Europace Advance Access originally published online on January 16, 2007
Europace 2007 9(2):94-97; doi:10.1093/europace/eul172
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SYNCOPE
Medium-term follow-up and modes of failure following epicardial pacemaker implantation in young children
1 Department of Thoracic and Cardiovascular Surgery of Johann Wolfgang Goethe University Hospital, Theodor-Stern-Kai 7, 60596 Frankfurt/Main, Germany; 2 Department of Pediatric Cardiology Johann Wolfgang Goethe University Hospital, Frankfurt am Main, Germany
Manuscript submitted 24 November 2005. Accepted after revision 10 November 2006.
* Corresponding author. Tel: +49 69 6301 6527; fax: +49 69 6301 83279. E-mail address: farhad{at}bakhtiary.de
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Abstract |
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Aims Young children suffering from congenital or post-operative AV-block require life-long pacemaker stimulation. Due to the anatomical prerequisites initially epicardial electrodes are implanted and the generator is placed in the upper abdominal wall. The following study investigated modes of failure leading to reoperation in this group of technically challenging patients.
Methods and results Between October 2000 and May 2005, a total of 21 infants (age 3 days to 5 years) underwent pacemaker implantation using a subxyphoidal incision for newborns (and a partial lower or complete median sternotomy for older children). Nine patients had previous cardiac surgery for complex congenital defects. The remaining 12 young children suffered from congenital AV-Block (CAVB). Twenty-one bipolar epicardial electrodes (Medtronic Capsure® epi) were fixed to the right ventricle, 15 had additional implantation of a bipolar atrial lead. The pacemaker generator (Medtronic Kappa® 701) was implanted into the right upper abdominal wall. Indications for revision were recorded. No mortality was observed; pacing and sensing parameters remained stable up to a 5-year follow-up. A total of four reoperations occurred. Three of the four revisions were caused by ventricular electrode fracture. At revision, two electrodes were broken at the crossing between the pericardial cavity and the abdominal wall, one bipolar lead at the Y-division into the two tip electrodes. One reoperation was due to a pacemaker recall. All revisions were performed without complications.
Conclusion In our institute epicardial pacing in young children was associated with a satisfactory clinical outcome, but also a significant number of failures leading to reoperation, mainly due to electrode fracture caused by the muscular activity of this patient group. Reoperations were performed at a low risk.
Key Words: Pacemakers, Infants, Epicardial leads
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Introduction |
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Implantation of mainly single chamber pacemakers in the paediatric population has been performed since the late 1960s.1
Since then, this challenging field of pacing experienced a significant improvement.2–4 Despite all these improvements, pacemaker implantation in paediatric patients, especially in small infants, remains a technically challenging procedure particularly when epicardial leads are implanted. In the past fixation of epicardial electrodes was associated with a significant failure rate due to deterioration of pacing and sensing parameters during medium- and long-term follow-up.5 Recent advances in epicardial pacing lead technology, especially steroid elution and bipolar configuration of tip electrodes, have narrowed the gap between epicardial and endocardial leads in terms of chronic pacing thresholds and sensing characteristics.6
As more infants with complex congenital cardiac defects are being successfully treated with surgical repair, the population of small infants requiring permanent pacing is likely to increase in the near future.1 Especially, in these children with severely impaired ventricular function optimal haemodynamic outcome is mandatory, therefore atrioventricular (AV)-synchronized pacing using dual-chamber pacemakers should be performed whenever possible.
The present study investigates prospectively the clinical outcome and modes of failure leading to reoperation in our group of young children undergoing epicardial pacemaker implantation. Additionally, our medium-term results of modern single- and dual-chamber pacemakers and bipolar, steroid-eluting epicardial leads are reported.
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Methods |
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Between October 2000 and May 2002, a total of 21 young children underwent pacemaker implantation (Table 1). Patient ages ranged from 3 days to 5 years (mean, 2.5 years and median, 225 days). Nine had previous cardiac surgery for tetralogy of Fallot (n = 4) or other complex defects (univentricular heart in three patients and AV-canal in two patients) followed by complete AV-block; the remaining 12 children suffered from Congenital AV Block (CAVB) (Table 2).
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The surgical technique consisted of a subxyphoidal incision or partial lower sternotomy for infants with CAVB and a complete median sternotomy for the reoperations after previous cardiac surgery. The free and inferior walls of the right ventricle were exposed and the first epicardial electrode was fixed to that ventricle. In all 21 patients a bipolar, steroid eluting electrode was used (Medtronic Capsure® epi 4968, Medtronic Inc., Minneapolis, MN, USA). One arm of the electrode was sutured to the inferior and the other to the free wall using three Prolene 6/0 sutures for each electrode arm (two for the preformed electrode holes and one to fix the electrode's base to ensure good contact with the epicardium). Having achieved satisfactory results for sensing and pacing parameters, in 15 patients the right atrium was exposed and the second epicardial electrode (bipolar, steroid eluting Medtronic Capsure® epi 4968, Medtronic Inc.), was placed at the lateral wall with a maximum distance between the two arms of the electrode. Both electrodes were fixed to the diaphragmatic pericardium to prevent dislocation leaving a loop inside the pericardium for patient growth. In six patients with CAVB only single-chamber pacemakers were implanted, as the atrium could not be exposed from a subxyphoidal incision and the parents had refused a larger incision. The leads were then connected to the single- or dual-chamber pacemaker generator. In 20 children Medtronic Kappa 700/900 pacemakers were used, one very small infant received the very thin Ela Medical Talent DR (Ela Medical, Le Flessis, Robinson, France). The generators were implanted into the right upper abdominal wall below the mobilized rectus abdominis muscle and fixed by an additional suture. Leads were placed below the pacemaker crescent-shaped.
All children were referred to the paediatric intensive care unit until weaning from artificial ventilation and then to the normal ward for the remaining post-operative in-hospital period. A first follow-up examination was performed 6 weeks post-operatively with follow-up visits every 6 months. The follow-up examination included history, a complete physical examination, and pacemaker telemetry (pacing threshold, sensing values, impedance, and event recorder). Each change in programming was documented. Follow-up was 100%.
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Results |
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Surgical outcome
Operation time was 67 ± 32 min (45 ± 23 for the subxyphoidal approaches or partial lower sternotomies and 91 ± 39 for the complete sternotomies in reoperations, Table 2).
Early mortality was 0% and none of the children died during the follow-up period. Weaning from artificial ventilation was achieved 3.4 ± 2.5 h post-operatively in the CAVB patients and 34 ± 26 h in the redo-cases (after previous heart surgery procedures) depending on the underlying disease. In 15 patients, we were able to implant successfully a dual chamber pacemaker. In the other six infants, single-chamber generators were used via a subxyphoidal approach. Inotropic support had to be administered in four of the redo-patients prior to pacemaker implantation; in these children VVI pacing was present due to loss of capture of the implanted temporary atrial pacing electrodes. Following pacemaker implantation, the inotropic medication was reduced and discontinued following AV-resynchronization. The later post-operative course was uneventful in all young children; blood loss through the pericardial drain was negligible. All patients were discharged from hospital after a mean stay of 9.8 ± 4.5 days (3.5 ± 2.3 days for the CAVB patients) ranging from 3 to 21 days.
Pacing results
The intraoperative measurement of a total of 36 epicardial leads revealed satisfactory data (Tables 3 and 4), only in two cases a second fixation of the ventricular electrode was required to achieve a satisfactory R-wave. No intraoperative complication occurred, especially no bleeding was observed during epicardial lead fixation.
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The follow-up period was a maximum of 61 months with a mean follow-up time of 41.2 months. Figure 1A and B shows the course of pacing thresholds and sensing parameters for both leads during the medium-term follow-up. One year post-operatively the programmed output was still low (mean 2.5 ± 0.5 V for the ventricular and mean 2.5 ± 1.0 V for the atrial electrode). All of the young children, in whom a DDD-pacemaker was implanted, maintained dual-chamber pacing.
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In all children sinus node function remained normal, so 97% of beats were atrial sensing and ventricular pacing, only in 3% atrial and ventricular pacing were observed by the pacemaker (telemetric data).
A total of four reoperations occurred during the follow-up period (maximum of 5 years), Three of the four revisions were caused by ventricular electrode fracture (all intrapericardial, none in the pacemaker pocket). At revision, two electrodes were broken at the crossing between thorax and the abdominal wall, one bipolar lead at the division into the two tip electrodes (Figure 2A and B). Lead fracture was not seen at the pericardial fixation suture, but at the diaphragm. One reoperation was due to a pacemaker recall (Medtronic Kappa in an abdominal position). All revisions were performed by electrode or pacemaker change without complications. Pacing and sensing parameters of the revised electrodes remained stable during medium-term follow-up.
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Discussion |
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Our results only using bipolar steroid-eluting epicardial electrodes demonstrated superior medium-term results compared with earlier reports,6
,7 with maintenance of DDD pacing in 100% over 1 year in patients where this mode was intended. Pacing and sensing parameters of bipolar electrodes remained stable. The success rate was reached with a total of four reoperations, three of them due to electrode problems.8
For a permanently optimal haemodynamic outcome, immediate AV-resynchronization and maintenance of dual-chamber pacing during follow-up is required.9 The major limitation of dual-chamber pacing in small infants has been mostly due to the design and placement technique of epicardial electrodes.8 Unfortunately, the rather small number of implantations in children compared with the adult population has not promoted inventions for a long period of time. Recently new steroid-eluting screw-in and bipolar electrodes have been designed, as left ventricular epicardial pacing has become popular in cardiac resynchronization therapy.10
Pacemaker implantation is associated with an increased risk of revision.8,9,11–13 The major cause for reoperation in our series was lead fracture. The predominant place for this electrode complication was the crossing between the pericardial cavity and the abdominal wall. The diaphragm works as a hinge point during the intensive muscular activity of young infants.
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Summary |
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In summary, the results of the present study showed that, despite the overall good clinical outcome, epicardial pacing in young children was associated with a significant number of failures leading to reoperation, mainly due to electrode fracture caused by the muscular activity of this patient group.
To avoid this complication, the electrodes should be cushioned with tissue at this point if possible. Fixation to the pericardium to prevent dislocation should be avoided, in recent cases we created a crescent-shaped course of the electrodes and have not since seen lead fracture at this point. An alternative approach could be placement of an additional electrode that can be used later in case of lead fracture. Reoperations were performed at a low risk. Also dual chamber pacemaker implantation was feasible even in newborn and very small infants with a low perioperative complication rate.
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Footnotes |
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Presented at Venice arrhythmias 2005, Venice, 2–5 October. 
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References |
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[1] Cohen MI, Rhodes LA, Spray TL, Gaynor JW. Efficacy of prophylactic epicardial pacing leads in children and young adults. Ann Thorac Surg 2004; 78: 197–203.
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[6] Cutler NG, Karpawich PP, Cavitt D, Hakimi M, Walters HL. Steroid-eluting epicardial pacing electrodes: six year experience of pacing thresholds in a growing pediatric population. Pacing Clin Electrophysiol 1997; 20: 2943–8.[CrossRef][Medline]
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[11] Villein E, Martelli H, Bonnet D, Iserin L, Butera G, Kachaner J. Characteristics and results of epicardial pacing in neonates and infants. Pacing Clin Electrophysiol 2000; 23: 2052–6.[CrossRef][Medline]
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[13] Fortescue EB, Beruld CI, Cecchin F, Walsh EP, Triedman JK, Alexander ME. Comparison of modern steroid-eluting epicardial and thin transvenous pacemaker leads in pediatric and congenital heart disease patients. J Interv Card Electrophysiol 2005; 14: 27–36.[CrossRef][Web of Science][Medline]
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