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From the University of Ottawa, Canada (G.N.); University of Washington,
Seattle (A.P.H.); University of Iowa Hospital, Iowa City (R.K.); Gibson, Dunn
and Crutcher, Inc, Denver (D.P.); University of Rochester, Rochester (A.J.M.);
Medical College of Virginia, Richmond (J.O.); San Diego State University, San
Diego (B.R.); University of North Carolina at Chapel Hill (S.S.);
Columbia-Presbyterian Medical Center, New York (M.L.W.).
Correspondence to Graham Nichol, MD, Clinical Epidemiology Unit, F6, Ottawa Civic Hospital, 1053 Carling Ave, Ottawa, Ontario, Canada K1Y 4E9.
External CPR and defibrillation were first described as effective
treatments for sudden cardiac arrest >30 years ago. However, survival
after out-of-hospital cardiac arrest is still poor. The American Heart
Association previously addressed this problem by emphasizing the
importance of the chain of survival4 : early
access, early CPR, early defibrillation, and early advanced life
support. Because early defibrillation is the single most important
intervention, the American Heart Association challenged manufacturers
to develop simple, low-cost automatic defibrillators for use by
targeted groups at locations in which large numbers of people
congregate.5
We previously proposed extension of this enhanced defibrillation
strategy to include defibrillation by minimally trained members of the
public, referred to as PAD.6 This strategy seeks
to concentrate distribution of AEDs at specific sites at which sudden
cardiac arrest occurs frequently (eg, public places in which large
numbers of older people are present, such as airports and casinos).
In addition, training of personnel to provide early defibrillation when
sudden cardiac arrest occurs in airlines, trains, or buses offers an
additional opportunity to improve survival after sudden cardiac
arrest.
In 1994, a group of representatives from the
scientific, industrial, medical, nursing, public health, engineering,
and regulatory communities met to discuss this new strategy to treat
sudden cardiac arrest.7 Since then, considerable
advances have occurred: defibrillators are smaller and easier to use,
and early defibrillation programs are being implemented in casinos,
work sites, and airlines in the United States. Therefore, a second
conference was convened April 17–19, 1997, in Washington, DC. This
conference attracted more than 500 participants, with extensive
representation from the scientific, industrial, clinical, and
regulatory communities. The remainder of this report outlines the
content of the sessions, the interactive workshops that constituted the
formal program, and the recommendations of conference participants.
Level 1: Traditional First-Responder Defibrillation
Level 2: Nontraditional First-Responder Defibrillation
Level 3: Citizen CPR Defibrillation
Level 4: Minimally Trained Witness Defibrillation
A potential for misunderstanding exists when discussions about PAD are
interpreted as efforts advocating AED use at a different level. It is
critical to convey a clear understanding of which level of PAD is under
discussion.
In summary, the consensus expressed at this conference was that local
data must drive local solutions. In cities in which the current
approach to sudden cardiac arrest results in good survival, PAD may
have limited impact. However, existing approaches to sudden cardiac
arrest result in poor survival rates (ie, <5% survival to hospital
discharge) in most settings. PAD may be of critical importance in these
communities.
Some experts believe that biphasic waveforms are not superior to other
waveforms in defibrillation. This view is based primarily on two facts.
First, all or almost all waveforms in currently available external
defibrillators can defibrillate if the shock strength is sufficiently
high. Second, as yet, no studies in humans have demonstrated that
survival after sudden cardiac arrest is greater with a biphasic
truncated exponential waveform than with other waveforms.
There is no consensus on the optimum shock strength for the output of a
biphasic truncated exponential external defibrillator. In one study,
the defibrillation efficacy of a 130-J truncated exponential biphasic
waveform was equivalent to that of a 200-J critically damped sine
waveform.13 However, the statistical power was
insufficient to determine whether the defibrillation efficacy of a
130-J biphasic truncated exponential waveform was less than that of a
360-J critically damped sine waveform. Although prehospital studies of
defibrillation with the biphasic truncated exponential waveform are
under way, the results of these studies are not available at
present. In summary, until more information is available, clinical
trials of PAD should include multiple waveforms and multiple
devices.
Several manufacturers have responded to the American Heart
Association's challenge to develop a small, lightweight, simple
defibrillator for use by the public (Table
These studies are corroborated by studies of the relationship
between time to defibrillation and survival in traditional EMS systems.
In a pooled analysis of cardiac arrests occurring in Tucson,
Ariz, and Seattle, Wash, there was no threshold below which further
decreases in time to defibrillation were not associated with greater
survival (T. Valenzuela, unpublished data, April 17, 1997). Recent
European studies have demonstrated similar findings (M. Holmberg,
unpublished data, April 17, 1997). Therefore, implementation of
expanded use of defibrillation with further shortening of the time to
defibrillation should be associated with increased survival regardless
of the time to defibrillation in the existing EMS system.
Related work has demonstrated that most survivors of sudden cardiac
arrest have acceptable quality of life and that PAD is potentially
associated with an incremental cost-effectiveness ratio that is
comparable to that of other common medical therapies (G. Nichol, MD,
unpublished data, April 17, 1997). Collectively, this work demonstrates
that PAD should be evaluated as a therapy for sudden cardiac death.
The primary hypothesis of the trial is that trained, targeted
responders with a standard EMS system will increase
survival–to–hospital discharge rates among patients who experience
out-of-hospital sudden cardiac arrest compared with survival in a
standard EMS system alone. The term "targeted responders" includes
paramedical personnel and public service workers such as policemen and
firemen. It may also include individuals who work or live in buildings
that have a high density of individuals who are likely to be at
increased risk of sudden cardiac arrest (ie, >50 years old).
Secondary questions will include whether PAD is associated with
increased survival at 3 months after discharge, increased
neurologically intact survival, decreased time to defibrillation, or an
attractive incremental cost-effectiveness ratio compared with the
standard EMS system. It is likely that there will be insufficient power
to detect differences in neurologically intact survival among
device-related subgroups. However, the effectiveness of individual
devices may be compared in terms of an intermediate outcome, such as
restoration of spontaneous circulation. Only those devices that meet
FDA approval criteria will be used in the trial.
The ideal primary outcome would be 30-day survival with intact
neurological function. However, it may be impractical to use this as an
outcome, because individual consent would be needed to examine patients
and medical records. Because informed consent may be difficult to
obtain after resuscitation from sudden cardiac arrest, information
about functional outcomes will be missing for some patients. If this
information is missing for a large number of patients or is
preferentially missing from patients enrolled in either intervention
arm, then the results of the study may be biased. As an alternative, a
primary outcome of 30-day survival may be supplemented by information
about hospital discharge status.
Assessment of the quality of life of survivors of sudden cardiac arrest
will be included in the clinical trial to demonstrate that PAD
decreases morbidity as well as mortality. Once again, this may be
technically difficult, given the need for informed consent. Therefore,
study centers that are able to obtain more detailed quality-of-life
data from survivors should be encouraged to do so as part of an
ancillary study.
There are a number of logistical issues surrounding a large-scale trial
in which intact social units (communities, worksites, malls, high-rise
apartment buildings, etc) are the unit of randomization and
analysis. A matched-pair design is proposed to allow
randomization of one unit each to intervention or control status. To
make placement of devices efficient, sites will have to have
substantial population density within range of an available AED. This
implies that sites will consist of high-density housing units or other
sites where large numbers of people would gather for a sustained period
of time. Within those sites, a significant event rate must occur to
detect a difference between the two interventions. Available population
and event rate information forms the basis of the sample size necessary
for any trial. Each of these issues has been addressed in the proposed
clinical trial of PAD.
Alternative numbers of study sites (20 to 50) have been considered.
However, underestimation of the sample size needed and overestimation
of the number of likely events is a frequent problem in clinical trial
design.17 Therefore, higher numbers of
randomizable sites will be considered to ensure that the study has
sufficient power to detect a meaningful difference.
The generalizability of this study will depend in part on understanding
the factors that contribute to effective PAD. To the extent that it is
possible to do so within the context of a clinical trial, diverse sites
should be selected to evaluate PAD in a variety of settings. This
strategy will facilitate development of a template to describe
community or site needs for successful implementation of PAD in other
settings.
Issues of consent are recognized to be problematic in the
setting of an unconscious and dying patient. A formal procedure has now
been sanctioned by the Food and Drug Administration and Department of
Health and Human Services that allows institutional review boards to
waive the requirement for informed consent on such investigations. In
addition, assurance of an assumption of liability will be important in
obtaining participation from study sites.
The cost of PAD should be compared with that of the existing EMS system
so that decision makers can determine whether early defibrillation
offers sufficient value for money. However, hospital costs may be
difficult to obtain without informed consent from patients. At a
minimum, the costs of implementing and maintaining the defibrillation
program and the duration of hospitalization of survivors should be
required. More detailed information may be obtained as part of an
ancillary study.
Potentially significant covariates of the effectiveness of PAD include
response time intervals (such as time to defibrillation), initial
rhythm, whether or not bystander CPR was instituted, and demographic
variables (age, sex, ethnicity). Collection of these data will aid
in the interpretation of the results of the study.
Workshop attendees concluded that the training of targeted responders
should focus on psychomotor skills (eg, pad placement) and safety
issues (eg, stand clear). They advocated a curriculum that was designed
around goals rather than the detailed content included in current CPR
training. For naive users or laypersons, the workshop attendees
recommended a fixed curriculum that focuses on safety and addressed the
emotional issues involved in resuscitating strangers. Psychomotor
skills, knowledge, decision-making, and self-confidence issues were
acknowledged to be extremely important. Time for questions and
discussion of misconceptions is essential.
By being proactive, state EMS directors can facilitate the transition
toward PAD while securing a leadership role. Becoming involved in the
early stages of state law modification, data coordination, and training
standardization will ensure the appropriate integration.
Assistance with training of lay responders and the establishment of a
protocol for turning over patients from lay responders to EMS personnel
are key roles for EMS providers. Feedback for all responders,
particularly stress management services for lay responders, may also be
provided by EMS personnel when needed. The location of AEDs in the
community should be reported to the local EMS to create a truly
integrated system. Such information will be useful for planning and
coordination as well as resource allocation. For best results,
dispatchers should be trained to provide advice on the use of an
on-site AED by a layperson.
Strong support exists for continuing the requirement of physician
medical control for AEDs. Two-way communication between AED users and
those who provide medical oversight is necessary to identify problems
and solutions. Evaluation of PAD can be facilitated by
consistent use of the National Uniform Prehospital Data Set
(UPHDS, NHTSA, 1994). However, for complete evaluation of this
approach, the proposed clinical trial on PAD is essential for verifying
improved outcome from cardiac arrest.
Conference workshop participants made a specific recommendation that
providing AED training for the formal EMS first responders who are not
already trained in that skill is a first priority. The group
recommended that initial PAD should focus on "targeted first
responders" rather than the general public or "naive"
responder.
However, the ability of AEDs to accurately detect, analyze, and
treat pediatric ventricular fibrillation and shockable ECG
rhythms has not been investigated adequately in young patients.
Moreover, safe and effective defibrillation doses have not been defined
for AED use in children, and the potential risk of delivering excessive
defibrillation suggests that safety issues be evaluated before
widespread AED use is recommended for young children and infants.
Therefore, children
Physician-scientists, engineering experts, device manufacturers, and
representatives of the Food and Drug Administration
have also collaborated to develop guidelines for the assessment of AEDs
for PAD.18 These guidelines include criteria for
evaluation of the arrhythmia analysis algorithms used
in AEDs, for evaluation of alternative waveforms for defibrillation,
and for enhancement of safety.
Close collaboration between physician-scientists and
representatives of the Food and Drug Administration
will continue to ensure that the effectiveness of PAD is evaluated in a
sufficiently rigorous and timely manner.
At the national level, the proposed Cardiac Arrest Survival Act seeks
to increase implementation of PAD. This legislation proposes to develop
and disseminate a model training program for those who care for victims
of sudden cardiac arrest. It also proposes inclusion of education about
defibrillation in health and safety curricula. States are encouraged to
incorporate defibrillation into Good Samaritan legislation to address
liability concerns. Finally, a national database would be established
to compare survival after sudden cardiac arrest across the United
States. A federal commission would review these data and make
recommendations for additional improvements to EMS systems.
In summary, clear communication about the nature of early
defibrillation programs and ongoing legislation will improve our
ability to implement and evaluate such programs so as to improve
survival after sudden cardiac arrest.
© 1998 American Heart Association, Inc.
Special Reports
American Heart Association Report on the Second Public Access Defibrillation Conference, April 17–19, 1997
Key Words: defibrillation • heart arrest
Introduction
During the past 20
years, morbidity and mortality rates for nearly all types of
cardiovascular disease have declined. However, there
has been little decline in incidence or improvement in outcome after
sudden cardiac arrest. Each day 
1000 Americans experience sudden
cardiac arrest.1 2 Of these, 70% experience
ventricular fibrillation. Although patients with advanced
cardiac conditions have at least a 50% incidence of sudden
death,3 individuals with severe heart disease
collectively constitute only a very small percentage of sudden deaths
in this country.1 Therefore, although prevention
is clearly the best approach to the problem of sudden cardiac arrest,
such preventive treatments may be difficult and costly to
implement.
Levels of PAD
The four levels of defibrillation are as follows.
This level includes defibrillation efforts by police, highway
patrol personnel, and firefighter personnel. In many locations,
firefighters are the first responders to cardiac emergencies, and yet
they are often prohibited by regulations and states codes from
providing early defibrillation.
This level includes defibrillation efforts by lifeguards, security
personnel, and airline flight attendants.
This level refers to citizens and laypeople who have received AED
training. These individuals are interested in providing emergency
cardiac care, usually in the setting of a home in which a family member
who is a high-risk patient resides.
This level refers to individuals who happen to witness a
cardiopulmonary emergency and have an AED available (for
example, through a worksite defibrillation program). In general, this
level occurs most commonly in the home or at a worksite where one group
of people has been trained and other groups have not. The untrained
witness wants to help out and assist, but she has not yet received
formal AED training. Another example of this level is possible if AEDs
become accessible in the so-called "fire-extinguisher mode," in
which the AED location is displayed prominently and any witness to an
emergency has access to these devices. At present, both Food and
Drug Administration and state regulations permit physician prescription
of AEDs to individual homes. This level will become more feasible with
the introduction of newer technology that provides more voice prompts
to the user, automatic 911 dialing, and possibly 911
dispatcher–assisted defibrillation.
Current State of EMS
The existing EMS systems in some cities are highly effective at
treating sudden cardiac arrest. For example, the EMS systems of Seattle
and King County, Washington, have reported survival to discharge of
13.9% and 17.2%, respectively, among all cases of sudden cardiac
arrest.8 9 However, many other cities are unable
to achieve such results. For example, an EMS system of firefighters
providing CPR and defibrillation followed by paramedics providing
advanced life support had a survival–to–hospital discharge rate of
1.4% in New York City10 ; an EMS system of
paramedics providing advanced life support had a survival–to–hospital
discharge rate of 1.8% in Chicago.11 In such
cities, the presence of urban congestion and large residential or
office buildings result in a prolonged time interval between the onset
of cardiac arrest and the provision of defibrillation because
horizontal and vertical times to the treatment of victims of sudden
cardiac arrest are prolonged. Provision of early defibrillation by a
strategy such as PAD may dramatically improve outcomes after sudden
cardiac arrest in these communities.
Current Technology
The technology available to treat sudden cardiac arrest is
evolving rapidly because of changes in knowledge and device design.
Knowledge about the optimal waveform type and shock strength that
should be used in AEDs is increasing. There are two types of waveforms,
monophasic and biphasic (Figure
). With monophasic waveforms, the
current travels in only one direction. With biphasic waveforms, the
current passes from one pad to the other, then reverses. At
present, the majority of approved AEDs use a monophasic truncated
or monophasic damped sine exponential waveform. Recent work suggests
that the truncated biphasic exponential waveform may be superior for
external defibrillation. For example, animal and human studies of
internal defibrillation have reported that the defibrillation
thresholds and the median shock strength required to defibrillate are
significantly lower for some biphasic waveforms than for monophasic
waveforms.12 Cardiac
electrophysiological studies of external
(transthoracic) truncated exponential and the underdamped
sine biphasic waveforms in patients receiving an implantable
cardioverter-defibrillator demonstrated that both of these biphasic
waveforms were equally successful or more successful at defibrillating
than external critically damped sine wave shocks of the same or higher
energy.13 14 These preliminary findings should be
confirmed by additional studies, because not all truncated biphasic
external waveforms are equally efficacious for
defibrillation.15
View larger version (18K):
[in a new window]
Figure 1. Monophasic and biphasic waveforms. ). The number and type of
available devices are rapidly evolving. In future, the price, weight,
and complexity of these devices will most likely continue to
decrease.
View this table:
[in a new window]
Table 1. Automatic External Defibrillators Available for Use in Early
Defibrillation
Current Research
Several American and international investigators have
demonstrated promising results from uncontrolled field studies of
expanded use of defibrillation. For example, in a midsize American
community, 58% of patients with ventricular fibrillation
who were defibrillated early by police survived to discharge, compared
with 26% of such patients defibrillated by
paramedics.16 During the first 5 years of the
Quantas Airlines cardiac arrest program, 9% of all passengers who
experienced sudden cardiac arrest and were defibrillated by flight
attendants (n=22) were long-term survivors (M.F. O'Rourke, unpublished
data, April 17, 1997). Early defibrillation by first aid personnel at
the Melbourne Cricket Ground in Australia was associated with a
survival–to–hospital discharge rate of 67% among patients with
ventricular fibrillation or pulseless
ventricular tachycardia (n=24) (J. Wassertheil,
unpublished data, April 17, 1997). Although these studies were
uncontrolled, they have demonstrated the potential benefit of expanded
use of defibrillation for sudden cardiac death.
Clinical Trial to Evaluate PAD
The need for a clinical trial to evaluate the effectiveness and
costs of community-based PAD should be readily apparent. In addition to
answering these important clinical questions,
representatives from the Food and Drug Administration
have stated that a well-conducted clinical trial is essential to define
appropriate usage, labeling, and approval of device(s). The trial must
answer questions of effectiveness as well as documenting the potential
for misapplication of the device and for undesirable outcomes. There
are concerns that use of AEDs will become more widespread in many
communities and may contaminate any controlled experiment. Therefore,
there is some urgency to initiate a large multicenter clinical trial of
PAD. The American Heart Association Task Force on Automatic External
Defibrillators has proposed a study design for such a trial.
Training
Field research conducted to date was reviewed with the intention
of determining the length of training time, content, and
recertification interval required. For training of targeted responders,
2 to 4 hours appears to be adequate; less may be sufficient. The core
content included by most investigators is CPR and AED training. Several
investigators have divided the training into two sessions, with CPR
taught separately from AED use, to minimize confusion. The formal
retraining interval remains unclear from the research conducted to
date, but a 12-month interval appears to be adequate.
Interface with EMS System
With the advent of local, state, and national initiatives to
implement PAD, careful consideration should be given to the interface
of this new method of care with the existing EMS system. The concept of
PAD takes a direction different from that of past advances in public
health and safety. It will most likely involve changes to local and
state EMS and medical practice acts, as well as to the traditional way
that quality assurance, oversight, and monitoring is conducted. The
implication is that a totally new component of the EMS system will come
into existence.
Pediatric Issues
Current AHA guidelines for pediatric resuscitation apply adult
basic life support techniques and AED use to victims of prehospital
cardiac arrest 
8 years old. Although the prevalence of
ventricular fibrillation appears to be lower in the
pediatric population than in the adult population, high-risk
subpopulations (eg, patients with congenital heart disease) can be
identified. These subgroups of high-risk children and adolescents might
be appropriate for inclusion in PAD programs. As in adults, promptly
recognized and treated ventricular fibrillation in the
pediatric population has better short- and long-term outcomes than
resuscitation from asystole or pulseless electrical activity.
Therefore, the use of AEDs for early identification and treatment of
ventricular fibrillation is relevant to the care of
pediatric cardiac arrest victims. 8 years old should be included in a clinical
trial of PAD.
Regulatory Considerations
Physician-scientists and representatives of the
Food and Drug Administration have collaborated closely to address
concerns about the feasibility of conducting clinical trials of
therapies for sudden cardiac arrest with a waiver of informed consent
or with deferred consent. Guidelines for conducting clinical trials
dealing with therapies for medical emergencies have recently been
modified (Federal Register, October 2, 1996). These new rules balance
the need to provide special protection for these vulnerable subjects
with the need for investigation of promising new interventions. The
implication for any clinical trial of PAD is that studies involving
targeted lay responders are now possible.
Public Policy Considerations
In April 1997, a coalition of interested parties successfully
completed a 2-year effort to introduce and pass a bill allowing level 2
PAD in the state of Florida. The major elements of this bill state that
physicians can prescribe an AED for use by a layperson. Laypersons can
use this device to treat another person if the user is trained
appropriately in CPR and in defibrillation using an AED and calls 911
as soon as possible. Laypersons are encouraged but not required to
register the device with the local EMS agencies. The prescribing
physician and the lay user will not be held liable if each has acted as
an ordinary reasonable and prudent person. A key lesson from this
successful initiative is that the coalition consisted of a broad range
of representatives from EMS systems, legal
representatives, the American College of Emergency
Physicians, the American College of Cardiology, and the
American Heart Association. Other interested parties should consider
applying this model in their own jurisdiction.
Recommendations
Five recommendations were made by conference participants. First,
the existing first-responder curriculum for AEDs should be reviewed. A
curriculum for targeted responders should be developed by either
modification of the existing curriculum for first responders or
development of a new curriculum. Research training issues that should
be addressed include the length of training and the retention interval.
Second, inclusion of children >8 years of age as candidates for AED
use by targeted responders should be considered. Third, a clinical
trial is urgently needed to evaluate the effectiveness, safety, and
cost-effectiveness of PAD. Such a clinical trial of PAD should include
several different types of AEDs. Fourth, American Heart Association
affiliates should collaborate with other interested parties to modify
legislation so that early defibrillation is permissible throughout the
United States. Finally, the American Heart Association, American
College of Cardiology, National Heart, Lung, and Blood
Institute, state EMS directors, representatives of the
Food and Drug Administration, and other interested parties should have
an ongoing discussion about the implementation and safety of early
defibrillation.
Selected Abbreviations and Acronyms
AED
=
automatic external defibrillator
CPR
=
cardiopulmonary resuscitation
EMS
=
emergency medical services
PAD
=
public access defibrillation
Footnotes
Reprint requests to Pat Bowser, 3606 Reposo Way, Belmont, CA 94002.
References
Top
Introduction
Levels of PADThis article has been cited by other articles:
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