Philips Medical Systems is currently seeking clearance to the FDA advisory panel to sell its HeartStart Home Defibrillator for over-the-counter AED home use. What does this mean for the future of public access defibrillation? Also, what are the concerns surrounding this decision? EP Lab Digest recently spoke with Wendy Katzman, Business Director, HeartStart Home Defibrillator at Philips, to find out more.

When did the HeartStart Home Defibrillator first become available on the market?
       The HeartStart Home Defibrillator received FDA clearance in November 2002. This was for prescription-use only. It was the first of a new generation of defibrillators specifically designed for home use.

Figure 1.

Philips HeartStart Home Defibrillator.

What are the benefits to having a home-use defibrillator?
       Nearly 80% of sudden cardiac arrests happen in the home and the critical issue is time. For the best chance of survival, a defibrillator should be applied within five minutes. However, emergency response times vary throughout the country. The average response time in a typical community is about nine minutes. HeartStart gives you a chance to be prepared in those first few crucial minutes while waiting for professional responders to arrive. For each minute delay in defibrillating somebody, the chance of survival decreases by about 10 percent. After just 10 minutes, very few people survive. So when you consider about how long it takes for emergency responders to arrive, it quickly becomes clear why less than 5% of people actually survive in this country from cardiac arrest.

Do you know approximately how many HeartStarts have been sold so far, with a prescription?
       Philips has shipped approximately 5,000 HeartStart Home Defibrillators thus far.

Defibrillators in the home have been a hot topic in the news lately. Some question whether or not it is safe to offer them without a prescription. Are there any potential dangers of AED home use? If so, how would you address those concerns? Why do you think some are nervous about offering it without a prescription?
       One concern seems to be that people will not call 911 in an emergency if they have a home defibrillator. Included in all of the materials that come with the HeartStart Home Defibrillator, responders are instructed to call 911 first during an emergency. One study you may have read about in the news recently was the Public Access Defibrillation (PAD) Trial, which was just published in the New England Journal of Medicine. In the PAD study, in which there were about 20,000 people trained, there was no failure to call 911. This has been Philips’ experience as well. Our experience is that people do call 911 first.

Figure 2.

The HeartStart is part of a new generation of defibrillators designed specifically for the home.

What would be the protocol to follow if a patient was having chest pains and who owned a HeartStart Home Defibrillator?
       The HeartStart Home Defibrillator is intended for use on someone who is unresponsive and not breathing. If a person has any doubt, the indications are to apply the pads. So if somebody is conscious, breathing and having chest pains, you should call 911. If the person is unconscious and not breathing, again, first call 911, and then get the HeartStart. If there is any doubt, apply the pads — the HeartStart is only designed to only shock the heart rhythm that needs to be shocked. It is designed for safety.

Describe how the HeartStart works. What are the steps that need to be taken once the HeartStart is activated? Can anyone use it?
       The HeartStart Home Defibrillator is specifically designed for use by virtually anyone to help save a life. If you suspect that someone is in sudden cardiac arrest — they are not breathing and you can't wake the person — call 911 first. Then follow this three-step process to restart a heart: Pull, Place & Press.
Step 1. Pull the cartridge handle — it's marked “PULL” in large letters. This initiates the clear calm voice that will guide you through the process.
Step 2. Place the pads on the patient's chest. The voice instructions tell you exactly what to do. HeartStart can even sense and adapt to your actions. If you are moving quickly, the voice prompts stay with you. If you are taking more time, HeartStart provides increasingly detailed instructions to help you place the pads correctly. Once HeartStart senses that the pads have been applied to the skin, it automatically begins analyzing the patient's heart rhythm. HeartStart decides whether a shock is needed — you don't have to.
Step 3. Press the shock button. If HeartStart decides a shock is needed, it will instruct you to press the flashing orange button. HeartStart is designed to only let you deliver a shock if it determines one is needed. HeartStart even provides CPR coaching.

Describe the study published in Circulation in which sixth graders used an AED.
       This was with an earlier generation HeartStart. In the study, naive sixth-grade children were compared with trained paramedics in the use of an automated external defibrillator (AED). What was found was that trained paramedics were only moderately faster at applying the AED than the naive sixth graders in a simulated response scenario. We are talking about a time comparison within seconds!
       It is studies like this one, as well as others Philips has conducted, which demonstrate that the HeartStart Home Defibrillator has a history of safety and effectiveness. Philips is now seeking over-the-counter clearance in order to make it more easily available for people who choose to be prepared.

Is the HeartStart Home Defibrillator different than AEDs available in malls and other public places?
       There are a couple of ways that the AEDs differ. For example, the HeartStart FR2 is a HeartStart defibrillator that you might see on an airplane. The FR2 has an LCD screen, which enables a physician on board a plane to view the heart rhythm. Of course, someone at home does not need to have that type of information, because most laypeople don’t understand how to look at a heart rhythm.
       Another unique feature designed to help home users is how HeartStart adapts to your pace. Finally, HeartStart provides CPR coaching. These are some of the key differences that Philips focused on to help make the HeartStart Home Defibrillator as easy as possible for laypeople to use it in an emergency situation.

When do you expect to hear the FDA’s decision?
       The decision and the timing of the decision are in the hands of the FDA.

What would be the approximate cost of the HeartStart if approved?
       The cost of a home defibrillator today is $1,995.

How do you envision the future of public access defibrillation? Once they became available without a prescription, where would they be sold?
       Today the HeartStart Home Defibrillator is sold primarily through Philips. Should the FDA decide to remove the prescription requirement for HeartStart, it would continue to be sold through Philips. Philips would also explore other outlets where consumers might go to buy the HeartStart. These could be places such as pharmacies, or different types of internet sites or retail stores. We will work with various partners to build relationships to help make it easier for people to buy a HeartStart Home Defibrillator.

Would you recommend that people still consult with their doctor before buying one?
       Philips views the HeartStart Home Defibrillator as safety equipment. Think about the other steps that you take in your life to prepare for once-in-a-lifetime emergencies: for example, to prevent a house fire, you have a fire extinguisher and a smoke detector. In your car, you wear a seat belt and you rely on airbags because you don’t know when a traffic accident will occur. That is very much what sudden cardiac arrest is like; it strikes without warning, and the majority of people have no previously recognized symptoms of heart disease. Having a HeartStart is another thing you can do to be prepared to help save somebody’s life. If someone does have concerns about their health or an existing medical condition, they should talk to their doctor, because the defibrillator is not a replacement for seeking medical care.

For more information, please visit: www.HeartStartHome.com
or call (866) 333-4246

Breaking News: FDA Clears the Philips HeartStart Home Defibrillator for Over-the-Counter Sale

- Royal Philips Electronics announced on September 16 U.S. FDA clearance of the HeartStart Home Defibrillator for sale without a prescription. The FDA’s decision follows the favorable consensus of the Circulatory System Devices Panel, which met on July 29, 2004 and supported removing the prescription requirement. Defibrillators provide therapy for the most common cause of sudden cardiac arrest (SCA), a leading cause of death among adults in the U.S. The Philips HeartStart Home Defibrillator is now the first defibrillator cleared for over-the-counter sale, a move that will help make the HeartStart Home Defibrillator more easily available to consumers for home use, where the majority of cardiac arrests occur. “It is important to recognize that for a substantial percentage of SCA victims, cardiac arrest is the first sign of heart disease,” said Dr. Jeremy Ruskin, Director of the Cardiac Arrhythmia Service at Massachusetts General Hospital. “We know that access to early defibrillation helps save lives. Removal of the prescription requirement for the HeartStart Home Defibrillator gives people freedom of choice to be better prepared for unexpected cardiac arrest — a rare but life-threatening emergency.” Sudden cardiac arrest claims approximately 340,000 lives each year. Defibrillators provide treatment for ventricular fibrillation, the most common cause of sudden cardiac arrest. For each minute that passes before defibrillation therapy is administered to a victim, the chance for survival decreases by about 10 percent. It takes an average of nine minutes for emergency professionals to reach a victim in a typical community. In recent years, communities, businesses and schools have deployed defibrillators in an effort to improve survival. Published studies show that survival rates can increase dramatically when defibrillators are deployed in public places. While the majority of cardiac arrests occur in the home, the chance of survival can be less than half the chance of survival in public places. At the recent Circulatory System Devices panel meeting, physicians, professional organizations and cardiac arrest survivors concurred that greater access to defibrillators will help save lives from what is often a treatable, yet unpredictable, emergency. Cleared by the FDA in 2002 for sale by prescription, the HeartStart Home Defibrillator is a new-generation defibrillator designed specifically for use in the home. Patented technologies and an award-winning design make it fast to learn and easy to use. In addition, specially designed infant/child pads make the HeartStart Home Defibrillator appropriate for use on infants and children under the age of 8 or weighing less than 55 lbs. This Infant/Child SMART Pads cartridge will continue to be available by prescription. “The HeartStart Home Defibrillator was designed to help virtually anyone use this life-saving technology,” said Deborah DiSanzo, vice president and general manager for cardiac resuscitation at Philips Medical Systems. “The FDA’s decision will help accelerate our vision of making defibrillator technology broadly accessible to help save lives that would otherwise be lost to sudden cardiac arrest.”