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Remote management is partially replacing routine follow-up in patients implanted with cardiac implantable electronic devices (CIEDs). Although it reduces clinical staff time compared with standard in-office follow-up, a new definition of roles and responsibilities may be needed to review remote transmissions in an effective, efficient, and timely manner. Whether remote triage may be outsourced to an external remote monitoring center (ERMC) is still unclear.
The aim of this health care quality improvement project was to evaluate the feasibility of outsourcing remote triage to an ERMC to improve patient care and health care resource utilization.
Patients (N=153) with implanted CIEDs were followed up for 8 months. An ERMC composed of nurses and physicians reviewed remote transmissions daily following a specific remote monitoring (RM) protocol. A 6-month benchmarking phase where patients’ transmissions were managed directly by hospital staff was evaluated as a term of comparison.
A total of 654 transmissions were recorded in the RM system and managed by the ERMC team within 2 working days, showing a significant time reduction compared with standard RM management (100% vs 11%, respectively, within 2 days;
The outsourcing of RM management to an ERMC safely provides efficacy and efficiency gains in patients’ care compared with a standard in-hospital management. Moreover, the externalization of RM management could be a key tool for saving dedicated staff and facility time with possible positive economic impact.
ClinicalTrials.gov NCT01007474; http://clinicaltrials.gov/ct2/show/NCT01007474
Remote monitoring (RM) management of patients implanted with cardiac implantable electronic devices (CIEDs) (such as implantable defibrillators) enables early detection of clinically relevant events and complications while partially replacing routine follow-up [
Efficient allocation of health care professionals’ time is crucial due to the limited resources available for RM activities today and prospectively in the future, given the patient population growth and accompanying follow-up burden [
The aim of this quality improvement project is to evaluate the feasibility of outsourcing the triage of CIED remote follow-up in the management of relevant clinical and technical events in a timely manner. We would like to assess if this approach is safe, effective, and efficient and to evaluate the implications in hospital resource utilization. Our purpose, in other words, is to demonstrate that the proposed triage model consents prompt event management, completeness of remote transmission review, and ability in detecting and prioritizing events (efficacy and safety) and that it might imply a reduction in the use of hospital resources required for daily remote CIED management (efficiency).
From April 2016 to December 2016, an ERMC composed of 1 trained nurse and 1 supporting physician (HTN Spa, Brescia, Italy) performed daily reviews of remote transmissions from 153 CIED patients implanted in the hospital, S Raffaele Giglio Hospital of Cefalù (Italy): 62 single- or dual-chamber pacemakers (IPGs), 15 single- or dual-chamber implantable cardioverter defibrillators (ICDs), and 76 cardiac resynchronization therapy defibrillators (CRT-Ds). The presented experience is included in the validation effort of Medtronic FOCUSON, a service aiming to save time for health care professionals to enable a higher quality of care. The FOCUSON service is built around a highly skilled team that classifies transmitted patient data based on agreed protocol and promptly notifies the physician, allowing efficient and effective patient treatment.
All consecutive patients enrolled in the CareLink network (CLN) in the considered time frame were considered for this analysis. CLN is an internet-based service that provides device-related and physiologic patient data similar to data that formerly required an office visit, together with training and support services. The key component of the CLN is the CareLink monitor, an in-home monitor for patients who have received a Medtronic implanted cardiac device. All patients were included in the ClinicalService project (ClinicalTrials.gov, NCT01007474). This medical care quality improvement project was approved by the medical director and conforms to the principles outlined in the Declaration of Helsinki. Each patient provided informed consent for data collection and analysis. The activity is based on a well-defined legal framework, where the parts agree on responsibility, safety requirements, data ownership, data managing, and compliance and compare current remote management models.
As standard practice before outsourcing, there were 3 physicians performing electrophysiology and ambulatory activities. No nurse was dedicated to the ambulatory service, so RM relied on physicians only. All staff were well trained to manage RM activities, even in the absence of a prespecified shared protocol. Despite RM being considered as an important part of clinical practice, remote follow-up was often carried out in the middle of other activities in free time slots. Patients usually transmitted data 3 times per year, with a specific date scheduled by the physician during the annual in-office visit. These routine, scheduled, remote device interrogations were structured to mirror in-office device checks. Prespecified alerts related to device functionality and clinical events (called CareAlerts) were activated and were able to trigger automatic transmissions, for the purpose of emergency clinical and technical RM of patients implanted with a device with wireless capabilities, but without any check planned for lost transmissions or disconnected monitors.
The patients included in the service were enrolled by the health care provider in CLN, and details from the patient file as well as their identification numbers were recorded. This anonymous patient identification number was used in all formal communications between ERMC and the health care providers. Patients’ clinical history (eg, implant indication, cardiomyopathy etiology, and atrial fibrillation history) and relevant information (eg, pacemaker dependency, drug therapy with a special attention to oral anticoagulation therapy, and implanted device and leads details) were available for the monitoring center through the
Remote management flowchart. Green events are all transmissions not reporting device detections listed as low or high priority. In case of missed scheduled transmissions or disconnected monitors, the external remote monitoring center (ERMC) inform the technical team responsible for contacting the patient. RRT: recommended replacement time; TAO: oral anticoagulation therapy; AT/AF: atrial tachyarrhythmia/atrial fibrillation; CRT: cardiac resynchronization therapy; SVC: superior vena cava. DOO, VOO, and AOO are programming modes.
With the aim of effectively reviewing transmissions and managing all possible clinically and technically relevant events, a transmission color-code classification was predefined by the hospital physicians to prioritize device clinical and technical conditions. The different types of relevant events related to each color code are represented in
On the basis of the received RM data, the clinical response was at the discretion of the involved clinicians. When the patient had to be contacted, a standardized telephone interview was conducted by the medical staff to evaluate the patient’s health condition (worsened dyspnea, increased weight, patient’s compliance with the medical therapy, etc). In addition to the interview details, the hospital staff reported all follow-up clinical actions on the CareLink website. In some cases, prioritized events would not require any action, for example, in case of an event already managed with the appropriate therapy (eg, atrial arrhythmias with optimized drug therapy, intrathoracic fluid accumulation, and other events previously known to the staff), or for which clinicians would rather wait to monitor the status of the event.
The aim of this health care quality improvement project was to assess if outsourcing the triage of CIEDs’ remote follow-up is safe, effective, and efficient to manage relevant clinical and technical events in a timely manner and improve hospital resource utilization. Time to review all transmissions and time to report prioritized events, according to the protocol flowchart, were considered as end points for efficacy and safety.
Efficiency was defined as the ability to improve transmission review and event analysis with reduced hospital resources and was evaluated, in the same recipient of patients, through the comparison with the standard practice of the same hospital in the 6 months preceding the project.
Continuous data were summarized as mean and SD or median and the first and the third quartiles (Q1-Q3), categorical data as counts and percentages. Differences in proportions were compared by applying chi-square analysis. Continuous Gaussian variables were compared by the Student
An alpha level of .05 was considered for each test. All statistical analyses were performed using SAS 9.4 version software (SAS Institute Inc, Cary, NC, USA).
A total of 153 patients with an implanted CIED were included in the project and followed remotely on the CareLink RM network (Medtronic, Minneapolis, MN) for 8.4 (SD 1.1) months, with a total follow-up period of 107 years.
Demographics and baseline patient characteristics are presented in
From April 2016 to December 2016, 654 transmissions were recorded and reviewed by ERMC corresponding to 613 (95% CI 568-662) transmissions for 100 patient-years. In particular, CRT-D devices transmitted more than the other CIEDs, with 802 (95% CI 729-882) transmissions per 100 patient-years. Transmissions with prioritized events represented 15.7% of the total transmissions, with 82.5 (95% CI: 66.9-102) amber transmissions and 14.1 (95% CI 8.5-23.3) red transmissions per 100 patient-years (
Demographics and baseline patient characteristics.
Patient characteristics | Total (N=153) | CRT-Da (N=76) | ICDb (N=15) | IPG+CRT-Pc (N=62) | |
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Age at first implant (years), mean (SD) | 68 (11) | 69 (9) | 64 (13) | 68 (13) |
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Male, n (%) | 112 (73.2) | 55 (72) | 15 (100) | 42 (68) |
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Ischemic cardiopathy | 56 (37) | 31 (41) | 11 (73) | 14 (23) |
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Acute myocardial infarction | 35 (23) | 28 (37) | 7 (47) | 0 (0 ) |
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History of heart failure | 107 (70.0) | 67 (88) | 5 (27) | 35 (56) |
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New York Heart Association III-IV | 54 (35) | 56 (74) | 2 (13) | 0 (0) |
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History of ventricular tachycardia/ventricular fibrillation | 36 (24) | 27 (36) | 5 (33) | 4 (7) |
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Ventricular fibrillation/flutter | 2 (1) | 2 (3) | 0 (0) | 0 (0) |
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History of atrial tachycardia/atrial fibrillation | 72 (47) | 18 (24) | 3 (20) | 51 (82) |
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Left bundle branch block | 54 (35) | 46 (61) | 0 (0) | 8 (13) |
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History of stroke/transischemic attack | 10 (7) | 6 (8) | 4 (27) | 0 (0) |
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Diabetes | 41 (27) | 19 (25) | 4 (27) | 18 (29) |
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Beta-blocker | 75 (61) | 54 (75) | 7 (64) | 14 (34) |
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Diuretic | 74 (60) | 56 (78) | 8 (73) | 10 (24) |
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Antiplatelet | 18 (15) | 15 (21) | 0 (0) | 3 (7) |
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Oral anticoagulants | 21 (17) | 16 (22) | 2 (18) | 3 (7) |
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Amiodaron | 4 (3) | 4 (6) | 0 (0) | 0 (0) |
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Calcio-antagonist | 6 (5) | 3 (4) | 0 (0) | 3 (7) |
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Angiotensin-converting enzyme-inhibitor/angiotensin receptor blockers 2 | 51 (41) | 39 (54) | 5 (46) | 7 (17) |
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Digitalis | 1 (1) | 1 (1) | 0 (0) | 0 (0) |
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Less than 12 months | 29 (20) | 26 (36) | 2 (13) | 1 (2) |
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12-36 months | 59 (41) | 43 (59) | 7 (47) | 9 (16) |
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More than 36 months | 57 (39) | 4 (6) | 6 (40) | 47 (83) |
aCRT-D: cardiac resynchronization therapy defibrillator.
bICD: single- or dual-chamber implantable cardioverter defibrillator.
cIPG + CRT-P: single- or dual-chamber pacemaker + cardiac resynchronization therapy pacemaker.
d124 patients with data about medication at baseline, 72 CTR-Ds, 11 ICDs, and 41 IPGs.
e145 patients with available date of implant, 73 CRT-Ds, 15 ICDs, and 57 IPGs.
Rate of transmission, overall and by priority.
Transmission priority | All (n=153, 107 patient-years) | CRT-Da (n=76, 53 patient-years) | ICDb (n=15, 10 patient-years) | IPGc (n=61, 61 patient-years) | CRT-Pd (n=1, 1 patient-year) | |
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Transmissions, n | 654 | 426 | 50 | 176 | 2 |
Annual rate of transmissions per 100 patient-years (95% CI) | 613 (568-662) | 802 (729-882) | 504 (382-665) | 410 (354-476) | —e | |
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Transmissions, n (%) | 551 (84.3) | 364 (85.4) | 40 (80.0) | 147 (83.5) | 0 (0.0) |
Patients with green transmission, n | 141 | 67 | 14 | 60 | 0 | |
Annual rate of transmissions per 100 patient-years (95% CI) | 517 (475-561) | 648 (585-718) | 393 (288-536) | 333 (283-391) | — | |
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Transmissions, n (%) | 88 (13.5) | 53 (12.4) | 9 (18.0) | 24 (13.6) | 2 (100) |
Patients with amber transmission, n | 50 | 28 | 4 | 17 | 1 | |
Annual rate of transmissions per 100 patient-years (95% CI) | 82.5 (66.9-102) | 94.4 (72.1-124) | 88.4 (46.0-170) | 54.3 (36.4-81.1) | 277 (69.2-1106) | |
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Transmissions, n (%) | 15 (2.2) | 9 (2.2) | 1 (2.0) | 5 (1.7) | 0 (0.0) |
Patients with red transmission, n | 9 | 5 | 1 | 3 | 0 | |
Annual rate of transmissions per 100 patient-years (95% CI) | 14.1 (8.5-23.3) | 16.0 (8.3-30.8) | 9.8 (1.4-69.7) | 11.3 (4.7-27.2) | — |
aCRT-D: cardiac resynchronization therapy defibrillator.
bICD: single- or dual-chamber implantable cardioverter defibrillator.
cIPG: single- or dual-chamber pacemaker.
dCRT-P: cardiac resynchronization therapy pacemaker.
eNot applicable.
Most of the amber transmissions reported arrhythmia events, whereas two-thirds of the red transmissions presented system issues (
Following the protocol, ERMC communicated all high-priority (red) transmissions to the hospital within 24 hours of transmission review, and 96.4% of the amber transmissions were reported within 48 hours. Overall, when we consider the additional time from transmission reception to transmission review and the time from review to communication, 91.7% of red transmissions were reported within 1 working day and 95.4% of amber transmissions within 2 working days (
Red transmissions required urgent visit or hospitalization in 60% (9/15) of the cases, whereas 92% (81/88) of amber events were managed totally remotely (
(A) Distribution of transmission by priority; (B) low-priority detected events; and (C) high-priority detected events. CRT-D: cardiac resynchronization therapy defibrillator, ICD: single- or dual-chamber implantable cardioverter defibrillator, IPG: single- or dual-chamber pacemaker, CRT-P: cardiac resynchronization therapy pacemaker.
Time from transmission to communication with the hospital.
Clinical response to reported events.
Clinical response | Total (N=103), n (%) | Amber (n=88), n (%) | Red (n=15), n (%) |
Heath care utilization required | 16 (15.5) | 7 (8.0) | 9 (60.0) |
Hospitalization for device replacement | 7 (6.8) | 4 (4.5) | 3 (20.0) |
Hospitalization for lead revision | 2 (1.9) | —a | 2 (13.3) |
Hospitalization for cardiovascular reasons | 1 (1.0) | — | 1 (6.7) |
In-office visit required | 6 (5.8) | 3 (3.4) | 3 (20.0) |
Event resolved remotely | 87 (84.5) | 81 (92.0) | 6 (40.0) |
New transmission required | 17 (16.5) | 11 (12.5) | 6 (40.0) |
Not urgent actionb | 70 (68.0) | 70 (79.5) | — |
aNot applicable.
bEvent previously managed, monitoring the status of the event. The proportions are calculated on the total number of reported events (103, 88 amber, and 15 red).
Among the 153 patients followed by ERMC, 126 were remotely managed in the hospital from June 2015 to December 2015. In the ERMC phase, the median time to review was significantly reduced from 11 days (Q1-Q3: 4-25 days) to less than 24 hours (Q1-Q3: 0-1 day;
During the ERMC phase, patients were more compliant to the remote transmissions schedule than in the benchmarking phase, and the total number of annual transmissions per 100 patients increased from 350 to 608, respectively (
(A) Distribution of time from transmission to review, benchmarking phase versus external remote monitoring center (ERMC) phase; and (B) Percentage of reviewed transmissions, benchmarking phase versus ERMC phase. RM: remote monitoring.
Rate of reviewed transmissions, benchmarking phase versus external remote monitoring center phase.
Device type | Benchmarking phase | Monitoring center phase | |||||
Total exposure time (years) | Reviewed TXa, n | Annual rate of hospital physician reviewed TX per 100 patient-years (95% CI) | Total exposure time (years) | Reviewed TX, n | Annual rate of hospital physician reviewed TX per 100 patient-years (95% CI) |
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Overall (patients, n=126) | 105 | 368 | 350 (316-387) | 89 | 78b | 88 (69-109) | <.001 |
CRT-Dc (n=55) | 41 | 214 | 527 (461-603) | 39 | 42 | 108 (78-146) | <.001 |
ICDd (n=12) | 10 | 35 | 366 (263-509) | 8 | 6 | 75 (28-163) | <.001 |
IPGe (n=58) | 54 | 115 | 213 (177-255) | 41 | 5 | 12 (4-28) | <.001 |
CRT-Pf (n=1) | 1 | 4 | 411 (154-1096) | 1 | 0 | —g | — |
aTX: transmissions.
b10 (14.7%) were classified as red.
cCRT-D: cardiac resynchronization therapy defibrillator.
dICD: single- or dual-chamber implantable cardioverter defibrillator.
eIPG: single- or dual-chamber pacemaker.
fCRT-P: cardiac resynchronization therapy pacemaker.
gNot applicable.
This research showed that externalizing part of RM follow-up is safe, effective, and efficient in supporting a hospital previously challenged to guarantee high-quality standards of RM follow-up in terms of (1) time to review transmissions, both scheduled and unscheduled, to enable timely medical action as necessary; (2) dedicated staff and facility time to perform RM; and (3) patient compliance to RM, measured as the rate of transmissions per year.
The ERMC’s staff reviewed and managed all high-priority transmissions within 2 hours and 96.4% of the low-priority events within 2 working days, escalating only 15.7% of all transmissions to hospital staff due to a prioritized event being detected. The frequency of prioritized events was relatively high compared with the 8.2% presented by Cronin et al [
It is well known that RM is a valuable tool that is able to support the follow-up of patients with an implanted CIED; however, it requires organizational changes in the hospital workflow to achieve optimal patient follow-up [
Ensuring patient compliance is another key component to optimal follow-up, especially as patients can get disconnected from the system and may need support to reconnect. Moreover, with time, patient attention can decrease during follow-up and the use of RM may become intermittent. Our data showed that during the ERMC phase, the total number of remote transmissions increased by 74% as the monitoring center also communicated with the technical team to ensure that all patients would remain connected. This can also contribute to avoid variability in care between patients as well as encourage patient engagement in follow-up.
Regarding staff burden, with the escalation of prioritized events only, even with the large increase in the number of transmissions, the proportion of transmissions requiring review was reduced by 75%. If we apply the time to review transmissions (including administrative time) considered in Cronin et al [
We reported results of a single center experience, sharing the problems with efficacy and efficiency of the RM in a hospital where there was no standard center-specific protocol established for RM apart from the Heart Rhythm Society recommendations. Moreover, our practice may not be the standard of care across different health care systems. Further studies are required to deeply investigate if an ERMC strategy will be recommended in centers with a larger number of monitored patients and with predefined RM strategies.
Due to the limited sample size, we were not able to identify specific subgroups more eligible than others to receive external remote monitoring triage. Future studies could possibly be designated to address the topic.
Once the ERMC phase was completed, we noted that some areas of improvement are still required in the process of externalization of RM, such as refining prioritization of events based on ongoing medical therapy (eg, oral anticoagulant therapy).
Whether the externalization of RM management is able to improve the adherence to guidelines and recommendations and its effects on clinical outcome were not in the scope of this study.
This experience in Cefalù Hospital’s cardiology department demonstrated that outsourcing part of the remote follow-up of patients through an ERMC is safe, effective, and efficient compared with standard RM performed at a hospital level. All the transmissions were reviewed within 2 working days and prioritized events were communicated promptly by ERMC, leading to a faster review of important events by hospital staff without the triaging burden. In a scenario of limited resources, such externalization of RM could be a key tool to save dedicated staff and facility time for more crucial patient care activities.
cardiac implantable electronic device
CareLink network
cardiac resynchronization therapy defibrillator
cardiac resynchronization therapy pacemaker
external remote monitoring center
implantable cardioverter defibrillator
single- or dual-chamber pacemaker
incidence rate ratio
remote monitoring
The authors wish to thank Dr Gardini (Health Telematic Network Spa, Brescia, Italy) for his efforts in the external remote monitoring center management and Renato Gardelli, Lorenza Mangoni di S Stefano, Emmanuelle Nicolle, Mirko De Melis, and Matthew Cook, all Medtronic Inc employees, for project management activities, data management technical support, and statistical analysis. This research was performed within the framework of the Italian ClinicalService project, a national cardiovascular data repository and medical care project funded by Medtronic Italia, an affiliate of Medtronic Inc. No other funding sources were involved in the research. The authors are responsible for the design and conduct of this research.
None declared.