Resuscitation 84 (2013) 149 153
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Resuscitation
jo u rn al hom epage : www.elsevier.com/locate/resuscitation
Clinical paper
Impacting sudden cardiac arrest in the home: A safety and effectiveness
study of privately-owned AEDs
Dawn B. Jorgensona,", Tamara B. Younta, Roger D. Whiteb, P.Y. Liuc,
Mickey S. Eisenbergd, Lance B. Beckere
a
Philips Healthcare, Bothell, WA, United States
b
Mayo Clinic, Rochester, MN, United States
c
Fred Hutchinson Cancer Research Center, Seattle, WA, United States
d
Department of Medicine, University of Washington, Seattle, WA, United States
e
Center for Resuscitation Science, Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, United States
a r t i c l e i n f o a b s t r a c t
Article history:
Background: Sudden cardiac arrest (SCA) remains a major public health problem. The majority of SCA
Received 23 February 2012
events occur in the home; however, scant data has been published regarding the effectiveness of privately
Received in revised form
owned AEDs.
11 September 2012
Methods: The study, initiated in 2002 under prescription labeling, continued with over the counter avail-
Accepted 19 September 2012
ability in 2004 and was completed in 2009. Surveillance methods included annual surveys, follow-up
phone calls, media reports, and use queries upon order of replacement pads. AED owners reporting
emergency use of the device were contacted for an in-depth interview, and the ECG and event data in
Keywords:
the device s internal memory were evaluated.
Automated external defibrillator
Results: 25 cases were identified in which an AED was used on a patient in SCA. Two uses were on children.
Cardiac arrest
The SCA was witnessed in 76% (19/25) of the cases. In 56% (14/25), the patient presented in VF and at
Resuscitation
Defibrillation least one shock was delivered. All 14 patients who were shocked had termination of VF; 6 (43%) required
Emergency medical services
more than one shock due to refibrillation. Shock efficacy was 100% (25/25) for termination of VF for
Safety
all delivered shocks. Of the patients with a witnessed arrest who were shocked, 67% (8/12) survived to
hospital discharge. There were no circumstances of unsafe emergency use of the AED or harm to the
patient, responder, or bystanders.
Conclusions: People who purchase an AED for their home, even without previous AED experience, are
able to use the device successfully in both adults and children. The high survival rate observed in this
study demonstrates that lay responders with privately owned AEDs can successfully and safely use the
devices.
© 2012 Elsevier Ireland Ltd. All rights reserved.
1. Introduction disseminated to facilitate more timely defibrillation and increase
survival. AEDs have gone from exclusive use by highly trained
Sudden cardiac arrest (SCA) is a leading cause of death and responders (paramedics) to successful use by lay responders in
a major public health problem worldwide.1 However, because of airports and airplanes, casinos, and other public places where sig-
its unpredictable nature, patients cannot be identified a priori.2 nificant numbers of people gather.4
Prompt defibrillation for those patients in ventricular fibril- Increasing public awareness of SCA and defibrillation has helped
lation (VF) is the definitive treatment. Delayed defibrillation drive the placement of AEDs still further to locations such as
is far less successful, with reduced survival for every passing churches, schools, and libraries. However, studies have shown that
minute from the moment of cardiac arrest.3 Over the past 30 approximately 80% of SCAs occur in the home, and the survival
years, automated external defibrillators (AEDs) have been broadly rate is lower in the home than in public places.5,6 As early as 1984,
studies were conducted with AEDs in the homes of SCA survivors
to see if family members could be adequately trained to use the
device effectively.7 In 1989, 59 patients at high risk were provided

A Spanish translated version of the abstract of this article appears as Appendix
an AED; there were 10 arrests over a 57 month period, and the
in the final online version at http://dx.doi.org/10.1016/j.resuscitation.2012.09.033.
devices were used in 6 events.8 Only two patients were in VF, one
"
Corresponding author at: Philips Healthcare, 22100 Bothell Everett Highway,
died at the scene and one was resuscitated with residual neurologic
Bothell, WA 98021, United States. Tel.: [phone]; fax: [phone].
deficits.
E-mail address: [e-mail] (D.B. Jorgenson).
0300-9572/$  see front matter © 2012 Elsevier Ireland Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.resuscitation.2012.09.033
150 D.B. Jorgenson et al. / Resuscitation 84 (2013) 149 153
Table 1
Over the past 15 years, AEDs have undergone significant human
Patient and responder demographics.
factors design development, such as incorporating voice prompts
to guide users. User testing in simulated use scenarios has demon- Adult patients, Pediatric patients, Responders, n = 24
n = 23 n = 2 (1 unknown)
strated the ability of minimally trained and lay responders and even
untrained people to use the devices.9,10 Despite concerns regarding
Age Median: 68 years, 4.5 months, 5 years Median: 63 years,
range: 26 90 years range: 33 82 years
safety issues and cost,11 an FDA panel supported over-the-counter
Gender 20 male, 3 female 1 male, 1 female 14 male, 10 female
(OTC) sales of one AED model in 2004.12 This study was initiated to
capture infrequent home AED use data.
Table 2
Location of arrest and responder s relationship to patient.
2. Methods
Location n
This was a prospectively-designed observational post-market
Home 18
study voluntarily initiated by the manufacturer. Information was
Family business 2
collected from owners of the HeartStart Home AED, model M5068A, Exercise facility 2
Street/parking lot 1
from November 2002 to December 2009. This is a semi-automatic
Church 1
device with adhesive pads and voice prompts to guide the user. At
Club 1
study initiation, in 2002, the devices were sold only with a physician
prescription. In November 2004, OTC sales were allowed and the
Relationship n
FDA mandated a surveillance study. For pediatric patients (under
None 5
8 years old or 55 pounds) a special pad cartridge inserted into
Wife 5
the device reduces the delivered energy; this pediatric cartridge
Neighbor 4
Husband 2
remains available only through a prescription.
Daughter 2
The study was approved by Western Institutional Review Board,
Friend 2
and a Data Safety Monitoring Committee routinely reviewed data.
Father 2
All participation was voluntary, and persons interviewed provided
Mother 1
consent. Son-in-law 1
Brother-in-law 1
Multiple methods were employed to identify AED uses:
" Product labeling and the manufacturer s website encouraged
uses were excluded from analysis. In one case, an AED owner who
reporting uses to the manufacturer. Incentivized product regis-
had a child at high risk for SCA routinely kept a pediatric car-
tration cards, shipped with each AED, offered a practice kit or
tridge installed in the device. This owner witnessed an arrest at
accessory kit. Owners who contacted the manufacturer for any
a parking lot where an adult had been involved in a bicycle/auto
reason were added to the registered owners database. All reg-
accident with resulting severe blunt trauma. She retrieved the AED
istered owners were sent a yearly survey inquiring if the AED
from her car but was unable to remove the pediatric cartridge to
had been taken to the scene of an emergency, even if pads were
insert an adult cartridge. One 50 J pediatric energy shock was deliv-
never applied to a patient. If a survey was not returned, follow-up
ered; defibrillation was unsuccessful. In addition, reports of AED
telephone calls were used.
use on family dogs were excluded; in these cases the resuscitation
" Media reports on the Internet were scanned for reported uses.
attempts failed.
" The only avenue for purchasing home replacement pad cartridges
was directly from the manufacturer; all who called for replace-
3. Results
ment pads were queried regarding a use.
There were 25 cases where the device was used on a patient in
Owners who indicated they had taken their AED to the scene of an
SCA. These uses were identified through direct calls to the manu-
emergency were asked to volunteer for a recorded interview con-
facturer (13), owner surveys (10), and Internet reporting (2). OTC
ducted by a healthcare professional. The interviewer asked specific
purchasers accounted for 18 uses and prescription-device pur-
questions on safety and efficacy, and the responder described the
chasers accounted for 7 uses, including 2 pediatric patients. In
use in his or her own words. The interview was designed to cap-
addition, there were 10 uses where the AED was placed on patients
ture any difficulty in using the AED, and responder information
not in cardiac arrest; one of these was a pediatric patient.
(age, gender, training), patient information (age, gender, previous
conditions), and resuscitation factors (location of arrest, bystander
CPR, shock delivery, patient outcome). 3.1. Uses on patients in SCA
If an AED was used in an emergency, a replacement device was
sent in exchange for the involved AED so its internal memory could Patient and responder demographics are provided in Table 1.
be examined. The memory includes use time, number of shocks, The majority of AED uses, 18 (72%), occurred in the home (Table 2)
patient impedance, shock analysis decisions, and ECG. Each case with a responder who was a family member, 14 (56%). Most respon-
was categorized in terms of a patient in SCA or a patient who was ders, 17 (68%), had no formal medical training; the remainder were
recognized as not being in SCA or was determined later not to have physician/dentist (3), registered nurse (2), military caregivers (2),
been in SCA (e.g., shortness of breath or loss of consciousness). and CPR/AED instructor (1). Table 3 presents the responders level
The inclusion criteria required that the AED be owned by an indi- of CPR and AED exposure prior to use; the most common, 18 (72%),
vidual and intended for the  home. If the owner brought the AED involved watching the CD that is shipped with the AED. Two respon-
along when leaving home (e.g., in their car), that use was included ders reported no formal AED training; one knew the patient had an
wherever it occurred. Those who declined to participate or could AED and retrieved it, and the other had seen an AED demonstrated
not be contacted were excluded. Uses with insufficient information, on television and remembered that it was supposed to be easy to
no interview, and no exchanged AED (for memory examination) use. Both patients treated by these two responders survived and
where the report could not be verified were excluded. Two reported later received an ICD implant.
D.B. Jorgenson et al. / Resuscitation 84 (2013) 149 153 151
Table 3
In the second pediatric case, the mother of a five-year-old boy
Level of CPR & AED exposure (multiple answers permitted).
with congenital atrioventricular canal defect and pulmonary steno-
CPR and AED exposure n sis had an AED because their doctor ordered it after the insertion
of an artificial heart valve. After waking the child for the first day
Watched product training video 18
of kindergarten, she saw him fall and not get up. She applied the
Read product materials 8
Current CPR (d"5 years ago) 9
AED and delivered one shock then began CPR using the AED CPR
CPRa > 5 and d" 10 years ago 3
instruction set. He refibrillated and the AED advised a second shock,
CPRa > 10 and d" 20 years ago 1
which she delivered. He survived this episode and received an ICD
CPRa > 20 and d" 30 years ago 6
implant.
CPRa > 30 years ago 1
Practiced use 2
Watched TV demonstration show 2
Watched demonstration by AED distributor 1
3.3. Uses of the AED on patients not in SCA
First aid class (year unknown) 1
a
Some responders specified that their CPR class did not cover AED training, par-
There were 9 instances of AED use on adults and 1 use on a child
ticularly those who took the class a long time ago.
not in arrest. In all cases, the AED did not advise a shock. In each
case concern for the patient resulted in caregivers applying the AED
Table 4
even though in several instances the patient was conscious and/or
Resuscitation characteristics.
breathing (allowed under AED instructions). In all but two cases,
Characteristic Percentage (n)
EMS was called and assumed care. Brief summaries of these cases
are given as follows:
Witnessed 76% (19/25)
CPR performed 88% (22/25)
CPR before AED applied to patient 52% (11/21, 1 unknown)
AED CPR instruction set utilized 55% (12/22)
" A responsive man who had had a previous myocardial infarction
Patients presenting in VF 56% (14/25)
was having severe chest pain, shortness of breath, and sweating.
Patients with refibrillation 43% (6/14)
The patient felt better within minutes after the AED was applied;
Shock efficacy 100% (25/25)
EMS was not called.
" A woman who had previously had a stroke became unresponsive.
The AED was applied but no CPR was performed. The responder
Table 4 presents a summary of event characteristics. SCA was
reported breathing and faint pulses at the neck and wrist. The
witnessed in 19 (76%) of the 25 cases. In 22 (88%) cases, CPR was
patient reportedly had another stroke.
performed and in 12 (55%) cases the user initiated the AED s CPR
" A physician self-applied pads when he was in atrial fibrillation
instruction set and audio metronome for compression timing. In
to see  what the AED would do and reported he  knew it would
14 (56%) cases, the patient presented in VF and at least one shock
not shock.
was delivered; the median shock number was 1 (range 1 5). The
" A patient with an extensive cardiac history reported she was not
median (range) time from pads placed on the patient to the first
feeling well and was light-headed. She checked her pulse and
shock was 21 (15 53) s. All 14 patients who were shocked had ter-
self-applied oxygen and the AED. She reported relief and did not
mination of VF; 6 of the 14 (43%) required more than one shock
call EMS.
due to refibrillation. Shock efficacy was 100% (25/25) for termina-
" A responder applied his AED to a man who was conscious and
tion of VF for all delivered shocks. Of the 14 shocked, 12 (86%) had
sweating. He thought the man was having a myocardial infarction
a witnessed arrest and 2 (14%) had an unwitnessed arrest.
and wanted to be ready.
A summary flowchart is shown in Fig. 1. Both patients with an
" A responder was called to a neighbor s home because someone
unwitnessed arrest who were shocked survived to hospital admis-
had collapsed. The responder applied the AED as he was not sure
sion but later died in hospital. Of the 12 patients with a witnessed
if the patient was breathing and thought there was a slight pulse.
arrest who were shocked, 8 (67%) survived to hospital discharge.
" A wife noticed that her husband, who had an extensive cardiac
Of the remaining 4 patients, 3 were known to have died (one had
history, could not speak. She checked for signs of stroke and
a pulse during transport but the resuscitation was stopped due
applied the AED, wanting to be prepared.
to a DNR order) and 1 survived to hospital admission but had a
" A woman reported that her husband was unresponsive on two
poor prognosis; death is assumed. There were 7 patients with a
separate occasions; each time, she applied the AED.
witnessed arrest who presented with a non-shockable rhythm. All
" An AED was placed on a two-year-old child, with a history of long
of these patients died; 6 were in asystole/PEA and 1 reportedly
QT syndrome, after a four-year-old sibling (also diagnosed with
regained sinus rhythm with CPR but rearrested and expired during
long QT syndrome) alerted their mother. The AED was applied
transport.
after a seizure started because the mother  knew it would not
hurt her. CPR was started. EMS arrived, and the child recovered.
3.2. Pediatric SCA
Due to the scarcity of pediatric SCA events, a brief qualitative 3.4. Safety and post-use assessment
summary of two uses is presented. A 4.5-month-old baby girl, who
had survived a previous SCA, was defibrillated by her parents.13 The post-use interview included questions about both patients
The patient s physician had recommended an AED to the family. and rescuers, including specific inquiries regarding shock safety
The father reported the infant had been awakened to have propra- and inappropriate shocks. There were no reported instances of
nolol administered; she began crying, became limp and apneic and unsafe emergency use of the AED or harm during use to the patient,
then lost consciousness. The father began CPR, called EMS, placed responder, or bystanders. Responders who treated patients in SCA
the AED with pediatric pads in an anterior/posterior position, and reported they felt adequately trained in 24 (96%) of the cases; one
delivered one shock. The infant was awake and crying when EMS felt she should have rehearsed more in order to be faster. Twenty-
arrived. The infant had an ICD implanted and survived to hospital four of 25 (96%) reported they would use the AED again if needed,
discharge. while one rescuer was uncertain.
152 D.B. Jorgenson et al. / Resuscitation 84 (2013) 149 153
Fig. 1. Event summary flowchart.
4. Discussion witnessed VF arrest and subsequent shock survived to hospital
discharge. In one use a responder (a prescription purchaser) was
Efforts to disseminate AEDs to public areas were initiated in unable to remove a pediatric cartridge, resulting in the delivery
1993, yet the overall survival rate for SCA in the U.S. remains at of a pediatric energy dose to an adult. Of note, this same owner
approximately 7%.14,15 In 2000, Valenzuela studied AED use in responded to another adult SCA about one year later with a success-
casinos by security officers.16 Fifty-six of the 105 patients (53%) ful outcome. In all other uses the responders were able to use the
survived to hospital discharge. In 2002, Caffrey demonstrated the AEDs as intended, and there were no safety issues or harm reported
successful use of AEDs at three Chicago airports.17 In that study, 18 to bystanders or responders or effectiveness issues.
patients presented in VF and 11 (61%) were resuscitated, a survival There are several limitations to this study of privately owned
rate for witnessed VF/VT quite similar to that in this report. The AEDs. The number of patients with SCA treated with AEDs was
Public Access Defibrillation Trial in 2004 studied randomized AED small. Although we queried owners, it is likely there were uses not
placement in community units such as shopping malls, recreation reported to us thus the ability to discover complications or adverse
centers and hotels.18 There were 30 survivors out of 128 arrests events from AED use was limited. Efforts were made to encourage
(23%) in the AED arm. In another study of public access defibrilla- owners to register their devices; however, the portable nature of
tion, an AED was applied in 4.4% of VF arrests, with spontaneous the AEDs along with the inherent difficulties of following owners
pulses present in 84% by the end of EMS care, resulting in a 52.5% (who marry, change names, die, give away their AEDs, etc.) and the
survival rate.19 In 2008, the Home Automated External Defibrilla- reluctance of private AED owners to participate in this type of sur-
tor Trial (HAT) enrolled 7001 patients at increased risk for sudden vey made this process difficult. It may be that responders were more
cardiac arrest. They compared survival with an AED in the home to likely to report a use or be interviewed if the use was successful.
a control group without AEDs who were instructed to call EMS and Although we interviewed responders and reviewed the electron-
perform CPR.20 During the two-year enrollment period and two- ically recorded memory of the AEDs, we did not have access to
year follow-up period, AEDs were used on 32 patients, 14 received medical records for verification.
an appropriate shock, and 4 survived to discharge. Mortality did
not differ significantly between the groups. It is noteworthy that 5. Conclusions
for the HAT study, AEDs were provided to specific high-risk indi-
viduals with training and follow-up whereas this study followed Although the number of uses was small, this study demonstrates
people who purchased an AED due to personal choice. the safety and effectiveness of home AEDs used by lay persons
While 80% of SCAs occur in the home,5 data on private AED use with no or minimal training. Both adult and pediatric patients
is limited. In this study there were very few uses reported from were defibrillated and survived. There were no reports of injury
owners who purchased their AEDs with a prescription, and we to responders, bystanders, or patients. In many cases CPR was per-
found no obvious differences in these uses or training versus those formed with the guidance of the AED s CPR instruction set. In this
who purchased OTC. Many owners could not recall the condition study, the survival rate in patients with witnessed arrest and a
under which they purchased their AED. shockable rhythm treated with home AEDs was similar to rates
In this study, the ability of home users, some with no training reported for airports and casinos. The data suggests AED technol-
or experience, to use an AED has been demonstrated. We have ogy designed for home use appears to be safe and effective, and
reported that, of home AEDs uses, 8 of 12 (67%) patients with may be an important additional strategy for treatment of SCA.
D.B. Jorgenson et al. / Resuscitation 84 (2013) 149 153 153
Conflict of interest statement 6. Weisfeldt ML, Everson-Stewart S, Sitlani C, et al. Ventricular tachyarrhythmias
after cardiac arrest in public versus at home. N Engl J Med 2011;364:313 21.
7. Cummins RO, Eisenberg MS, Bergner L, Hallstrom A, Hearne T, Murray JA.
Dawn Jorgenson and Tamara Yount are employees of Philips
Automatic external defibrillation: evaluations of its role in the home and in
Healthcare which manufacturers the AED used in this study. The emergency medical services. Ann Emerg Med 1984;13:798 801.
8. Eisenberg MS, Moore J, Cummins RO, et al. Use of the automatic external defi-
other authors have no conflict to declare.
brillator in homes of survivors of out-of-hospital ventricular fibrillation. Am J
Cardiol 1989;63:443 6.
Acknowledgements 9. Callejas S, Barry A, Demertsidis E, Jorgenson D, Becker LB. Human factors impact
successful lay person automated external defibrillator use during simulated
cardiac arrests. Crit Care Med 2004;32:S406 13.
We thank the AED owners and responders who shared their
10. Mosesso VN, Shapiro AH, Stein K, Burkett K, Wang H. Effects of AED device fea-
personal stories with us. We would also like to thank Michael Sayre
tures on performance by untrained lay persons. Resuscitation 2009;80:1285 9.
11. Brown J, Kellermann AL. The shocking truth about automated external defibril-
for his work on the Data Safety and Monitoring Board and Robin
lators. JAMA 2000;284:1438 41.
Havrda, Karen Uhrbrock, Richard O Hara, Garth Bammer, Francesca
12. Eisenberg M. On approving the over-the-counter sale of automated external
Infantine and Emily Mydynski for their invaluable assistance with
defibrillators. Ann Emerg Med 2005;45:25 6.
13. Bar-Cohen Y, Walsh EP, Love BA, Cecchin F. First appropriate use of automated
this study.
external defibrillator in an infant. Resuscitation 2005;67:135 7.
This work was supported by Philips Healthcare, Bothell, WA.
14. Kerber RE, Becker LB, Bourland JD, et al. Automatic external defibrillators for
public access defibrillation: recommendations for specifying and reporting
arrhythmia analysis algorithm performance, incorporating new waveforms, and
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