Pending Policies - DME
Nonwearable Automatic External Defibrillator (AED) for Home Use
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A nonwearable automatic external defibrillator (AED) for home use is considered experimental, investigational and/or unproven.
Sudden cardiac arrest (SCA) and sudden cardiac death (SCD) refer to the sudden cessation of cardiac activity with hemodynamic collapse, typically due to sustained ventricular tachycardia/ventricular fibrillation. These events mostly occur in patients with structural heart disease (that may not have been previously diagnosed), particularly coronary heart disease (CHD). The event is referred to as SCA (or aborted SCD) if an intervention (e.g., defibrillation) or spontaneous reversion restores circulation and the event is called SCD if the patient dies.
The specific causes of SCA vary with the population studied and patient age. SCA most commonly results from hemodynamic collapse due to ventricular fibrillation (VF) in the setting of structural heart disease. The outcome following SCA depends upon numerous factors including the underlying cause and the rapidity of resuscitation. Most individuals suffering from SCA become unconscious within seconds to minutes as a result of insufficient cerebral blood flow. There are usually no premonitory symptoms. If symptoms are present, they are nonspecific and include chest discomfort, palpitations, shortness of breath, and weakness.
Although several interventions can improve the likelihood of VF resuscitation, the single most important is early delivery of an external electric shock to reset the cardiac rhythm and restore spontaneous circulation. Early defibrillation is consistently associated with a greater likelihood of survival, which decreases by approximately five percent with each additional minute from collapse to defibrillation. (1)
A nonwearable automatic external defibrillator (AED) is a portable device designed to analyze a patient’s EKG, the heart rhythm and, automatically deliver an electric shock (fully automated AED), or advise the user to deliver the shock (semi-automated AED) in an attempt to restore a normal heart rhythm. The AED unit is designed for use by laypersons and basic life support-trained personnel. They are widely available in a variety of public settings (airports, schools, and other public areas). Society has embraced this use and legislation has been passed that supports the implementation of public access to defibrillation (PAD) programs into communities and protects lay rescuers and organizations implementing these programs from liability.
The Philips HeartStart Home OTC Defibrillator (Philips Medical Systems, Seattle, WA) received U.S. Food and Drug Administration (FDA) approval through the 510(k) process on September 16, 2004. The previous version of the HeartStart was available by prescription only, while the HeartStart Home OTC External Cardioverter-Defibrillator (ECD) was approved for home use without a prescription. Data submitted to the FDA demonstrated that the device could be used successfully in a mock rescue by laypersons based on written instructions and the device itself. There was no evidence, however, to demonstrate that use of the device in the home by untrained persons improves outcomes. (2)
On January 28, 2015, the FDA issued a final order to require the filing of premarket approval (PMA) application for automated external defibrillator (AED) systems. PMA applications undergo a more rigorous review than what was required to market these devices in the past. From January 2005 through September 2014, the FDA received approximately 72,000 medical device reports associated with the failure of these devices. Since 2005, manufacturers have conducted 111 recalls, affecting more than two million AEDs. The problems associated with many of these recalls and reports included design and manufacturing issues, such as inadequate control of components purchased from other suppliers.
AEDs currently on the market will remain available while manufacturers work to meet the new PMA requirements. The FDA does not intend to enforce the PMA requirement for AEDs until August 3, 2016, as long as manufacturers notify the FDA of their intent to file a PMA by May 4, 2015. The FDA does not intend to enforce the PMA requirement for currently marketed, necessary AED accessories until February 3, 2020. (3)
This policy was originally created in 1990; this section of the current policy has been updated with searches of scientific literature through September 2018. Following is a summary of the key literature to date.
Nonwearable Automatic External Defibrillators (AEDs)
In the Home Automatic External Defibrillator Trial (HAT) by Bardy et al. (2008), 7001 patients with previous anterior-wall myocardial infarction (MI) who were not candidates for an implantable cardioverter-defibrillator were randomly assigned to receive one of two responses to sudden cardiac arrest (SCA) occurring at home: either the control response (calling emergency medical services [EMS] and performing cardiopulmonary resuscitation [CPR]) or the use of an AED, followed by calling emergency services and performing CPR. (4) The median age of the patients was 62 years; 17% were women. The median follow-up was 37.3 months. Overall, 450 patients died: 228 of 3506 patients (6.5%) in the control group and 222 of 3495 patients (6.4%) in the AED group (hazard ratio, 0.97; 95% confidence interval, 0.81 to 1.17; P=0.77). Mortality did not differ significantly in major prespecified subgroups. Only 160 deaths (35.6%) were considered to be from SCA from tachyarrhythmia. Of these deaths, 117 occurred at home; 58 at-home events were witnessed. AEDs were used in 32 patients. Of these patients, 14 received an appropriate shock, and 4 survived to hospital discharge. There were no documented inappropriate shocks. Investigators concluded that for survivors of anterior-wall MI who were not candidates for implantation of a cardioverter–defibrillator, access to a home AED did not significantly improve overall survival, as compared with reliance on conventional resuscitation methods.
Mark et al. (2010) randomly selected a subset of 1,007 study patients and their spouse/companions from the 7,001 patients who had previously participated in the HAT study. (5) Selected patients and their spouse/companions participated in a structured quality of life (QOL) interview at baseline and then at 12 and 24 months post-randomization. The primary QOL measures were the Medical Outcomes Study 36-Item Short-Form (SF-36) psychological well-being (reflecting anxiety and depression) and vitality (reflecting energy and fatigue) subscales. For patients and spouse/companions, the psychological well-being and vitality scales did not differ significantly between those randomly assigned an AED plus CPR training and controls who received CPR training only. None of the other QOL measures collected showed a clinically and statistically significant difference between treatment groups. Patients in the AED group were more likely to report being extremely or quite a bit reassured by their treatment assignment. Spouse/companions in the AED group reported being less often nervous about the possibility of using AED/CPR treatment than those in the CPR group. Authors concluded that adding access to a home AED to CPR training did not affect quality of life either for patients with a prior anterior MI or their spouse/companion but did provide more reassurance to the patients without increasing anxiety for spouse/companions.
In a 2012 review, Stokes et al. assessed the effectiveness of the AED, consistencies and variations among studies, and how varying outcomes can be resolved. (6) Reviewers found that:
• Use of AEDs by emergency medical technicians (EMTs) compared to manual defibrillators showed equal or superior survival;
• AED use by trained responders likely to be near victims, such as fire/rescue, police, airline attendants, and casino security guards showed improvement in all venues but not all programs;
• Broad public access initiatives demonstrated increased survival despite low rates of AED use;
• Home AED programs did not show improved survival;
• Successful programs have placed devices in high-risk sites, maintained the AEDs, recruited a team with a duty to respond, and conducted ongoing assessment of the program.
Rea et al. (4) noted in an article about AED’s and specifically to AEDs for use in private homes, that since approximately three-quarters of SCAs occur in private homes, one strategy to reduce mortality is to distribute AEDs for use in the home. He noted that home use of AEDs was investigated in a randomized trial of 7001 patients with previous anterior wall myocardial infarction who were not candidates for an implantable cardioverter-defibrillator. The median age was 62 years and the median left ventricular ejection fraction was 45 percent. The designated rescuers were predominantly female (83 percent) and their median age was 58 years. Patients were randomly assigned to AED use followed by calling EMS and performing cardiopulmonary resuscitation (CPR) or to the control response of calling EMS and performing CPR. Access to a home AED did not improve survival as compared to conventional resuscitation (6.4 versus 6.5 percent, hazard ratio, 0.97; 95% CI 0.81 to 1.17). The authors noted that several factors may have contributed to the lack of benefit in this trial:
• The incidence of sudden cardiac arrest (2.3 percent) and overall mortality were lower than predicted.
• One-half of the tachyarrhythmia arrests that took place at home were witnessed (58 of 117), and an AED was used in only 32 patients.
• Spouses and companions in the control group received training in resuscitation, with frequent reminders.
In determining whether AEDs are appropriate for home use, cost and the increasing role of implantable cardioverter-defibrillators in individuals at high risk of SCA must be taken into consideration.
Summary of Evidence
Automatic external defibrillators (AEDs) have become an important component of emergency medical systems (EMS), and the use of AEDs in public places is growing. There is insufficient evidence in the published medical literature, however, to demonstrate that use of AEDs in the home by laypersons improves outcomes. An AED in the home is primarily considered a safety device kept in the home as a precautionary measure to address a possible acute event, rather than a device for active treatment. There are no clinical trials that establish the efficacy of nonwearable AEDs for home use in high risk patients.
Practice Guidelines and Position Statements
None of the following professional society guidelines include a recommendation for home use of automatic external defibrillators (AEDs).
• 2010 electrical therapies section of the AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care; (7)
• 2012 American College of Cardiology Foundation (ACCF)/AHA Task Force on Practice Guidelines/Heart Rhythm Society(HRS) focused update of their 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities; (8)
• 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction; (9)
• 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. (10)
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The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.
A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
1. Rea, Thomas D, et.al. Automated external defibrillators. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Available at: <http://www.uptodate.com> (accessed July 19, 2017).
2. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. New Device Clearance. Philips HeartStart Home OTC Defibrillator. Available at: <http://www.fda.gov> (accessed July 19, 2017).
3. U.S. Food and Drug Administration (FDA). FDA takes steps to improve reliability of automated external defibrillators [news release]. January 28, 2015. Available at: <http://www.fda.gov> (accessed July 19, 2017).
4. Bardy GH, Lee KL, Mark DB et al. Home Use of Automated External Defibrillators for Sudden Cardiac Arrest. N Engl J Med. 2008; 358(17):1793-1804. PMID 18381485
5. Mark DB, Anstrom KJ, McNulty SE, et.al. Quality of Life Effects of Automatic External Defibrillators in the Home: Results from the Home Automatic External Defibrillator Trial (HAT). Am Heart J. 2010; 159(4):627-634. PMID: 20362722
6. Stokes NA, Scapigliati A, Trammell AR, et al. The effect of the AED and AED programs on survival of individuals, groups and populations. Prehosp Disaster Med. 2012 Oct; 27(5):419-24. PMID 22985768
7. Link MS, Atkins DL, Passman RS, et al. Part 6: electrical therapies: automated external defibrillators, defibrillation, cardioversion, and pacing: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2; 122(18 Suppl 3):S706-19. PMID 20956222
8. Tracy CM, Epstein AE, Darbar D, et al. 2012 ACCF/AHA/HRS focused update of the 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. Circulation. 2012 Oct 2; 126(14):1784-800. PMID 22965336
9. O’Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29; 61(4):485-510. PMID 23256913
10. 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. Circulation. 2017 Oct 30. PMID 29084731
|11/15/2018||Document updated with literature review. Coverage unchanged. Added references 6-10.|
|8/15/2017||Document updated with literature review. Coverage unchanged.|
|10/1/2016||Reviewed. No changes.|
|6/15/2015||Document updated with literature review. Entire document revised to remove any reference to wearable defibrillators. This medical policy will now address only nonwearable external defibrillators. Title changed from “Automatic External Defibrillators (AEDs) (Wearable and Nonwearable)”.|
|4/15/2014||Document updated with literature review. The following 2 indications were added to the coverage criteria: 1) As a bridge to permanent AICD placement and 2) As a bridge for patients with severe heart failure awaiting transplantation. In addition, clarification added to bulleted criteria of "documented prior MI” adding the following: "(>48 hours post MI)".|
|12/15/2013||Document updated with literature review. Coverage unchanged.|
|9/15/2008||Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.|
|9/1/2006||Revised/updated entire document|
|2/27/2004||Revised/updated entire document|
|3/1/1998||Revised/updated entire document|
|5/1/1990||New medical document|
|Title:||Effective Date:||End Date:|
|Nonwearable Automatic External Defibrillator (AED) for Home Use||08-15-2017||11-14-2018|
|Nonwearable Automatic External Defibrillator (AED) for Home Use||10-01-2016||08-14-2017|
|Nonwearable Automatic External Defibrillator (AED) for Home Use||06-15-2015||09-30-2016|
|Automatic External Defibrillators (AEDs) (Wearable and Nonwearable)||04-15-2014||06-14-2015|
|Automatic External Defibrillators (AEDs) (Wearable and Nonwearable)||12-15-2013||04-14-2014|
|Automatic External Defibrillators (AEDs) (Wearable and Nonwearable)||09-15-2008||12-14-2013|
|Automatic External Defibrillators (AEDs) (Wearable and Nonwearable)||09-01-2006||09-14-2008|
|Automatic External Defibrillator for Home Use||02-27-2004||08-31-2006|
|Automatic External Defibrillator (AED)||05-01-1990||02-26-2004|