He hopes never again to experience those symptoms, and that just might be the case because in early March, the 69-year-old became the first person in Indiana to have implanted in his chest a new heart attack warning device. Lutheran Hospital is one of eight sites in the nation participating in the ALERTS clinic trials of the AngelMed Guardian System, made by Angel Medical Systems of Shrewsbury, N.J.
The implant, about the size of a heart pacemaker, sits near Clancy's heart, a wire from it threaded into the right side of his heart. The wire picks up the slightest changes in electrical activity before any symptoms are felt. A wireless pager-like device is worn on his belt or kept somewhere within 6 feet of his body and uses Bluetooth technology to pick up readings from the implant.
“When it detects something is wrong, there's a two-mode alarm on the pager. One is audio-visual with lights and sounds,” voicing one of two messages: “‘Call your doctor in the next day or two; or call 911.'”
The other alarm system is internal, with different vibrations emitted by the implant and felt by Clancy. So if he doesn't have the pager near, he still feels the warning vibrations in his chest.
Clancy knows the system is working. Soon after it was activated, he and his wife were awakened in the middle of the night by the vibrations and the “call your doctor in the next day or two” message.
“I could even hear the vibrations,” said Pat Clancy, Joe's wife.
They had been warned the system might need additional calibrating to ensure his normal heart rhythm and electrical activity were correctly programmed into the system.
The technology for AngelMed is not new, said Dr. Sree Karanam, Clancy's cardiologist, but previously cardiologists were looking at signals outside the heart, such as when someone wears a portable EKG Holter monitor. But signals from inside the heart are the most sensitive and earliest detection of an impending heart attack. It is not uncommon for physical symptoms to be felt an hour, sometimes longer, after the actual start of a heart attack.
“This is picking up signals even earlier than the biomarkers such as C-reactive protein,” Karanam said. Increased levels of the protein are found in the blood after a heart attack. “When there's damage to the heart muscle, the heart attack has already started and enzymes have been released.”
The Clancys, who will celebrate their 50th wedding anniversary this summer, say the early-warning system is giving them peace of mind.
“This is just incredible,” Joe Clancy said, noting when Karanam asked if he would consider participating in the study, “I thought, ‘God's kept me here for a reason. Maybe I can help someone else. ”
AngelMed was tested in Brazil and is now approved for use in that country. Spokeswoman Marcia Makoviecki said the company hopes to have 50 U.S. sites participating by year's end.
Clancy's heart attack resulted in placement of stents in three blocked arteries. The sales engineer for Habel Brothers is back at work because he did not ignore symptoms and got to the hospital right away. But that's not the case for many people, Karanam said, noting, “Well over a quarter of heart attacks are silent, especially in people who have diabetes.” Too often, noticeable symptoms are ignored.
Lutheran hopes to enroll 10 to 15 more patients in the study. Subjects must meet certain qualifications, including a history of at least one heart attack or angioplasty to open up a blocked artery. Patients can have diabetes, but not a very slow or very fast heart beat or be in kidney failure.
Cost for the system, implantation and monitoring is about $20,000, but Karanam said, “It's going to be cost-effective in the long run if (patients) come to the hospital sooner. Then you are preventing further damage to the heart muscle, and these people will be less prone to congestive heart failure.”