Europace Advance Access originally published online on April 17, 2008
Europace 2008 10(7):832-837; doi:10.1093/europace/eun093
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Pacing
Routine follow-up after pacemaker implantation: frequency, pacemaker programming and professionals in charge
1 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Bolognalaan 12, 3584 CJ Utrecht, The Netherlands; 2 Department of Cardiology, University Medical Centre Utrecht, The Netherlands; 3 Department of Cardiology, Sint Lucas Andreas Hospital, Amsterdam, The Netherlands; 4 Department of Cardiology, VieCuri Medical Center, Venlo, The Netherlands; 5 Department of Cardiology, Vlietland Hospital, Schiedam, The Netherlands
Manuscript submitted 18 December 2007. Accepted after revision 24 March 2008.
* Corresponding author. Tel: +31 30 2506545; fax: +31 30 2505481.E-mail address: j.w.m.vaneck-2{at}umcutrecht.nl
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Abstract |
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Aims: To describe current evidence of the frequency, contents, and involved professionals of the routine follow-up visits in patients who have received a pacemaker (PM).
Methods and results: The multicentre FOLLOWPACE study prospectively collected data during implantation and follow-up of 1526 patients who received a PM for the first time. A total of 4914 follow-up visits were studied. Mean follow-up was 394 days with a mean of 3.2 visits per patient. At all follow-up visits, the battery condition was tested in >93%, the stimulation threshold in >91%, and sensing in >87%. The pacemaker parameters as stimulation and sensing thresholds, lead impedances, and percentages of pacing remained stable over time, but these values did depend on the lead location, lead fixation, and pulse duration. The majority of PM (re-)programming was performed during implantation and/or shortly before hospital discharge (50%). PM re-programming during follow-up was most frequently performed by the PM technician alone (95%).
Conclusion: Crucial PM parameters are regularly checked. Re-programming of PM parameters declined during the first year after PM implantation. The majority of PM checks were carried out by the PM technician, indicating the major influence of the allied professional on the quality and safety of the pacing therapy.
Key Words: Pacemaker, Follow-up, Device monitoring
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Introduction |
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Since the first pacemaker (PM) implantation in 1958,1
guidelines have been developed and regularly updated to optimize chronic cardiac pacing.2–4 These guidelines address the implantation procedure and the selection of the appropriate PM system, pacing settings and mode in relation to pacing indications, patient characteristics, and underlying cardiac disorder(s). The subsequent follow-up of the PM patient after implantation has received less attention, but is of similar importance in terms of patient benefits and safety of the pacing therapy.
After the first publication on recommendations for routine follow-up in 1977 by Furman,5 only a small number of studies on this topic have been published.2,6–11 These studies primarily focus on the requirements of the infrastructure of the pacemaker clinic and the training of the professionals in charge. Although attempts have been made to establish a sensible follow-up schedule, based on the occurrence of events after implantation and possible PM failure, these studies were all retrospective. Large prospective studies on the frequency and contents of routine follow-up visits, PM re-programming, and PM replacement are not available. Hence, evidence-based recommendations on the follow-up of pacemaker patients cannot (yet) be provided.
To evaluate the current routine of follow-up of patient with an implanted PM, a nationwide prospective follow-up study in the Netherlands was initiated in 2003; the FOLLOWPACE study.12 The purpose of the present interim analysis was to quantify the visit frequency, contents of the visits (e.g. frequency and type of PM programming), and personnel involved in the follow-up. Second, we assessed the stability over time of different pacing parameters, such as stimulation thresholds, lead impedances, and pulse durations. These findings can be instrumental for the formulation of guidelines for a more effective follow-up of patients who receive a PM.
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Methods |
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Patients
The FOLLOWPACE study was executed in 23 PM implanting centres in the Netherlands between 2003 and 2007. Before the start of the study, 115 hospitals in the Netherlands performed PM implantations and routine follow-up and 35 hospitals were selected and invited to participate in the FOLLOWPACE study. The selection of these centres was based on their numbers of annual 1st PM implantations. For reasons of representativeness, centres with high and small volume of annual PM implantations and that in between were invited to participate. The design of the FOLLOWPACE study has been published previously.12
,13 In brief, any consecutive patient aged 18 years or over, receiving a first PM for conventional reasons14 in one of the participating centres, was a candidate for the study. Patients were not eligible if they refused to sign informed consent, were taking any investigational drug or have a non-approved or investigational PM implanted, or had diseases that were likely to cause death or significant morbidity during the study period. The protocol for this study was approved by the Ethics Commission of the University Medical Center (UMC) Utrecht, The Netherlands. Study data were directly entered on-line in an electronic case report form, which was specifically designed for the study. The present study analysed all included patients (n = 1526).
Pacemaker implantation
During hospitalization for implantation, information on the patient's medical history, medication use, duration of the implantation procedure, personnel involved in the implantation procedure, performed measurements of the leads and PM, and changes made in PM mode and settings before hospital discharge was gathered.12,13
Follow-up visits
A follow-up visit was defined as an outpatient visit to the clinic where the PM was implanted and where the patient visited a cardiologist and/or an associated professional for a physical and/or PM check-up. Both, routine (pre-planned) visits and extra visits due to the occurrence of unexpected events, symptoms or any other reason, were considered in this analysis. Data on the time windows between consecutive visits, personnel involved at these visits, measurements on leads and pacemaker device, and changes in PM mode and settings were documented.
Data analysis
For continuous parameters, we computed the mean and the standard deviation in case of normal distributed parameters, the median and range if the variable was non-normally distributed, and percentages in case of categorical parameters. To determine differences in stimulation thresholds measured at the same visit but depending on pulse duration (4 different groups), we performed the Kruskal–Wallis test. To determine differences in sensing thresholds according to lead location, we used the Mann–Whitney test. Differences in lead impedances and percentages of pacing, depending on lead fixation or pacing mode, were analysed by using Students’ t-test, as these variables were normally distributed. To determine the stability over time of various pacing parameters (stimulation thresholds, sensing thresholds, lead impedances, and percentages of pacing), we first selected the patients with paired data on the first three follow-up visits and tested whether there were significant changes or trends over time. For variables with normal distributions, this was performed by analysis of variances, and for non-normally distributed variables, this was performed by Friedman's two-way analysis of variance test. P-values <0.05 were considered statistically significant. All analyses were performed using S-Plus Version 6.2.1 (Insightful Corp. Seattle, WA, USA).
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Results |
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The baseline characteristics of the 1526 patients are given in Table 1. The majority of patients were male (57.0%) and the mean age at implantation was 73.8 years. Hypertension was the most common co-morbidity (69.1%), followed by prior atrial arrhythmias (37.8%), diabetes (34.8%), hypercholesterolemia (28.1%), and coronary artery disease (25.8%). Heart failure was present in 9.3% of the patients and was the primary indication for implantation in 3.0% of all patients. The primary indication for implantation mainly comprised atrio-ventricular (AV) conduction disturbances, sick sinus syndrome, and brady-tachycardias (75.3%). This was also reflected by the choice of the PM mode, which was most often the DDD (R) mode (68%).
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In the 1526 patients, a total of 4914 visits during the follow-up were conducted. Mean follow-up was 394 days. The follow-up ranged widely from 0 month to 36 months, adding up to a total of 1424 person-years of follow-up. The mean number of follow-up visits per patient was 3.2. The first three follow-up visits occurred after a median of 37, 140, and 299 days, respectively, after first PM implantation. In the cohort, 673 patients were followed-up for more than 11 months, of these 673 patients 296 (44%) were followed-up regularly at 2, 6, and 12 months, 234 patients (35%) were followed-up more frequently in the first year after implantation, and 143 patients (21%) less frequently.
In 
90% of the follow-up visits, both the stimulation and sensing thresholds were tested (Table 2). Atrial and right ventricular lead impedances were tested less frequently (respectively, 66 and 88% at the first follow-up visit). The battery status and percentages of atrial and/or ventricular pacing were again almost always (>90%) measured across the first three follow-up visits and ventriculo-atrial conduction and far-field R wave in the atrial channel were tested in 30% of all follow-up visits.
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In the majority of the patients, both the atrial and right ventricular lead stimulation thresholds were tested using a pulse duration of 0.35–0.40 ms at each visit. There were no statistically significant differences in median values of stimulation thresholds measured at different pulse durations.
Sensing signals were higher for right ventricular leads (median 8.60 vs. 2.25 mV in the atrial lead at the first follow-up visit). Both the atrial and right ventricular lead impedances were lower when an active lead fixation method was used (487 vs. 590 
in passive fixation for the atrial lead at the first follow-up visit). The percentages of atrial pacing did depend on the pacing mode, where the percentage of atrial pacing is highest in AAI(R) mode (43% at first follow-up visit). The difference in percentage of right ventricular pacing between the different pacing modes was only statistically significant at the first follow-up visit where the percentage of ventricular pacing was higher in patients in which the PM system is programmed in DDD(R) mode [72 vs. 60% in VVI(R) mode at first follow-up visit] (P = 0.02). There were no statistically significant differences or trends over time in median values of stimulation and sensing thresholds or mean values of lead impedances or percentages of pacing, and therefore results of the tests are not shown in Table 2.
PM settings were changed during the entire follow-up period but the number of changes markedly declined after 6 months from 54 to 23% (Table 3). The majority of re-programming involved the pulse amplitude of both the atrial and right ventricle pacing, where the latter was changed most in the period between 2 and 6 months after implantation (31.6%). Re-programming of the sensing thresholds, the paced lower rate, the AV delay, and the switching on of the rate response pacing occurred less frequently. Re-programming of the remaining PM parameters occurred in <6% of all patients.
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Information on personnel involved in changing PM parameters is given in Table 4. Only during implantation, the level of participation of the PM technician was similar to that of the cardiologist. Subsequently, over 90% of all PM setting changes were performed by the PM technician, whereas in
10%, the cardiologist was consulted regarding these changes. Participation of the PM manufacturer representative was almost negligible in this series (0–1%).
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Discussion |
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This prospective nationwide study of routine follow-up in patients who received a PM demonstrates that crucial aspects of the chronic pacing therapy such as battery condition, thresholds of atrial and ventricular pacing and sensing, and lead impedances were consistently measured during routine follow-up. The purpose of these measurements is the detection and/or prevention of the common events such as lead dislocation, insulation defects, lead fractures or disconnections, and premature battery depletion, thus promoting the safety of chronic pacing. The stability of all measurements was analysed on a subset of patients for which data on the first three follow-up visits were available. In theory, this might have lead to biased results. However, as the number of follow-up visits in the first year after PM implantation is limited, for patients included in the studied cohort less than one year ago, data on some follow-up visits were not available for analysis.15
However, it is not excluded that some measurements that are considered to be crucial to the safety of the PM patient were not consistently measured. For example, when the interval between visits was short in case of an unplanned visit due to a purely medical problem, the cardiologist and/or PM technician might assume that the repeated check of the specific parameter was not related to the medical problem. The most frequently changed parameters were atrial and ventricular pulse amplitudes, aimed to improve PM pulse generator longevity.16–20 Re-programming of the sensor for rate adaptive pacing occurred rather frequently. However, which patients benefit most from rate adaptive pacing and which sensor settings are best is still matter of debate.21 The AV delay was mostly altered at implantation. The manufactures’ selected default AV delay appears to be sensible and valid for the majority of the patients.22 Other parameters are only changed in a minority of patients, such as PM mode, pulse duration, mode switch, and arrhythmia therapy. We did consider providing information on initial PM programming and changes of the implanted pacemakers. However, PM types differed strongly in the FOLLOWPACE study, and therefore it was almost impossible to include all default values of all different PM variables and to describe the adjustments after implantation. Furthermore, the sample sizes of the patients with the same pacemakers and the same settings were small and did not allow for statistical analyses.
At 1 year after PM implantation, the percentage of ventricular pacing in DDD(R) mode PM's declined from 71 to 65%. We arbitrarily interpreted this change to be a consequence of recent insights in the relationship between right ventricular pacing and possible deterioration of cardiac function.23
We found that the majority of PM controls and programming during the follow-up was carried out exclusively by the PM technician (95% of the controls after 1st PM implantation). The cardiologist was consulted in <10%. This highlights the responsibility in the current routine of the allied professionals for the quality and safety of the pacing therapy.24 In the Netherlands, the PM technician is a well-trained nurse-practioner or allied professional who assists the cardiologist at the PM implantation and who carries out the routine PM device checks. The PM technician checks the running algorithms and programs such as pacing and sensing thresholds, output, stored ECG data, and performs re-programming in interaction with the cardiologist. On the basis of the results of the regular PM checks, the PM technician also determines the time interval to the next PM check. In addition, the PM technician is instructed to immediately contact the cardiologist in charge if an important physical or mental problem of the patient or a device-related problem is suspected. The task and responsibilities as well as the required skills and level of education and training are documented and matter of continuous discussion in Dutch device implanting centres. The transition of responsibilities from the cardiologist to the allied personnel is only warranted when the allied professional has had specific training and experience.25 In the ESC Guidelines,4 some recommendations and comments have been made, but to our best knowledge detailed information on the position and contribution to the pacing therapy of the allied professionals in the various Western countries is lacking. Our study is probably the first one that reports the role of the allied professionals in daily practice of cardiac pacing.
Although we studied the influence and presence of cardiologists and allied personnel in the follow-up, the level of training, skills, and experience was not quantified. Also, changes in PM and lead settings were systematically documented, but the specific reasons for these changes were not provided. We did not collect information whether the follow-up visit was elective or unplanned. Hence, determining the exact frequency and contents of follow-up visits based on this data only is less straightforward.
The presented data mirror the current routine PM follow-up in the Netherlands and subsequent analyses will eventually show whether the methods and timing of current routine follow-up can be optimized without loss of benefits, safety, and cost-effectiveness. These results can fuel current guidelines on the measurements and interventions regarding pacemaker settings in a general setting of patients with a PM.
In the near future, home monitoring can become a new useful tool for monitoring patients, with a potential improvement in patient follow-up and early detection of changes in the arrhythmic condition of the patient.26,27 This study did confirm that in most cases the essential parameters in a pacemaker remain constant in the first year after PM implantation and this may assist in developing guidelines for home monitoring. Subsequently, implementation studies or even randomized trials are needed to determine the most effective strategy—in terms of frequency, contents, and professionals—for the follow-up of PM patients.
Limitations
The results of this study can be considered as preliminary, as the follow-up of the included patients is still continuing. For the analysis presented, approximately half of the patients had a follow-up period of more than 1 year. The results of this study are, therefore, most valid for the early period (1 year) after the initial PM implantation. Follow-up data of 101 patients (7%) in whom the PM was very recently implanted with reference to the time of the analyses were not available. Of the initially invited 35 centres, 10 centres did not include any patient. These 10 centres were all smaller centres (<40 PM annual 1st PM implantations) and therefore the population of patients receiving a PM in low volume centres is underrepresented in our study sample. However, the number of small centres decreased in recent years as regulations on the minimal number of PM implants per year by a cardiologist became more strict, and second, because several small hospitals merged with large volume hospitals in the Netherlands.28
Conclusion
This prospective study disclosed that, in general, crucial PM parameters are regularly checked and attention is paid to the safety of cardiac pacing throughout the follow-up. Pacing stimulation and sensing thresholds as well as lead impedances and percentages of pacing remain stable over time, but these values depend on the lead location, lead fixation, and pulse duration. Re-programming of PM parameters declined during the first year after PM implantation. The majority of PM controls were carried out by the PM technician, indicating the major influence of the allied professional on the quality and safety of chronic cardiac pacing.
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The FOLLOWPACE study is granted by the Dutch College of Health Care (CVZ/VAZ grant number 01236), all distributors and manufacturers of implantable cardiac arrhythmia devices in the Netherlands, The Netherlands Pacemaker Registry Foundation, Groningen, The Jacques H. de Jong Foundation, and The Roger Crowson Foundation for Human Arrhythmias Studies.
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The authors acknowledge the cooperation of the patients included in this study and cardiologists and pacemaker technicians of the following hospitals in the Netherlands: Bernhoven Hospital, Veghel; Amphia Hospital, Breda; Diaconessen Hospital, Meppel; Medical Center Alkmaar, Alkmaar; Reinier de Graaf Hospital, Delft; Hospital group Twente, Hengelo; VieCuri Medical Center, Venlo; Zaans Medical Center, Zaandam; St Antonius Hospital, Nieuwegein; Alysis Rijnstate Hospital, Arnhem; Vlietland Hospital, Schiedam; Deventer Hospital, Deventer; VU Medical Center, Amsterdam; Twenteborg Hospital, Almelo; Spaarne Hospital, Heemstede; Westfries Hospital, Hoorn; Atrium Medical Center, Heerlen; Rijnland Hospital, Leiderdorp; University Medical Center, Groningen; Maxima Medical Center, Veldhoven; Antonius Hospital, Sneek; Hospital De Tjongerschans, Heerenveen; Canisius Wilhelmina Hospital, Nijmegen; Diaconessen Hospital, Leiden.
Conflict of interest: none declared.
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References |
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