Cardiac implantable electronic devices (CIEDs) with wireless technology include pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization devices, and implantable loop recorders. These devices store clinically valuable data with regard to system integrity, arrhythmias, and more recently, heart failure parameters.
Wireless technology has provided the means to access this data in a timely fashion. Remote monitoring (RM) employing wireless technology provides near continuous monitoring and is largely independent of patient involvement. The devices transmit data on a daily to 3-week basis. Pre-specified alerts can be transmitted from the device to a bedside transmitter, which relays the data to an Internet portal to be viewed anywhere in the world where the provider has web access. It is important to distinguish RM from remote device interrogation, which employs inductive technology to substitute for an in-person evaluation. Remote device interrogation requires that the patient participate in downloading the data and does not provide continuous monitoring.
Remote monitoring has not only been demonstrated to be valuable in the early management of arrhythmias (including VT, VF, and atrial fibrillation),1 but also in reducing hospitalizations, strokes related to atrial arrhythmias,2 inappropriate shocks, and increasing battery longevity.3 Mega-cohort nonrandomized trials have demonstrated that RM is associated with a reduction in mortality.4 Furthermore, there also appears to be a dose effect. The frequency with which RM is employed is correlated with its mortality benefit in patients with ICDs and pacemakers.5 The clinical rationale for instituting RM led to the HRS Consensus Statement in 2015, which provides a Class 1A recommendation that all patients with CIEDs be offered RM as part of the standard follow-up management strategy.6
Remote monitoring has changed the paradigm for CIED management. Scheduled office visits now recognized as “well baby visits” are being replaced by RM and alert-driven “sick” visits. This strategy is in line with the ongoing healthcare reforms that aim to reduce healthcare services while maintaining quality care. This paradigm has been advocated as a way to significantly reduce time spent in device clinics while improving patient care. CMS has created a defined policy that permits monthly reimbursement for the monitoring of implantable cardiac monitors and quarterly reimbursement for monitoring of pacemakers, defibrillators, and CRT devices. (Table 1)
Despite all these rationales for instituting RM, the reality is that significant numbers of patients either do not receive devices with wireless capability or are not enrolled in RM, even after undergoing implantation of a CIED with this technology.
What are the Barriers to Incorporating RM Into Clinical Practice? (Table 2)
Acceptance. Device implantation is a psychologically traumatic event. Patients have to come to terms with their illness and the change in their body image. Patients need support, and look to the in-person visit as an opportunity to ask questions and obtain reassurance. Patients may perceive RM as impersonal and feel abandoned in their time of need. Education is of paramount importance in achieving acceptance of a remote monitoring strategy.7
Technological Savvy and Language. The patient population receiving CIEDs is generally older and frequently lacking in technological savvy. These patients, as well as those with a language barrier, commonly feel overwhelmed by the technology. They are incapable of following instructions in manuals, and balk at setting up transmitters. The introduction of “plug and play” cellular transmitters has largely eliminated this issue.
Cost. This is an issue for patients whose insurance does not cover the entire recurring bill. High-deductible insurance plans have made patients acutely aware of this issue. In these instances, patients need to be convinced that the benefit of RM is worth the expense. Healthcare professionals need to strive to make the RM strategy cost neutral for the patient by reducing in-person office visits.
Infrastructure: Managing the “Virtual Patient.”8 The most important barrier to the successful adoption of RM in the real world is the failure to appreciate that implementing RM into a practice is much more than simply implanting a CIED with wireless technology and instructing an allied health professional (AHP) to look at the web portal. The infrastructure inherent in clinical trials with research coordinators needs to be replicated in the practice setting to achieve successful RM.
With conventional in-person office visits, patients interact with the front desk staff, see a physician or an AHP who documents the findings in the EHR, and are billed and rescheduled at the conclusion of the visit. Once patients receive a CIED and have RM rather than in-person office visits, they become a “virtual patient” residing on the cloud. Their CIEDs send data to the Internet at a minimum of every 3 months or potentially every day. The practice needs to assume responsibility for a continuous data stream arriving at different Internet portals, create appropriate documentation for reimbursement, and schedule future device downloads. The practice needs to recognize the complexity of this issue, and invest in clerical resources to replicate the office infrastructure that is required for in-person office visits including schedulers, billers, and clinical staff. The successful implementation of RM hinges on addressing all aspects of the workflow and involves the patient, physician, device representative, AHP, and clerical office staff. (Figure 1)
Maintenance of Compliance. Failure of a patient to maintain connectivity to their modem is akin to “no shows” in the office. Continued connectivity cannot be taken for granted. The Internet portals need to be monitored to determine whether a patient is connected. Different device companies’ Internet portals provide a variety of alerts that a patient’s CIED is not connected. A clerical staff member needs to continually follow-up on patients who are not transmitting. There are various reasons why a patient may not transmit, including simply not plugging the transmitter into the wall socket, unplugging the transmitter, traveling without the device, loss of phone service, lack of cellular service, etc. Resolving these issues can be time consuming.
Financial Viability and Appropriate Staffing. The financial viability of providing RM is a barrier to incorporating these services in clinical practice. Reimbursement for RM requires documentation in the medical record of a full remote interrogation every 91 days, underscoring the need for continued connectivity. Simply reviewing and dismissing a download on the Internet portal does not suffice.
The allocation of the clerical workload of RM to nurse practitioners is not commensurate with their pay grade. On the other hand, training and maintaining redundant clerical staff to monitor web portals that schedule patients and maintain compliance is time consuming and cost prohibitive. Appropriate staffing is essential if remote monitoring is to be fiscally sound.
Clerical staff and EKG technicians that become facile with RM technology are in high demand and difficult to retain. Finding and securing technicians with these skills is one of the many barriers to remote monitoring. Practices will frequently need to train these technicians in-house and will find it hard to keep them employed once they are trained, as their new skill set will open doors to other jobs. These clinical staff members are commonly recruited by industry to higher paying jobs, leaving the clinical practice to reinvest in retraining new staff members. Outsourcing these tasks to a RM service (e.g., ScottCare’s Ambucor) is a potential financially viable solution to be investigated by the clinical practice.
Availability of MRI conditionally safe wireless pacemakers. Remote monitoring requires devices with wireless capability. Not all device companies provide a pacemaker with wireless technology. For example, Medtronic does not have a pacemaker with wireless technology, and has promoted remote follow-up and MRI conditionally safe features to compete with companies providing pacemakers with RM capability. Boston Scientific and BIOTRONIK now offer both these features in their pacemakers, and it is likely that all companies will incorporate these technologies within the next 2 years.
Connectivity. The CIED with wireless technology needs to connect to a modem that is connected to the Internet. There are 3 potential ways for the modem to connect to the Internet: 1) landline, 2) cellular wireless, or 3) wireless or Ethernet connection to the patient’s home Internet. Connectivity is a barrier when the patient does not have a landline, the device company does not provide a cellular option, or the cost of the cellular service is passed on to the patient. The choice of a given device for a patient needs to take into consideration which of these options is available to the patient and whether there may be a monthly charge borne by the patient. The complexity of setting up the modem with a landline or connecting to the home Internet is a significant impediment to connectivity in the elderly and in patients with a language barrier.
Multiple Web Portals and EMR Interoperability. The heterogeneity of 4 different proprietary web portal interfaces poses an ongoing barrier to the widespread adoption of RM. Health professionals and clerical staff are faced with the daunting task of remaining facile with evolving RM software and remembering their passwords to all sites. Unfortunately, device companies continue to develop proprietary RM features as a way to differentiate themselves from one another rather than working together to achieve a uniform RM workflow. This is the greatest impediment to training staff to provide this service.
Today, the patient’s medical record resides in the EMR. Data transmitted by the CIED to the web portal needs to be mined for clinically relevant information and then uploaded to the EHR, where this information can be viewed in the context of the patient’s medical record. The lack of uniform interoperability between the 4 different device web portals and the many more proprietary EMR systems is an enormous challenge to providing streamlined RM services. Third-party companies have designed bridging software with variable success. These include ScottCare (OneView) and Medtronic (Paceart). (Figure 2)
Liability. The assumed responsibility for monitoring a continuous stream of clinical data that, if missed, may adversely affect patient outcomes, poses a great concern for practices. Some physicians have erroneously assumed that if they do not provide this service, then they could not be held legally responsible for information that was not available to them. Although I am unaware of any legal case testing this hypothesis, legal opinion would recommend following the guidelines. The HRS Consensus Statement provides a Class IA recommendation for RM. Furthermore, patients should sign a consent form delineating the details of RM, including the hours of monitoring, how alerts are handled, and their responsibility to maintain connectivity.9
Patient Privacy. The transmission of clinical data to the Internet provides multipoint continuous access to private patient data. The employment of third-party companies to help manage this data and enter it into the patient EHR further exposes patients to identity theft, and as such, poses a barrier to patient acceptance of RM services.
Clinical Practice Solutions
In an ideal world, patients are educated about RM prior to receiving their device by their physician. The implanting physician educates the patient about how the technology works and emphasizes the continuous monitoring capability, the safety, and the reduced need for office visits. Patients are reassured that “well baby visits” can be performed over the Internet and that they will have access to in-person visits when necessary. Patients are informed as to the limitation of the technology. Remote monitoring is not an emergency lifeline service.
Immediately after implant, in an attempt to further improve acceptance and thus compliance with setting up RM, the patient’s CIED is paired at the bedside with a cellular transmitter. The device company representative is responsible for demonstrating the transmitter to the patient and the patient’s family. The patient is then instructed to have the transmitter plugged into a power jack in the hospital room. The first remote download is made in-hospital by the patient initiating an in-person download, or automatically in the case of BIOTRONIK.
The patient is discharged and seen within 2 weeks in the office, where the patient is re-educated about RM by an AHP and is provided with a consent form outlining the patient’s and clinic’s responsibilities with regard to RM. The patient plugs in the device at home, and RM ensues. The patient’s data is transmitted to the Internet portal that is monitored by an appropriately trained AHP (cardiac technician) to look for daily alerts and quarterly downloads. Addressing clinic workflow for CIED RM has been shown to dramatically improve observed efficacy and quality.10 The AHP triages the data on the basis of acuity, deciding on whether the information needs to simply be added to the electronic medical record awaiting physician signature, or whether the patient may need to be called to come into the office or be admitted to the ER. Repeat alerts are addressed with clinical protocols to reduce their frequency. Quarterly downloads are evaluated and transmitted to the EHR. Rescheduling, connectivity, and billing issues are communicated to the appropriate members of the RM team. Interoperable software is employed to seamlessly upload data gathered from all web portals to the EHR, where the physician can make decisions on the RM download in the context of the patient’s medical record. Practices that do not have the manpower to create the infrastructure to manage RM can engage a third party to provide the clerical and technical requirements. (Figure 2)
The value of a RM strategy for managing patients with CIEDs has been established. The successful implementation of this strategy requires an appreciation for the staff required, the workflow, and the need for interoperability between the device company software and the EMR.
Disclosure: The author has no conflicts of interest to report regarding the content herein. Outside the submitted work, Dr. Movsowitz reports receiving personal fees as a consultant from Ambucor/ScottCare, and receiving personal fees as a consultant/speaker from BIOTRONIK, St. Jude Medical, and Boston Scientific.
- Varma N, Epstein A, Irimpen A, et al, TRUST Investigators. Efficacy and safety of automatic remote monitoring for ICD follow-up: the TRUST trial. Circulation. 2010;122:325-332.
- Mabo P, Victor F, Bazin P, et al. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J. 2012;33:1105-1111.
- Guedon-Moreau L, Lacroix D, Sadoul N, et al. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J. 2012;34:605-614.
- Saxon LA, Hayes DL, Gilliam FR, et al. Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study. Circulation. 2010;122:2359-2367.
- Varma N, Piccini, JP, Snell J, et al. Relationship between level of adherence to automatic wireless remote monitoring and survival in pacemaker and defibrillator patients. J Am Coll Cardiol. 2015;65(24):2601-2610.
- Slotwiner D, Varma N, Akar JG, et al. HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular electronic implantable devices. Heart Rhythm. 2015;12(7):e69-e100.
- Kohn CS, Petrucci RJ, Baessler C, Soto DM, Movsowitz C. The effect of psychological intervention on patients” long-term adjustment to ICD: a prospective study. Pacing Clin Electrophysiol. 2000;23(4 Pt 1):450-456.
- Movsowitz C, Mittal S. Remote patient management using implantable devices. J Interv Card Electrophysiol. 2011;31(1):81-90.
- Cotton VR, Gillis AM, Halligan D, Movsowitz CM. Medico-legal considerations of remote monitoring. Cardiovascular Business. 2012;6(5):12-13.
- Davenport EE, Cooper TL, Tucker AG, et al. Improved workflow for CIED remote monitoring management: a quantitative study. Heart Rhythm. 2016;13(5):AB01-06.