Last updated May 22, 2023

Practical Management of the Remote Device Clinic

General Concepts

RM considerations

In patients with CIEDs, RM is recommended as part of the standard of care. (I, A)
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In patients with CIEDs on RM, routine surveillance of lead function and battery status is recommended to ensure device integrity (I, B-R)
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In patients with CIEDs on RM with a device capable of continuous connectivity, connectivity should be maintained. (I, C-EO)
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RM payment/reimbursement models

For the care of patients with CIEDs on RM, it is recommended that health care payers adopt adequate reimbursement for RM that is tailored to regional health system care patterns and facilitates sustainable and cost-effective CIED follow-up care. (I, B-NR)
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Administrative and Nonclinical Staff

Patient enrollment techniques

In patients with an ILR, enrollment in an RM program is recommended prior to discharge given the daily availability of diagnostic data. (I, C-EO)
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In patients with a CIED, it can be beneficial to initiate RM prior to discharge or within 2 weeks of CIED implantation. (IIa, B-NR)
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Managing and updating manufacturer websites

For the care of patients with CIEDs on RM who undergo device change or upgrade, have a change in vital status, or request clinic transfer, it is recommended that there is a process to update patient information on the manufacturer web-based platform in a timely manner to avoid gaps in RM. (I, C-EO)
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Techniques to optimize patient connectivity

For the care of patients with CIEDs on RM who lose connectivity, it is recommended that clinics have an established process that includes dedicated clinic staff to facilitate reconnection. (I, C-EO)
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Staffing of Remote Monitoring Clinics

Staffing requirements for RM

For the care of patients with CIEDs on RM, a team-based organizational model with formal policies, procedures, and clear definitions of the roles and responsibilities of qualified staff is recommended to optimize all related RM tasks. (I, B-NR)
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For the care of patients with CIEDs on RM, it is recommended that there is adequate dedicated time to perform all RM tasks, including scheduled and nonscheduled transmissions, patient follow-up, and administrative tasks. (I, B-NR)
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For the care of patients with CIEDs on RM, it is recommended that the staff-to-patient ratios in RM clinics reflect the increasing unscheduled transmission workload. (I, B-NR)
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For the care of patients with CIEDs on RM, it is reasonable for clinics to have a minimum of 3.0 full-time equivalents per 1000 patients on RM, comprising both clinical and administrative staff. (IIa, C-LD)
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Staff credentialing and qualifications for RM

For the care of patients with CIEDs on RM, it is recommended that clinical providers who independently prescribe, interpret, and document RM possess appropriate education and/or certification. (I, C-EO)
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For the care of patients with CIEDs on RM, it is recommended that clinics regularly conduct quality improvement reviews to support current evidence-based standards. (I, C-EO)
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Technical Considerations in Remote Monitoring

Devices with noncontinuous RM

In patients with CIEDs on RM in the absence of continuous connectivity, remote transmissions are recommended at least every 3–12 months for PMs and every 3–6 months for ICDs. (I, C-EO)
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In patients with CIEDs on RM in the absence of continuous connectivity, as the device approaches elective replacement, the frequency of remote transmissions should be increased to every 1–3 months. (I, C-EO)
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Site-based RM

For patients with CIEDs in centers without onsite device interrogation capability, it is reasonable to use site-based remote interrogation technology to facilitate access to care. (IIa, C-EO)
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For patients with CIEDs in centers with onsite device interrogation capability, it is reasonable to use site-based remote interrogation technology to provide expedited care. (IIa, C-EO)
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Alert-based Remote Monitoring

Alert-based RM

In patients with CIEDs and a component with a safety advisory, it is recommended that continuous connectivity be added to scheduled remote or in-person interrogation to enable early detection of actionable events. (I, B-R)
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In patients with pacemakers (PMs) on RM with consistent and continuous connectivity, and in the absence of recent alerts or other cardiac comorbidity, it is reasonable to schedule in-person visits every 24 months. (IIa, B-R)
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In patients with ICDs on RM with consistent and continuous connectivity, and in the absence of recent alerts or other cardiac comorbidity, it is reasonable to schedule in-person visits every 24 months. (IIa, B-R)
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Programming Considerations for Optimal Remote Monitoring

Manufacturer and device-specific knowledge

For the care of patients with CIEDs on RM, it is recommended that clinic staff are knowledgeable about the specific differences between, and within, manufacturers’ devices and their RM platforms to optimize patient care. (I, C-EO)
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Programming for clinical indications with different types of CIEDs

In patients with CIEDs on RM, it is recommended that alert parameters be customized to clinical indications. (I, B-R)
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In patients with ICDs on RM, it is recommended that the ICD be programmed to alert the clinic for all ventricular shock therapies. (I, C-LD)
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In patients with CIEDs on RM, it is reasonable to remotely monitor HF diagnostics to detect incident HF and/or progression. (IIa, B-R)
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In patients with CIEDs on RM with CRT, it is reasonable that the CIED be programmed to alert the clinic when there is a low percentage of biventricular pacing. (IIa, C-LD)
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In patients with CIEDs on RM with atrial arrhythmia monitoring capabilities, it is reasonable that the CIED be programmed to alert the clinic of the first episode, a prolonged episode, or a high burden of atrial arrhythmia. (IIa, C-LD)
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In patients with ICDs on RM, it is reasonable that the CIED be programmed to alert the clinic for all ventricular anti-tachycardia pacing therapies. (IIa, C-LD)
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For the care of patients with CIEDs on RM, it is reasonable that the CIED be programmed to alert the clinic for excessive percentage of RV pacing. (IIa, C-EO)
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Special programming considerations for ILRs

In patients with ILRs on RM, it is recommended that clinic staff confirm an actionable event transmission by reviewing the electrograms to exclude misdiagnoses. (I, B-NR)
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In patients with ILRs on RM, it is recommended that programmed alerts be tailored to the clinical indication. (I, B-NR)
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In patients with ILRs on RM and frequent undersensing and/or oversensing, reprogramming is recommended. (I, B-NR)
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In patients with ILRs on RM for unexplained syncope, it is recommended to emphasize to the patient the need to perform a symptom marking or manual transmission immediately following syncope to obtain a symptom-rhythm correlation. (I, B-NR)
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In patients with ILRs on RM for cryptogenic stroke, it is reasonable to adjust the sensitivity to improve detection of atrial fibrillation (AF). (IIa, B-NR)
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In patients with ILRs on RM with consistent connectivity, in-office visits are not indicated for routine patient care. (III - No Benefit, C-EO)
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Managing Alerts

Defining high-priority alerts

In patients with CIEDs on RM, it is recommended that for concerns related to critical device or lead function, high-priority alerts be programmed to promptly notify the clinic. (I, B-R)
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Programming considerations to minimize inappropriate alerts

In patients with CIEDs on RM from whom sufficient clinical data have been received, it is recommended that alert parameters be reprogrammed to avoid nonactionable alerts. (I, C-EO)
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For the care of patients with CIEDs on RM, it is reasonable for clinics to review and react to high-priority alerts within 1 business day. (IIa, C-EO)
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Timeline recommendations for alert management

For the care of patients with CIEDs on RM, it is recommended that patients and their caregivers be informed that automatic alerts transmitted by RM do not substitute for an emergency management system. (I, C-EO)
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Remote Monitoring Reporting

Communication of the RM report to patients

For the care of patients with CIEDs on RM, it is reasonable for the results of all remote device transmissions to be shared with patients, based on patient preferences for content and mode of communication, and clinic workflows. (IIa, C-EO)
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Techniques for incorporating reports into EHRs

For patients with CIEDs on RM, it is recommended that patient health information privacy be maintained when incorporating reports into EHRs. (I, C-EO)
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For the care of patients with CIEDs on RM, it can be beneficial to use universally accepted data element definitions and exchange formats when incorporating reports into EHRs. (IIa, C-EO)
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For the care of patients with CIEDs on RM, it may be beneficial to use patient management software to incorporate reports into EHRs. (IIb, C-LD)
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Patient Education for Remote Monitoring

Patient education for participation and compliance

In patients with CIEDs on RM, patient education should be delivered in plain language, at a basic reading level, and be individualized to support patient communication preferences and educational needs throughout the continuum of care. (I, C-LD)
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In patients with CIEDs on RM, comprehensive patient education about RM is recommended for patients, families, and caregivers prior to device implantation to guide shared decision-making regarding device selection. (I, C-EO)
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In patients with CIEDs on RM, it is recommended that patient education start before implant and include the importance of ensuring ongoing connectivity to improve post-implant patient compliance and monitoring effectiveness. (I, C-EO)
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In patients with CIEDs on RM, providing a hands-on education session with the RM device can be beneficial. (IIa, C-LD)
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Patient education of clinic-specific policies

In patients with CIEDs on RM, it is reasonable to communicate clinic-specific policies associated with RM to the patient. (IIa, C-EO)
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Manufacturer Responsibilities With Remote Monitoring

Manufacturers’ role to optimize individual patient care

For the care of patients with CIEDs on RM, manufacturers should provide clinic staff with adequate training, education, and technical support to optimize individual patient connectivity. (I, C-EO)
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In patients with CIEDs on RM, the manufacturer should provide an RM system that is reliable, safe, accurate, and meets the needs of the patient. (I, C-EO)
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For the care of patients with CIEDs on RM, manufacturers should include key stakeholders in the design and development of technologies for RM. (I, C-EO)
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For the care of patients with CIEDs on RM, manufacturers should provide prompt notification of disconnection to the clinic, and to the patient to restore connectivity. (I, C-EO)
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Manufacturers’ role in the management of patient safety advisories via RM

For the care of patients with CIEDs on RM, manufacturers should contact the managing clinics with details of a safety advisory and assist in identifying affected patients both immediately and on a regular basis. (I, C-EO)
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For the care of patients with CIEDs with an advisory and on RM, manufacturers should provide guidance to clinics on optimal alert settings to manage the safety advisory. (I, C-EO)
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Support surrounding implantation from manufacturers

For patients undergoing CIED implantation, it is recommended that manufacturers provide adequate resources, including personnel as appropriate, to ensure enrollment and connectivity to RM platforms before discharge or within 2 weeks of implantation. (I, C-EO)
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Third-party Resources for Remote Monitoring

Use of third-party resources in RM

For the care of patients with CIEDs on RM, it is reasonable to use third-party resources to alleviate RM workload for staff. (IIa, C-EO)
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For the care of patients with CIEDs on RM, it is reasonable to inform patients about the use of third-party resources to facilitate patient care. (IIa, C-EO)
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Geographic Differences With Remote Monitoring Practices

Availability of RM

For the care of patients with CIEDs, health systems should identify local barriers, and develop strategies to optimize the successful use of RM globally. (I, C-EO)
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Recommendation Grading

Disclaimer

The information in this patient summary should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health.

Overview

Title

Practical Management of the Remote Device Clinic

Authoring Organization

Publication Month/Year

May 19, 2023

Document Type

Consensus

Country of Publication

US

Target Patient Population

Patients with cardiovascular implantable electronic device

Inclusion Criteria

Male, Female, Adolescent, Adult, Child, Older adult

Health Care Settings

Ambulatory, Outpatient

Intended Users

Nurse, nurse practitioner, physician, physician assistant

Scope

Management

Diseases/Conditions (MeSH)

D001281 - Atrial Fibrillation, D013610 - Tachycardia, D006333 - Heart Failure, D017147 - Defibrillators, Implantable, D017180 - Tachycardia, Ventricular, D010138 - Pacemaker, Artificial, D014693 - Ventricular Fibrillation, D058998 - Remote Sensing Technology

Keywords

atrial fibrillation, heart failure, cardiac resynchronization therapy, implantable cardioverter-defibrillator, ventricular fibrillation, ventricular tachycardia, cardiovascular implantable electronic device (CIED), defibrillator, pacemaker, atrial tachycardia (AT), remote device clinic, implantable loop recorder, ILR, artificial intelligence, anti-tachycardia pacing, elective replacement indicator, implantable pulse generator, non-sustained ventricular tachycardia, remote monitoring

Source Citation

Ferrick AM, Raj SR, Deneke T, Kojodjojo P, Lopez-Cabanillas N, Abe H, Boveda S, Chew DS, Choi J-I, Dagres N, Dalal AS, Dechert BE, Frazier-Mills CG, Gilbert O, Han JK, Hewit S, Kneeland C, Mirza SD, Mittal S, Ricci RP, Runte M, Sinclair S, Alkmim-Teixeira R, Vandenberk B, Varma N, 2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic. Heart Rhythm 2023. This guideline has been copublished in EP Europace, Journal of Arrhythmia, and Journal of Interventional Cardiac Electrophysiology.