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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 32, No 4, July/August 2021
194
AFRICA
The extractions were all performed via a percutaneous
transvenous superior approach. A standard infraclavicular
incision was used to extract the pacemaker generator. A stepwise
procedure was followed: if the lead could not be removed using
a standard stylet and gentle traction, a locking stylet was used to
remove the lead. If the locking stylet failed to free the lead with
gentle traction, a mechanical extraction sheath (Cook Medical
9–13 French, 40.6 cm Evolution RL controlled-rotation dilator)
was used. Occasionally an additional mechanical extraction
sheath (Cook Medical 9–11 French, 13.6 cm Evolution Shortie
mechanical dilator sheath) was required to free the proximal
extent of the lead. Once the lead was successfully extracted,
haemostasis of the axillary and subclavian veins was secured
using a figure-of-eight suture. In all cases of device infection,
an extensive pocket capsulectomy was performed, followed by
wound closure with interrupted nylon sutures.
Definitions published in the 2009 and 2017 Heart Rhythm
Society (HRS) expert consensus statement on cardiovascular
implantable electronic device lead management and extraction
and the 2018 European Heart Rhythm Association (EHRA)
expert consensus statement on lead extraction were used to
define patient outcomes.
7,16,17
A lead-removal procedure is defined as removal of a pacing
or ICD lead using any technique.
7,16
Lead explant is defined as
lead removal using simple traction techniques (no locking stylets,
telescoping sheaths or femoral extraction tools) or leads implanted
for less than one-year duration.
6,7
Lead extraction is defined as the
removal of at least one lead that has been implanted for more than
one year, or a lead, regardless of duration of implant, requiring
the assistance of specialised equipment that is not included as part
of the typical implant package, and/or removal of a lead from a
route other than the implant vein.
7,16
Major complications/serious adverse events are defined as
any of the outcomes related to the procedure that are life-
threatening or result in death (cardiac or non-cardiac).
7,16
Minor
complications are defined as any undesired event related to the
procedure that requires medical intervention or minor procedural
intervention and does not persistently or significantly limit the
patient’s function, nor does it threaten life or cause death.
7,16
Complete procedural success is defined as a lead-extraction
procedure with removal of all targeted leads and all lead material
from the vascular space, with the absence of any permanently
disabling complication or procedure-related death.
7,16
Clinical
success is defined as lead extraction procedures with removal
of all targeted leads and lead material from the vascular space
or retention of a small portion of the lead (
≤
0.4 cm) that does
not negatively impact on the outcome goals of the procedure.
7,16
Statistical analysis
Statistical analyses were performed using SPSS Statistics for
Macintosh version 24.0 (IBM, USA). Normally distributed
continuous variables are reported as means [standard deviations
(SD)], and as medians [interquartile ranges (IQR)] when skewed.
Discrete data are presented as numbers and percentages. The
mortality difference between the extraction group and the explant
group was assessed using the chi-squared test; the Kaplan–Meier
and log rank tests were used to assess the cumulative survival
difference. A
p
-value < 0.05 represents a statistically significant
difference.
Results
A total of 53 patients underwent percutaneous transvenous
CIED (lead/s and generator) removal at GSH and UCTPAH
between 1 January 2008 and 31 December 2019. Twenty-six
(49%) patients required CIED lead extractions and 27 (51%) had
their CIED leads explanted.
The baseline characteristics of the patients and the details
of their CIEDs are presented in Table 1. The mean age of
the patients was 59.1 (16.0) years, 50.9% were male, 50.9%
had systemic hypertension, 30.2% had diabetes mellitus and
47.2% had cardiomyopathy. The leading indication for CIED
implantation was complete heart block (37.7%). The most
common CIED removed was a single-chamber permanent
pacemaker (35.8%). The main indication for CIED removal was
device infection (69.2%) (Fig. 1A, B). The majority of infected
CIEDs removed were for culture-negative endocarditis (Fig. 2)
and all patients who had CIED infection had received multiple
courses of antibiotics prior to referral.
A total of 75 leads was removed (40 extractions and 35
explants) (Table 2). The CIEDs were removed after a median
(IQR) of 243 (53–831) days since the primary implantation.
Extraction occurred after a median (IQR) of 831 (359–2546) days
from the date of CIED implantation. For CIED extractions, a
locking stylet was required in 92.3% and a mechanical extraction
sheath was used in 73.1% of patients.
Extraction-related complete procedural success was achieved
in 84.6% and clinical success was achieved in 96.2% of patients.
One patient who had a lead extraction died a few hours post lead
extraction (mortality rate 3.8 %). She had a successful extraction
of four leads (two atrial, one right ventricle and one coronary
sinus) for CIED infection. She had unexplained ventricular
fibrillation and cardiac arrest the morning after the procedure.
There were no other major complications.
Minor complications ocourred in one patient (3.8%). This
was due to a small lead fragment (< 1 cm) that embolised in
the lung without complications and could not be retrieved with
Table 1. Baseline characteristics
Variables
Removal (extraction
and explant) (
n
= 53)
Extraction
(
n
= 26)
Explant
(
n
= 27)
Age,
n
(SD), years
59.1 (16.0)
57.8 (16.3) 60.2 (15.9)
Male gender,
n
(%)
27 (50.9)
17 (65.4)
10 (37)
Systemic hypertension,
n
(%)
27 (50.9)
10 (38.5) 17 (63.0)
Diabetes mellitus,
n
(%)
16 (30.2)
7 (26.9)
9 (33.3)
Dyslipidaemia,
n
(%)
16 (30.2)
10 (38.5)
6 (22.2)
Coronary artery disease,
n
(%)
15 (28.3)
9 (34.6)
6 (22.2)
Chronic kidney disease,
n
(%)
8 (15.1)
6 (23.1)
2 (7.4)
Cardiomyopathy,
n
(%)
25 (47.2)
14 (53.8) 11 (40.7)
Atrial fibrillation,
n
(%)
11 (20.8)
6 (23.1)
5 (18.5)
Chronic obstructive airway
disease,
n
(%)
4 (7.5)
2 (7.7)
2 (7.4)
Single-chamber permanent
pacemaker
19 (35.8)
5 (19.2)
14 (51.9)
Dual-chamber permanent
pacemaker
9 (17.0)
7 (26.9)
2 (7.4)
CRT-P
8 (15.1)
5 (19.2)
3 (11.1)
CRT-D
4 (7.5)
3 (11.5)
1 (3.7)
Dual-chamber ICD
2 (3.8)
1 (3.8)
1 (3.7)
Single-chamber ICD
11 (20.8)
5 (19.2)
6 (22.2)
CRT-P, cardiac resynchronisation therapy pacemaker; CRT-D, cardiac resyn-
chronisation therapy defibrillator; ICD, implantable cardioverter defibrillator.