Medical Policy

 

Subject: Wearable Cardioverter Defibrillators
Document #: MED.00055 Publish Date:    08/29/2018
Status: Revised Last Review Date:    07/26/2018

Description/Scope

This document addresses the wearable cardioverter defibrillator, an external vest-like garment device that is intended to perform the same tasks as an implantable cardioverter defibrillator (ICD), without requiring any invasive procedures.

Position Statement

Medically Necessary:

The wearable cardioverter defibrillator is considered medically necessary for individuals at high-risk of sudden cardiac arrest, who meet the following criteria (A and B):

  1. Individuals must meet the medical necessity criteria for an implantable cardioverter defibrillator*; and
  2. Individuals must have ONE of the following documented medical contraindications to implantation of an implantable cardioverter defibrillator (1, 2, or 3):
    1. Those awaiting a heart transplantation - on waiting list and meet medical necessity criteria for heart transplantation;** or
    2. Those with a previously implanted cardioverter defibrillator that requires explantation due to infection (for example, device pocket or lead infection, endocarditis) with waiting period before reimplantation of an implantable cardioverter defibrillator; or
    3. Those with an infectious process or other temporary condition (for example, recovery from surgery, lack of vascular access) that precludes immediate implantation of an implantable cardioverter defibrillator.

 * Refer to SURG.00033 Cardioverter Defibrillators
**Refer to TRANS.00033 Heart Transplantation

Investigational and Not Medically Necessary:

The wearable cardioverter defibrillator is considered investigational and not medically necessary for all other indications, including but not limited to, the following:

  1. Individuals with a history of an acute myocardial infarction within the last 40 days;
  2. Individuals with drug-refractory class IV congestive heart failure who are not candidates for heart transplantation;
  3. Individuals with a history of psychiatric disorders that interfere with the necessary care and follow-up;
  4. Individuals in whom a reversible triggering factor for ventricular tachycardia/ventricular fibrillation can be definitely identified, such as ventricular tachyarrhythmias in evolving acute myocardial infarction or electrolyte abnormalities;
  5. Individuals with terminal illnesses;
  6. Individuals with newly diagnosed nonischemic dilated cardiomyopathy during the initial 3 months of guideline directed medical therapy.
Rationale

The U.S. Food and Drug Administration (FDA) granted clearance for the Lifecor Wearable Cardioverter Defibrillator (WCD®) 2000 system via premarket application approval in December 2001, based on clinical data submitted to the FDA by the manufacturer, which has subsequently been published in the peer-reviewed literature, and referred to as the BIROAD and WEARIT studies (Feldman, 2004).  The trials consisted of prospective, non-randomized studies, which compared the outcomes of the WCD with historical controls of subjects suffering sudden cardiac arrest (SCD) who called 911 emergency services.  While this study demonstrated that the WCD could detect arrhythmias and appropriately deliver a counter shock, its long-term efficacy will depend on user compliance, and from a practical perspective, the WCD cannot be continuously worn.  For example, the BIROAD and WEARIT studies included 289 subjects; there were 12 deaths reported, and 50% occurred in those who were either not wearing the device or wearing it inappropriately.  Additionally, 68 of the 289 subjects discontinued wearing the device due to comfort issues or adverse reactions.  Therefore, an implantable cardiac defibrillator (ICD) is considered the gold standard and, as such, a WCD would be considered an alternative to an ICD only in the small subset of individuals that have co-morbidities or other contraindications for an ICD.  For example, individuals with an infected ICD requiring removal may benefit from a WCD worn during the limited interim period until an ICD can be reimplanted.  Additionally, a small subset awaiting heart transplantation may be considered at high risk for arrhythmia, but are not candidates for an ICD due to co-morbidities.  A WCD may be considered an alternative to an ICD in these individuals while they are on the heart transplant waiting list.

Additional prospective data from the Prospective Registry of Patients Using the Wearable Defibrillator (WEARIT-II) Registry were published in 2015.  The WEARIT-II Registry enrolled 2000 subjects with ischemic (n=805, 40%), or nonischemic cardiomyopathy (n=927, 46%), or congenital/inherited heart disease (n=268) prescribed a WCD between August 2011 and February 2014.  Clinical data, arrhythmia events, ICD implantation, and improvement in left ventricular ejection fraction (LVEF) were captured.  The median age was 62 years; the median LVEF was 25%. The median WCD wear time was 90 days with median daily use of 22.5 hours.  There was a total of 120 episodes of sustained ventricular tachyarrhythmias in 41 individuals, of whom 54% received appropriate WCD shocks.  Only 10 subjects (0.5%) received inappropriate WCD therapy.  The rate of sustained ventricular tachyarrhythmias by 3 months was 3% among those individuals with ischemic cardiomyopathy and congenital/inherited heart disease and 1% among subjects with nonischemic disease (p=0.02).  At the end of WCD use, 840 subjects (42%) were implanted with an ICD.  The most frequent reason not to implant an ICD following WCD use was improvement in LVEF.  The authors concluded that the WEARIT-II data demonstrated a high rate of sustained ventricular tachyarrhythmias at 3 months in at-risk individuals who were not eligible for an ICD and suggested that the WCD can be safely used to protect against potentially lethal cardiac events during this period of risk assessment (Kutyifa, 2015).  Additional retrospective and database study of WCD use in subgroups of at-risk individuals with newly diagnosed cardiomyopathy (ischemic and nonischemic) were reported with results that indicate a possible role for the WCD in the first few months following a new diagnosis of cardiomyopathy.  Further study is needed to inform about this possible use for the WCD (Salehi, 2016; Singh, 2015).

There has been interest in offering WCDs to individuals in the immediate post myocardial infarction (MI) period, when they are considered at high risk of arrhythmia.  However, the Defibrillator in Acute Myocardial Infarction Trial (DINAMIT) demonstrated that an ICD is not indicated during this period (Hohnloser, 2004).  The DINAMIT trial randomized 674 subjects to receive either an ICD or no ICD within 40 days of an MI.  All participants had reduced ejection fractions (LVEF less than or equal to 35%) and impaired cardiac autonomic function.  The primary outcome was mortality from any cause, and the secondary outcome was death from arrhythmia.  During a mean follow-up of 30 ± 13 months, there was no difference in overall mortality between the 2 groups.  Of 120 subjects who died, 62 were in the ICD group, and 58 were in the control group.  There were 12 deaths due to arrhythmia in the ICD group and 29 in the control group.  There were 50 deaths from nonarrhythmic causes in the ICD group, however, and 29 in the control group.  The authors concluded that ICD therapy does not reduce overall mortality in high-risk subjects who have recently had an MI.  Although ICD therapy was associated with a reduction in arrhythmia-related death, this was offset by an increase in nonarrhythmic-related death.  While the nonrandomized BIROAD study investigated subjects treated with a WCD in the immediate post MI period, the results of the large randomized DINAMIT study provide a higher level of evidence, which may be extrapolated to WCD.

Two prospective, randomized, controlled trials compared the use of ICDs to that of conventional therapy: the Multi-Center Automatic Defibrillator Implantation Trial (MADIT; n=196) and the Multi-Center Automatic Defibrillator Implantation Trial II (MADIT II; n=1232).  Both trials were conducted on subjects with coronary artery disease (CAD) who had experienced MIs and who had reduced LVEFs.  Both trials were well designed and of good quality.  The observed all-cause mortality rate in the conventionally treated group was somewhat lower in MADIT II (19.8%, with average follow-up at 20 months) than in MADIT (38.6%, with average follow-up at 27 months), suggesting some differences in the baseline mortality risk between these 2 populations.  Both trials reported that ICD treatment resulted in more statistically significant reductions in all-cause mortality (primary endpoint) than conventional therapy did.  The MADIT and MADIT II trials provide consistent evidence that individuals with CAD, prior MI and reduced LVEF who meet selection criteria for either trial have significantly reduced mortality when treated with an ICD than when given conventional therapy (Moss, 1996).  However, results of the MADIT II trial concluded that risk of SCD in those with LVEF less than or equal to 30% increases as a function of time from MI.  The survival benefit associated with ICD placement appears to be greater for remote MI and remains substantial for up to (greater than or equal to) 15 years after MI.  “There appeared to be a trend toward increasing survival benefit associated with ICD therapy as time from MI increased.”  These findings can also be extrapolated to use of the WCD device (Wilber, 2004). 

Additional study of the WCD in the early high risk period following an acute MI is ongoing.  The Vest Prevention of Early Sudden Death Trial and the VEST registry data, both sponsored by the Zoll manufacturer and the University of California at San Francisco, have an estimated primary completion date of May 2018 and a study completion date of December, 2018.  This study is analyzing individuals within 7 days of an MI who have ventricular dysfunction (LVEF ≤ 0.35) to determine if use of the WCD can impact mortality by reducing the incidence of SCD during the first 3 months following acute MI (NCT01446965).  To date, nothing has been published about clinical outcomes data from this ongoing trial and registry.

There have been few additional studies of the WCD.  Rao evaluated the short- and long-term outcomes of individuals with congenital structural heart disease (CSHD) and those with inherited arrhythmias (IA) who received a WCD for the prevention of SCD.  The study population included 162 subjects with CSHD (n=43) and IA (n=119) who were prospectively followed up in a nationwide registry from 2005 to 2010.  The mortality rates were compared using Kaplan-Meier survival analysis.  It was noted that subjects with CSHD had a greater frequency of left ventricular dysfunction (ejection fraction < 30%) than did those with IA (37% vs. 5%, respectively; p=0.002).  The predominant indication for WCD was pending genetic testing in the IA group and transplant listing in the CSHD group.  Compliance with the WCD was similar in the two groups (91%).  WCD shocks successfully terminated 3 ventricular tachyarrhythmias in the subjects with IA during a median follow-up of 29 days of therapy (corresponding to 23 appropriate WCD shocks per 100 subject-years).  No arrhythmias occurred in the subjects with CSHD during a median follow-up of 27 days, and no subjects died while actively wearing the WCD.  At 1 year of follow-up, the survival rates were significantly lower among the subjects with CSHD (87%) than among those with IA (97%, p=0.02).  The authors concluded that the data suggested the WCD can be safely used in high-risk adult individuals with IA and CSHD, although the subjects with IA showed a greater rate of ventricular tachyarrhythmias during therapy but significantly lower long-term mortality rates (Rao, 2011).

Background/Overview

The implantable cardioverter defibrillator (ICD) has been proven to be effective in reducing mortality in individuals with episodes of ventricular arrhythmias or in survivors of SCD, often seen in those with coronary artery disease (CAD).  More recently, randomized studies, (that is, the MADIT I and MADIT II trials) have demonstrated that ICDs are effective prophylactic therapy in those who are considered at high risk for lethal arrhythmias, such as those with prior MI and reduced LVEF.  ICDs consist of implantable leads in the heart that connect to a pulse generator implanted beneath the skin of the chest or abdomen.  In the past, ICD placement required a thoracotomy, but current technology allows implantation with only a minor surgical procedure, with the cardiac leads placed percutaneously.  Potential adverse effects of ICD placement are bleeding, infection, pneumothorax, and delivery of unnecessary counter shocks.

The wearable cardioverter defibrillator (WCD) is an external device that is intended to perform the same tasks as an ICD, without requiring any invasive procedures.  It consists of a vest that is worn continuously underneath the clothing. Part of this vest is the ‘electrode belt’ that contains the cardiac monitoring electrodes and the therapy electrodes that deliver a counter shock.  The vest is connected to a monitor with a battery pack and alarm module that is worn on the belt.  The monitor contains the electronics that interpret the cardiac rhythm and determine when a counter shock is necessary.  The alarm module alerts the wearer to certain conditions by lights or voice messages. The U.S. Food and Drug Administration (FDA) gave clearance to the Lifecor WCD® 2000 system via premarket application approval in December 2001 for “Adult patients 18 years and older who are at risk for sudden cardiac arrest and are either not candidates for or refuse an implantable defibrillator.”  The trade name of the WCD 2000 System was changed to LifeVest® in 2002, and the LIFECOR business was acquired by ZOLL Medical Corporation (Philadelphia, PA) in 2006.  On December 17, 2015 the FDA expanded its clearance of the LifeVest system to include the following:

The LifeVest® system is indicated for patients under 18 years of age who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. Patients must have a chest circumference of 26 inches (66 centimeters) or greater and a weight of 18.75 kilograms (41.3 pounds) or greater.

According to the updated FDA label for the LifeVest device, the following is provided within the updated Summary of Safety and Effectiveness data (SSED, 2015):

The clinical information provided in this submission did not identify any additional safety concerns associated with use of the LifeVest in patients under the age of 18, who are of the appropriate size for the device, than were seen in the complete clinical study for patients over the age of 18 submitted in the Original PMA. Data from the literature cited below has shown the LifeVest’s ability to successfully convert a sudden cardiac arrest to a life-sustaining rhythm in patients as young as thirteen. Four patients in the 3-17 age group and five patients in the 18-21 age group experienced a sudden cardiac arrest during LifeVest use that was successfully converted to a life-sustaining rhythm. While a successful shock was not reported in a patient younger than 13, the AHA dosing guidelines for external defibrillation suggest that we can expect an appropriate shock to be effective in any patient who meets the weight requirement stated in the Indications for Use.

There are three peer-reviewed articles on the use of the LifeVest specifically in the pediatric population which were described in the literature as follows:  

One recent paper describes 4 pediatric individuals prescribed a WCD from a single site (Everitt, 2010).  All carried a diagnosis of anthracycline-induced cardiomyopathy.  None of these individuals had an appropriate or inappropriate shock.  Two trial participants had documented noncompliance with wear, which resulted in failure to detect and treat a life-threatening arrhythmia in one.  While no trial subjects received an appropriate treatment in this study, none received an inappropriate treatment despite the inappropriately detected rhythm caused by ECG noise.  The paper concluded that the WCD is a short-term alternative for children at risk for SCD, who can be properly fit with the WCD, where the risk of ICD use is greater than the benefit.

In a paper by Collins (2010), 81 multi-site WCD individuals from 9-18 years old, and 103 subjects aged 19-21, were retrospectively reviewed.  In subjects aged 19–21 years, there were five appropriate treatments in 2 subjects and one inappropriate treatment in a single subject.  In subjects ≤ 18 years of age, there was one inappropriate therapy, due to sinus tachycardia and artifact, and one withholding of therapy, due to a device-device interaction. Compliance was generally similar to adults among these younger individuals, with an average daily use of 19 hours, and non-compliance or comfort issues only being recorded for 7-11% of trial participants.  This paper concluded that the WCD could be an appropriate therapy for pediatric individuals who are at risk for SCD, as they had two appropriate treatments in their young adult population (age 19-21).  However, they had no appropriate treatments in their pediatric population (age 9-18).

The third paper by LaPage (2008) detailed the fatal device-device interaction between the WCD and a unipolar epicardial pacemaker.  Such interactions are not unique to pediatric individuals nor are they unique to wearable defibrillators, being extensively described in the ICD and AED literature.  LifeVest manuals have included specific warnings about pacemaker interactions since the initial FDA approval.  These warnings advise physicians to use appropriate caution when prescribing the LifeVest device to an individual who is dependent on a pacemaker.  There was only one serious adverse event reported in the literature for pediatric subjects using the LifeVest.

The updated FDA premarket approval requires that a post-approval study be performed as follows:

The study will consist of a serial, prospective data collection of patients under 18 years of age utilizing the LifeVest WCD who meet the proposed indication for the treatment of life-threatening arrhythmias. The data will be collected via medical order database, device generated records, and customer call reports for each device use. Patient demographics collected will include age, gender, and ICD-9 code(s) describing the patient’s condition. Performance information will include daily compliance with use, duration of use, appropriate therapy delivery, ECG recordings during appropriate therapy delivery, and any available description of the circumstances found within the Call Report Database.  Safety data to be included are inappropriate defibrillation therapy delivery, ECG recordings during inappropriate therapy delivery and any available description of the circumstances found within the Call Report Database, and adverse events reported to ZOLL through the customer support or technical support departments. The data on the first 150 patients who meet the proposed indication will be collected and data will be obtained from the returned device (P010030/S056).

Definitions

Cardiac arrhythmia: A disturbance in the electrical activity of the heart that manifests as an abnormality in the heart rate or heart rhythm. Individuals with arrhythmias may experience a wide variety of symptoms ranging from palpitations to fainting.

Coronary artery: A pair of vessels that supply blood to the myocardium (middle layer of the walls of the heart).

Coronary artery disease: This condition involves narrowing of the coronary arteries that is sufficient enough to prevent adequate blood supply to the myocardium.

Defibrillation: A treatment in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, in order to restore the normal heart rhythm.

Ejection fraction: A measure of ventricular contractility.

Electrophysiologic study of the heart: This is a test of the electrical conduction system of the heart (the system that generates the heart beat).

Fibrillation: This term refers to very rapid contractions or twitching of small muscle fibers in the heart.

Tachycardia: An abnormally rapid heartbeat.

Ventricle: One of two lower chambers of the heart.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

 

93745

Initial 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

 

 

HCPCS

 

K0606

Automatic external defibrillator, with integrated electrocardiogram analysis, garment type

 

 

ICD-10 Diagnosis

 

 

All diagnoses

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications:

  1. Adler A, Halkin A, Viskin S. Wearable cardioverter-defibrillators. Circulation. 2013; 127(7):854-860.
  2. Auricchio A, Klein H, Geller CJ, et al. Clinical efficacy of the wearable cardioverter defibrillator in acutely terminating episodes of ventricular fibrillation. Am J Cardiol. 1998; 81(10):1253-1256.
  3. Beauregard LA. Personal security: clinical applications of the wearable defibrillator. Pacing Clin Electrophysiol. 2004; 27(1):1-3.
  4. Bigger JT Jr. Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular arrhythmias after coronary artery bypass surgery. The CABG-PATCH Trial Investigators. N Engl J Med. 1997; 337(22):1569-1575.
  5. Boehmer JP. Device therapy for heart failure. Am J Cardiol. 2003; 91(6A):53D-59D.
  6. Chung MK, Szymkiewicz SJ, Shao M, et al. Aggregate national experience with the wearable cardioverter-defibrillator: event rates, compliance, and survival. J Am Coll Cardiol. 2010; 56(3):194-203. Available at: http://content.onlinejacc.org/article.aspx?articleid=1142987. Accessed on June 25, 2018.
  7. Collins KK, Silva JN, Rhee EK, Schaffer MS. Use of a wearable automated defibrillator in children compared to young adults. Pacing and Clinical Electrophysiology. 2010; 33(9):1119-1124.
  8. Duncker D, Haghikia A, Konig T, et al. Risk for ventricular fibrillation in peripartum cardiomyopathy with severely reduced left ventricular function-value of the wearable cardioverter/defibrillator. Eur J Heart Fail. 2014; 16(12):1331-1336.
  9. Duncker D1, König T1, Hohmann S1, et al. Ventricular arrhythmias in patients with newly diagnosed nonischemic cardiomyopathy: Insights from the PROLONG study. Clin Cardiol. 2017; 40(8):586-590.
  10. Epstein AE, Abraham WT, Bianco N, et al. Wearable cardioverter-defibrillator use in patients perceived to be at high risk early post myocardial infarction. J Am Coll Cardiol. 2013; 62(21):2000-2007.
  11. Erath JW, Vamos M, Benz AP, Hohnloser SH. Usefulness of the WCD in patients with suspected tachymyopathy. Clin Res Cardiol. 2018; 107(1):70-75.
  12. Erath JW, Vamos M, Sirat AS, Hohnloser SH. The wearable cardioverter-defibrillator in a real-world clinical setting: experience in 102 consecutive patients. Clin Res Cardiol. 2017; 106(4):300-306.
  13. Everitt MD, Saarel EV. Use of the wearable external cardiac defibrillator in children. Pacing and Clinical Electrophysiology. 2010; 33(6):742-746.
  14. Feldman AM, Klein H, Tchou P, et al. Use of a wearable defibrillator in terminating tachyarrhythmias in patients at high risk for sudden death: results of the WEARIT/BIROAD. Pacing Clin Electrophysiol. 2004; 27(1):4-9.
  15. Hohnloser SH, Kuck KH, Dorian P, et al. Prophylactic use of an implantable cardioverter-defibrillator after acute myocardial infarction. N Engl J Med. 2004; 351(24):2481-2488.
  16. Kao AC, Krause SW, Handa R, et al.; Wearable defibrillator use In heart Failure (WIF) Investigators. Wearable defibrillator use in heart failure (WIF): results of a prospective registry. BioMed Cardiovas Disord. 2012; 12:123.
  17. Klein HU, Goldenberg I, Moss AJ. Risk stratification for implantable cardioverter defibrillator therapy: the role of the wearable cardioverter-defibrillator. Eur Heart J. 2013; 34(29):2230-2242.
  18. Klein HU, Meltendorf U, Reek S, et al. Bridging a temporary high risk of sudden arrhythmic death. Experience with the wearable cardioverter defibrillator (WCD). Pacing Clin Electrophysiol. 2010; 33(3):353-367.
  19. Kondo Y, Linhart M, Andrié RP, Schwab JO. Usefulness of the wearable cardioverter defibrillator in patients in the early post-myocardial infarction phase with high risk of sudden cardiac death: A single-center European experience. J Arrhythm. 2015; 31(5):293-295.
  20. Kutyifa V, Moss AJ, Klein H, et al. Use of the wearable cardioverter defibrillator in high-risk cardiac patients: data from the Prospective Registry of Patients Using the Wearable Cardioverter Defibrillator (WEARIT-II Registry). Circulation. 2015; 132(17):1613-1619.
  21. LaPage MJ, Canter CE, Rhee EK. A fatal device-device interaction between a wearable automated defibrillator and a unipolar ventricular pacemaker. Pacing Clin Electrophysiol. 2008; 31(7):912-915.
  22. Leyton-Mange JS, Hucker WJ, Mihatov N, et al. Experience with wearable cardioverter-defibrillators at 2 academic medical centers. JACC Clin Electrophysiol. 2018; 4(2):231-239.
  23. Opreanu M, Wan C, Singh V, et al. Wearable cardioverter-defibrillator as a bridge to cardiac transplantation: A national database analysis. J Heart Lung Transplant. 2015; 34(10):1305-1309.
  24. Pouleur AC, Barkoudah E, Uno H, et al.; VALIANT Investigators. Pathogenesis of sudden unexpected death in a clinical trial of patients with myocardial infarction and left ventricular dysfunction, heart failure, or both. Circulation. 2010; 122(6):597-602.
  25. Rao M, Goldenberg I, Moss AJ, et al. Wearable defibrillator in congenital structural heart disease and inherited arrhythmias. Am J Cardiol. 2011; 108(11):1632-1638.
  26. Reek S, Geller JC, Meltendorf U, et al. Clinical efficacy of a wearable defibrillator in acutely terminating episodes of ventricular fibrillation using biphasic shocks. Pacing Clin Electrophysiol. 2003; 26(10):2016-2022.
  27. Reek S, Meltendorf U, Geller JC, et al. The wearable cardioverter defibrillator (WCD) for the prevention of sudden cardiac death – a single center experience. Z Kardiol. 2002; 91(12):1044-1052 (abstract available in English; article in German).
  28. Salehi N, Nasiri M, Bianco NR, et al. The wearable cardioverter defibrillator in nonischemic cardiomyopathy: a US National Database Analysis. Can J Cardiol. 2016; 32(10):1247.e1-1247.
  29. Sheppard R1, Mather PJ, Alexis JD, et al. Implantable cardiac defibrillators and sudden death in recent onset nonischemic cardiomyopathy: results from IMAC2. J Card Fail. 2012; 18(9):675-681.
  30. Singh M, Wang NC, Jain S, et al. Utility of the wearable cardioverter-defibrillator in patients with newly diagnosed cardiomyopathy: A decade-long single-center experience. J Am Coll Cardiol. 2015; 66(23):2607-2613.
  31. Solomon SD, Zelenkofske S, McMurray JJ, et al. Sudden death in patients with myocardial infarction and left ventricular dysfunction, heart failure, or both. N Engl J Med. 2005; 352(25):2581-2588.
  32. Steinbeck G, Andresen D, Seidl K, et al.; IRIS Investigators. Defibrillator implantation early after myocardial infarction. N Engl J Med. 2009; 361(15):1427-1436.
  33. Verdino RJ. The wearable cardioverter-defibrillator. J Am Coll Cardiol. 2010; 56(3):204-205.
  34. Wäßnig NK1, Günther M2, Quick S2, et al. Experience with the wearable cardioverter-defibrillator in patients at high risk for sudden cardiac death. Circ. 2016; 134(9):635-643.
  35. Wilber DJ, Zareba W, Hall WJ, et al. Time dependence of mortality risk and defibrillator benefit after myocardial infarction. Circulation. 2004; 109(9):1082-1084.
  36. Zishiri ET, Williams S, Cronin EM, et al. Early risk of mortality after coronary artery revascularization in patients with left ventricular dysfunction and potential role of the wearable cardioverter defibrillator. Circ Arrhythm Electrophysiol. 2013; 6(1):117-128.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm. 2017.
  2. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC Guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014; 130(25):e344-e426.
  3. Blue Cross Blue Shield Association. Wearable cardioverter-defibrillator as a bridge to implantable cardioverter-defibrillator treatment. TEC Assessment, 2010; 25(2).
  4. Epstein AE, Abraham WT, Bianco NR, et al. Wearable cardioverter-defibrillator use in patients perceived to be at high risk early post-myocardial infarction. J Am Coll Cardiol. 2013; 62(21):2000-2007.
  5. 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. J Am Coll Cardiol. 2008; 51(21):e1-62. Available at: http://circ.ahajournals.org/content/117/21/2820.full.pdf. Accessed on June 25, 2018.
  6. Goldberger JJ, Cain ME, Hohnloser SH, et al. American Heart Association/American College of Cardiology Foundation/Heart Rhythm Society Scientific Statement on Noninvasive risk stratification techniques for identifying patients at risk for sudden cardiac death. A Scientific Statement from the American Heart Association Council on Clinical Cardiology Committee on Electrocardiography and Arrhythmias and Council on Epidemiology and Prevention. J Am Coll Cardiol. 2008; 52(14):1179-1199. Available at: http://content.onlinejacc.org/article.aspx?articleid=1139251. Accessed on June 25, 2018.
  7. Gronda E, Bourge RC, Costanzo MR, et al. Heart rhythm considerations in heart transplant candidates and considerations for ventricular assist devices: International Society for Heart and Lung Transplantation Guidelines for the Care of Cardiac Transplant Candidates—2006. J Heart Lung Trans. 2006; 25(9):1043-1056. Available at: http://www.jhltonline.org/article/PIIS1053249806004578/fulltext. Accessed on June 24, 2018.
  8.  Jessup M, Abraham WT, Casey DE, et al. writing on behalf of the 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult Writing Committee. 2009 Focused Update: ACCF/AHA guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009; 119(a4):1977-2016. Available at: http://circ.ahajournals.org/content/119/14/1977.full. Accessed on June 25, 2018.
  9. Kushner FG, Hand M, Smith SC, et al. 2009 Focused Updates: ACC/AHA Guidelines for the management of patients with ST-elevation myocardial infarction (Updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (Updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009; 54(23):2205-2241. Available at: http://content.onlinejacc.org/article.aspx?articleid=1140245. Accessed on June 25, 2018.
  10. 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.
  11. National Heart, Lung, and Blood Institute (NHLBI). Evaluating the Effectiveness of the LifeVest Defibrillator and Improving Methods for Determining the Use of Implantable Cardioverter Defibrillators (VEST/PREDICTS). NCT00628966. Last updated November 11, 2011. Available at: https://clinicaltrials.gov/ct2/show/NCT00628966?term=Vest+Prevention+of+Early+Sudden+Death+and+PREDiction+of+ICD&rank=1. Accessed on June 25, 2018.
  12. Piccini JP, Allen LA, Kudenchuk PJ, et al. Wearable cardioverter-defibrillator therapy for the prevention of sudden cardiac death: a Science Advisory from the American Heart Association. Circulation. 2016; 133(17):1715-1727. Available at: http://circ.ahajournals.org/content/early/2016/03/28/CIR.0000000000000394.full.pdf+html. Accessed on June 25, 2018.
  13.  Priori SG, Blomström-Lundqvist C, Mazzanti A, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: the Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). Endorsed by: Association for European Pediatric and Congenital Cardiology (AEPC). Eur Heart J. 2015; 36(41):2793-2867. Available at: http://eurheartj.oxfordjournals.org/content/early/2015/08/28/eurheartj.ehv316. Accessed on June 25, 2018.
  14.  University of California, San Francisco and Zoll Medical Corporation. Vest Prevention of Early Sudden Death Trial and VEST Registry. NCT01446965. Last updated November 9, 2017. Available at:   https://clinicaltrials.gov/ct2/show/NCT01446965?cond=NCT01446965&rank=1. Accessed on June 25, 2018.
  15. U.S. Food and Drug Administration. Center for Devices and Radiological Health (CDRH) 510(k) Premarket Notification Database. LifeVest® System Summary of Safety and Effectiveness. No. P010030/S056. Rockville, MD: FDA. December 17, 2015. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010030S056B.pdf. Accessed on June 25, 2018.
  16. Uyei J, Braithwaite RS. Effectiveness of wearable defibrillators: systematic review and quality of evidence. Int J Technol Assess Health Care. 2014; 30(2):194-202.
  17. Zipes DP, Camm AJ, Borggrefe M, et al. ACC/AHA/ESC 2006 Guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death). Eur Heart J. 2006; 27(17):2099-2140.
  18. Zoll Medical Corporation. Study of the Wearable Defibrillator in Heart-Failure Patients (SWIFT). NCT01326624. Last updated December 6, 2017. Available at: http://clinicaltrials.gov/ct2/show/NCT01326624. Accessed on June 24, 2018.
Websites for Additional Information
  1.  American Heart Association information. Available at: http://www.americanheart.org/ Accessed on June 24, 2018. 
Index

Cardioverter Defibrillators
Lifecor WCD 2000 System
LifeVest
Sudden Cardiac Arrest
Wearable Cardioverter Defibrillators

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. 

Document History

Status

Date

Action

Revised

07/26/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording was updated from “Current Effective Date” to “Publish Date.” The acronyms (WCD, ICD, others) were removed from the Position Statements. The Rationale and References sections were updated.

Reviewed

08/03/2017

MPTAC review. References were updated.

Revised

08/15/2016

MPTAC review. Interim MPTAC review approved the addition of newly diagnosed NIDCM during the initial treatment period of 3 months of GDMT to the investigational and not medically necessary indications for the WCD.

Revised

08/04/2016

MPTAC review. Updated the formatting in the Position Statement section. Examples were added to Criterion No. B2 and B3. The Rationale, Background and References were updated. Removed ICD-9 codes from Coding section.

Reviewed

08/06/2015

MPTAC review. References were updated.

Reviewed

08/14/2014

MPTAC review. References were updated.

Reviewed

11/14/2013

MPTAC review. References were updated.

Reviewed

11/08/2012

MPTAC review. References were updated. Updated Coding section to include 01/01/2013 CPT descriptor change.

Reviewed

11/17/2011

MPTAC review. The Rationale and References were updated.

Reviewed

11/18/2010

MPTAC review. References and Coding were updated.

Reviewed

11/19/2009

MPTAC review. References were updated.

Reviewed

11/20/2008

MPTAC review. Consideration was given to expansion of medically necessary indications/criteria to add the immediate post-acute MI recovery period (first 40 days) in response to specialty society recommendation but no revision to existing criteria was approved by MPTAC. Annual Review research was also performed. The Rationale and Reference sections were updated. Updated Coding section with 01/01/2009 CPT changes.

Revised

11/29/2007

MPTAC review. The criteria considered investigational and not medically necessary regarding: “History of an acute myocardial infarction within thirty days” has been revised from 30 to 40 days post-MI for consistency with SURG.00033 (ICD criteria regarding no history of MI in the last forty days).  Also, the phrase “investigational/not medically necessary” was clarified to read “investigational and not medically necessary.”  References were also updated.

Reviewed

12/07/2006

MPTAC review. References and coding were updated.

Revised

12/01/2005

MPTAC revised. Added additional indication for WCD i.e., patients with an infectious process or other temporary condition that precludes initial implantation of an ICD.

Revised

09/22/2005

MPTAC review. Position Statement: Provided clarification that candidates must have a documented medical contraindication to ICD placement with either of the following: those awaiting a heart transplantation - on waiting list and meets medical necessity criteria for heart transplantation, or those with a previously implanted ICD that requires explantation due to infection with waiting period before ICD reinsertion.

Revised

07/14/2005

MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

07/28/2005

MED.00049

Automatic External Defibrillators and Wearable Cardioverter Defibrillators

WellPoint, Inc.

04/28/2005

9.04.04

Wearable Cardioverter Defibrillators for Prevention of Sudden Cardiac Death