TY - JOUR
AU - Hoekstra, Wybo H G J
AB - Abstract Background Remote follow-up of implanted implantable cardioverter defibrillators (ICDs) may offer a solution to the problem of overcrowded outpatient clinics, and may also be effective in detecting clinical events early. Data obtained from remote follow up systems, as developed by all major device companies, are stored in a central database system, operated and owned by the device company. A problem now arises that the patient's clinical information is partly stored in the local electronic health record (EHR) system in the hospital, and partly in the remote monitoring database, which may potentially result in patient safety issues. Methods To address the requirement of integrating remote monitoring data in the local EHR, the Integrating the Healthcare Enterprise (IHE) Implantable Device Cardiac Observation (IDCO) profile has been developed. This IHE IDCO profile has been adapted by all major device companies. Results In our hospital, we have implemented the IHE IDCO profile to import data from the remote databases from two device vendors into the departmental Cardiology Information System (EPD-Vision). Data is exchanged via a HL7/XML communication protocol, as defined in the IHE IDCO profile. Conclusions By implementing the IHE IDCO profile, we have been able to integrate the data from the remote monitoring databases in our local EHRs. It can be expected that remote monitoring systems will develop into dedicated monitoring and therapy platforms. Data retrieved from these systems should form an integral part of the electronic patient record as more and more out-patient clinic care will shift to personalized care provided at a distance, in other words at the patient's home. Remote monitoring, ICD, pacemaker, implantable devices, data exchange, IHE, standardization Background The implementation of the results of large randomized trials showing the effectiveness of implantable cardioverter defibrillators (ICDs) in clinical practice has led to an exponential rise in the number of implanted ICDs, although the number of ICD implants seems to have stabilized in recent years (Figure 1). In particular, the wide-spread application of an ICD for primary prevention has led to a dramatic increase in implantations. Figure 1. Open in new tabDownload slide Number of implantable cardioverter defibrillator (ICD) implantations per year (Leiden University Medical Center (LUMC)). The growing number of ICD recipients is resulting in a rapidly increasing workload with respect to the follow-up of these patients (Figure 2). A regular follow-up of a pacemaker patient is scheduled every six months or even over a longer period. In contrast, the follow-up period of an ICD patient is usually 3–6 months. Patients with a Cardiac Resynchronization Therapy ICD (CRT-D) device often require even more frequent check-ups, again leading to a greater burden on staff and time at the outpatient clinic. Figure 2. Open in new tabDownload slide Number of implantable cardioverter defibrillator (ICD) follow-ups per year (LUMC). Remote monitoring of implanted devices: Benefits and drawbacks Remote follow-up of implanted pacemakers or ICDs can offer a solution to the problem of overcrowded outpatient clinics, and will bring considerable convenience to the patients since they will have to visit the outpatient clinic less frequently.1 Remote monitoring has already been introduced in the international guidelines,2 although the clinical and health economics impact of remote monitoring are still under discussion.3,4 A remote monitoring system would make it possible to schedule a remote follow-up between in-clinic follow-ups.5 Furthermore, remote monitoring may allow early detection of ICD or lead failures without requiring any patient intervention.6 In addition, remote monitoring enables early detection of arrhythmias like atrial fibrillation or confirmation of appropriate or inappropriate shock delivery while the patient is still at home (Table 1). Table 1. Benefits of remote monitoring of implanted devices Benefits . Convenient solution for the hospital, reducing the time required for patient follow-up and physician time. Convenient solution for patients who need to travel to the clinic less frequently. Timely detection and identification of arrhythmia and other events, thereby preventing or limiting hospitalizations. Benefits . Convenient solution for the hospital, reducing the time required for patient follow-up and physician time. Convenient solution for patients who need to travel to the clinic less frequently. Timely detection and identification of arrhythmia and other events, thereby preventing or limiting hospitalizations. Open in new tab Table 1. Benefits of remote monitoring of implanted devices Benefits . Convenient solution for the hospital, reducing the time required for patient follow-up and physician time. Convenient solution for patients who need to travel to the clinic less frequently. Timely detection and identification of arrhythmia and other events, thereby preventing or limiting hospitalizations. Benefits . Convenient solution for the hospital, reducing the time required for patient follow-up and physician time. Convenient solution for patients who need to travel to the clinic less frequently. Timely detection and identification of arrhythmia and other events, thereby preventing or limiting hospitalizations. Open in new tab All major device companies have developed a remote follow-up solution. At regular intervals (depending on the setup of the specific remote monitoring system) the implanted device will connect to a receiving system at the patient's home, and then send data on the status of the device and of the patient to the central database system, operated by the device company. The physician can log into a secure website and check the data from the remote follow-up for each patient. However, until now it has not been possible to integrate the data from remote monitoring system into the local electronic health record (EHR) system, which potentially may create patient safety issues. In other words, data are stored on different systems and may not be accessible for all healthcare providers. This may potentially result in patient safety issues as it may be difficult to keep track of all information available and information may only be accessible for certain doctors or technicians. Ideally all information should be available in the EHR system. Need for standardized data exchange Therefore there is a need to be able to import data from the remote monitoring database system and to integrate the data into the local EHR. To obtain this goal there is a need for a standard set of observations, communicated in standard messages, such as therapy settings, events, device self-monitoring. Furthermore, there should be a consistent presentation of data from all devices. Methods Integrating the Healthcare Enterprise (IHE) IHE is a shared initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. Systems that support IHE ‘Integration Profiles’ ideally work together in a standardized way, are easier to implement, and help care providers to use information more effectively. The ultimate goal is efficient delivery of optimal patient care.7 In various domains, IHE integration profiles specify how topic data for a specific domain can be exchanged based on existing standards. Therefore, IHE is not a standard: it merely specifies which standards should be used in a certain domain, and how they should be used. IHE Implantable Device Cardiac Observation (IDCO) To address the requirement of integrating remote monitoring data in the local EHR, the IHE Patient Care Domain (PCD) IDCO profile has been developed. The IHE IDCO profile defines a standards-based transfer of device interrogation information from the interrogation system into the information management system. Strong device vendor participation in the IDCO profile development is an acknowledgement of its importance. The IHE IDCO profile is part of the IHE domain. See Figure 3 for a schematic overview of the IHE IDCO system model. Figure 3. Open in new tabDownload slide Integrating the Healthcare Enterprise (IHE) Implantable Device Cardiac Observation (IDCO) profile system model. EHR: Electronic Health Record system; RF: Radio Frequency. Features of the IHE PCD IDCO profile are: Standard set of observations Communicated in standard messages Consistent presentation of data from all devices Direct link between interrogating device and local EHR. Cardiac device outpatient follow-up The IHE IDCO profile not only brings a solution to the problem of data in the remote monitoring database that is not available locally in the Cardiology Information System (CIS). The profile also brings a solution to the following problem. During outpatient clinic device follow-up, measurements are performed with the use of a so-called programmer. Such a programmer system can connect wirelessly to the device implanted in the patient, and then can extract the device data (e.g. settings, status, events) from the device. Furthermore, it can also be used to reprogram the settings of the device, if necessary. However, after the measurements are performed, the information needs to be typed in by hand into the CIS from a paper report printed on the programmer. The IHE IDCO profile also brings a solution to this problem, by defining standards for this specific data exchange. Nomenclature An important part of the IHE PCD IDCO profile is the nomenclature, the definition of the variables that are exchanged. Companies that implement the IHE PCD IDCO profile not only need to exchange data in a standard way, but they also should make the data available using uniquely defined data definitions. The IEEE Standards Association is defining sets of terminology for ‘point-of-care’ medical device communication. One of these sets is IEEE 11073-10103 which supports terminology for implantable cardiac devices. A draft version of this standard is available, but still subject to change. Representatives from all major device vendors are taking part in the IEEE 11073-10103 project group. Device vendor involvement and implementation All large cardiovascular implantable device vendors are involved in the development of the IHE IDCO profile, and in the development of the IEE 11073-10103 nomenclature standard. All companies have already partially or completely implemented the IHE profile and IEEE standard and have a hardware/software solution available which can be used to communicate with an EHR or data management system. The implementation from Biotronik, Boston Scientific and St Jude Medical is freely available, but Medtronic has only implemented the IHE IDCO profile to communicate with their proprietary solution Paceart™. Both Biotronik and St Jude Medical have also already implemented the possibility for data exchange between a programmer and the EHR. Results LUMC implementation In our department (LUMC Cardiology) we have implemented the IHE IDCO profile to import data from the remote databases from two device vendors into the departmental Cardiology Information System (CIS) (EPD-Vision™, version 10.3, LUMC). A new software module has been developed in EPD-Vision to import data from the remote monitoring databases from Biotronik and Boston Scientific. Data is exchanged via a HL7/XML communication protocol, as defined in the IHE IDCO profile. Data from the remote monitoring database is transferred either automatically by querying the remote database (Boston Scientific) or manually by exporting data from the remote monitoring database or programmer (Biotronik). In both cases, the data is available in the format as defined in the IEEE 11073-10103 standard. St Jude remote monitoring has not been implemented in our department, while Medtronic does not provide the software tools to obtain the data from their remote monitoring solution. Implementation details, EPD-Vision The variables in the datasets from the remote monitoring database (Boston Scientific and Biotronik) or from the programmers (Biotronik) are in the IEEE 11073-10103 defined format. The variables have been mapped to the corresponding variables in EPD-Vision™, and thus are visible in EPD-Vision™ in the same manner as the data from the in-house follow-up. Data is only transferred to the local EHR once per three months or, if an event has occurred, as detected by the remote monitoring system. Discussion and conclusion The growing number of recipients of ICDs and more complex devices are leading to a rapidly increasing workload with respect to follow-up of these patients. To amend this problem, all major device companies have developed a system for remote monitoring of these devices. Remote monitoring will lessen the burden of follow-ups on the clinic and staff, and it will improve the efficiency of patient care. It is also attractive from a patient's perspective, since it may lead to greater reassurance and prevents long and timely trips to the hospital. However, as a result, part of the patient's clinical information is now stored in the local EHR system in the hospital, while another part is only available in the remote monitoring database. From the perspective of patient safety this is not an ideal situation. The IHE IDCO profile has been developed to bring a solution to this problem, and to the problem that information from the interrogating devices (programmers) cannot be transferred electronically in to the EHR system. Implementation of the IHE IDCO profile also allows for transfer of data from the interrogation device (programmer) to the local information system, which overcomes the need for manual entry of the in-house follow up data. In our hospital, we have implemented the IHE IDCO profile to store data from the remote monitoring database and programmers in our local information system (EPD-Vision™). In this way, remote follow up data can be viewed as if it was acquired during in-house follow-up. An important part of the IHE IDCO profile is the nomenclature, the definition of the variables that are exchanged. The IEEE 11073-10103 standard terminology set as developed by the IEEE Standards Association is a prerequisite for the implementation of the IHE PCD IDCO profile. With the IEEE 11073-10103 standard set of variables, the hospital only needs to do the mapping between the data set of the vendor and the data set of the local EHR system once, instead of devising a different mapping for each vendor. The IEEE 11073-10103 standard terminology would also be very beneficial to implement in national and international cardiovascular registries, since it will allow for easy data transfer from a local EHR to a national registry, and for data exchange between national and international registries, such as the ESC EurObservational Research Programme.8,9 Future developments It can be expected that remote monitoring systems will develop into dedicated monitoring and therapy platforms. Data retrieved from these systems should form an integral part of the electronic patient record as more and more out-patient clinic care will shift to personalized care provided at a distance, in other words at the patient's home. To accomplish such networking solutions, data exchange between all systems involved is of utmost importance. The first steps have been taken but the ultimate solution is still far ahead. Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Conflict of interest The authors declare that there is no conflict of interest. References 1 Raatikainen M J , Uusimaa P, van Ginneken M Met al. . Remote monitoring of implantable cardioverter defibrillator patients: A safe, time-saving, and cost-effective means for follow-up . Europace 2008 ; 10 : 1145 – 1151 . Google Scholar Crossref Search ADS PubMed WorldCat 2 Wilkoff B L , Auricchio A, Brugada Jet al. . HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of techniques, indications, personnel, frequency and ethical considerations: Developed in partnership with the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA); and in collaboration with the American College of Cardiology (ACC), the American Heart Association (AHA), the European Society of Cardiology (ESC), the Heart Failure Association of ESC (HFA), and the Heart Failure Society of America (HFSA). Endorsed by the Heart Rhythm Society, the European Heart Rhythm Association (a registered branch of the ESC), the American College of Cardiology, the American Heart Association . Europace 2008 ; 10 : 707 – 725 . Google Scholar Crossref Search ADS PubMed WorldCat 3 Al-Khatib S M , Piccini J P, Knight Det al. . Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: Results from a randomized pilot clinical trial . J Cardiovasc Electrophysiol 2010 ; 21 : 545 – 550 . Google Scholar Crossref Search ADS PubMed WorldCat 4 Bikou O , Licka M, Kathoefer Set al. . Cost savings and safety of ICD remote control by telephone: A prospective, observational study . J Telemed Telecare 2010 ; 16 : 403 – 408 . Google Scholar Crossref Search ADS PubMed WorldCat 5 Ricci RP, Morichelli L, D'Onofrio A, et al. Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the HomeGuide Registry. Europace. Epub ahead of print 29 January 2013. DOI: 10.1093/europace/eus440 . 6 Guedon-Moreau L , Chevalier P, Marquie Cet al. . Contributions of remote monitoring to the follow-up of implantable cardioverter-defibrillator leads under advisory . Eur Heart J 2010 ; 31 : 2246 – 2252 . Google Scholar Crossref Search ADS PubMed WorldCat 7 Integrating the Healthcare Enterprise. Welcome to Integrating the Healthcare Enterprise, http://www.ihe.net (2002, accessed 26 March 2013) . 8 National Cardiovascular Data Registry. Standards for registration, transparency and quality, http://www.ncdr.nl (2008, accessed 26 March 2013) . 9 European Society of Cardiology. EURObservational research programme, http://www.escardio.org/guidelines-surveys/eorp/Pages/welcome.aspx (1997, accessed 26 March 2013) . © The European Society of Cardiology 2013 This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) © The European Society of Cardiology 2013
TI - Remote monitoring of patients with implanted devices: data exchange and integration
JF - European Journal of Preventive Cardiology
DO - 10.1177/2047487313487483b
DA - 2013-06-01
UR - https://www.deepdyve.com/lp/oxford-university-press/remote-monitoring-of-patients-with-implanted-devices-data-exchange-and-ltHco2g55T
SP - 8
EP - 12
VL - 20
IS - 2_suppl
DP - DeepDyve
ER -