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From the Division of Cardiology, Medical University of South Carolina, Charleston, SC.
Correspondence to Dr Michael R. Gold, Division of Cardiology, Medical University of South Carolina, 25 Courtenay Drive, ART 7031, Charleston,
SC 29425-5920, E-mail goldmr@musc.edu.
(Circ Arrhythm Electrophysiol. 2012;5:587-593.)
© 2012 American Heart Association, Inc.
Circ Arrhythm Electrophysiol is available at http://circep.ahajournals.org DOI: 10.1161/CIRCEP.111.964676
587
588 Circ Arrhythm Electrophysiol June 2012
Table 2. Subcutaneous Implantable Cardioverter-Defibrillator low voltage gradient.20 By contrast, endocardial defibrilla-
Patient Selection tion results in uneven energy delivery, with potentially high
S-ICD Candidate Selection voltage gradients that can damage myocytes through the
process of electroporation, leading to transient myocardial
Favorable Factors Relative Contraindications
stunning.19,21 In animal models using serum troponin levels
Young and active Recurrent monomorphic VT as a measure of myocardial injury following defibrillation,
CHD that limits lead placement Bradycardia requiring pacing endocardial defibrillation resulted in significant troponin
Indwelling catheters Indication for CRT release at 35 J, while subcutaneous defibrillation with 80
Immunocompromised High risk for VT (e.g. sarcoidosis, ARVD) J did not cause troponin release.22,23 Several studies have
Inherited channelopathies Preference for remote monitoring
identified a relationship between ICD shocks and mortal-
ity.24-27 Though it is unknown whether ICD shocks are a risk
S-ICD indicates subcutaneous implantable cardioverter–defibrillator;
factor for mortality or a risk marker for disease severity,
VT, ventricular tachycardia; CHD, congenital heart disease; CRT, cardiac
resynchronization therapy; ARVD, arrhythmogenic right ventricular dysplasia. a defibrillation technique that minimizes myocyte damage
theoretically may mitigate any potential hazard. This may
be of particular importance in patients with already reduced
Subcutaneous Implantable Cardioverter- left ventricular systolic function whose limited reserve may
Defibrillator Advantages not withstand endocardial defibrillation associated myocar-
The subcutaneous ICD was initially developed for dial injury.
patients who were not candidates for transvenous ICDs,
such as those with some congenital heart abnormalities or Subcutaneous Implantable
no venous access. However, there are several advantages Cardioverter-Defibrillator Limitations
of the subcutaneous approach that may make it a preferred In its current iteration there are several limitations of
approach for prevention of SCD rather than simply an alter- S-ICDs that may make the approach unsuitable for certain
native to transvenous ICDs in select patient populations patient populations. The device is designed to deliver high
(Table 2). energy shocks for termination of lethal arrhythmias but, with
Without requiring venous access there is no risk of vascular the exception of 30 s of backup pacing for postshock asys-
injury and presumably a very low risk of systemic infection. tole, does not have backup pacing ability for bradyarrhyth-
Such an intravascular sparing procedure can be important mias. Even in the absence of a clear bradycardia indication
when infectious risks are high or venous access must be pre- for pacing, a small percentage of patients who require ICDs
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served for other needs, such as hemodialysis. Patients with go on to require pacing at a later time.28 Additionally, biven-
artificial valves or those receiving chronic immunosuppres- tricular pacing in addition to an ICD (CRT-D) has been dem-
sion may be excellent candidates for a subcutaneous ICD, as onstrated to reduce heart failure hospitalizations and mortality
the consequences of systemic infection are more serious in in patients with heart failure, QRS prolongation, and reduced
these populations. left ventricular systolic function.29-31 Cardiac resynchroniza-
In addition to a simplified implantation procedure, the tion therapy remains an important therapeutic intervention not
subcutaneous approach also avoids the risks associated with available with an S-ICD. In fact, patients with any pacing indi-
endovascular lead extraction. With the failure rate of trans- cation are best served with a transvenous ICD.
venous leads variably reported as 28% to 40% at 8 years,12 a Whereas the S-ICD is not intended for treatment of bra-
subcutaneous approach could substantially reduce risks asso- dyarrhythmias, the treatment available for ventricular tach-
ciated with lead extraction and is particularly suited to young yarrhythmias is limited to high energy shocks without the
patients with a long life expectancy and higher lead failure ability to first attempt pace termination. Antitachycardia
rates due to active lifestyles. This includes patients with pacing (ATP) has been shown to be a safe and effective
several genetic disorders where the risk of bradycardia and therapy for initial treatment of spontaneous fast VT, thereby
monomorphic VT is low, such as Brugada syndrome, long QT limiting the number of shocks delivered.32 Though the asso-
syndrome, and hypertrophic cardiomyopathy. Additionally, ciation of both appropriate and inappropriate shocks with
the S-ICD may prove beneficial in patients anticipating car- mortality is not fully understood, optimal ICD program-
diac transplantation by avoiding significant endovascular ming frequently incorporates initial attempts at ATP in an
fibrosis that may complicate surgical lead extraction at the effort to avoid high energy shocks. This programming is
time of transplant. supported by data suggesting that the potentially deleteri-
Paradoxically, the S-ICD may have some cosmetic advan- ous effect of ICD shocks can be mitigated in part by use of
tages despite its larger size. The anatomic location in the lat- ATP.33 Therefore, the S-ICD should be avoided in patients
eral axilla is preferred anecdotally, particularly by women, to with known monomorphic VT and potentially those at
the prepectoral location of ICDs in some patients. high risk for VT, such as sarcoidosis or right ventricular
There may also be an inherent benefit to subcutaneous dysplasia.
versus transvenous defibrillation. While S-ICDs have higher In general, the clinical results with the use of dual cham-
energy requirements for effective defibrillation, the energy ber ICDs have been disappointing. Dual chamber pacing has
is distributed more evenly throughout the myocardium.19 In been associated with worse clinical outcomes compared with
fact, with approximately 10% of delivered energy reach- backup single chamber pacing.28,34 Moreover, the addition of
ing the heart, cardiac myocytes are exposed to a relatively an atrial lead has not improved arrhythmia discrimination.26,35,36
Rowley and Gold Subcutaneous ICD 591
However, recent data suggest that monitoring of atrial tachyar- America and Europe, but even more so in other geographies
rhythmias has important prognostic significance,37-39 though with fewer electrophysiologists.
such information is not available with the S-ICD. In patients Interestingly, the S-ICD does not separately evaluate atrial
requiring a primary or secondary prevention device who also activity, though it had the highest specificity for ventricular
have atrial arrhythmias, the ability to monitor atrial activ- arrhythmias when compared with both single chamber and
ity provides the opportunity to manage electrophysiological dual chamber transvenous systems in START. There are
comorbidities more comprehensively. Whether judicious use several possible explanations for this finding, including the
of atrial detection offsets any deleterious effects of an addi- earlier use of morphology discriminators in the S-ICD com-
tional lead and the often observed increased ventricular pacing pared with late stage morphology discriminators used by
remains to be determined. most transvenous ICD systems, the number of data points
Most transvenous ICDs are also capable of being monitored obtained for morphology template comparison, or the ultra
remotely, which simplifies follow-up, reduces office visits, far field electrograms that are used for interpretation. The
and is associated with better patient outcomes. At present, the improved specificity may lead to further analysis of current
S-ICD has no remote monitoring capabilities. ICDs and ultimately result in improved arrhythmia discrimi-
Because of the higher energy requirements for subcuta- nation. Long term data are still needed to insure that this
neous defibrillation the pulse generator is larger compared improved detection with induced rhythms translates into better
with contemporary transvenous ICDs. Despite its larger discrimination of spontaneous arrhythmias as well as extrac-
size the anticipated battery life of the S-ICD is approxi- ardiac signals, both biological (eg, pectoral and diaphragmatic
mately 5 years, which is somewhat shorter than transvenous myopotentials) and extrinsic noise.
defibrillators, and may impact the cost effectiveness of this Although the S-ICD has been demonstrated to identify
device. and treat ventricular arrhythmias accurately and effectively,
In the absence of a previously standardized S-ICD system, there are several technical limitations that will limit its more
long term safety and efficacy data are not currently available. widespread use. The absence of any pacing ability, other than
While several European centers have presented their follow- postshock, eliminates several important clinical therapies,
up data for the S-ICD, the research and clinical cardiology including back up pacing for bradyarrhythmias, resynchroni-
community have significantly greater data and experience zation therapy for heart failure, and antitachycardia pacing.
with transvenous systems. An improved long term under- Whereas patients who develop a pacing indication after place-
standing of battery life, lead durability, appropriate and inap- ment of an S-ICD can still have endovascular pacing leads
propriate shocks, effective shocks, requirement for addition of placed, this eliminates or significantly reduces the more favor-
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a transvenous pacing lead, pain associated with subcutaneous able risk profile of the S-ICD and is a very costly strategy.
defibrillation, and patient preference will help tailor patient Furthermore, additional diagnostic information and the sim-
selection. plicity of follow-up associated with remote monitoring capa-
bilities is a technical limitation of the S-ICD at this time.
Discussion There are many patients in whom the limitations of the
The development of an entirely subcutaneous ICD repre- S-ICD appear less than the long term complications and risks
sents one of the most significant changes in implantable of transvenous devices. Therefore, the S-ICD may be a pre-
ICD technology in the last 10 years and may change the ferred approach for primary prevention in young patients,
approach to many subjects at increased risk of SCD. There dialysis patients, those with previous infected systems, and
are several important implications of the subcutaneous those with inherited diseases such as Brugada syndrome, long
approach. First, it provides a clinically proven ICD system QT syndrome, or idiopathic VF where the risk of VT is very
for patients who are either not eligible for a traditional endo- low. The role of subcutaneous ICDs in other populations will
vascular ICD or are at high risk for endovascular lead place- evolve over time as long term data become available compar-
ment. Such patients may now be able to receive clinically ing outcomes with transvenous ICDs.
proven protection from SCD without the risks associated Clearly some patients will not be candidates for an S-ICD
with endovascular leads. Second, by standardizing a sub- and others will be excellent candidates; the majority of
cutaneous system, important clinical outcomes can be com- patients requiring an ICD, however, will likely be candidates
pared more directly with other available traditional ICDs, for either a subcutaneous or transvenous device. The largest
thereby further tailoring each system to patient populations determinant of device selection is likely to be clinician prefer-
that are likely to benefit most from each therapy. Third, ence and experience. With relatively few clinicians currently
the improved specificity of arrhythmia discrimination pro- trained in the S-ICD implant technique, it is likely that the
vides additional insight into successful sensing vectors and transvenous approach will continue to be preferred, especially
arrhythmia algorithms. Finally, ICD technology can be dis- as long term efficacy and safety data continue to be acquired.
seminated more widely as fluoroscopy, and training in elec- However, with increased physician training in implant tech-
trophysiology is not needed for the implant procedure. The nique as well as patient selection, the S-ICD is likely to gain
need for defibrillation efficacy testing will be determined by in popularity.
ongoing studies, but the potential exists eventually for this
system to be implantable in any facility with sterile proce- Conclusion
dure rooms and a physician with basic surgical skills. This The subcutaneous approach to ICD implantation was devel-
would widely expand implant centers, not only in North oped initially for patients in whom a transvenous approach
592 Circ Arrhythm Electrophysiol June 2012
was not feasible. Having demonstrated effective arrhythmia experience with a novel subcutaneous implantable defibrillator system in
a single center. Clin Res Cardiol. 2011;100:737-744.
detection, discrimination, and termination, the first purpose
15. Jolley M, Stinstra J, Tate J, Pieper S, Macleod R, Chu L, Wang P, Triedman
built entirely subcutaneous ICD was developed. With appro- JK. Finite element modeling of subcutaneous implantable defibrillator
priate patient selection, the S-ICD is emerging as an effective electrodes in an adult torso. Heart Rhythm. 2010;7:692-698.
alternative to transvenous systems for primary and secondary 16. Grace AA, Smith WM, Hood MA, Connelly DT, Wright J, Fynn S,
Crozier I, Melton I, Cappato R, Bardy GH. A prospective, randomised
prevention of sudden cardiac death. comparison in humans of defibrillation efficacy of a standard trans-
venous ICD system with a totally subcutaneous implantable defibrillator
Disclosures system (S-ICD). European Society of Cardiology. September 7, 2005;
Stockholm.
Dr Gold is a consultant, is involved in clinical trials, and receives
17. Burke MC, Coman JA, Cates AW, Lindstrom CC, Sandler DA, Kim SS,
honoraria from Boston Scientific, Cameron Health, Medtronic, St.
Knight BP. Defibrillation energy requirements using a left anterior
Jude, and Sorin. chest cutaneous to subcutaneous shocking vector: implications for a
total subcutaneous implantable defibrillator. Heart Rhythm. 2005;2:
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appropriate therapy in implantable cardioverter-defibrillators: results of a ◼ tachyarrhythmias
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