New HRS/EHRA Expert Consensus on Monitoring of Cardiovascular Implantable Electronic Devices:

What This Means for the Allied Health Professional Allied health professionals play a major role in the follow-up of patients with cardiovascular implantable electronic devices (CIEDs). A recently released consensus document from the HRS and EHRA contains recommendations for follow-up for specific types of devices and provides guidelines for performance for the specific personnel involved in giving care to these patients. This article will discuss general issues of follow-up and then will look at recommendations related to the allied health professional. The document HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations was first presented at the HRS meeting in May. An increasing number of devices are implanted each year, such that it is estimated in North America alone there are 3,675,000 pacemaker and ICD follow-up ‘encounters’ per year. Because of the magnitude of this type of care delivery, a need to address care issues was recognized. A couple of definitions that were covered in the introductory portion of the document that are especially pertinent to this discussion are the following: • Cardiovascular Implantable Electronic Device (CIED): this includes pacemakers, implantable cardioverter-defibrillators, cardiac resynchronization devices, implantable loop recorders, and implantable cardiovascular monitors. • Clinically Employed Allied Professional (CEAP): this includes nurses, physician assistants, technologists, technicians, and engineers involved in the care of a patient with a CIED. They all work collaboratively with or under direct supervision of a CIED physician. They are not employees of a manufacturer. Goals of Monitoring CIEDs Four primary goals of CIED monitoring were discussed. These were categorized as patient related, CIED related, disease related, and communication. Included within the patient-related realm are optimization of quality of life and device function, identification of at-risk situations and initiation of actions/follow-ups, and triage of non-CIED health problems/referring. CIED-related goals include documenting appropriate device behavior and correcting abnormal behavior, maximizing generator longevity within safe limits, and identifying need for battery change or lead alterations. The goals of disease-related CIED monitoring include documentation of arrhythmias and correlation with symptoms, as well as documentation of heart failure related variables in the setting of a resynchronization device or with hemodynamic devices. In addition, for both of the above, device monitoring can provide information related to response to therapy. Finally, the follow-up goals related to communication include the maintenance of a database, timely communication related to care issues, and provision of technical expertise and education to patients and others. Minimum Frequency of Monitoring The recommended minimum frequency of CIED monitoring (in person or remote) is seen in Table 1. It should be understood that more frequent monitoring may be required, depending on the clinical situation. CEAPs who are responsible for scheduling of device follow-ups should be aware of these guidelines so that they can help ensure appropriate frequency of follow-up, manage staff resources, and educate patients on the importance of keeping their appointments. Role of the CEAP The authorized CEAP with device management expertise may be responsible for conducting the follow-up clinic, but it must be understood that the physician who signs off is ultimately responsible. The CEAP is usually responsible for maintaining the follow-up schedule, based on the type of device implanted, and if a CRT device is involved, appropriate heart failure team follow-up would be included. The CEAP may also be responsible for much of the record maintenance required. Stored information should include the original device indication and patient history, implant operative record and values at implant, and access to prior transmissions, remote downloads, and in-clinic assessments. Systematic assessment and processing of remote data is imperative, as is having a plan for dealing with after-hours situations. A plan also needs to be in place to respond to safety alerts, advisories, and recalls. A large part of the CEAP role involves answering patient questions. The CEAP and physician must communicate regularly about current opinion and knowledge related to device function and life with devices, i.e., EMI, travel, battery depletion, sports participation, intimacy, etc. The CRT patient will experience a more complicated follow-up regime, and heart failure specialists and their teams will also have a need for a set process of managing transmissions, appointments, and educational issues. Industry employed allied professionals may also play an active role in the follow-up setting. However, it should be understood that their activities should only be at the request of the responsible physician. They may provide technical support with the physician close enough to respond within minutes, and may provide support in follow-up clinic; however, the physician is ultimately responsible for all care. Industry professionals shall not provide technical support related to a competitive manufacturer’s device except in an emergency. Implantation of a CIED is not the end of the story. These devices provide therapy; this means that device parameters must be monitored and modified as needed, in response to patients’ changing needs. The CEAP who is trained in device therapy brings a great deal to the care setting. The constantly increasing number of devices being implanted leads to exponentially greater follow-up numbers. CEAPs must be continually educated and made aware of guidelines that affect their practice.