Wireless Remote Monitoring: The New Standard of Care

Introduction

Wireless remote monitoring (RM) has fundamentally changed the paradigm of how physicians and allied professionals manage patients with cardiovascular implantable electronic devices (CIEDs). Multiple randomized clinical trials, as well as analysis of large registry data sets, provide a wealth of data demonstrating the superiority of strategies that incorporate wireless RM. Benefits include reduced frequency of routine office visits, early detection of significant abnormal findings such as device malfunction or actionable arrhythmias, reduction in both appropriate and inappropriate shocks, extended battery longevity, early detection of atrial fibrillation, and even an association with a reduction in all-cause mortality. Despite the overwhelming evidence, adoption of RM across the United States has been variable, with some practices embracing the technology more rapidly than others. This brief review will summarize the evidence supporting the advantages of a strategy that includes wireless remote monitoring, including recommendations on how to incorporate the technology into clinical practice, and key recommendations from the 2015 HRS Expert Consensus Statement on Remote Interrogation and Monitoring for CIEDs.¹ 

Technology

Wireless remote monitoring transceivers now include wireless data transmission capability, eliminating the need for patients to connect to home phone lines or cable modems. This dramatically simplifies the home setup for patients, removing what was previously a significant barrier. This also makes it easier for clinics to implement RM technology for all of their patients, regardless of the device brand. 

Evidence Supporting Benefits of Remote Monitoring

The evidence supporting the benefits of wireless remote monitoring can be divided into the following categories:

• Safety: Randomized controlled trials have compared the safety and effectiveness of a strategy that incorporates remote monitoring to reduce the frequency of in-person office evaluations vs the routine paradigm of quarterly or bi-annual office interrogations for patients with pacemakers and ICDs. These studies have demonstrated that RM is safe and effective, and can be used to significantly reduce the number of routine scheduled in-office visits.^2,3
• Early event detection: RM provides the benefit of early detection of significant arrhythmias.^3,4
  • Fewer shocks and increased battery longevity: The ECOST trial demonstrated that RM permits identification of non-sustained arrhythmias, which permits intervention to avoid both appropriate as well as inappropriate shocks, unnecessary capacitor charging, and thereby reduces both the number of shocks and increases battery longevity.⁵ The investigators observed a 52% reduction in inappropriate shocks, and a 72% reduction in hospitalizations for inappropriate shocks. 
  • Atrial fibrillation: RM permits the accurate detection of paroxysmal atrial fibrillation with unprecedented sensitivity and accuracy.⁶ This enables physicians to consider management strategies following HRS/ACC/AHA guidelines, including:⁷
    • Rate control vs rhythm control.
    • Rhythm control strategies (antiarrhythmic drug therapy, catheter ablation).
    • Thromboembolic prophylaxis.
    • Avoidance of inappropriate shocks.
• Mortality benefit: Three studies have demonstrated an association between all-cause mortality and use of RM. The ALTITUDE mega-cohort study of patients who received an ICD or CRT-D and were monitored in Boston Scientific’s LATITUDE RM network was the first observational registry to associate RM with a reduction in all-cause mortality.⁸ IN-TIME was a randomized controlled trial of patients with chronic systolic heart failure who received either a dual-chamber ICD or CRT-D.⁹ Patients were randomly assigned to receive standard follow-up with vs without RM. The study endpoint was a composite of all-cause mortality, hospitalization for congestive heart failure, change in New York Heart Association functional class, and change in patient self-assessment. At one year, 18.9% of patients with RM vs 27.2% of controls reached the primary outcome (P = .013), with 10 vs 27 deaths in the respective study groups. Observational data from a large cohort of patients in St. Jude Medical’s Merlin.net Patient Care Network examined survival among patients with all types of CIEDs (pacemakers, ICDs, CRT-Ds, and CRT-Ps), and found not only improved survival for all patient groups, but also that the degree of benefit corresponded with the degree of adherence to RM.¹⁰

​​New Paradigm of CIED Monitoring

The advances of wireless remote monitoring technology in combination with the evidence supporting its benefits require that we reevaluate the relative value of routine in-person device interrogations. Office visits are time- and resource-intensive for patients. For many patients, an office visit requires time off from work or the assistance of others to provide care for dependent individuals at home. At a minimum, patients must dedicate the time and resources to travel to and from the office as well as commit the time to wait to be seen, checked in, evaluated, and then scheduled for the following visit. The vast majority of visits are routine, with no actionable events detected (e.g., battery depletion, significant arrhythmia, or device malfunction). Remote monitoring yields the same data available at in-person visits and has the significant advantages of providing alerts within hours of an actionable event.

Based on these facts, the writing committee of the HRS Expert Consensus Statement recommended unequivocally that an event-based paradigm for managing patients with CIEDs be implemented, with annual routine scheduled in-person visits.¹ Additional in-person visits should be scheduled as guided by the results of wireless remote monitoring.

Successful implementation of this event-based paradigm of RM depends upon 3 components:

1. Patient education.
2. Prompt initiation of RM at the time of CIED implant hospital discharge. 
3. The device clinic must be restructured to accommodate the workflow of RM with predominantly event-driven (not routine) in-person office visits. 

Patient Education

The concept of RM should be discussed with the patient as part of the CIED pre-implant informed consent. When appropriately educated about the technology, patient acceptance is near universal. Topics discussed with the patients and caregivers should include the following:

Some facilities utilize an informed consent at the time of patient enrollment to document that the patient has received and understands the essential components of the RM process.¹¹ While such a formal acknowledgement may not be considered necessary by most device clinics, the writing committee does recommend that the health care provider (physician or allied professional) responsible for educating the patient document in the medical record that the exchange took place, and that the patient expressed understanding and agreement to participate in the RM service. 

Initiation of Remote Monitoring

When feasible, RM should be initiated at the time of CIED implant and should have the transceiver by the time of discharge (Figure 1). At the post-operative wound check appointment, patients can be informed if the device is transmitting appropriately or if troubleshooting is necessary. This immediate feedback following CIED implant gives the patient confidence in the process and reinforces the essential role that RM will serve during the life cycle of their CIED. 

Device Clinic Organization

Remote monitoring requires that staff be assigned to downloading the RM transmissions and requires there to be a process for review, triage, and intervention when action is needed. One scheme used in the HomeGuide Registry is outlined in Figure 2.⁶ Device clinics that are organized around a RM paradigm, with predominantly event-driven in-person office visits, are able to devote additional time to patients with abnormal device function or with significant arrhythmias. Of course, all CIED clinics must accommodate a wide range of legacy devices, many of which do not have wireless RM capability. As these older devices reach end of service, it will be easier for device clinics to streamline organization around the wireless RM paradigm.  

Consensus Statement Key Recommendations:

•  A strategy of remote CIED monitoring, combined with at least one in-office evaluation per year, is recommended over a calendar-based schedule of in-person CIED evaluation alone (when technically feasible).
• All patients should be offered RM as the standard of care for patients with a CIED.
• RM should be implemented at the time of CIED implant, if possible.
• Patients should be educated about the nature of RM, including expectations and responsibilities.

Conclusions

Wireless RM of CIEDs represents the beginning of a fundamental change in how patients and health care providers will collaborate in the future. Sensors that silently monitor physiological data will provide warning to health care providers, enabling intervention at earlier points in the disease process and thereby reducing morbidity and mortality, as has been demonstrated for CIED remote monitoring. As technology and scientific evidence advances, it will be the responsibility of health care providers to implement these new and disruptive treatment paradigms into clinical practice. 

Disclosure: The author has no conflicts of interest to report regarding the content herein.   

References

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