo L, Gupta MS; FREEDOM Steering Committee. Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: The Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial. Am Heart J. 2010;159:944–48. https://doi.org/10.1016/j.ahj.2010.02.034. The study aims to evaluate the effectiveness of frequent systematic optimization of atrioventricular and interventricular delays in cardiac resynchronization therapy (CRT) in patients.

•• Abraham WT. Disease management: remote monitoring in heart failure patients with implantable defibrillators, resynchronization devices, and haemodynamic monitors. Europace. 2013;15(Suppl 1):i40-6. https://doi.org/10.1093/europace/eut105. Devices like cardiac resynchronization therapy and implantable cardioverter defibrillators improve outcomes and enable remote patient monitoring. These devices require high-intensity remote monitoring for successful parameter deviation detection and therapy direction.CrossRefPubMed

•• Lappegård KT, Moe F. Remote monitoring of CIEDs-For both safety, economy and convenience? Int J Environ Res Public Health. 2021;19:312. https://doi.org/10.3390/ijerph19010312. Recent research highlights the increasing use of remote monitoring systems for cardiac implantable devices, potentially increasing safety, patient satisfaction, and potentially offering economic advantages.CrossRefPubMedPubMedCentral

• Mittal S. Editorial commentary: remote monitoring of cardiac implantable electronic device patients: why is a medical necessity perceived as an unnecessary burden? Trends Cardiovasc Med. 2016;26:578–9. https://doi.org/10.1016/j.tcm.2016.04.003. Remote monitoring of cardiac resynchronization devices (CIEDs) has become increasingly popular due to their clinical value, including early management of arrhythmias, reduced hospitalizations, and increased battery longevity.CrossRefPubMed

• Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabés JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylén I, Tolosana JM. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021;42:3427–520. https://doi.org/10.1093/eurheartj/ehab364. ESC Guidelines develop educational tools and implementation programs, encouraging National Cardiac Societies to endorse, adopt, translate, and implement them to improve disease outcomes through thorough clinical recommendations.CrossRefPubMed

• Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, Shamseer L, Tetzlaff JM, Akl EA, Brennan SE, Chou R, Glanville J, Grimshaw JM, Hróbjartsson A, Lalu MM, Li T, Loder EW, Mayo-Wilson E, McDonald S, McGuinness LA, Stewart LA, Thomas J, Tricco AC, Welch VA, Whiting P, Moher D. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. https://doi.org/10.1136/bmj.n71. The PRISMA 2020 statement, updated to reflect advancements in systematic review methodology, includes a 27-item checklist, expanded abstract checklist, and revised flow diagrams for original and updated reviews.

•• Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editors. Cochrane handbook for systematic reviews of interventions. 2nd ed. Chichester (UK): John Wiley & Sons; 2019. The Cochrane Handbook provides detailed guidance on preparing and maintaining Cochrane systematic reviews on healthcare interventions, covering standard methods, specialized topics, and data collection.

• Higgins JPT, Savović J, Page MJ, Elbers RG, Sterne JA. Assessing risk of bias in a randomized trial. 2nd ed. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane handbook for systematic reviews of interventions. Chichester, UK: John Wiley & Sons; 2019b. pp. 205–228. This chapter discusses version 2 of the Cochrane risk-of-bias tool for randomized trials, which assesses bias in specific trial domains using signaling questions. The tool’s overall risk of bias is the least favorable assessment.

•• Watanabe E, Yamazaki F, Goto T, Asai T, Yamamoto T, Hirooka K, Sato T, Kasai A, Ueda M, Yamakawa T, Ueda Y, Yamamoto K, Tokunaga T, Sugai Y, Tanaka K, Hiramatsu S, Arakawa T, Schrader J, Varma N, Ando K. Remote management of pacemaker patients with biennial in-clinic evaluation: continuous home monitoring in the Japanese at-home study: a randomized clinical trial. Circ Arrhythm Electrophysiol. 2020;13:e007734. https://doi.org/10.1161/CIRCEP.119.007734. A study in Japan found that replacing in-office follow-ups with remote follow-ups for two years in pacemaker patients did not increase the occurrence of major cardiovascular events and reduced resource consumption.

10.

•• Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, Binet D, Daubert JC; COMPAS Trial Investigators. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J. 2012;33:1105–11. https://doi.org/10.1093/eurheartj/ehr419. The COMPAS randomized trial found that long-term remote monitoring of pacemakers significantly reduced the number of ambulatory visits and major adverse events in patients. The study found that remote monitoring was a safe alternative to conventional care, reducing hospitalizations and ambulatory visits.

11.

•• García-Fernández FJ, Osca Asensi J, Romero R, Fernández Lozano I, Larrazabal JM, Martínez Ferrer J, Ortiz R, Pombo M, Tornés FJ, Moradi Kolbolandi M. Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE). Eur Heart J. 2019;40:1837–46. https://doi.org/10.1093/eurheartj/ehz067. The RM-ALONE trial evaluated the safety and efficiency of a simplified protocol for monitoring cardiac implantable devices using remote monitoring. The study found that the protocol reduced hospital visits and staff workload, with a 79.2% reduction in in-office evaluations compared to the Home Monitoring group.CrossRefPubMedPubMedCentral

12.

•• Catalan-Matamoros D, Lopez-Villegas A, Tore-Lappegard K, Lopez-Liria R. Patients’ experiences of remote communication after pacemaker implant: The NORDLAND study. PloS One. 2019;14:e0218521. https://doi.org/10.1371/journal.pone.0218521. The study analyzed the experiences of patients with telemonitoring pacemakers six months after their implant. Results showed positive experiences, but telemonitoring patients received less information about their diagnosis. Improving the quality and timing of information is necessary for future remote communication healthcare services for people with pacemaker implants.

13.

•• Perl S, Stiegler P, Rotman B, Prenner G, Lercher P, Anelli-Monti M, Sereinigg M, Riegelnik V, Kvas E, Kos C, Heinzel FR, Tscheliessnigg KH, Pieske B. Socio-economic effects and cost saving potential of remote patient monitoring (SAVE-HM trial). Int J Cardiol. 2013;169:402–7. https://doi.org/10.1016/j.ijcard.2013.10.019. The SAVE-trial evaluated the safety, reliability, and improvements of using the BIOTRONIK Home Monitoring®-System in pacemaker and implanted cardioverter defibrillator patients. Results showed a significant reduction in outpatient clinic follow-ups, lower costs, and better detection of clinically necessary unscheduled visits, indicating its safety.CrossRefPubMed

14.

• Crossley GH, Chen J, Choucair W, Cohen TJ, Gohn DC, Johnson WB, Kennedy EE, Mongeon LR, Serwer GA, Qiao H, Wilkoff BL; PREFER Study Investigators. Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers. J Am Coll Cardiol. 2009;54:2012–9. https://doi.org/10.1016/j.jacc.2009.10.001. The study compared remote pacemaker interrogation for earlier diagnosis of clinically actionable events compared to traditional transtelephonic monitoring and in-person evaluation. Results showed that remote interrogation detected actionable events more quickly and frequently than transtelephonic recordings, with the use of transtelephonic strips being of little value.

15.

•• Amara W, Montagnier C, Cheggour S, Boursier M, Gully C, Barnay C, Georger F, Deplagne A, Fromentin S, Mlotek M, Lazarus A, Taïeb J; SETAM Investigators. Early detection and treatment of atrial arrhythmias alleviates the arrhythmic burden in paced patients: The SETAM Study. Pacing Clin Electrophysiol. 2017;40:527–36. https://doi.org/10.1111/pace.13062. A study comparing remote monitoring (RM) and conventional follow-up for atrial tachyarrhythmias (ATAs) found that RM patients were diagnosed and treated earlier, leading to a lower ATA burden. The study enrolled 595 patients with sinus rhythm and a CHA2DS2-VASc score of ≥2.

16.

•• Lima C, Martinelli M, Peixoto GL, Siqueira SF, Wajngarten M, Silva RT, Costa R, Filho R, Ramires JA. Silent atrial fibrillation in elderly pacemaker users: a randomized trial using home monitoring. Ann Noninvasive Electrocardiol. 2016;21:246–55. https://doi.org/10.1111/anec.12294. The study evaluated the incidence of silent atrial fibrillation (AF) in elderly patients with a pacemaker with remote monitoring. Results showed that AF episodes were detected in 21.6% of patients, with left atrial diameter and diastolic dysfunction being predictors. Continuous remote monitoring helps detect AF recurrence early.CrossRefPubMed

17.

•• Varma N, Epstein AE, 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;122:325–32. https://doi.org/10.1161/CIRCULATIONAHA.110.937409. The Lumos-T trial tested the safety and effectiveness of remote home monitoring with automatic daily surveillance (HM) for implantable cardioverter-defibrillator follow-up. Results showed HM reduced total in-hospital device evaluations by 45% without affecting morbidity, and provided sufficient assessment in the majority of follow-ups. HM allows faster detection of actionable events compared to conventional monitoring.

18.

•• Bautista-Mesa RJ, Lopez-Villegas A, Peiro S, Catalan-Matamoros D, Robles-Musso E, Lopez-Liria R, Leal-Costa C. Long-term cost-utility analysis of remote monitoring of older patients with pacemakers: The PONIENTE study. BMC Geriatr. 2020;20:474. https://doi.org/10.1186/s12877-020-01883-3. This study compared remote monitoring (RM) and conventional monitoring (CM) in older patients with pacemakers in the hospital. After five years, total costs were lower in the RM group by 23.02%, with patients’ perspective saving more. The incremental cost-effectiveness ratio of CM became positive.CrossRefPubMedPubMedCentral

19.

• Jang JP, Lin HT, Chen YJ, Hsieh MH, Huang YC. Role of remote monitoring in detection of atrial arrhythmia, stroke reduction, and use of anticoagulation therapy - a systematic review and meta-analysis. Circ J. 2020;84:1922–30. https://doi.org/10.1253/circj.CJ-20-0633. A systematic review and meta-analysis found that remote monitoring (RM) is effective in detecting atrial arrhythmia, reducing stroke risk, and guiding anticoagulation therapy in patients with wearable cardiac devices, and in reducing stroke risk in those with CIED.CrossRefPubMed

20.

• Crossley G, Boyle A, Vitense H, Sherfesee L, Mead RH. Trial design of the clinical evaluation of remote notification to reduce time to clinical decision: The Clinical evaluation Of remote NotificatioN to rEduCe Time to clinical decision (CONNECT) study. Am Heart J. 2008;156:840–6. https://doi.org/10.1016/j.ahj.2008.06.028. The CONNECT study found that wireless remote monitoring with automatic clinician alerts significantly reduced the time from clinical event to clinical decision in patients with arrhythmias, cardiovascular disease progression, and device issues compared to standard in-office care. This also reduced the mean length of stay per CV hospitalization visit.CrossRefPubMed

21.

• Boriani G, Da Costa A, Quesada A, Ricci RP, Favale S, Boscolo G, Clementy N, Amori V, Mangoni di S Stefano L, Burri H, MORE-CARE Study Investigators. Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial. Eur J Heart Fail. 2017;19:416–25. https://doi.org/10.1002/ejhf.626. The MORE-CARE trial evaluated the clinical efficacy and safety of remote monitoring in heart failure patients implanted with a biventricular defibrillator. Results showed no significant difference in mortality or risk of CV or device-related hospitalization, but a 38% reduction in healthcare resource utilization was observed due to reduced in-office visits.

22.

• Okabe T, Afzal MR, Hummel JD, Daoud EG, Houmsse M, Kalbfleisch SJ, Augostini RS. First clinical use of real-time remote programming in cardiac implantable electronic devices. J Cardiovasc Electrophysiol. 2020;31:2759–61. https://doi.org/10.1111/jce.14698. The report discusses the commercial application of RemoteControl technology for real-time remote testing and programming of cardiac implantable electronic devices, minimizing COVID-19 infection exposure and potential applications.CrossRefPubMed

23.

• Parthiban N, Esterman A, Mahajan R, Twomey DJ, Pathak RK, Lau DH, Roberts-Thomson KC, Young GD, Sanders P, Ganesan AN. Remote monitoring of implantable cardioverter-defibrillators: a systematic review and meta-analysis of clinical outcomes. J Am Coll Cardiol. 2015;65:2591–600. https://doi.org/10.1016/j.jacc.2015.04.029. This study compared remote monitoring (RM) of implantable cardioverter-defibrillators (ICD) with in-office follow-up. Results showed RM had comparable clinical outcomes to office follow-up, but a reduction in all-cause mortality was observed in RM trials with daily transmission verification. RM benefits include faster clinical event detection and reduced inappropriate shocks.CrossRefPubMed

24.

• Chen Y, Huang QF, Sheng CS, Zhang W, Shao S, Wang D, Cheng YB, Wang Y, Guo QH, Zhang DY, Li Y, Lowres N, Freedman B, Wang JG. Detection rate and treatment gap for atrial fibrillation identified through screening in community health centers in China (AF-CATCH): a prospective multicenter study. PLoS Med. 2020;17:e1003146. https://doi.org/10.1371/journal.pmed.1003146. Despite disease education and specialist referral, only a small proportion of patients attended specialist clinics for OAC (oral anticoagulant) treatment. The study suggests that increasing appropriate OAC therapy in known AF is necessary to prevent AF-related stroke and to close the gap in AF detection and treatment in China.

25.

• Kolk MZH, Narayan SM, Clopton P, Wilde AAM, Knops RE, Tjong FVY. Reduction in long-term mortality using remote device monitoring in a large real-world population of patients with implantable defibrillators. Europace. 2023;25:969–77. https://doi.org/10.1093/europace/euac280. A study assessing the long-term effect of remote monitoring (RM) on implantable cardioverter-defibrillators (ICDs) found that it reduced all-cause and cardiac mortality in a real-world ICD population. Remote monitoring was associated with higher risk of appropriate ICD-therapy.

26.

•• Varma N, Braunschweig F, Burri H, Hindricks G, Linz D, Michowitz Y, Ricci RP, Nielsen JC. Remote monitoring of cardiac implantable electronic devices and disease management. Europace. 2023 Aug 2;25(9):euad233. https://doi.org/10.1093/europace/euad233. Remote monitoring of cardiac implantable devices has evolved from curiosity to standard of care, providing clinically actionable information and extending patient management from device to disease management.

27.

•• Sterne JAC, Sutton AJ, Ioannidis JPA, Terrin N, Jones DR, Lau J, Carpenter J, Rücker G, Harbord RM, Schmid CH, Tetzlaff J, Deeks JJ, Peters J, Macaskill P, Schwarzer G, Duval S, Altman DG, Moher D, Higgins JP. Recommendations for examining and interpreting funnel plot asymmetry in meta-analyses of randomised controlled trials. BMJ. 2011;343:d4002. https://doi.org/10.1136/bmj.d4002. Funnel plots and tests for asymmetry are used to examine meta-analysis bias, but should not be confused with publication bias, and their interpretation and testing recommendations are provided..CrossRefPubMed

Title: Long-Term Remote vs. Conventional Monitoring of Pacemakers: Systematic Review and Meta-Analysis of Randomized Controlled Trials
Authors: Antônio Silva Menezes Junior
André Rivera
Isabele Ayumi Miyawaki
Douglas Mesadri Gewehr
Bárbara Nascimento
Publication date: 26-09-2023
Publisher: Springer US
Keywords: Pacemaker
Pacemaker
Pacemaker
Published in: Current Cardiology Reports / Issue 11/2023
Print ISSN: 1523-3782
Electronic ISSN: 1534-3170
DOI: https://doi.org/10.1007/s11886-023-01963-x

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Heart Failure Video

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.

Watch now

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Long-Term Remote vs. Conventional Monitoring of Pacemakers: Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract

Purpose of Review

Recent Findings

Summary

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose of Review

Recent Findings

Summary

Please log in to get access to this content

Other articles of this Issue 11/2023

Index-Guided High-Power Radiofrequency Catheter Ablation for Atrial Fibrillation: A Systematic Review and Meta-Analysis Study

Obesity, Cardiorespiratory Fitness, and Cardiovascular Disease

Advances in Screening for Radiation-Associated Cardiotoxicity in Cancer Patients

TAVR in TAVR: Where Are We in 2023 for Management of Failed TAVR Valves?

Genetic Engineering of Donor Pig for the First Human Cardiac Xenotransplantation: Combatting Rejection, Coagulopathy, Inflammation, and Excessive Growth

Novel Approaches to the Failing Congenital Heart

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page