CLINICAL RESEARCH
Europace (2009) 11, 75–79 doi:10.1093/europace/eun293
Pacing and Cardiac Resynchronization Therapy
Effects of increasing age onto procedural parameters in pacemaker implantation: results of an obligatory external quality control program Bernd Nowak1* and Bjo¨rn Misselwitz 2 on behalf of the Expert Committee ‘Pacemaker’, Institute of Quality Assurance Hessen 1 Cardiovascular Center Bethanien (CCB), Im Pruefling 23, D-60389 Frankfurt a.M., Germany; and 2Institute of Quality Assurance Hessen, Frankfurter Str. 10 –14, D-65760 Eschborn, Germany
Received 13 August 2008; accepted 8 October 2008; online publish-ahead-of-print 7 November 2008
Aims
----------------------------------------------------------------------------------------------------------------------------------------------------------Keywords
Pacemaker implantation † Age † Complications † Procedural parameters † Quality control
Introduction 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
* Corresponding author. Tel: þ49 69 9450280; fax: þ49 69 461613. E-mail address:
[email protected] Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2008. For permissions please email:
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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 The database of the obligatory external quality control program was evaluated retrospectively for the years 2003 – and results 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. Pwave 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.
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B. Nowak and B. Misselwitz
pacemaker implantation, evaluating the database of the Institute of Quality Assurance Hessen in the federal state of Hessen, Germany.
Methods
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).
Results 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. 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
Figure 1 Pacing indication according to age groups.
Figure 2 Percentage of dual- and single-chamber implants according to age groups, with a steady decline of dual-chamber devices in the elderly.
is shown in Figure 2. With increasing age, the number of dualchamber devices implanted declines steadily.
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. 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.
Discussion 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.
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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.
Age (years)
