Automatic Early Defibrillators in Nursing homes
I. The background
Sudden death because of ventricular fibrillation is considered to be a leading cause of death in the U.S.A. (Annual Review of Medicine, Vol. 54: 235-243) “Each day 1000 Americans experience cardiac arrest.” (Blanchard SM, Knisley SB, Walcott GP, Ideker RE, 1994) Early defibrillation is the important determinant of patient survival and is the key point in cardiopulmonary resuscitation. (Annual Review of Medicine, Vol. 54: 235-243). One of the options which provides rapid defibrillation is an automated external defibrillator (AED). Nursing homes belong to the category of institutions where the cases of ventricular fibrillation are very rapid and these places are among the first ones which require widespread use of AEDs. Unfortunately, the availability of automated external defibrillators in nursing homes remains a problem which depends on many factors.
At the beginning of the 1990s only some EMTs (Emergency Medical Technicians) were legally permitted to use AEDs. In 1994 no more than 36 states in America authorized use of AEDs by EMTs. There years later nearly all states had regulations and laws to allow EMT defibrillation. The spread of defibrillation by EMTs increased after the US Department of Transportation issued in 1994 EMT Basic National Standard Curriculum which gave sanction to train EMTs to maintain and operate AEDs. Bailey in the report The National Association of State EMS Directors AED Study Results came to the conclusion that one of the main challenges of the early defibrillation initiatives was “the need for legislation to enable various levels of health care professionals, public safety personnel, and in some cases, lay citizens to use AEDs.” (Bailey, 1996). Here the problem arose, as the researcher noted, because of the difference in legal interpretation of the medical term – the use of automatic early defibrillation. To apply defibrillator – is it a medical act which needs proper qualification or just a first aid? If it is a medical act, then the personnel who work with it must be specially trained and certified. The researcher remarked: “In most states, AED use is considered a medical act (68 percent) and individuals who use AEDs are required to be certified or licensed (78 percent).” (Bailey, 1996). So, in early 1990s the legal system could not permit the wide use of automatic early defibrillator first of all, because of wrong interpretation of the term itself.
Later on, due to the expanding studies of the process of AEDs and the experiments which proved its efficiency and necessity for widespread use, the interpretation of the term changed. The medical focus somewhat shifted to the public needs. In Improving Survival From Sudden Cardiac Arrest: The “Chain of Survival” Concept, published in early nineties, American Heart Association stated that the principle of early defibrillation should be adopted by all communities. This principle required that all personnel “must carry an AED and be trained to operate it” (Cummins, Ornato, Thies, Pepe, 1991). Also the same paper held that health professionals whose duty was to respond when a cardiac arrest happened “should have a defibrillator available either immediately or within 1 to 2 minutes.” (Cummins, Ornato, Thies, Pepe, 1991).
In 1995 the Journal of Emergency Medical Services identified the main obstacles of realization of early defibrillation programs. Among the mentioned obstacles there was a lack of state legislation, and a lack of appropriately trained stuff. The survey of state EMS directors, which was conducted in 1996, showed that not more than half of EMTs and less than one quarter of non-EMT first responders were equipped and trained to defibrillate. (JEmerg Med Services. 1997;(suppl):S5–S8). This problem roots from the history of the issue.
Recently, the activity of public organizations has been provoked filing the gaps of legislation in both levels: state and federal. The American Heart Association, one of the most active fighters for AEDs authorization, claimed in the guidelines that “… all personnel whose jobs require that they perform basic CPR [should] be trained to operate and permitted to use defibrillators, particularly AEDs. The AHA emphasized one the point that early defibrillation was considered to be the standard of care in the community. “Failure of emergency personnel to have a defibrillator available during a cardiac arrest is difficult to defend.” (Guidelines for cardiopulmonary resuscitation and emergency cardiac care, III: adult advanced cardiac life support, 1992).
At the state level the authorization of AEDs based on Good Samaritan laws which mostly concerned liability of those who were involved in rescue of the victim. “The new state legislation on AEDs, a model for a version that’s soon expected to be introduced nationally, is designed to promote widespread use of AEDs by easing training and other bureaucratic requirements.” (Piloto, 1997). Though, each state adopted its own legislation on AEDs. For example, in Florida, the legislation permitted both categories: laypersons and qualified stuff the use of AEDs for the purpose of saving the life of other people in case of cardiac arrest. In addition, The Florida state Good Samaritan law required that any person, including the one licensed to practice medicine, in good faith rendering treatment by the use of AEDs, would not be liable for any civil damages which resulted from such treatment or any act, or failure to act in arranging further treatment, under any circumstances. In Massachusetts, however, this law was expanded to the following version: any person trained according to the guidelines of American Red Cross or the American Heart Association, or any person who met the requirements of a training course in basic cardiac life support, in accordance with the standards of the AHA, would not be liable for omissions or acts, resulting from rendering defibrillation.
Another difference of AED state laws and regulations lies in training requirements. In some states training should be fulfilled by nationally recognized organizations. Other states ask for coordination with EMS, record keeping and medical direction while training is conducted.
At the federal level AED legislation is based on Cardiac Arrest Survival Act (May 23, 2000). This Act, among other things, provides an additional measure of immunity, addresses placement AEDs in federal buildings, and so on. Other action passed at a federal level and intended to support AED deployment are: the FAA ruling which deals with AEDs placement on airlines; the OSHA advisory which gives recommendations of AEDs at the workplace; and the GAO report which suggests cardiac arrest data collection.
Political factors. The market of AED is have been ruled by the Federal Drug Administration (FDA). The policy of FDA has dubious effect on AED availability. Thus, according to the report written by a group of colleagues Myron L. Weisfeldt, Richard E. Kerber, R. Pat McGoldrick; Arthur J. Moss, Graham Nichol, Joseph P. Ornato, David G. Palmer, Barbara Riegel, a key factor to availability of AEDs “lies with the appropriate legal requirements for FDA approvals, postmarket tracking, and medical device reporting.” (Public Access Defibrillation Conference, December 8-10, 1994). Here, as one of the major obstacles of AEDs widespread usage Myron L. Weisfeldt and associates mention the discrepancy between the high criteria for FDA approval and “relatively small premarket clinical trials to document AED efficacy in controlled settings.” (Public Access Defibrillation Conference, December 8-10, 1994). These clinical trials should involve not less than 25 patients and their efficiency must be documented using all reliable evaluative data. Then, in the postmarket stage, additional evaluation is required. The evaluation, according to the standards, should cover 150 consecutive events at EMS sites, where reliable data proves performance characteristics, device safety, and efficacy. All these measures are intended by the FDA to seek the “development of a standardized, stronger medical device–reporting database to track AED efficacy and safety.” (Public Access Defibrillation Conference, December 8-10, 1994). On the whole, the regulatory measures of the FDA create a major challenge to availability of AEDs.
Additionally, in order to make AEDs available for public use, state and local EMS systems need to be closely involved into the whole process. However, in different states these systems vary in their structure and relations to other agencies. It means that choice and decision which relates to placing AEDs or training the use of AEDs should be made by each locality. This second political factor, among other things, evidences a flexible approach to the issues of AEDs, and, at the same time, it is believed to be a “key to AED access among EMS providers.” (Public Access Defibrillation Conference, December 8-10, 1994).
Economic factors. The cost of automated external defibrillators ranges from $3500 to $5000. As it may be seen, AEDs as life-saving equipment are very costly and because of such significant price they constitute a moderate market. Consequently, the cost of AEDs creates a barrier to a more general use. Myron L. Weisfeldt at al. in the report addressing access defibrillation issues drive to the conclusion that “a very large market (of AEDs) would be realized if AEDs were to become generally available to the public.” (Public Access Defibrillation Conference, December 8-10, 1994). The costs of production and distribution, according to the report of Myron L. Weisfeldt at al., can be reduced by increasing volume and simplifying units. However, the report holds, this is not possible, because AED still needs extensive studies, for instance, recordkeeping, extensive testing, making medical device reports, which add to the cost per every unit. (Public Access Defibrillation Conference, December 8-10, 1994).
Although since the beginning of the initiative of the AHA sufficient funds were spent on the development of AEDs, AED market opportunities haven’t yet become attractive for major investments. (Public Access Defibrillation Conference, December 8-10, 1994). Researchers, who analysed economic basis of AEDs in the United States concluded that AEDs may achieve a large market, “but potential investors perceive the market demand for AEDs as limited.” (Public Access Defibrillation Conference, December 8-10, 1994).
Social factors. The availability of AED may vary according to the deference in social levels. More reach people may afford buying their own defibrillators, while the disadvantaged are materially restricted. This problem may be solved by medical insurance, which can provide with defibrillators for free. However, this social factor is closely connected with the economic attractiveness and perspectives of AED market. If insurance companies find covering the cost of this life-saving equipment profitable, they will include AED in medical insurance. But, to my mind, this will happen only after economic hardships (price, volume, market reliability and so on) of AED programme are overcome.
According to AARC Clinical Practice Guideline there are some cases when general ethics contradicts processional ethics. This contradiction may also cause an obstruction for AED availability.
First, there are cases in medical practice when patients express their desire not to be resuscitated. In such cases health care specialists have solve dilemma: whether to follow the desire of the patient or to save patient’s life.
Also an ethical contradiction may occur when the treating physician determines continued resuscitation to be futile. Will the physician stop the procedure or complete it, irrespective of any fact or evidence?
Finally, ethics may oppose professional accomplishment of duties when “immediate danger to the rescuers is present due to the environment, patient’s location, or patient’s condition.” (AARC Clinical Practice Guideline). In this case the following dilemma occurs: to save the live o the patient at the expense of other lives or by sacrificing the lives of the rescuers?
II. The Analysis of Policy Alternatives
In modern medicine immediate defibrillation is considered to be “the standard of care for treatment of ventricular fibrillation and should be undertaken before initiation of other advanced life support measures, such as endotracheal intubation.” (JAMA Vol. 284 No. 11). Today advanced technology suggests some variances of defibrillation. One of the alternatives to an AED is an implantable cardioverter-defibrillator (ICD). It is also designed to detect abnormal heart rhythm and suppress arrhythmia immediately. The patient’s arrhythmia will be converted to normal rhythm by delivering a powerful electrical shock to the heart. Electrodes of ICD are inserted through the veins of the patient to the heart, the pulse generator is surgically implanted under the skin in the area of the chest.
Among the advantages of ICD, modern scientists single out its capability of sudden death prevention. Also, as the studies show, this device relieves the patient’s concern about fainting spells. ICD provides a piece of mind and many of patients resume to normal life, even to driving. The uncertainty of the shocks, according to what researchers claim, is adapted by most patients. (Blanchard SM, at al 1994, 153-178)
Notwithstanding the significance of its benefits, ICD can have many potential risks. The first is that the ICD needs a surgical procedure, which itself may cause death of the patient. The second risk is in delivering wrong shocks, when actually the patient does not need them. If this happens, the patient should notify the doctor. Another problem rises when the patient needs to change the battery. This procedure also requires surgical operation, which holds its own risks, as was mentioned above. And finally, there is a potential risk of malfunctioning of ICD, which needs special programming of audible alerts by an electrophysiologist. This alert can also go off, and in this case the patient should contact his/her doctor.
However, it is not less important to mention positive and negative potential of AEDs, which constitute the topic of research. The negative potential of AED use lies in the following:
1) AED shock may be hazardous in patients who are less than 90 lb;
2) A electrical shock can be accidentally delivered to the rescuers;
3) During defibrillation electric arcing can occur because of the aluminized backing on some of the systems. This arcing, among other things, may cause patient burns, or impaired transmission of current.
4) The permanent pacemakers may have malfunction, resulting from wrong placing of defibrillator pads or paddles.
5) In the time of cardiac arrest AED equipment may be out of reach.
Among the benefits of AEDs specialists noted the following:
– AEDs are easy to use and can be successfully applied in different settings: in-hospital and out-of-hospital, transport and so on.
– AEDs are effective in the cases of cardiac arrest on the patients of all ages with ventricular fibrillation or pulseless ventricular tachycardia.
– AEDs do not need to be implanted surgically into a patient.
III. Comparison of all the alternatives
Sweeney TA and associates conducted a research to determine whether the use of AED in an EMS system where the response time is 4 minutes and the first responders are emergency medical technicians can affect survival from cardiac arrest. In order conduct the research, the Sweeney TA and associates used the following methods: “controlled, crossover study (AED versus no AED) of consecutive cardiac arrests managed by 24 FREMT fire companies took place from 1992 to 1995 in Charlotte, North Carolina, a city of 455,000.” (Annals of Emergency Medicine. 31(2):234-40, 1998 Feb.) The researchers stratified the patients according to Utstein criteria. The results of the study showed that among 627 patients, 243 had witnessed arrests of cardiac as bystanders. Survival to hospital discharge was achieved in 5 of 110 participating patients (4.6%; 95% confidence interval [CI] 0.6% to 8.4%), where AED compared with 7 of 133 (5.3%, 95% CI 1.5% to 9.1%) without AED (P = .8). Both groups could be compared regarding their gender, age, congestive heart failure or diabetes, history of myocardial infarction, bystander CPR, arrest at home, and whether or not was the initial rhythm in ventricular fibrillation (VF). Irrespective of causes of the arrests, and whether they were witnessed by EMS personnel or bystanders, with an initial rhythm of VF or ventricular tachycardia (VT), 5 of 77 (6.5%, 95% CI 1.0% to 12.0%) with AED the rate o survival compared with 8 of 105 patients (7.6%, 95% CI 2.5% to 12.7%) without AED (P = .8). The scientists concluded that the significant differences between the two groups did not affect survival. Thus, addition of AEDs to this EMS system did not raise survival rates from sudden cardiac death.
The next study was performed by Antoni Mart?nez-Rubio and Gonzalo Bar?n-Esquivias. The group of scientists stated the problem of their research in the following way: sudden cardiac death remains a major problem in modern hospitals. Antoni Mart?nez-Rubio and Gonzalo Bar?n-Esquivias noted that “The capability to provide early defibrillation within any patient-care areas should be considered as an obligation (“standard of care”) of the modern hospital.” (Indian Pacing and Electrophysiology Journal, 4(3): 114-121) In order to prove the efficiency of early defibrillation, the researchers applied automatic defibrillators to monitor and treat patients in intensive care units and coronary care units. The researchers documented 1,240 hours of monitoring and 1,988 episodes of rhythm change. It was found out that the device detected ventricular arrhythmias with the sensitivity of 100% and its specificity was 97%. The mean time response to shock was 14,4 sec. The researchers noted that there were no adverse events or complications. 35 arrhythmic episodes were treated by the device. Al the arrhythmic episodes were successfully converted to normal rhythm with the first shock success of 93,4%. The results of the second study proved high efficiency of automatic defibrillators in intensive care units and coronary care units of the hospital.
Thus, I have investigated the point of early defibrillation treated and monitored with automatic defibrillators in nursing homes. In the frames of my investigation I have discussed the problem of public access and availability of defibrillators through showing the main factors (social, economic, ethical, legal, and political) and their influence on the issue. Also I have analysed positive and negative potential of some of the options in the process of defibrillation. And finally, I compared capabilities of defibrillators and their impact on survival in different conditions.
The analysis of the findings:
Early defibrillation is highly effective in hospital setting to monitor and treat ventricular arrhythmias. Though, in comparison with internal defibrillators, external ones may be out of reach in the moment of cardiac arrest and the first responders may not be professional health care specialists or emergency medical technicians. This disadvantage of external defibrillators was questioned in the study of Sweeney TA and associates. Unexpectedly, the study showed that the first help given by a layperson, as compared with the outcomes of specialists’ assistance, does not have a significant impact on the survival rate.
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