CDU Canadian Correspondent

A Canadian company has created a device that it says can detect a heart attack up to eight minutes before a patient experiences symptoms of the attack, then can alert emergency medical staff and direct them to the patient's exact location. The Vital Positioning System (VPS), developed by Medical Intelligence (Quebec City, Quebec), combines a digital wireless ECG, artificial intelligence and telecommunications technology in a single belt worn around the patient's thorax. President Louis Massicotte told Cardiovascular Device Update that the idea for the VPS came to him one day while he was jogging. "Just before I went jogging, my wife said, 'Louis, I'm not sure you're in good shape. Maybe you should go slowly.' And then I got this idea as I was running that I could create an automatic alert for cardiac patients."

The VPS is equipped with artificial intelligence software that couples data for normal and abnormal heart conditions from the general population with baseline data collected from the individual patient. This enables emergency medical staff to distinguish non-threatening anomalies in a patient's heart rhythms from more serious changes that can lead to myocardial infarction and other serious heart conditions. "It's a self-learning system," Massicotte explained. "If your heart is used to living with a certain kind of arrhythmia every day, the system will understand that this kind of arrhythmia doesn't need any kind of alert. The system adapts itself to you and your heart. And the more you wear it the more it knows what would constitute an alert for you."

Once the cardiac activity sensors in the VPS belt detect advance signs of a cardiovascular event, it transmits these by cell phone or pocket PC to emergency services personnel as far as 60 miles away. A small global positioning system (GPS) and a transmitter enable staff to pinpoint the patient's location within 30 feet, monitor the patient's heart activity remotely on screen and talk to the patient through a two-way microphone. Sylvain Plante, MD, a cardiac surgeon, told CDU that medical staff are then able to get immediate answers to key questions. "How is he doing is he experiencing any symptoms? Does he have someone with him? It's as if the patient were connected to a monitor in the intensive care unit 24 hours a day, except that he's sitting at home or is out for a walk."

Plante said a rupture of atherosclerotic plaque that obstructs the blood flow in the affected artery triggers specific electrocardiographic changes that are several minutes ahead of symptoms, or signs of trouble in heart rate variability, that can lead to death. Last year, Plante was approached by Medical Intelligence to conduct an animal study to see if the VPS would accurately capture the lag time between the first changes in a patient's heart and actual heart attack. "If we can cover that gap with such a device then we could provide patients with rapid access to care," he said.

Patterns of acute myocardial infarction (AMI), typical arrhythmias and other conditions not related to heart attack formed part of the informational database for Plante's animal model. He used that information to simulate arrhythmias and MIs. By inflating an angioplasty balloon within an animal's artery and blocking the flow of blood, he was able to produce "a good imitation of a heart attack." The VPS also provided the monitor with very clear images of the changes occurring prior to the actual onset of heart attack. "Our objective was to test the capacity of the device to detect those early electrocardiographic changes that occur at the outset of heart attack," he said. "We wanted to see if the system was able to record, but also send the information. It did just that."

While the device has potential for patients who have already had a cardiac event, who live alone, who have poor heart function, or who are on waiting lists for bypass surgery, Plante believes it could have broader applications. It could be used to diagnose palpitations and arrhythmias in people who have occasional symptoms and for whom existing 24-hour monitors don't work, he said. A subcutaneous implantable version of the VPS, currently being developed at Medical Intelligence, also could track the movements of autism and Alzheimer's disease patients using the GPS technology. "Or for parents of those kids with severe allergies to bee sting or to peanuts and who are suffocating because of a spasm in the upper airway," Plante said. "After a few seconds it would translate into some rhythm trouble, so you would be able to detect that and say 'Oh, oh, there's something going on with my kid.'"

For now, Massicotte is content to market the VPS for cardiac use only. In the past year, he and co-inventor Jean-Francois Montplaisir have demonstrated the device for emergency 911 services and cellphone and alarm system companies across Canada. So far, the most encouraging response has been from emergency services staff and cardiologists in Europe, so much so that Massicotte plans to test commercial appetite for the device there before introduction to the U.S. market. "We don't have a distribution partner for the moment, but we don't know yet if we'll need it because the reaction is very good everywhere we go."

Massicotte has pegged the VPS purchase price at below $1,600 in the U.S. and expects to win Canadian, European and FDA approvals for the device within six months.