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Interact CardioVasc Thorac Surg 2008;7:275-277. doi:10.1510/icvts.2007.169714 © 2008 European Association of Cardio-Thoracic Surgery
Entirely polytetrafluoroethylene coating for pacemaker system contact dermatitisDepartment of Cardiothoracic Surgery, Nagoya University Hospital, P.O. Box 466-0065, 65 Tsurumai-cho, Syouwa, Nagoya, Aichi, Japan Received 9 October 2007; received in revised form 19 November 2007; accepted 20 November 2007
*Corresponding author. Tel.: +81 052 744 2375; fax: +81 052 744 2383.
A 63-year-old man underwent pacemaker implantation for complete atrio-ventricular block. The patient repeated admissions for skin necrosis, and generator or pacemaker system was re-implanted each time. The patient was admitted with skin necrosis of the generator pocket three years after re-implantation. A skin patch test was positive on almost all components of the pacemaker system. The patient underwent pacemaker system removal and re-implantation of polytetrafluoroethylene (PTFE) sheets coating pericardium leads and generator. There has been no recurrence. PTFE sheet coating is effective to treat pacemaker system contact dermatitis.
Key Words: Pacemaker system; Skin patch test; Polytetrafluoroethylene
Pacemaker system contact dermatitis is a rare complication. The diagnosis is difficult, and it often takes a long time to confirm it. A skin patch test is important for diagnosis. Management of contact dermatitis is difficult. We report a patient who developed skin necrosis around the pacemaker implantation site, and whose skin patch test was positive on almost all components of the pacemaker system. He was successfully treated by entirely coating the pacemaker system with PTFE sheets.
A 63-year-old man with complete atrio-ventricular block received a VVI pacemaker (Medtronic) with a pericardial lead in 1978. A generator was replaced in 1983 because of battery exhaustion. Soon after the operation, re-replacement of a new generator (Medtronic) was performed due to skin necrosis of the pacemaker pocket. A DDD pacemaker with trans-venous leads was implanted in the left chest wall for system exchange in August 1989, when the ventricular lead was accidentally inserted into the left ventricular via the atrial septal. The system was unknown. A generator (Medtronic) was replaced for battery exhaustion in September 1998. Six months later, localized redness of the skin developed above the generator site. In August 1999, since the pocket was infected, replacement of a new generator (Pacesetter, Trilogy DR+ 2360L) was performed under the left major pectoral muscle. The patient presented with a local swelling – redness around the incision of the left chest wall in December 2003. A new pacemaker system (Medtronic, Kappa KDR 721) was implanted under the right major pectoral muscle and the leads were coated with 0.2 mm thick PTFE sheets (Gore-Tex Surgical Membrane, W.L. Gore and Assoc, Flagstaff, AZ) to prevent injury at the next operation. And that time, the old system on the left chest wall was removed. Three years later, the patient developed skin necrosis of the generator pocket on the right lateral side. The patient had no fever, and laboratory data showed no sign of infection. We suspected pacemaker system contact dermatitis, so we recommended removal of all pacemaker systems and new pacemaker system implantation under general anesthesia. But the patient rejected an invasive operation, so that he underwent only a translocation of the generator into another new pocket under the right major pectoral muscle in local anesthesia. Two months later, the patient was re-admitted for swelling of the skin incision at the new pocket. Although the patient had no fever, pocket fluctuation was recognized. Blood white cell count was 5600 µl and the fractions were normal. C-reactive protein (CRP) was low (0.03 mg/dl). The blood and tissue culture were negative, but IgE was increased (461 IU/ml). Skin patch tests were performed and revealed positive reaction to almost all components of the pacemaker system; polyurethane (80A, 75D), silicone rubber (MDX-70, Med4719), polysulfone (amber, beige), barium sulfate filled (Table 1).
Finally, the patient underwent removal of the old pacemaker system and re-implantation of a new pacemaker system (Intermedics, NEXUS I Plus) entirely coated with 0.2 mm thick PTFE sheets (Gore-Tex Surgical Membrane, W.L. Gore and Assoc, Flagstaff, AZ) under cardiopulmonary bypass via a median sternotomy. Intraoperative finding was that only below the swelling site of right chest, the old leads were not coated with PTFE sheets. Pericardial leads were placed on the right atrial appendage and anterolateral wall of left ventricular. The new generator was implanted under the right muscus rectus abdominis (Fig. 1). Except for tip and ring electrode, all of the pacemaker system was coated with 0.2 mm thick PTFE sheets, using silicone adhesive. After a 6-month follow-up, there is no recurrence of contact dermatitis.
Raque and Goldschmidt [1] reported pacemaker contact dermatitis in 1970. Since then various reports were described [2, 3]. Reported allergens are titanium [4], nickel, mercury, epoxy resin [5], polyurethane, cadmium, chromat, cobalt, silicone [1], polychloroparaxylene (parylene), and so on. Titanium and nickel are the most often reported as allergens of pacemaker system contact dermatitis. Skin patch test showed no reaction to titanium in this patient. But Jean-Pierre Déry and colleagues [6] stated that titanium testing is thought to be unreliable because this test is performed using titanium tetrachloride, which must be highly diluted with water and quickly hydrolyzed to insoluble titanium dioxide. Therefore, it was undeniable that titanium was also an allergen in this patient because the generator had been exposed before. Some of the case reports noted that the skin patch test was negative about pacemaker system contact dermatitis. It is important that a negative reaction does not deny pacemaker system contact dermatitis. Additionally, corticosteroid use can result in a false negative reaction. Treatments of contact dermatitis were described in various case reports. Rikke Skoet and colleagues [5] stated that topical corticosteroid can reduce skin symptoms (erythema, plaques, vesicles, swelling), but recurrence is common. The only complete treatment is removal of all the allergens. In most cases, symptoms of arrhythmia cannot compromise the state of non-existence of pacemaker. So that it is recommended that pacemaker system is coated with non-allergenic materials. Recently, it has been reported that 0.2 mm thick PTFE sheet coating is an effective method in Japan. In those reports, there were no recurrences during follow-up. But it still has possibilities that PTFE allergy exists. Importantly dermatitis can occur after months or years post-implantation. The mechanism of this disease is considered a delayed-type hypersensitivity (type III or/and IV) reaction. Cautious long-term follow-up is necessary.
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Abstract
1. Introduction
