Download Implantable Cardioverter Defibrillator

Protocol
Implantable Cardioverter Defibrillator
(70144)
Medical Benefit
Preauthorization
Yes
Effective Date: 01/01/16
Next Review Date: 11/16
Review Dates: 02/07, 02/08, 03/09, 01/10, 01/11, 09/11, 09/12, 01/13, 01/14,
05/14, 01/15, 11/15
Preauthorization is required.
The following Protocol contains medical necessity criteria that apply for this service. The criteria
are also applicable to services provided in the local Medicare Advantage operating area for those
members, unless separate Medicare Advantage criteria are indicated. If the criteria are not met,
reimbursement will be denied and the patient cannot be billed. Please note that payment for
covered services is subject to eligibility and the limitations noted in the patient’s contract at the
time the services are rendered.
Populations
Individuals:
• With a high risk of
sudden cardiac death
due to ischemic
cardiomyopathy in
adulthood
Interventions
Interventions of interest are:
• Transvenous implantable
cardioverter defibrillator
placement
Comparators
Comparators of interest are:
• Medical management
without implantable
cardioverter-defibrillator
placement
Individuals:
• With a high risk of
sudden cardiac death
due to nonischemic
dilated cardiomyopathy
in adulthood
Interventions of interest are:
• Transvenous implantable
cardioverter defibrillator
placement
Comparators of interest are:
• Medical management
without implantable
cardioverter-defibrillator
placement
Individuals:
• With a high risk of
sudden cardiac death
due to hypertrophic
cardiomyopathy in
adulthood
Interventions of interest are:
• Transvenous implantable
cardioverter defibrillator
placement
Comparators of interest are:
• Medical management
without implantable
cardioverter-defibrillator
placement
Outcomes
Relevant outcomes
include:
• Overall survival
• Morbid events
• Quality of life
• Treatment-related
morbidity
• Treatment-related
mortality
Relevant outcomes
include:
• Overall survival
• Morbid events
• Quality of life
• Treatment-related
morbidity
• Treatment-related
mortality
Relevant outcomes
include:
• Overall survival
• Morbid events
• Quality of life
• Treatment-related
morbidity
• Treatment-related
mortality
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Protocol
Implantable Cardioverter Defibrillator
Last Review Date: 11/15
Populations
Individuals:
• With high risk of sudden
cardiac death due to an
inherited cardiac ion
channelopathy
Interventions
Interventions of interest are:
• Transvenous implantable
cardioverter defibrillator
placement
Comparators
Comparators of interest are:
• Medical management
without implantable
cardioverter-defibrillator
placement
Individuals:
• With indications for
implantable cardioverter
defibrillator without
need for antibradycardia
pacing and without
arrhythmias responsive
to antitachycardia pacing
Interventions of interest are:
• Subcutaneous implantable
cardioverter defibrillator
placement
Comparators of interest are:
• Transvenous implantable
cardioverter-defibrillator
placement
Outcomes
Relevant outcomes
include:
• Overall survival
• Morbid events
• Quality of life
• Treatment-related
morbidity
• Treatment-related
mortality
Relevant outcomes
include:
• Overall survival
• Morbid events
• Quality of life
• Treatment-related
morbidity
• Treatment-related
mortality
Description
The automatic implantable cardioverter defibrillator (ICD) is a device designed to monitor a patient’s heart rate,
recognize ventricular fibrillation (VF) or ventricular tachycardia (VT), and deliver an electric shock to terminate
these arrhythmias to reduce the risk of sudden death. A subcutaneous ICD (S-ICD) has been developed that does
not employ transvenous leads, with the goal of reducing lead-related complications.
Summary of Evidence
The evidence for transvenous implantable cardioverter-defibrillator (TV-ICD) placement in individuals with high
risk of sudden cardiac death (SCD) in adulthood due to ischemic or nonischemic cardiomyopathy includes
multiple well-designed, well-conducted randomized controlled trials (RCTs) and systematic reviews of these
trials. Relevant outcomes include overall survival, morbid events, quality of life, and treatment-related morbidity
and mortality. There is an extensive literature base on the use of ICDs in patients with prior arrhythmogenic
events and ischemic cardiomyopathy. Earlier trials first demonstrated a benefit in overall mortality for survivors
of cardiac arrest and patients with potentially lethal cardiac arrhythmias. Multiple, well-done, RCTs have also
demonstrated a benefit in overall mortality for patients with ischemic cardiomyopathy and reduced ejection
fraction. RCTs of early ICD implantation following acute myocardial infarction (MI) do not support a benefit for
immediate ICD implantation versus delayed implantation for at least 40 days. For nonischemic cardiomyopathy
(NICM), there is less clinical trial evidence available, but the available evidence from a limited number of RCTs
enrolling patients with NICM, and from subgroup analysis of RCTs with mixed populations, supports a survival
benefit for this group. There is no high-quality evidence available to determine whether early versus delayed
implantation improves outcomes for patients with NICM, and it is not possible to determine the optimal waiting
period for ICD implantation following onset of NICM. At least one cohort study reports that most patients who
meet criteria for an ICD at the time of initial NICM diagnosis will no longer meet the criteria for an ICD several
months after initiation of treatment. The evidence is sufficient to determine qualtitatively that the technology
results in a meaningful improvement in the net health outcome.
The evidence for TV-ICD placement in individuals with high risk of SCD in adulthood due to hypertrophic cardiomyopathy (HCM) includes several large registry studies. Relevant outcomes include overall survival, morbid
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Last Review Date: 11/15
events, quality of life, and treatment-related morbidity and mortality. In these studies, the annual rate of
appropriate ICD discharge ranged from 3.6% to 5.3%. Given the long-term high risk of patients with HCM for SCD
risk, with the assumption that appropriate shocks are life-saving, these rates are considered adequate evidence
for the use of SCDs in patients with HCM. The evidence is sufficient to determine qualitatively that the
technology results in a meaningful improvement in the net health outcome.
The evidence for TV-ICD placement in individuals with high risk of SCD due to an inherited cardiac ion channelopathy includes small cohort studies of patients with these conditions treated with ICDs. Relevant outcomes
include overall survival, morbid events, quality of life, and treatment-related morbidity and mortality. The
limited available evidence for patients with long QT syndrome (LQTS), catecholaminergic polymorphic
ventricular tachycardia (CPVT), and Brugada syndrome (BrS) reports high rates of appropriate shocks. No studies
were identified on the use of ICDs for patients with short QT syndrome (SQTS). Studies comparing outcomes
between patients treated and untreated with ICDs are not available. However, given the relatively small patient
populations and the high risk of cardiac arrhythmias, clinical trials are unlikely. The evidence is insufficient to
determine the effects of the technology on health outcomes.
The evidence for S-ICD placement in individuals with indications for a TV-ICD but without indications for antibradycardia pacing and without arrhythmias responsive to antitachycardia pacing includes nonrandomized
controlled studies and case series. Relevant outcomes include overall survival, morbid events, quality of life, and
treatment-related morbidity and mortality. Nonrandomized controlled studies report success rates in
terminating laboratory-induced VFs that are similar to TV-ICD. However, there is scant evidence on comparative
clinical outcomes of both types of ICD over longer periods of time. Case series report high rates of detection and
successful conversion of VT, and inappropriate shock rates that are in the range reported for TV-ICD. This
evidence is not sufficient to determine whether there are small differences in efficacy between the two types of
devices, which may be clinically important due to the nature to the disorder being treated. Also, the adverse
event (AE) rate is uncertain, with variable rates reported. At least one RCT is currently underway to compare SICD with TV-ICD. The evidence is insufficient to determine the effects of the technology on health outcomes.
Policy
Adults
The use of the automatic implantable cardioverter defibrillator (ICD) may be considered medically necessary in
adults who meet the following criteria:
Primary Prevention
•
Ischemic cardiomyopathy with New York Heart Association (NYHA) functional class II or class III symptoms, a
history of myocardial infarction at least 40 days before ICD treatment, and left ventricular ejection fraction
of 35% or less; or
•
ischemic cardiomyopathy with NYHA functional class I symptoms, a history of myocardial infarction at least
40 days before ICD treatment and left ventricular ejection fraction of 30% or less; or
•
nonischemic dilated cardiomyopathy and left ventricular ejection fraction of 35% or less, after reversible
causes have been excluded, and the response to optimal medical therapy has been adequately determined;
or
•
hypertrophic cardiomyopathy (HCM) with one or more major risk factors for sudden cardiac death (history
of premature HCM-related sudden death in one or more first-degree relatives younger than 50 years; left
ventricular hypertrophy greater than 30 mm; one or more runs of nonsustained ventricular tachycardia at
heart rates of 120 beats per minute or greater on 24-hour Holter monitoring; prior unexplained syncope
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inconsistent with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a
physician experienced in the care of patients with HCM.
•
diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for
sudden cardiac death (see Policy Guidelines):
o
congenital long QT syndrome; OR
o
Brugada syndrome; OR
o
short QT syndrome; OR
o
catecholaminergic polymorphic ventricular tachycardia.
Secondary Prevention
•
Patients with a history of a life-threatening clinical event associated with ventricular arrhythmic events such
as sustained ventricular tachyarrhythmia, after reversible causes (e.g., acute ischemia) have been excluded.
The use of the ICD is considered investigational in primary prevention patients who:
•
have had an acute myocardial infarction (i.e., less than 40 days before ICD treatment);
•
have NYHA Class IV congestive heart failure (unless patient is eligible to receive a combination cardiac
resynchronization therapy ICD device);
•
have had cardiac revascularization procedure in past three months (coronary artery bypass graft [CABG] or
percutaneous transluminal coronary angioplasty [PTCA]) or are candidates for a cardiac revascularization
procedure; or
•
have noncardiac disease that would be associated with life expectancy less than one year.
Pediatrics
The use of the ICD may be considered medically necessary in children who meet any of the following criteria:
•
survivors of cardiac arrest, after reversible causes have been excluded;
•
symptomatic, sustained ventricular tachycardia in association with congenital heart disease in patients who
have undergone hemodynamic and electrophysiologic evaluation; or
•
congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular
dysfunction or inducible ventricular arrhythmias.
•
hypertrophic cardiomyopathy (HCM) with one or more major risk factors for sudden cardiac death (history
of premature HCM-related sudden death in one or more first-degree relatives younger than 50 years;
massive left ventricular hypertrophy based on age-specific norms; prior unexplained syncope inconsistent
with neurocardiogenic origin) and judged to be at high risk for sudden cardiac death by a physician
experienced in the care of patients with HCM.
•
diagnosis of any one of the following cardiac ion channelopathies and considered to be at high risk for
sudden cardiac death (see Policy Guidelines):
o
congenital long QT syndrome; OR
o
Brugada syndrome; OR
o
short QT syndrome; OR
o
catecholaminergic polymorphic ventricular tachycardia.
The use of the ICD is considered investigational for all other indications in pediatric patients.
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Protocol
Implantable Cardioverter Defibrillator
Last Review Date: 11/15
Subcutaneous ICD
The use of a subcutaneous ICD may be considered medically necessary for adults or children who have an
indication for ICD implantation for primary or secondary prevention for any of the above reasons and meet all of
the following criteria:
•
Have a contraindication to a transvenous ICD due to one or more of the following: (1) lack of adequate
vascular access; (2) compelling reason to preserve existing vascular access (i.e., need for chronic dialysis;
younger patient with anticipated long-term need for ICD therapy); or (3) history of need for explantation of
a transvenous ICD due to a complication, with ongoing need for ICD therapy.
•
Have no indication for antibradycardia pacing; AND
•
Do not have ventricular arrhythmias that are known or anticipated to respond to antitachycardia pacing.
The use of a subcutaneous ICD is considered investigational for individuals who do not meet the criteria
outlined above.
Policy Guidelines
This Protocol addresses the use of ICD devices as stand-alone interventions, not as combination devices to treat
heart failure (i.e., cardiac resynchronization devices) or in combination with pacemakers. Unless specified, the
policy statements are referring to transvenous ICDs.
Indications for pediatric ICD use are based on American College of Cardiology/American Heart Association/Heart
Rhythm Society (ACC/AHA/HRS) guidelines published in 2008, which acknowledged the lack of primary research
in this field on pediatric patients. These are derived from nonrandomized studies, extrapolation from adult
clinical trials, and expert consensus.
Criteria for ICD Implantation in Patients with Cardiac Ion Channelopathies
Individuals with cardiac ion channelopathies may have a history of a life-threatening clinical event associated
with ventricular arrhythmic events such as sustained ventricular tachyarrhythmia, after reversible causes, in
which case they should be considered for ICD implantation for secondary prevention, even if they do not meet
criteria for primary prevention.
Criteria for ICD implantation in patients with cardiac ion channelopathies are derived from results of clinical
input, a 2013 consensus statement from the HRS, European Heart Rhythm Association (EHRA), and the AsiaPacific Heart Rhythm Society on the diagnosis and management of patients with inherited primary arrhythmia
syndromes (Priori et al, 2013), 2013 guidelines from the ACC, AHA, HRS, the American Association of Thoracic
Surgeons, and the Society of Thoracic Surgeons on device-based therapy of cardiac rhythm abnormalities (Tracy
et al, 2013), and a report from the HRS/EHRA’s Second Consensus Conference on Brugada syndrome
(Antzelevitch et al, 2005).
Indications for consideration for ICD implantation for each cardiac ion channelopathy are as follows:
•
•
Long QT syndrome:
o
Patients with a diagnosis of LQTS who are survivors of cardiac arrest.
o
Patients with a diagnosis of LQTS who experience recurrent syncopal events while on beta-blocker
therapy.
Brugada syndrome:
o
Patients with a diagnosis of BrS who are survivors of cardiac arrest.
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Protocol
•
•
Implantable Cardioverter Defibrillator
Last Review Date: 11/15
o
Patients with a diagnosis of BrS who have documented spontaneous sustained ventricular tachycardia
(VT) with or without syncope.
o
Patients with a spontaneous diagnostic type 1 ECG who have a history of syncope, seizure, or nocturnal
agonal respiration judged to be likely caused by ventricular arrhythmias (after noncardiac causes have
been ruled out).
o
Patients with a diagnosis of BrS who develop ventricular fibrillation (VF) during programmed electrical
stimulation.
Catecholaminergic polymorphic ventricular tachycardia:
o
Patients with a diagnosis of CPVT who are survivors of cardiac arrest.
o
Patients with a diagnosis of CPVT who experience recurrent syncope or polymorphic/bidirectional VT
despite optimal medical management, and/or left cardiac sympathetic denervation.
Short QT syndrome:
o
Patients with a diagnosis of SQTS who are survivors of cardiac arrest.
o
Patients with a diagnosis of SQTS who are symptomatic and have documented spontaneous VT with or
without syncope.
o
Patients with a diagnosis of SQTS or are asymptomatic or symptomatic and have a family history of
sudden cardiac death.
NOTE: For congenital LQTS, patients may have one or more clinical or historical findings other than those
outlined above that may, alone or in combination, put them at higher risk for sudden cardiac death. These may
include patients with a family history of sudden cardiac death due to LQTS, infants with a diagnosis of LQTS with
functional 2:1 atrioventricular block, patients with a diagnosis of LQTS in conjunction with a diagnosis of Jervell
and Lange-Nielsen syndrome or Timothy syndrome, and patients with a diagnosis of LQTS with profound QT
prolongation (greater than 550 msec). These factors should be evaluated on an individualized basis by a clinician
with expertise in LQTS in considering the need for an ICD implantation.
Medicare Advantage
For Medicare Advantage an implantable automatic defibrillator is medically necessary when the following
indications are met:
1. Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible
cause.
2. Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an
electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a
transient or reversible cause.
3. Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT
syndrome or hypertrophic cardiomyopathy.
4. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction (LVEF)
less than 0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 40 days
prior to defibrillator insertion. The EP test must be performed more than four weeks after the qualifying MI.)
5. Documented prior MI and a measured LVEF less than 0.30; patients must not have:
a. New York Heart Association (NYHC) classification IV;
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b. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
c. Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA)
within past three months;
d. Had an enzyme positive MI within past month and must not have had an acute MI in the past 40 days;
e. Clinical symptoms or findings that would make them a candidate for coronary revascularization; or
f.
Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood
of survival less than one year.
6. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III heart
failure, and measured LVEF less than 35%;
7. Patients with non-ischemic dilated cardiomyopathy (NIDCM) greater than nine months, NYHA Class II and III
heart failure, and measured LVEF less than 35%;
8. Patients who meet all current Centers for Medicare & Medicaid Services (CMS) coverage requirements for a
cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure;
All indications must meet the following criteria:
a. Patients must not have irreversible brain damage from preexisting cerebral disease;
b. MIs must be documented and defined according to the consensus document of the Joint European
Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial
Infarction;
Indications 3 - 8 (primary prevention of sudden cardiac death) must also meet the following criteria:
a. Patients must be able to give informed consent;
b. Patients must not have:
1. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
2. Had a CABG or PTCA within the past three months;
3. Had an acute MI within the past 40 days;
4. Clinical symptoms or findings that would make them a candidate for coronary revascularization;
5. Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a
likelihood of survival less than one year;
c. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography;
d. The patient receiving the defibrillator implantation for primary prevention is enrolled in either a Food
and Drug Administration (FDA)-approved category B investigational device exemption (IDE) clinical trial,
a trial under the CMS Clinical Trial Policy or a qualifying data collection system including approved
clinical trials and registries.
e. Providers must be able to justify the medical necessity of devices other than single lead devices. This
justification should be available in the patient’s medical record.
9. Patients with NIDCM greater than three months, NYHA Class II or III heart failure, and measured LVEF less
than 35%, only if the following additional criteria are also met:
a. Patients must be able to give informed consent;
b. Patients must not have:
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1. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
2. Had a CABG or PTCA within the past three months;
3. Had an acute MI within the past 40 days;
4. Clinical symptoms or findings that would make them a candidate for coronary revascularization;
5. Irreversible brain damage from preexisting cerebral disease;
6. Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a
likelihood of survival less than one year;
c. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography;
d. MIs must be documented and defined according to the consensus document of the Joint European
Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial
Infarction;
e. The patient receiving the defibrillator implantation for this indication is enrolled in either an FDAapproved category B IDE clinical trial, a trial under the CMS Routine Services of a Clinical Trial Policy, or a
prospective data collection system meeting the following basic criteria:
1. Written protocol on file;
2. Institutional Review Board review and approval;
3. Scientific review and approval by two or more qualified individuals who are not part of the research
team;
4. Certification that investigators have not been disqualified.
CMS will determine whether specific registries or clinical trials meet these criteria.
f.
Providers must be able to justify the medical necessity of devices other than single lead devices. This
justification should be available in the patient’s medical record.
Other Indications
All other indications for implantable automatic defibrillators not currently covered in accordance with these
criteria may fall under clinical trials.
Background
Automatic implantable cardioverter defibrillators (ICD) monitor a patient’s heart rate, recognize ventricular
fibrillation (VF) or ventricular tachycardia (VT), and deliver an electric shock to terminate these arrhythmias to
reduce the risk of sudden death. Indications for ICD implantation can be broadly subdivided into (1) secondary
prevention, i.e., their use in patients who have experienced a potentially life-threatening episode of VT (near
sudden cardiac death); and (2) primary prevention, i.e., their use in patients who are considered at high risk for
sudden cardiac death but who have not yet experienced life-threatening VT or VF.
The standard ICD involves placement of a generator in the subcutaneous tissue of the chest wall. Transvenous
leads are attached to the generator and threaded intravenously into the endocardium. The leads sense and
transmit information on cardiac rhythm to the generator, which analyzes the rhythm information and produces
an electrical shock when a malignant arrhythmia is recognized.
A totally subcutaneous ICD (S-ICD®) has also been developed. This device does not employ transvenous leads
and thus avoids the need for venous access and complications associated with the venous leads. Rather, the SPage 8 of 16
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ICD® uses a subcutaneous electrode that is implanted adjacent to the left sternum. The electrodes sense the
cardiac rhythm and deliver countershocks through the subcutaneous tissue of the chest wall.
Several automatic ICDs are approved by U.S. Food and Drug Administration (FDA) through the premarket
approval application (PMA) process. FDA-labeled indications generally include patients who have experienced
life-threatening VT associated with cardiac arrest or VT associated with hemodynamic compromise and
resistance to pharmacologic treatment. Devices manufactured by Guidant are approved by FDA for use “in
patients at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced at least
one of the following: an episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular
tachyarrhythmia; recurrent, poorly tolerated sustained ventricular tachycardia (VT); or a prior myocardial
infarction (MI), left ventricular ejection fraction of less than or equal to 35%, and a documented episode of
nonsustained VT, with an inducible ventricular tachyarrhythmia.”
On July 18, 2002, FDA expanded the approved indications for the Guidant ICD devices to include the
prophylactic use of Guidant ICDs for cardiac patients who have had a previous heart attack and have an ejection
fraction that is 30% or less. This expanded indication is based on the results of the second Multicenter
Automatic Defibrillator Implantation Trial (MADIT II trial), which is discussed here. Medtronic devices are
approved “to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment
of life-threatening ventricular arrhythmias.” Other devices have approval language similar to that of Medtronic.
Regulatory Status
Transvenous Implantable Cardioverter Defibrillators
The Food and Drug Administration (FDA) has approved a large number of ICDs through the premarket approval
(PMA) process (FDA product code: LWS). A 2014 review of FDA approvals of cardiac implantable devices
reported that, between 1979 and 2012, FDA approved 19 ICDs (seven pulse generators, three leads, nine
combined systems) through new PMA applications.1 Many originally-approved ICDs have undergone multiple
supplemental applications. A summary of some currently-available ICDs is provided in Table 1 (not an exhaustive
list).
Table 1: Implantable Cardioverter Defibrillator with FDA Approval
Device
Ellipse/Fortify Assura Family
(originally: Cadence Tiered Therapy
Defibrillation System)
Current Plus ICD (originally: Cadence
Tiered Therapy Defibrillation System)
Dynagen, Inogen, Origen, and Teligen
Family (originally: Ventak, Vitality,
Cofient family)
Evera Family (originally: Virtuosos/
Entrust/Maximo/Intrisic/Marquis
family)
Subcutaneous Implantable
Defibrillator System
St. Jude Medical, Inc. (St. Paul, MN)
Original PMA
Approval Date
July 1993
Transvenous
St. Jude Medical, Inc. (St. Paul, MN)
July 1993
Transvenous
Boston Scientific, Inc. (Marlborough, MA)
January 1998
Transvenous
Medtronic, Inc. (Minneapolis, MN)
December 1998
Transvenous
Cameron Health, Inc. (San Clemente, CA);
acquired by Boston Scientific, Inc.
September 2012
Subcutaneous
Manufacturer
Type
Subcutaneous ICDs
In September 2012, the FDA approved the Subcutaneous Implantable Defibrillator (S-ICD®) System (Cameron
Health, Inc, San Clemente, CA; acquired by Boston Scientific, Inc. Marlborough, MA), through the PMA process
for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic
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bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that
is reliably terminated with anti-tachycardia pacing.
In March 2015, the Emblem S-ICD™ (Boston Scientific, Inc.), which is smaller and longer-lasting than the original
S-ICD, was cleared for marketing through a PMA supplement.
NOTE: ICDs may be combined with other pacing devices, such as pacemakers for atrial fibrillation, or
biventricular pacemakers designed to treat heart failure. This evidence review addresses ICDs alone, when used
solely to treat patients at risk for ventricular arrhythmias.
Related Protocol
Biventricular Pacemakers (Cardiac Resynchronization Therapy) for the Treatment of Heart Failure
Services that are the subject of a clinical trial do not meet our Technology Assessment Protocol criteria and are
considered investigational. For explanation of experimental and investigational, please refer to the Technology
Assessment Protocol.
It is expected that only appropriate and medically necessary services will be rendered. We reserve the right to
conduct prepayment and postpayment reviews to assess the medical appropriateness of the above-referenced
procedures. Some of this Protocol may not pertain to the patients you provide care to, as it may relate to
products that are not available in your geographic area.
References
We are not responsible for the continuing viability of web site addresses that may be listed in any references
below.
1. Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electronic devices via original and
supplement premarket approval pathways, 1979-2012. JAMA. Jan 22-29 2014; 311(4):385-391. PMID
24449317
2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Use of implantable cardioverter
defibrillators for prevention of sudden death in patients at high risk for ventricular arrhythmia. TEC
Assessments 2002; 17(Tab 10).
3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Use of implantable cardioverter
defibrillators for prevention of sudden death in patients at high risk for ventricular arrhythmia. TEC
Assessments 2004; 19(Tab 19). PMID
4. Desai AS, Fang JC, Maisel WH, et al. Implantable defibrillators for the prevention of mortality in patients with
nonischemic cardiomyopathy—a meta-analysis of randomized controlled trials. JAMA. 2004; 292(23):28742879.
5. Uhlig K, Balk EM, Earley A, et al. Assessment on Implantable Defibrillators and the Evidence for Primary
Prevention of Sudden Cardiac Death. Rockville (MD); 2013.
6. Raviele A, Bongiorni MG, Brignole M, et al. Early EPS/ICD strategy in survivors of acute myocardial infarction
with severe left ventricular dysfunction on optimal beta-blocker treatment: The Beta-blocker Strategy plus
ICD trial. Europace. 2005; 7(4):327-337.
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7. Steinbeck G, Andresen D, Seidl K, et al. Defibrillator implantation early after myocardial infarction. N Engl J
Med. 2009; 361(15):1427-1436.
8. Maron BJ, Spirito P, Shen WK, et al. Implantable cardioverter-defibrillators and prevention of sudden cardiac
death in hypertrophic cardiomyopathy. JAMA. 2007; 298(4):405-412.
9. Ellenbogen KA, Levine JH, Berger RD, et al. Are implantable cardioverter defibrillator shocks a surrogate
forsudden cardiac death in patients with nonischemic cardiomyopathy? Circulation. Feb 14 2006;
113(6):776-782. PMID 16461817
10. Magnusson P, Gadler F, Liv P, et al. Hypertrophic cardiomyopathy and implantable defibrillators in Sweden:
inappropriate shocks and complications requiring surgery. J Cardiovasc Electrophysiol. Oct 2015;
26(10):1088-1094. PMID 26178879
11. Kadish A, Schaechter A, Subacius H, et al. Patients with recently diagnosed nonischemic cardiomyopathy
benefit from implantable cardioverter-defibrillators. J Am Coll Cardiol. 2006; 47(12):2477-2482.
12. Bansch D, Antz M, Boczor S, et al. Primary prevention of sudden cardiac death in idiopathic dilated
cardiomyopathy: the Cardiomyopathy Trial (CAT). Circulation. 2002; 105(12):1453-1458.
13. Zecchin M, Merlo M, Pivetta A, et al. How can optimization of medical treatment avoid unnecessary
implantable cardioverter-defibrillator implantations in patients with idiopathic dilated cardiomyopathy
presenting with “SCDHeFTcriteria?”. Am J Cardiol. Mar 1 2012; 109(5):729-735. PMID 22176998
14. Sheppard R, Mather PJ, Alexis JD, et al. Implantable cardiac defibrillators and sudden death in recent onset
nonischemic cardiomyopathy: results from IMAC2. J Card Fail. Sep 2012; 18(9):675-681. PMID 22939035
15. Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of
Cardiac Rhythm Abnormalities: a report of the American College of Cardiology/American Heart Association
Task Force on Practice Guidelines (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update
for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices): developed in collaboration with the
American Association for Thoracic Surgery and Society of Thoracic Surgeons. Circulation. 2008;
117(21):e350-408.
16. Jessup M, Abraham WT, Casey DE, et al. 2009 focused update: ACCF/AHA Guidelines for the Diagnosis and
Management of Heart Failure in Adults: a report of the American College of Cardiology
Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with
the International Society for Heart and Lung Transplantation. Circulation. 2009; 119(14):1977-2016.
Available online at: http://content.onlinejacc.org/cgi/reprintsidebar/1953/1915/1343. Last accessed
November 2009.
17. Horner JM, Kinoshita M, Webster TL, et al. Implantable cardioverter defibrillator therapy for congenital long
QT syndrome: a single-center experience. Heart Rhythm. Nov 2010; 7(11):1616-1622. PMID 20816872
18. Conte G, Sieira J, Ciconte G, et al. Implantable cardioverter-defibrillator therapy in Brugada syndrome: a 20year single-center experience. J Am Coll Cardiol. Mar 10 2015; 65(9):879-888. PMID 25744005
19. Dores H, Reis Santos K, Adragao P, et al. Long-term prognosis of patients with Brugada syndrome and an
implanted cardioverter-defibrillator. Rev Port Cardiol. Jun 2015; 34(6):395-402. PMID 26028488
20. Steven D, Roberts-Thomson KC, Inada K, et al. Long-term follow-up in patients with presumptive Brugada
syndrome treated with implanted defibrillators. J Cardiovasc Electrophysiol. Oct 2011; 22(10):1115-1119.
PMID 21545364
Page 11 of 16
Protocol
Implantable Cardioverter Defibrillator
Last Review Date: 11/15
21. Daoulah A, Alsheikh-Ali AA, Ocheltree AH, et al. Outcome after implantable cardioverter-defibrillator in
patients with Brugada syndrome: the Gulf Brugada syndrome registry. J Electrocardiol. May-Jun 2012;
45(3):327-332. PMID 22074744
22. Roses-Noguer F, Jarman JW, Clague JR, et al. Outcomes of defibrillator therapy in catecholaminergic
polymorphic ventricular tachycardia. Heart Rhythm. Jan 2014; 11(1):58-66. PMID 24120999
23. Berul CI, Van Hare GF, Kertesz NJ, et al. Results of a multicenter retrospective implantable cardioverter
defibrillator registry of pediatric and congenital heart disease patients. J Am Coll Cardiol. 2008; 51(17):16851691.
24. Silka M, Kron J, Dunnigan A, et al. Sudden cardiac death and the use of implantable cardioverterdefibrillators in pediatric patients. Circulation. 1993; 87(3):800-807.
25. Alexander ME, Cecchin F, Walsh EP, et al. Implications of implantable cardioverter-defibrillator therapy in
congenital heart disease and pediatrics. J Cardiovasc Electrophysiol. 2004; 15(1):72-76.
26. Lewandowski M, Sterlinski M, Maciag A, et al. Long-term follow-up of children and young adults treated with
implantable cardioverter-defibrillator: the authors’ own experience with optimal implantable cardioverter
defibrillator programming. Europace. 2010; 12(9):1245-1250.
27. Persson R, Earley A, Garlitski AC, et al. Adverse events following implantable cardioverter defibrillator
implantation: a systematic review. J Interv Card Electrophysiol. Aug 2014; 40(2):191-205. PMID 24948126
28. Ezzat VA, Lee V, Ahsan S, et al. A systematic review of ICD complications in randomised controlled trials
versus registries: is our ‘real-world’ data an underestimation? Open Heart. 2015; 2(1):e000198. PMID
25745566
29. Kirkfeldt RE, Johansen JB, Nohr EA, et al. Complications after cardiac implantable electronic device
implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. May 2014;
35(18):1186-1194. PMID 24347317
30. van Rees JB, de Bie MK, Thijssen J, et al. Implantation-related complications of implantable cardioverter
defibrillators and cardiac resynchronization therapy devices: a systematic review of randomized clinical
trials. J Am Coll Cardiol. Aug 30 2011; 58(10):995-1000. PMID 21867832
31. Maytin M, Jones SO, Epstein LM. Long-term mortality after transvenous lead extraction. Circ Arrhythm
Electrophysiol. Apr 2012; 5(2):252-257. PMID 22362891
32. Administration. FaD. Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator
(ICD) Leads Manufactured by St. Jude Medical, Inc.: FDA Safety Communication. 2014;
http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm314930.htm. Accessed September, 2014.
33. Hauser RG, Katsiyiannis WT, Gornick CC, et al. Deaths and cardiovascular injuries due to device-assisted
implantable cardioverter-defibrillator and pacemaker lead extraction. Europace. Mar 2010; 12(3):395-401.
PMID 19946113
34. Birnie DH, Parkash R, Exner DV, et al. Clinical predictors of Fidelis lead failure: report from the Canadian
Heart Rhythm Society Device Committee. Circulation. Mar 13 2012; 125(10):1217-1225. PMID 22311781
35. Hauser RG, Maisel WH, Friedman PA, et al. Longevity of Sprint Fidelis implantable cardioverter-defibrillator
leads and risk factors for failure: implications for patient management. Circulation. Feb 1 2011; 123(4):358363. PMID 21242478
36. Gould PA, Gula LJ, Champagne J, et al. Outcome of advisory implantable cardioverter-defibrillator
replacement: one-year follow-up. Heart Rhythm. Dec 2008; 5(12):1675-1681. PMID 19084804
Page 12 of 16
Protocol
Implantable Cardioverter Defibrillator
Last Review Date: 11/15
37. Eckstein J, Koller MT, Zabel M, et al. Necessity for surgical revision of defibrillator leads implanted long-term:
causes and management. Circulation. May 27, 2008; 117(21):2727-2733. PMID 18490526
38. Kleemann T, Becker T, Doenges K, et al. Annual rate of transvenous defibrillation lead defects in implantable
cardioverter-defibrillators over a period of > 10 years. Circulation. May 15, 2007; 115(19):2474-2480. PMID
17470696
39. Poole JE, Gleva MJ, Mela T, et al. Complication rates associated with pacemaker or implantable cardioverter
defibrillator generator replacements and upgrade procedures: results from the REPLACE registry.
Circulation. Oct 19 2010; 122(16):1553-1561. PMID 20921437
40. Ricci RP, Pignalberi C, Magris B, et al. Can we predict and prevent adverse events related to high-voltage
implantable cardioverter defibrillator lead failure? J Interv Card Electrophysiol. Jan 2012; 33(1):113-121.
PMID 21882010
41. Cheng A, Wang Y, Curtis JP, et al. Acute lead dislodgement and in-hospital mortality in patients enrolled in
the national cardiovascular data registry implantable cardioverter-defibrillator registry. J Am Coll Cardiol.
2010; 56(20):1651-1656. PMID
42. Borleffs CJ, van Erven L, van Bommel RJ, et al. Risk of failure of transvenous implantable cardioverter
defibrillator leads. Circ Arrhythm Electrophysiol. Aug 2009; 2(4):411-416. PMID 19808497
43. Faulknier BA, Traub DM, Aktas MK, et al. Time-dependent risk of Fidelis lead failure. Am J Cardiol. Jan 1
2010; 105(1):95-99. PMID 20102898
44. Smit J, Korup E, Schonheyder HC. Infections associated with permanent pacemakers and implanted
cardioverter-defibrillator devices: A 10-year regional study in Denmark. Scand J Infect Dis. 2010; 42(9):658664.
45. Nery PB, Fernandes R, Nair GM, et al. Device-related infection among patients with pacemakers and
implantable defibrillators: incidence, risk factors, and consequences. J Cardiovasc Electrophysiol. 2010;
21(7):786-790. PMID
46. Sohail MR, Hussain S, Le KY, et al. Risk factors associated with early-versus late-onset implantable
cardioverter-defibrillator infections. J Interv Card Electrophysiol. Aug 2011; 31(2):171-183. PMID 21365264
47. Chua JD, Wilkoff BL, Lee I, et al. Diagnosis and management of infections involving implantable electrophysiologic cardiac devices. Ann Intern Med. Oct 17 2000; 133(8):604-608. PMID 11033588
48. Borleffs CJ, Thijssen J, de Bie MK, et al. Recurrent implantable cardioverter-defibrillator replacement is
associated with an increasing risk of pocket-related complications. Pacing Clin Electrophysiol. Aug 2010;
33(8):1013-1019. PMID 20456647
49. Daubert JP, Zareba W, Cannom DS, et al. Inappropriate implantable cardioverter-defibrillator shocks in
MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol. Apr 8 2008;
51(14):1357-1365. PMID 18387436
50. Tan VH, Wilton SB, Kuriachan V, et al. Impact of programming strategies aimed at reducing nonessential
implantable cardioverter defibrillator therapies on mortality: a systematic review and meta-analysis. Circ
Arrhythm Electrophysiol. Feb 2014; 7(1):164-170. PMID 24446023
51. Auricchio A, Schloss EJ, Kurita T, et al. Low inappropriate shock rates in patients with single- and
dual/triplechamber implantable cardioverter-defibrillators using a novel suite of detection algorithms:
PainFree SST trial primary results. Heart Rhythm. May 2015; 12(5):926-936. PMID 25637563
Page 13 of 16
Protocol
Implantable Cardioverter Defibrillator
Last Review Date: 11/15
52. Lee DS, Krahn AD, Healey JS, et al. Evaluation of early complications related to De Novo cardioverter
defibrillator implantation insights from the Ontario ICD database. J Am Coll Cardiol. 2010; 55(8):774-782.
PMID
53. Furniss G, Shi B, Jimenez A, et al. Cardiac troponin levels following implantable cardioverter defibrillation
implantation and testing. Europace. Feb 2015; 17(2):262-266. PMID 25414480
54. Kobe J, Reinke F, Meyer C, et al. Implantation and follow-up of totally subcutaneous versus conventional
implantable cardioverter-defibrillators: a multicenter case-control study. Heart Rhythm. Jan 2013; 10(1):2936. PMID 23032867
55. Gold MR, Theuns DA, Knight BP, et al. Head-to-head comparison of arrhythmia discrimination performance
of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. J Cardiovasc
Electrophysiol. Apr 2012; 23(4):359-366. PMID 22035049
56. Pettit SJ, McLean A, Colquhoun I, et al. Clinical experience of subcutaneous and transvenous implantable
cardioverter defibrillators in children and teenagers. Pacing Clin Electrophysiol. Dec 2013; 36(12):1532-1538.
PMID 24033753
57. Jarman JW, Lascelles K, Wong T, et al. Clinical experience of entirely subcutaneous implantable cardioverter
defibrillators in children and adults: cause for caution. Eur Heart J. Jun 2012; 33(11):1351-1359. PMID
22408031
58. Lambiase PD, Barr C, Theuns DA, et al. Worldwide experience with a totally subcutaneous implantable
defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J. Jul 1 2014; 35(25):1657-1665.
PMID 24670710
59. Olde Nordkamp LR, Brouwer TF, Barr C, et al. Inappropriate shocks in the subcutaneous ICD: Incidence,
predictors and management. Int J Cardiol. Sep 15 2015; 195:126-133. PMID 26026928
60. Weiss R, Knight BP, Gold MR, et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter
defibrillator. Circulation. Aug 27 2013; 128(9):944-953. PMID 23979626
61. Gold MR, Weiss R, Theuns DA, et al. Use of a discrimination algorithm to reduce inappropriate shocks with a
subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. Aug 2014; 11(8):1352-1358. PMID
24732366
62. Burke MC, Gold MR, Knight BP, et al. Safety and efficacy of the totally subcutaneous implantable
defibrillator: 2-year results from a pooled analysis of the IDE Study and EFFORTLESS Registry. J Am Coll
Cardiol. Apr 28 2015; 65(16):1605-1615. PMID 25908064
63. Boersma L, Burke MC, Neuzil P, et al. Infection and Mortality After Implantation of the Subcutaneous ICD
Following Transvenous ICD Extraction. Heart Rhythm. Sep 1 2015. PMID 26341604
64. Knops RE, Brouwer TF, Barr CS, et al. The learning curve associated with the introduction of the
subcutaneous implantable defibrillator. Europace. Aug 31 2015. PMID 26324840
65. Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverter-defibrillator. N
Engl J Med. Jul 1 2010; 363(1):36-44. PMID 20463331
66. Theuns DA, Crozier IG, Barr CS, et al. Longevity of the subcutaneous implantable defibrillator: long-term
followup of the European Regulatory Trial cohort. Circ Arrhythm Electrophysiol. Oct 2015; 8(5):1159-1163.
PMID 26148819
67. 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. Nov 6 2012; 60(19):19331939. PMID 23062537
Page 14 of 16
Protocol
Implantable Cardioverter Defibrillator
Last Review Date: 11/15
68. Aydin A, Hartel F, Schluter M, et al. Shock efficacy of subcutaneous implantable cardioverter-defibrillator for
prevention of sudden cardiac death: initial multicenter experience. Circ Arrhythm Electrophysiol. Oct 2012;
5(5):913-919. PMID 22923274
69. El-Chami MF, Levy M, Kelli HM, et al. Outcome of subcutaneous implantable cardioverter defibrillator
implantation in patients with end-stage renal disease on dialysis. J Cardiovasc Electrophysiol. Aug 2015;
26(8):900-904. PMID 25952566
70. Kooiman KM, Knops RE, Olde Nordkamp L, et al. Inappropriate subcutaneous implantable cardioverter
defibrillator shocks due to T-wave oversensing can be prevented: Implications for management. Heart
Rhythm. 2014; 11(3):426-434. PMID
71. Brisben AJ, Burke MC, Knight BP, et al. A new algorithm to reduce inappropriate therapy in the S-ICD system.
J Cardiovasc Electrophysiol. Apr 2015; 26(4):417-423. PMID 25581303
72. Groh CA, Sharma S, Pelchovitz DJ, et al. Use of an electrocardiographic screening tool to determine
candidacy for a subcutaneous implantable cardioverter-defibrillator. Heart Rhythm. Aug 2014; 11(8):13611366. PMID 24755323
73. Yancy CW, Jessup M, al. e. 2013 ACCF/AHA guideline for the management of heart failure: A Report of the
American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.
AHA Journal 2013 (June 2013).
74. Tracy CM, Epstein AE, Darbar D, et al. 2012 ACCF/AHA/HRS focused update incorporated into the
ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: A Report of the
American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines
and the Heart Rhythm Society. J Am Coll Cardiol. 2013; 61(3):e6-e75.
75. Kusumoto FM, Calkins H, Boehmer J, et al. HRS/ACC/AHA Expert Consensus Statement on the Use of
Implantable Cardioverter-Defibrillator Therapy in Patients Who Are Not Included or Not Well Represented in
Clinical Trials. J Am Coll Cardiol. 2014; 64(11):1143-1177.
76. Gersh BJ, Maron BJ, Bonow RO, et al. 2011 ACCF/AHA guideline for the diagnosis and treatment of
hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart
Association Task Force on Practice Guidelines. Circulation. Dec 13 2011; 124(24):e783-831. PMID 22068434
77. Baddour LM, Epstein AE, Erickson CC, et al. Update on cardiovascular implantable electronic device
infections and their management: a scientific statement from the American Heart Association. Circulation.
Jan 26 2010; 121(3):458-477. PMID 20048212
78. Priori SG, Wilde AA, Horie M, et al. HRS/EHRA/APHRS expert consensus statement on the diagnosis and
management of patients with inherited primary arrhythmia syndromes: document endorsed by HRS, EHRA,
and APHRS in May 2013 and by ACCF, AHA, PACES, and AEPC in June 2013. Heart Rhythm. Dec 2013;
10(12):1932-1963. PMID 24011539
79. Antzelevitch C, Brugada P, Borggrefe M, et al. Brugada Syndrome: Report of the Second Consensus
Conference: Endorsed by the Heart Rhythm Society and the European Heart Rhythm Association.
Circulation. February 8, 2005; 111(5):659-670.
80. Khairy P, Van Hare GF, Balaji S, et al. PACES/HRS expert consensus statement on the recognition and
management of arrhythmias in adult congenital heart disease: developed in partnership between the
Pediatric and Congenital Electrophysiology Society (PACES) and the Heart Rhythm Society (HRS). Endorsed
by the governing bodies of PACES, HRS, the American College of Cardiology (ACC), the American Heart
Association (AHA), the European Heart Rhythm Association (EHRA), the Canadian Heart Rhythm Society
Page 15 of 16
Protocol
Implantable Cardioverter Defibrillator
Last Review Date: 11/15
(CHRS), and the International Society for Adult Congenital Heart Disease (ISACHD). Can J Cardiol. Oct 2014;
30(10):e1-e63. PMID 25262867
81. Centers for Medicare and Medicaid Services. Medicare policy. http://www.cms.gov/medicarecoveragedatabase/overview-and-quick-search.aspx?id=148. Accessed August 2014.
Page 16 of 16