Putting a Heart Saver in Hands of Novices

By MARK FRITZ

July 16, 1998 12 AM PT

TIMES STAFF WRITER

Joe Kozina’s life is devoted to death, particularly when it happens suddenly, in public, with people around to see it take place. Particularly when there’s a chance it may not be permanent.

With a zeal that is almost evangelical, the Sacramento cardiologist has been urging stores, stadiums and other places where people converge to equip themselves with a sophisticated piece of medical equipment called an automated defibrillator. The newest of these devices is so easy to use, he says, that even novice rescuers can deliver a life-saving jolt of electricity to sudden victims of cardiac arrest.

As part of his crusade for “public access defibrillation,” Kozina has helped the American Heart Assn. lobby for a California law that would protect ordinary people from lawsuits if they decided to grab one of these machines, read the directions and zap somebody’s haywire heart in an emergency.

Their bill, however, died in a committee as abruptly as a coronary case, the victim of what proponents said was a lethal bit of 11th-hour lobbying by trial lawyers opposed to laws limiting lawsuits.

This dispute over a machine with a name that many people can barely pronounce is only one of many taking place in statehouses and city halls across the country. The American Heart Assn., a network of activists like Kozina and a trio of big manufacturers are leading a broad push to put a potent tool for surviving one of the nation’s most common forms of death into the hands of everyday people.

In the last six months, 11 states have passed laws allowing lay people to use a defibrillator, and 10 others are considering similar legislation. The laws generally would protect nonprofessionals from lawsuits if they decided to defibrillate someone who looked like they needed it.

“Four months ago it seemed like an exotic topic,” said Richard Cauchi, who tracks medical trends for the National Conference of State Legislatures. “Now it seems like one of the hot topics in health care.”

Yet in many places the machines are triggering philosophical hand wringing and political infighting over to what degree the masses should be able to freely wield such powerful medical technology, and whether distributing them widely is worth the cost. A dozen states still prohibit lay people from using the machines, and several others require levels of training that proponents say are not only unnecessary but prohibitive to the point of costing lives.

‘A Lot of Turf Battles Going On’

Many insurance companies won’t pay for them if a heart patient wants one for home and won’t extend coverage to businesses that want them for their workers. A Palm Springs synagogue wanted a defibrillator on hand for its largely elderly congregation, but its insurer wouldn’t provide liability coverage.

And in many communities, police officers are balking at becoming more like paramedics, just as some paramedics are leery about the police and public horning in on their duties.

“There’s a lot of turf battles going on,” said Kozina.

Cardiac arrest is the sudden loss of heart function. The victims aren’t breathing and have no pulse rate, and doctors consider them clinically dead, though there is a window of less than 10 minutes during which there is a chance of survival.

Defibrillators for years have been used to reverse one of the most common types of cardiac arrest, ventricular fibrillation, by delivering an electric shock that kick-starts the heart back into syncopated rhythm. The rescuer fires a back-arching blast of voltage through a pair of electrodes pressed against the victim’s chest.

Yet an estimated 250,000 Americans die every year mainly because rescuers can’t reach them in time. The heart association declared war on the disease in 1994 by urging medical manufacturers to build a simple device that could be posted in public places.

The latest generation of supposedly idiot-proof defibrillators cost about $3,000 and weigh five pounds. Unlike their bigger manually operated cousins, these devices are designed to diagnose the victim’s distress and automatically decide whether a shock is needed. Some have only a single button.

Devices Turning Up in a Variety of Places

The simplicity and portability of these devices are already changing the dynamics of public safety by turning up in Seattle police cars, Las Vegas casinos, golf courses, shopping malls, commercial airlines and even amusement parks such as Disneyland.

The laptop-sized defibrillators have even become a fashionable acquisition of the cardiac-prone affluent. “I heard about someone the other day who bought one for his home and one for his yacht,” said Shelly Cohen, a spokeswoman for Physio-Control Corp., a Redmond, Wash., defibrillator manufacturer.

California was poised to adopt the most liberal public-access defibrillator law in the land. Besides granting broad immunity from lawsuits--even businesses which put them on the premises would be protected--the proposal did not require even minimum training. The goal was to create a climate that would make reaching for a portable defibrillator as legally risk-free and culturally reflexive as breaking the glass on a fire extinguisher case.

“I thought ‘Let’s take this to the next level,’ ” said Mark Burgat, an American Heart Assn. lobbyist. “It seemed a shame to make a person think twice about whether they were going to get into trouble for using one of these things.”

Some high-profile places, including Sacramento’s Arco Arena, expressed interest in deploying defibrillators if they could get some liability protection, Burgat said.

The law, sponsored by Republican Assemblyman Bill Leonard of San Bernardino, passed the Health Committee with unanimous support but died in the Judiciary Committee on May 5. The six Republicans voted for it, but nine Democrats abstained and Democratic Assemblywoman Diane Martinez of Alhambra voted no.

Republicans generally favor laws protecting businesses from lawsuits. Burgat said the Democrats gave in to what he said was last-minute pressure from trial lawyers, a traditional party ally.

“I love the American Heart Assn., but that’s a bunch of bull,” said Martinez. She said supporters didn’t make a case for why the law was necessary. She also said she was troubled by the breadth of the bill.

“Why is there a blanket immunity and why isn’t there any training on it?” she said.

California’s Good Samaritan law protects people from lawsuits if they render medical care in an emergency situation. Yet state health code provisions specifically require that anyone who uses a defibrillator must be trained at least four hours.

Rick Simons, president of the Consumer Attorneys of California, said the group lobbied against the legislation because it would have essentially granted legal immunity to people who violated state regulations requiring training.

Yet defibrillator advocates argue that the California training regulations are typical of laws that haven’t kept pace with technology, and that the new defibrillators are easier than performing cardiopulmonary resuscitation.

Some critics insist that the automated devices are not 100% foolproof and could, theoretically, actually give people a heart attack. Proponents say the machines are more likely not to shock people who really need it, rather than the reverse.

Though California’s bill is dead for now, Burgat said supporters will try to reintroduce it. In the meantime, advocates say the lack of liability protection is keeping the devices shelved and costing lives.

“I can’t give them away,” said Kozina, whose group has purchased 30 defibrillators in the hope of spreading them around to malls and offices.

Kozina in particular finds the defeat of the bill galling. As part of his effort to get people used to the idea of having defibrillators around, his nonprofit organization--the Public Access Defibrillator League--raised money to install them inside the state Capitol, mere minutes from the Assembly floor.

“The same people who won’t let their citizens have it have four of them,” said Kozina.

If lawyers have an interest in fighting liability protections, manufacturers have a stake in blanketing the country with the devices. The industry is largely dominated by Physio-Control; SurVivaLink Corp. of Minneapolis; and Heartstream Inc. of Seattle, which was recently acquired by the Hewlett-Packard Co.

A Major Push to Broaden Access

The big manufacturers also are financing various pilot projects around the country and routinely issue press releases announcing dramatic rescues with their particular brands. Kozina gets his machines at a discount from SurVivaLink, and both the company and Kozina helped the heart association lobby for the legislation.

Right now the industry is focusing on getting the nation’s 260,000 police cars to carry defibrillators, and to make them as de rigueur as fire extinguishers in places where there are concentrations of people.

The market’s ultimate potential is so big that it defies estimate, said Ben Andrew, medical technology analyst with Vector Securities International in Deer Park, Ill. He said portable defibrillator sales went from about $25 million in 1996 to nearly double that last year, and should hit $100 million next year.

In an effort to assuage liability anxiety, Physio-Control even promises to indemnify anybody who buys its devices. The industry is also promoting the idea that it may be more legally hazardous not to have a defibrillator on the premises. A court ordered Lufthansa last year to pay $2.75 million for failing to provide timely medical care to a man who had a heart attack aboard a flight, and United Airlines this year said it would add defibrillators to its planes after it was sued in a similar case.

Yet for each defibrillator put in an airplane or police car, somebody has to assume responsibility for using it. Many police shy away from performing such things as CPR.

“I don’t think you want to lose sight of a primary purpose of the police officer, which is to catch a perpetrator or to prevent a crime,” said Jim Pasco, executive director of the Fraternal Order of Police. “We don’t want to be the all-around handyman.”

Police in Muncie, Ind., refused to take part in a defibrillator experiment because of liability worries, until an off-duty officer had a heart attack and was saved by a sheriff’s deputy who was carrying one, said Mary Newman, coordinator of the Indiana project.

Burgat said many paramedics in California don’t carry defibrillators and he’s not aware of any police officers who do, mainly because the state requires too many hours of training.

Utah recently waived older public safety training requirements and has begun distributing the devices to state police. Rhode Island also has begun training state police in defibrillator use. Florida, the nation’s leader in public-access defibrillation, plans to put one in each of its 1,800 highway patrol cars.

Some critics say there is no evidence that putting a defibrillator in every police car--or in every building, for that matter--is worth the cost.

“There’s a bandwagon mentality that is driving this issue,” grumbled Dr. Arthur Kellerman of Emory University in Atlanta. “We have a general fascination in American medicine that if something is neat and works and does great stuff, it ought to be promoted without regard to the costs or the trade-offs.”

The devices require maintenance and can be misused, said Kellerman, and patients who are defibrillated need a whole range of medical treatment to aid their recovery.

He said there is little good scientific evidence that peppering a community with defibrillators works. For every successful increase in survival rates in cities such as Seattle and Rochester, Minn., where defibrillators were put in police cars, there are places such as Cincinnati and Memphis, where the impact was negligible.

The first and perhaps only California community to embrace the concept of public-access defibrillation is Palm Springs, where the Institute of Critical Care Medicine has distributed nearly 50 machines to golf courses, gated communities, senior citizen buses, country clubs, museums and a mobile home park. Hundreds of average people were trained to use them.

The results? After investing more than $100,000 over more than three years, the devices have been used eight times and saved two lives, said Gad Amith, director of the institute’s Early Defibrillation Project.

Was it worth it? Amith said the community would need hundreds of the machines to account for the randomness and suddenness of heart attacks.

“Some people take the romantic point of view that you can’t put a price on human life,” he said. “But, yes, you can. The cost of doing this in terms of possible gain, I got to tell you, it’s not good.”

The American Heart Assn. is planning to begin a definitive study later this year. It intends to distribute defibrillators to 300 stores, health clubs, trailer parks and other places, then compare the impact with survival rates in 300 comparable places without defibrillators.

Kellerman and other skeptics say the association should wait for the study results before promoting defibrillator deployment, which he said saps money from other programs, such as heart disease prevention. Proponents say the devices are so effective that getting them out into the mainstream is only common sense.

“How many studies were done on the safety of fire extinguishers?” Kozina said.

Widespread Home Use Deemed Imminent

The fire extinguisher analogy is one that defibrillator devotees reach for repeatedly. The industry would like nothing better than to make defibrillators a fixture in the home, where nearly 80% of heart attacks occur.

“I can guess in five to 10 years you will probably be able to buy one of these things at Wal-Marts,” said Kevin O’Grady, western sales manager for SurVivaLink.

Critics, though, point out that studies done in Seattle of defibrillators placed in homes found that some people weren’t able to collect themselves in time to save a loved one. Still, scientists are already working on the next generation of even more user-friendly defibrillators, including cheap disposable devices and lightweight models that could be worn like a vest. Others would automatically dial 911.

University of Arizona Dr. Terence D. Valenzuela said he believes widespread home use of defibrillators is imminent. He is so sold on the devices that he bought one for himself.

“I trained my kids to use it when they were 8 and 9 1/2,” he said. “I’m perfectly confident they can employ it.”

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

In a Heart-Beat

How one portable defibrillator works:

1. Electrodes placed on patient’s chest.

2. Unit turned on.

3. “Analyze” button pressed.

4. Unit displays “Shock advised,” or “No shock advised.”

5. If shock advised, “shock” button pressed and preset charge of electricity is delivered.

On/off button

Display screen

Analyze button