|Subject:||Automated External Defibrillators for Home Use|
|Policy #:||DME.00032||Current Effective Date:||07/15/2014|
|Status:||Reviewed||Last Review Date:||05/15/2014|
An automated external defibrillator (AED) is a portable machine that uses an algorithm to distinguish ventricular fibrillation (VF) from other cardiac rhythms, advise the rescuer that a shockable rhythm is present, and then allow for the delivery of the appropriate amplitude shock to "restart" the individual's heart. This document addresses AEDs for home use.
Note: This document does not address wearable cardioverter defibrillators. For information related to these devices, please see MED.00055 Wearable Cardioverter Defibrillators.
Investigational and Not Medically Necessary:
Automated external defibrillators for home use are considered investigational and not medically necessary.
The implantable cardioverter defibrillator (ICD) is currently the "gold-standard" treatment for preventing sudden cardiac death (SCD) in high-risk individuals, including those with a previous history of sudden cardiac arrest (SCA) and those at risk for ventricular arrhythmias, such as individuals with prior myocardial infarction (MI) and reduced ejection fraction.
Defibrillation success using AEDs in experimental and clinical models has been demonstrated, and clinical studies suggest that AED use in public locations, (such as airports and casinos), improves survival from SCA. The Public Access Defibrillation (PAD) trial, sponsored by the National Institutes of Health (NIH), was a multicenter study in which community-based AED training was employed in "high-risk" settings, that included 1,260 community sites and residential locations with more than 250 persons older than age 50 years on site for most of the day, or sites where a cardiac arrest had occurred within the two years prior to the study. Sites were randomized to rescuers trained in cardiopulmonary resuscitation (CPR) alone or those trained in CPR and defibrillator use. Approximately 20,000 lay volunteers were trained, representing almost 10 volunteers per available defibrillator. The primary endpoint of the study was the number of subjects who survived to hospital discharge. More cardiac arrests occurred in the CPR-defibrillator locations (n=129) than in the CPR-alone locations (n=103). Twenty-nine individuals in the CPR-defibrillator group survived to hospital discharge (22.5%), compared with only 15 in the CPR alone group (14.6%) (p=0.042). Notably, there was only one survival to hospital discharge in each group when SCA occurred in a residential unit. Investigators drew the following conclusions from the study results:
An important issue not addressed in the PAD study is whether or not AED use in the home setting improves health outcomes and survival beyond that achieved with the standard emergency response (EMS call, in addition to CPR). The Home Use of Automatic External Defibrillators to Treat Sudden Cardiac Arrest Trial (HAT), sponsored by the National Heart, Lung and Blood Institute (NHLB), enrolled an estimated 7,000 individuals who were randomized, following anterior MI, into either a group that received standard lay response to SCA (call EMS and begin CPR) or to a group that received home AED and the standard response. The primary endpoint was all-cause mortality in the two arms of the trial with secondary endpoints of survival free from post-arrest neurological impairment and diminished quality of life (QOL) for affected individuals and spouses. This Phase III trial enrolled participants for more than two years and followed for an additional two years at 200 cardiology clinics. Results of this study were published in 2008 and 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 (Bardy, 2008; Mark, 2010).
A large randomized controlled trial (RCT) (n=2589) conducted by Rubertsson and colleagues (2014) compared mechanical chest compressions and simultaneous defibrillation with conventional CPR in individuals who are undergoing SCA outside of a hospital (LUCAS in Cardiac Arrest Study [LINC]). The primary outcome measure was 4-hour survival and the secondary outcome measure was survival up to 6 months with a good neurological outcome. Neurological outcomes were assessed using the Cerebral Performance Category (CPC) score; a score of 1 or 2 was classified as a "good" outcome. Final results showed that there were no statistically significant differences in 4-hour survival between participants treated with conventional CPR and those treated with mechanical chest compressions and simultaneous AED. At 6 months of follow-up, participants in both groups demonstrated good neurological outcomes. Mechanical chest compression and AED did not demonstrate a net improvement in effectiveness when compared with manual CPR techniques.
Sudden cardiac arrest (SCA) is estimated to account for over 250,000 deaths annually. Although all known heart diseases can lead to SCA, the life-threatening arrhythmia of ventricular fibrillation (VF) is the leading cause. Early recognition of arrhythmia and subsequent defibrillation is the most important factor in survival from a cardiac arrest due to VF. Approximately 80 percent of people who suffer SCA are at home when it happens.
An AED, or automated external defibrillator, is a portable machine that is designed to use an algorithm to distinguish VF from other cardiac rhythms, advise the rescuer that a shockable rhythm is present, and then allow for the delivery of the appropriate amplitude shock to "restart" the individual's heart. AEDs are designed to be used by lay rescuers or "first responders."
The U.S. Food and Drug Administration (FDA) cleared the HeartStart Home OTC Defibrillator (Philips Medical Systems, Seattle, WA) for home use through the 510(k) approval process on September 16, 2004. The previous version of this device required a prescription. However, this device is available without a prescription (FDA, 2004). There are additional devices for home use that have also been cleared by the FDA, (for example, the HeartSine Samaritan® PAD [HeartSine Technologies, Inc., San Clemente, CA]). On January 25, 2010 the Circulatory System Devices Panel of the FDA Center for Devices and Radiological Health (CDRH) issued a recommendation that, "AEDs be classified as Class III medical devices and be subject to the regulations in accordance with premarket approval (PMA) applications." According to the FDA, AED devices, although historically classified as Class III devices, have not been subject to the requirement of submitting a premarket approval (PMA) application to demonstrate affirmatively a reasonable assurance of safety and effectiveness. Instead, they have been allowed to enter the market following FDA clearance of a 510(k) submission, usually reserved to lower risk devices. This 2010 FDA decision to require AED devices to meet PMA protocols followed an extensive review and analysis of available safety and outcomes data on AED device performance and will reportedly now require AED manufacturers to submit PMA applications for FDA approval for all previously cleared AED devices (FDA, 2010). In March 2013, this initial decision was reaffirmed when the FDA and its Circulatory System Devices Panel announced a proposed order that will require manufacturers to submit PMAs for all AEDs. This proposed order is based on the reports of 45,000 adverse events and 88 recalls received by the FDA between 2005 and 2013, many due to battery failure and improper maintenance (FDA, 2013).
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 to death.
Coronary artery: Vessels that supply blood to the myocardium (middle layer of the walls of the heart). Coronary arteries subdivide into branched vessels that travel down the length of the heart supplying oxygenated blood to the myocardium.
Coronary artery disease: This condition refers to narrowing of the coronary arteries sufficient to prevent adequate blood supply to the myocardium.
Defibrillation: A process in which an electronic device sends an electric shock to the heart to attempt to restore the normal heart rhythm.
Ejection fraction: The ejection fraction is the percentage of blood that is pumped out with each heartbeat. A measure of ventricular contractility.
Fibrillation: 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.
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 are Investigational and Not Medically Necessary:
|E0617||External defibrillator with integrated electrocardiogram analysis|
|ICD-9 Diagnosis||[For dates of service prior to 10/01/2015]|
|ICD-10 Diagnosis||[For dates of service on or after 10/01/2015]|
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
Automatic External Defibrillator
HeartStart Home OTC Defibrillator
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.
|Reviewed||05/15/2014||Medical Policy & Technology Assessment Committee (MPTAC) review. No change to Position Statement. Rationale and References were updated.|
|Reviewed||05/09/2013||MPTAC review. No change to stance. Definitions and References were updated.|
|Reviewed||05/10/2012||MPTAC review. No change to stance. References were updated.|
|Reviewed||05/19/2011||MPTAC review. No change to stance. The Background and References were updated.|
|Reviewed||05/13/2010||MPTAC review. No change to stance. The Background section and References were updated.|
|Reviewed||05/21/2009||MPTAC review. No change to stance. The Rationale, Background and References sections were updated.|
|Reviewed||05/15/2008||MPTAC review. No change to stance. References and Background sections were updated.|
|02/21/2008||The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.|
|Reviewed||05/17/2007||MPTAC review. No change to stance. References were updated.|
|Reviewed||06/08/2006||MPTAC review. No change to stance. Document was renumbered from former MED.00049 to DME.00032. References were updated.|
|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|
|07/28/2004||MED.00049||Automatic External Defibrillators and Wearable Cardioverter-Defibrillators|
|WellPoint Health Networks, Inc.||06/24/2004||9.04.05||Automated External Defibrillators for Home Use|