Thomas Cox has had two cardiac emergencies in the last three years.
Cardiologist Allan Murphy implants an experimental
device in Thomas Cox's chest.
An experimental device implanted in his chest Wednesday might help alert the 51-year-old Newport News resident if the next emergency is on the way.
Cox is the first person at Riverside Regional Medical Center — and the first in Virginia — to participate in a clinical trial of a new implantable cardiac monitor and alert system.
Riverside was one of 14 sites chosen to participate in the nationwide AngelMed Guardian system trial. Fewer than 50 patients across the U.S. have received the device, said Maurice Talbot, an AngelMed field clinical engineer.
The AngelMed Guardian device is surgically inserted in a patient's chest like a pacemaker. The device detects, analyzes and stores information about Cox's heart. If something's wrong, the device vibrates and sends an alert to a pager-like gadget that Cox is supposed to keep with him at all times. The pager will light up and beep once if Cox should see his doctor and five times if it's an emergency.
Every year, more than a million people in the U.S. have heart attacks, according to the National Institutes of Health.
But patients often don't go to the hospital until about three hours after symptoms start, and about 300,000 people die before reaching the hospital, said Dr. Allan Murphy, a cardiologist and lead investigator for the study at Riverside.
That's because many people don't realize that they're having a heart attack. Heart attacks don't always feel like a severe, crushing pain across the chest. Mild symptoms could be mistaken for a pulled muscle or indigestion, Murphy said.
"Heart attacks can be sneaky," he said. "I often tell folks you don't get an invitation in the mail."
Ideally, the system can also give peace of mind if someone's experiencing symptoms but the system tells them nothing's wrong, Murphy said. That way, they won't have to go through the barrage of tests that easily cost $5,000 or more to determine if it's a heart attack.
"If this brings in people early, it will save lives and save money," he said.
The system has received Food and Drug Administration clearance for clinical trials, but not for general use yet. This clinical test will examine the system's effectiveness, and it might take years before it's considered for general use in the U.S., Murphy said.
The system has already been approved for commercial use in Brazil, said Marcia Makoviecki of Angel Medical Systems, the New Jersey-based company behind the product.
Risks are expected to be similar to pacemaker surgery, Murphy said.
Riverside will try to enroll about two dozen patients in the study, which is funded mostly by the company. A good candidate is someone who has had a heart emergency in the last six months and who's at high risk of having another, said Virginia Oehmann, a registered nurse and research coordinator for Riverside's trial.
That's why Murphy asked Cox, who had a heart attack in mid-June, if he wanted to participate in the study.
"I said yeah," said Cox, who works as a coronary care unit secretary at Riverside. "Working in a heart department, I see this every day."
Cox was caught off guard when his first cardiac emergency struck in early 2006. He wasn't feeling well driving to work, but didn't think anything of it until co-workers said he looked pale. His blood pressure was checked and he underwent an electrocardiogram, which reads the electrical activity of the heart.
"The next thing I knew, I was in the ER," he said.
From the emergency department, he went to the cardiac catheterization lab to have his heart examined. The doctor found a blockage and put in a stent.
Afterward, Cox changed his diet — no more two or three helpings at mealtime — scaled back on the cigarettes and started exercising. But it doesn't take long for old habits to return, he said.
"Sometimes you have to answer the phone a few times before it's a wake-up call," he said. "The last one was a wake-up call."
In mid-June, he had a heart attack. He had a severe headache and at first thought it was a stroke. He told his wife to take him to the emergency department. That's when the second stent went in.
"The last one was not pleasant," said his wife, Sharon Thomas. "I was real scared."
It was a harrowing drive to the hospital in the rain, with Cox beside her telling her she wasn't going fast enough.
"From the experience we had last time, I think it is a wise thing to do," she said of the implantable device.
On Wednesday afternoon, after medication lulled Cox to sleep, Murphy made a 2- to 3-inch incision and began cauterizing a pocket beneath Cox's skin to house the device.
He attached a pacemaker lead, which is a long wire covered with rubbery insulation, to Cox's heart. Then he connected the lead to the cardiac monitoring device and flushed the wound to ward off infection.
Murphy finished by stapling the wound shut. The procedure took a little more than an hour.
The device won't be turned on for another week or so, until Cox has had a chance to heal. It may not be turned on for six months, if he's picked to be part of the control group, Oehmann said.
The battery will wear out, just like a pacemaker battery does, which will call for another surgical procedure to replace the battery in a few years, she said.
Another heart attack could happen, but it depends on him. He has to exercise and watch what he eats, Cox said.
And he hopes the device will give him some peace of mind.
"I was telling someone the other day, 'I can't go to the ER every time I have chest pain. I'd be in the ER every day,'" Cox said. "This will help set my mind at ease."
One daughter is in college now. Another graduates from high school next year. "I'd like to be around for a while."
Published: August 26, 2009