Perhaps the single greatest challenge of remote monitoring of cardiac implantable electronic devices (CIEDs) is managing the volume and flow of data. Each manufacturer has a proprietary lexicon, communication protocol, and web portal. Clinicians managing hundreds of patients with different CIEDs from multiple manufacturers must log onto different web portals to review and download the data, then create individual patient reports, and incorporate the findings into the electronic health record (EHR). It is a time-consuming and inefficient process that has spawned an industry of products designed to assist clinicians managing CIED data. These products range from stand-alone EHRs designed to manage CIED data, to cloud-based software solutions, to complete turnkey solutions that manage every aspect of the remote monitoring process, assisting patients in setting up the transceiver and delivering a ready-to-sign report to the overreading physician’s inbox.

The ideal state would be one in which the data are accessible at a single access point, ideally within the EHR, in a graphical user interface that makes no distinction of proprietary brand and has the essential data organized in a consistent structure, using common definitions for each data element. Once reviewed, the data could be seamlessly repurposed to create a report for billing, submission to a registry, quality improvement, research, or other purposes.

The challenge we presently face managing CIED data is the same problem that clinicians face across the field of health care: data are isolated in silos. Although we have tremendously advanced diagnostic and therapeutic equipment, communicating the vast quantities of complex data generated during the delivery of health care is predominantly done by image files (such as PDFs) that, from the perspective of the computer, strip the data of all meaning. This is both inefficient and harmful to patient care.

Creating the infrastructure and the environment to overcome this lack of interoperability is the focus of intense international efforts by clinicians, regulatory agencies, the EHR industry, and the medical device industry. There are two foundational building blocks necessary to achieving data interoperability, which only health care providers have the expertise to create:

Since 2006, the Heart Rhythm Society (HRS) has led a multistakeholder collaboration to address the specific challenge of managing data from CIEDs with the objectives of creating a controlled vocabulary and developing consensus around a communication protocol and structure.¹ This ongoing collaboration includes physicians, staff from the HRS and the American College of Cardiology, engineers from all CIED manufacturers and many EHR manufacturers, as well as the U.S. Food and Drug Administration.

In this chapter, I will provide an overview of the CIED standardized nomenclature and the interoperability profile, point out where it is being used today and how it has started to change the industry that creates products to manage CIED data, and finally discuss future work and goals.

Controlled vocabularies are the fundamental building blocks upon which interoperability depends.² Often, there are several words that can be used to describe a finding, programming parameter, or pathophysiologic phenomenon. Humans are easily able to interpret and disambiguate these terms, but computers are not. It is therefore essential that clinicians define vocabulary pertinent to their field. Data produced by CIEDs and necessary for managing patients with these devices lend itself to developing consensus around a single semantic definition because most of the elements are similar regardless of the manufacturer. For example, managing a patient’s pacemaker requires similar information regardless of vendor: battery voltage, lead function, programmed parameters, and arrhythmias detected are similar regardless of manufacturer.

Developing this controlled vocabulary was the first task for the multistakeholder collaboration of the HRS. Physician volunteers identified approximately 200 data elements deemed essential for managing a follow-up or remote evaluation of a CIED (Table 7.1). Engineers from each of the CIED manufacturers collaborated to ensure that the definition of each data element was consistent, regardless of proprietary brand. This was then submitted to the Institute of Electrical and Electronics Engineers (IEEE), the standard development organization recognized internationally as the governing body of the controlled vocabulary for CIED data. IEEE Standards Association is a globally recognized standards-setting body that develops consensus standards through an open process that engages industry and a broad stakeholder
community. The nomenclature received final approval from IEEE on August 27, 2012.³ It has also been recognized and received approval from the International Organization for Standardization.