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Ann Thorac Surg 1999;68:1380-1383
© 1999 The Society of Thoracic Surgeons
a Division of Pediatric Cardiology, Childrens University Hospital, Zurich, Switzerland
b II Medical Clinic, Johannes Gutenberg University, Mainz, Germany
c Department of Cardiothoracic Surgery, University Hospital, Lund, Sweden
Address reprint requests to Dr Bauersfeld, Division of Pediatric Cardiology, Childrens University Hospital, Steinwiesstr 75, 8032 Zurich Switzerland
e-mail: bauersfe{at}kispi.unizh.ch
| Abstract |
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Methods. Autocapture devices (Pacesetter Microny SR+ and Regency SR+; Pacesetter, Solna, Sweden) and steroid-eluting epicardial pacing leads (Medtronic CapSure Epi 10366; Medtronic, Inc, Minneapolis, MN) were implanted in 14 children. Thresholds, telemetry data, evoked response, and polarization signals were obtained at discharge and follow-up, and battery service life was calculated.
Results. During a median follow-up of 6.5 months, autocapture pacing was applied in 12 of 14 children. The automatically adjusted pulse amplitude of autocapture devices demonstrated low-energy pacing with no significant changes between discharge and 6 months follow-up (1.1 ± 0.3 versus 0.9 ± 0.3 V). Autocapture-programmed pacemakers had calculated life spans of 7.8 ± 1.4 years (Microny) and 21.0 ± 1.6 years (Regency). No adverse effects were noted.
Conclusions. Autocapture-controlled pacing with bipolar epicardial pacing leads is feasible and safe in children. Autocapture programming results in substantial energy savings and extends battery life markedly.
| Introduction |
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| Patients and methods |
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Implantation procedure
Standard implant techniques were used, and surgical access, lead, and pacemaker position are given in Table 1. A pulse generator was replaced with an autocapture device in one patient, with the lead already in place for 4 years. Lead impedance, ventricular pacing, and sensing thresholds were determined intraoperatively to confirm adequate lead positioning. Postoperative care included continuous electrocardiographic monitoring for at least 24 hours in all patients and Holter analysis in 11 ambulatory children.
Data collection
Pacemaker telemetry data, pacing thresholds, R wave, evoked-response signals, and polarization signals were obtained before discharge and at 1, 3, and 6 months postimplant and thereafter at 6-month intervals. Pacemakers were programmed to collect autocapture-determined pacing thresholds continuously to provide trend data at follow-up. Battery service life calculations were performed assuming 100% pacing, stable thresholds, and a mean rate of 100 beats per minute in VVIR pacing mode. A mean heart rate of 100 beats per minute was chosen for analysis as Holter-determined mean heart rates were approximately 100 beats per minute in our investigated patients. Six months follow-up data were also collected from an age-matched control group (mean age, 35 ± 10 months) comprising 11 children who had various VVIR devices attached to the same epicardial lead (Medtronic CapSure Epi 10366). The output voltage of the pulse generators in the control group were programmed with high safety margins to guarantee capture in case of physiologic or nonphysiologic threshold variations.
Statistical analyses
The descriptive statistics are, if not otherwise stated, presented as mean ± standard error of the mean. Appropriate t tests were used to analyze the difference between paired variables. A p value less than 0.05 was considered statistically significant. For statistical analysis, data for up to 6 months follow-up (n = 7) were used although some patients had 18 months of follow-up, for a total observation time of 126 months. Statistical analysis regarding energy consumption between autocapture devices and conventional devices was not done because of the differences in intrinsic current drain in the different models.
| Results |
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| Comment |
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This study evaluated the feasibility of the autocapture principle in combination with an epicardial pacing lead in a series of children. For as long as 18 months of follow-up autocapture pacing could be applied to 12 of 14 study patients. Measured data from autocapture-programmed pacemakers showed stable evoked-response and polarization signals, as well as low pulse energy and battery current values. Although evoked-response signals were similar, battery current values of autocapture-programmed pacemakers were slightly higher in our study compared with those of a multicenter study using transvenous leads in adult patients [14]. However, when compared with an age-matched control group with various conventional VVIR devices connected to the same epicardial lead, the autocapture devices had impressive stimulation energy savings with very low battery current drain. Besides constant low energy consumption for up to 18 months of follow-up, the fact that one lead was implanted for more than 4 years and functioned well indicates that energy consumption remains low for many years. Battery service life calculations showed a markedly prolonged battery life, with some life expectancies beyond 20 years with Regency generators and 9 years with Microny generators, which is about two to four times longer than with conventional output settings. Thus, the energy savings of autocapture enables small generators with reasonable battery life expectancies to be implanted in preterm infants [15]. However, the service life calculations did not account for changes in lead impedance, pacing thresholds, or heart rates and therefore, represent rough estimations of what could theoretically be attainable as maximum battery service life. Assuming a two- to threefold safety margin with conventional output programming, patients with relatively high stimulation thresholds have even more benefit from autocapture than patients with a low stimulation threshold. The maximum autocapture-controlled output is limited to 4.5 V/0.49 ms. High stimulation thresholds therefore preclude the use of autocapture and require conventional output program settings. Inadequate low evoked response and relatively high polarization signals that precluded autocapture programming were detected in only 2 of 14 children. In addition one child had a threshold increase, with desired safety margins beyond the back-up pulse settings, which required conventional reprogramming. However back-up pulses, while still programmed with autocapture settings, prevented loss of capture. This had been the case with conventional settings because of the low stimulation threshold determined at earlier pacemaker follow-up. Autocapture was not beneficial in one child with intermittent complete heart block. While most children were completely pacemaker dependent, no adverse effect of autocapture was seen and no loss of capture was documented or suspected.
In conclusion, autocapture-controlled pacing is feasible in most children with bipolar epicardial pacing leads. Inadequate evoked response and high polarization signals or high pacing thresholds occasionally precluded the activation of autocapture programs. Autocapture programming resulted in substantial energy savings and extended battery service life markedly; therefore, children would require fewer pulse generator replacements. In addition, back-up pulses yield an increase in safety by accounting for varying thresholds resulting from physiologic or nonphysiologic factors. The medium-term results with steroid-eluting bipolar epicardial leads are encouraging, and substantial benefits from the use of the autocapture function can be expected. Although the epicardial approach is sometimes mandatory for anatomic reasons, more extensive use of it in infants without cardiac malformations appears to be feasible to preserve their venous system.
| References |
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