Carmen Quinones wasn’t feeling good when she got home one day last month after getting some blood work done to monitor her diabetes.
She was short of breath and pale. She had to lie down.
Then her chest started vibrating.
About a year earlier, soon after her first heart attack, Quinones had a device implanted that would warn her when she was having another heart attack. Now, the alarm was going off, telling her to call her doctor. (If her heart problem had been more severe, a more urgent alarm with more vibrations would have told her to call 911.)
Her doctor sent the Woodbury, N.J., woman to the emergency department at Our Lady of Lourdes Medical Center in Camden, N.J. In short order, she was having a stent replaced. The old one was blocked.
Doctors later told her she probably would have had a heart attack in a day or so.
Quinones, 54, who emerged from the episode without new heart damage, was thankful that she was among those testing the experimental heart-attack alarm, known as the AngelMed Guardian System.
“I felt great, because that saved my life,” she said.
The day may come when high-risk patients will routinely be able to choose devices like the one Quinones has, sparing them from wondering whether every case of heartburn or pain in their chest is a heart attack. The warning systems, which include an internal electrocardiogram that monitors changes in heartbeats, may be particularly helpful for the thousands of patients who don’t have typical heart-attack symptoms and wait too long before seeking medical help.
Devender Akula, an electrophysiologist at Lourdes who was involved with the trial, said the experimental alarm brought “added peace of mind” for patients likely to have a heart attack, which occurs when a blockage in a blood vessel keeps the heart from getting enough oxygen. He sees it as a “big game-changer in the future.”
The study, which enrolled 1,020 patients, ended in July. David Keenan, vice president of clinical and regulatory affairs for Angel Medical Services, said the New Jersey company will begin its final data analysis in January. If the device gets FDA approval, it could be commercially available by 2015, he said. It is already in use in Brazil and Germany.
The AngelMed Guardian is implanted under the skin near the collarbone. Patients also carry a device about the size of a beeper. (Quinones puts hers in a little purse she wears around her neck.) When the heart shows signs of inadequate oxygen, the implanted monitor vibrates, and the exterior device shows a red or yellow light.
St. Jude Medical, an international medical-device maker based in St. Paul, Minn., has licensed the technology and is testing a version it added to its implantable cardioverter defibrillators (ICDs) – devices that shock the heart when its rhythm is dangerously out of whack. The company plans to enroll more than 5,000 people at up to 200 sites. Europe has approved the special ICDs.
“The beauty of this technology is that it has the potential not only to provide an early alert that a heart attack may be imminent, but it also may provide information that a heart attack has not occurred,” said Mark Carlson, vice president of global clinical affairs and chief medical officer at St. Jude.
Being able to rule out a heart attack is especially important for patients whose ICDs have shocked the heart, he said. Their rhythm problems may be caused either by electrical abnormalities or a heart attack. Knowing a heart attack has not occurred can spare patients from expensive tests and procedures, Carlson said.
Neither company would say what the price is likely to be if their device becomes commercially available, although Keenan narrowed it down to between $2,000 and $20,000.
Akula, who is also involved in the St. Jude trial, said that Brazilian records show a false positive rate with AngelMed of less than 5 percent and a false negative rate of less than 4 percent.
Keenan said that 1.2 million Americans have heart attacks each year, and 400,000 of them die. AngelMed is targeting the group most likely to have repeat heart attacks, including those with diabetes or kidney problems.
Many of those people, he said, have “miserable quality of life” because “they basically sit around waiting for the next one to happen.”
John Fontaine, an electrophysiologist at Drexel Cardiology who also participated in the AngelMed trial, said the device will be most useful for the 70 percent of heart-attack patients who don’t have traditional symptoms. They may have been having a heart attack for three or four hours before going to the emergency department. Heart damage can be minimized when patients get care within 90 minutes.
Fontaine said hospitals have gotten better at moving patients through the system quickly, but many patients still aren’t getting care fast enough.
“We haven’t found a way to accurately address the patient issue in terms of arriving at the hospital in a timely fashion.”