Bernard Lown, MD
Our newspaper of record, the Boston Globe, headlines on its front page, “FDA approves sales of home defibrillators”(09-17-04) The article explains the reason given for FDA approval, “that the average person can safely operate the machines. When used appropriately, defibrillators can dramatically improve a patient’s prospects for survival.” Both statements are true. Any life saved is precious and worthy of the effort . I should be elated at this popularization, since some 48 years ago, I had invented the direct current defibrillator (DC). (1) Yet, I am not at all pleased, in fact I feel disquieted.
What accounts for my attitude? In my mind the over-the-counter availability of defibrillators substitutes market forces for public health interventions, It introduces practices without scientific evidence of benefit. It astronomically escalates health care costs. It does not address the complexity of the cardiac arrest problem. It ultimately preempts preventive cardiology by promoting technology as a mythical substitute. Instead of enhancing communitarian values, it further atomizes society into individual consumers left to their own devices.
An effective strategy against the formidable problem of sudden death requires identification of the individual patient at risk. Screening for telltale markers can now be readily carried out. It is senseless to leave such a determination to market forces rather than to the medical profession. Clearly defibrillators will now be purchased by those who are readily hyped by fear of impending sudden death and by those affluent who may not be at risk at all. While this may be a bonanza for the instrument makers, it is no boon for public health.
The technology of automatic external defibrillators (AED) has evoked enormous enthusiasm. Indeed the AED is a much simplified, efficient method for defibrillating patients with ventricular fibrillation or ventricular tachycardia, the most common causes of out of hospital cardiac arrest. Its use by first responders has proven safe and effective in optimizing survival in individual cases. Yet various randomized community studies have not shown a strong survival benefit among those who have experienced a cardiac arrest. The study conducted more than a decade ago by firefighters in Memphis, Tennessee is illustrative. (2) Patients treated by firefighting companies equipped with AEDs had no greater rate of hospital discharge compared to those treated by firefighters not using the device.
One needs to question the wisdom of promoting the widespread application of a technology for home-based defibrillation though lacking supportive scientific evidence of cost effectiveness. Current AEDs are priced at about $2000. There are additional costs for maintenance as well as replacement. Far more important is the fact that when confronted with crisis, people who are inadequately trained do not perform. In a study of 50 operators 21 (42%) failed to defibrillate the patient. (3) For a rare event a single training session is inadequate, it must be frequently reinforced.
In locations where there exits a high density of cardiac arrest prevalence, positing an AED might afford a cost acceptable benefit. A study of appropriate locations concluded that only eight sites were suitable, these included international airports, shopping malls, large sporting events etc, among such locations there was an incidence of 0.1 arrests per year. (4) When one moves to less frequented sites such as governmental offices and retail stores, the arrest rate drops to a minuscule 0.003 per year or less, suggesting the need of 300 AEDs at these locations for a device to be available for the one arrest encountered per year.(5) Members of the US Agency for Healthcare Research and Quality estimate that AEDs would cost approximately $1.5 million per quality adjusted life year added.(6) Clearly home events would be far less frequent and therefore far more costly.
Additional problems have to be considered. An event must be witnessed for the device to have utility. If the victim is sleeping, in the bathroom, typing away by oneself at a computer, or in the basement tinkering with the furnace, or attending to the laundry, or a spouse had gone out shopping or for whatever reason, the AED is of little value. I can already anticipate the response. Why not have the subject carry a simple sensor that activates an alarm in case of a cardiac arrest? The concatenation of further ancillary technologies stretches the imagination. Ultimately the home is converted to a medical intensive care unit. The constant alert to impending doom inevitably undermines emotional tranquility and will exact psychological costs as well. One needs to question whether increasing dominion over our lives by the medical industrial complex is the proper direction for achieving greater health?
Of no small concern is the fact that the current US health bill is a staggering $2.3 trillion and rising at the rate of 10-20% per year. A large part of the inflation is driven by the entry of novel unevaluated technologies and the endless unnecessary procedures. The US can ill afford such escalation. Already 50 million Americans are uninsured and millions more are inadequately insured. These numbers will certainly further increase as health costs mount. At the same time as expenditures are skyrocketing, quality of care is plummeting. In fact, contrary what every American believes, we have one of the worst health care systems among developing nations. Our system was ranked 37th by the World Health Organization in 2000.
The optimal way to address the growing toll of heart disease and sudden death is through prevention. As Brown and Kellerman editorialize, instead of purchasing an AED money would be better spent “on a bicycle, a smoking cessation program, a health club membership, or a treatment of hypertension… ” (5)
1. Lown B, Neuman J, Amarasingham R, Berkovits BV: Comparison of alternating current
with direct current electroshock across the closed chest. Am J Cardiol 1962; 10: 223.
2. Kellerman AL, Hackman BB, Somes G, et al Impact of first-responder defibrillation in an urban emergency medical service system. JAMA 1993;270:1708.
3.Roccia WD, Modic PE, Cuddy MA. Automated external defibrillator use among the general population. Journal Dental Education 2003;67:1355
4. Becker L, Eisenberg M FahrenbruchC, Cobb L. Public locations of cardiac arrest. implication for public access defibrillation Circulation 1998;97:2106
5. Stryer D, Laurence W. Automated external defibrillators. Annals Int Med. Letters 2002;137:622.
6. Brown J, Kellerman AL The shocking truth about automated external defibrillators. JAMA 2000;284: 1438.
*Originally posted (12 September 2004) on ProCor (www.procor.org), a global communication network promoting cardiovascular health in developing countries. ProCor was founded by Dr. Lown in 1997 to encourage knowledge sharing among a global community about preventive strategies.