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Remote Monitoring of Cardiac Implantable Electronic Devices (CIED)
Abstract
With increasing indications and access to cardiac implantable electronic devices (CIEDs) worldwide, the number of patients needing CIED follow-up continues to rise. In parallel, the technology available for managing these devices has advanced considerably. In this setting, remote monitoring (RM) has emerged as a complement to routine in-office care. Rigorous studies, randomized and otherwise, have demonstrated advantages to patient with CIED management systems, which incorporates RM resulting in authoritative guidelines from relevant professional societies recommending RM for all eligible patients. In addition to clinical benefits, CIED management programs that include RM have been shown to be cost effective and associated with high patient satisfaction. Finally, RM programs hold promise for the future of CIED research in light of the massive data collected through RM databases converging with unprecedented computational capability. This review outlines the available data associated with clinical outcomes in patients managed with RM with an emphasis on randomized trials; the impact of RM on patient satisfaction, cost-effectiveness, and healthcare utilization; and possible future directions for the use of RM in clinical practice and research.
... This streamlining of information, with an implantable medical device in a patient, allows for the reduction of face-to-face interactions, surgical procedures, or routine maintenance visits, thus supporting cost-effective practice measures. In the case of cardiac patients with cardiac implantable electronic devices (CIEDs), current models are capable of: (1) monitoring physiological function in real-time by acquiring data automatically on a frequent basis (e.g., daily); (2) alerting a provider to any information and warnings about device integrity; and (3) allowing for remote monitoring of the patient's health condition without any manual interventions from providers [2,3]. For patients with significant cardiac disease and/or arrhythmias, implantable electronic devices such as permanent pacemakers, defibrillators, and cardiac resynchronization therapy (CRT) devices can assist with maintaining baseline cardiac function for the patient and the avoidance of life-threatening outcomes [4]. ...
... Sensors within the devices can transmit patient data such as respiratory rate (RR), physical activity levels (based on vital sign values), short recordings of intracardial cardiograms, heart rate (HR), night-time pulse, temperature, a rapid-shallowbreathing-index, thoracic impedance, and heart-sounds [5]. In addition, there is an algorithm within the devices that can use multiple sensors to track trends and alert providers if worsening heart conditions are identified in the patient [3]. Thus, implantable cardiac medical devices can provide instantaneous communication to the provider of the patient's functional, cardiac status and can prompt follow-up procedures if needed, including: (1) rapid treatment and response if the patient's status deteriorates (such as the delivery of a life-saving electrical shock due to a life-threatening arrhythmia); and (2) reassurance that there is immediate support should a serious event occur, as the device communicates directly to the provider in real-time. ...
... Research on publicly perceived security suggests that once a case of CIED-hacking is made public, will the perceived patient threat level increase and only then will it influence decision-making rather than the latter having commenced prospectively; (2) Trust: These threats impair patients' trust in the device, in the treatment plan, and in the relationship with the provider and/or medical institution; of note, once a sufficiently dramatic successful hacker attack is reported in the media, trust in CIEDs will be undermined for an extended period of time, and may be generalised to similar devices as suggested by research on the effects of device malfunction and recalled, e.g., due to production issues [19]; and (3) Subjective threat potential: Compared to cyber threats in the healthcare sector, where medical devices are temporarily out of order as a result of a cyber attack, the perceived threat (as depicted under point 2 above) is increased in smart CIEDs due to: (1) being unlike other medical devices, the CIED is not stationary but travels with the patient, rendering the perceived threat a consistent "patient-targeted threat" with concomitant and additional consequences of mental injury; (2) the threat can not be quantified in a usable way as it is not statistical; and (3) being subjected to a crime, including the malicious intent of a third party, can cause more stress than a purely technical failure with the device itself. Points (1) to (3) indicate that those institutions that are failing to prepare their patients for the risks of CIED-reliant treatment in the presence of this highly individualised, inescapable, and unquantifiable vulnerability, have the potential to unwittingly shift patients' risk perceptions and thus treatment preferences and choices such as consenting to an implantable device. These adjustments in health care decisions could also be potentially mediated by public coverage of first incidents and resulting public debates and (mis)perceptions. ...
Advancements in digitalisation with cardiac implantable electronic devices (CIEDs) allow patients opportunities for improved autonomy, quality of life, and a potential increase in life expectancy. However, with the digital and functional practicalities of CIEDs, there exists also cyber safety issues with transferring wireless information. If a digital network were to be hacked, a CIED patient could experience both the loss of sensitive data and the loss of functional control of the CIED due to an unwelcome party. Moreover, if a CIED patient were to become victim of a cyber attack, which resulted in a serious or lethal event, and if this information were to become public, the trust in healthcare would be impacted and legal consequences could result. A cyber attack therefore poses not only a direct threat to the patient’s health but also the confidentiality, integrity, and availability of the CIED, and these cyber threats could be considered “patient-targeted threats.” Informed consent is a key component of ethical care, legally concordant practice, and promoting patient-as-partner therapeutic relationships [1]. To date, there are no standardised guidelines for listing cybersecurity risks within the informed consent or for discussing them during the consent process. Providers are responsible for adhering to the ethical principles of autonomy, beneficence, non-maleficence, and justice, both in medical practice generally and the informed consent process specifically. At present, the decision to include cybersecurity risks is mainly left to the provider’s discretion, who may also have limited cyber risk information. Without effective and in-depth communication about all possible cybersecurity risks during the consent process, CIED patients can be left unaware of the privacy and physical risks they possess by carrying such a device. Therefore, cyber risk factors should be covered within the patients’ informed consent and reviewed on an ongoing basis as new risk information becomes available. By including cyber risk information in the informed consent process, patients are given the autonomy to make the best-informed decision.
... This streamlining of information, with an implantable medical device in a patient, allows for the reduction of face-to-face interactions, surgical procedures, or routine maintenance visits, thus supporting cost-effective practice measures. In the case of cardiac patients with cardiac implantable electronic devices (CIEDs), current models are capable of: (1) monitoring physiological function in real-time by acquiring data automatically on a frequent basis (e.g., daily); (2) alerting a provider to any information and warnings about device integrity; and (3) allowing for remote monitoring of the patient's health condition without any manual interventions from providers [2,3]. For patients with significant cardiac disease and/or arrhythmias, implantable electronic devices such as permanent pacemakers, defibrillators, and cardiac resynchronization therapy (CRT) devices can assist with maintaining baseline cardiac function for the patient and the avoidance of life-threatening outcomes [4]. ...
... Sensors within the devices can transmit patient data such as respiratory rate (RR), physical activity levels (based on vital sign values), short recordings of intracardial cardiograms, heart rate (HR), night-time pulse, temperature, a rapid-shallowbreathing-index, thoracic impedance, and heart-sounds [5]. In addition, there is an algorithm within the devices that can use multiple sensors to track trends and alert providers if worsening heart conditions are identified in the patient [3]. Thus, implantable cardiac medical devices can provide instantaneous communication to the provider of the patient's functional, cardiac status and can prompt follow-up procedures if needed, including: (1) rapid treatment and response if the patient's status deteriorates (such as the delivery of a life-saving electrical shock due to a life-threatening arrhythmia); and (2) reassurance that there is immediate support should a serious event occur, as the device communicates directly to the provider in real-time. ...
... Research on publicly perceived security suggests that once a case of CIED-hacking is made public, will the perceived patient threat level increase and only then will it influence decision-making rather than the latter having commenced prospectively; (2) Trust: These threats impair patients' trust in the device, in the treatment plan, and in the relationship with the provider and/or medical institution; of note, once a sufficiently dramatic successful hacker attack is reported in the media, trust in CIEDs will be undermined for an extended period of time, and may be generalised to similar devices as suggested by research on the effects of device malfunction and recalled, e.g., due to production issues [19]; and (3) Subjective threat potential: Compared to cyber threats in the healthcare sector, where medical devices are temporarily out of order as a result of a cyber attack, the perceived threat (as depicted under point 2 above) is increased in smart CIEDs due to: (1) being unlike other medical devices, the CIED is not stationary but travels with the patient, rendering the perceived threat a consistent "patient-targeted threat" with concomitant and additional consequences of mental injury; (2) the threat can not be quantified in a usable way as it is not statistical; and (3) being subjected to a crime, including the malicious intent of a third party, can cause more stress than a purely technical failure with the device itself. Points (1) to (3) indicate that those institutions that are failing to prepare their patients for the risks of CIED-reliant treatment in the presence of this highly individualised, inescapable, and unquantifiable vulnerability, have the potential to unwittingly shift patients' risk perceptions and thus treatment preferences and choices such as consenting to an implantable device. These adjustments in health care decisions could also be potentially mediated by public coverage of first incidents and resulting public debates and (mis)perceptions. ...
Advancements in digitalization with cardiac implantable electronic devices (CIEDs) allow patients opportunities for improved autonomy, quality of life and potential increase in longevity. However, with the digital and functional practicalities of CIEDs, there exists also cyber safety issues with transferring wireless information. Informed consent is a key component of both ethical care and promoting therapeutic relationships through chosen patient-centred treatment plan(s). To date, there are no standardised guidelines for listing cyber security risks within the informed consent or for discussing during the consent process.
With these cyber risk concerns, further challenges arise due to: 1) cyber risk scenarios are difficult for health care institutions to plan for (considered as an ambiguous threat) and result in ineffective and inconsistent protective measures, 2) cyber threats can impair trust in the device, the treatment plan and the patient provider relationship; and 3) the perceived threat to CIED patients is elevated because CIEDs are mobile in the patient and the stress to the patients about cyber attacks could be higher than from a technical malfunction. In addition, institutions who have not informed their CIED patients about cyber security risk(s), are involuntarily shifting patients’ risk perceptions and treatment choices. If a health care network were to be hacked, a CIED patient could experience both the loss sensitive data and the possible loss of control of the CIED by an unwelcome party. Furthermore, if a CIED patient were to become victim of a cyber attack that resulted in a serious or lethal event, and this information were to become public, the trust in healthcare would be impacted and legal consequences could result. A cyber attack therefore poses not only a direct threat to the patient’s health but also the confidentiality, integrity and availability of the CIED, and these cyber threats should be considered patient targeted threats. Providers are responsible for adhering to ethical principles of autonomy, beneficence, non-maleficence and justice, both in medical practice and the informed consent process. At present, the decision to include cyber security risks is mainly left to the provider’s discretion, who may also have limited cyber risk information. Without effective and in-depth communication about all possible cybersecurity risks during the consent process, CIED patients can be left unaware of the privacy and physical risks they possess by wearing such a device. Cyber risk factors should be covered within the patients’ informed consent and reviewed on an ongoing basis as new risk information becomes available. By including cyber risk information in the informed consent process, patients are given the autonomy to make the best-informed decision.
... В задачи врача кардиолога-аритмолога также входит назначение инструментальных исследований для диагностики нарушений системы ЭС, в случае выявления технических осложнений системы ЭС пациенты направляются на оперативное лечение -реимплантацию ЭКС и/или электрода. технология персонального телемониторинга для повышения эффективности реабилитации пациентов с имплантированным ЭКс В последние годы приобретает актуальность использование интерактивных телекоммуникационных технологий для решения лечебно-диагностических и реабилитационных мероприятий у пациентов с имплантированным ЭКС с функцией Home Monitoringпостоянный домашний мониторинг пациента [8,[20][21][22][23]. Как отмечено в клинических рекомендациях по применению имплантируемых антиаритмических устройств (ИАУ) Всероссийского научного общества специалистов по клинической электрофизиологии, аритмологии и кардиостимуляции, динамическое наблюдение процесса лечения и реабилитации пациентов с ЭКС и ИКД становится совершенно новым направлением в кардиологии [9]. ...
... 11 | No 1 | con-med.ru | 31 ковых электростимулов [8,21]. Кроме того, в рандомизированном клиническом исследовании показано, что автоматический постоянный телемониторинг такого параметра ЭС, как кумулятивная продолжительность правожелудочковой ЭС, является предиктором прогрессирования сердечной недостаточности, госпитализации и отдаленной выживаемости [23]. ...
... [6,7]. Наличие функции автоматической записи информации в память ЭКС об имевшихся кардиоваскулярных событиях и регистрация внутриполостных электрограмм во время этих событий позволяют оценить адекватность режима и установленных параметров ЭС, а также эффективность проводимой терапии [21]. ...
In the following review article, the principles and approaches of medical rehabilitation in patients with implanted pacemakers are discussed. It was shown that total benefit results from cooperation among medical, physical and psychological components of rehabilitation program and optimisation of the mode and parameters of cardiac pacing. Social adaptation of the patients with implantable pacemakers is of paramount importance and should be directed on avoidance of external electromagnetic fields and their influence on pacemaker functions, which in turn may be life-threatening for patient and the staff as well. The indications to diagnostic and treatment regimens including physiotherapeutic procedures should be clearly defined in order to avoid potential influence of electromagnetic interference on cardiac pacemaker. The well-structured medical rehabilitation programs need to be organised in order to improve quality of life and patients survival with regard to growing tendency of implantation of cardiac pacemakers.
... less frequent. [1,2] These differences need to be considered to understand the benefits of this technology. For example, automatic, daily transmissions are associated with higher probability of early detection of lead malfunctions when compared with periodic detection RM systems. ...
... For instance, in-office setup of wireless pacemakers led to greater patient compliance and successful transmission in 91% of patients, as compared to 22%, in the home setup group (P < 0.0001). [2,15] In addition, the 2015 Heart Rhythm Society Expert Consensus Statement endorses the use of RM patient agreement and/or contract to improve patient compliance. [2,11] outcomes Many different study methodologies were employed in the study of RM [ Table 2]. ...
... [2,15] In addition, the 2015 Heart Rhythm Society Expert Consensus Statement endorses the use of RM patient agreement and/or contract to improve patient compliance. [2,11] outcomes Many different study methodologies were employed in the study of RM [ Table 2]. The very large databases of the manufacturers allow for "Big Data" analyses, which cannot be achieved with standard randomized clinical trials. ...
... The digital technology available today has given the opportunity to choose from a variety of options that use cellular, satellite networks to communicate and follow up the patients with CIEDs. There is an ever-improving capability to remotely monitor the patient's health, device function, or check battery life without disturbing the routine of the patient [7]. Wireless capabilities with home transmitters that communicate automatically and relay data to the physician are offered by most major companies, which lead to an easier monitoring and follow-up of the patient. ...
... The median time from randomization to detection of AF was 41 days with implantable loop recorders. This early identification of AF is important for prevention of recurrence of stroke in this high-risk population by early initiation of anticoagulation [7,15]. ...
Purpose of review:
With the evolution in digital medicine to identify and monitor cardiac electrophysiological (EP) conditions, increased access to cardiac implantable electronic devices (CIEDs), and reimbursements for non-face-to-face care, remote patient monitoring (RPM) is becoming a key part of the EP service line. RPM of cardiac electrophysiological conditions including the use of CIEDs has improved the quality of care and high patient satisfaction and proved to be cost-effective. The focus of this review is literature on RPM in EP, evidence from randomized trials, and observational studies including those of Apple Watch and future of CIEDs.
Recent findings:
RPM has progressed to use implantable devices and wearable technologies like sensors embedded in smartphones and apps. American College of Cardiology recently launched a digital transformation network to support digital navigation and RPM across different cardiovascular diseases. The information presented here can inform healthcare providers of the most widely implemented and effective forms of RPM for patients with chronic EP conditions.
... As demonstrated in recent studies (e.g., Hawkins et al., 2016), these data can be used to predict future cardiac events, as well as acute CHF decompensation. CIED data are typically sent to clinicians and not incorporated in patient-facing technologies (Zeitler & Piccini, 2016). However, there is an interest in displaying CIED data to patients, illustrated by recent research (e.g., Daley et al., 2017;Rohani Ghahari et al., 2018) and device vendor Medtronic's release of MyCareLink Heart™, a "portfolio of pacemakers that can communicate directly with patients' smartphones and tablets" (Medtronic plc, 2019). ...
... However, there is an interest in displaying CIED data to patients, illustrated by recent research (e.g., Daley et al., 2017;Rohani Ghahari et al., 2018) and device vendor Medtronic's release of MyCareLink Heart™, a "portfolio of pacemakers that can communicate directly with patients' smartphones and tablets" (Medtronic plc, 2019). Thus, it is reasonable to consider CIED data as another source of information for empowering patients with CHF by raising awareness about self-care and self-monitoring, delivering just-in-time alerts or recommendations, and supporting decision making (Cornet, Voida, & Holden, 2017;Mirro et al., 2018;Zeitler & Piccini, 2016). ...
Valid design of patient-centered digital health or health information technology (IT) systems is based on a thorough and accurate understanding of both “user reality” and “clinical reality.” Type 1 Design Error (User-Reality Error) occurs when designers do not accommodate user characteristics, tasks, context of use, needs, or preferences. Type 2 Design Error (Clinical-Reality Error) occurs when designers do not accommodate the clinical reality, including biomedical knowledge, clinical workflows, and organizational requirements. Both types of errors can invalidate the design, leading to products being rejected by patient end-users or their healthcare delivery systems, product non-use or inappropriate use, and risk of harm. This paper describes our attempts to achieve valid health IT design and avoid the two design errors. We performed iterative, patient-centered design to prototype a mobile application, Power to the Patient (P2P), supporting heart failure self-care management. Our multidisciplinary team of human factors, cardiology, and design experts developed and iteratively refined requirements based on data collection, review, and testing with patient research participants, a patient advisory board, a clinical advisory board, and experts on the team. We describe our process and reflect on working with multiple stakeholders toward the goal of valid health IT design.
... In [10], 21% of health remote monitoring patients are not willing to use the system device. Redundant wiring is one of the reasons in [2] as it leads to obstruction of mobility, hazard and discomfort for the babies. ...
... Redundant wiring is one of the reasons in [2] as it leads to obstruction of mobility, hazard and discomfort for the babies. While in [10,11], the efficiency of the device also needs to be considered and has yet to be analysed. Lower cost devices [12] that are more compact and [11] and have low power consumption for ease of mobility are preferred. ...
E-Health remote monitoring systems have bloomed rapidly with a myriad of applications. This paper discusses a design of a remote monitoring device for biomedical field. Four biomedical sensors which are electrocardiography (ECG), airflow, galvanic skin response and temperature with two boards which are the e-Health Shield Board V2.0 and Arduino Uno Board are used. The results show satisfactory output for each experiment using two test subjects. The device able to achieve high accuracy where percentage of temperature difference is less than 1% compared to the commercial devices with an average power consumption of each working sensor on board is ≤9W.
... South Africa (3.15%), and Ethiopia (2.54%) [15,19,21,39,40]. However, data from China, Turkey, and Spain indicate that pocket-site hematomas and infections are which could improve outcomes by identifying lead dislodgement earlier [41,42]. Pacemaker-induced tachycardia, which is uncommon these days, happened in 5.5% of patients in our study. ...
Introduction
Pacemakers (PMs) are used to treat patients with severe bradycardia symptoms. They do, however, pose several complications. Even with these risks, there are only a few studies assessing PM implantation outcomes in resource-limited settings like Ethiopia and other sub-Saharan countries in general. Therefore, this study aims to assess the mid-term outcome of PM implantation in patients who have undergone PM implantation in the Cardiac Center of Ethiopia by identifying the rate and predictors of complications and death.
Methodology
This retrospective study was conducted at the Cardiac Center of Ethiopia from October 2023 to January 2024 on patients who had PM implantation from September 2012 to August 2023 to assess the midterm outcome of the patients. Complication rate and all-cause mortality rate were the outcomes of our study. Multivariable logistic regression was used to identify factors associated with complications and death. To analyze survival times, a Kaplan–Meier analysis was performed.
Results
This retrospective follow-up study included 182 patients who underwent PM implantation between September 2012 and August 2023 and were at least 18 years old. The patients' median follow-up duration was 72 months (Interquartile range (IQR): 36–96 months). At the end of the study, 26.4% of patients experienced complications. The three most frequent complications were lead dislodgement, which affected 6.6% of patients, PM-induced tachycardia, which affected 5.5% of patients, and early battery depletion, which affected 5.5% of patients. Older age (Adjusted Odds Ratio (AOR) 1.1, 95% CI 1.04–1.1, p value < 0.001), being female (AOR 4.5, 95%CI 2–9.9, p value < 0.001), having dual chamber PM (AOR 2.95, 95%CI 1.14–7.6, p value = 0.006) were predictors of complications. Thirty-one (17%) patients died during the follow-up period. The survival rates of our patients at 3, 5, and 10 years were 94.4%, 92.1%, and 65.5% respectively with a median survival time of 11 years. Patients with a higher Charlson comorbidity index before PM implantation (AOR 1.2, 95% CI 1.1–1.8, p = 0.04), presence of complications (AOR 3.5, 95% CI 1.2–10.6, p < 0.03), and New York Heart Association (NYHA) class III or IV (AOR 3.3, 95% CI 1.05–10.1, p = 0.04) were associated with mortality.
Conclusion
Many complications were experienced by patients who had PMs implanted, and several factors affected their prognosis. Thus, it is essential to identify predictors of both complications and mortality to prioritize and address the manageable factors associated with both mortality and complications.
... Conductive yarns form the basis for the textile sensors where process such as knitting, weaving, printing of conductive polymers on nonconductive fabrics were introduced for the formation of conductive yarn 16 . Several textile based electrodes were reported for measurement of ECG [17][18][19][20][21][22][23][24][25][26] . A hybrid textile electrode has been proposed for ECG measurement 16 and motion tracking. ...
Background: Personal health monitoring with wearable electronics has gained momentum in the recent years due to its usage in flexible textile-based sensors/electrodes for recording of physiological vital parameters. Such system provides scope for long term ambulatory ECG measurement and motion tracking applications. The selection /design of textile sensors play a vital role as it has to overcome skin irritations, improve the skin-electrode impedance required for conductivity. The composition of textile materials, shape and size of the textile electrodes contributes significantly towards the conductivity. Objective: To assess the proposed Cardif system for its suitability to introduce in the clinical routine Method: The proposed textile electrodes were designed using knit jersey conductive material. The skin –contact impedance of the proposed textile material, was measured using two electrode impedance method and measurement was done for different age groups by varying the frequency. Results: The measurement results showed that the impedance was decreasing with increasing frequency and was found to be below 1.5Mohm/cm2 in the frequency range of 20Hz to 1KHz for three different age groups. The performance of the CARDIF was assessed using heart rate, RR interval, SNR as well as qualitative assessment through visual inspection and were compared with gel based disposable Ag/AgCl electrodes. Qualitative and quantitative analysis was performed and the various results confirm the proposed textile electrodes for continuous patient monitoring applications.
... RM allows for the early detection of device abnormalities and actionable patient events. For patients, this has led to fewer hospitalizations, strokes, heart failure exacerbations, and early attention to increasing arrhythmia burdens [4,5]. Those patient benefits have been realized with the convenience of transmitting from home without exposure to the health risks of physically entering hospital environments (i.e., hospital-acquired infections). ...
Background: Remote monitoring (RM) for cardiac implantable electronic devices (CIED) is a class 1A recommendation by expert consensus. RM incorporation into CIED management allows for early detection of abnormalities, improved patient satisfaction, and enhanced device clinic efficiency. Cleveland Clinic Abu Dhabi (CCAD) established the first RM program in the United Arab Emirates in 2015, with over 1000 patients enrolled. We report patient RM compliance as an indicator of the overall benefit of our service, aiming to encourage the widespread application of RM technology in the Middle East and other emerging markets. Objective: To detail the implementation and efficacy of RM service for CIED patients at CCAD to be modeled after as the standard of care for the region. Methods: Patients are enrolled in RM before hospital discharge and undergo device and wound checks one week later in the device clinic. Additional patient education is provided at that time. Subsequent follow-up includes routine in-person evaluations as well as scheduled RM transmissions. Patient compliance is measured as the proportion of received RM transmissions in relation to all scheduled transmissions. Results: A total of 1084 patients were enrolled in RM between December 2015 and May 2022. The overall RM compliance rate at 1-year post-implant was 85%. Conclusion: Our study shows that the establishment of a large-scale RM program in the Middle East region is feasible and associated with excellent patient participation and compliance. We encourage RM integration as the standard of care for CIED patients in our region and areas of the world where such integration has been lagging.
... Such devices enable re-synchronization upon the detection of cardiac anomalies and transmit via app patient's data to a physician in real-time [8]. The results demonstrate that telemonitoring has augmented beneficial effects on clinical outcomes of heart failure, including, a reduction in mortality, heart failure hospitalization, all cause hospitalization and also an improvement in Quality of Life [9][10][11][12][13][14][15][16][17][18][19][20][21]. The COVID-19 pandemic promoted an increased use of digital health for connecting physicians to patients. ...
The high health care costs and poor quality associated with heart failure have led to the development of remote patient monitoring (RPM or RM) systems and cost-effective disease management strategies. RM of cardiac implantable electronic devices (CIEDs) is the application of communication technology to patients carrying a pacemaker (PM), an implantable cardioverter defibrillator (ICD) for cardiac resynchronization therapy (CRT) or an implantable loop recorder (ILR). The aim of this study is to define and analyze the benefits of modern telecardiology to provide patients with remote clinical assistance especially for patients with implantable devices for early detection of the development of heart failure as well as the limitations inherent therein. Furthermore, the study examines the benefits of telemonitoring in chronic and cardiovascular diseases proposing holistic care. A systematic review was conducted using Preferred Reporting Items for Systematic Reviews and Meta-Analyses-PRISMA methodology. The results highlight that telemonitoring has augmented beneficial effects on clinical outcomes of heart failure, including, a reduction in mortality, heart failure hospitalization, all cause hospitalization and also an improvement in Quality of Life.
... 3 Manufacturers vary in what is considered a red vs yellow alert and in when these data get transmitted to the clinics. 178 For example, some devices provide continuous connectivity, while others provide only noncontinuous (or intermittent) connectivity. Some device RM systems are connected to a mobile transmitter, while others utilize a stationary transmitter. ...
Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.
... 3 Manufacturers vary in what is considered a red vs yellow alert and in when these data get transmitted to the clinics. 178 For example, some devices provide continuous con- ...
Abstract Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third‐party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence‐based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.
... At St. Bartholomew's Hospital, a tertiary referral hospital, the CIED clinic serves a large geographical area, covering northeast London and other external referrals. Typically, around 95% of patients complete remote downloads in the comfort of their own home, which can decrease financial costs for both patients and healthcare systems while improving patient satisfaction [12]. Previously, once AF was detected and a decision was made to anticoagulate, patients' general practitioners (GP) were informed, via a clinical letter, of the diagnosis and guidance to have the patient start anticoagulation. ...
For patients with cardiac implantable electronic devices (CIEDs), arrythmias such as atrial fibrillation (AF) can be detected and actions taken to rapidly assess and initiate treatment where appropriate. Actions include timely initiation of anticoagulation, review of blood pressure, and optimization of cholesterol/lipids to prevent unfavorable outcomes, such as stroke and other cardiovascular complications. Delays to initiating anticoagulation can have devastating consequences. We sought to implement a virtual clinic, where a pharmacist reviews patient referrals from a CIED clinic after detecting AF from the CIED. Anticoagulation choice is determined by patient-specific factors, and a shared patient–provider decision to start oral anticoagulation is made. In addition, blood pressure readings and medications are assessed with lipid-lowering therapies for optimization. A total of 315 patients have been admitted through this clinic and anticoagulated over a two-year span; in addition, 322 successful interventions were made for optimization of cardiac therapy. Rapid initiation of anticoagulation within five days of referral was likely to have reduced unfavorable outcomes, such as stroke and other cardiovascular optimizations, leading to improved patient outcomes.
... Firstly, most CIEDs today hold a record of all VTs and nsVTs that fulfil sensor criteria. 28 Thus, a reliable estimation of patients' arrhythmic burden can be derived by interrogating these devices. Secondly, due to the relatively high cost of implantation, ICDs are only covered by the Greek public health system if patients have had a documented episode of aborted cardiac death, VT or VF, or inducible VT/VF during an electrophysiology study study, and thus, our patient cohort suffers increased risk of ventricular arrhythmias. ...
Aims:
The Iron Intravenous Therapy in Reducing the burden of Severe Arrhythmias in HFrEF (RESAFE-HF) registry study aims to provide real-word evidence on the impact of intravenous ferric carboxymaltose (FCM) on the arrhythmic burden of patients with heart failure with reduced ejection fraction (HFrEF), iron deficiency (ID), and implanted cardiac implantable electronic devices (CIEDs).
Methods and results:
The RESAFE-HF (NCT04974021) study was designed as a prospective, single-centre, and open-label registry study with baseline, 3, 6, and 12 month visits. Adult patients with HFrEF and CIEDs scheduled to receive IV FCM as treatment for ID as part of clinical practice were eligible to participate. The primary endpoint is the composite iron-related endpoint of haemoglobin ≥ 12 g/dL, ferritin ≥ 50 ng/L, and transferrin saturation > 20%. Secondary endpoints include unplanned HF-related hospitalizations, ventricular tachyarrhythmias detected by CIEDs and Holter monitors, echocardiographic markers, functional status (VO2 max and 6 min walk test), blood biomarkers, and quality of life. In total, 106 patients with a median age of 72 years (14.4) were included. The majority were male (84.9%), whereas 92.5% of patients were categorized to New York Heart Association II/III. Patients' arrhythmic burden prior to FCM administration was significant-19 patients (17.9%) received appropriate CIED therapy for termination of ventricular tachyarrhythmia in the preceding 12 months, and 75.5% of patients have frequent, repetitive multiform premature ventricular contractions.
Conclusions:
The RESAFE-HF trial is expected to provide evidence on the effect of treating ID with FCM in HFrEF based on real-world data. Special focus will be given on the arrhythmic burden post-FCM administration.
... We verified a high acceptance of this technology with professionals and patients. 31 ...
Background
The remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) has become a common method of in-home monitoring and follow-up in high-income countries given its effectiveness, safety, convenience, and the possibility of early intervention. However, in Brazil, RM is still underutilized.
Objectives
This observational study aims to demonstrate our experience of using RM in Brazil and the predictive factors of RM of CIED follow-up in Brazil.
Methods
This was a prospective cohort study of patients with a CIED. Event rates are reported and clinical responses to those findings and outcomes based on the detection of RM. A logistic regression model was performed to identify predictors of more events, with P < .05 for statistical significance.
Results
This study evaluated consecutive 119 patients: 30.2% with pacemakers, 42.8% with implantable cardioverter-defibrillator, 22.7% with cardiac resynchronization therapy (CRT) with defibrillator, and 3.3% with CRT with pacemaker. Events were detected in 63.9% of the cases in 29.5 ± 23 months of follow-up. The outcomes found were that 44.5% needed elective evaluation in medical treatment and 23.5% needed immediate evaluation in therapy. Logistic regression analysis showed that the groups with CRT or CRT with defibrillator (75.0%), reduced ejection fraction (76.5%), and New York Heart Association functional class ≥II (75.0%) had the highest RM event rates.
Conclusions
RM proved to be effective and safe in the follow-up of patients with CIEDs in Brazil, allowing early interventions and facilitating therapeutic management.
... An analysis of Boston Scientific devices linked to the NCDR-ICD registry showed that when race was not identified as White, there was an associated lower rate of both remote monitoring enrollment and activation. 51 This is critically important because remote monitoring has been associated with a broad range of clinical, economic, and quality-of-life benefits 52 and is recommended for all eligible patients. 53 ...
Racial and ethnic differences in treatment—cardiovascular and otherwise—have been documented in many aspects of the American health care system and can be seen in implantable cardioverter-defibrillator (ICD) patient selection, counseling, and management. ICDs have been demonstrated to be a powerful tool in the prevention of sudden cardiac death, yet uptake across all eligible patients has been modest. Although patients who do not identify as White are disproportionately eligible for ICDs in the United States, they are less likely to see specialists, be counseled on ICDs, and ultimately have an ICD implanted. This review explores racial and ethnic differences demonstrated in ICD patient selection, outcomes including shock effectiveness, and postimplantation monitoring for both primary and secondary prevention devices. It also highlights barriers for uptake at the health system, physician, and patient levels and suggests areas of further research needed to clarify the differences, illuminate the driving forces of these differences, and investigate strategies to address them.
... Some patients may additionally have a 'remote monitor' that allows communication with the device without requiring face-to-face follow-up. 7 Remote monitoring is performed via a secure webbased platform. It has evolved to automatic data acquisition on a frequent basis with unscheduled transmission of predefined alerts to the CIED provider (device clinic). ...
... There are numerous publications both from randomized clinical trials and large real-world cohorts showing the clinical and economic benefits of RM in traditional CIEDs, such as pacemakers, defibrillators, and cardiac resynchronization therapy devices. 18 Therefore, international physician societies have designated RM as a class I indication For comparison between age groups, patients younger than 55 years of age were used as a reference group, which all other age groups were compared against. *The number of patients only includes those with at least two transmissions. ...
While previous generations of insertable cardiac monitors (ICMs) required a bedside monitor for remote monitoring (RM), the Confirm Rx™ ICM (Abbott, Chicago, IL, USA) utilizes Bluetooth®, Wi-Fi/cellular technology, and a smart device to connect to the RM system. We aimed to characterize compliance, connectivity, and event transmission timing with the Confirm Rx™ ICM RM system. The study cohort included American patients who received the Confirm Rx™ ICM with SharpSense™ technology within three months of release (May-July 2019). Compliance with RM was quantified as the proportion of patients registering the patient app on their smart device and transmitting at least once. Connectivity was measured as the median number of days between consecutive transmissions per patient. Event transmission time was measured from episode detection to availability on the Merlin.net™ RM system (Abbott). Time from transmission until review by a clinician was examined. Values for device connectivity, episode transmission timing, and clinician view times were reported as median [first quartile, third quartile]. Of 5,666 patients who received a Confirm Rx™ ICM, 97% registered their patient app and 92% transmitted data at least once. Among those utilizing RM (aged 66 ± 15 years; 49% female), connectivity occurred every 1.5 [1.2, 2.4] days, or 4.7 times per week. Patient-reported symptoms were transmitted to Merlin.net™ within 2.9 [2.1, 3.8] minutes of event onset and viewed by the clinician within 0.9 [0.4, 3.1] days, while device-detected episodes without symptoms were transmitted within 18.5 [11.2, 36.5] hours and then viewed within 0.8 [0.3, 2.5] days. This real-world study demonstrated excellent patient compliance with the smartphone-based RM paradigm enabled by Confirm Rx™, suggesting the suitability of this technology for future cardiac implantable devices.
... The key component of our protocol was remote surveillance of implanted CIEDs supplemented by regular office visits. Modern CIEDs have a greatly increased capacity to determine arrhythmic changes and report such changes quickly [11]. Remote monitoring technology also provides other necessary non-arrhythmia alerts, such as heart failure status, patients' activity levels, battery status of the device, pacing, and integrity of the defibrillator leads, etc. [12]. ...
Background:
Antiarrhythmic drugs are often used in the management of patients with atrial fibrillation (AF). Sotalol is conventionally initiated in the inpatient setting for monitoring efficacy and adverse effects, including QTc interval prolongation and torsades de pointes (TdP) proarrhythmia.
Objective:
We aimed to evaluate the efficacy and safety of outpatient initiation of sotalol for the treatment of AF in a select group of patients with cardiac implantable electronic devices (CIEDs): permanent pacemakers (PPMs), implantable cardioverter defibrillators (ICDs), and implantable loop recorders (ILRs) capable of continuous rhythm monitoring remotely.
Methods:
We conducted our clinical study in a real-world practice setting with longitudinal follow-up of the study cohort. We included adult patients with symptomatic paroxysmal and persistent AF eligible for sotalol for rhythm control strategy and who had CIEDs in our study. Patients with a known contraindication to sotalol were excluded. After making a shared management decision with patients, sotalol was initiated as an outpatient, with regular clinical encounters with patients to assess the efficacy and safety of treatment, and monitoring cardiac rhythm and QTc intervals with CIEDs utilizing their remote monitoring platforms.
Results:
The study cohort comprised 105 patients; 38 (36%) females, mean age ± standard deviation (SD) 73.9 ± 10.36 years, and with a CHA2DS2-VASc score of 3.26 ± 1.37 and left ventricular ejection fraction of 60.16 ± 9.10%. Twenty-six (24.8%) patients were implanted with PPMs, 10 (9.5%) with dual-chamber ICDs, and 69 (65.7%) with ILRs. Over a follow-up period of 23 ± 15 months, sotalol was continued at a steady median dose of 80 mg twice daily, 105 ± 42 mg (mean ± SD) in 77 (73%) patients who maintained sinus rhythm, and discontinued in 28 (27%) patients because of inefficacy or development of adverse effects. No adverse effects relating to QTc prolongation and TdP or mortality were observed during the study period.
Conclusions:
Effective and safe outpatient initiation and maintenance of sotalol therapy is possible in select patients who have CIEDs for continuous remote monitoring and surveillance capabilities.
... 11 The evolution and maturation of remote monitoring of cardiac implantable electronic devices (CIEDs) could serve as a useful paradigm for technology-enabled arrhythmia management. 12 Developed in the late 1990s, remote monitoring of CIEDs has tailored clinician-facing software applications, robust electronic health record integration, mature workflows, stable reimbursement, a large body of observational and trial evidence informing professional society guidelines, and even a career path for allied health professionals, who are a critical constituency of the Heart Rhythm Society. ...
... 7 The remote monitoring of CIEDs has also been shown to reduce health-care utilization, decrease time to clinical decision-making, and reduce inappropriate shocks in patients with implantable cardioverter-defibrillators. 8 We acknowledge that telemedicine is not appropriate for all patients. Certain degrees of technical savviness and health literacy are required on the patient's part to enable them to participate fully in the visit. ...
... The automation of health monitoring systems cannot fully replace physical patient monitoring, where a patient gets a chance to directly interact with a health physician. The utilization of automated e-health systems can save time and reduce the amount of resources required in cases of emergency [6]. ...
Cardiac implantable electronic devices (CIEDs) have shown to improve autonomy, quality of life, morbidity and mortality (relative reduction of mortality by 30% at 3 years follow-up) [1]. However, CIEDs possess a cyber vulnerability. With these exemplary safety concerns, we theorise: 1) Cybersecurity risks are difficult for medical institutions to plan (ambiguous nature of threat), which results in ineffective cyber defense measures, 2) Cyber threats can impair trust in the device, treatment plan and patient-provider relationship; and 3) As CIEDs “go” with the patient and the cyber risk can not be quantified, patients’ stress levels are higher from the perceived cyber threats than from a technical malfunction.From a literature review and subsequent position paper submission, the rationale for the research project was formulated. The methodology consists of two qualitative studies assessing both providers’ and patients’ perspectives of cybersecurity risks with CIEDs and a risk assessment of CIED manufacturer manuals. For designing the two qualitative studies, we postulated: 1) providers lack understanding about cybersecurity risks with CIEDs and thus do not include these risks in the informed consent due to either “not wanting to raise patients’ anxiety levels except for known serious adverse events”, or not wanting to “extend time with consenting patients for low-probability issues” [13] and 2) patients are not aware of the cyber risks with CIEDs. From the results of these studies, we plan to develop white papers to promote standards and guidelines for cybersecurity related risks with CIEDs to the inform consent-processes as well as manufacturers’ manuals.KeywordsCybersecurity VulnerabilityCardiac Implantable Electronic DevicesPerceived Cyber Risks and Threats
Although the concepts of pacing have been around for more than half a century, technological advances in cardiac implantable electronic devices (CIEDs) have changed the landscape for patients in need of pacing support or sudden death prevention. Nurses encounter patients with CIEDs in all aspects of the health care setting. Because exciting CIED therapies are on the horizon, nurses must stay up-to-date to promote optimal outcomes for CIED patients. This essential guide provides nurses with a comprehensive overview of the principles of pacing and implantable cardioverter defibrillators (ICDs), as well as innovative technologies such as leadless cardiac pacemakers and subcutaneous ICDs.
Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.
Migration of surgical and other procedures that require anesthesia care from a hospital to a free-standing ambulatory surgery center (ASC) continues to grow. Patients with cardiac implantable electronic devices (CIED) might benefit from receiving their care in a free-standing ASC setting. However, these patients have cardiovascular comorbidities that can elevate the risk of major adverse cardiovascular events. CIEDs are also complex devices and perioperative management varies between devices marketed by various manufacturers and require consultation and ancillary services, which may not be available in a free-standing ASC. Thus, perioperative care of these patients can be challenging. Therefore, the suitability of this patient population in a free-standing ASC remains highly controversial. Although applicable advisories exist, considerable discussion continues with surgeons and other proceduralists about the concerns of anesthesiologists. In this Pro-Con commentary article, we discuss the arguments for and against scheduling a patient with a CIED in a free-standing ASC.
Spurred by federal legislation, professional organizations, and patients themselves, patient access to data from electronic cardiac devices is increasingly transparent. Patients can collect data through consumer devices and access data traditionally shared only with health care providers. These data may improve screening, self-management, and shared decision-making for cardiac arrhythmias, but challenges remain, including patient comprehension, communication with providers, and sustained engagement. Ways to address these challenges include leveraging visualizations that support comprehension, involving patients in designing and developing patient-facing digital tools, and establishing clear practices and goals for data exchange with health care providers.
Background:
The number of patients with cardiac implantable electronic devices (CIEDs) is growing, creating substantial workload for device clinics.
Objective:
This study aimed to characterize the workflow and quantify clinic staff time requirements to manage CIED patients.
Methods:
A time and motion workflow evaluation was performed in 11 US and European CIED clinics. Workflow tasks were repeatedly timed during one business week of observation at each clinic. Observations were inclusive of all device models/manufacturers present. Mean cumulative staff time required to review a Remote device transmission and for an In-person clinic visit were calculated, including all necessary clinical and administrative tasks. Annual staff time for follow-up of 1 CIED patient was modeled using CIED transmission volumes, clinical guidelines, and published literature.
Results:
A total of 276 in-person clinic visits and 2,173 remote monitoring activities were observed. Mean staff time required per remote transmission ranged from 9.4-13.5 minutes for therapeutic devices (pacemaker, ICD, CRT) and 11.3-12.9 mins for diagnostic devices (insertable cardiac monitors (ICMs)). Mean staff time per in-person visit ranged from 37.8-51.0 mins and 39.9-45.8 mins, for therapeutic devices and ICMs respectively. Including all remote and in-person follow-ups, the estimated annual time to manage one CIED patient ranged from 1.6-2.4 hours for therapeutic devices and 7.7-9.3 hours for ICMs.
Conclusions:
CIED patient management workflow is complex and requires significant staff time. Understanding process steps and time requirements informs implementation of efficiency improvements, including remote solutions. Future research should examine the heterogeneity in patient management processes to identify the most efficient workflows.
Clinicaltrial:
Policy Points Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Our analysis of health privacy laws indicates that most US patients may have little access to their own digital health data in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation and the California Consumer Privacy Act grant greater access to device-collected data. Our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices.
Context:
Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Whether patients have either legal or normative claims to data collected by these devices, particularly in the raw, granular format beyond that summarized in their medical records, remains incompletely explored.
Methods:
Using pacemakers and implantable cardioverter-defibrillators (ICDs) as a clinical model, we outline the clinical ecosystem of data collection, relay, retrieval, and documentation. We consider the legal implications of US and European privacy regulations for patient access to either summary or raw device data. Lastly, we evaluate ethical arguments for or against providing patients access to data beyond the summaries presented in medical records.
Findings:
Our analysis of applicable health privacy laws indicates that US patients may have little access to their raw data collected and held by device manufacturers in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation (GDPR) grants greater access to device-collected data when the processing of personal data falls under the GDPR's territorial scope. The California Consumer Privacy Act, the "little sister" of the GDPR, also grants greater rights to California residents. By contrast, our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. Smartphone applications are increasingly involved in the collection, relay, retrieval, and documentation of these data. Therefore, we argue that smartphone user agreements are an emerging but potentially underutilized opportunity for clarifying both legal and ethical claims for device-derived data.
Conclusions:
Current health privacy legislation incompletely supports patients' normative claims for access to digital health data.
The field of mechanical circulatory support is changing rapidly due to multiple factors. Innovations in pump design have led to improved hemocompatibility and reduced adverse events, yet essential challenges remain including managing an aging population of patients with multiple comorbid conditions. Fiscal constraints are also creating pressure to deliver ongoing care for patients supported on mechanical circulatory support outside of the hospital. In this chapter, we discuss these different drivers of change as well as potential solutions including through the use of digital health technology and mobile health devices.
Sotalol, a Vaughan-Williams Class III antiarrhythmic medication, is used to manage atrial arrhythmias. Due to its QT-prolonging effect and subsequent increased risk of torsade de pointes, many centers admit patients during the initial dosing period. Despite its widespread use, little information is available regarding dosing protocols during this period. In this multicenter investigation, dosing protocols in patients initiating sotalol therapy were examined to identify predictors of successful sotalol initiation. Over a 4-year period, patients admitted to 5 hospitals in the United States for inpatient telemetry monitoring during initiation for nonresearch purposes were enrolled. A 3-day course of 5 of 6 doses of sotalol was considered successful completion of the loading protocol. Of the 213 enrolled patients, over 90% were successfully discharged on sotalol. Significant bradycardia, ineffectiveness, and excessive QT prolongation were reasons for failed completion. Absence of a dose adjustment was a strong predictor of successful initiation (odds ratio: 6.6, 95% confidence interval: 1.3-32.7, P = .02). Hypertension, use of a calcium channel blocker, use of a separate β-blocker, and presence of a pacemaker were predictors of dose adjustments. Marginal structural models (ie, inverse probability weighting based on probability of a dose adjustment) verified that these factors also predicted successful initiation via preventing any dose adjustment and suggests that considering these factors may result in a higher likelihood of successful initiation in future investigations. In conclusion, we found that the majority of patients admitted for sotalol initiation are successfully discharged on the medication. The study findings suggest that factors predicting need for dose adjustment can be used to identify patients who could undergo outpatient initiation. Prospective studies are needed to verify this approach.
Influenza is associated with an increased risk of cardiovascular events. Influenza's association with ventricular arrhythmias (VAs) has not been adequately studied. We investigated the relation of seasonal influenza activity with the incidence of VAs requiring therapy in patients with an implantable cardiac defibrillator or cardiac resynchronization therapy defibrillator. We retrospectively studied 163,831 patients with an implantable cardiac defibrillator or cardiac resynchronization therapy defibrillator who were enrolled in the Abbott Medical Merlin.net remote-monitoring network between January 2009 and December 2015. We used cross-correlation to assess the temporal relationship between influenza activity and the incidence of VAs requiring shock or antitachycardia pacing (ATP). We used a generalized linear model to test the possible effect of seasonal influenza activity on the occurrence of VAs requiring shock or ATP treatment, after adjustment for within-patient effects, age, gender, device type, and calendar year. We found a significant correlation between influenza activity and the incidence of VAs requiring shock or ATP treatment. The multivariate generalized linear model showed that during high influenza activity, patients were more likely to have a VA treated with shock (odds ratio = 1.06, p < 0.001) or ATP (odds ratio = 1.06, p < 0.0001). The impact of high influenza activity was most prominent during the years 2014 and 2015. We conclude that high influenza activity is associated with increased risk of VAs requiring therapy.
Purpose of review:
Recent evidence has demonstrated substantial benefits associated with remote monitoring of cardiac implantable electronic devices (CIEDs), and treatment guidelines have endorsed the use of remote monitoring. Familiarity with the features of remote monitoring systems and the data supporting its use are vital for physicians' care for patients with CEIDs.
Recent findings:
Remote monitoring remains underutilized, but its use is expanding including in new practice settings including emergency departments. Patient experience and outcomes are positive, with earlier detection of clinical events such as atrial fibrillation, reductions in inappropriate implantable cardioverter-defibrillator (ICD) shocks and potentially a decrease in mortality with frequent remote monitoring utilizaiton. Rates of hospitalization are reduced among remote monitoring users, and the replacement of outpatient follow-up visits with remote monitoring transmissions has been shown to be well tolerated. In addition, health resource utilization is lower and remote monitoring has been associated with considerable cost savings. A dose relationship exists between use of remote monitoring and patient outcomes, and those with early and high transmission rates have superior outcomes.
Summary:
Remote monitoring provides clinicians with the ability to provide comprehensive follow-up care for patients with CIEDs. Patient outcomes are improved, and resource utilization is decreased with appropriate use of remote monitoring. Future efforts must focus on improving the utilization and efficiency of remote monitoring.
The field of arrhythmia monitoring is changing rapidly. The rapid advent of technology in combination with marked improvements in cellular communication and an increased desire by patients to be actively engaged in their care has ushered in a new era of clinical care. Today, physicians need to think about their patients outside the traditional in-office setting. Two technologies that embody this changing landscape are smartphone-based electrocardiographic (ECG) monitors and remote monitoring of cardiac implantable electronic devices (CIEDs). Smartphone-based ECG monitors allow the patient to assume a greater stake in their own care. They purchase the monitor, couple it to their smartphone, own it forever, and can capture a representative ECG whenever they want to assess symptoms. The physician needs to accept that this approach is vastly different from the use of standard ambulatory external ECG monitors that have been used for years in clinical practice. A similar paradigm shift is underway with respect to the care of the CIED patient. Remote follow-up was once considered an acceptable alternative to in-office calendar-based follow-up of CIEDs. Today, guidelines recommend remote monitoring to be the preferred method for device follow-up. Remote monitoring is tailor made for the current evolution to a value-based healthcare system, having been demonstrated to reduce scheduled office visits, hospital admissions, and mortality. It is now time to educate patients and physicians on the value of remote monitoring and to ensure that clinical practices develop the infrastructure needed to enroll, monitor, and manage their patients.
Purpose:
Currently, cardiac implantable electronic devices allow remote monitoring (RM) based on periodic (Boston Latitude [LAT], Medtronic Carelink [MCL], St. Jude Merlin [SJM]) or daily transmissions (Biotronik Home Monitoring [BHM]). The aim of this study was to compare all the current RM systems in normal practice and investigate the effect of periodicity of RM transmissions on early detection of clinical and device-related events.
Methods:
Two hundred eleven ICD patients (mean age 69 ± 11 years, 158 males), were remotely followed up for 1 year (61 with BHM, 49 with LAT, 65 with MCL, 36 with SJM). Remote follow-ups were configured quarterly, except for the BHM (daily transmissions).
Results:
The event-free rates were 49 % with BHM, 57 % with LAT, 57 % with MCL, and 58 % with SJM (long-rank, p = 0.23). BHM generated 304 (interquartile range, 184-342) transmissions per patient in a year, LAT 9 (8-11), MCL 7 (5-10), and SJM 8 (7-14) (p < 0.000001). Eighty actionable events occurred at 1 year follow-up, 69 (86 %) with RM systems: BHM was associated with a higher cumulative rate of actionable events. At a multivariate analysis, daily transmissions were independently associated with an increased probability of event detection as compared to periodic transmission systems. The chance of event detection is reduced by 20 % (p = 0.036) for a 1-month increase of the between-transmission interval (27 % for actionable events, p = 0.004).
Conclusions:
Although all RM systems effectively detected major events, daily transmission was associated with a higher probability of early event detection.
Demographic and technological changes are driving increased utilization of cardiac implantable electronic devices (CIEDs) remote monitoring. In the USA, fee-for-service model of healthcare delivery, services rendered are valued based upon time, intensity, and technical or practice expense costs. As a consequence of this perspective, and to contain spending, Medicare has grouped physician services into families. Spending within each family of services must, by law, remain budget neutral. Cardiac implantable electronic devices monitoring services, remote and in-person, are grouped into one family. As the volume of services within this family increases, the individual encounters are destined to be discounted into ever decreasing portions. However, if the value of remote monitoring is demonstrated to extend beyond the previous boundaries of in-person interrogations, a rational request can be made to reconsider the relative value of remote monitoring. Outcome data supporting the value-added benefits of remote monitoring are rapidly accumulating, including (i) patient convenience, with reduced use of office services, (ii) equal safety compared with in-person evaluation, (iii) shorter detection time to actionable events (arrhythmias, cardiovascular disease progression, and device malfunction), (iv) reduced length of stay for hospitalizations, (v) reduced inappropriate shocks, (vi) increased battery longevity, and (vii) a relative reduction in the risk of death. Fully automatic wireless technology, only recently widely implemented, will add considerable clinical efficiencies and further increase the value of remote monitoring. The U.S. challenge will be to appropriately define the relative value of CIEDs remote monitoring now that outcome data have demonstrated its value extends beyond in-person interrogation. Published on behalf of the European Society of Cardiology. All rights reserved.
Aims
The Effectiveness and Cost of ICD follow-up Schedule with Telecardiology (ECOST) trial evaluated prospectively the economic impact of long-term remote monitoring (RM) of implantable cardioverter defibrillators (ICDs).
Methods and results
The analysis included 310 patients randomly assigned to RM (active group) vs. ambulatory follow-ups (control group). Patients in the active group were seen once a year unless the system reported an event mandating an ambulatory visit, while patients in the control group were seen in the ambulatory department every 6 months. The costs of each follow-up strategy were compared, using the actual billing documents issued by the French health insurance system, including costs of (i) (a) ICD-related ambulatory visits and transportation, (b) other ambulatory visits, (c) cardiovascular treatments and procedures, and (ii) hospitalizations for the management of cardiovascular events. The ICD and RM system costs were calculated on the basis of the device remaining longevity at the end of the study. The characteristics of the study groups were similar. Over a follow-up of 27 months, the mean non-hospital costs per patient-year were €1695 ± 1131 in the active, vs. €1952 ± 1023 in the control group (P = 0.04), a €257 difference mainly due to device management. The hospitalization costs per patient-year were €2829 ± 6382 and €3549 ± 9714 in the active and control groups, respectively (P = 0.46). Adding the ICD to the non-hospital costs, the savings were €494 (P = 0.005) or, when the monitoring system was included, €315 (P = 0.05) per patient-year.
Conclusion
From the French health insurance perspective, the remote management of ICD patients is cost saving.
Clinical trials registration
NCT00989417, www.clinicaltrials.gov
Aim
Remote follow-up (FU) of implantable cardiac defibrillators (ICDs) allows for fewer in-office visits in combination with earlier detection of relevant findings. Its implementation requires investment and reorganization of care. Providers (physicians or hospitals) are unsure about the financial impact. The primary end-point of this randomized prospective multicentre health economic trial was the total FU-related cost for providers, comparing Home Monitoring facilitated FU (HM ON) to regular in-office FU (HM OFF) during the first 2 years after ICD implantation. Also the net financial impact on providers (taking national reimbursement into account) and costs from a healthcare payer perspective were evaluated.
Methods and results
A total of 312 patients with VVI- or DDD-ICD implants from 17 centres in six EU countries were randomised to HM ON or OFF, of which 303 were eligible for data analysis. For all contacts (in-office, calendar- or alert-triggered web-based review, discussions, calls) time-expenditure was tracked. Country-specific cost parameters were used to convert resource use into monetary values. Remote FU equipment itself was not included in the cost calculations. Given only two patients from Finland (one in each group) a monetary valuation analysis was not performed for Finland. Average age was 62.4 ± 13.1 years, 81% were male, 39% received a DDD system, and 51% had a prophylactic ICD. Resource use with HM ON was clearly different: less FU visits (3.79 ± 1.67 vs. 5.53 ± 2.32; P < 0.001) despite a small increase of unscheduled visits (0.95 ± 1.50 vs. 0.62 ± 1.25; P < 0.005), more non-office-based contacts (1.95 ± 3.29 vs. 1.01 ± 2.64; P < 0.001), more Internet sessions (11.02 ± 15.28 vs. 0.06 ± 0.31; P < 0.001) and more in-clinic discussions (1.84 ± 4.20 vs. 1.28 ± 2.92; P < 0.03), but with numerically fewer hospitalizations (0.67 ± 1.18 vs. 0.85 ± 1.43, P = 0.23) and shorter length-of-stay (6.31 ± 15.5 vs. 8.26 ± 18.6; P = 0.27), although not significant. For the whole study population, the total FU cost for providers was not different for HM ON vs. OFF [mean (95% CI): €204 (169–238) vs. €213 (182–243); range for difference (€−36 to 54), NS]. From a payer perspective, FU-related costs were similar while the total cost per patient (including other physician visits, examinations, and hospitalizations) was numerically (but not significantly) lower. There was no difference in the net financial impact on providers [profit of €408 (327–489) vs. €400 (345–455); range for difference (€−104 to 88), NS], but there was heterogeneity among countries, with less profit for providers in the absence of specific remote FU reimbursement (Belgium, Spain, and the Netherlands) and maintained or increased profit in cases where such reimbursement exists (Germany and UK). Quality of life (SF-36) was not different.
Conclusion
For all the patients as a whole, FU-related costs for providers are not different for remote FU vs. purely in-office FU, despite reorganized care. However, disparity in the impact on provider budget among different countries illustrates the need for proper reimbursement to ensure effective remote FU implementation.
Background:
Current guidelines recommend at least 24 hours of electrocardiographic (ECG) monitoring after an ischemic stroke to rule out atrial fibrillation. However, the most effective duration and type of monitoring have not been established, and the cause of ischemic stroke remains uncertain despite a complete diagnostic evaluation in 20 to 40% of cases (cryptogenic stroke). Detection of atrial fibrillation after cryptogenic stroke has therapeutic implications.
Methods:
We conducted a randomized, controlled study of 441 patients to assess whether long-term monitoring with an insertable cardiac monitor (ICM) is more effective than conventional follow-up (control) for detecting atrial fibrillation in patients with cryptogenic stroke. Patients 40 years of age or older with no evidence of atrial fibrillation during at least 24 hours of ECG monitoring underwent randomization within 90 days after the index event. The primary end point was the time to first detection of atrial fibrillation (lasting >30 seconds) within 6 months. Among the secondary end points was the time to first detection of atrial fibrillation within 12 months. Data were analyzed according to the intention-to-treat principle.
Results:
By 6 months, atrial fibrillation had been detected in 8.9% of patients in the ICM group (19 patients) versus 1.4% of patients in the control group (3 patients) (hazard ratio, 6.4; 95% confidence interval [CI], 1.9 to 21.7; P<0.001). By 12 months, atrial fibrillation had been detected in 12.4% of patients in the ICM group (29 patients) versus 2.0% of patients in the control group (4 patients) (hazard ratio, 7.3; 95% CI, 2.6 to 20.8; P<0.001).
Conclusions:
ECG monitoring with an ICM was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke. (Funded by Medtronic; CRYSTAL AF ClinicalTrials.gov number, NCT00924638.).
Current guidelines recommend using remote patient monitoring (RPM) for implantable cardioverter-defibrillators (ICD), but the patterns of adoption of this technology have not been described. Successful use of RPM depends on: 1) enrollment of the patient into an RPM system and 2) subsequent activation of RPM by the enrolled patient. We examined RPM enrollment and activation rates and the patient, physician, and institutional determinants of RPM use.
Information about the use of RPM-capable devices was obtained from the Boston Scientific Corporation (BSC) ALTITUDE program and linked to the NCDR® ICD Registry™. Patients were first categorized as "RPM-enrolled" and "RPM-not enrolled" and the RPM-enrolled patients were further categorized into "RPM-active" and "RPM-inactive" groups based on whether they transmitted RPM data. Variables associated with RPM enrollment and activation were identified using multivariable logistic regression. Among 39,158 patients with newly-implanted RPM-capable devices, 62% (n=24,113) were RPM-enrolled. Of those enrolled, 76% (n=18,289, or 47% of the entire cohort) activated their device. RPM enrollment was highly variable among institutions. The hospital-specific median odds ratio for RPM enrollment was 3.43, signifying that physician/institutional factors are associated with RPM enrollment. In contrast, the hospital-specific median odds ratio for RPM activation was 1.69. Age, race, health insurance, geographic location and health-related factors were similarly associated with both RPM enrollment and activation.
RPM technology is used in less than half of eligible patients. Lack of enrollment into RPM systems is the major cause of under-utilization and this primarily relates to the local practice environment.
Remote monitoring (RM) in patients with advanced heart failure and cardiac resynchronization therapy defibrillators (CRT-D) may reduce delays in clinical decisions by transmitting automatic alerts. However, this strategy has never been tested specifically in this patient population, with alerts for lung fluid overload, and in a European setting.
The main objective of Phase 1 (presented here) is to evaluate if RM strategy is able to reduce time from device-detected events to clinical decisions.
In this multicenter randomized controlled trial, patients with moderate to severe heart failure implanted with CRT-D devices were randomized to a Remote group (with remote follow-up and wireless automatic alerts) or to a Control group (with standard follow-up without alerts). The primary endpoint of Phase 1 was the delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year.
The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25(th)-75(th) percentile, 1-4) days vs 29 (25(th)-75(th) percentile, 3-51) days respectively, P=.004. In-hospital visits were reduced in the Remote group (2.0 visits/patient/year vs 3.2 visits/patient/year in the Control group, 37.5% relative reduction, P<.001). Automatic alerts were successfully transmitted in 93% of events occurring outside the hospital in the Remote group. The annual rate of all-cause hospitalizations per patient did not differ between the two groups (P=.65).
RM in CRT-D patients with advanced heart failure allows physicians to promptly react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits.
Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF).
The rapidly increasing number of patients with implantable cardioverter-defibrillators (ICD) places a large burden on follow-up providers. This study investigated the possibility of longer in-office follow-up intervals in primary prevention ICD patients under remote monitoring with automatic daily data transmissions from the implant memory.
Conducted in 155 ICD recipients with MADIT II indications, the study compared the burden of scheduled and unscheduled ICD follow-up visits, quality of life (SF-36), and clinical outcomes in patients randomized to either 3- or 12-month follow-up intervals in the period between 3 and 27 months after implantation. Remote monitoring (Biotronik Home Monitoring) was used equally in all patients. In contrast to previous clinical studies, no calendar-based remote data checks were performed between scheduled in-office visits. Compared with the 3-month follow-up interval, the 12-month interval resulted in a minor increase in the number of unscheduled follow-ups (0.64 vs. 0.27 per patient-year; P = 0.03) and in a major reduction in the total number of in-office ICD follow-ups (1.60 vs. 3.85 per patient-year; P < 0.001). No significant difference was found in mortality, hospitalization rate, or hospitalization length during the 2-year observation period, but more patients were lost to follow-up in the 12-month group (10 vs. 3; P = 0.04). The SF-36 scores favoured the 12-month intervals in the domains 'social functioning' and 'mental health'.
In prophylactic ICD recipients under automatic daily remote monitoring, the extension of the 3-month in-office follow-up interval to 12 months appeared to safely reduce the ICD follow-up burden during 27 months after implantation.
NCT00401466 (http://www.clinicaltrials.gov/ct2/show/NCT00401466).
Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up.
We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators.
Two hundred patients implanted with a wireless transmission-enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained.
Overall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution.
Remote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations.
ClinicalTrials.gov NCT00873899; http://clinicaltrials.gov/show/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f).
Aims
The need for ongoing and lifelong follow-up (FU) of patients with cardiac implantable electric devices (CIED) requires significant resources. Remote CIED management has been established as a safe alternative to conventional periodical in-office FU (CFU). An economic model compares the long-term cost and consequences of using daily Home Monitoring® (HM) instead of CFU.
Methods and results
A cost–consequence evaluation comparing HM vs. CFU was performed using a Markov cohort model and data relating to events and costs identified via a systematic review of the literature. The model is conservative, without assuming a reduction of cardiovascular events by HM such as decompensated heart failure or mortality, or considering cost savings such as for transportation. Also cost savings due to an improved timing of elective device replacement, and fewer FU visits needed in patients near device replacement are not considered. Over 10 years, HM is predicted to be cost neutral at about GBP 11 500 per patient in either treatment arm, with all costs for the initial investment into HM and fees for ongoing remote monitoring included. Fewer inappropriate shocks (−51%) reduce the need for replacing devices for battery exhaustion (−7%); the number of FU visits is predicted to be halved by HM.
Conclusion
From a UK National Health Service perspective, HM is cost neutral over 10 years. This is mainly accomplished by reducing the number of battery charges and inappropriate shocks, resulting in fewer device replacements, and by reducing the number of in-clinic FU visits.
Introduction
Few data are available on actual follow-up costs of remote monitoring (RM) of implantable defibrillators (ICD). Our study aimed at assessing current direct costs of 1-year ICD follow-up based on RM compared with conventional quarterly in-hospital follow-ups.
Methods and results
Patients (N = 233) with indications for ICD were consecutively recruited and randomized at implant to be followed up for 1 year with standard quarterly in-hospital visits or by RM with one in-hospital visit at 12 months, unless additional in-hospital visits were required due to specific patient conditions or RM alarms. Costs were calculated distinguishing between provider and patient costs, excluding RM device and service cost. The frequency of scheduled in-hospital visits was lower in the RM group than in the control arm. Follow-up required 47 min per patient/year in the RM arm versus 86 min in the control arm (p = 0.03) for involved physicians, generating cost estimates for the provider of USD 45 and USD 83 per patient/year, respectively. Costs for nurses were comparable. Overall, the costs associated with RM and standard follow-up were USD 103 ± 27 and 154 ± 21 per patient/year, respectively (p = 0.01). RM was cost-saving for the patients: USD 97 ± 121 per patient/year in the RM group versus 287 ± 160 per patient/year (p = 0.0001).
Conclusion
The time spent by the hospital staff was significantly reduced in the RM group. If the costs for the device and service are not charged to patients or the provider, patients could save about USD 190 per patient/year while the hospital could save USD 51 per patient/year.
Remote monitoring (RM) is a form of telemedicine technology that permits implanted pacemakers and implantable cardioverter-defibrillators to transmit diagnostic information for review by health care professionals without patients needing to visit the device follow-up clinic. A bedside transmitter in the patient's home conveys the device data using standard telecommunication protocol to a protected internet-accessible RM data server, which authorized health care professionals can access at any time using standard web browser software. Evidence indicates it can accelerate identification of clinical events and potential device problems. RM raises important medicolegal issues concerning the protection of a patient's rights and the safeguarding of patient health information related to the collection, storage, and use of patient device information that must be addressed by follow-up centres. This position statement recommends that remote monitoring be available at all device follow-up clinics as an integral part of the standard of care of device patients and also provides helpful advice to centres for the proper design, implementation, and integration of a remote monitoring system into the clinic.
Aims
The HomeGuide Registry was a prospective study (NCT01459874), implementing a model for remote monitoring of cardiac implantable electronic devices (CIEDs) in daily clinical practice, to estimate effectiveness in major cardiovascular event detection and management.
Methods and results
The workflow for remote monitoring [Biotronik Home Monitoring (HM)] was based on primary nursing: each patient was assigned to an expert nurse for management and to a responsible physician for medical decisions. In-person visits were scheduled once a year. Seventy-five Italian sites enrolled 1650 patients [27% pacemakers, 27% single-chamber implantable cardioverter defibrillators (ICDs), 22% dual-chamber ICDs, 24% ICDs with cardiac resynchronization therapy]. Population resembled the expected characteristics of CIED patients. During a 20 ± 13 month follow-up, 2471 independently adjudicated events were collected in 838 patients (51%): 2033 (82%) were detected during HM sessions; 438 (18%) during in-person visits. Sixty were classified as false-positive, with generalized estimating equation-adjusted sensitivity and positive predictive value of 84.3% [confidence interval (CI), 82.5–86.0%] and 97.4% (CI, 96.5–98.2%), respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during HM sessions. Median reaction time was 3 days [interquartile range (IQR), 1–14 days]. Generalized estimating equation-adjusted incremental utility, calculated according to four properties of major clinical interest, was in favour of the HM sessions: +0.56 (CI, 0.53–0.58%), P < 0.0001. Resource consumption: 3364 HM sessions performed (76% by nurses), median committed monthly manpower of 55.5 (IQR, 22.0–107.0) min × health personnel/100 patients.
Conclusion
Home Monitoring was highly effective in detecting and managing clinical events in CIED patients in daily practice with remarkably low manpower and resource consumption.
AimsThe ECOST trial examined prospectively the long-term safety and effectiveness of home monitoring (HM) of implantable cardioverter defibrillators (ICD).Methods and resultsThe trial's primary objective was to randomly compare the proportions of patients experiencing ≥1 major adverse event (MAE), including deaths from all causes, and cardiovascular, procedure-related, and device-related MAE associated with HM (active group) vs. ambulatory follow-ups (control group) in a sample of 433 patients. The 221 patients assigned to the active group were seen once a year, unless HM reported an ICD dysfunction or a clinical event requiring an ambulatory visit, while the 212 patients in the control group underwent ambulatory visits every 6 months. The characteristics of the study groups were similar. Over a follow-up of 24.2 months, 38.5% of patients in the active and 41.5% in the control group experienced ≥1 MAE (P < 0.05 for non-inferiority). The overall number of shocks delivered was significantly lower in the active (n = 193) than in the control (n = 657) group (P < 0.05) and the proportion of patients who received inappropriate shocks was 52% lower in the active (n = 11) than in the control (n = 22) group (P < 0.05). At the end of the follow-up, the battery longevity was longer in the active group because of a lower number of capacitor charges (499 vs. 2081).Conclusion
Our observations indicate that long-term HM of ICD is at least as safe as standard ambulatory follow-ups with respect to a broad spectrum of MAE. It also lowered significantly the number of appropriate and inappropriate shocks delivered, and spared the device battery.Clinical trials registrationNCT00989417.
Background:
Expanding indications for cardiovascular implantable electronic devices are accompanied by an increasing burden of device clinic follow-up. Remote monitoring (RM) may be less time-consuming compared to in-office follow-up; however, its effect on the device clinic workflow has not been clarified.
Objective:
To determine the impact of RM on device clinic workflow.
Methods:
Detailed workflow data were prospectively collected over a 2-week period in a busy device clinic.
Results:
Five hundred remote transmissions were received from 434 patients between March 1 and March 16, 2011--346 implantable cardioverter-defibrillator, 84 pacemaker, and 70 implantable loop recorder transmissions--on 4 RM platforms (CareLink 56.4%, Merlin.net 21.4%, LATITUDE 17.8%, and Home Monitoring 4.4%). The mean time spent per transmission was 11.5 ± 7.7 minutes, which was less than in-person interrogations (27.7 ± 9.9 minutes; P <.01). Of 500 transmissions, 135 (27.0%) demonstrated clinically important findings; however, only 41 (8.2%) were forwarded for physician review. Of 500 transmissions, 138 (27.6%) were unscheduled, and these were more likely to contain a clinically important event (56 of 138 [40.6%] vs 79 of 362 [21.8%]; P = .0001). A total of 5.8% of the transmissions were duplicate. Transmissions that revealed clinically important findings took longer to process than those that did not (21.0 ± 7.4 minutes vs 10.1 ± 2.1 minutes; P <.05). A total of 49.2% of the scheduled remote transmissions were missed because of patient noncompliance. Telephone follow-up of patients (mean 21 patients/d) who missed scheduled remote transmissions took a mean of 55.1 (range 20-98) min/d.
Conclusions:
Analysis of RM transmissions has significant implications for the device clinic workflow. Nonactionable transmissions are rapidly processed, allowing clinicians to focus on clinically important findings. However, poor patient compliance complicates the workflow efficiency of currently available systems.
Aims
The aims of the study are to develop a cost-minimization analysis from the hospital perspective and a cost-effectiveness analysis from the third payer standpoint, based on direct estimates of costs and QOL associated with remote follow-ups, using Merlin@home and Merlin.net, compared with standard ambulatory follow-ups, in the management of ICD and CRT-D recipients.
Methods and results
Remote monitoring systems can replace ambulatory follow-ups, sparing human and economic resources, and increasing patient safety. TARIFF is a prospective, controlled, observational study aimed at measuring the direct and indirect costs and quality of life (QOL) of all participants by a 1-year economic evaluation. A detailed set of hospitalized and ambulatory healthcare costs and losses of productivity that could be directly influenced by the different means of follow-ups will be collected. The study consists of two phases, each including 100 patients, to measure the economic resources consumed during the first phase, associated with standard ambulatory follow-ups, vs. the second phase, associated with remote follow-ups.
Conclusion
Remote monitoring systems enable caregivers to better ensure patient safety and the healthcare to limit costs. TARIFF will allow defining the economic value of remote ICD follow-ups for Italian hospitals, third payers, and patients. The TARIFF study, based on a cost-minimization analysis, directly comparing remote follow-up with standard ambulatory visits, will validate the cost effectiveness of the Merlin.net technology, and define a proper reimbursement schedule applicable for the Italian healthcare system.
Trial registration: NCT01075516.
Remote monitoring of cardiac implanted electronic devices (CIED: pacemaker, cardiac resynchronisation therapy device and implantable cardioverter defibrillator) has been developed for technical control and follow-up using transtelephonic data transmission. In addition, automatic or patient-triggered alerts are sent to the cardiologist or allied professional who can respond if necessary with various interventions. The advantage of remote monitoring appears obvious in impending CIED failures and suspected symptoms but is less likely in routine follow-up of CIED. For this follow-up the indications, quality of care, cost-effectiveneness and patient satisfaction have to be determined before remote CIED monitoring can be applied in daily practice. Nevertheless remote CIED monitoring is expanding rapidly in the Netherlands without professional agreements about methodology, responsibilities of all the parties involved and that of the device patient, and reimbursement. The purpose of this consensus document on remote CIED monitoring and follow-up is to lay the base for a nationwide, uniform implementation in the Netherlands. This report describes the technical communication, current indications, benefits and limitations of remote CIED monitoring and follow-up, the role of the patient and device manufacturer, and costs and reimbursement. The view of cardiology experts and of other disciplines in conjunction with literature was incorporated in a preliminary series of recommendations. In addition, an overview of the questions related to remote CIED monitoring that need to be answered is given. This consensus document can be used for future guidelines for the Dutch profession.
One quarter of strokes are of unknown cause, and subclinical atrial fibrillation may be a common etiologic factor. Pacemakers can detect subclinical episodes of rapid atrial rate, which correlate with electrocardiographically documented atrial fibrillation. We evaluated whether subclinical episodes of rapid atrial rate detected by implanted devices were associated with an increased risk of ischemic stroke in patients who did not have other evidence of atrial fibrillation.
We enrolled 2580 patients, 65 years of age or older, with hypertension and no history of atrial fibrillation, in whom a pacemaker or defibrillator had recently been implanted. We monitored the patients for 3 months to detect subclinical atrial tachyarrhythmias (episodes of atrial rate >190 beats per minute for more than 6 minutes) and followed them for a mean of 2.5 years for the primary outcome of ischemic stroke or systemic embolism. Patients with pacemakers were randomly assigned to receive or not to receive continuous atrial overdrive pacing.
By 3 months, subclinical atrial tachyarrhythmias detected by implanted devices had occurred in 261 patients (10.1%). Subclinical atrial tachyarrhythmias were associated with an increased risk of clinical atrial fibrillation (hazard ratio, 5.56; 95% confidence interval [CI], 3.78 to 8.17; P<0.001) and of ischemic stroke or systemic embolism (hazard ratio, 2.49; 95% CI, 1.28 to 4.85; P=0.007). Of 51 patients who had a primary outcome event, 11 had had subclinical atrial tachyarrhythmias detected by 3 months, and none had had clinical atrial fibrillation by 3 months. The population attributable risk of stroke or systemic embolism associated with subclinical atrial tachyarrhythmias was 13%. Subclinical atrial tachyarrhythmias remained predictive of the primary outcome after adjustment for predictors of stroke (hazard ratio, 2.50; 95% CI, 1.28 to 4.89; P=0.008). Continuous atrial overdrive pacing did not prevent atrial fibrillation.
Subclinical atrial tachyarrhythmias, without clinical atrial fibrillation, occurred frequently in patients with pacemakers and were associated with a significantly increased risk of ischemic stroke or systemic embolism. (Funded by St. Jude Medical; ASSERT ClinicalTrials.gov number, NCT00256152.).
Professional practice guidelines recommend that pacemaker recipients be followed regularly. However, the majority of scheduled ambulatory visits is unproductive and imposes a heavy burden on the health-care system.
The COMPAS randomized, multicentre, non-inferiority trial examined the safety of long-term remote monitoring of pacemakers. Between December 2005 and January 2008, 538 patients were randomly assigned to remote monitoring follow-up (active group) vs. standard care (control group). The primary objective was to confirm that the proportion of patients who experienced at least one major adverse event (MAE), including all-cause death and hospitalizations for device-related or cardiovascular adverse events, was not >7% higher in the active than in the control group. MAE-free survivals and quality of life were compared in both groups. The characteristics of the study groups were similar. Over a follow-up of 18.3 months, 17.3% of patients in the active and 19.1% in the control group experienced at least one MAE (P < 0.01 for non-inferiority). Hospitalizations for atrial arrhythmias (6 vs. 18) and strokes (2 vs. 8) were fewer (P < 0.05), and the number of interim ambulatory visits was 56% lower (P < 0.001) in the active than the control group. Changes in pacemaker programming or drug regimens were made in 62% of visits in the active vs. 29% in the control group (P < 0.001). Quality of life remained unchanged in both groups.
Remote monitoring was a safe alternative to conventional care and significantly lowered the number of ambulatory visits during long-term follow-up of permanently paced patients. ClinicalTrials.gov identifier: NCT00989326.
This document represents expert consensus concerning the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs). The views expressed are of the international writing group consisting of seven cardiac electrophysiologists representing the Heart Rhythm Society (HRS), six from the European Heart Rhythm Association (EHRA) as well as one heart failure specialist representing the Heart Failure Society of America and another from the Heart Failure Association of the European Society of Cardiology. Members from our writing group also represented the American College of Cardiology (Kenneth A. Ellenbogen, MD), the European Society of Cardiology (Silvia G. Priori, MD, PhD), and the American Heart Association (David L. Hayes, MD). The topic covered by this document includes the monitoring of CIEDs with a description of the technology, indications for use, personnel involved in monitoring and the frequency and types of monitoring events. Also covered are issues in regard to data management, regulatory environments, reimbursement and ethical considerations in respect to device inactivation. This statement summarizes the opinion of the writing group members based on their own experience in treating patients, as well as a review of the literature, and is directed to all health care professionals, health care institutions, CIED manufacturers and governmental, reimbursement and regulatory bodies who are involved in the care of patients with CIEDs. When using or considering the guidance given in this document, it is important to remember that the ultimate judgment regarding care of a particular patient must be made by the health care provider and patient in light of all the circumstances presented by that patient.
Remote monitoring (RM) of implantable cardioverter-defibrillators (ICD) is an established technology integrated into clinical practice. One recent randomized controlled trial (RCT) and several large device database studies have demonstrated a powerful survival advantage for ICD patients undergoing RM compared with those receiving conventional in-office (IO) follow-up.
Remote monitoring (RM) technology embedded within cardiac rhythm devices permits continuous monitoring, which may result in improved patient outcomes.
This study used "big data" to assess whether RM is associated with improved survival and whether this is influenced by the type of cardiac device and/or its degree of use.
We studied 269,471 consecutive U.S. patients implanted between 2008 and 2011 with pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) with pacing capability (CRT-P)/defibrillation capability (CRT-D) with wireless RM. We analyzed weekly use and all-cause survival for each device type by the percentage of time in RM (%TRM) stratified by age. Socioeconomic influences on %TRM were assessed using 8 census variables from 2012.
The group had implanted PMs (n = 115,076; 43%), ICDs (n = 85,014; 32%), CRT-D (n = 61,475; 23%), and CRT-P (n = 7,906; 3%). When considered together, 127,706 patients (47%) used RM, of whom 67,920 (53%) had ≥75%TRM (high %TRM) and 59,786 (47%) <75%TRM (low %TRM); 141,765 (53%) never used RM (RM None). RM use was not affected by age or sex, but demonstrated wide geographic and socioeconomic variability. Survival was better in high %TRM versus RM None (hazard ratio [HR]: 2.10; p < 0.001), in high %TRM versus low %TRM (HR: 1.32; p < 0.001), and also in low %TRM versus RM None (HR: 1.58; p < 0.001). The same relationship was observed when assessed by individual device type.
RM is associated with improved survival, irrespective of device type (including PMs), but demonstrates a graded relationship with the level of adherence. The results support the increased application of RM to improve patient outcomes.
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Introduction
Remote monitoring (RM) is becoming the new standard for follow-up of patients with cardiac implantable electronic devices. The aim of the present study was to evaluate patients’ acceptance and satisfaction of RM by using a specific designed questionnaire.
Methods
The questionnaire is composed of 12 items aimed at analyzing 5 aspects of patient’s acceptance and satisfaction of RM, with a scale ranging from 0 (the worst) to 4 (the best). The questionnaire was submitted to 163 ICD patients (147 male, 71 ± 12 years, 39 CRT-D), and followed by the CareLink Network Medtronic system, after a median follow-up of 20 months (13–26 months). Cronbach’s alpha for reliability of the administered questionnaire was 0.73.
Results
The mean score of all 12 items was 3.5 ± 0.3; in detail: (i) relationship with healthcare provider 3.3 ± 0.7; (ii) ease of use of network technology 3.5 ± 0.5; (iii) related psychological aspects 3.5 ± 0.4; (iv) implication of general health 3.4 ± 0.6; (v) overall satisfaction 3.8 ± 0.3. CareLink naïve patients had better scores than those with previous in-person follow-up experience (3.6 ± 0.6 vs. 3.4 ± 0.7, p = 0.027), while no differences were observed between wireless and inductive systems, neither considering the living distance from the hospital. The main independent predictor of patient satisfaction was the implantation of CRT-D [Exp(beta) = 6.80 (1.34–34.62)] (p = 0.021). No correlation was found between age and ease of use of RM, while a positive correlation was observed between age and benefits on psychological aspects (p
Background
An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial.
Methods
We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II–III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1:1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT00538356.
Findings
We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65·5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58·7%). At 1 year, 63 (18·9%) of 333 patients in the telemonitoring group versus 90 (27·2%) of 331 in the control group (p=0·013) had worsened composite score (odds ratio 0·63, 95% CI 0·43–0·90). Ten versus 27 patients died during follow-up.
Interpretation
Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure. Such telemonitoring is feasible and should be used in clinical practice.
Funding
Biotronik SE & Co. KG.
Background and aims
Implantable cardioverter-defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized-controlled trial.
Methods and results
Patients indicated for single- or dual-chamber ICD are eligible for the study and are implanted an RM capable Biotronik ICD. ICD programming and alert-based clinical responses in the RM group are highly standardized by protocol. As of December 2011, recruitment has been completed and 416 patients have been enrolled. Subjects are followed for a minimum of 12 months and a maximum of 24 months, ending in January 2013. Disease-specific costs from a societal perspective have been defined as primary endpoint and will be compared between RM and standard-care groups. Secondary endpoints include ICD shocks (including appropriate and inappropriate shocks), cardiovascular hospitalizations and cardiovascular mortality and additional health economic endpoints.
Conclusions
The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic endpoint in 2014. Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM.
Clinicaltrials.gov identifier: NCT 00787683.
Cardiac implantable electronic devices (CIEDs) store clinically valuable, time-sensitive information regarding system integrity, arrhythmias, and heart failure parameters. Remote monitoring has impacted clinical practice by reducing scheduled office visits, providing protocols for device recalls and advisories, and facilitating the management of unscheduled encounters. The successful implementation of remote monitoring into clinical practice requires a new work flow and additional staff; the use of the electronic medical record to manage the data emanating from CIEDs poses an additional challenge. Solutions to these issues are discussed, and projections are made regarding the management of CIEDs in a modern electrophysiology practice.
Remote monitoring (RM) of defibrillators (implantable cardioverter defibrillators [ICDs]) and cardiac resynchronization therapy devices (CRTDs) has been shown to be cost effective, convenient, and associated with reduced mortality and a reduction in the time to physician intervention for actionable events. However, patient compliance with monitoring over time and what factors might influence such compliance have not been well described. This study sought to identify factors contributing to patient noncompliance with RM of ICDs and CRTDs in a large real-world population.
Deidentified data on U.S. patients enrolled in the Medtronic CareLink RM system were used to compare patients with no (noncompliant, n = 14,848) and with ≥2 RM transmissions (compliant, n = 103,284) during a 14-month period.
Overall noncompliance with RM was 21%. Younger age (≤40), female sex, wanded device, Medicare Census Division, and small clinic size all predicted patient noncompliance (P < 0.01). Device type (ICD vs CRTD) did not (P = 0.52). Multivariate analysis suggested clinically important predictors of noncompliance to be: age ≤40, odds ratio (OR) 2.64 (95% confidence interval, 2.42-2.88); Medicare Census Division (Mountain vs West North Central), OR 2.15 (1.96-2.37); and small clinic size (1-4 vs >100 patients), OR 4.38 (3.92-4.91).
There is room for improvement in RM usage among enrolled patients. Younger patients, smaller clinics, and certain geographic areas may be targets for research into interventions to further improve the use of RM.
Objective
In the SAVE-trial we evaluated the safety, reliability and improvements of patient management using the BIOTRONIK Home Monitoring®-System (HM) in pacemaker (PM) and implanted cardioverter defibrillator (ICD) patients.
Design
115 PM (Module A) and 36 ICD-patients (Module B) were recruited 3 months after implantation.
Patients
65 patients in Module A were randomised to HM-OFF and had one scheduled outpatient clinic follow-up (FU) per year, whereas patients randomised to HM-ON were equipped with the mobile transmitter and discharged without any further scheduled in-office FU. In Module B 18 patients were randomised to HM-OFF and followed by standard outpatient clinic controls every 6 months; 18 patients were randomised to HM-ON receiving remote monitoring plus one outpatient clinic visit per year; unscheduled follow-ups were performed when necessary.
Results
The average follow-up period was 17.1 ± 9.2 months in Module A and 26.3 ± 8.6 months in Module B. In both modules, the number of FUs per year was significantly reduced (Module A HM-ON 0.29 ± 0.6 FUs/year vs HM-OFF 0.53 ± 0.5 FUs/year; p < 0.001; Module B HM-ON 0.87 ± 0.25 vs HM-OFF 1.73 ± 0.53 FU/year, p < 0.001). Cost analysis was significantly lower in the HM-ON group compared to the HM-OFF group (18.0 ± 41.3 and 22.4 ± 26.9€ respectively; p < 0.003). 93% of the unscheduled visits in Module B were clinically indicated, whereas 55% of the routine FUs were classified as clinically unnecessary.
Conclusion
Remote home monitoring of pacemaker and ICD devices was safe, reduced overall hospital visits, and detected events that mandated unscheduled visits.
Remote wireless follow-up of implanted pacemakers (PM) has become an attractive method of follow-up. Although wireless PM follow-up has several advantages compared with transtelephonic and office-based follow-up, its utility depends on successful transmission.
Initial in-office setup of wireless PM will improve transmission rate as compared with home setup.
A total of 202 consecutive patients from 2 medical centers were included in this retrospective study. Patients in the home setup group (N = 101) had traditional home setup of wireless PM, whereas patients in the in-office group (N = 101) had setup of PMs by allied health professionals during the postoperative office visit. Successful transmission was defined as successful initial wireless transmission of PM data by 2 months postimplant.
Of the 101 patients in the home setup group, 22 (22%) patients had successful transmission. Of the 101 patients in the in-office group, 92 (91%) patients had successful transmission (P < 0.0001). Logistic regression analysis showed that that the in-office group was independently associated with successful transmission (odds ratio: 114.5; 95% confidence interval: 32.1-408.4; P < 0.0001).
In patients implanted with PM capable of remote wireless data transmission, initial home setup of the wireless monitoring device was frequently unsuccessful. In-office PM setup was associated with a significantly higher rate of successful transmission.
Purpose: Some implantable cardioverter-defibrillators (ICDs) are now able to monitor intrathoracic impedance. The aim of the study was to describe the use of such monitoring in clinical practice and to evaluate the clinical impact of the fluid accumulation alert feature of these ICDs.
Methods and Results: Five hundred thirty-two heart failure (HF) patients implanted with these ICDs were followed up for 11 ± 7 months. A clinical event (CE) was deemed to have occurred if it resulted in hospitalization or milder manifestations of HF deterioration. Three hundred sixty-two acute decreases in intrathoracic impedance (Z events) occurred in 230 patients. Of these episodes, 171 (47%) were associated with a CE within 2 weeks of the Z event. In another 71 (20%) Z events, drug therapy was adjusted despite the absence of overt signs of clinical deterioration. The rate of unexplained Z events was 0.25 per patient-year and 25 hospitalizations were not associated with Z events. The audible alert was disabled in a group of 102 patients (OFF group). HF hospitalizations occurred in 29 (7%) patients in the ON group and 20 (20%, P < 0.001) patients in the OFF group. The rate of combined cardiac death and HF hospitalization was lower in patients with Alert ON (log-rank test, P = 0.007).
Conclusions: The ICD reliably detected CE and yielded low rates of unexplained and undetected events. The alert capability seemed to reduce the number of HF hospitalizations by allowing timely detection and therapeutic intervention.
Heart failure patients with implantable cardioverter-defibrillators (ICDs) or an ICD for resynchronization therapy often visit the hospital for unscheduled examinations, placing a great burden on healthcare providers. We hypothesized that Internet-based remote interrogation systems could reduce emergency healthcare visits.
This multicenter randomized trial involving 200 patients compared remote monitoring with standard patient management consisting of scheduled visits and patient response to audible ICD alerts. The primary end point was the rate of emergency department or urgent in-office visits for heart failure, arrhythmias, or ICD-related events. Over 16 months, such visits were 35% less frequent in the remote arm (75 versus 117; incidence density, 0.59 versus 0.93 events per year; P=0.005). A 21% difference was observed in the rates of total healthcare visits for heart failure, arrhythmias, or ICD-related events (4.40 versus 5.74 events per year; P<0.001). The time from an ICD alert condition to review of the data was reduced from 24.8 days in the standard arm to 1.4 days in the remote arm (P<0.001). The patients' clinical status, as measured by the Clinical Composite Score, was similar in the 2 groups, whereas a more favorable change in quality of life (Minnesota Living With Heart Failure Questionnaire) was observed from the baseline to the 16th month in the remote arm (P=0.026).
Remote monitoring reduces emergency department/urgent in-office visits and, in general, total healthcare use in patients with ICD or defibrillators for resynchronization therapy. Compared with standard follow-up through in-office visits and audible ICD alerts, remote monitoring results in increased efficiency for healthcare providers and improved quality of care for patients.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00873899.
The study aim was to evaluate patient acceptance and content with remote follow-up (FU) of their implantable cardioverter defibrillator (ICD) and to estimate patients' wish for changes in remote follow-up routines.
Four hundred seventy-four ICD patients at the device follow-up clinic at Rigshospitalet using CareLink® (Medtronic) remote follow-up, who had made ≥2 transmissions, received a questionnaire.
Three hundred eighty-five patients (81.2%) answered. Mean time with ICD was 56 ± 45 months and mean age was 62 ± 13 years; 80% was male. Diagnosis related to ICD implant was: ischemic heart disease in 56% and dilated cardiomyopathy in 21%. Twenty-six percent had primary prophylactic indication. Mean time on remote FU was 16.4 ± 6.9 months. Mean time spent on in-clinic FU (two-way transport and FU) was 4 h and 36 min ± 7 h and 50 min, excluding 12 patients from Greenland and Faroe Islands. Ninety-five percent of the patients was very content or content with remote FU compared to in-clinic FU; 3% was less content and 2% was not content. For scheduled transmissions, 21% of the patients wished for a faster reply (sms or e-mail) compared to current practice with a letter. Eighty-four percent preferred more detailed information concerning ICD leads, battery status, and ICD therapies. A total of 96 patients (25%) had performed extra unscheduled remote transmissions: 20 due to shock, 20 due to alarm, 35 due to palpitations, and 18 for other or combined reasons.
Ninety-five percent of the patients were content with the remote FU. Only 25% had unscheduled transmissions and most unscheduled transmissions were for appropriate reasons. Eighty-four percent of the patients wished for a more detailed response and 21% wished for a faster reply after routine transmissions.
We are in the midst of a rapidly evolving era of technology-assisted medicine. The field of telemedicine provides the opportunity for highly individualized medical management in a way that has never been possible before. Evolving medical technologies using cardiac implantable devices with capabilities for remote monitoring permit evaluation of multiple parameters of cardiovascular physiology and risk, including cardiac rhythm, device function, blood pressure values, the presence of myocardial ischaemia, and the degree of compensation of congestive heart failure. Cardiac risk, device status, and response to therapies can now be assessed with these electronic systems of detection and reporting. This document reflects the extensive experience from investigators and innovators around the world who are shaping the evolution of this rapidly expanding field, focusing in particular on implantable pacemakers, implantable cardioverter defibrillators, devices for cardiac resynchronization therapy (both with and without defibrillation properties), loop recorders, and hemodynamic monitoring devices. This document covers the basic methodologies, guidelines for their use, experience with existing applications, and the legal and reimbursement aspects associated with their use. To adequately cover this important emerging topic, the International Society for Holter and Noninvasive Electrocardiology and the European Heart Rhythm Association combined their expertise in this field. We hope that the development of this field can contribute to improve care of our cardiovascular patients.
Ann Noninvasive Electrocardiol 2012;17(1):36–56
Heart failure is associated with frequent hospitalizations, often resulting from volume overload. Measurement of intrathoracic impedance with an implanted device with an audible patient alert may detect increases in pulmonary fluid retention early. We hypothesized that early intervention could prevent hospitalizations and affect outcome.
We studied 335 patients with chronic heart failure who had undergone implantation of an implantable cardioverter-defibrillator alone (18%) or with cardiac resynchronization therapy (82%). All devices featured a monitoring tool to track changes in intrathoracic impedance (OptiVol) and other diagnostic parameters. Patients were randomized to have information available to physicians and patients as an audible alert in case of preset threshold crossings (access arm) or not (control arm). The primary end point was a composite of all-cause mortality and heart failure hospitalizations. During 14.9±5.4 months, this occurred in 48 patients (29%) in the access arm and in 33 patients (20%) in the control arm (P=0.063; hazard ratio, 1.52; 95% confidence interval, 0.97-2.37). This was due mainly to more heart failure hospitalizations (hazard ratio, 1.79; 95% confidence interval, 1.08-2.95; P=0.022), whereas the number of deaths was comparable (19 versus 15; P=0.54). The number of outpatient visits was higher in the access arm (250 versus 84; P<0.0001), with relatively more signs of heart failure among control patients during outpatient visits. Although the trial was terminated as a result of slow enrollment, a post hoc futility analysis indicated that a positive result would have been unlikely.
Use of an implantable diagnostic tool to measure intrathoracic impedance with an audible patient alert did not improve outcome and increased heart failure hospitalizations and outpatient visits in heart failure patients. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT 00480077.
A worldwide cardiac pacing and implantable cardioverter-defibrillator (ICD) survey was undertaken for calendar year 2009 and compared to a similar survey conducted in 2005. There were contributions from 61 countries: 25 from Europe, 20 from the Asia Pacific region, seven from the Middle East and Africa, and nine from the Americas. The 2009 survey involved 1,002,664 pacemakers, with 737,840 new implants and 264,824 replacements. The United States of America (USA) had the largest number of cardiac pacemaker implants (225,567) and Germany the highest new implants per million population (927). Virtually all countries showed increases in implant numbers over the 4 years between surveys. High-degree atrioventricular block and sick sinus syndrome remain the major indications for implantation of a cardiac pacemaker. There remains a high percentage of VVI(R) pacing in the developing countries, although compared to the 2005 survey, virtually all countries had increased the percentage of DDDR implants. Pacing leads were predominantly transvenous, bipolar, and active fixation. The survey also involved 328,027 ICDs, with 222,407 new implants and 105,620 replacements. Virtually all countries surveyed showed a significant rise in the use of ICDs with the largest implanter being the USA (133,262) with 434 new implants per million population. This was the largest pacing and ICD survey ever performed, because of mainly a group of loyal enthusiastic survey coordinators. It encompasses more than 80% of all the pacemakers and ICDs implanted worldwide during 2009.
The primary objective was to determine if wireless remote monitoring with automatic clinician alerts reduces the time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular (CV) disease progression, and device issues compared to patients receiving standard in-office care. A secondary objective was to compare the rates of CV health care utilization between patients in the remote and in-office arms.
In addition to providing life-saving therapy, implantable cardioverter-defibrillators collect advanced diagnostics on the progression of the patient's heart disease. Device technology has progressed to allow wireless remote monitoring with automatic clinician alerts to replace some scheduled in-office visits.
The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) study was a multicenter, prospective, randomized evaluation involving 1,997 patients from 136 clinical sites who underwent insertion of an implantable cardioverter-defibrillator (including cardiac resynchronization therapy devices) and were followed up for 15 months. Health care utilization data included all CV-related hospitalizations, emergency department visits, and clinic office visits.
The median time from clinical event to clinical decision per patient was reduced from 22 days in the in-office arm to 4.6 days in the remote arm (p < 0.001). The health care utilization data revealed a decrease in mean length of stay per CV hospitalization visit from 4.0 days in the in-office arm to 3.3 days in the remote arm (p = 0.002).
Wireless remote monitoring with automatic clinician alerts as compared with standard in-office follow-up significantly reduced the time to a clinical decision in response to clinical events and was associated with a significant reduction in mean length of CV hospital stay. (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision [CONNECT]; NCT00402246).
To assess the cost-effectiveness and the cost utility of remote patient monitoring (RPM) when compared with the usual care approach based upon differences in the number of hospitalizations, estimated from a meta-analysis of randomized clinical trials (RCTs).
We reviewed the literature published between January 2000 and September 2009 on multidisciplinary heart failure (HF) management, either by usual care or RPM to retrieve the number of hospitalizations and length of stay (LOS) for HF and for any cause. We performed a meta-analysis of 21 RCTs (5715 patients). Remote patient monitoring was associated with a significantly lower number of hospitalizations for HF [incidence rate ratio (IRR): 0.77, 95% CI 0.65-0.91, P < 0.001] and for any cause (IRR: 0.87, 95% CI: 0.79-0.96, P = 0.003), while LOS was not different. Direct costs for hospitalization for HF were approximated by diagnosis-related group (DRG) tariffs in Europe and North America and were used to populate an economic model. The difference in costs between RPM and usual care ranged from €300 to €1000, favouring RPM. These cost savings combined with a quality-adjusted life years (QALYs) gain of 0.06 suggest that RPM is a 'dominant' technology over existing standard care. In a budget impact analysis, the adoption of an RPM strategy entailed a progressive and linear increase in costs saved.
The novel cost-effectiveness data coupled with the demonstrated clinical efficacy of RPM should encourage its acceptance amongst clinicians and its consideration by third-party payers. At the same time, the scientific community should acknowledge the lack of prospectively and uniformly collected economic data and should request that future studies incorporate economic analyses.
Outcome data for patients receiving implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices treated outside of clinical trials are lacking. No clinical trial has evaluated mortality after device implantation or after shock therapy in large numbers of patients with implanted devices that regularly transmit device data over a network.
Survival status in patients implanted with ICD and CRT devices across the United States from a single manufacturer was assessed. Outcomes were compared between patients followed in device clinic settings and those who regularly transmit remote data collected from the device an average of 4 times monthly. Shock delivery and electrogram analysis could be ascertained from patients followed on the network, enabling survival after ICD shock to be evaluated. One- and 5-year survival rates in 185,778 patients after ICD implantation were 92% and 68% and were 88% and 54% for CRT-D device recipients. In 8228 patients implanted with CRT-only devices, survival was 82% and 48% at 1 and 5 years, respectively. For the 69,556 ICD and CRT-D patients receiving remote follow-up on the network, 1- and 5-year survival rates were higher compared with those in the 116,222 patients who received device follow-up in device clinics only (50% reduction; P<0.0001). There were no differences between patients followed on or off the remote network for the characteristics of age, gender, implanted device year or type, and economic or educational status. Shock therapy was associated with subsequent mortality risk for both ICD and CRT-D recipients.
Survival after ICD and CRT-D implantation in patients treated in naturalistic practice compares favorably with survival rates observed in clinical trials. Remote follow-up of device data is associated with excellent survival, but arrhythmias that result in device therapy in this population are associated with a higher mortality risk compared with patients who do not require shock therapy.
Monitoring implantable cardiac device function and patient condition is important. The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) trial tested the hypothesis that remote home monitoring with automatic daily surveillance (HM) is safe and effective for implantable cardioverter-defibrillator follow-up for 1 year and enables rapid physician evaluation of significant events.
In total, 1339 patients were randomized 2:1 to HM or conventional follow-up. Follow-up checks occurred at 3, 6, 9, 12, and 15 months after implantation. HM was used before office visits at 3 and 15 months in the HM group. At 6, 9, and 12 months, HM only was used but was followed by office visits if necessary. Conventional patients were evaluated with office visits only. Scheduled office visits and unscheduled evaluations, incidence of morbidity, and time elapsed from first event occurrence in each patient to physician evaluation were tracked for each group. HM and conventional patients were similar (age, 63.3+/-12.8 versus 64.0+/-12.1 years; gender, 72.0% versus 73.1% male; New York Heart Association class II, 55.9% versus 60.4%; pathology: left ventricular ejection fraction, 29.0+/-10.7% versus 28.5+/-9.8%; coronary artery disease, 64.8% versus 71.7%; primary prevention indication, 72.2% versus 73.8%; and dual-chamber implants, 57.8% versus 56.6%). HM reduced total in-hospital device evaluations by 45% without affecting morbidity. In the HM group, 85.8% of all 6-, 9-, and 12-month follow-ups were performed remotely only, indicating that HM provided sufficient assessment in the majority. Median time to evaluation was <2 days in the HM group compared with 36 days in the conventional group (P<0.001) for all arrhythmic events.
HM is safe and allows more rapid detection of actionable events compared with conventional monitoring in patients with implantable electronic cardiac devices.
We sought to determine the utility of combined heart failure (HF) device diagnostic information to predict clinical deterioration of HF in patients with systolic left ventricular dysfunction.
Some implantable devices continuously monitor HF device diagnostic information, but data are limited on the ability of combined HF device diagnostics to predict HF events.
The PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) was a prospective, multicenter observational study in patients receiving cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillators. HF events were independently adjudicated. A combined HF device diagnostic algorithm was developed on an independent dataset. The algorithm was considered positive if a patient had 2 of the following abnormal criteria during a 1-month period: long atrial fibrillation duration, rapid ventricular rate during atrial fibrillation, high (> or =60) fluid index, low patient activity, abnormal autonomics (high night heart rate or low heart rate variability), or notable device therapy (low CRT pacing or implantable cardioverter-defibrillator shocks), or if they only had a very high (> or =100) fluid index. We used univariate and multivariable analyses to determine predictors of subsequent HF events within a month.
We analyzed data from 694 CRT defibrillator patients who were followed for 11.7 +/- 2 months. Ninety patients had 141 adjudicated HF hospitalizations with pulmonary congestion at least 60 days after implantation. Patients with a positive combined HF device diagnostics had a 5.5-fold increased risk of HF hospitalization with pulmonary signs or symptoms within the next month (hazard ratio: 5.5, 95% confidence interval: 3.4 to 8.8, p < 0.0001), and the risk remained high after adjusting for clinical variables (hazard ratio: 4.8, 95% confidence interval: 2.9 to 8.1, p < 0.0001).
Monthly review of HF device diagnostic data identifies patients at a higher risk of HF hospitalizations within the subsequent month. (PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure; NCT00279955).
To evaluate patients' acceptance and satisfaction of the Home Monitoring (HM) remote control system after 1 year of follow-up by a self-made questionnaire (HM Acceptance and Satisfaction Questionnaire, HoMASQ) specifically designed for this purpose.
The HoMASQ contains 12 items designed to investigate five different aspects strictly connected to patient's acceptance and satisfaction of remote monitoring: (i) relationship with their healthcare provider, (ii) easy of use of HM technology, (iii) related psychological aspects, (iv) implications on general health, and (v) overall satisfaction. Each item was rated on a five-point scale: from 0 to 4 with favourable responses score > or =2. The theoretical maximum total score (the highest detected acceptance and satisfaction level) was 48. The HoMASQ was given to 119 patients followed by HM during the 1-year follow-up visit. Ninety-nine percent of all the administered questionnaire items were answered. The mean total score was 40.8 +/- 5.4 with a mean percentage of favourable answers of 96.3 +/- 18.8% (CI 95.2 - 97.2%). The mean scores for each of the five areas of the HoMASQ were: 3.0 +/- 0.9 for relationship, 3.4 +/- 0.6 for easy of use, 3.4 +/- 0.9 for psychological aspects, and 3.4 +/- 0.8 for clinical implication and overall satisfaction. Cronbach's alpha for reliability of the HoMASQ was 0.73.
A high level of acceptance and satisfaction after 1-year remote control by HM was detected by the five-point scale HoMASQ, which showed a good internal reliability.
Remote monitoring is increasingly becoming the new standard of care for implantable cardioverter defibrillator (ICD) follow-up. We sought to determine whether remote monitoring of ICDs improves patient outcomes compared with quarterly device interrogations in clinic.
In this single-center pilot clinical trial, adult patients with an ICD were randomly assigned to remote monitoring versus quarterly device interrogations in clinic. The primary endpoint was a composite of cardiovascular hospitalization, emergency room visit for a cardiac cause, and unscheduled visit to the electrophysiology clinic for a device-related issue at 1 year. We also examined health-related quality of life, costs, and patient satisfaction with their ICD care. Of 151 patients enrolled in this trial, 76 were randomized to remote monitoring and 75 to quarterly device interrogations in clinic. There was no significant difference in the primary endpoint (32% in the remote monitoring arm vs 34% in the control arm; P = 0.8), mortality, or cost between the 2 arms. Quality of life and patient satisfaction were significantly better in the control arm than in the remote monitoring arm at 6 months (83 [25th, 75th percentiles 70, 90] vs 75 [50, 85]; P = 0.002 and 88 [75, 100] vs 75 [75, 88]; P = 0.03, respectively), but not at 12 months.
We showed no significant reduction in cardiac-related resource utilization with remote monitoring of ICDs. However, given the small number of patients in our study, the real clinical and health economics impact of remote monitoring needs to be verified by a large, multicenter, randomized clinical trial.
