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J Thorac Cardiovasc Surg 1999;117:523-528
© 1999 Mosby, Inc.
SURGERY FOR CONGENITAL HEART DISEASE |
From the Beatrix Children's Hospital, Division of Pediatric Cardiology, and Thoracic Center, University of Groningen, Groningen, The Netherlands.
Received for publication July 7, 1998. Revisions requested Sept 17, 1998; revisions received Oct 9, 1998. Accepted for publication Oct 20, 1998. Address for reprints: Gertie C. M. Beaufort-Krol, MD, Beatrix Children's Hospital, Division of Pediatric Cardiology, Hanzeplein 1, PO Box 30001, 9700 RB Groningen, The Netherlands.
| Abstract |
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| Introduction |
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| Methods |
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Surgical technique
The epicardial leads (mostly bipolar) were inserted by standard surgical techniques either through a lateral thoracotomy, a midline sternotomy, or a subxiphoid approach, whatever seemed appropriate considering heart morphologic condition and/or previous cardiac operation. The bipolar steroid-eluting epicardial leads consist of 2 patches with electrodes (platinized, porous, cathode 6.0 mm2; anode 14.0 mm2). Both electrode ends were fixed on the epicardium with two 6-0 Prolene sutures (Ethicon, Inc, Somerville, NJ) for each electrode. Care was taken to fix the electrode ends in such a way that they could not dislocate. The smaller electrode (cathode) was fixed closest to the sinus node (atrial position) or on the best available site on the ventricle, often on the diaphragmatic site of the right ventricular surface, which is almost always free of epicardial fibrosis after previous cardiac operation. The other electrode (anode) was fixed at least 1 cm from the other electrode, which was sometimes challenging in small babies. The surplus of length is dealt with by making wide loops of the electrode within the pericardium and within the pacemaker pocket. In small babies, it might be necessary to open both rectal sheaths to create a large enough pacemaker pocket. The pacemaker box and redundant electrode were placed behind the rectal muscle. Endocardial leads were inserted through the cephalic (by direct access) or subclavian (by puncture and with a removable sheath) vein. Occasionally an endocardial lead was introduced transmurally by passing the electrode through the wall of the appropriate cardiac chamber, fixing it with a purse-string suture.
Lead function analysis
The acute measurements were performed with a Pacing System Analyzer (PSA 5311; Medtronic, Inc). Stimulation voltage thresholds were measured with a pulse width of 0.5 ms. Sensing thresholds were measured by filtered P and R wave amplitudes. Slew rates and impedances were measured. During follow-up (1 day, 6 weeks, and 3 months after implantation and every 6 months thereafter) the minimum energy threshold in microjoules (1 microjoule = (volts)2 · milliseconds · 1000/
) to standardize the measurements of stimulation thresholds was used.
5 P and R wave amplitudes and impedances were performed at each visit. P wave amplitudes of more than 3.5 mV were noted as 4 mV, and R wave amplitudes of more than 7 mV were noted as 8 mV.
Statistical analysis
Data are expressed as mean ± SD. Log rank test and Kaplan-Meier product-limit estimates of survival curves were used for longevity of leads. Patient deaths were considered as lost to follow-up. To compare patient characteristics, we used the Student t test or a
2 test. To compare pacing and sensing characteristics during the follow-up, we used repeated measurements of analysis of variance, followed by the Student t test for paired values. The analysis was performed with a statistical computer program (NCSS, Kaysville, Utah).
| Results |
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Lead survival
The 2-year survival of the leads was similar between the 2 groups (group I, 91% ± 5%; group II, 86% ± 7%; P = .97; Fig. 1, A). The mean follow-up was 2.9 ± 1.6 years in group I and 3.1 ± 1.7 years in group II (P = .61). The number of lead failures was 4 in both groups (P = .85). All failures occurred in bipolar leads. In group I, 1 lead had to be removed because of a pocket infection, and the other 3 leads had to be removed because of an exit block (1 week, 0.5 year, and 5.75 years after implantation). The exit block 1 week after implantation occurred in a child in whom a previous epicardial screw lead had left numerous scars in the epicardium. In group II, 1 lead had to be removed because of a pocket infection; 2 leads had to be removed because of an exit block (1 and 1.5 years after implantation), and 1 lead had to be removed because of a broken connection between the lead and the header of the pacemaker. When we exclude the 2 pocket infections from the data of the survival analysis, the 2-year survival remains similar between the 2 groups (93% ± 5% vs 87% ± 7%; P = .94). The pacing and sensing characteristics of the mentioned 2 leads in the patients with a pocket infection were not incorporated in the long-term measurements.
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The acute stimulation voltage thresholds were higher in group I than in group II (1.2 ± 0.5 V vs 0.7 ± 0.2 V; P = .02). Both the minimum energy thresholds of the ventricular leads (1.2 ± 1.3 mJ vs 0.7 ± 0.4 mJ; P = .17) and the slew rates (1.8 ± 1.1 V/s vs 1.2 ± 0.6 V/s; P = .12) of the ventricular leads were similar.
Chronic
There was an increase in stimulation thresholds of all leads in both groups in the early postoperative period. This was less for the steroid-eluting epicardial leads. Later during follow-up, there was no difference in stimulation thresholds between the two groups (Fig. 1
, B). During follow-up the stimulation thresholds did not increase in either group.
Sensing characteristics
Acute
The sensed P wave amplitudes were lower in group I than in group II (2.3 ± 1.6 mV vs 3.6 ± 0.9 mV; P = .02). The sensed R wave amplitudes were similar in the two groups (13.1 ± 7.8 mV vs 12.1 ± 3.3 mV; P = .44).
Chronic
During follow-up there was no statistically significant difference in sensing thresholds of P and R waves between the 2 groups (Fig. 1
, C). After an initial artificial decrease, caused by the difference in the technique of measurement, the sensing threshold of the R wave remained similar in the two groups. All sensing problems, detected during 24-hour ambulatory monitoring in both groups, could be solved by changing the pacemaker sensitivity settings.
Impedances
Acute
Atrial impedances tended to be higher in group I (723 ± 227
vs 609 ± 122
; P = .07). Ventricular impedances were higher in group I (993 ± 333
vs 507 ± 157
; P = .0004).
Chronic
Atrial impedances were lower in group I than in group II (Fig. 1
, D). There was no difference in ventricular impedances between the two groups during follow-up. All measured values of impedances were within the normal range.
| Discussion |
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Choice of pacing lead at implantation
Although for some children the choice of pacing leads is limited to epicardial leads (eg, after an operation such as a total cavopulmonary connection), for most children the choice of pacing leads can be in favor of either an epicardial or an endocardial lead. The choice of pacing lead was based primarily on the age of the child; young children received an epicardial lead, whereas older children received an endocardial lead. However, because the results of endocardial leads were better than those of nonsteroideluting epicardial leads,
1,2 there is a tendency to implant endocardial leads at a younger age. The results of our study show that steroid-eluting epicardial leads are as good as endocardial leads. Therefore the choice of the pacing lead will be determined mainly by the advantages and disadvantages of either implantation technique. Advantages of epicardial leads are the applicability in every child, the possibility to combine the implantation of the leads with a corrective or palliative operation, fewer problems with the growth of the child, and the absence of the need for anticoagulation in children with a right-to-left shunt. Disadvantages of epicardial leads are the more extensive surgical procedure and the damage to the epicardial wall, which may result in difficulty in finding epicardium without scars for implantation of another epicardial lead. An advantage of endocardial leads is the less extensive surgical procedure. Disadvantages of endocardial leads are the small size of the veins, the risk of venous obstruction,
15 and the need for the accommodation of the lead to the child's growth.
Choice of pacing lead for the future
The advantages and disadvantages relate to the period of implantation of the leads. Although the results of transvenous endocardial pacing in young infants are encouraging,
16,17 we also have to consider the consequences of the choice of the lead for the future. Particularly in young children who will need pacing for the whole of their lives, it can be expected that multiple subsequent leads will be required. Although the methods for extraction of pacing leads are improving,
18 serious complications of the extraction procedure have been described, and sometimes a heart operation is required.
19 When lead extraction fails, a situation with multiple leads in 1 vein in a child, who was in need of pacing from birth, may occur. Multiple leads in the same vein may result in several complications, such as an increased risk of venous obstruction
15 and an inability of the surgeon to insert new additional leads, when necessary. Because our study shows that steroid-eluting epicardial leads are a good alternative to endocardial leads, it would perhaps be reasonable to pace children epicardially as long as possible and save their veins for a period later during lifetime.
Study limitations
A limitation of this study is the relatively short follow-up time. However, this also applies for the studies with endocardial leads in young infants.
16,17 A disadvantage of the steroid-eluting epicardial leads in this study was the lower impedances of the atrial leads during follow-up, which means that more energy may be required for pacing, which could limit the longevity of the pacemaker unit. The follow-up time in our study was too short to evaluate the longevity of the pacemaker unit. Perhaps new designs of the steroid-eluting epicardial leads with smaller surfaces of the electrodes may improve impedance values in children, because animal studies have shown that the impedances of these leads remained high during a follow-up of 6 months.
8 Further longitudinal studies are needed to compare steroid-eluting epicardial leads with endocardial leads in young infants to answer the question of which pacing lead implanted in infancy will have a reduced complication rate during adulthood. In addition, it can be worthwhile to investigate whether the use of steroid-eluting endocardial pacing leads in children may improve the results of endocardial pacing further.
| Conclusions |
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| Acknowledgments |
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| References |
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