Cardiovascular implantable electronic devices have increased in number and complexity and with technological advancements, all cardiovascular implantable electronic devices now have the ability to monitor their own function, record arrhythmias and other physiological parameters, and send wireless communication to health care providers. Reference Wilkoff, Auricchio and Brugada1,Reference Slotwiner, Varma and Akar2 In addition to monitoring the cardiovascular implantable electronic device itself, it is equally important to evaluate the patient and the impact of any cardiovascular implantable electronic device- related consequences with appropriate ancillary testing. Reference Dasgupta, Madani and Figueroa3–Reference Mah, Prakash and Porras5 In an effort to characterise current follow-up practice patterns regarding cardiovascular implantable electronic device follow-up and ancillary testing, we surveyed paediatric electrophysiologists and allied health professionals at institutions involved in the care of children with cardiovascular implantable electronic devices.
Methods
An 11 question survey (Table 1) was electronically distributed to all members of the Paediatric and Congenital Electrophysiology Society to evaluate follow-up for pacemakers, implantable cardioverter defibrillators, and implantable loop recorders. Cardiac resynchronization therapy devices were excluded from the questionnaire due to small number of patients. The main outcome measures were variations in frequency of in person evaluation, frequency of remote monitoring, and cardiovascular implantable electronic device-related ancillary testing (echocardiogram, ambulatory monitoring, chest X-ray, and exercise stress testing. All responses were received in a de-identified format. After responses were obtained, direct comparisons of results were made with published expert consensus recommendations. Reference Wilkoff, Auricchio and Brugada1,Reference Slotwiner, Varma and Akar2
Table 1. CIED follow-up survey questions and variables
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CIED = cardiovascular implantable electronic device; ERI = elective replacement indicator; RM = remote monitoring.
Results
The survey was sent to 102 institutions. A total of 88 institutions completed the survey (86%). Overall, 92% of respondents believed that the implanting centre should provide cardiovascular implantable electronic device follow-up and management in order to ensure consistency and programming optimisation. Amongst cardiovascular implantable electronic device monitoring personnel, the preliminary review of the transmitted data was predominantly performed by a nurse (53%), technician (26%), nurse practitioner (13%), and physician (6.5%). Concordance or discordance between Expert Consensus Statement Recommendations Reference Wilkoff, Auricchio and Brugada1,Reference Slotwiner, Varma and Akar2 and current Paediatric and Congenital Electrophysiology Society cardiovascular implantable electronic device monitoring practice variations are shown in Table 2.
Table 2. Contrast between expert consensus statement recommendations and current PACES CIED monitoring practices
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CIED = cardiovascular implantable electronic device; PACES = Paediatric and Congenital Electrophysiology Society; RM = remote monitoring.
Frequency of cardiovascular implantable electronic device in person evaluation
Only 3% of respondents performed an in-person evaluation within 1 week of the cardiovascular implantable electronic device implantation. For the remainder, in person evaluation occurred at 1–2, 2–4, and 4–8 weeks by 47, 6.4, and 34% of respondents, respectively for the first time post implant in-person evaluation. Patients with pacemakers and implantable cardioverter defibrillators were evaluated at least once a year subsequently with substantial variability in frequency (Fig 1a). Majority of implantable loop recorders patients (80%) had in-person evaluation at least once a year (3% every 3 months, 16% every 6 months, and 61% every 12 months). Majority of respondents (68%) reported that they did not follow CMS published Medicare frequency guidelines for pacemakers.
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Figure 1. ( a ) Results of in-person evaluation (IPE) frequency from time of first CIED implantation follow-up to time nearing end of replacement indicator. ( b ) Results of remote monitoring (RM) frequency from time of first CIED implantation follow-up to time nearing end of replacement indicator. CIED = cardiovascular implantable electronic device; ICD = implantable cardioverter defibrillator; PPM = permanent pacemaker.
Frequency and type of cardiovascular implantable electronic device remote monitoring
Ninety four percent of respondents performed remote monitoring for all cardiovascular implantable electronic device patients. Apart from the 23% of respondents who still utilised transtelephonic transmissions for pacemaker patients, the remainder of respondents utilised automated manufacturer-specific wireless remote telemetry systems for all cardiovascular implantable electronic devices. Majority of respondents scheduled remote monitoring every 3 months for implantable cardioverter defibrillators and permanent pacemaker and every 6 months for implantable loop recorders until signs of battery depletion (Fig 2). A change in schedule to monthly transmissions was made by 18, 50, 27% respondents when the estimated battery longevity was <3 months, <6 months, and <12 months, respectively.
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Figure 2. Results of variations in CIED-related ancillary testing in patients with pacemakers. CIED = cardiovascular implantable electronic device; CXR = chest roentgenogram; Echo=echocardiogram; VP = ventricular paced.
Ancillary testing
Follow-up echocardiography was the most commonly performed investigation in patients with a structurally normal heart (frequency of every 2–3 years by 53% respondents for >50% ventricular pacing and by 26% of respondents for <50% ventricular pacing). Majority of respondents did not perform an exercise stress test, chest X-ray, or ambulatory Holter monitoring during follow-up.
Discussion
This survey shows that there continues to be a wide variation in cardiovascular implantable electronic device in person evaluation, remote monitoring, and cardiovascular implantable electronic device-related ancillary testing practices in the paediatric population. A variety of factors might be influential including patient age, patient/family preferences, patient symptoms, reimbursement schedules, cardiovascular implantable electronic device management resources, geographic location, cost of Wi-Fi and internet services, underlying CHD, and complex clinic scheduling. Since 2015, a major difference in paediatric cardiovascular implantable electronic device monitoring practice is the reduction in utilisation of TTM for monitoring pacemakers (down to 23% from 67%) and increase in wireless remote monitoring (up to 94% from 87%). Reference Boyer, Silka and Bar-Cohen6
While it may be impossible to counter some heterogeneity in clinical practice, a paediatric-specific cardiovascular implantable electronic device follow-up paradigm that provides recommendations for minimal frequency of in-person evaluation, remote monitoring, and ancillary testing in uncomplicated patients is necessary. Standardized guidelines may maximise the opportunity for early detection and intervention of cardiovascular implantable electronic device system problems, prolong cardiovascular implantable electronic device battery longevity, enable early detection of haemodynamic and adverse events, initiate appropriate follow-up with corrective action/safety alerts, and minimises unnecessary device in-person evaluation and excessive testing. Reference Wilkoff, Auricchio and Brugada1,Reference Slotwiner, Varma and Akar2,Reference Dechert, Serwer, Bradley, Dick and LaPage7–Reference Akar, Bao and Jones9 In particular, there are two phases after device implantation that are crucial and should be addressed in an expert consensus statement as immediate post implant “acute” phase and nearing elective replacement indicator phase. Many complications, such as lead dislocation and perforation, wound infection, and loose set-screws, can be seen within the first 7–10 days after implantation, if not recognised prior to discharge from the hospital. In this survey, <50% of respondents performed an in-person evaluation within 2 weeks of cardiovascular implantable electronic device implantation. When a cardiovascular implantable electronic device approaches elective replacement indicator, intensified surveillance frequency may be helpful. Reference Wilkoff, Auricchio and Brugada1,Reference Slotwiner, Varma and Akar2 Conversely, during the “maintenance” phase of the device, less frequent follow-up may be sufficient, thereby reducing patient travel, time, and economic burdens as well as surplus workload on the clinical providers. A 2015 Paediatric and Congenital Electrophysiology Society survey of cardiovascular implantable electronic device monitoring showed that remote monitoring utilisation did not reduce the frequency of in-person evaluation. Reference Boyer, Silka and Bar-Cohen6 The recent remote monitoring experience during the ongoing COVID19 pandemic has highlighted its utility in reducing in-person evaluation. Reference Bricker, Garson and Traweek10 However, despite the ease with which patients are able to send remote interrogations, the amount of data produced from these reports is extensive and time for staff to prepare, interpret reports, and follow-up with patients is substantial. While assessment of variability in programming various cardiovascular implantable electronic device alert settings triggering automatic remote transmissions was beyond the scope of this survey, this was also an area where a streamlined and standardised approach may benefit the patient and providers. Reference Wilkoff, Auricchio and Brugada1,Reference Slotwiner, Varma and Akar2,Reference Boyer, Silka and Bar-Cohen6,Reference Dechert, Serwer, Bradley, Dick and LaPage7
Another area of inconsistency highlighted by this survey and not previously addressed is cardiovascular implantable electronic device-related ancillary testing. Standardised ancillary testing in paediatric patients may be of benefit as many children will require a lifetime of cardiovascular implantable electronic device therapy that may include a range of hardware implanted during periods of physical growth and vigorous activity. Chest X-rays can be helpful in detecting lead-related problems such as coronary compression, myocardial strangulation, dislodgement, and fracture. Reference Berul, Villafane and Atkins4,Reference Mah, Prakash and Porras5 Echocardiography is useful in monitoring ventricular function in patients with high percentage of ventricular pacing and identifying endocardial lead-related complications. Reference Dasgupta, Madani and Figueroa3 Exercise testing can provide data for programming upper rates, arrhythmia detection parameters, as well as detecting QRS morphology and T wave changes. In patients with single chamber that utilise electrogram morphology template matches during sinus rhythm to discriminate between supraventricular and ventricular arrhythmias, exercise testing may be useful to avoid inappropriate implantable cardioverter defibrillator shocks in patients who develop rate related QRS changes such as bundle branch block. Exercise testing may be particularly useful in patients with subcutaneous implantable cardioverter defibrillators to select a more appropriate sensing vector as well as for troubleshooting T wave oversensing at higher heart rates. Furthermore, important physiologic data can be obtained to guide decision making for pacemaker programming and upgrades. Reference Bricker, Garson and Traweek10,Reference Gonzalez Corcia, Remy, Marchandise and Moniotte11 Periodic ambulatory Holter monitoring may be useful to identify subclinical device malfunction and arrhythmias. Reference Chudzik, Klimczak and Wranicz12
This survey should serve as a catalyst for proposing a framework for paediatric-specific guidelines for cardiovascular implantable electronic device follow-up and ancillary monitoring. The time frames for cardiovascular implantable electronic device monitoring published in expert consensus recommendations do not vary significantly from current paediatric practice, but given the higher incidence of device-related complications in paediatric patients, revisions to recommendation are needed. Reference Dechert, Serwer, Bradley, Dick and LaPage13 For example, in-person follow-up after cardiovascular implantable electronic device implantation should occur as early as possible, and at least within 4 weeks (instead of the recommended 12 weeks) as early detection of surgical wound, lead, and device implant complications have better outcomes when addressed in the acute post implant period. Reference Berul, Villafane and Atkins4 The proposed framework should also include guidance for performing ancillary testing such as imaging, ambulatory rhythm monitoring, and exercise stress testing for cardiovascular implantable electronic device optimisation. Reference Dasgupta, Madani and Figueroa3,Reference Bricker, Garson and Traweek10,Reference Chudzik, Klimczak and Wranicz12 This is an area that is currently not addressed in any published cardiovascular implantable electronic device clinical guidelines. Standardisation of cardiovascular implantable electronic device surveillance is likely to become even more important as technology advances into the realm of remote device programming. Reference Alexander and Baranchuk14 In addition, standardisation will provide benchmarks for adequate reimbursement and enable payers to recognise the human and technological resources necessary for cardiovascular implantable electronic device surveillance including ancillary testing to optimise care and safety of this vulnerable patient population.
Limitations
This study was based on a voluntary survey and may not reflect practice preferences of all paediatric electrophysiologists. However, respondents from 88 institutions is a relatively large number in the paediatric electrophysiologist community.
Conclusion
Our survey identified significant practice variations in cardiovascular implantable electronic device surveillance and ancillary testing practices amongst paediatric electrophysiologists. A consensus statement addressing standardised surveillance of paediatric cardiovascular implantable electronic devices and ancillary testing may be beneficial for early detection of cardiovascular implantable electronic device complications and subsequent alterations in management.
Conflicts of interest
None.