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Widow: CPR machine unknowingly used on husband

Tuesday, November 16, 2010

It's a story of medical progress versus patient consent. A Houston woman who lost her husband to sudden cardiac arrest this past summer says she was just starting to remember his smile when a letter arrived from the city of Houston. Opening the envelope opened a host of questions about a medical study that you, too, could be a part of without ever knowing it.

"He loved me unconditionally," Linda Todar said. "He gave me the happiest eight-and-a-half years of my life."

A wedding video, pictures and memories are all that Linda Todar has left of her husband, Richard Todar. After meeting late in life, they had only been married six-and-a-half years when Richard Todar had a massive heart attack.

"I got on that side of the bed, dialed 911, stuck the phone on speaker and put it on my shoulder and started doing CPR," Linda Todar said.

Linda Todar performed CPR on 77-year-old Richard Todar, who had had three previous heart attacks, until paramedics arrived. As they worked on him, Linda Todar says she heard a strange sound.

"The noise an iron lung makes, that's what I kept hearing," she said.

Richard Todar was transported to the hospital, but didn't make it. Now, Linda Todar is furious, not because of Richard Todar's death, but what she found out afterward.

"I was stunned. I was in complete shock," she said.

Three weeks after his death, Linda Todar received a rather blunt letter from the city of Houston informing her that her husband hadn't been given traditional CPR.

Instead, paramedics had used an automated CPR machine called AutoPulse. The FDA-approved device has a constricting band and a half backboard to be used during advanced cardiac life support.

The maker, ZOLL, touts its consistent compressions without interruptions, even while a patient is being transported. Houston is one of five sites worldwide involved in a study comparing it to traditional CPR.

"We know it's at least as good," Houston Fire Department Spokesman Pat Trahan said. "What we want to find out is in our workers' working circumstance, which one is better.

In most medical studies, patients must consent to participate. Of course, Richard Todar couldn't have given consent. In some emergency cases, especially when patients are unconscious, something called "waived consent" is used.

Federal regulations call for a strict series of steps before a study can begin -- a board of ethics review, community input and public advertising. In this case, consent is not sought from family members either.

"CPR must be initiated immediately. To seek informed consent would delay the intervention to that individual and therefore would be unethical," UT Health Dr. Anne Dougherty said.

Dougherty says the chances of a cardiac arrest patient surviving to the ER are between two and 15 percent. Of those, only half make it out of the hospital.

"That's a lousy outcome," she said. "We need to do better."

UH Director of Health Law Dr. William Winslade says waived consent studies are justified, but family members need to be included in the process after the fact.

"Anybody that is related to a person that was a subject without their knowledge needs to be treated with compassion, respect and understanding," Winslade said.

Trahan says the letter describing the study is being reworked to be more compassionate. The study is not. And Houston, he says, will benefit from it.

"We have gone in just the past 10 years from a survival rate of nearly one in five, to one in three. That's because we care enough to gather the information about our experiences and dealing with resuscitation of patients and trying to find out how to do better," Trahan said.

Linda Todar isn't convinced AutoPulse was better for her husband.

"This was my husband. It should have been my decision, and they didn't give me that option, and he would have been livid," she said.

Since 2008, almost 3,800 sudden cardiac arrest patients have been treated with AutoPulse machines here in Houston. The study is expected to end early next year. Find out more information about the machine at Circtrial.com.

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