Download Surgical Management of Implantation

JACC: CLINICAL ELECTROPHYSIOLOGY
VOL. 2, NO. 1, 2016
ª 2016 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
PUBLISHED BY ELSEVIER
ISSN 2405-500X/$36.00
http://dx.doi.org/10.1016/j.jacep.2015.09.011
Surgical Management of
Implantation-Related Complications
of the Subcutaneous Implantable
Cardioverter-Defibrillator
Tom F. Brouwer, MD,a Antoine H.G. Driessen, MD,b Louise R.A. Olde Nordkamp, MD, PHD,a
Kirsten M. Kooiman, CCDS,a Joris R. de Groot, MD, PHD,a Arthur A.M. Wilde, MD, PHD,a Reinoud E. Knops, MDa
ABSTRACT
OBJECTIVES This study assessed outcomes in patients in whom subcutaneous implantable cardioverter-defibrillator
(S-ICD) therapy was continued after implantation-related complications, in order to avoid conversion to transvenous ICD
therapy.
BACKGROUND Patients at risk for sudden cardiac death benefit from ICD therapy, despite a significant risk for complications. S-ICD has a similar complication rate as transvenous ICD therapy, but the absence of transvenous leads may
hold long-term benefits, especially in young ICD patients.
METHODS In the largest single-center cohort available to date, S-ICD patients implanted between 2009 and 2015 were
included.
RESULTS There were 123 patients at a median age of 40 years. During a median follow-up of 2 years, 10 patients
(9.4%) suffered implant-related complications. There were 5 infections, 3 erosions, and 2 implant failures for which 21
surgical procedures were needed. In 9 of 10 patients, S-ICD therapy could be continued after intervention. In 6 patients,
the period between extraction and reimplantation of the S-ICD system was bridged with a wearable cardioverterdefibrillator (WCD). The pulse generator was reimplanted at the original site in 5 patients and in 3 underneath the serratus
anterior muscle. One patient was not reimplanted following extraction due to recurrent infections. Conversion to a
transvenous ICD was not needed in any patient.
CONCLUSIONS In most patients with a complication, S-ICD therapy could be continued after intervention, avoiding
the need to convert to a transvenous system. Bridging to recovery with a WCD and submuscular implantation of the
pulse generator are effective treatment strategies to manage S-ICD complications. (J Am Coll Cardiol EP 2016;2:89–96)
© 2016 by the American College of Cardiology Foundation.
P
atients
cardiac
these complications are related to the use of transve-
death benefit from implantable cardioverter-
at
high
nous leads, causing significant morbidity such as
defibrillator
Conventional
thrombotic events, cardiac perforation, and lead
transvenous ICDs have been demonstrated to in-
endocarditis. Failure of transvenous leads, reported
crease survival, despite the fact that approximately
to be between 37% and 40% at 8 to 10 years’ follow-
10% to 15% of patients experience implant-related
up, results in inappropriate shocks, lead-extraction-
or long-term complications (1–5). A proportion of
related complications, and failure to effectively detect
(ICD)
risk
of
sudden
therapy.
Listen to this manuscript’s
audio summary by JACC:
Clinical Electrophysiology
Editor-in-Chief
Dr. David J. Wilber.
From the aDepartment of Clinical and Experimental Cardiology, Heart Center, Amsterdam Medical Center, University of
Amsterdam, Amsterdam, the Netherlands; and the bDepartment of Cardiothoracic Surgery, Heart Center, Amsterdam Medical
Center, University of Amsterdam, Amsterdam, the Netherlands. Dr. Knops has received an institutional research grant and
honoraria from Boston Scientific Inc. Dr. de Groot has received grants from St. Jude Medical, Atricure, Medtronic, and ZonMW/
NWO. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Manuscript received July 21, 2015; revised manuscript received September 9, 2015, accepted September 24, 2015.
90
Brouwer et al.
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016
FEBRUARY 2016:89–96
Management of S-ICD Complications
ABBREVIATIONS
and convert ventricular arrhythmias (2,6,7).
AND ACRONYMS
These are important limitations of transve-
2-incision technique (11). All patients were routinely
nous ICD therapy and are particularly relevant
evaluated prior to discharge, 2 weeks and 2 months
in young ICD patients with a life expectancy of
post-implant, and thereafter semi annually in the ICD
many decades.
clinic. Unscheduled visits were documented and used
dCMP = dilated
cardiomyopathy
DF-test = defibrillation
The
threshold test
subcutaneous
implantable
cardio-
DPP6 = dipeptidyl
verter-defibrillator (S-ICD), characterized by
aminopeptidase-like protein-6
the extrathoracic position of the lead, was
mutation
introduced to reduce harm associated with
ICD = implantable
transvenous leads (8). Young patients are
cardioverter-defibrillator
overrepresented in S-ICD cohorts because of
iCMP = ischemic
this presumed benefit, but randomized long-
cardiomyopathy
term follow-up data are lacking. Drawbacks
iVF = idiopathic ventricular
of the subcutaneous position are the larger
fibrillation
size of the device, which is needed to deliver
IQR = interquartile range
sufficient energy to meet the defibrillation
LQTS = long QT-syndrome
SAM = serratus anterior muscle
S-ICD = subcutaneous
requirements; the absence of pacing therapy
at low energy levels; and the need for 1 or 2
2010, S-ICD implantations were performed using the
for evaluation.
ENDPOINTS. Complications in this study are defined
as complications related to implantation of the S-ICD
system such as infection, hematoma, or skin erosion,
requiring surgical intervention such as reposition or
device extraction and were retrospectively identified
from patient’s medical records. Complications that
were adequately and definitively managed without
surgical intervention are not reported. The time to
complication
was
defined
as
interval
between
implant of the S-ICD and the moment of surgical
intervention for the complication. Follow-up data
were collected to the last follow-up visit.
implantable cardioverter-
additional incisions depending on the tech-
defibrillator
nique used for lead insertion, which might
STATISTICAL
WCD = wearable cardioverter-
increase the infection risk.
tested for normality and reported as mean SD or
defibrillator
ANALYSIS. Continuous
data
were
When device-related complications, such
medians with corresponding interquartile ranges
as pocket infection or erosion, occur, the treatment
(IQR) (25% to 75%). For discrete variables, percent-
options for transvenous and S-ICDs are different.
ages are calculated. Kaplan-Meier estimates for
Transvenous ICDs can be implanted on the contra-
complications were calculated and presented with
lateral side, which by design is not possible with the
corresponding 95% confidence intervals (CIs). All
S-ICD. Patients with a complication of the S-ICD are
statistical analyses were performed using SPSS
often explanted and converted to transvenous ICD
version 21 software (IBM, Armonk, New York).
therapy, which introduces risk of complications
associated with transvenous leads (9). Outcomes of
RESULTS
patients who have been reimplanted with an S-ICD
after a complication have not been reported.
We analyzed implant-related complications in pa-
PATIENT CHARACTERISTICS. A total of 123 patients
(56.9% male) who received an S-ICD were included in
tients with an S-ICD in the largest single-center
cohort available to date and report the outcome of
strategies focused on continuation of S-ICD therapy
after a complication.
METHODS
T A B L E 1 Baseline Characteristics of Patients With
an S-ICD (N ¼ 123)
Males/females
70/53 (57)
Median age, yrs
40 (26-51)
Body mass index, kg/m2
24.5 4.8
Prior myocardial infarction
24 (19.5)
Diabetes
6 (4.9)
single-center cohort study between February 2009
Atrial fibrillation
8 (6.5)
and February 2015. All consecutive patients who
Previous transvenous implant
16 (13)
received implantation with an S-ICD in our hospital
Left ventricular ejection fraction
46 14.9
were included, except for patients participating in the
ICD indication: primary
80 (65)
ongoing PRAETORIAN trial (A PRospective, rAndom-
Diagnosis
STUDY POPULATION. We conducted a retrospective
izEd Comparison of subcutaneous and tRansvenous ImplANtable Cardioverter Defibrillator Therapy)
Cardiomyopathy
43 (35.0)
Ischemic cardiomyopathy
20 (16.0)
Nonischemic cardiomyopathy
23 (18.7)
(NCT01296022) (10). The need for informed consent
Genetic arrhythmia syndromes
71 (57.7)
was waived by the institutional review board. Im-
Congenital heart disease
5 (4.1)
plantation of the S-ICD was performed under a com-
Other*
4 (3.3)
bination of local anesthesia, using lidocaine, and
conscious sedation in the catheterization laboratory
or operating room by 1 implanter (R.K.). From October
Values are n (%), median (25%–75%), or mean SD. *Family history of sudden
cardiac death and history of nonsustained ventricular tachycardia.
Brouwer et al.
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016
FEBRUARY 2016:89–96
Management of S-ICD Complications
the current analysis. Table 1 presents the baseline
threshold test (DF-test) failure due to malposition of
characteristics. The median age at implant was
the device 0.9% (95% CI: 0.0% to 2.7%) and 1 case of
40 years old (IQR: 26 to 51 years), and 80 (65%) patients
lead displacement 0.9% (95% CI: 0.0% to 2.7%). Of the
had a primary prevention indication. The underlying
first 31 patients receiving implants with the standard
diagnosis was ischemic cardiomyopathy in 16% and
implantation technique, 4 patients (12.9%) suffered a
nonischemic cardiomyopathy in 19%, genetic arrhy-
complication versus 6 of the last 92 (6.5%) who
thmia syndromes in 58%, congenital heart disease in
received implants using the 2-incision technique,
4%, and a family history of sudden cardiac death and
indicating a learning curve with respect to complica-
nonsustained ventricular tachycardia in another 3%.
tions. The median duration between implant and
Of the 123 patients, 92 (75%) received implants using
diagnosis of the complication was 24 days (IQR: 9 to
the 2-incision technique. The median follow-up was
185 days) and between implant and surgical inter-
27 months (IQR: 9 to 48 months).
vention 71 days (IQR: 46 to 274 days), as conservative
COMPLICATIONS. The absolute number of patients
that encountered a complication related to the
implantation of the S-ICD that required surgical
intervention was 10. Kaplan-Meier estimates for
complication-free survival at 1 and 2 years were 91.8%
(95% CI: 86.5% to 97.0%) and 90.6% (95% CI: 84.6%
to 96.3%), respectively (Figure 1).
There were a total of 8 infectious complications
that required surgical intervention: 5 cases of device
infection 4.6% (95% CI: 0.6% to 8.5%) and 3 cases of
pocket erosion 3.6% (95% CI: 0.0% to 7.6%). All cases
had positive biomarkers for infection (elevated Creactive protein or white cell count). Additionally
there were 6 patients with presumed infections. Five
patients had signs of superficial infection, and 1 had a
swollen pocket with elevated infection biomarkers.
All 6 patients were successfully managed with conservative antibiotic treatment only.
There were 2 acute noninfectious complications
requiring intervention: 1 case with defibrillation
treatment was attempted in most patients first. Table 2
displays the characteristics of patients with a complication. Complications not related to the implant procedure that were excluded from the analysis consisted
of 1 pulse generator malfunction, 1 case of oversensing, and 1 fatal case of lead endocarditis of a
concomitant pacemaker in a patient with congenital
heart disease, who was deemed inoperable. When
these complications were included, the rate at 2-year
follow-up was 11.8% (95% CI: 5.2% to 18.0%).
MANAGEMENT OF INFECTION-RELATED COMPLICATIONS.
All 5 infected S-ICD systems conferred a local infection and were extracted. The period between extraction and reimplantation of the S-ICD at the same
site was bridged for between 6 weeks and 3 months
with a wearable cardioverter defibrillator (WCD)
(LifeVest, Zoll Medical, Chelmsford, Massachusetts).
Patient #5 (Table 2) had a history of endocarditis in the
presence of a transvenous device and recurrent skin
infections due to eczema and chronic Staphylococcus
aureus colonization–associated furunculosis. This
patient suffered a local infection of the subcutaneous
F I G U R E 1 Kaplan-Meier Test for Freedom From Implant-
device approximately 2 months post–implant. The
Related Complications Requiring Surgical Intervention at
S-ICD was permanently extracted, and the patient was
2 Years Post-Implant
put on a novel drug regimen to prevent arrhythmias, as
the consensus was that recurrent infections imposed a
greater risk to this patient than interruption of ICD
therapy.
The antibiotic regimen consisted of oral flucloxacillin for a median duration of 10 days after extraction
of the device, according to local hospital protocol and
culture results. Clinical signs of infections and wound
healing determined the exact duration of antibiotic
treatment. The median duration between termination
of antibiotic treatment and reimplantation was 64
days (IQR: 56 to 76 days). There were 3 patients with
pocket erosion that required surgical intervention. In
all 3 patients, the first step in the management was
Two-year freedom of complications is 90.6% (95% confidence
repositioning of the can in a deeper subcutaneous
interval: 84.6 to 96.3).
position under the fibrotic layer of the original pocket.
This management proved successful in 1 patient. In
91
92
T A B L E 2 Overview of Implant-Related Complications per Patient, Subsequent Management, and Outcome
1 (43, female)
iCMP (1 )
2 (23, male)
Comorbidity
Implant Type
Days to
Complication
Acute Management
Device
Bridging
Therapy
Reimplantation
Course of
Follow-Up
Follow-Up Since
Last Surgical
Procedure
DM-II,
hypertension,
obesity
De novo
Pocket infection
WCC 17 CRP 9
-skin flora
12
Extraction day 12
3 months
LifeVest
Reimplant S-ICD
(subcutaneous)
Extraction 2nd implant
after 998 days.
Re-implanted in
sub-serratus position
after 636 days
4 months
DPP6
None
De novo
Pocket infection
WCC 9 CRP 116
-S. aureus
28
Extraction day 28
2 months
LifeVest
Reimplant S-ICD
(subcutaneous)
Unremarkable
55 months
3 (22, male)
dCMP (1 )
None
De novo
Pocket infection
WCC 12 CRP 80
-S. aureus
14
Extraction day 52
>6 weeks
LifeVest
Reimplant S-ICD
(subcutaneous)
Unremarkable
15 months
4 (15, male)
iVF (2 )
None
De novo
Infection of medial
incision
WCC 10 CRP 54
-S. aureus
20
Extraction at day 72
>6 weeks
LifeVest
Reimplant S-ICD
(subcutaneous)
Repositioning pulse
generator
sub-serratus at
34 days postreimplant due
to decubitus
9 months
5 (14, male)
LQTS (1 )
None
Post-TV-pacemaker
(endocarditis)
Pocket infection
WCC 9 CRP 78
-S. aureus
70
Extraction at day 71
No
NA
No device follow-up
(permanently
explanted);
conservative
medication treatment
6 (21, male)
dCMP (2 )
Congenital
aortic valve
stenosis
De novo
Pocket erosion
WCC 11 CRP 70
-No bacterial growth
437
Deeper subcutaneous
positioning pulse
generator at
484 days
No
NA
Unremarkable
45 months
7 (48, female)
iCMP (2 )
Myocardial
infarction
Post-TV-ICD
(lead dysfunction)
Pocket erosion
WCC 9 CRP 5
-No bacterial growth
190
1. Pulse generator
repositioning at
204 days
2. Extraction at
474 days postrepositioning
>3 months
LifeVest
Reimplant S-ICD
(subcutaneous)
Unremarkable
16 months
8 (49, male)
iCMP (1 )
Myocardial
infarction
and VT
Post TV-ICD
(pocket erosion)
1. Pocket erosion
WCC 12 CRP 1
2. Infected pocket
hematoma
-S. lugdunensis
183
1. Pocket revision at
195 days
2. Extraction at
440 days
3 months
LifeVest
Reimplant S-ICD
submusculus
serratus anterior
Unremarkable
17 months
9 (41, female)
DPP6 (1 )
None
De novo
Undersensing due
to improper lead
placement
0
Lead replacement at
day 56
No
NA
Unremarkable
71 months
10 (24, male)
DPP6 (1 )
None
De novo
DFT failure
-No culture
0
Deeper subcutaneous
positioning pulse
generator at
day 6
No
NA
Unremarkable
27 months
Brouwer et al.
Indication
(Prevention)
Management of S-ICD Complications
Patient #
(Age [yrs], Sex)
Type of
Complication
Pocket Culture
Results
NA
FEBRUARY 2016:89–96
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016
dCMP ¼ dilated cardiomyopathy; CRP ¼ C-reactive protein; DFT ¼ defibrillation threshold test; DPP6 ¼ dipeptidyl aminopeptidase-like protein 6 mutation; FU ¼ follow-up duration; iCMP ¼ ischemic cardiomyopathy; iVF ¼ idiopathic ventricular fibrillation;
NA = not applicable; LQTS ¼ long QT syndrome; S-ICD ¼ subcutaneous implantable cardioverter-defibrillator; TV-ICD ¼ transvenous implantable cardioverter-defibrillator; WCC ¼ white cell count.
Brouwer et al.
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016
FEBRUARY 2016:89–96
Management of S-ICD Complications
F I G U R E 2 Lateral Chest Radiograph Showing Failed and Successful Defibrillation Threshold Tests
(A) Lateral view shows anterior position of the pulse generator and ventral position of the lead, resulting in a failed defibrillation threshold test.
(B) Lateral view now shows repositioned leads and pulse generator. The parasternal lead is positioned directly on the sternum, and the pulse
generator is more posterior, resulting in a successful defibrillation test.
the other 2 patients, signs of pocket erosion recurred
of the tip of the lead to the fascia. The sleeve to
at 245 and 270 days after repositioning. In both pa-
fixate the lead to the xiphoid, which is currently
tients, the system was extracted to allow full recovery,
recommended by the manufacturer, had not yet
and they were fitted with a WCD for a period of 3
been introduced. The lead was repositioned, which
months. After this period, both patients underwent
resolved the oversensing.
successful reimplantation, one in the same subcu-
Patient #10 failed both the periprocedural DF-test
taneous position and the other in a deeper sub-
and a second DF-test the day after implant at 65
serratus anterior muscle (SAM) position. All 3
joules in standard and reversed polarity. The failed
patients were free from complications up to the last
DF-test was likely due to an inadequate shock
follow-up visit more than 1 year after reimplantation.
vector as both the pulse generator and lead were
Predictors of infection in transvenous systems
positioned too anteriorly and not close enough to
were assessed with univariate logistic regression
the chest wall fascia (Figure 2A). Both the lead and
models, but age, diabetes, concomitant transvenous
the pulse generator were repositioned directly on
device, infection of previous transvenous device, and
the fascia, and the pulse generator was moved in
anticoagulation were found not to be significantly
the posterior direction. The more posterior position
associated with S-ICD infection in this small cohort
can result in the pulse generator being partly
(data not shown).
placed in the natural space between the latissimus
MANAGEMENT OF ACUTE NONINFECTIOUS COMPLICATIONS.
dorsi and the SAMs, which we do not consider a
Patient #9 suffered an inappropriate shock approxi-
true submuscular implant of the pulse generator
mately 2 months post-implant due to oversensing of
(Figure 2B). After repositioning, 2 DF-tests were
myopotentials. Chest radiography revealed migration
successful at 65 J.
of the tip of the lead in the caudal direction and the
Entirely submuscular implantation of the pulse
proximal part of the coil toward the pulse generator.
g e n e r a t o r . In 3 patients who did not tolerate the
The lead was implanted using the 3-incision tech-
subcutaneous position, the pulse generator was
nique, which requires a distal incision and suturing
reimplanted
directly
under
the
SAM.
The
93
94
Brouwer et al.
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016
FEBRUARY 2016:89–96
Management of S-ICD Complications
F I G U R E 3 Sub-Serratus Anterior Muscle Implantation of the S-ICD Pulse Generator
(A) Lateral view of dissected serratus anterior muscle. Muscle slips are dissected in line with the fiber direction. (B) Pulse generator of the
subcutaneous implantable cardioveter-defibrillator (S-ICD) is placed underneath the muscle slips in the submuscular pocket. (C) Slips of the
muscle are sutured to close the submuscular pocket. (D) Post-operative view of sub-serratus anterior muscle implantation of S-ICD pulse
generator.
submuscular implant technique of the pulse gener-
as endocarditis, lead failure, and pocket erosion. In the
ator was successful in all 3 patients. Implants un-
10th patient, continuation of ICD therapy was deemed
derneath the SAM should be performed in the
less favorable then a medication-only strategy.
operating room in the presence a cardiothoracic surgeon because integrity of the long thoracic nerve is
COMPLICATION RATE. Although the sample size of
critical for shoulder function and damaging it can
this cohort was too small to provide a precise estimate
cause a winged scapula. In this implantation tech-
of the complications rate, it was similar to the large
nique, the pulse generator is positioned underneath
S-ICD cohort published study by Burke et al. (12),
the sixth and seventh muscle slip (Figures 3A and 3B),
which reported 9.6% complications at 2-year follow-
and the muscle slips are sutured from lateral to
up. No cases of blood-borne infection or endocardi-
medial (Figures 3C and 3D). Figure 4 presents an
tis were observed. Comparison of complication rates
anatomic illustration of the implant position.
to transvenous cohorts are impeded by varying
patient characteristics, follow-up durations, and
DISCUSSION
complication definitions. The Danish Pacemaker and
ICD registry reported a major complication rate of
MAIN FINDINGS. Our study provides several insights
5.8% (95% CI: 5.1% to 6.5%) for new implants at 180
regarding complications of S-ICD therapy. In 9 of the
days compared with 7.3% (95% CI: 1.7% to 10.8%) in
10 patients with a complication, S-ICD therapy could
this analysis when all complications requiring inter-
be continued after intervention. In these 9 patients,
vention were considered (13). The Swedish pace-
conversion to transvenous ICD therapy was an option
maker and ICD registry reported 10.1% complications
but not decided. The main reasons to continue S-ICD
at 1 year compared with 9.4% (95% CI: 3.0% to 13.5%)
therapy were patients’ and physicians’ preferences
in this cohort and for infections 3.0% versus 4.6%
and prior transvenous ICD–related complications such
(95% CI: 0.6% to 8.5%), respectively (14).
Brouwer et al.
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016
FEBRUARY 2016:89–96
F I G U R E 4 Submuscular Implantation of the Pulse Generator
Management of S-ICD Complications
cases of erosion or infection. More important, after
this bridging period, reimplantation at the original
site of implantation was successful in 5 of 6 patients.
This demonstrates that conversion to transvenous
ICD therapy in case of an S-ICD complication is not
necessary, and transvenous leads can be avoided.
In a nationwide cohort, we reported preiously that
in S-ICD patients with a device infection, 4 of 7
patients were reimplanted with a transvenous ICD
(9). Although no arrhythmia episodes were treated by
the WCD, we advocate this management for safety
and to avoid prolonged hospitalization.
All 3 cases of pocket erosion were initially managed
by repositioning the pulse generator in a deeper
subcutaneous layer without a bridging period with a
WCD, but this strategy proved to be effective in only
1 case. As skin erosion often occurs in the presence of
low-grade infection, extraction of the S-ICD system
followed by a bridging period with a WCD appears
appropriate in these cases.
IMPLANT POSITION. Failure of DT-testing in a pa-
tient (no. 10) with inappropriate positioning of the
S-ICD, underlines the importance of positioning the
Anatomical lateral view of the pulse generator positioned
underneath the slips of the serratus anterior muscle.
pulse generator directly on the fascia of the chest wall
centered in the mid-axillary line. Depending on the
size and the exact position of the latissimus dorsi
muscle, the pulse generator may also be partly placed
S-ICD patients, in general and in this cohort, are
underneath this muscle to allow a low defibrillation
younger than the traditional ICD population, with a
threshold and enough tissue to protect the skin from
median age of between 40 and 50 years old and with
the mechanical stress imposed by the pulse gener-
few comorbidities (15–17). Their presumed more
ator. In patients who do not tolerate the subcutane-
active lifestyle may have caused early post-procedural
ous position of the pulse generator, submuscular
complications. Previous transvenous ICD studies
implantation can be a successful implantation tech-
with younger patients between 29 and 48 years of
nique. However, the submuscular implantation is
age reported complication rates ranging between
more invasive and painful, it might therefore not be
17% and 27% during follow-up of 2.5 to 5.0 years,
suitable as the default implant technique for de novo
which is higher than that in older populations such as
implants.
SCD-HeFT (14% complications during 3.8 years
follow-up) (5,18–21). Many of these complications
were related to the transvenous lead failure and
dislodgement.
A proportion of this cohort consists of patients who
participated in the first-in-human study of the S-ICD.
In the first 31 patients, the complication rate was
twice that of the next 92 patients. Therefore the
complication rate is this cohort may be overestimated
because of a learning curve effect and this should
be taken into account when it is compared with
transvenous cohorts with presumably experienced
implanters.
STUDY LIMITATIONS. First,
it is a retrospective
cohort study of 123 patients without (randomized)
controls. Patients in this cohort do not represent the
typical ICD population as they are younger and have
less comorbidity. Patients included in the actively
recruiting PREATORIAN trial were excluded but are
not likely to introduce significant bias because all
patients with an ICD indication without need for
brady- or antitachycardia pacing indication are
eligible for the trial.
CONCLUSIONS
BRIDGING PERIOD. The use of a WCD for a period of
In most patients with a complication, subcutaneous
6 weeks to 3 months allows sufficient time for com-
ICD therapy could be continued after intervention,
plete recovery of the skin and subcutaneous tissue in
avoiding the need to convert to a transvenous system.
95
96
Brouwer et al.
JACC: CLINICAL ELECTROPHYSIOLOGY VOL. 2, NO. 1, 2016
FEBRUARY 2016:89–96
Management of S-ICD Complications
The complication rate in this cohort is similar to what
has been reported for transvenous ICDs, albeit that
the complication rate in this cohort may be overestimated because of a learning curve. Bridging time
with a wearable cardioverter-defibrillator allowed reimplantation at the original site of implantation. In
patients who do not tolerate subcutaneous placement
of the pulse generator, implantation of the pulse
generator underneath the SAM can be a viable treatment option.
PERSPECTIVES
COMPETENCY IN MEDICAL KNOWLEDGE: The
complication rate of S-ICDs is similar to that of
transvenous ICD therapy. S-ICD therapy can be
continued after a complication such as infection or
pocket erosion, avoiding the need to convert to
transvenous ICD therapy.
TRANSLATIONAL OUTLOOK: Additional research
REPRINT REQUESTS AND CORRESPONDENCE: Dr.
Tom F. Brouwer, Department of Cardiology, Academic
Medical Center, P.O. Box 22700, 1100 DE Amsterdam,
is needed to evaluate the potential long-term benefits
of subcutaneous ICD therapy compared with transvenous ICD therapy.
the Netherlands. E-mail: [email protected].
REFERENCES
1. Alter P, Waldhans S, Plachta E, Moosdorf R,
Grimm W. Complications of implantable cardioverter defibrillator therapy in 440 consecutive
patients. Pacing Clin Electrophysiol 2005;28:
926–32.
9. Olde Nordkamp LR, Dabiri Abkenari L,
Boersma LV, et al. The entirely subcutaneous
implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. J Am Coll
Cardiol 2012;60:1933–9.
2. Borleffs CJW, van Erven L, van Bommel RJ,
10. Olde Nordkamp LR, Knops RE, Bardy GH, et al.
et al. Risk of failure of transvenous implantable
cardioverter-defibrillator leads. Circ Arrhythm
Electrophysiol 2009;2:411–6.
Rationale and design of the PRAETORIAN trial: a
Prospective, RAndomizEd comparison of subcuTaneOus
and
tRansvenous
ImplANtable
cardioverter-defibrillator therapy. Am Heart J
2012;163:753–60.
3. Moss A, Zareba W, Hall W, et al. Prophylactic
implantation of a defibrillator in patients with
myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877–83.
4. Moss A, Hall W, Cannom D, et al. Improved
survival with an implanted defibrillator in patients
with coronary disease at high risk for ventricular
arrhythmia. Multicenter Automatic Defibrillator
Implantation Trial Investigators. N Engl J Med
1996;335:1933–40.
17. Lambiase PD, Barr C, Theuns DAMJ, et al.
Worldwide experience with a totally subcutaneous
implantable defibrillator: early results from the
EFFORTLESS S-ICD registry. Eur Heart J 2014;35:
1657–65.
11. Knops RE, Olde Nordkamp LR, de Groot JR,
Wilde AA. Two-incision technique for implantation
of the subcutaneous implantable cardioverter-
18. Schwartz PJ, Spazzolini C, Priori SG, et al. Who
are the long-QT syndrome patients who receive an
implantable cardioverter-defibrillator and what
happens to them? Data from the European LongQT
Syndrome
Implantable
CardioverterDefibrillator (LQTS ICD) registry. Circulation
defibrillator. Heart Rhythm 2013;10:1240–3.
2010;122:1272–82.
12. Burke MC, Gold MR, Knight BP, et al. Safety and
19. O’Mahony C, Lambiase PD, Quarta G, et al. The
Efficacy of the totally subcutaneous implantable
defibrillator. J Am Coll Cardiol 2015;65:1605–15.
long-term survival and the risks and benefits of
implantable cardioverter defibrillators in patients
with hypertrophic cardiomyopathy. Heart 2012;
98:116–25.
5. Bardy GH, Lee KL, Mark DB, et al. Amiodarone
or an implantable cardioverter-defibrillator for
congestive heart failure. N Engl J Med 2005;352:
225–37.
13. Kirkfeldt RE, Johansen JB, Nohr EA,
Jorgensen OD, Nielsen JC. Complications after
cardiac implantable electronic device implantations: an analysis of a complete, nationwide
cohort in Denmark. Eur Heart J 2014;35:1186–94.
6. Kleemann T, Becker T, Doenges K, et al. Annual
rate of transvenous defibrillation lead defects in
implantable cardioverter-defibrillators over a
14. Gadler F, Valzania C, Linde C. Current use of
implantable electrical devices in Sweden: data
from the Swedish pacemaker and implantable
period of >10 years.
2474–80.
Circulation 2007;115:
cardioverter-defibrillator registry. Europace 2014;
17:69–77.
7. Dorwarth U, Frey B, Dugas M, et al. Transvenous defibrillation leads: high incidence of
failure during long-term follow-up. J Cardiovasc
Electrophysiol 2003;14:38–43.
15. Aydin A, Hartel F, Schlüter M, et al. Shock efficacy of subcutaneous implantable cardioverterdefibrillator for prevention of sudden cardiac
death: initial multicenter experience. Circ
Arrhythm Electrophysiol 2012;5:913–9.
8. Bardy G, Smith W, Hood M, et al. An entirely
subcutaneous implantable cardioverter–defibrillator. N Engl J Med 2010;363:36–44.
conventional implantable cardioverter-defibrillators:
a multicenter case-control study. Heart Rhythm
2013;10:29–36.
16. Köbe J, Reinke F, Meyer C, et al. Implantation
and follow-up of totally subcutaneous versus
20. Corrado D, Calkins H, Link MS, et al. Prophylactic implantable defibrillator in patients with
arrhythmogenic right ventricular cardiomyopathy/
dysplasia and no prior ventricular fibrillation or
sustained ventricular
2010;122:1144–52.
tachycardia.
Circulation
21. Olde Nordkamp LR, Wilde AA, Tijssen JGP,
Knops RE, Van Dessel PFHM, De Groot JR. The ICD
for primary prevention in patients with inherited
cardiac diseases: indications, use, and outcome: a
comparison with secondary prevention. Circ
Arrhythmia Electrophysiol 2013;6:91–100.
KEY WORDS complication, erosion, ICD,
infection, S-ICD