International Journal of Cardiology 202 (2016) 368–377
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International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Review
Remote monitoring of implantable devices: Should we continue to ignore it? Matteo Bertini a,⁎, Lina Marcantoni a, Tiziano Toselli a, Roberto Ferrari b a b
Department of Cardiology, S. Anna Hospital, University of Ferrara, Cona-Ferrara, Italy Department of Cardiology and LTTA Center, University Hospital of Ferrara and Maria Cecilia Hospital, GVM Care and Research, E.S. Health Science Foundation, Cotignola, Italy
a r t i c l e
i n f o
Article history: Received 30 June 2015 Received in revised form 31 August 2015 Accepted 19 September 2015 Available online 21 September 2015 Keywords: Remote monitoring Inappropriate shock Implantable cardioverter defibrillator Heart failure
a b s t r a c t The number of patients with implantable cardioverter defibrillators (ICDs) is increasing. In addition to improve survival, ICD can collect data related to device function and physiological parameters. Remote monitoring (RM) of these data allows early detection of technical or clinical problems and a prompt intervention (reprogramming device or therapy adjustment) before the patient require hospitalization. RM is not a substitute for emergency service and its consultation is now limited during working hours. Thus, a consent form is required to inform patients about benefits and limitations. The available studies indicate that remote monitoring is more effective than traditional calendar face to face based encounters. RM is safe, highly reliable, cost efficient, allows quick reply to failures, and reduces the number of scheduled visits and the incidence of inappropriate shocks with a positive impact on survival. It follows that RM has the credentials to be the standard of care for ICD management; however, unfortunately, there is a delay in physician acceptance and implementation. The recent observations from randomized IN-TIME study that showed a clear survival benefit with RM in heart failure patients have encouraged us to review both the negative and positive aspects of RM collected in a little more than a decade. © 2015 Elsevier Ireland Ltd. All rights reserved.
1. Introduction
2. The history
Indications to implantable cardioverter defibrillators (ICDs) with or without cardiac resynchronization (CRT-D) are increasing. Clinical trials show that ICD with or without CRT improves survival in patients with arrhythmic cardiomyopathy and in those with heart failure (HF) of any cause. A correct programming of the device therapy is essential to ensure precise detection and termination of arrhythmias and itself imparts survival benefit [1]. ICD setting may need to be adapted to the progression of the clinical conditions [2]. Thus, post implant monitoring is an integral part of both devices and patient care [3] and it is a responsibility for the physician [4]. There is consensus for the need of in-clinic checks at 3- to 6-months intervals with increased frequency when the battery approaches replacement indication or in response to product advisories. The limit of this conventional follow-up is the lack of information in between the visits. Remote monitoring (RM) fills this gap, avoiding several in-person evaluations and has progressed from a curiosity and occasional use, to large prospective trials [5] opening new avenues for further exploration. We have reviewed the actual position, current success and still unresolved problems of RM [3,6–8].
The first attempts of RM were undertaken in the 1970s, in the USA. RM was performed by phone, transmitting just pacing rate and pulse duration as markers of the battery status and device failure, which, at the time, was common. The same approach failed to have an early impact in Europe, where the concept was introduced by Biotronik in 2001. Such a delay was mainly due to issues related to data transfer. Thereafter, RM was used to reduce multiple in-hospital contacts, particularly for elderly patients. Thus, the goal of the first studies was to prove safety and efficacy in reducing in-persons visits. Technical improvements and internet availability made the rest. Today each ICD has automatic transmission mechanisms independent of patient or physician interaction (Table 1). The devices are equipped with a micro-antenna for communication with a transmitter located close to the patient. They perform daily transmissions, with additional alerts for pre-specified out of range parameters, using the wireless global system for mobile communication network or landline communication, while the patient is at home. The alerts may relate to change in device performance (battery status, lead impedance), or programming (disabling of ventricular fibrillation therapy, insufficient safety margins for sensing or capture), or on occurrence of medical data (arrhythmias, heart rate variability, fluid accumulation). In this way, RM has progressed from mostly monitoring the device performance to provide information on the disease progression. The events generating the alert are transmitted to a central database, where they are processed and sent to physicians and or nurses by website, e-mail,
⁎ Corresponding author at: Department of Cardiology, University of Ferrara, Via Aldo Moro 8, 44124 Cona-Ferrara, Italy. E-mail address:
[email protected] (M. Bertini).
http://dx.doi.org/10.1016/j.ijcard.2015.09.033 0167-5273/© 2015 Elsevier Ireland Ltd. All rights reserved.
M. Bertini et al. / International Journal of Cardiology 202 (2016) 368–377
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Table 1 The different remote monitoring system. Biotronik Home Monitoring
Medtronic CareLink
Boston Scientific Latitude
St. Jude Medical Merlin.net
Sorin SMARTVIEW
Stationary or mobile Simple 2001 Radiofrequency
Stationary Interactive 2005 Radiofrequency
Stationary Interactive 2005 Radiofrequency
Stationary Vocal interactivity 2007 Radiofrequency
Stationary
Phone line, GSM, Ethernet Analog or GSM Scheduled FU; alert events; Scheduled FU; alert events patient initiated interrogation
Analog or GSM Scheduled FU; alert events; on patient demand
Yes Yes SMS; e-mail; fax 30 sec All memorized episodes Heart failure monitor
GSM network Scheduled FU; alert events; on patient demand. Yes Yes SMS; e-mail 10 sec All memorized episodes OptiVol, cardiac compass
Yes Yes Fax, phone 10 sec All memorized episodes Weight, blood pressure
Yes Yes SMS; e-mail; fax 7 sec All memorized episodes SonR, sleep apnea monitoring
Patient device
Transmitter
FDA approval Wireless communication with implanted device Data transmission GSM network Frequency of transmissions Scheduled FU; daily FU; alert events Remote follow up Remote monitoring Physician notification IEGM at remote follow up IEGM at alert event Sensor
Yes Yes SMS; e-mail; fax 30 sec All memorized episodes Corvue, ST segments monitoring
NA Radiofrequency
FU: follow up.
SMS, or fax [9]. The reliability of this system is excellent [10]. The TRUST trial [11] firstly explored the usefulness of RM in clinical practice demonstrating a median delay of 1 day from occurrence of the event to physician evaluation, compared to 1 month with conventional care. The CONNECT study [12], including patients with ICD or CRT-D confirmed these data. The IN-TIME study [13] also shows a median reaction time to contact the patient after a telemonitored alert of 1 day. Such rapid reaction time applies also for asymptomatic alerts, with the potential to improve outcome. Those results were unexpected, considering that just a few years ago the PREFER study showed that RM improved the mean reaction time from 7.7 months of the control arm to 5.7 months [14,15]. 3. The present Once the safety and reliability are confirmed, the remaining problems to be solved were reimbursement, privacy and fear of data overload [16]. Today, in theory, these concerns should no longer exist and an expert consensus document suggests implementation of RM in the daily practice for ICD recipients [17]. It was quickly recognized that the ever increasing office visits are impractical, onerous, and inefficient since the likelihood to miss potential serious problems occurring between device interrogations is high. The classical follow up checks do not anticipate problems and only b10% of planned in-clinic visits require device reprogramming or medications change. RM system based on patient-driven communication is also unable to detect asymptomatic problems while, the automatic ones provide continuous monitoring with transmission of alert data when the patient is unaware of the problem. Thus, at least half of the regularly scheduled visits can be omitted, without impairing patient safety [7]. Only 6% of patients undergo device reprogramming or admittance to hospital at in-clinic visits; thus 94% of these visits could be executed remotely [18]. 4. Can RM avoid clinic visits and follow-up? Clinic visits are still needed as no system allows remote device programming, diagnosis of co-morbidities and possibilities to change medication to the patients. In addition, the added value of patient/ physician relationship should not be underestimated. Regular follow-
up, however, can be avoided. The Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial [11] is the first that validated and recently confirmed [19] the ability for RM to avoid routine periodic in-clinic evaluations. RM reduced health care utilization by almost 50%, predominantly by reducing scheduled visits, the bulk of which did not require any clinical intervention [11] (Fig. 1). It is important to distinguish between remote follow-up, RM and patient initiated interrogation [17]. The remote follow-up is a scheduled automatic device interrogation, which replace in-office visit. It is aimed to assess device function (e.g. battery status, thresholds…). RM is an automatic unscheduled transmission of alert events (e.g. atrial fibrillation, abnormal lead impedance…) often requiring a visit. Patient-initiated device interrogation is a non-scheduled follow-up initiated manually by the patient because of a perceived clinical event [3]. Finally, RM may be integrated with sound alerts from device. Indeed, the sound alerts sometimes are erroneously felt from patients and RM may discriminate whether the problem is present or not and, consequently, determine an additional outpatient visit or just reassure the patient by phone. Something similar may happen also for the phantom shocks.
5. The workload In several European centers a nurse reviews the data and forwards some (not all) of them to the responsible physician. This model, implemented since 2005, is called “primary nursing” [20]. Each patient is assigned to a nurse; he or she screens and registers patient's data in the website. In case of critical events (arrhythmias, ICD intervention, change in electric or clinical parameters…) the nurse submits the case to the physician for decision making. The nurse can contact the patient, asking information about symptoms, clinical status, and compliance to medical therapy. The approach is bidirectional as in case of symptoms or device sound alerts, the patient is encouraged to contact the nurse for assistance (Fig. 2). The “HomeGuide Registry” study shows that, by so doing, the median manpower time required for 100 patients is only 55.5 min × health personnel per month [20]. This model is adopted in the “consensus document on cardiac implantable electronic devices remote monitoring” of the Italian Society of Pacing and Arrhythmology (AIAC) and it has become the standard in Italy [21].
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Fig. 1. The TRUST trial. Home Monitoring (HM) reduced resource utilization (scheduled and unscheduled clinic visits) by 45% in 1 year (left), reduced time to physician evaluation of arrhythmias (middle) and for silent events (right). Ref. [19].
6. Detection of system malfunction A significant proportion of ICD recipients might experience system complications at any time; the majority being lead-related [22,23]. 6.1. Lead integrity and system related complications Current ICDs have self-monitoring ability and record data in the device's memory, but the physician becomes aware of these only later, at scheduled follow-up visits, exposing the patient to risks. RM, on the contrary, offers a continuous surveillance with rapid event identification and notification. There are only sporadic false-positive alarms, as
the lower and upper limits for normal parameters range (i.e. impedance of the leads, strictly related to lead integrity) are programmable. Accordingly, Swerdlow et al. [24] demonstrated that the Medtronic lead integrity alert algorithm triggered an acoustic alert at least 3 days in advance, facilitating early interrogation in 76% of patients with lead failure. Continuous monitoring of sensing values and early detection of oversensing episodes is also helpful. A post-hoc analysis of the TRUST trial, revealed that RM permitted prompt detection of oversensing episodes (median 1 day in RM vs. 5 days in conventional follow-up) and facilitated management decisions, including surgery [25]. Observational experience shows that 90% of the lead failure is anticipated by episodes of electrical oversensing detected as ventricular tachyarrhythmias [26].
Fig. 2. The organizational model workflow called “primary nursing” with action items and responsibilities. Ref. [20].
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6.2. Leads under advisories Systematic replacement of ICD generator or implanted leads is associated with a substantial rate of complications, including death [16,27,28]. Often leads are replaced despite no electrical failure, 16% of the case in a recent study [29]. This strategy exposes patients to unnecessary risk particularly those who are not pacemaker-dependent or those with a primary prevention indication. Continuous remote surveillance is a valid alternative to avoid this. It provides an immediate detection of device or lead failure and avoids unnecessary replacements, thus reducing
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costs and morbidity/mortality. Accordingly, lead problems related to Medtronic's Sprint Fidelis were predicted by the Lead alert system in combination with CareLink [30]. On the contrary, the recent problems with St. Jude Medical's Riata lead due to cable externalization were not predictable by the Merlin system and caused huge implementation of follow-up in-person visits and many fluoroscopy controls of the leads. The consequences of lead faults are different [31]. A fractured Fidelis lead often causes inappropriate ICD shocks from sensed noise, whereas externalized Riata leads are less likely to produce inappropriate shocks and they are more difficult to detect. In general, according to Hauser
Fig. 3. Case report of a patient that experienced inappropriate shock: an episode of atrial fibrillation with very fast ventricular rate caused the inappropriate detection as ventricular fibrillation and the delivering of shock. From the top: atrial (A), right (VD) and left (VS) ventricular marker channels, atrial internal EGM, right and left internal EGM.
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et al. [32], 87% of the leads analyzed at a late stage of disintegration, produced electrical abnormalities, which could have been detected by RM. The ECOST trial reported a 2-year experience with RM in 40 recipients of high voltage ICD leads prone to fracture or under advisories [8]. Lead dysfunction was suspected whenever oversensing of noise artifacts and/or abrupt rise in pacing impedance was remotely transmitted. Need of lead replacement was confirmed in 4 out of 40 patients.
6.3. Reduction of inappropriate defibrillator shocks RM reduces inappropriate defibrillator shocks [33]. “Inappropriate” are the shocks delivered for causes other than ventricular tachycardia (VT) or ventricular fibrillation (VF) and have been reported in up to 17% of heart failure patients [34]. They are painful, affects quality of life, can lead to hospitalizations, premature battery depletion, lifethreatening arrhythmias and pump failure [34]. In the MADIT-RIT study [1] not only appropriate but also inappropriate activations of ICD (shocks or anti-tachycardia pacing (ATP)) were associated to increased mortality. The most common trigger for inappropriate activations of ICD is atrial fibrillation and other supraventricular tachycardias (Fig. 3). In a minority of cases, inappropriate shocks result from sensing abnormalities, conductor fracture, insulation failure, T wave and myopotential oversensing or electromagnetic interference. They are preceded for hours or even days by a “pre-shock” time with an incorrect detection of VT/VF without symptoms [26]. RM informs about these events long before they result in inappropriate shock. Already in 2007 Lazarus demonstrated the usefulness of RM to early detect (more than 64 days before a quarterly scheduled visit) inappropriate shocks [6]. A single-center experience using RM for surveillance of lead under advisory shows that fewer patients undergoing RM (27.3%) had inappropriate shock as compared to those with standard in-office follow-up (46.5%) [26]. A subanalysis of the ECOST trial [35] shows a 52% reduction of inappropriate shocks (with a 72% reduction in the risk of related hospitalizations) in the arm with RM.
6.4. Cost saving The cost benefit of RM is straightforward. There are less patient inhospital visits, less cost for patient transport and less time working hours of care-givers. The most cost saving is for patients who attend the visits and do not require change in device programming or pharmacological treatment. Even an isolated ICD shock, either appropriate or phantom, could be managed with a reassuring telephone call, thus avoiding an extra follow-up visit. The TRUST study confirms that RM reduced by 45% healthcare utilization [11]. Full patient engagement is important and communication and education on RM function should be continued over time as heart disease is a dynamic condition [36]. 7. Disease and patient management RM can be a useful tool also for disease's management. 7.1. Early arrhythmias detection Modern devices provide detailed information on arrhythmic events: day and hour of occurrence, onset mechanism, duration, eventual recurrences, mean and maximum ventricular rate, relative intracardiac electrogram, number and duration of mode switch and effect of therapies. This should result in more efficient and rapid treatment, thus reducing arrhythmia and stroke-related hospitalizations [33,37]. The available trial, however, was not powered to address this end-point. RM is particularly useful to detect asymptomatic atrial fibrillation (AF) episodes where a prompt clinical reaction may avoid atrial remodeling and risk of stroke (Fig. 4) [38–41]. In the recent IN-TIME study, a post-hoc analysis showed that patients with history of AF were more likely to benefit from RM than patients without [13]. Early AF detection is particularly relevant for heart failure (HF) as the two diseases have synergic deleterious effects and are considered “twin epidemics” [42]. Early detection of ventricular arrhythmias may also be important [34,43–46]. Notification of repetitive ATP, which is usually asymptomatic,
Fig. 4. Case report of an asymptomatic atrial fibrillation episode in a biventricular-ICD recipient. After the first sinus beat normally conducted to the ventricles, there is the AF onset. Of note the ventricular rate was not changed. From the top: atrial and ventricular (RV and LV) marker channel, atrial internal EGC, right and left internal EGM.
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is useful as evidenced by the ECOST trial as these alerts may precede electrical storm [35]. Early detection of ventricular arrhythmias that trigger repetitive shock therapy is less important as this is a highly symptomatic event that in any case encourages the patients to contact his physician [5]. (Fig. 5). 7.2. Heart failure Despite optimal medical and electrophysiological therapy, HF hospitalization rates remain high. Approximately 25% of discharged patients are readmitted within 30 days [47]. ICDs are capable to collect both
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noninvasive data recorded by the patients (blood pressure and body weight) and invasive data obtained by the device on cardiac function, allowing to follow the progression of HF. A great hope has been devoted to intrathoracic impedance as a surrogate marker of volume overload. Intrathoracic impedance inversely correlates with pulmonary capillary wedge pressure as vascular congestion decreases the electrical impedance across the lung. This is reported by the device before changes in body weight and symptoms development thus, theoretically, preventing hospital admission. Published results, however, are conflicting. No study has shown a clear clinical efficacy with fluid overload alerts, mainly because of too many false-positive, finally resulting in switching off the
Fig. 5. Case report of a patient that experienced an arrhythmic storm: multiple and repetitive shocks were delivered in a few minutes (a). The EGM analysis confirmed the appropriate intervention of the device (b).
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alarm. The DOT-HF study demonstrated an “expected” increase in outpatient HF clinic visits (P = 0.0001) but also an “unexpected” increase in hospitalizations (HR 1.79; 95% CI: 1.08–2.95; P = 0.022) in the OptiVol equipped ICD or CRT-D [48]. The ongoing phase 2 European MORECARE study will clarify whether RM including fluid overload alerts exerts a positive impact on patient outcome [48]. Other predictors of HF worsening are the AF burden, and changes in heart rate variability (HRV) and in SDAMM (standard deviation of 5 min median atrial-toatrial intervals) all of which can be detected by RM. Most likely a single parameter is suboptimal making multi-parametric monitoring better for clinical decision-making. A composite risk score has been tested in the PARTNERS-HF [36] observational multicenter study. Patients with a positive combined score had at least 2 of the following criteria: long AF duration, rapid ventricular rate during AF, high fluid index, low patient activity, abnormal autonomics (high night heart rate or low heart rate variability), or notable device therapy (low CRT pacing or ICD shocks). A positive score had a 5.5 fold increased risk of hospitalization for HF in the next month (HR 5.5; 95% CI: 3.4 to 8.8; P b 0.0001) independently from the correlation of the clinical variables (HR 4.8; 95% CI: 2.9 to 8.1; P b 0.0001) [49]. The study required a monthly inperson evaluation for downloading all the device-based diagnostic data. The EuroEco also shows a trend of fewer and shorter hospitalizations in the RM ICD cohort [50]. The IN-TIME trial [13] is the first randomized trial demonstrating benefits with RM for dual-chamber ICD and CRT recipients with advanced HF, but patients with permanent AF were excluded. At 12 months the RM group experienced less primary endpoint which was a composite of all-cause mortality, overnight hospitalization for worsening HF, change in NYHA class or change in patient global self-assessment (18.9% vs. 27.2%; odds ratio 0.63, 95% CI: 0.17–0.74). There were few deaths in the active group (Fig. 6) [13]. The ongoing REM-HF [51] and MORE-CARE [52] phase 2 studies hopefully will confirm the usefulness of RM in this setting. The first examines the likely mechanism of benefit and cost-effectiveness. The second
assesses whether RM in NYHA III/IV patients with CRT-D reduces death and hospitalizations. An alternative strategy is noninvasive monitoring with patientmanaged transmission of data (bodyweight, blood pressure, and heart rate) measured with external devices and combined with symptoms report. Although two meta-analyses suggest that this approach reduces morbidity and mortality [53,54], two large randomized controlled trials (TELE-HF and TIM-HF) failed to confirm this [55,56]. Implantable hemodynamic monitors of pulmonary artery pressure, intrathoracic impedance or left atrial pressure have also been proposed but the invasiveness and the often failure of the sensors are limiting factors. Although we do not still have definitive data, the possibility in the next future to tailor HF therapy by multiple RM parameters (bodyweight, blood pressure, intrathoracic impedance, HRV, AF burden, percentage of biventricular stimulation etc…) integrated to clinical visits is promising and, likely, could have a beneficial influence on the prognosis of HF patients. 8. Open problems Several challenges remain before RM will become routine in clinical practice. – First, standardization of workflow and data managing. According to the EHRA survey [37] two-thirds of the participant centers (64.3%) do not have a specific unit for RM and 25% do not have a standardized dedicated workflow. As results, only 6.4% of the collected data were transferred to clinical practice and reported in the patient's medical records. Ideally, the information should be available to all responsible physicians including electrophysiologist, HF specialists, cardiologists and general practitioner [57]. A small observational study showed that knowledge of RM data to a specialized team of cardiologists, HF nurses and general practitioners reduced HF
Fig. 6. The IN-TIME study. The Kaplan–Meier curves of 1-year all-cause mortality in the telemonitoring (blue) and control (green) group. Ref. [13].
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hospitalizations [58]. Equally, it is important to establish an appropriate programming to limit notification of only those alerts requiring a medical intervention. Importantly, we have to underline that RM determines less resources regarding outpatient clinic visits. However, the transmission of device data should be continuously checked by technicians or specialized nurses dedicated to RM, which require resources for acquisition of appropriate competence. Furthermore, the time dedicated to RM has different impact between technicians or specialized nurses and physicians [59]. These issues may be an economical problem especially in developing countries. – Second, economic issues. The cost of the technology and manpower for data management are still open problems. Particularly in Europe given the diversity of healthcare models. Usually the cost of RM is not reimbursed and just added to the overall cost treatment [60]. – Third, legal issue. The use of telemedicine per se is a clinical action and physicians have the responsibility for responding to the data provided. Several questions are still open. How fast should a physician react to the alerts? Is a 24 h, 7 days a week coverage needed? Is it legally acceptable to overlook event notifications outside the office hours? [15]. It is important to realize that RM does not substitute emergency care, to which the patient should continue to refer in case of serious symptoms or problems. It follows that the patient must be carefully informed and aware of the advantages and limitations of RM. In particular, the patient should receive detailed information about modality and timing of reaction after an alert, which are specific of the center. However, it has to be clear for the patient that RM cannot be a system for the management of the emergencies. It should be clearly explained to the patient that in case of emergency
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he should contact immediately the first aid department. Therefore, a written informed consent should be obtained ensuring that the patient has been properly informed and has agreed to use of this technology [61]. Practice guidelines are also needed on the appropriate role of RM for management of patients with ICD or other devices. – Four, data confidentiality. This is another issue of particular importance both for the producer and the physician. The patient at the time of signing the consent should be informed and agreed the precautions adopted to maintain privacy of his own data.
9. Conclusion RM, initially aimed to limit face-to-face visits and to monitor the device performance, has expanded to part of the disease management. Randomized trials and observational studies have consistently demonstrated the benefits of RM vs. conventional in-hospital follow-up, including a positive impact on survival (Table 2). The current generation of devices is reliable and automatically checks battery status, lead impedance, sensing and capture thresholds. The latest ESC guideline update for CRT suggests RM in high risk group patients [62,63]. Despite this, the adoption of RM remains poor and essentially limited to ICD [64]. There are several reasons for this. Innovations are not always accepted by the medical community and RM is not an exception. Some patients are reluctant to accept RM [65]. There are legal, although no challenges occurred in the last decade, and reimbursement issues. In the USA, even, where there is an established
Table 2 Clinical evidences of the benefit of RM in ICD patients. Study name
Author and year of publication
RM technology
TRUST (11)
Varma 2010
Biotronik RCT ICD Home Monitoring Boston Observational ICD Scientific CRT-D Latitude
ALTITUDE (45)
Saxon 2010
Study method
Device
Number Follow of up patients
Primary objective
Result
1450
In hospital device evaluation
Healthcare utilization was reduced by 45%
Survival
1 and 5 years survival rate were higher for the patients receiving remote follow up compared with patients receiving in clinic follow up with a 50% relative reduction in the risk of death Patients with a positive combined heart failure device diagnostics score had 5.5 fold increased risk of congestive heart failure hospitalization within the next month.
months 194,006
5 years
12 Utility of the combined heart failure months device diagnostic information (long atrial fibrillation, rapid ventricular rate, high fluid index, low patient activity, low heart rate variability, low CRT pacing, ICD shocks) to predict heart failure 15 Time from a clinical event to a months decision in response
PARTNERS-HF Whellan 2010 (50)
Medtronic Care link
Observational CRT-D
694
CONNECT (12)
Crossley 2011
Medtronic CareLink
RCT (non blinded)
ICD CRT-D
1997
ECOST (36)
Guedon-Moreau Biotronik RCT 2012 Home Monitoring
ICD
433
MORE-CARE (53)
Boriani 2013
Medtronic CareLink
CRT-D
Fase 1: 148
IN-TIME (13)
Hindricks 2014
Biotronik RCT Home Monitoring
RCT
15
ICD 664 CRT-D (permanent AF excluded)
The median time from clinical event to clinical decision per patient was reduced from 22 days for the in-office care to 4,6 days for the remote monitoring group. 27 Safety of RM in major adverse events RM was non-inferior to ambulatory follow-ups months (death from any cause, cardiovascular, and procedure or device-related major adverse effects) 12 Fase 1: to evaluate the delay from Fase 1: RM in patients with advanced months detected events to clinical decisions. heart failure allow physician to prompt react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits. The RM group experienced less primary 12 Outcome measure with a composite end point The difference in the primary months clinical score (all-cause of death, overnight hospital admission for heart outcome was mainly driven by the failure, change in NYHA class, change difference in mortality (8.7% in the in patient global self assessment) control group vs. 3.4% in the RM group).
CRT-D: cardiac resynchronization therapy defibrillator. ICD: implantable cardioverter defibrillator. RCT: randomized clinical trial. RM: remote monitoring.
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reimbursement program, RM is adopted only in 50% of the cases [45]. Often hospital care is not ready for RM approach with concern for the increased workload and the lack of organizational models [64]. We should not be discouraged by these difficulties. In 1970 cardiology was not prepared for primary angioplasty. It took more than 30 years before establishing well-functioning network. We need to look at the future and the goal is to use RM technology maintaining human relationship with the patients.
[13]
[14]
[15]
[16]
Abbreviations AIAC Italian Society of Pacing and Arrhythmology AF atrial fibrillation ATP antitachycardia pacing CRT cardiac resynchronization therapy HF heart failure ICD implantable cardioverter defibrillator RM remote monitoring VF ventricular fibrillation VT ventricular tachycardia
[17]
[18]
[19]
[20] [21]
Conflict of interest Roberto Ferrari reported that he received honorarium from Servier for steering committee membership consulting and speaking, and support for travel to study meetings from Servier. In addition, he received personal fees from Boehringer-Ingelheim, Novartis, Merck Serono and Irbtech. Matteo Bertini, Lina Marcantoni and Tiziano Toselli have no conflict of interest.
[22]
[23]
[24]
[25]
Acknowledgments This work was supported by a grant from Fondazione Anna Maria Sechi per il Cuore (FASC), Italy. The funders had no role in the study design, data collection and analysis, decision to publish or the preparation of the article.
[26]
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