Complications from the pacemaker pocket
prophylaxis, treatment and results
BY THOMAS CASTBERG
ThoraxRirurgi.rk aid. L, Bisbebjer hospital, 2200 Copenhagen, Denmark
ABSTRACT
281 patients who had permanent pacemaker
implanted between 1961-73 have been checked
at 4 month intervals over a period of 1 to 13 years.
Complications from the pacemaker pocket com-
prises haematoma, skin necrosis, infection of the
pocket, allergic reaction to the pulse generator,
pacemaker twiddlers syndrome, and muscle contrac-
tions. The causes for and treatment of 11 cases
with haematoma, skin necrosis or infection are
dealt with in detail.
INTTRODUCTION
The total number of implanted cardiac pace-
makers had exceeded 100.000 by 1972 (4), and
in 1974 4000 pacemakers were sold per month in
USA. In other parts of the world a similar activity
has been recorded (11). This enormous number
of pacemaker implantation has been followed by
electrode corrections and pulse generator replace-
ments, and the grand total of operations on pace-
maker patients is indeed very high. The treatment
with an implanted cardiac pacemaker has in later
years been an easy and reliable procedure with
very few complications. Break down of electrodes
or of components in the pulse generator is rarely
seen in the period of garantee. The major complica-
tions seen at the present time are caused by elec-
trode displacement, skin necrosis over the pulse
generator, or by infection around the pulse gene-
rator or the leads. The incidence of complications
from the pocket around the pulse generator varies
from 1 %-25 % (7, 12) including cases with
fatal sepsis.
The main reason for poor results seems to be
caused by lack of aseptic technique or surgical
experience.
MATERIAL AND METHODS
Implantation of pacemakers have been perform-
ed at the department of thoracic surgery at Bispe-
bjerg Hospital since 1961. From 1963 a standar-
dized technique of pacemaker treatment has been
followed: 1) External pacing through left brachi-
alis vein to evaluate the effect of pacemaker treat-
ment. 2) Implantation of a permanent pacemaker
either through a thoracotomy until 1967 using
Medtronics electrode and pulse generator or from
1968 by use of a transvenous electrode Elema EMT
588 B electrode and Elema pulse generator of types
153 B 70 and 169/70. 3) The patient is followed
up in our pacemaker clinic at 4 month intervals.
4 ) The pulse generator is changed according to
the manufactures advice electively after 24-30
months, or earlier if failure is demonstrated. The
operation is performed in a special theater in the
thoracic surgery unit, using full aseptic technique
including covering X-ray equipment with sterile
drapes. The skin incision is placed with regard to
scars from previous surgery avoiding narrow skin
flaps between the scars and thus avoiding necrosis
of the skin. It is important to stress that complete
51
Table 1 , Implantations - replacements - Corrections Table 2 .

7 operations or more 4 patients 30 operations Complications: Treatment:

6 operations 10 - 60 -
5
4 -
3 -
2
1
-

-
-
11 -
11 -
55
67
123 -
-
-
55
44
165 -
134 -
123 -
-
- Skin necrosis with infection

Skin necrosis without infection 3

6
i2 antibiotic
2 removed pacemaker
2 external pacemaker

revision
Haematoma 2
281 - 611 - Total 11
corrections 121 -

total 732 opeations

haemostasis should been secured in order to avoid
haematomas in the pocket. No drainage has been
used. The suture technique should be careful to
prevent canalization infection between the sutures,
or necrosis of the skin caused by too narrow stitch-
ing or too firm tying of the knots. Penicillin 2
mill x 2 has been given for 4 days postoperatively.
Between 1961 and 1973 295 patients had a
permanent pacemaker implanted of these 12 died
from surgery and 2 patients have not been followed
up. The series thus comprises 281 patients. Table
1 shows the number of surgical interventions. 123
patients had one operation while 4 patients had
more than 7 opertttions each. In total 732 operations
were performed. The complications are listed in
table 2. Nine patients had necrosis of the skin;
three were discovered before the pacemaker bed
was infected, and after revision of the wound
the course was without complications. In six cases
infection of the pacemaker pocket occurred. In
two cases the pacemaker system was removed and
a new one implanted in fresh tissue under cover
of antibiotics with an uncomplicated postoperative
course. In another 2 patients the pulse generator
was placed outside the body upon the skin because
of uncontrolable infection of the pocket and the
pacemaker treatment continued in that way. Both
patients were very old and unsuited for any re-
operation. The remaining 2 patients hade the pace-
maker system removed and the pacemaker treat-
ment stopped. The indication for pacemaker treat-
ment was uncompensated heart disease and total
block. One of the patients died at the age of 79
years living without pacemaker for the last 2 years.
The other patient is alive without uncompensated
heart disease 1v2 years after removal of the
pacemaker. It should be emphasized that this
complication with necrois of the skin is a late

Table 3 .

SUMMARY

281 patients treated with 611 pacemaker implantations

and 1 2 1 corrections

total 732 operations

Complications from the pacemaker pocket 11 patients = 4 "/o (1.5 % of operations)

Removal of the pacemaker 2 patients = 2 "/'o (0.3 "/'o of operations)
Pulsgenerator extern 2 patients = 2 % (0.3 % of operations)
Cured 7 patients

Complications from percutaneous electrode:

Sepsis: 5 cases with 1 death.

52
complication seen between 36 or 120 months after
the initial pacemaker implantation had taken place,
and after several replacement operations.
W e always make cultures of serous fluid and
haematomas in the pacemaker pocket, and in 2
cases an infection with a benign staphylococcus
aureus was succesfully treated with antibiotics
locally, i.e. daily puncture of the pacemaker pocket
with a big puncture needle, aspiration of the fluid
around the pulse generator for bacterial culture
and injection of antibiotics according to the resist-
ance pattern. Finally, the risk of having a per-
cutaneous electrode should be noted. 5 out of 302
patients had sepsis, one patient died from sepsis
cdused by the percutaneous electrode
Table 3 summarizes the results. Infection of the
pacemaker pocket was found in 4 % of the
patients, in 1.5 7: of the operations. In 2 cases
the treatment was given up, not because of uncon-
trollable infection, but because there was no indica-
tion for further pacemaker treatment. In the
remainder the infection was cured except in two
patients where the pacemaker treatment has con-
tinued for 3 and 2 years respectively, 2 with an
external pacemaker. No patient died due to the
infected pacemaker pocket. The most important
points in prevention of infection are: 1) Careful
dwpsis, 2) Skin incision carefully placed, 3)
Complete haemostasis, 4 ) Exact suturing technique,
5 ) Careful watching until removal of stitches, i.e.
simple surgical principles. Asepsis is essential in
imbedding such a big foreign body. Surgeon,
dssisting nurse, and patient should be properly
washed and dressed. Skin incision made cautiously,
again very careful haemostasis and exact technique
in suturing the skin should be employed; suction
drainage has been used by others for a few days.
Careful watching of the wound and the pacemaker
pocket until the sutures have been removed after
14 days is essential in these patients, who are often
old in poor general health. Accumulated fluid or
haematomas should be aspirated and cultures made
from each specimen, sometimes repeated aspiration
i 3 necessary.
Prophylactic treatment with antibiotics has been
rcutine in this series. It is very likely that this
treatment is superflouous and in our current series
we have stopped prophylactic treatment with anti-
biotics. As it will be seen the prevention of infec-
tion is based merely on simple surgecal principles.
The treatments of complications are: 1) Aspira-
tion of haematoma by puncture, 2) Local treatment
with antibiotics when signs of infection, 3) By
uncontrolled infection total replacement of the
pacemaker system in fresh tissue, 4 ) Treadning
necrosis of skin edges is revised promptly. Haema-
tomas should be aspirated; local treatment with
antibiotics started immediately if cultures are
positive. If the infection is not brought under
control by local treatment a total new system should
be implanted in fresh tissue. If the skin edges in
the wound shows signs of impending necrosis; the
wound should be revised without delay.
In one patient suspicion of allergic reaction
against the pulse generator could not be maintained
after repositioning of the same generator and this
patient is registred as an infected patient.
W e have seen no pacemaker twiddlers syndrome
probably because most of our pacemakers are pear-
shaped and therefore difficult to rotate. One
patient has persistent contractions around the pace-
maker in rectus muscle and is going to have a
bipolar transvenous electrode implanted in the near
future.
DISCUSSION
The surgical principles used in the present series
have given acceptable results.
It is important to emphasize that the procedure
takes place in a theater (7). Surgery in cardiologic
departments, X-ray departments carries a high
risk of infections (3, 1 2 ) .
When infection of the pacemaker pocket neces-
sitates reoperation one could make an attempt in
replacing the pulse generator, leaving the electrode
in place, and some ( 4 , 11) advise putting the
generator beneath the muscle fascia in these cases.
In all replacement operations it is advised to
extend the incision towards the middle and not
laterally to prevent skin necrosis, which occurs
more often in the lateral part of the abdominal
skin (5). In severe infections total replacement is
53
advised by most authors (3, 7, 8, 9, 1 2 ) and should
be the treatment of choice; though successful local
treatment with antibiotics in selected cases is re-
ported (Dargan:2, Furmann:5, own material:3).
An attempt to control the infected pacemaker
pocket by local ltreatment with antibiotics should
therefore be made before the decision of total
replacement of electrode and pulse generator is
made.
To exteriorise the pulse generator and leave it
outside on the skin if the pocket is infected in
very old and weak patients has been used in this
series and by others (8). It seems that the infection
along the electrode behaves in another way in these
patients who have been paced for years, so that
they do not get sepsis, in contrast to patients who
have infections from temporary pacing electrodes.
REFERENCES
1. Dargan, E. L. & Norman, S. C.: Ann. Thoracic Surg.
12: 297, 1971.
54
J. & Bohm, J.: Dtsch. Gesundh.
2 . Dressler, L., Witte,
Wes 28/36:1689, 1973.
3. Frior, W. B., Lopez, J. F., Nanson, E. M. & Mori
M.: Ann. Thoracic Surg. 6:431, 1968.
4. Furmann, R. W., Heller, A. J., Playforth, R. H.,
Bryant, L. R. & Trinkle, J. K.: Ann. Thoracic Surg.
14:54, 1972.
5 . Golden, G. T., Lorvett, W . L., Harrah, John D.,
Wellons, H. A. & Nolan, J. P.: Surgery 74:575,
1973.
6. Green, G. T.: Ann. Heart J. 83:265, 1972.
7. Lind Schoten, H., Meijne, N. G., Mellin, H. M. &
Overdifk, A. D.: J. Cardiovasc. Surg. 14:126, 1973.
8. Seremets, M. G., Degusman, V. C., Lyons, W. S. &
Peadoby jr., J. W.: Med. Ann. D. C. 42:165, 1973.
9 . Siddons, H. & Davies, G.: Thorax 28:177, 1973.
10: Sowton, E.: British Med. Journ. 11:11, 1968.
11. Thalen, H. J. Th., ed.: Cardiac pacing Van Gorcum
& Co. B. V. Assen The Netherlands 1973.
12. Urenholdt, A,, Hagfeldt,T., Fischer Hansen, J.
Leth, A. & Meibom J.: Danish Med. Bull. 21:151,
1974.