328 CASE REPORT VODISKAR ET AL
CONTACT ALLERGY TO SILICONE
Polytetrafluoroethylene-Coated
Pacemaker Leads as Surgical
Management of Contact Allergy
to Silicone
Janez Vodiskar, MD, Heike Schn€
oring, MD,
J€
org S. Sachweh, MD, Eberhard M€uhler, MD, and
Jaime F. Vazquez-Jimenez, MD
Departments of Pediatric Cardiac Surgery and Pediatric
Cardiology, Rheinisch-Westfaelische Technische Hochschule
Aachen University, Aachen, Germany
We have previously reported an 18-year-old girl with a
congenital heart defect who developed complete heart
block after one of her corrective surgeries and who
needed an epicardial pacemaker implantation. She
developed contact sensitivity to silicone compounds.
The problem was solved by implanting a silicone-free
FEATURE ARTICLES
pacemaker system utilizing silicone-free transvenous
leads. The patient was readmitted 2 years later due to
lead failure. As no silicone-free epicardial leads were
available, we decided to use standard silicone epicar-
dial leads and enclose the whole system in Gore-Tex
material (W.L. Gore & Associates, Flagstaff, AZ).
Based on our experience we would discourage the
use of silicone-free transvenous pacing leads for
epicardial use.
(Ann Thorac Surg 2014;97:328–9)
Ó 2014 by The Society of Thoracic Surgeons
C ontact sensitivity to various pacemaker compounds
has been reported by different authors [1–6]. Sili-
cone is often used to cover devices containing materials
proven to be allergenic, such as titanium, poly-
chloroparaxylene (parylene), or polyurethanes [3, 5]. We
have previously reported the history of a patient with a
complex heart defect, which developed complete heart
block after one of her corrective surgeries and thus
she needed a pacemaker implantation [1]. After a
problematic wound healing process it was established
that the patient is sensitive to silicone compounds. The
problem was than solved with the implantation of a
silicone-free pacemaker system using newly developed
silicone-free transvenous electrodes for epicardial
stimulation.
An almost 18-year-old girl was born with pulmonary
atresia with intact ventricular septum, atrial septal defect,
Accepted for publication April 29, 2013.
Address correspondence to Dr Vodiskar, Department of Pediatric Cardiac
Surgery, RWTH Aachen University, Pauwelsstr 30, Aachen, D-52074,
Germany; e-mail: jvodiskar@ukaachen.de.
Ó 2014 by The Society of Thoracic Surgeons
Published by Elsevier Inc
Ann Thorac Surg
2014;97:328–9
and a severe tricuspid valve insufficiency. After neonatal
biventricular repair the tricuspid valve had to be replaced
by a mechanical prosthesis (St. Jude Medical, St. Paul,
MN) and the right ventricular outflow tract was recon-
structed with a pulmonary homograft 2 1/2 years later.
After right ventricular outflow tract reconstruction she
developed complete atrioventricular block. Therefore, an
epicardial pacemaker system was implanted with right
upper abdominal quadrant generator placement (PICOS 01;
Biotronik Co, Berlin, Germany) and 4351M ventricular
epicardial lead (Medtronic Inc, Minneapolis, MN).
At the age of 11 years she underwent another recon-
struction of the right ventricular outflow tract using a
mechanical prosthesis. At the same time an epicardial
atrial electrode was placed and the pacemaker system
changed to a DDD system (Biotronik CYLOS DR-T;
Medtronic 4986-35 atrial lead). During the postoperative
course the abdominal pacemaker pocket ceased to heal.
In the following year she underwent multiple site-
pacing system replacements due to local healing prob-
lems. After establishing the allergic reaction to silicone
compounds the wound healing problem was solved by
removing the complete pacemaker system and replacing
it with a silicone-free system (Medtronic generator
E2DR31 ENPLUS). The electrodes used were newly
developed transvenous screw-in polyurethane leads
(Medtronic 904169). The electrodes were screwed deeply
into myocardial tissue and used for epicardial pacing.
In March 2010 she was admitted for a routine tooth
extraction. The pre-procedure electrocardiogram showed
dysfunction of the ventricular lead. An elevation of pacing
threshold to 7 volts, with stabile impendence and no signs
of a lead fracture were observed. The decision was made
to replace the ventricular lead and the generator with new
silicone-free transvenous lead and generator (Medtronic
ADAPTAL ADDR1PX generator and Medtronic 904169
lead). At discharge the new system showed good pace-
maker function with appropriate pacing and sensing
parameters.
In 2 months time she presented again with signs of
vertigo and palpitations. Clinically she was hemody-
namically stabile, with a heart frequency of 45 to 60 beats
per minute. Pacemaker parameters again showed a rise in
ventricular lead threshold. A probative therapy with
prednisolone was started. In the next few days we
observed a further rise of stimulation threshold which
evolved just before surgery into a complete exit block.
Taking into account that the previously implanted leads
were originally developed for transvenous application
and no availability of silicone-free epicardial leads,
another method for preventing allergic reaction was
sought. Thus, the following procedure was chosen. The
silicone-free transvenous electrodes were exchanged for
widely used silicone-coated bipolar steroid eluting
epicardial ventricular and atrial leads (Ventricle Med-
tronic Model 4968 and Atrium Medtronic Model 4986). To
minimize the tissue to pacemaker system contact both
atrial and ventricular electrodes were enclosed in a
Y-shaped, tubular 5-and 6-mm Gore-Tex prosthesis
(Fig 1). The generator was completely covered by a
0003-4975/$36.00
http://dx.doi.org/10.1016/j.athoracsur.2013.04.135
Ann Thorac Surg
2014;97:329–32
Fig 1. Atrial and ventricular electrodes enclosed in a Y-shaped,
tubular 5- and 6-mm Gore-Tex prosthesis.
Gore-Tex sheath. At the site of contact of the leads with
epicardium, the prosthesis was sewn over the lead heads
to the epicardium (Fig 2).
Postoperatively the patient recovered fully and the
operative wounds showed good healing without any
sings of infection or allergic reaction. Pacemaker param-
eters at discharge showed a pacing threshold of 1.2 V and
0.7 V at 0.5 ms for the atrium and ventricle, respectively;
impedance was stable at 1,498 Ohm.
At last follow-up at the end of October 2012 the patient
is doing well; postoperative wounds are fully healed and
had, since the last operation, shown no allergic reaction.
The pacemaker parameters were stable with lead pacing
thresholds of 0.5 V and 1.6 V at 0.4 ms for the atrium and
ventricle, respectively. Impedance on both electrodes is
stable and in the range of 600 Ohms.
Comment
Silicone compounds used to cover pacemaker system
components are a rare cause of wound healing problems
after pacemaker implantation [4]. It has already been
demonstrated that it is important to consider contact
allergy as an unusual cause of repetitive pacemaker
wound complications and manufacturer-based skin tests
may be required to discover a reaction to a specific system
component [1, 5].
We have proposed solving the problem of silicone-
contact allergy by implanting a silicone-free pacemaker
system [1]. Unfortunately, the only available silicone-free
leads at the time were leads made for transvenous
application. Our initial experience with these leads was
favorable and their application for epicardial pacing
seemed not to influence their function. We have observed
the failure of these leads after 2 years and the second time
Fig 2. At the site of contact of the leads with epicardium, the pros-
thesis is sewn over the lead heads to the epicardium.
Ó 2014 by The Society of Thoracic Surgeons
Published by Elsevier Inc
CASE REPORT IRIE ET AL 329
SPONTANEOUS WHOLE-LUNG TORSION
after 2 months. There were no signs of lead fracture and by
explantation a tissue reaction at the site of contact between
electrode head and myocardium was observed, which
could be the cause of the exit block we have described.
At the time of pacemaker system replacement there
were no silicone-free epicardial electrodes available, thus
we decided to use conventional epicardial electrodes and
prevent an allergy reaction by enclosing the whole system
in to Gote-Tex material, as previously described by Iguchi
et al [6]. After 2 years of follow-up we have observed no
allergic manifestations or pacemaker system or lead
dysfunction.
Based on this experience we would strongly discourage
the use of silicone-free transvenous pacing leads for
epicardial use and would recommend using either
custom made silicone-free epicardial leads if available or
completely covering the conventional silicone leads with
a less allergenic material such as Gore-Tex. At this time
there are no silicone-free epicardial leads available on the
market.
FEATURE ARTICLES
References
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2. Peters MS, Schroeer AL, van Hale HM, Broadbent JC.
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3. Abdallah HI, Balsara RK, O’ Riordan AC. Pacemaker contact
sensitivity: clinical recognition and management. Ann Thorac
Surg 1994;57:1017–8.
4. Maushagen E, Reichle B, Simon H. Circumscriptive erythema
after implantation of cardiac pacemaker. [Article in German]
Z Kardiol 1994;83:340–2.
5. Hayes DL, Loesl K. Pacemaker component allergy: case report
and review of the literature. J Interv Card Electrophysiol
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6. Iguchi N, Kasanuki H, Matsuda N, Shoda M, Ohnishi S,
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Spontaneous Whole-Lung Torsion
After Massive Pleural Effusion
and Atelectasis
Masahiro Irie, MD, Norihito Okumura, MD, PhD,
Jun Nakano, MD, PhD, Atsushi Fujiwara, MD,
Misa Noguchi, MD, Hidenao Kayawake, MD,
Akihiko Yamashina, MD, Tomoaki Matsuoka, MD, and
Kotaro Kameyama, MD, PhD
Department of Thoracic Surgery, Kurashiki Central Hospital,
Okayama, Japan
Accepted for publication April 29, 2013.
Address correspondence to Dr Irie, Department of Thoracic Surgery,
Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama, 710-8602,
Japan; e-mail: masa_irie@hotmail.com.
0003-4975/$36.00
http://dx.doi.org/10.1016/j.athoracsur.2013.04.133