Coverage Policy Manual
Policy #: 1997018
Category: Surgery
Initiated: August 1993
Last Review: July 2018
  Cardioverter Defibrillator; Implantable, Subcutaneous, and Wearable Cardioverter Defibrillator

Description:
Implantable Cardioverter Defibrillator (ICD)
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.
 
Indications for implantable cardioverter defibrillator (ICD) implantation can be broadly subdivided into (1) secondary prevention, ie, their use in patients who have experienced a potentially life-threatening episode of ventricular tachycardia (VT; (near sudden cardiac death); and (2) primary prevention, ie, their use in patients who are considered at high risk for sudden cardiac death but who have not yet experienced life threatening VT or ventricular fibrillation (VF).
 
Subcutaneous ICD (S-ICD)
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 S-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.
 
On September 28, 2012, the S-ICD® system by Cameron Health, Inc. was approved by the FDA “to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, continual (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), which is smaller and longer-lasting than the original S-ICD, was cleared for marketing through a PMA supplement.
 
Wearable Cardioverter Defibrillator (WCD)
The wearable cardioverter-defibrillator vest (WCD) is an external device in the form of a vest that is worn underneath clothing that achieved FDA approval in 2001 “for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator” (FDA summary of safety and effectiveness, 2001). Since 2001, the FDA has approved advances to the vest, but the description indication for the vest has not changed. The vest contains a cardiac monitor, battery, a cardioverter, and a defibrillator (FDA approval for hardware change, 2006). The cardioverter component is designed to treat ventricular tachycardia detected by the monitor by delivering a low-voltage shock to convert the ventricular tachycardia to a normal rhythm. The defibrillator component treats monitor detected ventricular fibrillation with a higher voltage electrical shock to arrest the abnormal rhythm allowing the heart to resume a normal rhythm. The vest comes with a non-wearable battery for recharging, and a non-wearable modem that allows the patient to download electrocardiographic and discharge data to a physician’s office for review.
 
The vest must be worn at all times in order to be effective. (It cannot be worn if the vest is exposed to water – if bathing). Two pivotal trials, including a combined 289 patients, resulted in the FDA approval of the vest (2001), and included 12 deaths, 6 of which occurred in patients who were not wearing the vest at the time of sudden cardiac death. The results of these trials were not published until 2004 (Feldman, et.al., 2004). The vest is relatively heavy and patients have discontinued the vest for reasons of discomfort.
 
Regulatory Status:
The U.S. Food and Drug Administration (FDA) has approved a large number of implantable cardioverter defibrillators (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 (7 pulse generators, 3 leads, and 9 combined systems) through new PMA applications (Rome, 2014).
 
Note: The wearable cardioverter-defibrillator vest was previously addressed in policy #2004056. This device was added to this policy in the 2015 Update of the policy. Policy # 2004056 was archived.

Policy/
Coverage:
EFFECTIVE SEPTEMBER 2015
 
I. Implantable Cardioverter Defibrillator (ICD)
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
An implantable cardioverter defibrillator meets primary coverage criteria for effectiveness and is covered for patients in any of the following circumstances:
 
      • Patients who are survivors of cardiac arrest due to VF or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes.
      • Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable.
      • Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiological study.
      • Patients with LVEF less than 35% due to prior MI who are at least 40 days post-MI and are in NYHA functional Class II or III.
      • Patients with nonischemic DCM who have an LVEF less than or equal to 35% and who are in NYHA functional Class II or III.
      • Patients with LV dysfunction due to prior MI who are at least 40 days post-MI, have an LVEF less than 30%, and are in NYHA functional Class I.
      • Patients with nonsustained VT due to prior MI, LVEF less than 40%, and inducible VF or sustained VT at electrophysiological study.
      • Patients with unexplained syncope, significant LV dysfunction, and nonischemic DCM.
      • Patients with hypertrophic cardiomyopathy who have 1 or more major risk factors for SCD.
      • Patients with ARVD/C who have 1 or more risk factors for SCD.
      • Patients with long-QT syndrome who are experiencing syncope and/or VT while receiving beta blockers.
      • Non-hospitalized patients awaiting transplantation.
      • Patients with Brugada syndrome who have had syncope.
      • Patients with Brugada syndrome who have documented VT that has not resulted in cardiac arrest.
      • Patients with catecholaminergic polymorphic VT who have syncope and/or documented sustained VT while receiving beta blockers.
      • Patients with cardiac sarcoidosis, giant cell myocarditis, or Chagas disease.
      • Patients with symptomatic sustained VT in association with congenital heart disease who have undergone hemodynamic and electrophysiological evaluation.
      • Patients with congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmia at electrophysiological study.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Any other use of the implantable cardioverter defibrillator does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, any other use of the implantable cardioverter defibrillator is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
II. Subcutaneous implantable Cardioverter Defibrillator (S-ICD) (Revised Effective March 2016)
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
The use of a subcutaneous ICD meets member benefit certificate primary coverage criteria 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;  or (2) history of need for explantation of a transvenous ICD due to a complication, with ongoing need for ICD therapy; AND
      • Have no indication for antibradycardia pacing; AND
      • Do not have ventricular arrhythmias that are known or anticipated to respond to antitachycardia
pacing.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of a subcutaneous ICD for individuals who do not meet the criteria outlined above does not meet member benefit certificate primary coverage criteria and is not covered
 
For members with contracts without primary coverage criteria, the use of a subcutaneous ICD is considered investigational for individuals who do not meet the criteria outlined above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
III. Wearable Cardioverter Defibrillator (WCD) (Revised Effective April 2017; July 2017)
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
The wearable cardioverter defibrillator meets primary coverage criteria for effectiveness and is covered for the following conditions:
 
      • Adult patients who meet qualifications for implantation of an ICD (see above criteria), but because of the presence of a medical condition (e.g., localized skin/soft tissue infection at or near site of ICD implant, systemic infection),  the implantation must be temporarily postponed  [maximum benefit 90 days or less], OR
      • Adult patients who have an ICD which must be removed because of medical complication (e.g., infected ICD pocket, systemic infection), and must undergo a waiting period until the ICD can be replaced [maximum benefit 90 days or less]; OR
      • Patients with Long QT syndrome who are being evaluated for effectiveness of medical therapy [maximum benefit 90 days or less]; OR
      • Patients with a recent [< 30 days] MI and LVEF less than or equal to 35% [by most recent ECHO]:
        • If revasularization was not performed and LVEF is not expected to improve, the WCD is covered for up to 2 months [maximum benefit 60 days or less]; OR
        • If revascularization (percutaneous or surgical) was performed, and there is an expectation of possible improvement in left ventricular function, the WCD is covered for up to 4 months [maximum benefit 120 days or less]; OR
      • Patients with newly diagnosed dilated cardiomyopathy not due to recent MI, with LVEF less than or equal to 35%, the WCD is covered for up to 4 months [maximum benefit 120 days or less].
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
The use of the wearable cardioverter defibrillator does not meet member benefit certificate Primary Coverage Criteria for effectiveness in the following instances:
 
      • Patients who would meet any of the above coverage criteria, but have a psychiatric disorder that could prevent the patient from adherence to appropriate use of the device; OR
      • Patients with terminal illness (e.g. malignancy, dementia) (level III B evidence, American College of Cardiology).
 
For members with contracts without primary coverage criteria, the use of the wearable cardioverter defibrillator is investigational in the instances listed above as not meeting primary coverage criteria. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Any other use of the wearable cardioverter defibrillator does not meet member benefit certificate primary coverage criteria. For members with contracts without primary coverage criteria, any other use of the wearable cardioverter defibrillator is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
EFFECTIVE PRIOR TO SEPTEMBER 2015
An implantable defibrillator meets primary coverage criteria for effectiveness and is covered for patients in any of the following circumstances:
    • Patients who are survivors of cardiac arrest due to VF or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes.
    • Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable.
    • Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiological study.
    • Patients with LVEF less than 35% due to prior MI who are at least 40 days post-MI and are in NYHA functional Class II or III.
    • Patients with nonischemic DCM who have an LVEF less than or equal to 35% and who are in NYHA functional Class II or III.
    • Patients with LV dysfunction due to prior MI who are at least 40 days post-MI, have an LVEF less than 30%, and are in NYHA functional Class I.
    • Patients with nonsustained VT due to prior MI, LVEF less than 40%, and inducible VF or sustained VT at electrophysiological study.
    • Patients with unexplained syncope, significant LV dysfunction, and nonischemic DCM.
    • Patients with HCM who have 1 or more major risk factors for SCD.
    • Patients with ARVD/C who have 1 or more risk factors for SCD.
    • Patients with long-QT syndrome who are experiencing syncope and/or VT while receiving beta blockers.
    • Non hospitalized patients awaiting transplantation.
    • Patients with Brugada syndrome who have had syncope.
    • Patients with Brugada syndrome who have documented VT that has not resulted in cardiac arrest.
    • Patients with catecholaminergic polymorphic VT who have syncope and/or documented sustained VT while receiving beta blockers.
    • Patients with cardiac sarcoidosis, giant cell myocarditis, or Chagas disease.
    • Patients with symptomatic sustained VT in association with congenital heart disease who have undergone hemodynamic and electrophysiological evaluation.
    • Patients with congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias at electrophysiological study.
 
Any other use of ICDs does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
 
For contracts without Primary Coverage Criteria, any other use of ICDs is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
 
The use of a subcutaneous ICD for all indications in adult and pediatric patients does not meet member benefit certificate primary coverage criteria because there is a lack of scientific evidence of effectiveness. This device is currently being studied in ongoing clinical trials (NCT 01296022 and NCT 01085435). (Effective January 2013)
 
For members with contracts without primary coverage criteria, the use of a subcutaneous ICD is considered investigational for all indications in adult and pediatric patients. Investigational services are specific contract exclusions in most member benefit certificates of coverage. (Effective January 2013)
 

Rationale:
Due to the detail, the entire rationale is not online. If you would like a hardcopy print, please email : codespecificinquiry@arkbluecross.com
 
Automatic implantable cardiac defibrillators were first used in survivors of near sudden cardiac death.  There has been ongoing interest in using AICDs as primary preventive therapy in patients with risk factors for sudden cardiac death.  Two successive randomized clinical trials, known as MADIT I and MADIT II (Multicenter Automatic Defibrillator Implantation Trial) compared the use of an AICD with conventional therapy among patients with coronary artery disease with a prior history of myocardial infarction and a current history of a reduced ejection fraction.  The key difference in the 2 trials was the patient selection criteria.  In the earlier MADIT I trial, patients were required to have an ejection fraction of less than 35% but also ventricular tachyarrhythmia as evidenced on an electrophysiologic study.  In the subsequent MADIT II trial, the patients were required to have a lower ejection fraction, less than 30%, but no electrophysiologic study was required.  The MADIT II trial potentially identified a much larger number of candidates for AICD implantation.
 
Analysis of these two studies indicates that there is a statistically significant improvement in overall mortality associated with AICD treatment compared with conventional therapy.
 
Subsequent to these studies, the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) was reported in January 2005, demonstrating that a singe-lead, shock only, implantable cardioverter-defibrillator decreased the risk of sudden death in patients with NYHA class II congestive heart failure (but not class III).  This same trial showed no difference in effectiveness between placebo and amiodarone.  The authors of the study provided the following caveat: “ICD therapy cannot be considered a single intervention, given the numerous possible permutations of this approach.  Consequently, we cannot emphasize too strongly that we evaluated only very conservatively programmed ICDs with a conservative detection algorithm and shock-only therapy.  We found strong evidence that this approach works; however, considerable caution should be used in extrapolating our results to other approaches to ICD therapy, such as those involving dual-chamber or biventricular pacing, since, as reported previously, they may not afford the same benefit or, for that matter, any benefit. “  Despite the lack of apparent benefit for patients with NYHA class III CHF, the authors continued to recommend use of the ICD for this group of patients because of results from other trials of ICDs in patients with NYHA class III CHF.
 
In an editorial accompanying the SCD-HeFT report, Alan Kadish, MD, Division of Cardiology, Department of Medicine, Northwestern University, provided the following recommendations:
“How should physicians apply the results of the recent ICD trials in clinical practice? Patients with ejection fractions of less than 31 percent should be considered for a single-chamber ICD to improve their survival.  Resynchronization therapy should be used when appropriate (see Coverage Policy #2002005).  Patients with ejection fractions of 31 to 40% pose a more difficult treatment challenge.  For patients with coronary disease, data from some trials support the use of electrophysiological testing as an additional risk stratification tool.  For patients with nonischemic cardiomyopathy, reimbursement guidelines and clinical judgment should be used to evaluate the risk-benefit ration of the use of ICDs for patients with an ejection fraction of 31 to 35 percent, and the use of ICDs is probably not beneficial for patients with an ejection fraction of more than 35 percent.”
 
In May, 2008, the ACC/AHA/HRS released new guidelines for device-based therapy of cardiac rhythm guidelines.
 
2010 Update
Steinbeck and colleagues reported on the IRIS trial, a randomized, prospective, open-label study assessing the prophylactic implantation of an ICD early after myocardial infarction (Steinbeck, 2009).  Patients were enrolled within 5 to 31 days after experiencing a myocardial infarction if they met one of the following two criteria; They had an LVEF of ≤ 40% and a heart rate of ≥ 90 beats per minute (bpm) or they experienced non-sustained VT during holter monitoring with a heart rate of at least 150 bpm  on days 5 to 31 post MI.  Patients with NYHA Class IV heart failure were excluded from participating in the trial.  898 enrolled patients were randomly selected to receive treatment with either an ICD and optimal medical therapy or optimal medical therapy alone.  
 
After 37 months of follow-up no significant difference was noted in survival between the two groups. There were 117 deaths in the control group (medical therapy alone) and 116 deaths in the ICD group. The authors report they found no evidence that ICD implantation improved survival in patients with acute myocardial infarction meeting the study criteria. There was a reduction in the risk of sudden cardiac death but the risk of nonsudden cardiac death was increased.  The authors report this observation needs to be studied further.   
 
Results of this study confirm the results of an earlier study, the Defibrillator in Acute Myocardial Infarction Trial (DINAMIT) which reported a reduction in the rate of death following acute MI (6 to 40 days post MI) caused by arrhythmia which was offset by an increase in death from other causes.  There remains a lack of evidence to support the use of ICD implantation in the early period (less than 40 days) following myocardial infarction.
 
2012 Update
A literature search was conducted through September 2012.  There was no new literature identified that would prompt a change in the coverage statement.  The following is a summary of the key literature identified.
 
Al-Khatib et al. published an analysis of whether ICD implantations in the U.S. followed evidence-based guidelines using a Medicare ICD registry (Al-Khatib, 2011). There were a total of 111,707 patients who received an ICD between January 2006 and June 2009. Of these, 25,145 (22.5%) did not meet the evidence-based criteria according to ACC/AHA/HRS guidelines (Epstein, 2008). Patients who did not meet evidence-based ICD criteria had a higher mortality than patients who did meet criteria (0.57% vs. 0.18%, respectively; p<0.001) and also had a higher rate of procedural complications (3.2 vs. 2.4%, respectively; p<0.001). Electrophysiologists had a lower rate of non-evidence-based ICD use compared to non-electrophysiologists (20.8% vs. 24.8%, respectively; p<0.001).
 
Zecchin et al. performed a cohort study on 503 consecutive patients diagnosed with idiopathic NICM to determine the extent to which indications for an ICD evolved over the several months following an initial NICM diagnosis (Zecchin, 2012). At initial diagnosis, 245 met SCD-HeFT criteria for an ICD, based on an ejection fraction less than 35% and class II-III heart failure, and 258 did not meet criteria for an ICD. At a mean follow-up of 5.4 months in which patients were treated with angiotensin-converting enzyme inhibitors and beta blockers, there were consistent improvements in ejection fraction and symptoms, such that less than one-third of evaluable patients (31%) still had indications for ICD. Of patients who initially did not have an indication for an ICD, a total of 10% developed indications for an ICD at follow-up. This study highlights the fact that a decision for ICD implantation should not be made prior to optimal treatment and stabilization of patients with newly diagnosed NICM, since the indications for ICD are not stable over time and will change in a substantial numbers of patients following treatment.
 
In 2011, ACCF/AHA guidelines were published on the management of patients with hypertrophic cardiomyopathy (Gersh, 2011). These guidelines contained the following statements about the use of ICD in patients with HCM:
 
Class I recommendations (Procedure or Treatment should be performed)
 
    • The decision to place an ICD in patients with HCM should include application of individual clinical judgment, as well as a thorough discussion of the strength of evidence, benefits, and risks to allow the informed patient’s active participation in decision making. (Level of Evidence: C)  
    • ICD placement is recommended for patients with HCM with prior documented cardiac arrest, ventricular fibrillation, or hemodynamically significant VT (Level of Evidence: B)  
 
Class IIa recommendations (Additional studies with focused objective needed)
 
    • It is reasonable to recommend an ICD for patients with HCM with:
        • Sudden death presumably caused by HCM in 1 or more first-degree relatives.155 (Level of Evidence: C)  
        • A maximum LV wall thickness greater than or equal to 30 mm. (Level of Evidence: C)
        • One or more recent, unexplained syncopal episodes. (Level of Evidence: C)  
    • An ICD can be useful in select patients with NSVT (particularly those <30 years of age) in the presence of other SCD risk factors or modifiers. (Level of Evidence: C)  
    • An ICD can be useful in select patients with HCM with an abnormal blood pressure response with exercise in the presence of other SCD risk factors or modifiers. (Level of Evidence: C)  
    • It is reasonable to recommend an ICD for high-risk children with HCM, based on unexplained syncope, massive LV hypertrophy, or family history of SCD, after taking into account the relatively high complication rate of long-term ICD implantation. (Level of Evidence: C)  
 
Class IIb recommendations (Additional studies with broad objectives needed; additional registry data would be helpful)
 
    • The usefulness of an ICD is uncertain in patients with HCM with isolated bursts of NSVT when in the absence of any other SCD risk factors or modifiers. (Level of Evidence: C)  
    • The usefulness of an ICD is uncertain in patients with HCM with an abnormal blood pressure response with exercise when in the absence of any other SCD risk factors or modifiers, particularly in the presence of significant outflow obstruction. (Level of Evidence: C)  
 
Class III recommendations: Harm
 
    • ICD placement as a routine strategy in patients with HCM without an indication of increased risk is potentially harmful. (Level of Evidence: C)  
    • ICD placement as a strategy to permit patients with HCM to participate in competitive athletics is potentially harmful. (Level of Evidence: C)  
    • ICD placement in patients who have an identified HCM genotype in the absence of clinical manifestations of HCM is potentially harmful. (Level of Evidence: C)  
 
2013 Update
Subcutaneous ICD
The first study on outcomes of an entirely subcutaneous ICD was published in 2010 (Bardy, 2010). This study described the development and testing of the device, including empiric evidence for the optimal placement of the subcutaneous electrode. In addition, 55 patients were tested in the electrophysiology lab for termination of induced arrhythmias and subsequently followed for a mean of 10.1 months for successful termination of detected arrhythmias and clinical outcomes. In the electrophysiology lab study, intraoperative ventricular fibrillation was induced in 53/55. All episodes were correctly detected by the subcutaneous ICD. In 52/53 patients, 2 consecutive episodes of ventricular arrhythmia were successfully terminated. In the final patient, the arrhythmia was terminated on one occasion but not on the other. In the cohort portion of this study, 54/55 patients were alive at last follow-up. The one death was due to renal failure, and this patient requested removal of the subcutaneous ICD prior to death. An infection at the generator site occurred in 2 patients, necessitating a revision procedure. Another 3 patients had lead dislodgement requiring repositioning. There were a total of 12 episodes of ventricular tachycardia that were detected by the subcutaneous ICD; all 12 episodes were successfully terminated by countershock.
 
The Subcutaneous versus Transvenous Arrhythmia Recognition Testing (START) study compared the performance of a subcutaneous ICD with a transvenous ICD for detecting arrhythmias in the electrophysiology lab (Gold, 2012). The patient population included 64 patients who were scheduled for ICD implantation. All patients had a transvenous ICD placed, as well as subcutaneous electrodes attached to a subcutaneous ICD. Arrhythmias were induced and the sensitivity and specificity of detection by each device was compared. For ventricular arrhythmias, sensitivity of detection was 100% for the subcutaneous ICD and 99% for the transvenous ICD. Specificity was 98.0% for the subcutaneous ICD device compared to 76.7% for the transvenous device (p<0.001).
 
Ongoing Clinical Trials
NCT 01296022- A prospective, non-randomized, multicenter clinical study sponsored by Cameron Health, Inc. Patients meeting eligibility criteria for implanting an S-ICD System will be enrolled in this clinical study, implanted with an S-ICD System, and followed prior to hospital discharge, and post-implant at 30 days, 90 days, and 180 days. After the 180-day post-implant follow-up visit, patients will continue to be followed semi-annually until study closure. Estimated study completion date is October 2013.
 
NCT 01085435- This study is a post-market observational study sponsored by Cameron Health, Inc. Patients enrolled will be followed for up to 60 months post implant with a subcutaneous ICD. The patients' perception of their therapy will be evaluated using Quality of Life assessments and the Registry will include an exploratory analysis of resource utilization and costs based on measures of clinical outcome such as complication rates, unscheduled hospitalizations and length of stay. Estimated study completion date is October 2016.
 
2014 Update
 
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Perrson et al published a systematic review and meta-analysis of adverse events following ICD Implantation (Persson, 2014). The authors included data from 35 cohort studies, reported in 53 articles. In-hospital serious adverse event rates ranged from 1.2-1.4%, most frequently pneumothorax (0.4-0.5%) and cardiac arrest (0.3%). Post-hospitalization complication rates were variable: device-related complications occurred in 0.1-6.4%; lead-related complications in 0.1-3.9%; infection in 0.2-3.7%; thrombosis in 0.2-2.9%; and inappropriate shock in 3-21%.
 
Lead Failure
The failure of ICD leads in several specific ICD devices has lead the U.S. FDA to require St. Jude Medical to conduct three-year postmarket surveillance studies to address concerns related to premature insulation failure and to address important questions related to follow-up of affected patients (FDA, 2014).
 
Inappropriate Shocks
Ten et al conducted a systematic review to identify outcomes and adverse effects associated with ICDs that have built-in therapy reduction programming (Tan, 2014). Six randomized trials and 2 nonrandomized cohort studies were included, including 7,687 patients (3,598 with conventional ICDs and 4,089 therapy reduction programming). A total of 267 patients received inappropriate ICD shocks (4.9%); 99 (3.4%) in the therapy reduction and 168 (6.9%) in the conventional programming group (relative risk 50%; 95% CI 37% to 61%; P<0.001). Therapy reduction programming was associated with a significantly lower risk of death compared with conventional programming (relative risk 30%; 95% CI 16% to 41%; P<0.001.)
 
Noncomparative Studies
A number of single-arm studies have been published that report on outcomes of patients treated with an S-ICD. The largest such study was reported by Lambiase et al, who described patients in the EFFORTLESS-ICD registry, a multicenter European registry to report outcomes for patients treated with
S-ICD (Lambiase, 2014). At the time of analysis, the registry included 472 patients, 241 of whom (51%) were enrolled prospectively, at a median follow up time of 498 days. Nine patients (2%) died during the reported period, none of which were known to occur in the perioperative period, although the cause of death was unknown for one patient. A total of 317 spontaneous episodes in 85 patients were recorded during the follow-up, of which 169 episodes received therapy in 59 patients. Of the 145 classified untreated episodes, 93 were adjudicated as inappropriate sensing, 37 were non-sustained VT/VF, 12 were non-sustained SVT above discrimination zone, and 3 were unclassified. Of the VT/VF episodes, the first shock conversion efficacy was 88%, with 100% overall successful clinical conversion after a maximum of five shocks. A total of 73 inappropriate shocks were recorded in 32 patients over an average follow-up of 18 months (360 day inappropriate shock rate of 7%).
 
Gold et al published a sub-analysis of patients in the S-ICD IDE study to evaluate a discrimination algorithm to reduce inappropriate shocks (Gold, 2014). Patients in the study could receive one of two shock detection algorithms, a single- or double-zone configuration. In the single zone configuration, shocks are delivered for detected heart rates above the programmed rate threshold. In the dual zone configuration, arrhythmia discrimination algorithms are active in a lower rate zone up to a shockable heart rate threshold. At hospital discharge, dual zone programming was used in 226 subjects (72%) and single zone programming was used in the remaining 88 subjects (28%). Inappropriate shocks occurred on 23/226 (10.2%) subjects with dual zone programming and 23/88 (26.1%; P<0.001) subjects with single zone programming. Freedom from appropriate shocks did not differ between the groups.
 
Subcutaneous ICD Safety: Inappropriate Shocks
Although Kobe et al reported no differences between inappropriate shock rates in patients treated transvenous ICD or S-ICD; noncomparative studies have reported relatively high rates of inappropriate shocks with S-ICD. Inappropriate shocks from S-ICDs often result from T-wave oversensing. Since the sensing algorithm and the discrimination algorithm for arrhythmia detection is fixed in the S-ICD, management to reduce inappropriate shocks for an S-ICD differs from that for a transvenous ICD. Kooiman et al reported inappropriate shock rates among 69 patients treated at a single center with a SICD between February 2009 and July 2012 who were not enrolled in one of 2 other concurrent trials (Kooiman, 2014). Over a total follow up of 1,316 months (median per patient of 21 months), the annual incidence of inappropriate shocks was 10.8%. In 8 patients, inappropriate shocks were related to T-wave oversensing. After patients underwent adjustment of the sensing vector, no further inappropriate shocks occurred in 87.5% of patients with T-wave oversensing.
 
Groh et al evaluated an electrocardiographic (ECG) screening test to determine patients who are potential S-ICD candidates who are at risk for T-wave oversensing (Groh, 2014). One hundred patients who had previously undergone transvenous ICD implantation and who were not receiving bradycardia pacing and did not have an indication for pacing were included. ECGs were obtained with lead placement to mimic the sensing vectors available on the S-ICD, and a patient was considered to qualify for S-ICD if the screening ECG template passed in any same lead supine and standing, at any gain, and without significant morphologic changes in QRS complexes. Of the included subjects who were potentially eligible for S-ICD, 8% were considered to fail based the ECG screening. The authors conclude that “More work is needed in S-ICD sensing algorithms to increase patient eligibility for the S-ICD.
 
Ongoing and Unpublished Clinical Trials
A search of the online database ClinicalTrials.gov in September 2015 found several ongoing randomized trials of ICD therapy:
 
 A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable
Cardioverter Defibrillator Therapy (PRAETORIAN) (NCT01296022) – PRAETORIAN is a randomized, open-label trial to compare S-ICD placement with transvenous ICD placement in patients with a class I or IIa indication for ICD therapy. The primary outcome is the number of patients with ICD-related adverse events. Enrollment is planned for 850 subjects; the estimated study completion date is June 2018.
 
Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction (REFINE-ICD) (NCT00673842) – REFINE-ICD is a randomized, open-label trial to compare prophylactic ICD placement with usual care in patients with a history of MI and better-preserved LV function. The primary outcome is mortality. Enrollment is planned for 1400 subjects; the estimated study completion date is December 2019.
 
Efficacy and Safety of ICD Implantation in the Elderly (NCT02121158) – This is a randomized, open-label trial to evaluate the safety and efficacy of ICD in preventing SCD in elderly patients with an indication for ICD for primary prevention. The primary outcome is all-cause mortality. Enrollment is planned for 85 subjects; the estimated study completion date is November 2015.
 
ACC/AHA Heart Failure Management Guidelines
In 2013, the American College of Cardiology (ACC) and American Heart Association issued practice guidelines on the management of heart failure which made the following recommendations about the use of implantable cardioverter defibrillator (ICD) devices as primary prevention (Yancy, 2013):
 
  • For patients with stage B heart failure, an ICD is reasonable in patients with asymptomatic ischemic cardiomyopathy who are at least 40 d post-MI, have an LVEF _30%, and on guideline directed medical therapy (GDMT). (Class of recommendation: IIa; level of evidence: B).
  •  For patients with stage C heart failure:
      • ICD therapy is recommended for primary prevention of sudden cardiac death (SCD) in selected patients with heart failure with reduced ejection fraction (HFrEF) at least 40 d post-post myocardial infarction (MI) with left ventricular ejection fraction (LEVF) ≤ 35% and NYHA class II or III symptoms on chronic GDMT, who are expected to live at least 1 year. (Class of recommendation: I; level of evidence: A).
      • ICD therapy is recommended for primary prevention of SCD in selected patients with HFrEF at least 40 d post-MI and LEVF ≤ 330% and NYHA class I symptoms while receiving GDMT, who are expected to live at least 1 year. (Class of recommendation: I; level of evidence: B).
      • An ICD is of uncertain benefit to prolong meaningful survival in patients with a high risk of nonsudden death such as frequent hospitalizations, frailty, or severe comorbidities. (Class of recommendation: IIb; level of evidence: B).
 
ACC/AHA Device-Based Therapy for Cardiac Rhythm Abnormalities Guidelines
In 2012, the ACC and AHA, together with the Heart Rhythm Society (HRS), the American Association of
Thoracic Surgeons, and the Society of Thoracic Surgeons, issued a focused update to 2008 guidelines for device-based therapy of cardiac rhythm abnormalities (Tracy, 2012).  The guidelines make the following recommendations related to ICD therapy in adults, all of which are based on the expectation that patients are receiving optimal medical therapy and have a reasonable expectation of survival with a good functional status for more than a year:
 
Class I recommendations:
  • ICD therapy is indicated in patients who are survivors of cardiac arrest due to ventricular fibrillation (VF) or hemodynamically unstable sustained ventricular tachycardia (VT) after evaluation to define the cause of the event and to exclude any completely reversible causes. (Level of Evidence: A).
  • ICD therapy is indicated in patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable. (Level of Evidence: B)
  • ICD therapy is indicated in patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or VF induced at electrophysiological study. (Level of Evidence: B)
  • ICD therapy is indicated in patients with LVEF less than or equal to 35% due to prior MI who are at least 40 days post-MI and are in NYHA functional Class II or III. (Level of Evidence: A)
  • ICD therapy is indicated in patients with nonischemic dilated cardiomyopathy (DCM) who have an LVEF less than or equal to 35% and who are in NYHA functional Class II or III. (Level of Evidence: B)
  • ICD therapy is indicated in patients with LV dysfunction due to prior MI who are at least 40 days post-MI, have an LVEF less than or equal to 30%, and are in NYHA functional Class I. (Level of Evidence: A)
  • ICD therapy is indicated in patients with nonsustained VT due to prior MI, LVEF less than or equal to 40%, and inducible VF or sustained VT at electrophysiological study. (Level of Evidence: B)
 
Class IIa recommendations:
 
  • ICD implantation is reasonable for patients with unexplained syncope, significant LV dysfunction, and nonischemic DCM. (Level of Evidence: C)
  • ICD implantation is reasonable for patients with sustained VT and normal or near-normal ventricular function. (Level of Evidence: C)
  • ICD implantation is reasonable for patients with HCM who have 1 or more major† risk factors for sudden cardiac death (SCD). (Level of Evidence: C)
  • ICD implantation is reasonable for the prevention of SCD in patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy who have 1 or more risk factors for SCD. (Level of Evidence: C)
  • ICD implantation is reasonable to reduce SCD in patients with long-QT syndrome who are experiencing syncope and/or VT while receiving beta blockers. (Level of Evidence: B)
  • ICD implantation is reasonable for nonhospitalized patients awaiting transplantation. (Level of Evidence: C)
  • ICD implantation is reasonable for patients with Brugada syndrome who have had syncope. (Level of Evidence: C)
  • ICD implantation is reasonable for patients with Brugada syndrome who have documented VT that has not resulted in cardiac arrest. (Level of Evidence: C)
  • ICD implantation is reasonable for patients with catecholaminergic polymorphic VT who have syncope and/or documented sustained VT while receiving beta blockers. (Level of Evidence: C)
  • ICD implantation is reasonable for patients with cardiac sarcoidosis, giant cell myocarditis, or Chagas disease. (Level of Evidence: C)
 
Class IIb recommendations:
  • ICD therapy may be considered in patients with nonischemic heart disease who have an LVEF of less than or equal to 35% and who are in NYHA functional Class I. (Level of Evidence: C)
  • ICD therapy may be considered for patients with long-QT syndrome and risk factors for SCD. (Level of Evidence: B)
  • ICD therapy may be considered in patients with syncope and advanced structural heart disease in who thorough invasive and noninvasive investigations have failed to define a cause. (Level of Evidence: C)
  • ICD therapy may be considered in patients with a familial cardiomyopathy associated with sudden death. (Level of Evidence: C)
  • ICD therapy may be considered in patients with LV noncompaction. (Level of Evidence: C)
 
Class III recommendations (not recommended):
  • ICD therapy is not indicated for patients who do not have a reasonable expectation of survival with an acceptable functional status for at least 1 year, even if they meet ICD implantation criteria specified in the Class I, IIa, and IIb recommendations above. (Level of Evidence: C)
  • ICD therapy is not indicated for patients with incessant VT or VF. (Level of Evidence: C)
  • ICD therapy is not indicated in patients with significant psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up. (Level of Evidence: C)
  • ICD therapy is not indicated for NYHA Class IV patients with drug-refractory congestive heart failure who are not candidates for cardiac transplantation or cardiac resynchronization/defibrillator. (Level of Evidence: C)
  • ICD therapy is not indicated for syncope of undetermined cause in a patient without inducible ventricular tachyarrhythmias and without structural heart disease. (Level of Evidence: C)
  • ICD therapy is not indicated when VF or VT is amenable to surgical or catheter ablation (e.g., atrial arrhythmias associated with the Wolff-Parkinson-White syndrome, RV or LV outflow tract VT, idiopathic VT, or fascicular VT in the absence of structural heart disease). (Level of Evidence: C)
  • ICD therapy is not indicated for patients with ventricular tachyarrhythmias due to a completely reversible disorder in the absence of structural heart disease (e.g., electrolyte imbalance, drugs, or trauma). (Level of Evidence: B)
 
The 2012 guidelines make the following recommendations related to ICD therapy in children:
Class I recommendations:
  • ICD implantation is indicated in the survivor of cardiac arrest after evaluation to define the cause of the event and to exclude any reversible causes. (Level of Evidence: B)
  • ICD implantation is indicated for patients with symptomatic sustained VT in association with congenital heart disease who have undergone hemodynamic and electrophysiological evaluation. Catheter ablation or surgical repair may offer possible alternatives in carefully selected patients. (Level of Evidence: C)
 
Class IIa recommendations:
ICD implantation is reasonable for patients with congenital heart disease with recurrent syncope of undetermined origin in the presence of either ventricular dysfunction or inducible ventricular arrhythmias at electrophysiological study. (Level of Evidence: B)
 
Class IIb recommendations:
ICD implantation may be considered for patients with recurrent syncope associated with complex congenital heart disease and advanced systemic ventricular dysfunction when thorough invasive and noninvasive investigations have failed to define a cause. (Level of Evidence: C)
 
Class III recommendations:
All Class III recommendations found in Section 3, “Indications for Implantable Cardioverter-Defibrillator Therapy,” apply to pediatric patients and patients with congenital heart disease, and ICD implantation is not indicated in these patient populations. (Level of Evidence: C)
 
ACC/AHA Expert Consensus Statement on ICD Therapy in Patients Not Well Represented in Clinical Trials
In 2014, HRS, ACC, and AHA published an expert consensus statement on the use of ICD therapy in patients who were not included or poorly represented in ICD clinical trials, which made a number of consensus-based guidelines on the use of ICDs in selected patient populations (Kusumoto, 2014).
 
2015 Update
This policy is being revised to combine the wearable cardiac defibrillator policy into the existing policy to create one policy for all of the different types of defibrillators available for use. This update focuses on the rationale for the use of the wearable cardiac defibrillator.
 
The available evidence on the wearable cardioverter defibrillator (WCD) consists of case series describing outcomes from patients using the device. There are no randomized controlled trials (RCTs) of WCD compared with standard care or alternative treatments. RCTs of patients undergoing permanent implantable cardioverter defibrillator (ICD) implantation can provide indirect evidence on the efficacy of the WCD if the indications for a permanent ICD are similar to the potential indications for WCD and if the performance of the WCD has been shown to approximate that of a permanent ICD.
 
U.S. Food and Drug Administration (FDA)‒labeled indications for the device are adult patients who are at risk for sudden cardiac arrest (SCA) and either are not candidates for or refuse an implantable ICD (U.S. Food and Drug Administration, 2015). Some experts (Beauregard, 2004) have suggested that the indications for a WCD should be broadened to include other populations at high risk for SCA. These potential indications include:
 
    • Bridge to transplantation (ie, the WEARIT population)
    • Bridge to implantable device or clinical improvement (ie, the BIROAD population)
        • Post bypass with ejection fraction (EF) less than 30%
        • Post bypass with ventricular arrhythmias or syncope within 48 hours of surgery
        • Post myocardial infarction with EF less than 30%
        • Post myocardial infarction with ventricular arrhythmias within 48 hours
    • Drug-related arrhythmias (during drug washout or after, during evaluation of long-term risk)
    • Patients awaiting revascularization
    • Patients too ill to undergo device implantation
    • Patients who refuse device therapy
 
WCD Effectiveness Compared With an Implantable Device
 
There are very few peer-reviewed published studies that report on clinical outcomes of WCDs and no studies that evaluate the efficacy of WCD in reducing mortality compared with alternatives. Despite the small amount of evidence, a TEC Assessment completed in 20103 concluded that the evidence is sufficient to conclude that the WCD can successfully terminate malignant ventricular arrhythmias. First, there is strong physiologic rationale for the device. It is known that sensor leads placed on the skin can successfully detect and characterize arrhythmias. It is also established that a successful countershock can be delivered externally. The use of external defibrillators is extensive, ranging from in-hospital use to public placement and use at home. The novelty of this device is in the way that it is packaged and
utilized.
 
Second, there is a small amount of evidence that supports that the device successfully terminates arrhythmias. Two uncontrolled studies were identified that directly tested the efficacy of the WCD. The first (Auricchio, 1998) was a small case series of 15 patients who were survivors of SCA and scheduled to receive an ICD. During the procedure to implant a permanent ICD, or to test a previously inserted ICD, patients wore the WCD while clinicians attempted to induce ventricular arrhythmias. Of the 15 patients, 10 developed ventricular tachycardia (VT) or ventricular fibrillation (VF). The WCD correctly detected the arrhythmia in 9 of 10 cases and successfully terminated the arrhythmia in all 9 cases. In 2010, Chung et al published an evaluation of WCD effectiveness for preventing sudden death based on a postmarket release registry of 3569 patients who received a (Chung, 2010). Investigators found an overall successful shock rate of 99% for VT or VF (79/80 cases of VT or VF among 59 patients). Fifty-two percent of patients wore the device for more than 90% of the day. Eight patients died after successful conversion of VT/VF.
 
In 2013, Tanawuttiwat et al reported the results of a retrospective, uncontrolled evaluation of 97 patients who received a WCD after their ICD was explanted due to device infection (Tanawuttiwat, 2013). Subjects wore the device for a median of 21 days; during the study period, 2 patients had 4 episodes of arrhythmia that were appropriately terminated by the WCD, 1 patient experienced 2 inappropriate treatments, and 3 patients experienced sudden death outside the hospital while not wearing their WCD device.
 
The WEARIT/BIROAD study (Feldman, 2004) was a prospective cohort study that evaluated 289 patients at high risk for sudden cardiac death (SCD) but who did not meet criteria for an ICD or who could not receive an ICD for several months. A total of 289 patients were enrolled and followed for a mean of 3.1 months. During this time, there were 8 documented episodes of arrhythmia requiring shock in 6 separate patients. Six of the 8 episodes were successfully resuscitated by the WCD. By group sequential analysis, the estimate of percent successful resuscitations was 69%. There was 99% confidence that the true rate of success was greater than 25% and 90% confidence that the true rate was greater than 44%. In the 2 cases of unsuccessful defibrillation, the authors reported that the WCD was placed incorrectly, with the therapy electrodes reversed and not directed to the skin. Clinical outcomes for longer term follow up for 758 patients prescribed a WCD for a transient or undefined arrhythmia risk who were prospectively enrolled in a registry have been published in abstract form (Goldenberg, 2013). This abstract reports that during the follow-up period, there were 15 “appropriate” shocks delivered. Details about the registry population, the patient selection process, and the outcomes are not sufficient to allow more complete evaluation of the study findings.
 
The WEARIT/BIROAD results underscore the difficulty in proper use and compliance with the device. Six patients suffered SCA that was likely due to wearing the device improperly or not wearing the device at all. This implied that a relatively high rate of nonadherence may be the main factor limiting the effectiveness of the WCD. Also, there was a fairly high rate of dropout (22%) over the approximately 3 months of follow-up. In a study of 134 consecutive, uninsured patients with cardiomyopathy and a mean EF of 22.5% (7.3%), Mitrani et al, reported noncompliance with a WCD was even greater. The dropout rate was 35% (Mitrani, 2013). The WCD was never used by 8 patients, and only 27% wore the device for more than 90% of the day. Patients who were followed for 72 (55) days wore the WCD for a mean of 14.1 (8.1) hours per day. Additionally, during follow-up, no arrhythmias or shock were detected. In a prospective registry of 82 heart failure patients eligible for WCDs, Kao et al reported 13 patients (15.9%) did not wear the WCD due to refusal, discomfort, or other/unknown reasons (Kao, 2012). These results suggest that the WCD is likely to be inferior to an ICD, due to suboptimal adherence and difficulty with correct placement of the device. Therefore, these data corroborate the assumption that the WCD should not be used as a replacement for an ICD but only considered in those situations in which the patient does not meet criteria for a permanent ICD.
 
Section Summary
There are no studies that directly compare the performance of a WCD with a permanent ICD. One small study in the electrophysiology lab demonstrated that the WCD can correctly identify and terminate most induced ventricular arrhythmias. A cohort study of WCD use estimated that the percent of successful resuscitations was approximately 70%. In that study, there was a high rate of nonadherence and dropouts, and failures to successfully resuscitate were largely attributed to incorrect use of the device and/or nonadherence. Other studies have also reported high rates of nonadherence. This evidence indicates that the WCD can successfully detect and terminate arrhythmias in at least some patients but that the overall performance in clinical care is likely to be inferior to a permanent ICD.
 
WCD as Bridge to ICD or Recovery
 
Temporary Contraindications to ICD
Contraindications to an ICD are few. According to the American College of Cardiology/American Heart Association guidelines on ICD use, the device is contraindicated in patients with terminal illness, with drug-refractory class IV heart failure, who are not candidates for transplantation, and in patients with a history of psychiatric disorders that interfere with the necessary care and follow-up postimplantation (Gregoratos, 1998).  It is not known how many patients refuse an ICD after it has been recommended for them.
 
There is a small number of patients who meet established criteria for an ICD but have a transient (ie, short-term) contraindication for an implantable device. The most common contraindication is an infectious process that precludes insertion or when an ICD is removed due to infection, and there must be a delay before reinsertion to treat the infection. The WCD may have benefit in this group, if the device is able to successfully detect and abort ventricular arrhythmias in this population. The study by Tanawuttiwat et al previously referenced provides some direct evidence that the WCD can be successful, but its successful use may be limited by nonadherence, given that 3 of the 97 patients included in the study died outside of the hospital while not wearing the WCD.
 
The WCD avoids potential complications associated with ICD implantation, but complication rates with current techniques for ICD placement are low. In 1 large trial of ICD versus antiarrhythmic drug therapy, (Gregoratos, 1998) complications of ICD implantation in 507 patients included hematomas in 13 (2.6%), bleeding requiring transfusion or reoperation in 6 (1.2%), infection in 10 (2.0%), pneumothorax in 8 (1.6%), and cardiac perforation in 1 (0.2%). Early mortality (within 30 days of procedure) was not higher for the ICD group (2.4%), compared with the medication group (3.5%).
 
Immediate Post-MI Period
The evidence on the use of a WCD as a bridge to permanent ICD placement was reviewed in a 2010 TEC Assessment  (BCBSA TEC, 2010).  The most common of these indications is for patients who are in the immediate postmyocardial infarction (MI) period. For these patients, indications for a permanent ICD cannot be reliably assessed immediately post-MI because it is not possible to determine the final EF until at least 30 days after the event. Because the first 30 days following an acute MI represent a high-risk period for lethal ventricular arrhythmias, there is a potential to improve mortality by using other treatments to prevent SCA.
 
Despite the rationale for this potential indication, the TEC Assessment concluded that the available evidence does not support the contention that any cardioverter defibrillator improves mortality in patients in the immediate post-MI period. One post hoc analysis of an RCT and 2 prospective RCTs was reviewed that led to this conclusion.
 
Secondary analysis of data from the MADIT-II trial evaluated whether an ICD improves mortality in the early post-MI period (Wilber, 2004). MADIT-II randomly assigned 1159 patients with prior MI and an EF of less than 30% to an ICD or control and showed an overall mortality benefit for patients treated with an ICD. The secondary analysis examined the benefit of ICD according to length of time from the original MI and showed that the benefit of ICD was dependent on the length of time since the original MI. Within the first 18 months post-MI, there was no benefit found for ICD implantation (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.51 to 1.81; p=0.92). In contrast, there was a significant mortality benefit when the length of time since MI was greater than 18 months (HR=0.55; 95% CI, 0.39 to 0.78; p=0.001). Two RCTs were specifically designed to address the question of early ICD use post-MI. The DINAMIT Study (Hohnloser, 2004)  evaluated the utility of an automatic ICD (AICD) for this patient population. This trial randomly assigned 342 patients with an acute MI and an EF of 35% or less. The primary outcome was death from any cause, and a predefined secondary outcome was death from an arrhythmia. After a mean follow-up of 30 months, there was no difference in overall survival for the ICD group compared with control (HR=1.08; 95% CI, 0.76 to 1.55; p=0.66). There was a significant difference for the ICD group in the secondary outcome of death from arrhythmia (HR=0.42; 95% CI, 0.22 to 0.83; p=0.009). The decrease in deaths from arrhythmias for the ICD group was offset by a corresponding increase in deaths due to nonarrhythmic cardiac causes. The authors suggest that the discrepancy in these outcomes may arise from the fact that patients in whom the ICD successfully aborted an arrhythmia may have eventually died from other cardiac causes, such as progressive heart failure.
 
The IRIS trial (Steinbeck, 2009) was similar in design to the DINAMIT trial. This study included 998 patients who were 5 to 31 days post-MI and had at least 1 other high-risk factor, either nonsustained ventricular tachycardia or a resting pulse greater than 90. Patients were followed for a mean of 37 months. Results of the IRIS trial were similar to DINAMIT, with no difference in overall mortality between the ICD and control groups (26.1% vs 25.8%, respectively, p=0.76). The ICD group had a decreased rate of SCD (6.1% vs 13.2%, respectively, p=0.049), which was offset by a higher rate of non-SCD (15.3% vs 8.6%, respectively, p=0.001). This study also reported noncardiac death, which was similar for the ICD and control groups (4.7% vs 4.0%, respectively, p=0.51).
 
In 2013, Epstein et al reported on registry data from 8453 post-MI patients who received WCDs for risk of SCA while awaiting placement of an ICD (Epstein, 2013). The WCD was worn a median length of 57 days (mean, 69 [61] days) with a median daily use of 21.8 hours. Appropriate shocks were delivered 309 times in 133 patients (1.6%), 91% of which were successful in resuscitating patients from ventricular arrhythmias. For shocked patients, 62% were revascularized post-MI and the left-ventricular ejection fraction (LVEF) averaged 23.8% (8.8%). While 1.4% of this registry population was successfully treated with WCDs, interpretation of registry data is limited. It is not possible to determine whether outcomes were improved without a control group, and the registry contained limited patient and medical information further limiting interpretation of results.
 
In 2014, Uyei et al reported results of a systematic review conducted with the goal of evaluating the effectiveness of WCD use in several clinical situations, including for individuals early (≤40 days) post-MI with an LVEF of 35% or less (Uyei, 2014). The authors identified 36 articles and conference abstracts, most of which (n=28 [78%]) were conference abstracts. Four studies (Chung et al [2010], (Chung, 2010)  Epstein et al [2013], (Epstein, 2013) and 2 conference abstracts) assessed the effectiveness of WCD use in post-MI patients. Outcomes reported were heterogeneous. For 2 studies that reported VF/VT-related mortality, on average 0.52% (2/384) of the study population died of VF or VT over 58.3 mean days of WCD use. For 2 studies that reported on VT/VF incidence, on average 2.8% (11/384) of WCD users experienced a VT and/or VF event over the course 58.3 (range, 3-146) mean days of WD use. Among those who experienced a VT/VF event, on average 82% (9/11) experienced successful termination of 1 or more arrhythmic events.
 
High-Risk Patients After Coronary Revascularization
One RCT (CABG PATCH) (Bigger, 1997) evaluated early ICD placement in high-risk post CABG patients, selected by a low LVEF and abnormalities on signal-averaged electrocardiogram. The trial followed patients for a mean of 32 months and reported on overall mortality. Results of this trial indicated no difference in overall mortality between the ICD and control groups (HR=1.07; 95% CI, 0.81 to 1.42). There were no other mortality outcomes reported. There was a higher rate of infections in the ICD group, both deep sternal infections (2.7 vs 0.4%, respectively, p<0.05) and superficial wound infections (12.3 vs 5.9%, respectively, p<0.05). The cumulative incidence of inappropriate shocks was 50% at 1 year and 57% at 2 years.
 
Zishiri et al performed a retrospective study that used registry data to compare outcomes with or without WCD use in patients with LVEF less than 35% after CABG surgery or percutaneous coronary intervention (PCI) (Zishiri, 2013).  A national registry maintained by the manufacturer was used to identify 809 patients treated with a WCD post-discharge, and a separate registry from the Cleveland Clinic was used to identify 4149 patients discharged without a defibrillator. At baseline, there were significant differences between groups on age, sex, LVEF, and time period of treatment. Of the 809 patients treated with WCD, 1.3% had documented appropriate defibrillation treatment for an arrhythmia. Post-CABG, 90-day mortality was 3% in patients with WCDs versus 7% without WCDs (p=0.03). Post-PCI, 90-day mortality was 2% in patients with WCDs versus 10% without WCDs (p<0.001). Adjusted long-term mortality risks, after a mean followup of 3.2 years, was also decreased in the WCD group (HR=0.74; 95% CI, 0.57 to 0.97; p=0.027). These differences in mortality persisted after propensity matching. However, interpretation of this registry data is limited because patients treated with a WCD differed from patients who were not treated, and these differences may not have been completely eliminated through propensity matching. Therefore, this evidence is not sufficient to determine whether WCDs improve outcomes post coronary revascularization.  In the 2014 Uyei et al systematic review previously described, 3 studies (Chung , 2010;  Epstein, 2013; 1 conference abstract) were identified that reported outcomes for WCDs after coronary revascularization for patients with LVEF of 35% or less (Uyei, 2014). Reported outcomes were heterogeneous across studies. In 1 study that reported on VT/VF-related mortality, 0.41% (1/243) of the study population died of VT or VF over the course of 59.8 days (mean or median not specified). Of those who experienced a VT/VF event, 7% of patients died over the course of “approximately 2 months” of WCD use. In another study, 50% of those with VT/VF events died over the course of 59.8 days.
 
High-Risk Patients Awaiting Heart Transplantation
There are no studies that specifically address this population of patients, but some patients awaiting transplantation have been included in studies with mixed populations. The WEARIT/BIROAD study, discussed previously, was a prospective cohort study that included patients awaiting transplant, but it also included other high-risk patients and did not report separately on the population of patients awaiting transplant (Feldman, 2004). Rao et al (Rao, 2011) published a case series of 162 patients with either congenital structural heart disease or inherited arrhythmias treated with WCD. Approximately one-third of these patients had a permanent ICD, which was explanted due to infection or malfunction. The remaining patients used the WCD either as a bridge to heart transplantation, during an ongoing cardiac evaluation, or in the setting of surgical or invasive procedures that increased the risk of arrhythmias. There were 4 patient deaths during a mean duration of WCD treatment of approximately 1 month, but none of these were related to cardiac causes. Two patients received a total of 3 appropriate shocks for VT/VF, and 4 patients received a total of 7 inappropriate shocks. The results of this study suggest that the WCD can be worn safely and can detect arrhythmias in this population, but the rate of inappropriate shocks is relatively high.
 
Newly Diagnosed Nonischemic Cardiomyopathy
Another potential indication for the WCD is in patients with newly diagnosed nonischemic cardiomyopathy. Similar to acute MI, in these patients the final EF is uncertain because some patients who are newly diagnosed with nonischemic cardiomyopathy show an improvement in EF over the ensuing several months. A post hoc analysis of the DEFINITE trial, (Kadish, 2006) which evaluated the use of an ICD in nonischemic dilated cardiomyopathy, examined the benefit of ICD use by time since diagnosis. This trial excluded patients with a clinical picture consistent with a reversible cause of cardiomyopathy and thus may differ from the population considered for a WCD. For the overall DEFINITE trial, there was a 35% reduction in overall mortality, but this difference did not meet statistical significance. In the reanalysis, patients were divided into recent diagnosis of cardiomyopathy (<3 months) and remote diagnosis (>9 months). The difference in survival was of borderline significance for the ICD group compared with controls, both for the recently diagnosed subgroup (HR=0.38; 95% CI, 0.14 to 1.00; p=0.05), and the remotely diagnosed subgroup (HR=0.43; 95% CI, 0.22 to 0.99; p=0.046).
 
Kao et al reported on a prospective registry of 82 heart failure patients who were eligible for a WCD (Kao, 2012).Dilated cardiomyopathy and EF less than 40% were diagnosed in 98.8% of patients and cardiac transplantation was indicated for 12 patients. During the study, use of the WCD was 75 (58) days during which time, no SCDs or deaths occurred. Improvement was reported in 41.5% of patients who no longer met the criteria for defibrillator use. ICD placement was reported in 34.1%.of patients and 1 patient received a heart transplant. As noted above, 13 patients (15.85%) did not wear the WCD due to refusal, discomfort or other/unknown reasons.
 
The 2014 Uyei et al systematic review previously described identified 4 studies (Saltzberg, 2012; Chung, 2010 and 2 conference abstracts) that assessed WCD use in newly diagnosed nonischemic cardiomyopathy (Uyei, 2014). In the 3 studies that reported VT/VF incidence, an average 0.57% (5/871) subjects experienced VT and/or VF over a mean duration of 52.6 days. Among those who did experience a VT/VF event, an average 80% experienced successful event termination.
 
Peripartum Cardiomyopathy
One study of WCD use in peripartum cardiomyopathy was published in 2012 (Saltzberg, 2012). This study included 107 women with peripartum cardiomyopathy treated with a WCD device during the period of 2003 through 2009. Patients were identified from a registry of WCD use maintained by the manufacturer of the device. The average length of time that the WCD was used was 124 (123) days. During this time, there were no shocks delivered, either appropriate shocks or inappropriate shocks. There were also no patient deaths during the time of WCD treatment. Following discontinuation of the WCD, there were 3 deaths over a mean follow-up of 3.0 (1.2) years. In a matched group of 159 women with nonischemic cardiomyopathy who wore the WCD for 96 (83) days, there were 2 appropriate shocks and 11 deaths.
 
In a smaller study reported in 2014, Duncker et al reported outcomes for 12 prospectively enrolled women with peripartum cardiomyopathy who were treated at a single center and followed over a median of 12 months (Duncker, 2014).  A WCD was recommended for 9 patients with LVEF of 35% or less and 7 of the 9 consented to wear the WCD. For these 7 patients, the median WCD wearing time was 81 days (mean, 133 days). In 3 patients, 4 episodes of VF were detected that led to delivery of a shock, which successfully terminated the arrhythmia in all cases. No inappropriate shocks were delivered. Among the 5 patients without WCD, no episodes of syncope, ventricular arrhythmias, or deaths occurred.
 
Section Summary
For patients with indications for an ICD but temporary contraindications, the use of a WCD for a temporary period of time is likely to improve outcomes. These patients are expected to benefit from an ICD, and the use of a WCD is a reasonable alternative because there are no other options for automatic detection and termination of ventricular arrhythmias.
 
Two RCTs of ICD use in the early post-acute MI period concluded that mortality was not improved compared with usual care. In both these trials, SCD was reduced in the ICD group, but non-SCD was increased, resulting in no difference in overall mortality. One trial of high-risk post-CABG patients also reported no benefit from implantation of a permanent ICD. Because a permanent ICD does not appear to be beneficial in these situations, a WCD would also not be beneficial for these patient populations.
 
For other indications, evidence is lacking concerning the impact of a WCD on outcomes. Case series for these conditions are not sufficient to determine whether a WCD improves outcomes compared with usual care.
 
Ongoing and Unpublished Clinical Trials
A search of online database ClinicalTrials.gov on September 04, 2015, identified 1 RCT evaluating WCDs that is ongoing:
 
Vest Prevention of Early Sudden Death Trial and VEST Registry (NCT01446965): This is single-blinded. RCT comparing WCD treatment with usual care in patients with recent MI and LVEF less than 35%. The primary outcome measure is mortality due to sudden death. Secondary outcomes are all-cause mortality, cardiovascular mortality, other cause-specific mortality, incidence of ventricular arrhythmias, adverse events due to the WCD, and compliance with the device. Enrollment is planned for 1900 subjects; the estimated study completion date is September 2015.
 
Two ongoing prospective cohort studies were identified evaluating the WCD: in patients with LV dysfunction or heart failure at high risk of SCD who are not eligible for an ICD (NCT01326624); and in patients presenting to emergency departments post-syncope (NCT02188147).
 
Summary of Evidence
The available data establish that the wearable cardioverter defibrillator (WCD) device can detect lethal arrhythmias and can successfully deliver a countershock in most cases. There are a small number of patients who meet established criteria for an implantable cardioverter defibrillator (ICD) but have a transient contraindication for an implantable device, most commonly an infectious process. In these patients who are scheduled for ICD placement, the WCD may be considered medically necessary as an interim treatment. The evidence shows that these patients benefit from a cardioverter defibrillator in general; and the WCD can detect and treat lethal arrhythmias in these patients.
 
For other bridging indications, particularly for the immediate post-myocardial infarction period, the evidence does not support the conclusion that the WCD improves outcomes. Two randomized controlled trials (RCTs) have reported that overall survival (OS) is not improved following treatment with a permanent ICD. While these 2 trials both reported a decrease in sudden cardiac death (SCD), there was a corresponding increase in non-SCD, resulting in no net benefit in survival. Similarly, for high-risk post coronary artery bypass graft patients, 1 RCT reported no difference in OS associated with early ICD placement. Thus, given the lack of evidence that a permanent ICD improves outcomes for these indications, a WCD is not expected to improve outcomes and is therefore considered investigational. For other potential indications, there are only case series or no relevant published evidence. Therefore it is not possible to conclude from the available evidence that net health outcome will be improved.
 
Practice Guidelines and Position Statements
Guidelines from the major cardiology specialty societies do not make specific recommendations for the use of WCD. For example, 2006 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on the treatment of patients with ventricular arrhythmias (Zipes, 2006) includes the following statement on WCD but does not include a formal recommendation: “The wearable automatic defibrillator has been approved in the United States by the FDA [Food and Drug Administration] for cardiac patients with a transient high risk for VF [ventricular fibrillation] such as those awaiting cardiac transplantation, those at very high risk after a recent MI [myocardial infarction] or an invasive cardiac procedure, or those requiring temporary removal of an infected implanted defibrillator for antibiotic therapy.” In 2014, the Heart Rhythm Society, ACC, and AHA issued a consensus statement on the use of ICD therapy in patients who are not included or not well-represented in clinical trials (Kusumoto, 2014). The statement does not contain formal recommendations regarding WCD use, but states, “The wearable cardioverter-defibrillator (WCD) may be an option as a ‘bridge to ICD’ for selected patients at high risk of sudden cardiac death due to ventricular arrhythmias, although the data are scant.”
 
In 2014, the ACC and AHA issued guidelines on the management of non-ST-elevation acute coronary syndrome (NSTE-ACS) (Amsterdam, 2014). These guidelines do not make specific recommendations regarding the use of WCDs, but do state the following:
 
“Life-threatening ventricular arrhythmias that occur >48 hours after NSTE-ACS are usually associated with LV dysfunction and signify poor prognosis. RCTs in patients with ACS have shown consistent benefit of implantable cardioverter-defibrillator therapy for survivors of VT or VF arrest. For other at-risk patients, especially those with significantly reduced LVEF, candidacy for primary prevention of sudden cardiac death with an implantable cardioverter-defibrillator should be readdressed ≥40 days after discharge. A life vest may be considered in the interim.”
 
In 2006, The International Society for Heart and Lung Transplantation issued guidelines for the care of cardiac transplant candidates that address the use of ICDs or WCDs (Gronda, 2006).  Recommendations related to the use of WCDs include:
    • Class I recommendations: An implanted or wearable ICD should be provided for Status 1B
patients [ie, dependent on intravenous medications or a mechanical assist device] who are
discharged home given that the wait for transplantation remains significant (Level of Evidence:
C).
    • Class IIa recommendations: It is reasonable to consider placement of a defibrillator in patients
with Stage D failure who are candidates for transplantation or LVAD destination therapy (see
subsequent considerations for mechanical circulatory support device [MCSD] referral: bridge or
destination) (Level of Evidence: C).
  
2017 Update
The policy was reviewed with a literature search using the MEDLINE database through March 2017. As a result of the review of literature, the policy statement is being updated to expand the coverage for the wearable cardioverter defibrillator to include indications for recent MI with LVEF less than or equal to 35% and newly diagnosed NIDCM with LVEF less than or equal to 35%.
 
In 2016 the AHA issued a Science Advisory on Wearable Defibrillator Use (Piccini, 2016).  Included in this document is a Class IIb, Level of Evidence C recommendation that the use of WCDs may be reasonable when there is concern about a heightened risk of SCD that may resolve over time or with treatment of left ventricular dysfunction; for example, in ischemic heart disease with recent revascularization, newly diagnosed non-ischemic dilated cardiomyopathy in patients starting guideline-directed medical therapy, or secondary cardiomyopathy (tachycardia mediated, thyroid mediated, etc.) in which the underlying cause is potentially treatable.  In addition, there is a Class IIb, Level of Evidence C recommendation that WCDs may be appropriate as bridging therapy in situations associated with increased risk of death in which ICDs have been shown to reduce SCD, but not overall survival such as within 40 days of MI.  
 
A search of the online database ClinicalTrials.gov on September 04, 2015, identified 1 RCT evaluating WCDs that is ongoing:
 
Vest Prevention of Early Sudden Death Trial and VEST Registry (NCT01446965): This is single-blinded. RCT comparing WCD treatment with usual care in patients with recent MI and LVEF less than 35%. The primary outcome measure is mortality due to sudden death. Secondary outcomes are all-cause mortality, cardiovascular mortality, other cause-specific mortality, incidence of ventricular arrhythmias, adverse events due to the WCD, and compliance with the device. Enrollment is planned for 1900 subjects; the estimated study completion date is September 2015.  As of this policy update, the VEST Registry is scheduled to recruit 2200 patients, but enrollement is not expected to be complete until late 2017.    There are a number of published small series and case reports, but no high-quality comparative data demonstrating the clinical utility of the WCD.

CPT/HCPCS:
33202Insertion of epicardial electrode(s); open incision (eg, thoracotomy, median sternotomy, subxiphoid approach)
33203Insertion of epicardial electrode(s); endoscopic approach (eg, thoracoscopy, pericardioscopy)
33215Repositioning of previously implanted transvenous pacemaker or implantable defibrillator (right atrial or right ventricular) electrode
33216Insertion of a single transvenous electrode, permanent pacemaker or implantable defibrillator
33217Insertion of 2 transvenous electrodes, permanent pacemaker or implantable defibrillator
33240Insertion of implantable defibrillator pulse generator only; with existing single lead
33241Removal of implantable defibrillator pulse generator only
33249Insertion or replacement of permanent implantable defibrillator system, with transvenous lead(s), single or dual chamber
33270Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed
33271Insertion of subcutaneous implantable defibrillator electrode
33272Removal of subcutaneous implantable defibrillator electrode
33273Repositioning of previously implanted subcutaneous implantable defibrillator electrode
93260Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; implantable subcutaneous lead defibrillator system
93261Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; implantable subcutaneous lead defibrillator system
93292Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; wearable defibrillator system
93745Initial set-up and programming by a physician or other qualified health care professional of wearable cardioverter-defibrillator includes initial programming of system, establishing baseline electronic ECG, transmission of data to data repository, patient instruction in wearing system and patient reporting of problems or events
E1399Durable medical equipment, miscellaneous
K0606Automatic external defibrillator, with integrated electrocardiogram analysis, garment type
K0607Replacement battery for automated external defibrillator, garment type only, each
K0608Replacement garment for use with automated external defibrillator, each
K0609Replacement electrodes for use with automated external defibrillator, garment type only, each

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