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The implantation rates of cardiac implantable electronic devices (CIEDs), including pacemakers and implantable cardioverter-defibrillators (ICDs), have increased over the last decades due to expanded indications and a progressively aging population []. To evaluate the clinical status of the patient and device functioning, current guidelines recommend that older patients with pacemakers should be evaluated every 3 to 12 months and patients with ICDs should be evaluated every 3 to 6 months []. This regimen imposes a considerable burden on patients and physicians if the patient is required to be seen in person.
Telemonitoring, referring to the process of using telecommunication and information technology to monitor the health status of a patient and device function from a distance, can reduce this burden by replacing some in-office visits with transmissions from the patients’ home []. Existing research indicated that telemonitoring is safe (eg, experiencing equal major adverse events to standard care) [,]. The advantages of telemonitoring include fewer inappropriate shocks for patients with ICDs [,] and fewer hospitalizations for patients with atrial arrhythmias and strokes [,,]. Moreover, there is a rapid detection of cardiovascular events and device malfunction [,], leading to a time reduction between clinical decision and intervention [].
Besides the effectiveness of telemonitoring, patient experience is essential in high-quality health care services. Overall, patients with pacemakers on telemonitoring reported positive experiences comparable to the experience of patients with in-hospital monitoring []. Telemonitored patients with pacemakers tended to receive less information about their diagnosis but no significant differences were found in other items, such as confidence in clinicians, treatment decision involvement, treatment satisfaction, and waiting time before admission []. Another study indicated that telemonitoring of patients with a cardiac resynchronization therapy defibrillator (CRT-D) was time-saving for both patients and physicians [].
Cost-effectiveness analyses are important to quantify the value of new interventions, informing both medical decision-making and public policy []. However, cost-effectiveness analyses depend on the perspective considered. The different perspectives are the health care payer perspective (eg, Medicare or Medicaid and British National Health Service), the patient perspective, the provider perspective (eg, physician), and the society perspective. The health care payer and societal perspectives differ from each other as the societal perspective includes indirect nonmedical costs (eg, transport) [].
ObjectivesAs cost-effectiveness analyses have shown heterogeneous results, it is still debatable whether telemonitoring is worth the investment relative to standard care. However, data on cost-effectiveness are important for health care payers to make decisions on the reimbursement of telemonitoring. Lack of reimbursement can be an important adoption barrier for new technology [,]. For these 2 reasons, this paper reviews the cost-effectiveness of telemonitoring, reviews how the results differ from different perspectives, and describes the key drivers of the cost-effectiveness of telemonitoring.
The review protocol was published by PROSPERO (International Prospective Register of Systematic Reviews; CRD42022322334). This systematic review was carried out in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting guideline of 2020 [], and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) [], which can be found in the . Guidelines for preparing a systematic review of health economic evaluations were followed [].
Literature SearchFor this review, PubMed, Embase, EconLit, and Web of Science Core Collection were systematically searched. The last search was performed on July 7, 2022. No filters (eg, publication date or type of study) were applied. Search strategies for all electronic databases can be found in .
Search strings were developed based on explorations of databases and previous reviews. The following key concepts were translated into strings: (1) CIEDs, (2) telemonitoring, and (3) economic evaluations (eg, cost-effectiveness analyses and cost-utility analyses). The latter was based on a validated search filter, designed to identify economic evaluations, and was broadened for this study to maximize sensitivity []. The search terms for CIEDs and telemonitoring were based on existing reviews [-].
Study SelectionStudies were included if their primary focus was on the cost-effectiveness of telemonitoring patients with a CIED. The eligibility criteria were defined a priori for study selection (). The population, intervention, comparator, and outcome strategy was applied to describe the criteria. Only complete and peer-reviewed studies were included. Specific exclusion criteria included partial economic evaluations, systematic reviews or reports, and studies without standard care as a control group. Only studies published in English, Dutch, French, or German were eligible for inclusion. The reference lists of the included studies were searched manually to identify relevant studies. Two reviewers (SR and AP) independently screened the titles and abstracts of all records using Rayyan (Rayyan Systems Inc) []. After the initial screening, full texts were retrieved and screened for a second time. The second screening round was independently performed by 2 reviewers (SR and AP). Reasons for exclusion were documented (). For both screening rounds, reviewers were blinded from each other’s decision, and disagreements were resolved through discussion.
Textbox 1. Eligibility criteria.Inclusion criteria
InterventionCardiac implantable electronic devices: pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy defibrillator, cardiac resynchronization therapy pacemaker, and loop recorderComparatorStudy designComplete health economic evaluations (within-trial and model-based)ContextLanguageEnglish, French, German, or DutchExclusion criteria
InterventionImplantable pulmonary artery pressure monitorStudy designPartial health economic evaluations (outcomes related to costs or effectiveness only)Specific criteriaSystematic reviews, reports, commentaries, congress abstracts, protocols, and animal studies
Figure 1. Flowchart of the study selection. Quality AssessmentTwo researchers (SR and AP) independently evaluated the original papers using the Consensus Health Economic Criteria (CHEC) checklist to assess the risk of bias []. The CHEC checklist included 19 items. Any disagreement was resolved by discussion and consensus. Interpretation of the CHEC list can be found in . The included studies were classified into 4 quality categories: excellent (score of 100%), good quality (score between 75% and 100%), moderate quality (score between 50% and 75%), and low quality (score <50%) [].
Synthesis of ResultsThe study characteristics and main outcomes of the original papers are presented in the Results section. SR extracted all data. A data extraction sheet was developed using an existing template []. The following information was extracted from the included studies: study identification, general study characteristics, results, and authors’ conclusion. The principal outcome measures were health outcomes, cost or income outcomes (eg, the impact on total cost or income, cost or income drivers, cost or income drivers per patient, and cost or income drivers as a percentage of the total cost impact), and incremental cost-effectiveness ratios (ICERs) or cost-utility ratios.
To facilitate comparison across studies, the following adjustments and interpretations were made. First, the cost or income outcomes were presented per patient per year, and different currencies were converted to US Dollar (reference year: 2019 and reference country: United States) []. Second, perspectives were categorized into the health care payer perspective, patient perspective, provider perspective, and societal perspective. For the purpose of our study, the provider includes physicians who are directly involved in the care of patients with CIED.
The selection process is shown in . From a total of 3305 publications, 15 (0.45%) unique publications were reviewed. Studies were excluded because one of the following reasons: (1) intervention: the paper did not describe telemonitoring patients with a CIED; (2) outcome: the paper contained only a cost analysis and not a cost-effectiveness analysis; and (3) study design or publication: the paper was a partial health economic evaluation, congress abstract, protocol, systematic review, animal study, or with no peer review.
PopulationCharacteristics of the included studies can be found in . All 15 (100%) studies had a primarily male population, except for the Nordland study, which had an almost equal sex distribution () []. The mean age of the population with pacemakers was between 75 (SD 24.64) and 81 (SD 6.47) years. The mean age of patients with an ICD or CRT-D was between 61 (SD 12.6) and 69 (SD not calculated) years, except for the PREDICT RM study, where >50% of the population was aged >75 years []. Furthermore, of the 15 studies, 1 (7%) included only older patients (with a mean age of 81 years) with pacemakers [], and 2 (13%) ICD or CRT-D studies only included patients with heart failure [,].
Table 1. Main characteristics of the included studies.StudyAuthor and yearPatients, nPopulation characteristicsAge (years), mean (SD)Male participant (%)CIEDa typePoniente []Bautista-Mesa et al [], 202255Mean age of 81 years81 (6.47)69PacemakerPREDICT RM []Hummel et al [], 201915,254N/Ab53% of participants aged ≥75 yearsc72ICDdTARIFFe []Ricci et al [], 2016209N/A69 (10.17)85ICD or CRT-DfNordland []Lopez-Villegas et al [], 202050N/A74.8 (24.64)52PacemakerEVOLVOg []Zanaboni et al [], 2013200Patients with heart failure66-69 (SD not reported)79ICD or CRT-DMORE-CAREh []Boriani et al [], 2016865Patients with heart failure66 (10)76CRT-DBurri et al []Burri et al [], 2013N/APatients with biventricular CRT-D65 (SD not reported)N/AICD or CRT-DRaatikainen et al []Raatikainen et al [], 200841N/A62 (10)83ICDAl-Khatib et al []Al-Khatib et al [], 2009151N/A63 (SD not reported)72ICD or CRT-DCONNECTi []Crossley et al [], 20111997N/A65 (12.1)71ICD or CRT-DECOSTj []Guédon-Moreau et al [], 2014310N/A60.7 (12.6)90ICDEuroEcok []Heidbuchel et al [], 2015303Patients with new or replacement VVI-ICDl or DDD-ICDm62.4 (13.1)81ICD or CRT-DSAVE-HMn trial []Perl et al [], 2013115Patients with dual chamber pacemaker74 (9)57PacemakerSAVE-HMn trial []Perl et al [], 201336Patients with ICD-implant due to primary prevention of sudden cardiac death62.5 (10)86ICDChew et al []Chew et al [], 20201830N/A66 (SD not reported)88ICD or CRT-DDario et al []Dario et al [], 20161171N/A77.5 (9)58PacemakerDario et al []Dario et al [], 2016930N/A67.5 (12)79ICDaCIED: cardiac implantable electronic device.
bN/A: not applicable.
cAge was a discrete variable in this study (higher of lower than 75 years old).
dICD: implantable cardioverter-defibrillator.
eTARIFF: Health Economics Evaluation Registry for Remote Follow-Up.
fCRT-D: cardiac resynchronization therapy defibrillator.
gEVOLVO: Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators.
hMORE-CARE: Monitoring Resynchronization Devices and Cardiac Patients.
iCONNECT: Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision.
jECOST: Effectiveness and Cost of ICD Follow-Up Schedule With Telecardiology.
kEuroEco: European Health Economic Trial on Home Monitoring in ICD Patients.
lVVI-ICD: single-chamber ICD.
mDDD-ICD: dual-chamber ICD.
nSAVE-HM: Socio-Economic Effects and Cost Saving Potential of Remote Patient Monitoring.
Study Designsand show the summary table of results. Of 15 studies, 11 (73%) were conducted in Europe [,,-,,,], 3 (20%) in the United States [,,], and 1 (7%) in Canada []. Of the 15 studies, 3 (20%) calculated the ICER [-], 1 (7%) calculated the cost-utility ratio [], and 11 (73%) calculated the cost impact of telemonitoring. All studies analyzed the health care payer perspective, with 33% (5/15) analyzing the patient perspective [,,,,], 13% (2/15) analyzing the societal perspective [,], and 13% (2/15) analyzing the provider perspective [,].
Table 2. Summary of the main results.StudyCountryDesignTime horizonCIEDa typeEffectCost-effectiveness in original currency and in reference year (in US $, 2019)ConclusionPacemaker studiesaCIED: cardiac implantable electronic device.
bRCT: randomized controlled trial.
cQALY: quality-adjusted life year.
dICER: incremental cost-effectiveness ratio.
eSAVE-HM: Socio-Economic Effects and Cost Saving Potential of Remote Patient Monitoring.
fN/A: not applicable.
gICD: implantable cardioverter-defibrillator.
hCRT-D: cardiac resynchronization therapy defibrillator.
iTARIFF: Health Economics Evaluation Registry for Remote Follow-Up.
jEVOLVO: Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators.
kThe values are statistically significant.
lMORE-CARE: Monitoring Resynchronization Devices and Cardiac Patients.
mQOL: quality of life.
nCONNECT: Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision.
oECOST: Effectiveness and Cost of ICD Follow-Up Schedule With Telecardiology.
pSF-36: The 36-Item Short Form Survey.
qEuroEco: European Health Economic Trial on Home Monitoring in ICD Patients.
Table 3. Summary table of results related to perspectives and key cost or income drivers.Study and perspectiveTotal cost or incomea impact compared to standard care in original currency in reference year (US $ ppb per year, 2019) and cost or incomea impact driversCost or incomea impact drivers pp (US $ pp per year, 2019)Cost or incomea impact drivers as a percentage of total cost or income impact (%)Pacemaker studies
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