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Healthcare personnel resource burden related to in-clinic follow-up of cardiovascular implantable electronic devices: a European Heart Rhythm Association and Eucomed joint survey

Giuseppe Boriani, Angelo Auricchio, Catherine Klersy, Paulus Kirchhof, Josep Brugada, John Morgan, Panos Vardas
DOI: http://dx.doi.org/10.1093/europace/eur026 1166-1173 First published online: 23 February 2011

Abstract

Aims A pilot European survey was conducted to assess the cumulative time spent by healthcare personnel for in-office follow-up of cardiac implantable electrical devices (CIEDs), including cardiac pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy (CRT) devices.

Methods and results Resource use data were collected during a session of in-clinic follow-up. Among 407 visits, 93% were scheduled and 7% unscheduled. Visit duration (total cumulative time) lasted a mean of 27 min for scheduled visits, and was ∼30% longer for unscheduled visits. Independent determinants of visit duration were: unscheduled visit (+7.6 min, P = 0.01), the need for device reprogramming (+7.5 min, P < 0.001), and the type of device checked, with CRT devices needing 9.1 and 6.6 more minutes than single- (P < 0.001) and dual-chamber devices (P = 0.002), respectively. Most visits involved two different types of healthcare personnel (239 of 407, 59%), simultaneously. The most frequent combination was the involvement of both a cardiologist and a nurse (216 of 407 visits with both of them only, and 65 additional visits with also an internal technician, an external technician, or both). Overall, an external technician was involved in 18% of visits.

Conclusions In ‘real-world’ practice, the follow-up of CIEDs nowadays requires important resources in terms of time dedicated by specialized personnel, corresponding to cardiologists, nurses, internal technicians, and external, industry-employed technicians. These observations should be the basis for addressing clinical, organizational, financial, and policy initiatives targeted to optimize follow-up procedures in order to face the increase in the number of patients treated with CIEDs expected for the next years.

  • Cardioverter-defibrillator
  • Cardiac implantable electrical devices
  • Cardiac resynchronization therapy, Follow-up
  • Pacemaker

Introduction

Device follow-up is an intrinsic and mandatory element of care for patients treated with cardiac implantable electrical devices (CIEDs). However, the growing electronic and therapeutic complexity of these devices, which widely span from devices able to deliver pacing for correcting bradyarrhythmia, to those able to continuously pace for treating heart failure [cardiac resynchronization therapy (CRT)], and finally to those able to deliver shock or antitachycardia pacing for terminating life-threatening ventricular tachyarrhythmias, has imposed significant burden stemming from their follow-up on outpatient clinics. The increase in the number of implanted CIEDs has also contributed to this burden.

The aim and frequency of follow-up visits, and the types of monitoring of CIEDs have been well described in the recent Heart Rhythm Society/European Heart Rhythm Association (EHRA) Expert consensus document.1 As properly emphasized by the document, the topic of device follow-up has been substantially neglected in the literature. Limited attention has been paid to ‘real-world' data on the utilization of human resources needed to conduct a routine or an emergency follow-up of patients with CIEDs; moreover, the time spent by each type of healthcare personnel and eventually the additional support provided by healthcare providers or payers has not been systematically assessed.

The well-recognized European healthcare system heterogeneity and related reimbursement system differences may generate difficulties for properly capturing information of resource utilization related to CIED follow-up. Nevertheless, systematically collected, this information will facilitate the continuity and standardization of follow-up of patients with CIEDs to serve the best interest of physicians, allied professionals, institutions, and competent authorities for maintaining the high quality, quantity, efficiency, and reliability that CIED patients deserve. Here, we report the results of a pilot snap-shot survey that collected information on the duration of follow-up visits during a 1 day outpatient clinic visit.

The aim of the present paper is to report the results of a pilot snap-shot survey promoted by EHRA that collected information on the duration of follow-up visits during a 1 day outpatient clinic in a series of teaching and non-teaching hospitals located in seven European countries. The study measured the total time, frequency, and relative time spent by each type of healthcare personnel for conducting a scheduled or unscheduled follow-up of CIEDs, including cardiac pacemakers (IPGs), implantable cardioverter-defibrillators (ICDs), and CRT devices.

Materials and methods

Patient population and data collection

Data were collected prospectively during in-hospital follow-up of patients with CIEDs (pacemakers, ICDs, or CRT devices) in a total of 26 centres from seven European countries including Italy, France, Germany, Greece, Spain, Switzerland, and the UK. A complete list of participating centres is reported in the Appendix. Recruitment of study centres was based on previous participation in studies and surveys promoted by EHRA. Resource use data were collected in each centre during a regular session of in-clinic follow-up scheduled by the hospital. Remote follow-up monitoring sessions were not considered for this study. Data were collected prospectively during 1 day of a device follow-up clinic. During that day, the time spent for each follow-up visit was recorded, as well as the type of visit (scheduled or unscheduled) and the type of CIEDs (pacemakers, ICDs, or CRT devices).

Resource use data were collected via data collection instruments administered during the course of an in-clinic follow-up of CIEDs. Clinical assessments and physical examinations were not specifically and separately analysed in this survey. A general case report form (CRF) reporting the annual follow-up burden per hospital was completed and an additional CRF, administered during the course of a follow-up visit, captured the natural resource units (i.e. the length of time in minutes spent by each healthcare personnel or technician) that were expended during the follow-up. A local Eucomed (European trade association for medical devices, Brussels, Belgium) study member was responsible for CRF administration in each centre, although his presence was not strictly required during the phase of data collection.

The actual length of each visit (actual visit time) was calculated from the data captured on the CRF, defined as the time between the patient's entry into the office and the patient's exit from the office after device check. All data were blinded and were then entered into a database, checked by the authors. The statistical analysis was performed by an independent statistician. Eucomed did not interfere with data analysis and preparation of the final manuscript.

Data analysis

The primary aim of this survey was the comparison of the total cumulative time expended by healthcare personnel in scheduled and unscheduled in-office visits for device checks. The total cumulative time (in minutes) was calculated as the sum of the specific time used by cardiologists, nurses, and internal and external technicians for the visit of every patient participating to this survey. The secondary aim was to describe the participation of different types of healthcare personnel (cardiologists, nurses, and internal and external technicians) involved in the follow-up, according to visit type (scheduled/unscheduled) and device checked (IPGs, ICDs, and CRT devices).

Stata 11.1 (Stata Corporation, College Station, TX, USA) was used for statistical analysis. The data were described via means and standard deviations (SD) or medians and 25th–75th percentiles (for continuous data) and as counts and per cent (if data were categorical). The association of type of visit and total visit time was assessed by means of a univariable general linear mixed model, with the healthcare centre included as random effect (to account for heterogeneity between centres). The association of type of visit and total visit time was adjusted for confounding in a multivariable model including the defibrillation capability of the device (yes/no), the type of pacing (single/dual/CRT) the need for reprogramming (yes/no), and the device's life (time from last implant/replacement, dichotomized at 5 years). The regression coefficient for visit, representing the (adjusted) difference in duration between unscheduled and scheduled visits, and its 95% confidence interval (95% CI) were computed.

To compare the involvement of each type of healthcare personnel across the type of follow-up visit (scheduled or unscheduled) and across each type of device, population-averaged panel-data (for healthcare centre) log-linear models were fitted by using general estimating equations.

A two-sided P-value <0.05 was considered statistically significant. With Bonferroni correction, post hoc comparisons between types of devices were considered statistically significant for P values <0.017.

Results

Patient disposition

Four hundred and twenty-six consecutive visits were included in the database. Nineteen visits had to be excluded due to missing data for the main outcome variable (time). Thereafter, 407 visits were included in the analysis, of which 43% of these were follow-up visits to check an IPG, 37% to check an ICD, and 20% were to check a CRT device (Figure 1).

Figure 1

Patient disposition: enrolment and analysis

Scheduled and unscheduled visits duration

Among 407 visits analysed, 378 (93%) were scheduled and 29 (7%) were unscheduled. The visits had occurred after a median of 6 months (25th–75th percentiles 3–8) and 3 months (25th–75th percentiles 2–6) following the previous visit, respectively (P= 0.019). Visit duration in terms of total cumulative time was ∼30% longer for unscheduled visits, with a mean of 35 min (SD 20, median 30 min, 25th–75th percentiles 20–43), while scheduled visits lasted a mean of 27min (SD 17, median 21 min, 25th–75th percentiles 15–35). The mean lengthening of visit duration induced by an unscheduled visit, computed from the mixed random effect model, was 6.6 min (95% CI 1.2–12.1, P= 0.017). This difference remained almost unchanged (7.6 min, 95% CI 1.8–13.4, P= 0.010) when adjusting for potential confounding variables (Table 1). Other independent determinants of visit duration were the need for device reprogramming (additional time 7.5 min, P < 0.001) and the type of device checked, with CRT devices needing 9.1 and 6.6 more minutes than single- (P < 0.001) and dual-chamber devices (P = 0.002), respectively, as shown in Table 1. Time devoted to follow-up of IPGs, ICDs, and CRT was 24 min (SD 16), 26 min (SD 18), and 33 min (SD 15), respectively, during scheduled visits, and 27 min (SD 15), 31 min (SD 19), and 56 min (SD 17), respectively, during unscheduled visits. No significant interaction was observed between type of device and type of visit. However, in patients with CRT devices the difference between unscheduled and scheduled visit duration tended to be larger [56 min (SD 17) vs. 33 min (SD 15), adjusted difference 19.4 min, 95% CI 8.6–30.1] than in patients without CRT device [30 min (SD 19) vs. 25 min (SD 17), adjusted difference 5.8 min, 95% CI−1.1 to 12.7].

View this table:
Table 1

Predictors of visit duration (in terms of total cumulative time)

PredictorCategoryMean (SD)Difference in minutes (95% CI)aP value
Unscheduled visitNo26.7 (16.8)
Yes34.8 (20.0)7.6 (1.8–13.4)0.010
Defibrillation capability (ICD and CRT-D)No24.8 (16.2)
Yes29.5 (12.6)1.8 (−1.4–5.1)0.27
Type of device<0.001
Single25.5 (17.9)
Dual24.6 (16.3)2.5 (−0.8 to 5.9)b
CRT34.3 (15.9)9.1 (4.8–13.3)b
ReprogrammingNo26.0 (15.5)
Yes30.6 (20.2)7.5 (4.3–10.6)<0.001
Time since device implantation≤5 years27.9 (16.3)
>5 years24.8 (19.8)0.0 (−3.6–3.5)0.99
  • Multivariable random effects mixed model (random effect for centre): Wald chi-square = 56.13, P-value <0.001.

  • aRegression coefficient from the multivariable random effect model.

  • bPost hoc comparisons for device: dual vs. single: P = 0.18; CRT vs. single: P < 0.001 (significant after Bonferroni correction); CRT vs. dual: difference= 6.6 min, 95% CI 2.4–10.8, P= 0.002 (significant after Bonferroni correction).

Reprogramming and visits duration

A reprogramming of the device was applied in 124 out of 407 checks (30%) and this had a significant impact on the duration of the visit, since both overall and for any type of CIEDs the cumulative visit time was longer when a change in programming was done (Tables 1 and 2).

View this table:
Table 2

Total cumulative visit time according to reprogramming of device

Without device reprogramming (n= 283)With device reprogramming (n= 124)Difference (95% CI)aP value
Overall25.8 (15.5)30.6 (20.1)8.5 (5.4–11.6)<0.001
By type of device
IPG28.6 (16.7)31.5 (19.8)8.3 (3.8–12.7)<0.001
ICD25.7 (14.6)31.2 (19.6)9.0 (5.2–12.8)<0.001
CRT23.7 (14.7)29.4 (7.5)8.3 (4.9–11.7)<0.001
  • All values are mean (SD).

  • aUnivariable mixed effects model (with random effect for centre).

Contribution of healthcare personnel to visits

The involvement of each type of healthcare personnel during the follow-up visits is shown in Figure 2 and in Table 3, with analysis on overall data and according to type of visit (scheduled/unscheduled) and type of device (IPGs/ICD/CRT device). Most visits made use of two different healthcare personnel (239 of 407, 59%), the most frequent combination being the involvement of both a cardiologist and a nurse (216 of 407 visits with both of them only, and 65 additional visits with also an internal technician, an external technician, or both). Follow-up visits were performed less often by a single person (92/407, 23%), most often by an internal technician (53 of 407 visits, 13%). External and internal technicians were less frequently involved than cardiologists or nurses, although they were present in 20–30% of visits. The distribution of healthcare personnel did not differ between scheduled and unscheduled visits and between different types of devices. The only exception was the involvement of the internal technician, who was significantly more frequently present in visits to check a CRT device than an IPG (P= 0.010), but not an ICD (Table 3). The mean time (±SD) spent per visit by each type of health personnel for scheduled and unscheduled visits was 13 ± 8 and 15 ± 8 min, respectively, for cardiologists; 13 ± 10 and 18 ± 10 min, respectively, for nurses; 13 ± 8 and 19 ± 8 min, respectively, for internal technicians and 13 ± 3 and 13 ± 3 min, respectively, for external technicians. As shown in Figure 2, for scheduled visits, the mean time devoted to a visit was the same for each healthcare personnel (Figure 2A), while there was a relative higher increase in the time contributed by nurse and internal technician, with respect to cardiologist and external technician, in the unscheduled visits (Figure 2B).

View this table:
Table 3

Contribution of each type of healthcare personnel to visits, overall, by type of visit (scheduled/unscheduled) and by type of device (including cardiac pacemaker/implantable cardioverter-defibrillators/cardiac resynchronization therapy) [population-averaged GEE model for panel data (for centre)]

Visit withOverallType of visitP valueType of deviceP value
ScheduledUnscheduledIPGICDCRT
Number of personnel0.300.36
192 (23%)86 (23%)6 (21%)39 (22%)41 (27%)11 (14%)
2239 (59%)221 (58%)18 (62%)109 (62%)89 (60%)39 (49%)
357 (14%)55 (15%)2 (7%)25 (15%)14 (9%)18 (22%)
419 (4%)16 (4%)3 (10%)2 (1%)5 (4%)12 (5%)
Cardiologist322 (79%)297 (79%)25 (86%)0.52144 (82%)111 (75%)65 (81%)0.78
Cardiologist alone23 (6%)21 (6%)2 (7%)0.5611 (6%)11 (7%)1 (1%)0.29
Nurse312 (77%)291 (77%)21 (72%)0.78129 (74%)114 (76%)67 (84%)0.67
Nurse alone16 (4%)15 (4%)1 (3%)0.636 (3%)9 (6%)1 (1%)0.09
Internal technician110 (27%)102 (27%)8 (28%)0.2934 (19%)41 (27%)34 (42%)0.020a
Internal technician alone53 (13%)50 (13%)2 (10%)0.9722 (13%)21 (14%)9 (11%)0.62
External technician73 (18%)67 (18%)6 (21%)0.7333 (19%)15 (10%)25 (31%)0.45
  • aPost hoc comparisons for device: ICD vs. IPG, P= 0.050; CRT vs. IPG, P= 0.010 (significant after Bonferroni correction); CRT vs. ICD P= 0.24.

Figure 2

Healthcare personnel contribution within in-office device check in scheduled (A) and unscheduled (B) visits. The mean time in minutes (SD) spent per visit by each type of health personnel (top) and the % of visits contributed by each type of healthcare personnel (bottom) are shown.

Visit duration and country of participating centres

The duration of in-clinic follow-up visits (total cumulative time) according to the country of participating centres is shown in Figure 3. Analysis of mean visit duration showed statistically significant differences (P < 0.001).

Figure 3

Mean visit time (total cumulative time) by country of participating centres. At statistical analysis P < 0.001.

Actual visits duration

Data on duration of in-office follow-ups in terms of actual visit time (independently on the number and type of healthcare personnel involved) are shown in Table 4. As shown, actual visit time was longer in unscheduled vs. scheduled visits, in case of check of a CRT device, and in case of device reprogramming. The analysis of actual visit time according to country of participating centres showed that the differences in visit duration did not reach statistical significance (P= 0.07).

View this table:
Table 4

Actual visit time according to type of visit, device, reprogramming, and country

VisitnActual time, mean (SD)P-valueaPost hoc P-valueb
Type of visit0.007
Scheduled39716.2 (9.2)
Unscheduled2919.3 (8.3)
Device<0.001
IPG18314.0 (7.5)
ICD15617.7 (10.0)vs. IPG 0.60
CRT8419.1 (9.6)vs. IPG<0.001; vs. ICD<0.001
Reprogramming<0.001
No29415.3 (8.7)
Yes12719.3 (9.7)
Country0.07
CH6424.3 (10.0)
France3122.7 (8.7)
Germany8114.4 (7.3)
Greece3415.8 (9.4)
Italy9412.9 (7.2)
Spain6819.9 (8.6)
UK5416.3 (7.8)
  • aUnivariable mixed effects model (with random effect for centre).

  • bWith Bonferroni correction significance at P<0.017.

Discussion

As with any other therapy comprising sophisticated technology, CIED therapy requires close monitoring and timely adjustment, which necessitates the availability of healthcare resources, including dedicated structures to provide the service, equipment, and personnel. The participation of a cardiologist and technical personnel or nurse, usually simultaneous, may be motivated by need of a deep understanding of the interaction between technology and arrhythmic substrate in the setting of a chronic disease management paradigm during CIED follow-up. Thus, CIED therapy monitoring appears to be a technical, specialized, and time-consuming procedure, requiring the interaction of several healthcare personnel, occasionally with the consultation of industry-employed allied professionals. For the first time in Europe, we provide data showing that CIED therapy monitoring is a time-consuming procedure, requiring the interaction of several healthcare personnel, and occasionally needing consultation of industry-employed allied professionals to safely and effectively deliver therapy. It is conceivable that the conclusions from this assessment on a European sample extend to other centres than those surveyed and to other healthcare systems as well.

Health technology assessment examines, among others economic and organizational aspects, the development, diffusion, and use of healthcare technology2,3; thus, there is a need to explore all the steps of the processes characterizing healthcare delivery in the ‘real-world' setting.4 This prospective study of the resource utilization related to follow-up of CIEDs addresses a relatively unexplored field of investigation. The results of this joint EHRA–Eucomed survey, conducted on more than 400 patients followed by a group of specialized centres from seven European countries, indicate that in ‘real-world' clinical practice the duration of in-clinic CIED follow-up visits, in terms of cumulative time, results to be ∼30 min in the case of scheduled visits, and longer in the case of unscheduled checks (7% of all the visits) or in cases of follow-up of CRT devices. The approach we employed (assessment of cumulative visit time) revealed how a conventional evaluation based on actual visit duration may have a series of limitations in analysing the complexity of CIED follow-up visits and substantially underestimates the amount of resources employed in this process of care. The present survey constitutes the first European initiative focused on in-clinic follow-up of CIEDs and since it covers a substantial gap of knowledge it may have a series of clinical, organizational, regulatory, and financial implications.

So far, the implantation procedure has been the focus of reimbursement for CIEDs in most healthcare systems, while all the following steps of follow-up, aimed at maintenance and improvement of device therapy, received much less consideration by competent authorities and third-party payers. Our data provide the basis for an accurate assessment, at a national or regional level, to address the appropriateness of reimbursement practices for CIED follow-up visits, with specific focus on the evidence that the follow-up of CRT devices requires significantly more resources in terms of time dedicated by specialized personnel. Moreover, present data can stimulate further studies targeted to assess the most appropriate approach to reimbursement of CIED follow-up checks, when performed in a remote mode.

On the basis of earlier generation of pacemakers, the follow-up of CIEDs has been traditionally considered a procedure with limited clinical relevance. However, the recent Heart Rhythm Society/EHRA Expert consensus document1 stresses how follow-up and monitoring programmes of current CIEDs have specific goals, related to the patient, his/her underlying diseases, his/her device, and coupled with the need for appropriate education of the patient and his/her relatives, communication to healthcare providers and storage of administrative and clinical data in patients records and administrative databases. The pilot nature of our project did not permit a detailed analysis of each component of in-clinic CIED follow-up checks and of related data management issues, hence no specific information were delivered on the workload corresponding to these procedures; information on remote monitoring are equally missing. Nevertheless, the present study captured an important burden for arrhythmia services. Projecting the amount of workload or CIED follow-up measured in this study into a broader and global perspective (i.e. represented by the number of encounters for CIED follow-up, which is estimated to be ∼2.2 million per year in Europe and 3.7 million in North America1), one may easily imagine that most of arrhythmia services are reaching or have already reached their maximum workload capacity. The Heart Rhythm Society recently conducted a survey exclusively focused on physician workforce trends in the USA and did not consider time spent by allied professionals and did not measure the time spent by physicians for CIED follow-up checks.5 The report confirms that the burden of CIED follow-up checks for physicians was already substantial and showed that CIED follow-up visits were the most frequent activity reported by electrophysiologists with around 49% of physicians performing more than 200 visits per year.5

As shown by our survey, follow-up of CRT devices is the most time-consuming activity and the most intense activity in terms of number of personnel involved. The recent conclusion of landmark trials such as MADIT-CRT6 and REVERSE7 anticipates a significant increase in the number of CRT implantations and consequently of follow-up visits. On the other hand, pacemaker implantation is the most frequently performed device activity. Furthermore, the demographic shift of general population in developed countries will most likely ensue in increase of pacemaker implantations. Given the current and even more future limited availability of human and personnel resources, there is a need to organize CIED follow-up in a more efficient way. In addition to organizing the in-person follow-up visits more efficiently, a remote technology for CIED follow-up may be a technological alternative targeted to reduce the workload for routine follow-up visits. Indeed, equivalency of in-person and remote follow-up for device management has been recently shown by the TRUST study.8 Therefore, a reassessment at various levels (physicians, hospital managers, regulatory agency, and public and private insurance agencies involved in healthcare) focusing on resources to be dedicated to arrhythmia services and/or on alternative organizational models (i.e. remote follow-up of CIEDs) is highly needed.

Our survey indicates that unscheduled follow-up checks account for ∼7% of the clinical activities performed in an outpatient clinic dealing with patients implanted with IPGs, ICDs, or CRT devices. In a single-centre retrospective analysis focused on ICD patients, Heidbüchel et al.9 reported that unscheduled visits accounted for 12% of device checks. In view of the different patient population and methods, the two findings appear to be in substantial agreement. Unscheduled visits appear to induce some pressure on outpatient clinics, not only in view of the urgent need to perform the check, but especially because of the longer time required for the visit, often including device reprogramming.

The follow-up of CIED devices may be particularly challenging when dealing with complex issues of troubleshooting,10,11 whose solution may require a high level of clinical and technical skill. In order to ensure the highest degree of clinical expertise, targeted to improve both patient and device performances, continuous education of all the healthcare personnel involved in CIED follow-up visits appears to be a mandatory priority for professional organizations and, primarily, for scientific associations. The EHRA is deeply involved in this field with dedicated, specialized programmes for the education and accreditation of both physicians and allied professionals.12 Initiatives targeted to accreditation and certification of the physicians and allied professionals may provide practical solution to the ongoing debate regarding who should be entitled to perform the follow-up of CIEDs.13 In a study performed in a tertiary referral centre, Schaer et al.13 showed how the follow-up of ICDs may require variable skill levels, according to the complexity of the situation. In case of emergencies, clinical problems or need for reprogramming the expertise of an electrophysiologist is required in order to guarantee the optimal level of care.13

For the first time, the present survey demonstrates that industry-employed technicians are also involved in the procedure of CIED follow-up visits. This additional service provided by industry at the time of follow-up appears to be appreciated in most arrhythmia clinics, but the activity of industry-employed technicians has always been supervised by physicians as advised in the Heart Rhythm Society/EHRA expert consensus document.1 From our survey, it is unclear as to what extent the involvement of external technicians may reflect the advantage of additional available workforce or the advantage of specialized technical knowledge, or the combination of multiple factors. It is important to note that industry-employed allied professionals who operate in Europe do not undergo any type of certification (and re-certification) by EHRA or by the European Society of Cardiology, thus inequalities in the level of service and quality of support may be expected. Our survey, however, did not capture this information as well physician or hospital satisfaction about the level of service provided by the industry.

Limitations

The present survey has a series of limitations, linked to the methods used and its observational design. The present study did not check for the specific level of care delivered during CIED follow-up visits. In view of the qualification of participating centres, the average level of care is presumed to be appropriate and in line with current recommendations1 and, anyway, the scope of the study was to collect data from daily practice without external interferences. This study prospectively collected data in a sample of centres from seven European countries, but was neither targeted nor powered to assess the differences in the practice of CIED follow-up among participating centres, or among different countries. It is possible that protocols, regulations, and specific organizational settings present some degree of heterogeneity, although the statistical models fitted accounted for this source of heterogeneity by including a random effect for centre.

The present survey did not specifically and separately analyse clinical assessments and physical examinations that may be associated with device follow-up. It is obvious that, with some heterogeneity, clinical assessment may be associated, with variable extent, with the procedure of device follow-up, especially when the activity of physicians is considered, while clinical assessment will be minimized when technicians take part to device check. In other terms, we considered the full time dedicated to a patient with a CIED, without a specific attention to how much was dedicated to clinical aspects (and could be classifiable as clinical assessment, with/without physical examination) and how much was more linked to device check and/or optimization of device programming according to patient's clinical status and conditions. It is common practice that the two tasks of device check and patient assessment are strictly interconnected and cannot be easily split, especially in heart failure patients with devices for CRT or, in general, in patients with a CIED who present urgent problems requiring an unscheduled check. In this perspective, it is important to stress that surveys are usually planned in order to give a general picture of practice, while more focused assessments require more specific evaluations, such as audits.

It is likely that the selection criteria used to identify the centres who participated to our survey (prior participation in EHRA activities) represent a bias, possibly towards active and careful centres. A detailed analysis of these factors would require a dedicated study on a larger scale. Finally, the present survey did not consider the follow-up of implantable loop recorders.

Conclusions

Without follow-up, CIED therapy is incomplete, and without adequate resources to achieve appropriate follow-up, the desired outcome represented by better patient quality and length of life is in jeopardy. The results of our European survey indicate that in ‘real-world' clinical practice, the follow-up of CIEDs requires important resources in terms of time dedicated by specialized personnel, corresponding to cardiologists, nurses, internal technicians, and, also, external, industry-employed technicians. These observations should be the basis for addressing clinical, organizational, financial, and policy initiatives targeted to face the increase in the number of patients treated with CIED that is expected to occur in the coming years.

Funding

The Eucomed CRM Telemonitoring Group funded independent data analysis for this study. The statistical analysis performed by the independent statistician (C.K.) was funded under a grant from Eucomed.

Acknowledgements

The authors thank Eucomed CRM Telemonitoring Group for the support in data collection.

Conflict of interest: G.B. had no potential conflicts of interest to declare. A.A.: Consulting Fees/Honoraria from Medtronic, Biotronik, St Jude Medical, Sorin, EBR System, Philips, Merck, Abbott, Biosense Webster, BMeye, Impulse Dynamics, Spectranetics. C.K.: Consulting Fees/Honoraria from Boston Scientific, Eucomed, Medtronic. P.K.: Consulting Fees/Honoraria from 3M Media, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, OMRON, MEDA Pharma, Medtronic, Sanofi Aventis, Servier, Siemens, TAKEDA, Baker AG; Research Grants from 3M Medica/MEDA Pharma, Cardiovascular Therapeutics, Medtronic, OMRON, Sanofi Aventis, St Jude Medical the German Federal Ministry for Education and Research (BMBF), Fondation LeDucq, the German Research Foundation (DFG), the European Union. J.B.: Consulting Fees/Honoraria from Boston Scientfic, Sorin, Biotronik, St Jude Medical. J.M.: Consulting Fees/Honoraria from Medtronic, St Jude Medical. P.V.: Consulting Fees/Honoraria from Bayer, Boehringer, Medtronic; Research Grants from Astra Zeneca, Servier, Sanofi Aventis.

Appendix

Participating centres and investigators involved in the EHRA–Eucomed survey on CIED in-clinic follow-up.

France: Clinique Pasteur, Toulouse (S. Boveda), Centre de Cardiologie du Nord, Saint-Denis, (O. Piot); Germany: Augusta-Kranken-Anstalt GmbH Bochum, Bochum (K.J. Altmaier), Kardiologische Schwerpunktpraxis, Heidelberg (M. Natour), HELIOS Klinikum Berlin Buch, Berlin (H. Schütt), Klinikum Coburg (A. Wystrach), University of Leipzig, Heart Centre, Leipzig (C. Eitel).

Italy: Istituto di Cardiologia, Università di Bologna, AO S. Orsola-Malpighi, Bologna (G. Boriani, M. Biffi, C. Martignani), Div. di Cardiologia. Milan Bicocca University and S. Gerardo Hospital, Monza (S. De Ceglia, G. Rovaris, A. Vincenti), Department of Cardiology, San Filippo Neri Hospital, Rome (R. Ricci), Cardiologia, Ospedali Riuniti di Bergamo, Bergamo (R. Brambilla, F. Paolo), Istituto Clinico Humanitas IRCCS, Milano (P. Galimberti, C. Ceriotti), Cardiologia, Ospedale S. Maria della Misericordia, Udine (L. Rebellato).

Spain: Cardiology, Hospital Clinico de Barcelona, Barcelona (J. Brugada), Cardiology Department, Hospital de Sant Pau, Barcelona (X. Viñolas), Cardiology, Hospital General Universitario La Paz, Madrid (J.L. Merino), Cardiology, Fundacion Jimenez Diaz, Madrid (J. Farrè).

Switzerland: Cardiology, University Hospital Basel, Basel (C. Sticherling), Cardiocentroticino, Lugano (T. Moccetti), Cardiologie, HUG – Hôpitaux Universitaires de Genève, Geneve (H. Burri).

UK: Morriston Hospital, Swansea, Wales (J. Berry, P. Rees), University Hospitals of Leicester NHS Trust (W.D. Toff), Southampton General Hospital, England (J. Morgan).

Greece: Cardiology, Heraklion University Hospital, Heraklion (P. Vardas), Cardiology, Errikos Dynan Hospital, Athens (G. Theodorakis), Athens Euroclinic, Athens (K. Katritsis).

References

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