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a Department of Pediatric Cardiac Surgery, RWTH Aachen University, Aachen, Germany
b Department of Dermatology, RWTH Aachen University, Aachen, Germany
c Department of Pediatric Cardiology, RWTH Aachen University, Aachen, Germany
Accepted for publication August 12, 2008.
* Address correspondence to Dr Oprea, University Hospital Aachen, Pauwelsstr. 30, Aachen, D-52074, Germany (Email: moprea{at}ukaachen.de).
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Introduction |
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A 12-year-old girl with a history of congenital heart disease consisting of pulmonary atresia with intact ventricular septum, atrial septal defect, and severe tricuspid valve insufficiency had undergone neonatal biventricular repair. At the age of 2.5 years the tricuspid valve was replaced by a mechanical prosthesis (St. Jude Medical, St. Paul, MN), and the right ventricular outflow tract was re-reconstructed with a pulmonary homograft. This procedure resulted in complete atrioventricular block, and an epicardial pacemaker system consisting of a PIKOS 01 generator (Biotronik Co, Berlin, Germany) with a 4951M ventricular epicardial lead (Medtronic Inc, Minneapolis, MN) was implanted and placed in the right upper abdominal quadrant.
Uncommonly, 4 months later the battery had already reached end-of-life. The entire pacing system was replaced again by an ACTROS DR generator (Biotronik) using two ventricular epicardial leads (Medtronic 4965-35 and Biotronik ELC 35-UP). The next generator exchange was deemed necessary at the age of 8 years.
After 17 months of uneventful clinical course, an erythema appeared related to the pacemaker pocket. It was successfully managed with local cooling and applications of acrinol dressings.
At the age of 11 years, the patient underwent another reconstruction of the right ventricular outflow tract using a mechanical prosthesis. Simultaneously, an atrial electrode (Medtronic 4968–35) was placed epicardially and the generator was exchanged (Biotronik CYLOS DR-T).
During the postoperative course, the abdominal pacemaker pocket wound ceased to heal. In assumption of possible infection, although swamp and other clinical or laboratory markers of infection were negative, the pacemaker pocket site was changed to the contralateral abdominal side. After 2 weeks a phlegmona-like lesion appeared in the area of the former pacemaker pocket, which was successfully treated conservatively. At this time an allergic reaction was suspected, but results of standard patch testings, including sensitivity to silicone, were negative.
The patient presented again 7 months later with localized redness, pain, and a fluctuant nontender subcutaneous vesicle, measuring 13 x 13 cm, with a skin fistula that developed in the vicinity of the new pacemaker pocket site. At the surgical exploration, the pacemaker pocket cavity was filled with whitish gelatinous material completely surrounding the generator. The pocket was débrided and the pacemaker was repositioned due to lack of other reasonable options at that time. Again, no evidence for infection was found.
The histologic examination was indicative for foreign body reaction. The manufacturers of the generators and leads provided complete skin patch test kits. After 24 to 48 hours they turned slightly positive to all silicone-containing components.
As expected, the patient presented again within 2 months showing identical local manifestations. Meanwhile, a custom-made pacemaker with a silicone-free connector block (Medtronic generator E2DR31 ENPULS) was ordered, and silicone-free leads (Medtronic 904169) were selected. The adapter caps on the generator header in this pacemaker were coated with polyurethane. The newly developed transvenous screw-in leads were coated with polyurethane as well.
The pacemaker system was completely removed and temporarily replaced by an epicardial external pacing device. The new pacemaker system was implanted using transvenous screw-in leads for epicardial pacing. Because there was a thick layer of adhesions, the cardiac muscle was exposed using sharp dissection. Next, the electrodes were screwed deeply into the myocardial tissue to obtain optimal contact (Fig 1). A new pacemaker pocket was created under the left pectoralis muscle, similar to a pocket for the transvenous route, to have a reasonable distance to the previous pacemaker pocket. Consequently, the leads were guided through the third intercostal space. After 10 months of follow-up, the patient's clinical course was uneventful.
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Comment |
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The presented case is of interest regarding the clinical course as well as the final treatment. The most common cause of skin reaction to a pacemaker is infection [1–8]. Thus in the presence of a typical local wound, an infection is the most likely assumption. However, one may suspect a different cause in the absence of fever, leucocytosis, and positive bacterial cultures. In addition, if the histologic examination shows extensive foreign body reaction, contact allergy may be most likely.
Although the results of standard skin patch tests for metals, polyurethane, polychloroparaxylene, epoxy, and silicone as well were negative at first, suspicion of allergic reaction remained. Obviously, it is important to obtain patch test results for all specific components and track the exact manufacturing lot of the pacing system to do an accurate skin testing. Thus, a basic negative skin testing does not necessarily eliminate contact allergy as a diagnosis [5, 8].
An allergic reaction to a pacemaker may occur within different intervals of time and manifest under various clinical aspects. Battery emptying a short time after implantation is presumed to be caused by fluid creating excessive current drain on the power source [3]. Circumscriptive erythema accompanied or not by pain, pruritus, or fluctuating swelling in the area of the pacemaker pocket may also be a form of appearance.
This case demonstrates that it is important to consider contact allergy as unusual cause of repetitive pacemaker wound complications. Furthermore, a specific, manufacturer-based skin test may be required to discover a reaction to a specific system component—a basic skin test may not be sufficient alone. Finally, it is important to keep in mind that customized pacemaker components are available and new surgical means may solve the problems.
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This article has been cited by other articles:
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  A. Kolodzinska, A. Kutarski, L. Koperski, M. Grabowski, B. Malecka, and G. Opolski Differences in encapsulating lead tissue in patients who underwent transvenous lead removal Europace, January 13, 2012; (2012) eur384v1. [Abstract] [Full Text] [PDF]
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