Clinical UM Guideline

This document addresses automated external defibrillators (AEDs) for home use to prevent sudden cardiac death (SCD) as a result of sudden cardiac arrest (SCA). An AED is a portable machine that uses an algorithm to distinguish shockable rhythms (ventricular fibrillation [VF] and ventricular tachycardia) from non-shockable cardiac rhythms (pulseless electrical activity and asystole), advises the rescuer that a shockable rhythm is present, and then allows for the delivery of the appropriate amplitude shock to “restart” the individual’s normal heart rhythm. Typically, an implantable cardioverter defibrillator (ICD) is placed when needed for prevention of SCD in high-risk individuals. Preventive options other than an implanted defibrillating device include AEDs and external wearable cardioverter defibrillators. This document does not address the medical necessity of wearable or implantable cardioverter defibrillators.

Note: Please see the following related documents for additional information:

• MED.00055 Wearable Cardioverter Defibrillators
• TRANS.00033 Heart Transplantation

Medically Necessary:

An automated external defibrillator (AED) for home use is considered medically necessary for an individual who meets the following criteria (A, B and C):

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; and
3. A caregiver, spouse, parent or other individual who is able to operate the AED is available in the home where the device is intended for use.

*Refer to applicable implantable cardioverter defibrillator guidelines used by the plan
**Refer to TRANS.00033 Heart Transplantation

Not Medically Necessary:

AEDs for home use are considered not medically necessary when the criteria above are not met.

AEDs for home use are considered not medically necessary when the individual has a wearable cardioverter defibrillator.

The following codes for treatments and procedures applicable to this guideline 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:

When services are Not Medically Necessary:
For the procedure code listed above when criteria are not met or for all other diagnoses not listed, or for situations designated in the Clinical Indications section as not medically necessary.

Sudden Cardiac Arrest

Sudden cardiac arrest (SCA) is estimated to occur in over 356,000 people every year and account for approximately 250,000 deaths annually (60-80% die prior to reaching a hospital); 3-5% of deaths are in children ages 5-19 years (approximately 40% of SCA in children are sports-related) (American Heart Association [AHA], 2022; Centers for Disease Control and Prevention [CDC], 2023).

The four diagnoses most commonly associated with SCA in children, adolescents and young adults include hypertrophic cardiomyopathy, long QT syndrome, catecholaminergic polymorphic ventricular tachycardia, and anomalous origin of the left coronary artery from the right sinus of Valsalva; while these are the most common diagnoses it is not an all-inclusive list of risk factors (Dalal, 2016). Similarly, the four leading causes of SCA irrespective of age are cardiomyopathy, coronary artery disease, valvular heart disease, and arrhythmias. Demographically, the highest risk population groups for SCA are older adults and men; Black men and women are more likely to die from out-of-hospital SCA than other races (CDC, 2023).

Prevention of Sudden Cardiac Death (SCD)

Typically, an implantable cardioverter defibrillator (ICD) is placed when needed for prevention of sudden cardiac death (SCD) in high-risk individuals. Preventive options other than an implanted defibrillating device include automated external defibrillators (AEDs) and external wearable cardioverter defibrillators.

An AED is a portable machine that is designed to use in the event of SCA to prevent SCD by employing an algorithm to distinguish shockable arrhythmias from other cardiac rhythms not amenable to defibrillation. An AED advises the rescuer when a shockable rhythm is present and prompts the delivery of the appropriate amplitude shock to attempt restoration of normal sinus heart rhythm. AEDs can be safely and effectively used by lay rescuers and first responders. The prompt initiation of cardiopulmonary resuscitation (CPR), recognition of a shockable arrhythmia, subsequent defibrillation and hospital transfer are the most important factors in survival from SCA. Approximately 80 percent of people who sustain an SCA are at home when it occurs (Erickson, 2021).

As mentioned, when an SCA occurs, prevention of SCD requires fast action. The AHA and American Academy of Pediatrics (AAP), along with other authoritative medical societies, have delineated consensus recommendations for the ‘chain-of-survival’ which includes immediate activation of emergency services (call 911), initiating bystander CPR, early defibrillation and ultimately advanced hospital care. Survival rates are extremely low and decrease by 10% each minute CPR and defibrillation (when indicated) are not administered (AAP, 2012; Erickson, 2021). It is estimated that nearly 60-80% of out-of-hospital SCA’s occur in a residential setting where the survival rate is less than half that of public spaces (Elhussain, 2023; Erickson, 2021).

Available literature indicates that defibrillation is recommended for the secondary prevention of SCD, due to ventricular fibrillation (VF) or ventricular tachycardia (VT) and as primary prevention for some indications. Typical examples of primacy SCD prevention strategies include reduction of blood lipids, cessation of smoking, and sufficient treatment of diabetes and arterial hypertension, but some risk factors for SCD are not due to underlying modifiable factors. ICD implantation is the generally accepted preventable treatment option for those who have experienced an episode of VF not accompanied by an acute myocardial infarction (MI) or other transient or reversible cause. Accepted guidelines prefer this treatment in individuals with sustained VT, causing syncope or hemodynamic compromise. As primary prevention, the literature shows that ICD use is superior to conventional antiarrhythmic drug therapy for those who have survived an MI and who have spontaneous, non-sustained VT (NSVT), a low left ventricular ejection fraction (LVEF), and inducible VT at electrophysiological study (EPS).

In 2009, the American College of Cardiology (ACC)/AHA published a focused update to the 2005 guidelines for the diagnosis and management of heart failure (HF) in adults (Hunt, 2009). The timeframe considered by consensus as adequate to determine if guideline directed medical therapy (GDMT) has been effective prior to ICD placement is 3 to 6 months. In 2013, a report of the American College of Cardiology Foundation (ACCF) Appropriate Use Criteria Task Force, Heart Rhythm Society (HRS), AHA, American Society of Echocardiography (ASE), Heart Failure Society of America (HFSA), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Cardiovascular Computed Tomography (SCCT), and Society for Cardiovascular Magnetic Resonance (SCMR) was issued, in which the following is noted regarding the timeframe for GDMT:

Patients who are going to receive substantial benefit from medical treatment alone usually show some clinical improvement during the first 3 to 6 months. Medical therapy is also assumed to include adequate rate control for tachyarrhythmias, including atrial fibrillation. Therefore, it is recommended that GDMT be provided for at least 3 months before planned reassessment of LV function to consider device implantation. If LV function improves to the point where primary prevention indications no longer apply, then device implantation is not indicated (Russo, 2013).

During this period of optimization of GDMT and ICD, and therefore an AED, is not routinely indicated.

Efficacy of AEDs for Home Use

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 1260 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 2 years prior to the study. Sites were randomized to rescuers trained in 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). A total of 29 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 1 survival to hospital discharge in each group when SCA occurred in a residential unit. Investigators drew the following conclusions from the study results:

• Trained laypersons can use AEDs safely to provide early defibrillation;
• Survival rate almost doubles when AEDs are added to CPR-trained response systems in public facilities with predefined increased risk;
• The survival rate in multi-unit residential facilities is very low (Hallstrom, 2004).

Primary studies and systematic reviews have continued to provide evidentiary support that the chance of survival following out-of-hospital SCA increases 50-74% when immediate defibrillation is employed in public places (Baekgaard, 2017; Gantzel Nielsen, 2021; Griffis, 2020; Kiyohara, 2019; Pollack, 2018). However, as previously reported, most SCA’s occur in private residences, where the survival rate (23%) is less than half that of public locations (52%) (Elhussain, 2023)

An important Issue not addressed In the PAD study was 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 (NHLBI), enrolled an estimated 7000 individuals who were randomized, following anterior MI. The study arms were well balanced regarding demographics and comorbidities. Individual’s enrolled were in stable condition and had a previous anterior-wall Q-wave or non-Q-wave MI were enrolled because these are the most common diagnoses contributing to SCA. Candidates for ICD were excluded from the study. Participants were randomized to 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 interventional arm was instructed to call emergency services and begin CPR only after placing the AED in contrast to the control arm which was instructed to call emergency services prior to beginning CPR [this order of instruction for incorporation of and AED in SCA rescue does not reflect current guideline recommendations – calling EMS is always the first step]. The study’s 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 2 years and followed them for an additional 2 years at 200 cardiology clinics. The median age at the time of enrollment was 62 years. An AED was applied to 32 participants during the trial period, of those 13 had an advisable shock and 12 were delivered; 4 survived the first 48 hours following the event. 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. Ultimately, the number of participants who received an advisable shock (0.3% of the AED arm) was extremely low (Bardy, 2008; Mark, 2010).

In 2013, Jorgenson and colleagues published results of a prospective, observational, post-market study voluntarily initiated by the manufacturer (HeartStart HomeAED). Surveillance methods which supplied data included annual surveys, follow-up phone calls, media reports, and inquiries prompted by orders for replacement pads. Home AED owners who reported emergency use of their device were contacted for an in-depth interview; electrocardiogram and event data from their device's internal memory were included in the study. A total of 25 individuals were identified in which an AED was used following a SCA; 2 uses were in children (4.5 months and 5 years). The majority of uses occurred in the home (n=18; 72%) and the device was most often activated by a family member (n=14; 56%), the majority (n=17, 68%) being laypersons. The cardiac event (SCA) was witnessed in 76% (19/25) of the cases. A total of 14 individuals (56%) presented in VF and at least one shock was delivered; 14 achieved termination of VF; 6 (43%) required more than one shock due to refibrillation (range:1-5 shocks). A total of 8 out of 12 (67%) study participants with a witnessed SCA survived to hospital discharge; none of the unwitnessed arrests survived to hospital discharge. Both children in the study who received shocks survived to hospital discharge. There were no reported adverse events caused by improper use of the home AED. This manufacturer-sponsored study demonstrates that use of an AED may contribute to enhanced likelihood of survival following SCA in the home.

In 2017, McLeod and colleagues published results of a retrospective analysis including 36 families with 44 children ages 1 day to 15 years (mean age 8.8 years), at increased risk of SCA. Families that were issued an AED for home use along with resuscitation training over the 11-year study period were enrolled. At the time of device issuance, the children’s diagnoses included long QT syndrome (50%), broad complex tachycardia (14%), hypertrophic cardiomyopathy (11%), and catecholaminergic polymorphic ventricular tachycardia (9%). Follow-up data was available for 1 to 11.5 years (mean of 6.2 years). Of the 44 children enrolled in the analysis, 35 (79%) had been prescribed an AED by their pediatrician, 6 of the 35 were awaiting ICD placement. The remaining 9 (20%) children received AEDs at parental request only. During the study period 3 children experienced an SCA and the AED device was used in 4 (9%) children, correctly distinguishing between shockable and non-shockable rhythms. Out of the 3 children that appropriately received electric shocks for ventricular fibrillation/tachycardia, 2 survived, while 1 died as a result of recurrent torsades de pointes. The study authors concluded:

Parents can be taught to recognize cardiac arrest, apply resuscitation skills, and use an automated external defibrillator. Prescribing an automated external defibrillator should be considered for children at increased risk of sudden arrhythmic death, especially where the risk/benefit ratio of an implantable defibrillator is unclear or delay to defibrillator implantation is deemed necessary.

In 2022, Atkins and colleagues published a systematic review conducted to evaluate the effectiveness of AEDs in treating out-of-hospital cardiac arrests (OHCA) that have occurred in children between the ages of 0-18. As a control, the study also included pediatric OHCAs in which an AED was not applied. The review demonstrated that for children ages 1-18, the application of an AED by a layperson significantly improved survival rates with significantly improved neurological outcomes at hospital discharge or 30 days (Relative Risk [RR]= 3.84 [95% confidence interval {CI}, 2.69–5.5] and RR=3.75, [95% CI, 2.97–4.72], respectively), and better survival rates to hospital discharge (RR=3.04 [95% CI, 2.18–4.25], RR=3.38 [95% CI, 2.17–4.16]), respectively). Study authors concluded that the use of AEDs by lay rescuers showed a significant association with improved survival and neurological outcomes at 30 days post-event and improved survival rates till hospital discharge in children aged 1-18 years. Data for AED application in children under 1 year of age was too limited to draw meaningful conclusions.

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 FDA cleared indication for use is, “For the termination of ventricular fibrillation and pulseless ventricular tachycardia. These devices are intended to be used on suspected victims of sudden cardiac arrest” (FDA, 2004). The previous version of this device required a prescription. However, this device is available without a prescription. On June 06, 2019, HeartStart Home OTC Defibrillator received FDA Premarket Approval (PMA) (FDA, 2019). 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 [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 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 for lower-risk devices. On February 3, 2015 the FDA issued a Final Order which now requires all AED devices to meet PMA protocols; AED manufacturers must now submit PMA applications for FDA approval for all previously cleared AED devices. In addition, this new order requires that all new AED devices and accessories have an approved PMA in effect before being placed in commercial distribution (FDA, 2015). This 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. The FDA maintains an updated list of approved AEDs on their website (FDA, 2023).

While the evidence basis regarding the efficacy of AED use, specifically in the home, remains to be definitely established in the peer-reviewed literature, in the event that an individual is a candidate for an ICD, but unable to receive one because they are awaiting heart transplantation, had to have the device temporarily removed or has a temporary condition preventing placement, access to an FDA approved home AED device is a clinically appropriate alternative to increase the chances of survival should an SCA event occur. In addition, since the individual cannot self-administer the AED, another individual who can operate the AED should be generally available should use be required.

Defibrillation: A process in which an electronic device (a defibrillator) gives the heart an electric shock, helping to re-establish normal contraction rhythms in a heart that is not properly beating.  This may be done using an external device or by a device implanted in the body.

Myocardial Infarction (MI): This is the medical term for “heart attack.” A MI occurs when the blood supply to part of the heart muscle (the myocardium) is severely reduced or blocked (stenosed).

Sudden Cardiac Arrest (SCA): Refers to a sudden cessation of cardiac activity such that the victim becomes unresponsive with no normal breathing and no signs of circulation. If corrective measures are not taken rapidly, this condition progresses to SCD.

Sudden Cardiac Death (SCD also called sudden death): Death resulting from an abrupt loss of heart function (cardiac arrest).

Peer Reviewed Publications:

1. Atkins DL, Acworth J, Chung SP, et al. Lay rescuer use of automated external defibrillators in infants, children and adolescents: A systematic review. Resusc Plus. 2022; 11:100283.
2. Bardy GH, Lee KL, Mark DB, et al.; HAT Investigators. Home use of automated external defibrillators for sudden cardiac arrest. N Engl J Med. 2008; 358(17):1793-1804.
3. Baekgaard JS, Viereck S, Møller TP, et al. The effects of public access defibrillation on survival after out-of-hospital cardiac arrest: a systematic review of observational studies. Circulation. 2017, 136:954-965.
4. Brugada J, Blom N, Sarquella-Brugada G, et al. Pharmacological and non-pharmacological therapy for arrhythmias in the pediatric population: EHRA and AEPC-Arrhythmia Working Group joint consensus statement. Europace. 2013; 15(9):1337-1382.
5. Cecchin F, Jorgenson DB, Berul CI, et al. Is arrhythmia detection by automatic external defibrillator accurate for children: sensitivity and specificity of an automatic external defibrillator algorithm in 696 pediatric arrhythmias. Circulation. 2001; 103(20):2483-2488.
6. Dalal A, Czosek RJ, Kovach J, et al. Clinical presentation of pediatric patients at risk for sudden cardiac arrest. J Pediatr. 2016; 177:191-196.
7. DeMaria AN. Structural heart disease. J Am Col Cardiol. 2014; 63(6):603-604.
8. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet. 1999; 353(9169):2001-2007.
9. Elhussain MO, Ahmed FK, Mustafa NM, et al. The role of automated external defibrillator use in the out-of-hospital cardiac arrest survival rate and outcome: a systematic review. Cureus. 2023; 15(10):e47721.
10. Elliott PM, Poloniecki J, Dickie S, et al. Sudden death in hypertrophic cardiomyopathy: identification of high risk patients. J Am Coll Cardiol. 2000; 36(7):2212-2218.
11. Fukuda T, Ohashi-Fukuda N, Kobayashi H, et al. Public access defibrillation and outcomes after pediatric out-of-hospital cardiac arrest. Resuscitation. 2017; 111:1-7.
12. Gantzel Nielsen C, Andelius LC, Hansen CM, et al. Bystander interventions and survival following out-of hospital cardiac arrest at Copenhagen International Airport. Resucictiation. 2021, 162:381-387.
13. Gersh BJ,Maron BJ, Bonow RO, et al.  2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011; 58(25):e212-260. 
14. Griffis H, Wu L, Naim MY, et al. Characteristics and outcomes of AED use in pediatric cardiac arrest in public settings: The influence of neighborhood characteristics. Resuscitation. 2020; 146:126-131.
15. Hallstrom AP, Ornato JP, Weisfeldt M, et al. Public Access Defibrillation (PAD) Trial Investigators. Public-access defibrillation and survival after out-of-hospital cardiac arrest. N Engl J Med. 2004; 351(7):637-646.
16. Hunt SA, Abraham WT, Chin MH, et al. 2009 focused update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009; 53(15):e1-90.
17. Jorgenson DB, Yount TB, White RD, et al. Impacting sudden cardiac arrest in the home: a safety and effectiveness study of privately-owned AEDs. Resuscitation. 2013; 84(2):149-153.
18. Kadish A. Public-access defibrillation: advances and controversies. Primary Care Perspectives. Medscape Primary Care. 2004; Volume 6(1).
19. Kiyohara K, Sado J, Kitamura T, et al. Public-access automated external defibrillation and bystander-initiated cardiopulmonary resuscitation in schools: a nationwide investigation in Japan. Europace. 2019; 21(3):451-458
20. Koster RW. Automatic external defibrillator: key link in the chain of survival. J Cardiovasc Electrophysiol. 2002; 13(1 Suppl):S92-S95.
21. Lee BK, Olgin JE. Role of wearable and automatic external defibrillators in improving survival in patients at risk for sudden cardiac death. Curr Treat Options Cardiovasc Med. 2009; 11(5):360-365.
22. Marenco JP, Wang PJ, Link MS, et al. Improving survival from sudden cardiac arrest: the role of the automatic external defibrillator. JAMA. 2001; 285(9):1193-1200.
23. 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.e7.
24. Maron BJ. Contemporary insights and strategies for risk stratification and prevention of sudden death in hypertrophic cardiomyopathy. Circulation. 2010; 121(3):445-456.
25. Maron BJ, McKenna WJ, Danielson GK, et al. ACC/ESC clinical expert consensus document on hypertrophic cardiomyopathy: a report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents and the European Society of Cardiology Committee for Practice Guidelines (Committee to Develop an Expert Consensus Document on Hypertrophic Cardiomyopathy). J Am Coll Cardiol. 2003; 42(9):1687-1713.
26. Maron MS, Rowin EJ, Wessler BS, et al. Enhanced American College of Cardiology/American Heart Association strategy for prevention of sudden cardiac death in high-risk patients with hypertrophic cardiomyopathy. JAMA Cardiol. 2019; 4:644-657.
27. McLeod KA, Fern E, Clements F, McGowan R. Prescribing an automated external defibrillator for children at increased risk of sudden arrhythmic death. Cardiol Young. 2017; 27(7):1271-1279.
28. Meischke H, Diehr P, Phelps R, et al. Psychologic effects of automated external defibrillator training: a randomized trial. Heart Lung. 2011; 40(6):502-510.
29. Olde Nordkamp LR, Postema PG, Knops RE, et al. Implantable cardioverter-defibrillator harm in young patients with inherited arrhythmia syndromes: A systematic review and meta-analysis of inappropriate shocks and complications. Heart Rhythm. 2016;13(2):443-454.
30. Ommen SR, Mital S, Burke MA, et al. 2020 AHA/ACC guideline for the diagnosis and treatment of patients with hypertrophic cardiomyopathy: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2020; 76(25):e159-240.
31. Pundi KN, Bos JM, Cannon BC, Ackerman. Automated external defibrillator rescues among children with diagnosed and treated long QT syndrome. Heart Rhythm. 2015; 12(4):776-781.
32. Sanna T, La Torre G, de Waure C, et al. Cardiopulmonary resuscitation alone vs. cardiopulmonary resuscitation plus automated external defibrillator use by non-healthcare professionals: a meta-analysis on 1583 cases of out-of-hospital cardiac arrest. Resuscitation. 2008; 76(2):226-232.
33. Solomon SD, Zelenkofske S, McMurray JJ, et al.; Valsartan in Acute Myocardial Infarction Trial (VALIANT) Investigators. Sudden death in patients with myocardial infarction and left ventricular dysfunction, heart failure, or both. NEJM. 2005; 352(25):2581-2588. Erratum in: NEJM. 2005; 353(7):744.
34. Sparks KE. Owning a home defibrillator: security blanket or excuse to do nothing? Primary Care Perspectives. Medscape Primary Care. 2004; Volume 6(1).
35. Stokes NA, Scapigliati A, Trammell AR, Parish DC. The effect of the AED and AED programs on survival of individuals, groups and populations. Prehosp Disaster Med. 2012; 27(5):419-424.
36. Weisfeldt ML, Everson-Stewart S, Sitlani C, et al.; Resuscitation Outcomes Consortium Investigators. Ventricular tachyarrhythmias after cardiac arrest in public versus at home. N Engl J Med. 2011; 364(4):313-321.

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. J Am Coll Cardiol. 2018; 72(14):e91-e220. [Erratum in: J Am Coll Cardiol. 2018; 72(14):1760.]
2. American Academy of Pediatrics. Policy Statement; Pediatric Sudden Cardiac Arrest. 2012. Available at: https://publications.aap.org/pediatrics/article/129/4/e1094/32355/Pediatric-Sudden-Cardiac-Arrest. Accessed on July 08, 2024. 
3. American Association for Respiratory Care (AARC) Clinical Practice Guideline: Resuscitation and Defibrillation in the Health Care Setting. 2004 revision and update to 1995 Guideline on defibrillation during resuscitation and the 1993 Guideline on resuscitation in acute care hospitals. Available at: http://rc.rcjournal.com/content/respcare/49/9/1085.full.pdf. Accessed on July 08, 2024.
4. American Heart Association. 2022 Heart Disease and Stroke Statistical Update Fact Sheet Children and Cardiovascular Disease. 2022. Available at: https://professional.heart.org/-/media/PHD-Files-2/Science-News/2/2022-Heart-and-Stroke-Stat-Update/2022-Stat-Update-factsheet-Children-and-CVD.pdf. Accessed on July 08, 2024.
5. Centers for Disease Control and Prevention. Cardiac Arrest. Updated May 15, 2024. Available at: https://www.cdc.gov/heart-disease/about/cardiac-arrest.html?CDC_AAref_Val=https://www.cdc.gov/heartdisease/cardiac-arrest.htm. Accessed on July 30, 2024. 
6. Drew BJ, Ackerman MJ, Funk M, et al. Prevention of torsade de pointes in hospital settings: a scientific statement from the American Heart Association and the American College of Cardiology Foundation. J Am Coll Cardiol. 2010; 55(9):934-947.
7. Emergency Cardiovascular Care (ECC) Committee, Subcommittees and Task Forces of the American Heart Association. 2005 American Heart Association Guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2005; 112(24 Suppl):IV1-203.
8. Epstein AE, DiMarco JP, Ellenbogen KA, et al. American College of Cardiology/American Heart Association/Heart Rhythm Society (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. May 2008. J Am Coll Cardiol. 2008; 51(21):e1-e62. Available at:  https://www.ahajournals.org/doi/10.1161/CIRCUALTIONAHA.108.189742. Accessed on July 08, 2024.
9. Erickson CC, Salerno JC, Berger S, et al. Sudden Death in the Young: Information for the Primary Care Provider. Pediatrics. 2021; 148(1):e2021052044.
10. Hazinski MF, Idris AH, Kerber RE, et al. Lay rescuer automated external defibrillator (public access defibrillation) programs: lessons learned from an international multi-center trial. Advisory statement from the American Heart Association Emergency Cardiovascular Committee; the Council on Cardiopulmonary, Perioperative, and Critical Care; and the Council on Clinical Cardiology. Circulation. 2005; 111(24):3336-3340.
11. Hunt SA, Abraham WT, Chin MH, et al. 2009 focused update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009; 53(15):e1-90.
12. Kushner FG, Hand M, Smith SC Jr, 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: https://www.jacc.org/doi/abs/10.1016/j.jacc.2009.10.015. Accessed on July 08, 2024.
13. Masoudi FA, Ponirakis A, de Lemos JA, et al. Executive Summary: Trends in U.S. Cardiovascular Care: 2016 Report From 4 ACC National Cardiovascular Data Registries. J Am Coll Cardiol. 2017; 69(11):1424-1426.
14. Myerburg RJ, Estes NA 3^rd, Fontaine JM, et al. Task Force 10: automated external defibrillators. J Am Coll Cardiol. 2005; 45(8):1369-1371.
15. O’Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013; 61(4):e78-140.
16. Ommen SR, Mital S, Burke MA, et al. 2020 AHA/ACC guideline for the diagnosis and treatment of patients with hypertrophic cardiomyopathy: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2020; 76(25):e159-240.
17. Ontario Ministry of Health and Long-term Care, Medical Advisory Secretariat (MAS). Use of automated external defibrillators in cardiac arrest. An evidence-based analysis. Toronto, ON: MAS; December 2005; 5(19).
18. Pollack RA, Brown SP, Rea T, et al. Impact of bystander automated external defibrillator use on survival and functional outcomes in shockable observed public cardiac arrests. Circulation. 2018; 137(20):2104-2113.
19. Priori SG, Bossaert LL, Chamberlain DA, et al. ESC-ERC recommendations for the use of automated external defibrillators (AEDs) in Europe. The European Society of Cardiology (ESC) and the European Resuscitation Council (ERC) Policy Conference: December 2002. Eur Heart J. 2004; 25(5):437-445.
20. Russo AM, Stainback RF, Bailey SR, et al.  ACCF/HRS/AHA/ASE/HFSA/SCAI/SCCT/SCMR 2013 Appropriate use criteria for implantable cardioverter-defibrillators and cardiac resynchronization therapy: A report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Heart Rhythm Society, American Heart Association, American Society of Echocardiography, Heart Failure Society of America, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. Heart Rhythm. 2013; 10(4):e11-58.
21. Samson RA, Berg RA, Bingham R. Use of automated external defibrillators for children: an Advisory Statement from the Pediatric Advanced Life Support Task Force, International Liaison Committee on Resuscitation. Circulation. 2003; 107(25):3250-3255. Available at: https://www.ahajournals.org/doi/10.1161/01.cir.0000074201.73984.fd. Accessed on July 08, 2024.
22. Shah MJ, Silka MJ, Silva JNA ,et al. 2021 PACES Expert Consensus Statement on the Indications and Management of Cardiovascular Implantable Electronic Devices in Pediatric Patients: Developed in collaboration with and endorsed by the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the American Heart Association (AHA), and the Association for European Paediatric and Congenital Cardiology (AEPC) Endorsed by the Asia Pacific Heart Rhythm Society (APHRS), the Indian Heart Rhythm Society (IHRS), and the Latin American Heart Rhythm Society (LAHRS). JACC Clin Electrophysiol. 2021;7(11):1437 1472.
23. Stiles MK, Wilde AAM, Abrams DJ, et al. 2020 APHRS/HRS expert consensus statement on the investigation of decedents with sudden unexplained death and patients with sudden cardiac arrest, and of their families. Heart Rhythm. 2021; 18(1):e1-e50.
24. 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. J Am Coll Cardiol. 2012; 60(14):1297-1313. Available at: https://www.ahajournals.org/doi/full/10.1161/cir.0b013e3182618569. Accessed on July 08, 2024.
25. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health 510(k) Premarket Notification Database. New device clearance: Philips HeartStart Home OTC Defibrillator (Seattle, WA) Summary of Safety and Effectiveness. No. K040904. September 16, 2004. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k040904.pdf. Accessed on July 08, 2024.
26. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health Premarket Approval Application (PMA). Philips HeartStart Home OTC Defibrillator (Seattle, WA). Summary of Safety and Effectiveness. PMA Number: P160029. June 06, 2019. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029B.pdf. Accessed on July 08, 2024.
27. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health 510(k) Premarket Notification Database. HeartSine Samaritan^® PAD (HeartSine Technologies, Inc., San Clemente, CA) Summary of Safety and Effectiveness. No. K041067. May 25, 2004. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/K041067.pdf. Accessed on July 08, 2024.
28. US. and Drug Administration (FDA). Automated External Defibrillators (AEDs). July 2023. Available at: https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds#check. Accessed on July 08, 2024. 
29. U.S. Food and Drug Administration (FDA). Automated External Defibrillators (AEDs). Final Order. February 3, 2015. Available at: https://www.federalregister.gov/articles/2015/02/03/2015-02049/effective-date-of-requirement-for-premarket-approval-for-automated-external-defibrillator-systems. Accessed on July 08, 2024.
30. Weisfeldt ML, Sitlani CM, Ornato JP, et al.; ROC Investigators. Survival after application of automatic external defibrillators before arrival of the emergency medical system: evaluation in the resuscitation outcomes consortium population of 21 million. J Am Coll Cardiol. 2010; 55(16):1713-1720.

1. American Heart Association. Available at: http://www.americanheart.org. Accessed on March 27, 2024.
2. National Heart, Lung and Blood Institute. Health Topics. Available at: https://www.nhlbi.nih.gov/health-topics/defibrillators. Accessed on July 08, 2024.
   • How to use an automated external defibrillator.
   • When should an automated external defibrillator be used?
3.  U.S. Food and Drug Administration (FDA). Automated External Defibrillators (AEDs). Updated July 06, 2023. Available at: https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds#FDA-Approved%20AEDs. Accessed on July 08, 2024. 

AED
Automatic external defibrillator
Avive Solutions
Cardiac Science
Defibtech
HeartSine Samaritan
Philips Medical
Physio-Control
ZOLL Medical

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.