Building an Infrastructure to Handle Incoming Data

Introduction

To an arrhythmia specialist, often an electrophysiologist, there are three types of heart rhythm data that need to be collected and placed into context with clinical data. All are critical to patient care: 1) implantable device data; 2) wearable device data; and 3) clinical data. Optimally, the data should be retrievable in context using a patient-centered perspective that looks across multiple locations of data collection and evaluates longitudinally (rather than sequentially) as segregated episodes. At the center of this patient-centric perspective is the concept of medical interoperability.^1,2 HIMSS (Healthcare Information and Management Systems Society) defines interoperability as “the extent to which systems and devices can exchange data, and interpret that shared data. For two systems to be interoperable, they must be able to exchange data and subsequently present that data such that it can be understood by a user.”1 Interoperability has been enhanced by the development of the IHE (Integrating the Healthcare Enterprise) IDCO (Implantable Device - Cardiac - Observation) data interchange protocol.³ This provided a standard document that defines a predictable way to interchange between device programmers or remote interrogation systems to device databases and electronic medical records (EMR). Ultimately, the data needs to be collected from multiple sources, and then presented to the medical professional — and preferably, to the patient as well — so that all information is available for decision making. (Figure 1)

Device Database

The EMR should be the centerpiece of the system for arrhythmia data collection, display, and distribution; however, problems with interoperability and limitations in data display often make it impractical for implantable device data and wearable device data. Although not the best or most complete solution, what is crucial for integration of device-centric data is a cardiovascular implantable electronic device (CIED) follow-up database. This is where core patient and device demographics are collected along with device programming, lead threshold, battery status, patient symptoms, and arrhythmia events. Data can be manually input into the CIED follow-up database, and imported data from programmer interrogation, device testing, and programmed data can improve the accuracy and efficiency of the system. Imported data can be received from the programmer from a USB stick through a wired intranet connection or through Wi-Fi or Bluetooth connections. Similarly, imported interrogations over the internet from secure remote interrogation databases hosted by the manufacturers permit the remote and in-person data to be placed longitudinally in context. This limited and CIED-centric EMR is often useful to collect Holter and event recorder information if a broader EMR is not available. However, once the data is collected in the CIED database, the data can be distributed to other data resources such as an EMR or data warehouse facilitated by the IDCO protocol. 

Electronic Medical Record 

When data is placed into an EMR, the data is sometimes not inserted as discrete searchable data elements, and therefore, can be less useful than when collected in a true database that preserves the structural elements. Also, the CIED data in the EMR is often inserted as a PDF image with little to no additional descriptive information, sometimes confusing the date of scanning of the image with the testing date. However, when imported with a true data interface employing the IDCO protocol, the CIED data can be displayed and graphed over time to allow trends to be detected. The promise of the EMR, making data searchable and useful, is usually thwarted by the way it is acquired or interfaced to other data sources; therefore, instead of the EMR, the CIED database is often the best way of searching for and creating clinical, quality, and administrative metrics. What the EMR usually does exceptionally well is distribute information and gather data from non-cardiovascular sources such as medications, allergies, hematologic, and blood chemistries. 

Remote and In-Person Evaluations

Evaluations of patients with CIEDs can be done in person or remotely; however, the information needs to be collected and arranged sequentially in a single context, in either the CIED database, the EMR, or both (Figure 2). In addition, in-person interrogations or programming evaluations often occur outside of the device clinic, such as in the operating room, emergency room, MRI suite, and other hospitals and clinics. Fortunately, most CIED devices keep a record of events in memory, and the data can be reconstructed in the CIED database or EMR. The priority should be on collecting the programming evaluations in the CIED clinic and the remote interrogations from the patient’s home, as this should allow a >90% accurate picture of the device and arrhythmias in the patient’s record.

Wearable Monitor Data

Arrhythmia data from wearable monitors (e.g., Holter monitors, event monitors, mobile continuous outpatient telemetry, or implantable loop recorders) overlap the assessments made on patients with CIED devices. Therefore, placing these data in context with the implantable data is highly desirable. Placing the data in the CIED database makes review (usually by the same clinicians) of the information more convenient and also widely distributed when in the EMR.

Clinical Data

Clinical integration of the remote and in-person CIED data, the wearable device data, and the clinical and administrative data, makes the investment in this clinical infrastructure extremely powerful. Linking this information (e.g., administrative, insurance, orders and billing to the problem list, clinical notes, arrhythmia-related data, device data, medications, allergies, and radiographic and blood tests) provides the platform for integrated care. Information, programming, and data interpretation standards and care pathways can be shared across the system as healthcare systems aggregate their data.

For instance, in the Cleveland Clinic Health System, remote monitoring is centralized at the main hospital, which collects data from patients in their homes from cities in the United States and from many other countries around the world. Programming evaluations are done at several hospitals and many geographically dispersed family health centers, and collected in a single CIED database (Paceart Optima System, Medtronic), where the clinical evaluations are completed by clinically employed allied professionals (CEAPs) and then sent to a central installation of EPIC (EMR) and billed. This data is available to the physicians, nurses, administrators, referring physicians, and directly to patients. Protocols for managing atrial fibrillation, ventricular arrhythmias, shocks, anticoagulation, and lead and battery dysfunction are consistently applied.

Personnel

The personnel staffing the collection and interpretation of CIED data is one of the most crucial elements of the system. CEAP and industry employed allied professionals (IEAPs; usually industry employed by the CIED manufacturer) are defined in a document published by the Heart Rhythm Society (HRS).⁴ The main point when either is employed in the delivery of care is that there is adequate training and supervision. When a clinic provides the technical services, then the allied professional must be employed by the supervising licensed independent practitioner (LIP) for a bill to be issued. In addition, for professional services to be billed, then the clinical service must employ the LIP. Although it is possible for the allied professional to develop the skills without having certification of the skill set, the International Board of Heart Rhythm Examiners (IBHRE) provides a high-level examination for allied professionals. Qualifying for the certified cardiac device specialist (CCDS) designation provides documentation of the highest level of skill in the interpretation and delivery of CIED care. IEAPs can also receive CCDS certification, and I recommend that manufacturer representatives also be required to have this documented skill level if used as part of the personnel in the CIED clinic. It is crucial to adequately assess the manpower needs of the device clinic for all aspects of care, including programming evaluations, remote interrogations, pre- and post-op evaluations, pre- and post-MRI evaluations, phone calls, and electronic communication. A well-managed device clinic, staffed with allied professionals and with skilled physician oversight, can manage both routine and emergency care of patients with a device; this includes handling recalls, episodes of device dysfunction, battery depletion, and arrhythmia events. Under these circumstances, it becomes the front door and the best welcoming service for retaining patients, by providing quality and high-touch care.

Pictures

As remote interrogation becomes the mainstay of CIED monitoring, it has become clear that outcomes are improved over standard in-person evaluations with transtelephonic evaluations.^5,6 Improved survival as well as reduced shocks and cost occur when remote monitoring is initiated at the time of implantation and continued over time. In particular, this becomes especially accessible for every patient with the transition to cellular capacity for all of the major CIED manufacturers. The next question is: how valuable is an early CIED check after implantation or replacement? That visit is mostly for the check of the incision, and usually there is no issue. We are working on what we anticipate is the next best practice, which is to combine a picture of the incision with a brief questionnaire of the patient’s well-being 7-14 days after the procedure with an interrogation evaluation. We would eliminate the initial programming evaluation until 12 weeks after the procedure, which would permit adjustment of the pacing outputs and set up future yearly evaluations with standard remote interrogation follow-up. The key to using photo evidence of the healing of the pocket is documentation in the EMR for examination at future visits. This same photo documentation in the EMR is useful at future yearly or ad hoc visits related to patient complaints. This has proven valuable in the documentation of CIED pocket infections.

Summary

CIED follow-up can be viewed as a very limited clinical activity. However, in the best tradition of integrated patient care and with the same developing standard for electronic medical records, CIED follow-up also has the ability to leverage all the best aspects of medical care. This includes direct telemetric access to accurate data (both in person and remotely), integration into the electronic medical record, access to administrative and quality standards, and improved outcomes. The infrastructure has now matured, and while it is fragmented, I believe those pieces can be assembled to provide quality, efficient, and economical care.

Disclosure: Dr. Wilkoff has no conflicts of interest to report regarding the content herein. Outside the submitted work, he reports personal fees from Medtronic, St. Jude Medical, Boston Scientific, Spectranetics, and ConvaTec.  

References

1. What is interoperability? HIMSS. Published April 5, 2013. Available online at https://www.himss.org/library/interoperability-standards/what-is-interoperability. Accessed December 12, 2016.
2. Center for Medical Interoperability. Available online at https://medicalinteroperability.org/. Accessed December 12, 2016.
3. PCD Implantable Device Cardiac Observation. IHE. Published September 28, 2016. Available online at https://wiki.ihe.net/index.php/PCD_Implantable_Device_Cardiac_Observation. Accessed December 12, 2016.
4. Lindsay BD, Estes NA 3rd, Maloney JD, Reynolds DW. Heart Rhythm Society Policy Statement Update: Recommendations on the Role of Industry Employed Allied Professionals (IEAPs). Heart Rhythm. 2008;5:e8-10.
5. Boriani G, Da Costa A, Quesada A, et al. Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial. Eur J Heart Fail. 2016 Aug 28.
6. Portugal G, Cunha P, Valente B, et al. Influence of remote monitoring on long-term cardiovascular outcomes after cardioverter-defibrillator implantation. Int J Cardiol. 2016;222:764-768.