Practice guidelines in Canada recommend that patients receiving cardiac pacemaker (PM), implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices, collectively referred to as cardiovascular implantable electronic devices (CIEDs), undergo routine device follow-up assessment of their CIED at regular intervals.
1- Fraser J.D.
- Gillis A.M.
- Irwin M.E.
- Nishimura S.
- Tyers G.F.
- Philippon F.
Guidelines for pacemaker follow-up in Canada: a consensus statement of the Canadian Working Group on Cardiac Pacing.
, 2- Gillis A.M.
- Philippon F.
- Cassidy M.R.
- Singh N.
- Dorian P.
- Love B.A.
- et al.
Guidelines for implantable cardioverter defibrillator follow-up in Canada: a consensus statement of the Canadian Working Group on Cardiac Pacing.
The purpose of these assessments is to evaluate the patient and the CIED including reprogramming of the device where clinically appropriate. Traditionally, these assessments have been conducted at a designated Device Follow-Up Clinic (DFC), which might be remote from the patient's location. Recently, CIEDs have been manufactured with remote monitoring (RM) capability, a technology that permits surveillance and device assessment virtually from any patient location accessible by a landline or mobile telephone. RM adds no new diagnostic or therapeutic capabilities to a CIED but is an important “enabling technology” that facilitates more efficient interaction between the CIED health care team and patient. Implantable hemodynamic monitors and implantable loop recorders are diagnostic devices that can also be followed by RM. They were included in the discussion of RM use by the European Heart Rhythm Association (EHRA).
3- Dubner S.
- Auricchio A.
- Steinberg J.S.
- Vardas P.
- Stone P.
- Brugada J.
- et al.
ISHNE/EHRA expert consensus on remote monitoring of cardiovascular implantable electronic devices (CIEDs).
However, hemodynamic monitors are not currently available in Canada and implanted loop recorder use is somewhat limited. Therefore, this document focuses solely on examining the clinical utility and potential role of RM for PM, ICD, and CRT patient follow-up. It also offers practical advice on RM integration into the routine practice of the modern DFC in the Canadian health care context but other readers might find some of the suggestions relevant to their situation.
CIEDs and Remote Monitoring
Most CIED manufacturers have developed RM systems specific to their own devices. There might be important differences in RM operation and features of which centres need to be cognizant, but the hardware components and principles of operation are similar. Patients receiving a CIED are given a small RM transmitter to take home and connect to their telephone line, preferably in the bedroom (units that communicate using mobile phone connections have also been introduced). The CIED sends information to the RM transmitter and it conveys the encrypted information by standard telecommunication protocol to a protected internet-accessible RM data server under the control of the CIED manufacturer. Presently, RM does not permit transmission of programmable setting changes from the DFC to the CIED; only the retrieval of data stored from the CIED. Any authorized health care team members may review the data from any location with internet access using standard internet web browser software. Thus, RM can be managed by DFC staff and represents an extended function of the DFC. Like any data obtained from in-clinic visits, RM data is useful in guiding patient management. Anonymized patient data might also be used by the manufacturer for retrospective analysis of trends, product reliability, and for the prediction of product advisories.
RM transmissions are of 3 types: (1) routine or prescheduled transmissions scheduled by the DFC staff to occur on a particular date, (2) CIED alert events, when CIED data are automatically transmitted when they fall outside a value range preprogrammed for the patient's CIED, and (3) patient-initiated transmissions. Routine and CIED alert transmissions are performed automatically by the RM system with minimal patient involvement. Patient-initiated transmissions are manually triggered when the patient suspects a CIED-related problem and require the patient perform several simple steps to start and complete the transmission. The RM system can be programmed to notify staff by sending a text, fax, e-mail, pager, or voicemail message if an alert event of predefined severity is received.
Scientific Evidence
A comprehensive literature search was performed on combined PubMed and Cochrane databases for the terms “remote monitoring” and “implantable defibrillator” or “pacemaker” or “cardiac implantable electronic device” published up to December 2011. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies. Most recent available guideline statements on the management of implantable devices and, if available, on the use of remote device monitoring from the Canadian Cardiovascular Society, Heart Rhythm Society (HRS), and EHRA were also reviewed. Recommendations were developed using the
Grading of
Recommendations
Assessment,
Development, and
Evaluation (GRADE) system after a critical evaluation of the literature and expert consensus.
4- Guyatt G.
- Oxman A.D.
- Akl E.A.
- Kunz R.
- Vist G.
- Brozek J.
- et al.
GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables.
The strength of each recommendation was categorized as “strong” or “weak (conditional)” and the quality of the evidence as “high,” “moderate,” “low,” or “very low.” The balance among desirable and undesirable consequences, values, and preferences were considered. These guidelines were externally reviewed by experts and modified, based on those reviews. All recommendations were unanimously approved.
Several early cohort studies, predominantly from single centres, examined the potential benefits of RM for CIEDs.
5- Hauck M.
- Bauer A.
- Voss F.
- Weretka S.
- Katus H.A.
- Becker R.
“Home monitoring” for early detection of implantable cardioverter-defibrillator failure: a single-center prospective observational study.
, 6- Joseph G.K.
- Wilkoff B.L.
- Dresing T.
- Burkhardt J.
- Khaykin Y.
Remote interrogation and monitoring of implantable cardioverter defibrillators.
, 7- Kollmann A.
- Hayn D.
- Garcia J.
- Trigo J.D.
- Kastner P.
- Rotman B.
- et al.
Feasibility of a telemedicine framework for collaborative pacemaker follow-up.
, 8Remote, wireless, ambulatory monitoring of implantable pacemakers, cardioverter defibrillators, and cardiac resynchronization therapy systems: analysis of a worldwide database.
, 9- Marzegalli M.
- Lunati M.
- Landolina M.
- Perego G.B.
- Ricci R.P.
- Guenzati G.
- et al.
Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation–ease of use, acceptance, and organizational implications.
, 10- Nielsen J.C.
- Kottkamp H.
- Zabel M.
- Aliot E.
- Kreutzer U.
- Bauer A.
- et al.
Automatic home monitoring of implantable cardioverter defibrillators.
, 11- Raatikainen M.J.
- Uusimaa P.
- van Ginneken M.M.
- Janssen J.P.
- Linnaluoto M.
Remote monitoring of implantable cardioverter defibrillator patients: a safe, time-saving, and cost-effective means for follow-up.
, 12- Ricci R.P.
- Morichelli L.
- Quarta L.
- Sassi A.
- Porfili A.
- Laudadio M.T.
- et al.
Long-term patient acceptance of and satisfaction with implanted device remote monitoring.
, 13- Ricci R.P.
- Morichelli L.
- Santini M.
Home monitoring remote control of pacemaker and implantable cardioverter defibrillator patients in clinical practice: impact on medical management and health-care resource utilization.
, 14- Ricci R.P.
- Morichelli L.
- Santini M.
Remote control of implanted devices through home monitoring technology improves detection and clinical management of atrial fibrillation.
, 15- Sacher F.
- Probst V.
- Bessouet M.
- Wright M.
- Maluski A.
- Abbey S.
- et al.
Remote implantable cardioverter defibrillator monitoring in a Brugada syndrome population.
, 16- Schoenfeld M.H.
- Compton S.J.
- Mead R.H.
- Weiss D.N.
- Sherfesee L.
- Englund J.
- et al.
Remote monitoring of implantable cardioverter defibrillators: a prospective analysis.
, 17- Theuns D.A.
- Rivero-Ayerza M.
- Knops P.
- Res J.C.
- Jordaens L.
Analysis of 57,148 transmissions by remote monitoring of implantable cardioverter defibrillators.
, 18- Varma N.
- Stambler B.
- Chun S.
Detection of atrial fibrillation by implanted devices with wireless data transmission capability.
These studies reported that RM significantly reduced the time required for CIED interrogation with improved patient and clinician satisfaction. Three of these studies also suggested that RM might reduce the number of inappropriate shocks delivered to ICD patients through earlier identification of lead and/or CIED problems.
19What evidence do we have to replace in-hospital implantable cardioverter defibrillator follow-up?.
, 20- Guedon-Moreau L.
- Chevalier P.
- Marquie C.
- Kouakam C.
- Klug D.
- Lacroix D.
- et al.
Contributions of remote monitoring to the follow-up of implantable cardioverter-defibrillator leads under advisory.
, 21- Spencker S.
- Coban N.
- Koch L.
- Schirdewan A.
- Muller D.
Potential role of home monitoring to reduce inappropriate shocks in implantable cardioverter-defibrillator patients due to lead failure.
The largest cohort study found that RM allowed earlier detection of atrial fibrillation (AF) and ventricular arrhythmias.
8Remote, wireless, ambulatory monitoring of implantable pacemakers, cardioverter defibrillators, and cardiac resynchronization therapy systems: analysis of a worldwide database.
Four cohort studies involving ICD patients with concomitant heart failure (HF) demonstrated the feasibility of RM to monitor CIED HF diagnostic characteristics (heart rate, heart rate variability, intrathoracic impedance), which informed therapeutic decision-making or predicted impending HF hospitalization.
22- Ellery S.
- Pakrashi T.
- Paul V.
- Sack S.
Predicting mortality and rehospitalization in heart failure patients with home monitoring–the Home CARE pilot study.
, 23- Masella C.
- Zanaboni P.
- Di Stasi F.
- Gilardi S.
- Ponzi P.
- Valsecchi S.
Assessment of a remote monitoring system for implantable cardioverter defibrillators.
, 24- Mullens W.
- Oliveira L.P.
- Verga T.
- Wilkoff B.L.
- Wilson Tang W.H.
Insights from internet-based remote intrathoracic impedance monitoring as part of a heart failure disease management program.
, 25- Santini M.
- Ricci R.P.
- Lunati M.
- Landolina M.
- Perego G.B.
- Marzegalli M.
- et al.
Remote monitoring of patients with biventricular defibrillators through the CareLink system improves clinical management of arrhythmias and heart failure episodes.
All of these early studies were limited by insufficient follow-up duration and nonrandomized trial design.
In the PM population, there have been 2 published multicentre, randomized trials that compared RM vs traditional in-clinic follow-up.
26- Halimi F.
- Clementy J.
- Attuel P.
- Dessenne X.
- Amara W.
Optimized post-operative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial.
, 27- Crossley G.H.
- Chen J.
- Choucair W.
- Cohen T.J.
- Gohn D.C.
- Johnson W.B.
- et al.
Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.
Both showed an increase in adverse clinical event detection frequency and a reduction in response time to those events with RM. Crossley et al. enrolled 875 patients; 382 had 1 or more clinical events. Most of these were nonsustained ventricular tachycardia or AF episodes longer than 48 hours. RM significantly increased detection of clinical events (two-thirds were detected by RM alone) with a reduction in time to detection (5.7 vs 7.7 months).
27- Crossley G.H.
- Chen J.
- Choucair W.
- Cohen T.J.
- Gohn D.C.
- Johnson W.B.
- et al.
Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.
Halimi et al. found that RM significantly reduced the time of hospitalization after a PM implant.
26- Halimi F.
- Clementy J.
- Attuel P.
- Dessenne X.
- Amara W.
Optimized post-operative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial.
That study followed patients an average of only 31 days yet demonstrated that RM significantly shortened medical reaction time for all adverse events by almost 5 days.
In the ICD population, there have been 5 published randomized trials comparing the efficacy of RM vs in-clinic assessment with regard to reduction of subsequent in-clinic visits and time to detection of clinical events.
28- Al-Khatib S.M.
- Piccini J.P.
- Knight D.
- Stewart M.
- Clapp-Channing N.
- Sanders G.D.
Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial.
, 29- Bikou O.
- Licka M.
- Kathoefer S.
- Katus H.A.
- Bauer A.
Cost savings and safety of ICD remote control by telephone: a prospective, observational study.
, 30- Crossley G.H.
- Boyle A.
- Vitense H.
- Chang Y.
- Mead R.H.
The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts.
, 31- Elsner C.H.
- Sommer P.
- Piorkowski C.
- Taborsky M.
- Neuser H.
- Bytesnik J.
- et al.
A prospective multicenter comparison trial of home monitoring against regular follow-up in MADIT II patients: additional visits and cost impact.
, 32- Varma N.
- Epstein A.E.
- Irimpen A.
- Schweikert R.
- Love C.
Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial.
In the largest multicentre trial, Crossley et al. followed 1997 ICD and/or CRT patients.
30- Crossley G.H.
- Boyle A.
- Vitense H.
- Chang Y.
- Mead R.H.
The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts.
After an average follow-up of 15 months, RM significantly reduced time from clinical event to medical decision by more than 79% compared with in-clinic visits (4.6 vs 20 days;
P < 0.001). The most common events were AF or fast ventricular rates (> 120 bpm). The number of clinic visits was reduced by 38% (3.9 vs 6.3). Total health care utilization was not significantly different between the 2 strategies but the hospitalization duration was shorter in the RM group (3.3 vs 4.0 days,
P = 0.002). In another large study (n = 1450), Varma et al. demonstrated a 45% reduction in clinic visits by RM with significant reductions in the time from onset of atrial or ventricular arrhythmias to physician assessment over 15 months of follow-up.
32- Varma N.
- Epstein A.E.
- Irimpen A.
- Schweikert R.
- Love C.
Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial.
Both of these studies showed no adverse safety events with RM, and both also failed to demonstrate a reduction in ICD therapy or morbidity/mortality using RM. Another smaller study showed no difference in clinic/hospital visits or patient quality of life with RM.
28- Al-Khatib S.M.
- Piccini J.P.
- Knight D.
- Stewart M.
- Clapp-Channing N.
- Sanders G.D.
Remote monitoring of implantable cardioverter defibrillators versus quarterly device interrogations in clinic: results from a randomized pilot clinical trial.
Two additional randomized trials comparing RM monitoring with in-office follow-up have been performed and their preliminary data presented. The
Evaluation of the “
Tele-follow-up” for the Follow-up of Implantable Defibrillators (EVATEL) study included 1501 patients from a variety of device manufacturers and found no difference in the primary end point (composite of death, hospitalization, inappropriate ICD therapy) but a significant reduction in inappropriate or ineffective ICD therapy (8.1% vs 5.5%,
P = 0.04).
33Mabo P, Defaye P, Sadoul N, et al. EVATEL: Remote follow-up of patients implanted with an ICD: the prospective randomized EVATEL study. Paper presented at: European Society of Cardiology Congress 2011. August 27-31, 2011; Paris, France.
However, 7% of patients in that study crossed over from RM to in-clinic visits mainly because of telephone connection difficulties. The
Effectiveness and
Cost
of ICD Follow-up
Schedule With
Telecardiology (ECOST) study involved 433 patients using a single manufacturer's device followed for up to 27 months. It, too, found that RM decreased inappropriate ICD shocks by 52% and hospitalizations by 72% and was noninferior to in-office follow-up in terms of major safety events including death.
34- Guedon-Moreau L.
- Lacroix D.
- Sadoul N.
- et al.
A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial.
Formal cost effectiveness analyses from these and other trials are pending.
RM offers other benefits that are difficult to study in a randomized trial but might be equally important from a patient and DFC perspective. Some centres that were early adopters of RM have reported improved device clinic efficiency by using RM. RM can be used during routine follow-up to identify the few patients with CIED issues that require in-clinic assessment while allowing most CIED patients without any CIED issues to be followed mainly by RM. Over the course of an average day, more assessments can be performed from RM transmissions than can occur from in-clinic visits because delays related to patient interaction are eliminated. This effectively increases the patient capacity of the DFC. RM transmission can be particularly useful when the response to a device advisory/recall mandates increased surveillance. The resulting increased volume of DFC visits can otherwise overwhelm an already overburdened clinic. RM also allows greater latitude in the decisions regarding explant and replacement of devices on advisory or those approaching end of service.
RM also has tangible benefits for patients. A number of countries, including Canada, have a population dispersed over a large area and DFCs tend to be concentrated in larger urban centres. This creates challenges for patients needing access to CIED-related care. RM can help decrease the inconvenience, patient expense, and risks associated with visiting the DFC and offers patients a sense of security, especially when a device advisory is involved. Some DFCs permit the patient to actively participate in his/her own care through patient-initiated unscheduled transmissions, and when allowed by the DFC, might contribute to psychological wellness.
In summary, available studies have consistently shown that RM reduces clinic visits and time to evaluation of clinical/arrhythmic events in PM and ICD populations without increasing adverse events. Recent trials have demonstrated a reduction in inappropriate ICD therapies and hospitalizations with RM. RM consistently reduces direct patient costs and transportation and waiting time that might partially account for increased patient satisfaction. Though these conclusions cannot be extrapolated to all patients subgroups, such as those with substantial physical or cognitive impairments, the evidence to date demonstrates that RM is efficacious and safe and offers substantive benefits to patients and DFC staff. This body of evidence served to inform the subsequent recommendations.
RecommendationValues and preferences. The recommendation places great value on RMs ability to more quickly identify actionable CIED issues, reduce direct patient costs related to follow-up visits, and improve DFC workflow and efficiency. These benefits accrue without an increment in adverse events.
- 2.
We recommend that RM should only be implemented in CIED patients who provide explicit consent after proper education about the nature of RM, its potential benefits and limitations, and how RM-transmitted information will be managed and used. The medicolegal implications of RM and the effect on patient privacy and confidentiality of personal health information should be included in such discussions (Strong Recommendation, Very Low-Quality Evidence).
Values and preferences. This recommendation places great value on the patient as an important stakeholder whose cooperation ensures the maximum benefit from RM.
Practical tip. RM transmission has important privacy and confidentiality implications for which the patients need to be informed.
Recommendation- 3.
We suggest that, in CIED patients in whom no device issues are identified, routine follow-up assessment during the maintenance phase should blend RM with in-clinic assessments beginning after the 3-month postimplant assessment, alternating assessments between in-clinic and RM transmissions in a 1:1 ratio (Conditional Recommendation, Low-Quality Evidence).
Values and preferences. This recommendation places great value on current CIED guideline recommendations concerning CIED follow-up assessment frequency and the need to integrate RM into, rather than superimpose RM on, the current assessment schedule. It also places value on patient convenience and DFC efficiency.
Practical tip. There is insufficient scientific evidence to support implementation of any single RM schedule across all centres. We encourages centres to take a flexible approach, tailor RM follow-up to the individual patient, and to recognize that the 1:1 ratio serves as a starting point.
Recommendation- 4.
We recommend that RM be used to supplement in-person monitoring of the patient and device in clinical circumstances that warrant more intensive surveillance of the CIED, and the evidence suggests that RM might be efficacious (Strong Recommendation, Low-Quality Evidence).
Values and preferences. This recommendation places value on the ability of RM to more frequently monitor CIED status and to quickly detect CIED system abnormalities with minimal negative effect on the patient.
- 5.
We recommend that DFCs develop the infrastructure, resources, policies, and procedures to optimally support the RM program in a manner analogous to in-clinic assessment (Strong Recommendation, Very Low-Quality Evidence).
Values and preferences. The recommendation places value on the importance of careful planning and development of appropriate policies and procedures that reflect the values of the centre and the objectives of RM at the centre before initiating an RM program.
Practical tip. RM improves DFC efficiency but has associated costs that need to be recognized and supported by centres through the allocation of sufficient resources.
Recommendation- 6.
We recommend that health professionals responsible for interpretation of RM transmissions and subsequent patient management decisions have the same qualifications, training, and experience as those performing in-clinic assessments (Strong Recommendation, Low-Quality Evidence).
Values and preferences. This recommendation places great value on RM data being as important and clinically useful as CIED gathered during in-clinic visits and the knowledge and expertise required to deal with RM data.
Values and preferences. Industry representatives are an important knowledge resource for DFC staff and have an important support role but this recommendation places great value on the autonomy of DFCs and the confidentiality of CIED data. Those responsible for CIED patient care must have the necessary training and experience, and be accountable for patient management decisions made.
Acknowledgements
We are indebted to the experts who generously agreed to review the document: Felix Ayala-Paredes, MD, Paul Dorian, MD, Vidal Essebag, MD, Chris Gray, MD, Andrew D. Krahn, MD, Aaron Low, MD, Ratika Parkash, MD, Shubhayan Sanatani, MD, Anthony Tang, MD, and Stanley Tung, MD.
Article Info
Publication History
Published online: March 06, 2013
Accepted:
November 29,
2012
Received:
November 13,
2012
Footnotes
The disclosure information of the authors and reviewers is available from the CCS on the following websites: www.ccs.ca and/or www.ccsguidelineprograms.ca.
This statement was developed following a thorough consideration of medical literature and the best available evidence and clinical experience. It represents the consensus of a Canadian panel comprised of multidisciplinary experts on this topic with a mandate to formulate disease-specific recommendations. These recommendations are aimed to provide a reasonable and practical approach to care for specialists and allied health professionals obliged with the duty of bestowing optimal care to patients and families, and can be subject to change as scientific knowledge and technology advance and as practice patterns evolve. The statement is not intended to be a substitute for physicians using their individual judgement in managing clinical care in consultation with the patient, with appropriate regard to all the individual circumstances of the patient, diagnostic and treatment options available and available resources. Adherence to these recommendations will not necessarily produce successful outcomes in every case.
Copyright
© 2013 Published by Elsevier Inc.