KNOXVILLE, Tenn. — The Baptist Heart Institute at Baptist Hospital of East Tennessee is the first and only medical facility in Tennessee, and one of only three facilities nationwide, to implant a new internal monitoring system that checks for signs of impending heart attack. Called the AngelMed Guardian® system, the device was developed to help reduce the time it takes patients to get to the emergency room.
The objective of the DETECT Feasibility Study is to provide a preliminary assessment of the safety and effectiveness the investigational Guardian® device. It works by monitoring the heart’s electrical signals for changes that indicate a heart attack. If the AngelMed Guardian system detects an abnormality, it will warn the person to seek immediate medical care. The AngelMed Guardian system can also warn the patient if the device detects problems that prevent it from working properly. In these situations, the patient will be alerted to visit their physician for an evaluation of the device.
Malcolm Foster, M.D., Principal Investigator for the DETECT study, is very excited about the trial. “If the Guardian system proves to be safe and effective, we may have a paradigm shift in the early detection and warning of heart attacks for high risk patients,” he said. “After the feasibility study, we look forward to participating in a large, multi-center trial.”
Maryville resident Donald Beltz, 65, was the fourth patient in Tennessee to receive the Guardian device. One month later, while watching the Super Bowl, the device warned of an impending heart attack. He immediately presented to Baptist Hospital where he was treated with a stent, preventing any heart damage.
Description of the Guardian System
The components of the AngelMed Guardian system are:
- A pacemaker-sized device to be implanted under the skin (known as the AngelMed Guardian IMD)
- An endocardial lead and lead adapter
- A pager-sized portable external alarm device (known as the EXD – External Alarm Device)
- A laptop computer that will be used by the doctor to program the device.
The AngelMed Guardian system is a diagnostic monitor that will be implanted under the skin in the upper left side of the chest in the same manner as a pacemaker. It will register the heart’s electrical signal (or “electrogram”) using a small wire positioned inside the heart (just like a pacemaker). Once implanted, it will continuously monitor the heart’s signal for anything unusual. If the monitor detects an abnormality, it will alert the patient to seek medical attention by vibrating gently underneath their skin - similar to a cell phone vibration. It will also send a signal to the EXD, which will then start beeping. Also, a light on the EXD will flash to indicate what kind of alarm is being signaled.
Even though the AngelMed Guardian system is implanted in the same manner and looks like a pacemaker, the use and implantation of the AngelMed Guardian system is considered experimental.
The Baptist Heart Institute has consented six patients for the DETECT Feasibility Study. A total of 20 patients nationwide have been enrolled the initial feasibility study, which is now closed.