Europace Advance Access originally published online on November 7, 2008
Europace 2009 11(1):75-79; doi:10.1093/europace/eun293
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Pacing and Cardiac Resynchronization Therapy
Effects of increasing age onto procedural parameters in pacemaker implantation: results of an obligatory external quality control program
1 Cardiovascular Center Bethanien (CCB), Im Pruefling 23, D-60389 Frankfurt a.M., Germany; 2 Institute of Quality Assurance Hessen, Frankfurter Str. 10–14, D-65760 Eschborn, Germany
Manuscript submitted 13 August 2008. Accepted after revision 8 October 2008.
* Corresponding author. Tel: +49 69 9450280; fax: +49 69 461613. E-mail address: b.nowak{at}ccb.de
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Abstract |
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Aims: The aim of the study was to evaluate the effects of increasing patients' age onto procedural parameters, especially complications, during primary pacemaker implantation, evaluating the database of the Institute of Quality Assurance Hessen in the federal state of Hessen, Germany.
Methods and results: The database of the obligatory external quality control program was evaluated retrospectively for the years 2003–2006. A total of 17 826 patients undergoing stationary primary pacemaker implantation have been registered in 72 centres. In single-chamber implants, the implant duration is shortest in non-agenarians. For dual-chamber implants, the implant duration shortens with increasing age. Thus, as well as fluoroscopy time is significantly shorter in the oldest patients. Atrial and ventricular pacing thresholds as well as R-wave amplitudes do not change with age. P-wave amplitudes showed a small but steady decline with increasing ages. Complications do not increase with advanced age.
Conclusion: In this large-scale real-life patient cohort of primary stationary pacemaker implantation, increasing age resulted only in reduced P-wave amplitudes. Higher age was not associated with an increased risk of complications. Thus, pacemaker implantations in the elderly can be performed with the same reliability as in younger patients.
Key Words: Pacemaker implantation, Age, Complications, Procedural parameters, Quality control
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Introduction |
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The mean age of our population is steadily increasing.1
Therefore, it can be assumed that more and more elderly patients have to undergo pacemaker implantation. Advanced age would be reasonably expected to increase the risk of pacemaker implant complications. A higher age of operated patients might and does serve as an explanation for higher complication rates during quality assurance audits.
Data on this topic are conflicting. Some studies found an increase in complication rates for pacemaker implantation,2–4 while others did not.5–8 In the Danish pacemaker register, no significant relation was found between age and lead displacement or dysfunction rate.9
Besides complication rates, intra-operatively measured values might deteriorate with increasing age. This was demonstrated for atrial sensing in single-lead VDD pacing, where sensing thresholds decreased and rates of atrial under-sensing increased with increasing patient age.10
The external obligatory quality control program has the advantage of collecting ‘real-life’ data of all inpatient stationary primary pacemaker implantations in Germany. It has a data completeness of above 95%. The participation in this program is linked to reimbursement of the procedures, thus providing a high rate of documentations.
The aim of the study was to evaluate the effects of increasing patients' age onto procedural parameters during primary pacemaker implantation, evaluating the database of the Institute of Quality Assurance Hessen in the federal state of Hessen, Germany.
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Methods |
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The database of the obligatory external quality control program in the federal state of Hessen, Germany, was evaluated retrospectively for the years 2003–2006. For every stationary primary pacemaker implantation, a data set has to be filed electronically. These data are collected centrally for each federal state in Germany. Based on these data, predefined quality benchmarks have to be reached by each implanting centre. If those benchmarks are missed, a structured dialogue is initiated. Every clinic in Germany is obliged to publish quality assurance data.
The data collected represent the period from implantation until discharge. Follow-up data are not available. Additionally, the quality assurance program collects data per hospital and does not differentiate between departments or implanters.
For this study, the patient population was separated into age decades. According to those decades, the following parameters were evaluated: sex, pacing indication, implanted single- or dual-chamber device, implantation duration and fluoroscopy time, pacing threshold, and measured amplitudes for atrial and ventricular leads.
The data set ‘complications’ comprises the following topics: any complication, if yes: asystolie, ventricular fibrillation, pneumothorax with intervention, haematothorax with intervention, pericardial effusion with intervention, pocket haematoma with intervention, lead dislocation, and device infection.
Statistics
Data were collected using a standardized questionnaire and further computerized and analysed by SPSS 12.0 for Windows.
The 95% confidence intervals were calculated for normal distribution (mean values) and for f-distribution (rate-based values).
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Results |
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Patients and indications
In the years 2003–2006, a total of 17 826 patients undergoing stationary primary pacemaker implantation in Hessen were registered, of whom 54.5% were male and the mean age was 75.5 ± 10.4 years (range: 1–104 years). These implantations have been performed in 72 centres with a minimum stationary implantation rate of 1 and a maximum implantation rate of 340 per year (mean 57.1 ± 55.6 implantations per year).
The indications for pacemaker implantation according to the German guidelines11,12 were AV block or fascicular block in 34.8%, sick sinus syndrome in 27.9%, atrial fibrillation with bradycardia in 26.2%, and others in 11%. Details for the pacing indications according to age groups are shown in Figure 1. With increasing age, the percentage of the documented pacing indication ‘atrial fibrillation’ increases and the percentage of the documented pacing indication ‘sick sinus syndrome’ decreases.
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A single-chamber device was implanted in 6631 patients (37.2%) and a dual-chamber device in 10 937 patients (61.4%), cardiac resynchronization device: 208 (1.2%), unspecified: 50 (0.3%). The distribution of single- and dual-chamber devices according to age is shown in Figure 2. With increasing age, the number of dual-chamber devices implanted declines steadily.
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Implantation parameters
The detailed results are shown in Table 1. In single-chamber implants, the implant duration is shortest in non-agenarians. For dual-chamber devices, the implant duration shortens with increasing age. Thus, as well as fluoroscopy time is significantly shorter in the oldest patients. For single-chamber implants, age has no effect on fluoroscopy time.
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Atrial and ventricular pacing thresholds as well as R-wave amplitudes do not change significantly with age. P-wave amplitudes showed a small but steady decline with increasing age.
Complications
The results for all complications in the different age groups are shown in Table 2. There is no significant difference concerning all complications or distinct complications with increasing age.
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Discussion |
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Increasing age of the population, and accordingly of patients, is an omnipresent topic in medicine. Adult pacemaker patients are usually in their mid-1970s when they have to undergo implantation. Increasing age might influence periprocedural parameters such as sensing and pacing thresholds. In addition, it is frequently believed that elderly patients are at risk of suffering more complications during device implantation, due to more comorbidities and reduced functional reserves.
Data gathered during quality assurance programs offer the possibility of evaluating ‘real-life’ data, which include high volume centres, usually participating in studies or registries. In our cohort, the mean number of stationary primary pacemaker implantations per centre per year was 57, with a minimum of 1 and a maximum of 304 implantations per year. Therefore, the data evaluated cover the whole range of clinics currently implanting pacemakers in the federal state of Hessen, Germany. As complication rates in pacemaker implantations are low, greater patient cohorts like these are needed to assess the influence of patient characteristics such as age.
As could be expected, the number of patients with the documented pacing indication atrial fibrillation increased and of those with sick sinus syndrome decreased with increasing patients' age. With increasing age, the use of dual-chamber devices declined, reaching 31.9% in those patients of 90 years and above, whereas the percentage of atrial fibrillation in this group was 28.7%. This is in accordance with recent data from the Netherlands, which showed that with advanced age there is a considerable drop in the implantation rate of dual-chamber systems.13
Implantation parameters
Concerning measured parameters, pacing thresholds in the atrium and the ventricle remained unchanged with increasing age. Only measured P-wave amplitudes showed a small but steady decline with older ages. These changes might reflect structural changes in the atrial myocardium which, on the other hand, increase the risk of developing atrial fibrillation. These data are in accordance with an older study showing an inverse correlation of atrial potentials measured with a fixed bipolar lead and patient age.14 Another study about single-lead VDD pacing demonstrated that sensing thresholds decreased and rates of atrial under-sensing increased with increasing patient age.10 Nevertheless, P-wave amplitudes remained overall in a satisfactory range, allowing stable device function.
We found no increase in implantation duration or fluoroscopy times with increasing age. On the contrary, implant durations for single- and dual-chamber devices, as well as fluoroscopy times for dual-chamber devices, were shortest for patients of 90 years or older. In addition, complications with subclavian vein access were lowest in this group, although not statistically significant. The explanation for these findings remains open for discussion. Shorter operation and fluoroscopy times without a deterioration of measured values or a rise in complications are usually attributed to more experienced implanters. So one may speculate that, due to high age and comorbidities, the oldest patients are possibly not operated by the less experienced physicians. This possible selection bias must be kept in mind while interpreting this particular result. Nevertheless, the patient group of 
90 years was small (835 patients) when compared with the next age decade (6069 patients) in which such effects have not been found.
Complications
The data presented here showed no rise in early pacemaker implantation complication rates with increasing patients' age. In addition, no distinct complication increased in elderly patients. There are studies that found a tendency for a higher complication rate in older patients of above 732 or 74 years of age.3 An analysis of the pacemaker selection in the elderly study demonstrated that advanced age and lower weight predicted for pneumothorax,4 while data from the mode selection trial study showed no association between age and complications.5 Another study showed no increase in complication rates in patients above 80 years of age.6 Data from a Dutch registry and a review paper did not find patients' age to be predictive for an increase in complication rates in pacemaker implantation.7,8 In the Danish pacemaker register, no significant relation between age and lead displacement or dysfunction rate was found.9 Another small study found no increase in complication rates in octogenarians for defibrillator implantation as well.15 The results from this large real-life patient cohort demonstrate that elderly patients can undergo primary pacemaker implantation with the same safety and low complication rate as younger patients.
Nevertheless, the overall early complication rate was 5.2%, thus being considerably higher than an early complication rate of 3.0% within the first 3 months in a high-volume single-centre experience.3 In the Danish pacemaker registry, a perioperative complication rate of only 2.8% is reported.16 This may be due to the fact that in Denmark pacemaker implantations are only performed in 14 centres, with 89% of the implanters having done more than 100 implantations. Nevertheless, the Swedish pacemaker registry reports a complication rate of 7.4%, but due to the inclusion of replacement operations these data are not directly comparable with ours.17
Our data are in accordance with previously published data reporting higher complication rates with subclavian vein puncture when compared with a cephalic vein access.7,18,19 With a look at specific early complications, atrial and ventricular lead dislocations are most frequent, followed by haematoma und pneumothorax. Next frequent is asystolie, which seems to be primarily related to the underlying bradycardia. Pericardial effusion, ventricular fibrillation, early device infection, and haematothorax occurred relatively seldom. These data confirm that vascular access and lead placement are the critical determinants of implant complications, independent of patient age. Thus, these skills deserve special attention during implant training.
In our patient cohort, complication rates were higher in dual chamber when compared with single-chamber or single-lead VDD implantations. Although one study showed comparable complication rates for single- and dual-chamber implantations,20 these results are in accordance with the majority of studies reporting identical results.2,3,7,18,21
Limitations
The quality assurance program evaluates only stationary pacemaker implantations. Outpatient procedures are not yet included in the program. Most procedures in Germany are performed as inpatient implantations. The number of ambulatory implants is believed to be steadily increasing, but exact numbers are not yet available. For this reason, the data presented here are subject to a selection bias.
Although the data collection for quality assurance purposes is obligatory, there is no formal audit to validate the data. Nevertheless, the data are linked to the operations and procedures codes and the diagnosis related group classification used for reimbursement. This provides an indirect control of some of the data obtained, e.g. for the number of patients dying in hospital, or for reoperations caused by complications. In cases where quality aims are not met, a ‘structured dialogue’ is initiated, which allows a case by case validation of the documented data. But it has to be assumed that the data are based on a reliable documentation by the physicians.
Concerning the values measured intra-operatively, it has to be acknowledged that the measurements concerning pacing system analysers, or reporting single best or mean values are not standardized. However, the authors believe that the values obtained reflect current clinical practice in a great cohort of patients.
The data collection of the quality assurance ends with the discharge of the patient from hospital. Therefore, late complications that may mainly occur during follow-up, such as infections or lead dislodgements21–23 are not documented in this part of the quality assurance program.
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Conclusions |
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TopAbstractIntroductionMethodsResultsDiscussionConclusionsReferences |
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In this large-scale real-life patient cohort of primary stationary pacemaker implantation increasing age resulted in a small but steady decline in P-wave amplitudes. Implantation and fluoroscopy times for dual-chamber implants tended to shorten with increasing age. Higher age was not associated with an increased risk of complications. Thus, pacemaker implantations in the elderly can be performed with the same reliability as in younger patients.
Conflict of interest: none declared.
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References |
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[1] Hargreaves MR, Doulalas A, Ormerod OJM. Early complications following dual chamber pacemaker implantation: 10-year experience of a regional pacing centre. Eur J Card Pacing Electrophysiol (1995) 5:133–8.
[2] Wiegand UKH, Bode F, Bonnemeier H, Eberhard F, Schlei M, Peters W. Long-term complication rates in ventricular, single lead VDD, and dual chamber pacing. PACE (2003) 26:1961–9.[Medline]
[3] Eberhardt F, Bode F, Bonnemeier H, Boguschewski F, Schlei M, Peters W, et al. Long term complications in single and dual chamber pacing are influenced by surgical experience and patient morbidity. Heart (2005) 91:500–6.
[4] Link MS, Mark Estes NA III, Griffin JJ, Wang PJ, Maloney JD, Kirchhoffer JB, et al. Complications of dual chamber pacemaker implantation in the elderly. J Interv Card Electrophysiol (1998) 2:175–9.[CrossRef][Web of Science][Medline]
[5] Ellenbogen KA, Hellkamp AS, Wilkoff BL, Camunas JL, Love JC, Hadjis TA, et al. Complications arising after implantation of DDD pacemakers: the MOST experience. Am J Cardiol (2003) 92:740–9.[CrossRef][Web of Science][Medline]
[6] Rosenheck S, Geist M, Weiss A, Hasin Y, Weiss TA, Gotsman MS. Permanent cardiac pacing in octogenarians. Am J Geriatr Cardiol (1995) 4:42–7.[Medline]
[7] Eck van JWM, Hemel van NM, Zuithof P, Asseldonk van JPM, Voskuil TLHM, Grobbee DE, et al. Incidence and predictors of in-hospital events after first implantation of pacemakers. Europace (2007) 9:884–9.
[8] Bailey SM, Wilkoff BL. Complications of pacemakers and defibrillators in the elderly. Am J Geriatr Cardiol (2006) 15:102–7.[Web of Science][Medline]
[9] Møller M, Arnsbo P, Asklund M, Christensen PD, Gadsbøll N, Svendsen JH, et al. Quality assessment of pacemaker implantations in Denmark. Europace (2002) 4:107–12.
[10] Wiegand UKH, Potratz J, Bode F, Schneider R, Peters W, Bonnemeier H, et al. Age dependency of sensing performance and AV synchrony in single lead VDD pacing. PACE (2000) 23:863–9.[Medline]
[11] Lemke B, Fischer W, Schulten HK. Richtlinien zur Herzschrittmachertherapie. Indikation, Systemwahl, Nachsorge. Z Kardiol (1996) 85:611–27.[Web of Science]
[12] Lemke B, Nowak B, Pfeiffer D. Leitlinien zur Herzschrittmachertherapie. Z Kardiol (2005) 94:704–20.[CrossRef][Web of Science][Medline]
[13] Roeters van Lennep JE, Zwinderman AH, Roeters van Lennep HWO, van Hemel NM, Schalij MJ, van der Wall EE. No gender differences in pacemaker selection in patients undergoing their first implantation. PACE (2000) 23:1232–8.[Medline]
[14] Brandt J, Attewell R, Fahraeus T, Schüller H. Acute atrial endocardial P wave amplitude and chronic pacemaker sensitivity requirements: relation to patient age and presence of sinus node disease. PACE (1990) 13:417–24.[Medline]
[15] Noseworthy PA, Lashevsky I, Dorian P, Greene M, Cvitkovic S, Newman D. Feasibility of implantable cardioverter defibrillator use in elderly patients: a case series of octogenarians. PACE (2004) 27:373–8.[Medline]
[16] Danish Pacemaker and ICD Register. www.pacemaker.dk/stat2006.pdf.
[17] Swedish Pacemaker Register. Annual Statistical Report (2006) www.pacemakerregistret.se/icdpmr/annualReport/2006/annualReport_2006_PM.pdf.
[18] Chauhan A, Grace AA, Newell SA, Stone DL, Shapiro LM, Schofield PM, et al. Early complications after dual chamber versus single chamber pacemaker implantation. PACE (1994) 17:2012–5.[Medline]
[19] Parsonnet V, Bernstein AD, Lindsay B. Pacemaker-implantation complication rates: an analysis of some contributing factors. J Am Coll Cardiol (1989) 13:917–21.[Abstract]
[20] Aggarwal RK, Connelly DT, Ray SG, Ball J, Charles RG. Early complications of permanent pacemaker implantation: no difference between dual an single chamber system. Br Heart J (1995) 73:571–5.
[21] Kiviniemi MS, Pirnes MA, Eränen HJK, Kettunen RVJ, Hartikainen JEK. Complications related to permanent pacemaker therapy. PACE (1999) 22:711–20.[Medline]
[22] Harcombe AA, Newell SA, Ludman PF, Wistow TE, Sharples LD, Shofield PM, et al. Late complications following permanent pacemaker implantation or elective unit replacement. Heart (1998) 80:240–4.
[23] Massoure PL, Reuters S, Lafitte S, Laborderie J, Bordachard P, Clementy J, et al. Pacemaker endocarditis: clinical features and management of 60 consecutive cases. PACE (2007) 30:12–9.[Medline]
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