Who is Guardian for?
Guardian is indicated for use in patients who have had prior acute coronary syndrome (ACS) events, including heart attacks, and who remain at high risk for recurrent events.
How does it work?
Guardian monitors your heart 24-7 and alerts in real-time of ACS events, including heart attacks, by vibrating in your chest and providing audible and visual alerts on a handheld device
What is the Guardian?
The Guardian System
The Guardian System permits people at high-risk of ACS events to know when an ACS event may be occurring.
The Guardian System includes a cardiac monitoring and alerting device that is implanted using the same surgical procedure as a single chamber pacemaker. Unlike a pacemaker, Guardian continuously monitors your heart’s electrical signal for rapid changes that occur during resting heart rate which could indicate your heart muscle is not getting enough oxygen. The system can detect a heart attack even if a person has no symptoms or has atypical symptoms that are more prevalent in woman, elderly and diabetics. Atypical symptoms can be experienced as indigestion, shortness of breath, discomfort in the throat, jaw, neck, or arms without classic chest pain.
When the Guardian detects a potential ACS event, it vibrates inside your chest, alerting you that you need to call 9-1-1. Additionally, a pager-sized accessory will provide beeps and flashes, to inform you to take action.
Once you arrive at the hospital, your doctor can review the electrogram waveforms that caused the alarm along with other historical information collected by the Guardian. This information is reviewed with standard of care results to help inform on the best course of action in providing an appropriate treatment pathway.
Guardian Procedure
Once your Cardiologist has determined that the Guardian is needed, an implant surgery will be scheduled. The surgery is similar to implanting a pacemaker and includes surgically implanting a sensing lead into your heart and attaching it to the Guardian device. This is typically done on an outpatient basis under conscious sedation and the surgery should take about 1 hour. The Guardian will start collecting your heart data every 90 seconds. About 10 to 14 days later you will have a follow-up visit where the Guardian will be programmed according to the signals it has collected. The Guardian sets its ACS detection thresholds based upon each patient’s own heart signal normal profile so that ACS event detection is customized for each individual patient.
At the follow up visit you will be given an external patient alerting accessory and will be trained on what to do when patient notification occurs.
If you have an Emergency alarm you should call 9-1-1 to be transported to the ER for evaluation. A chest pain protocol will start from ambulance to admission to determine what tests and/or potential intervention will take place.
The Guardian can also provide a non-urgent “See Doctor” alert if there is a condition which requires attention but does not indicate a heart attack. For example, a See Doctor alert can occur if you forget to take your Beta Blockers since the Guardian will detect fast heart rates.
If you have an Emergency alarm you should call 9-1-1 to be transported to the ER for evaluation. A chest pain protocol will start from ambulance to admission to determine what tests and/or potential intervention will take place.
The Guardian can also provide a non-urgent “See Doctor” alert if there is a condition which requires attention but does not indicate a heart attack. For example, a See Doctor alert can occur if you forget to take your Beta Blockers since the Guardian will detect fast heart rates.
See Doctor alerts can also occur due to detection of arrhythmia, or other abnormal heart rate or heart rhythms which merit review by a doctor.
Guardian patients must return to their cardiologist every 6 months for a check-up to have data from the implanted device reviewed.
The Guardian has an expected battery life of 6 years. Typically surgical replacement of your Guardian uses the previously implanted intracardiac lead. The replacement procedure should take less than 1 hour.
Guardian patients must return to their cardiologist every 6 months for a check-up to have data from the implanted device reviewed.
The Guardian has an expected battery life of 6 years. Typically surgical replacement of your Guardian uses the previously implanted intracardiac lead. The replacement procedure should take less than 1 hour.
Two types of patient notification
Emergency alarm
Acute coronary syndrome event detected. Immediately call 9-1-1 for transport to emergency care.
See Doctor alert
An abnormal heart rate or heart rhythm has been detected. Call your doctor within 72 hours for an appointment.
Frequently Asked Questions
Wondering if the Guardian is right for you? Here are some of the most frequently asked questions and answers.