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June 2012

Advances in Arrhythmia and Electrophysiology

Subcutaneous Implantable Cardioverter Defibrillator


Christopher P. Rowley, MD; Michael R. Gold, MD, PhD

I mplantable cardioverter-defibrillators (ICDs) represent a


very effective therapy for primary and secondary preven-
tion of sudden cardiac death (SCD). However, implantation
often required an epicardial or transvenous lead for sens-
ing, similar to the initial ICD systems developed more than
25 years ago. As a consequence of the inability or desire not
of endocardial leads using a transvenous approach is associ- to place endovascular leads in such patients, a subcutaneous
ated with significant procedural and long term complications. approach emerged as case reports, primarily in the pediatric
An entirely subcutaneous ICD (S-ICD) has been developed, population.6-8 However, these early hybrid systems were tra-
potentially eliminating many of the complications associated ditional transvenous ICDs with leads placed in the subcutane-
with traditional transvenous ICDs. This novel approach has ous space, and only later incorporated dedicated subcutaneous
been demonstrated to be a reliable and effective system for leads.9 As the feasibility of a dedicated S-ICD became appar-
detection and termination of ventricular arrhythmias. The ent, so did greater recognition of the increasing long term risks
available therapeutic interventions are a result of the unique of endovascular lead placement, including intravascular infec-
characteristics of a high energy subcutaneous delivery sys- tion, pneumothorax, vein thrombosis, and lead fracture.10,11
tem, and therefore require appropriate patient selection to Similarly, the morbidity and mortality associated with revi-
optimize therapeutic benefit and minimize the limitations of sion and extraction of chronic endocardial leads highlighted
the first generation S-ICD. By maintaining the effectiveness potential long term benefits of a subcutaneous device.12 The
of conventional ICDs while limiting the associated compli- clinical requirement to avoid a transvenous approach, as well
cations, the S-ICD provides an alternative therapy for clini- as the apparent benefits, including risk avoidance, ultimately
cians treating many patients at risk for SCD. This review resulted in more formal attempts to develop an entirely sub-
will examine the development of the subcutaneous ICD, its cutaneous ICD. As a novel approach for prevention of sudden
advantages, limitations, and potential clinical role in the cardiac death, the development of an S-ICD required demon-
treatment of ventricular tachyarrhythmias and prevention stration of a highly sensitive arrhythmia detection algorithm
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of SCD. as well as reliable defibrillation.

Background Arrhythmia Detection


Despite advances in cardiovascular care, SCD remains a sig- A subcutaneous ICD presents unique challenges for identifica-
nificant public health issue.1 A variety of nonpharmacologic tion of life threatening ventricular tachyarrhythmias. Because
therapies for primary and secondary prevention of SCD exist, of the subcutaneous electrode location, myopotentials, noise,
including ICDs by endovascular lead implantation or place- and low voltage electrograms make diagnostic discriminators
ment of epicardial defibrillation patches. Nonimplantable fundamentally different than that of transvenous ICDs. This
strategies for SCD protection in high risk patients have also raises concern of the ability to detect ventricular tachyarrhyth-
been attempted, including a wearable defibrillator vest,2,3 mias accurately, and in particular ventricular fibrillation (VF).
as well as automated external defibrillator use at home in In contrast, the ultra far field signal recorded with subcutane-
selected cohorts.4 The subcutaneous ICD provides an alterna- ous leads more closely mimics the surface ECG, and theoreti-
tive device for treatment of SCD.5 cally may improve arrhythmia discrimination.
The development of an entirely subcutaneous ICD was Subcutaneous versus Transvenous Arrhythmia Recognition
motivated initially by special circumstances where a tra- Testing (START) was designed as a prospective study to com-
ditional endovascular system was not practical. It was first pare arrhythmia detection with transvenous and subcutaneous
applied in the pediatric population, where congenital ana- signals.13 A library of induced arrhythmias was constructed
tomic variation often precludes safe endocardial lead place- at the time of ICD implantation, with simultaneous record-
ment; the technique was extended to other patient populations ing of transvenous and cutaneous signals. These recordings
in whom venous access may be obstructed, may need to be were then played back into the header of each device offline
preserved, or in which chronic endovascular leads may have to assess the comparative efficacy of the sensing algorithms
a very high risk of secondary infection, as in the case of to discriminate ventricular and supraventricular tachyar-
patients with chronic indwelling catheters. These systems rhythmias. The sensitivity for the detection of ventricular

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

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588  Circ Arrhythm Electrophysiol  June 2012

Table 1. Primary Results From START Comparing


Transvenous and Subcutaneous Discrimination for Induced
Ventricular and Supraventricular Arrhythmias
Specificity Results
for Transvenous* and S-ICD Systems
Single Chamber Dual Chamber S-ICD
Appropriately withheld therapy 115 100 49
Inappropriate defibrillation 35 47 1
Specificity 76.7% 68% 98%
*Pooled results from 3 manufacturers with devices programmed in single
chamber or dual chamber mode.
S-ICD indicates subcutaneous implantable cardioverter-defibrillator; START, Figure 1. Comparison of transvenous and S-ICD defibrillation
Subcutaneous versus Transvenous Arrhythmia Recognition Testing thresholds. Paired defibrillation threshold data in 49 consecu-
Data from Gold MR, Theuns DA, Knight BP, Sturdivant JL, Sanghera R, tive patients demonstrates the higher energy requirements for
Ellenbogen KA, Wood MA, Burke MC. Head-to-head comparison of arrhythmia subcutaneous defibrillation. The mean defibrillation thresholds
for transvenous (*) and subcutaneous configurations (†) were
discrimination performance of subcutaneous and transvenous ICD arrhythmia
11.1 J and 36.6 J, respectively. Adapted from N Engl J Med
detection algorithms: the START study. J Cardiovasc Electrophysiol. Article first 2010;363:36-44, with permission.
published online: 28 Oct 2011.

used in this study were placed to mimic the location of the


tachyarrhythmias was uniformly excellent. However, the
present commercially developed S-ICD system. The larger
S-ICD showed the best specificity for discrimination of supra-
energy requirement for subcutaneous defibrillation places
ventricular arrhythmias (Table 1). Moreover, dual chamber
technological constraints on the S-ICD system, including
algorithms did not improve transvenous arrhythmia detection.
larger pulse generator size, shorter battery life, and limited
Although START showed that the S-ICD very accurately
provision of nonshock therapies such as temporary pacing.
detects and discriminates ventricular or supraventricular
Therefore, any subcutaneous ICD system must optimize
tachyarrhythmias at implantation, other causes of inappro-
energy output by using a lead configuration that promotes
priate detection are possible in ambulatory or chronically
efficient and effective defibrillation that is technologically
implanted patients. In this regard, inappropriate shocks due
and biologically achievable.
to myopotential sensing, double counting, and suboptimal
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The efficiency of subcutaneous defibrillation has been


sensing vector selection have been observed in studies of
shown by finite element modeling to be improved by longer
implanted S-ICD systems.14 These often can be mitigated
electrode coil length as well as using configurations that place
by optimal programming and vector selection to improve
the shock vector close to the center of ventricular myocar-
electrograms and limit artifact. The current S-ICD sys-
dial mass.15 As such, other shock vectors have been assessed
tem, for example, allows for several vectors to be used for
for defibrillation using various combinations of electrode
arrhythmia detection, including distal to proximal electrode
lead length, lead placement, and pulse generator location.
as well as either electrode or pulse generator. The system
Grace et al16 evaluated an anterolateral shock vector using
automatically selects the best vector that avoids noise, QRS
an 8 cm left parasternal electrode and a left lateral thoracic
double counting, and T-wave oversensing. Diagnostic algo-
can, and reported a defibrillation threshold (DFT) of 36.6 J,
rithms then are applied for arrhythmia detection, including
with patient not defibrillated up to 83 J. Burke et al17 evalu-
an optional discrimination zone to distinguish supraven-
ated an anterior-anterior vector by placing an anterior can in
tricular tachycardia from ventricular tachycardia. When
a clavicular pocket and an anterior cutaneous defibrillation
this approach was applied to 137 induced episodes of VF
patch electrode. In 7 of 9 patients (78%), successful defibril-
in 53 patients, all episodes were appropriately detected.
lation was achieved using 50 J, whereas 2 patients required
Additionally, there were no inappropriate shocks for atrial
100 J to terminate VF. Lieberman et al18 evaluated an anterior-
fibrillation, sinus tachycardia, or supraventricular tachycar-
posterior shock vector placing the can in a low medial pecto-
dia in 10 months of follow-up.5 Despite these encouraging
ral position and a 25 cm coil electrode tunneled posteriorly
results, there are no prospective comparisons of arrhythmia
between the 6th and 10th intercostal spaces. Using this shock
detection between subcutaneous and transvenous ICDs with
configuration, 26 out of 32 patients (81%) were defibrillated
long term follow-up.
using 35 J or less. Of those, 18 patients were defibrillated
with 17 J or less.
Arrhythmia Termination These pivotal studies demonstrated the ability to terminate
Because of the subcutaneous placement of the shocking ventricular arrhythmias using a variety of shock vectors and
electrode, the energy required for successful defibrilla- with variable energy requirements, thus leading to develop-
tion is higher than for transvenous ICDs (Figure 1). In a ment of the fully implantable S-ICD. Prior to permanent
comparative study performed at the time of ICD implanta- implantation and long term testing of the present S-ICD
tion, the average defibrillation threshold for transvenous system, 4 lead configurations were tested using specific ana-
and S-ICDs was 11.1±8.5 J and 36.6±19.8 J, respectively tomic landmarks. The configuration with the lowest mean
(P<0.001), using a binary search algorithm.5 The electrodes defibrillation threshold at 32.5±17 J used a left lateral pulse
Rowley and Gold   Subcutaneous ICD   589

generator and an 8 cm coil electrode positioned along the left


parasternal margin.5 Other configurations tested (defibrilla-
tion threshold) included a left pectoral pulse generator with
a left parasternal 4 cm coil electrode at the inferior sternum
(40.4±13.7 J), a left pectoral pulse generator with an 8 cm
coil electrode curving from the left inferior parasternal line
across to the inferior margin of the left sixth rib (40.1±14.9 J),
and a left lateral pulse generator with a left parasternal 5 cm
oval disk (34.3±12.1 J).
Following selection of the optimal S-ICD configuration,
the system then was evaluated in 59 patients who each had
2 episodes of VF induced at the time of implantation. Of
these, 58 patients (98%) were successfully converted with 65
J on both occasions.5 The 59th patient was defibrillated suc-
cessfully during the first but not second attempt. Following
permanent implantation of the S-ICD, the device was set to
deliver only 80 J shocks to ensure an adequate safety mar-
gin. During a mean 10 months of follow-up there were 12
episodes of spontaneous ventricular tachycardia occurring in
3 patients that were treated successfully. The successful ter- Figure 2. Anatomic locations of S-ICD components with sensing
mination of VF and sustained ventricular tachycardia (VT) vectors. The sensing vector can be selected from the proximal
electrode B-CAN (primary), the distal electrode A-CAN (second-
also had been balanced with appropriately withheld thera- ary), or the distal to proximal electrode A-B (alternate).
pies in patients with detected but nonsustained episodes.14 In
a single center experience reporting on 31 S-ICD implants,
52 sustained episodes of VF induced at the time of implant is programmed “on”, tachyarrhythmias occurring between
were detected appropriately and treated in all episodes.14 170 and 240 bpm initiate arrhythmia discrimination analy-
Four patients had spontaneous ventricular tachyarrhyth- sis. This step wise approach to arrhythmia discrimination
mias in an average of 286 days of follow-up, which were all incorporates template matching that is conceptually similar
treated successfully. to that found in transvenous devices. However, transvenous
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ICDs typically use a limited number of analysis points for


The Subcutaneous Implantable morphological comparison, whereas the S-ICD evaluates up
Cardioverter-Defibrillator to 41 points of the ventricular complex in an effort to improve
An entirely subcutaneous ICD (Cameron Health signal resolution. Rhythm analysis is performed using an 18
Incorporated) has been developed and is the first subcutane- of 24 beats duration criteria.13
ous ICD permanently implanted with long term follow-up.5 During device implantation arrhythmia termination is tested
As noted previously, acute studies at the time of transvenous using 65 J shocks to establish an adequate safety margin.
ICD implantation demonstrated effective rhythm detection However, following implantation the device output is non-
and defibrillation. The S-ICD can be implanted by use of programmable and will only deliver 80 J shocks. The average
anatomic landmarks, obviating the need for fluoroscopy, capacitor charge time is 14±2 seconds, which is significantly
thereby reducing radiation exposure for both the patient and longer than that of transvenous ICDs. After capacitor charg-
physician. With this system the pulse generator is placed in ing and prior to shock delivery, the arrhythmia is reconfirmed
a left lateral position between the midaxillary and the ante- to ensure the presence of a sustained ventricular arrhythmia.
rior axillary lines. The pulse generator is connected to a 3
If initial therapy is unsuccessful the device can reverse shock
mm tripolar parasternal electrode (polycarbonate urethane)
polarity automatically. Postshock asystole occurring for more
that is tunneled 1 to 2 cm to the left of and parallel with the
than 3.5 seconds triggers demand pacing at 50 bpm using a
sternal midline via 2 parasternal incisions. The electrode has
200 mA biphasic transthoracic pulse, and is available for 30
a distal sensing electrode next to the manubriosternal junc-
seconds. Up to 24 treated events can be stored with 120 sec-
tion and a proximal sensing electrode next to the xiphoid
process, with an 8 cm shocking coil separating the 2 sensing onds of recorded electrogram per event from arrhythmia onset
electrodes. to termination.
Rhythm detection is performed using 1 of the 3 vectors Complications of S-ICD implantation include lead migra-
formed between available combinations of either sensing tion, pocket infection, and parasternal lead dislodgement in
electrode and pulse generator (proximal-to-canister (CAN), the absence of adequate anchoring at the distal electrode.5,14
distal-to-CAN, and distal to proximal; Figure 2). Three Long term data regarding lead durability is not yet available.
different algorithms are applied to each cardiac signal to Inappropriate shock therapy has been described resulting
prevent double counting and T-wave oversensing.13 After from myopotentials, oversensing, and double counting. In
the optimal sensing vector is automatically selected by the 1 report these issues were primarily resolved with software
S-ICD, the heart rate then is calculated as the average of updates and alternative vector selection, though 1 patient
the last 4 intervals. When the optional discrimination zone required lead repositioning.14
590  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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