This Clinician’s View opinion piece is written by Usman Siddiqui, MD, medical director of electrophysiology at AdventHealth Celebration.
Every year, more than 800,000 people in the United States experience a heart attack (myocardial infarction), and about one in five are silent, occurring without the patient’s knowledge. In addition, approximately 25% of heart attack survivors will experience a second myocardial infarction within five years of their first.
Avertix’s Guardian™ System, the first and only implantable device approved by the U.S. Food and Drug Administration (FDA) for use in patients who have had prior acute coronary syndrome (ACS) events and remain at high risk for recurrent ACS events, measures sustained ST-segment changes to help detect ACS events in real-time. This includes both silent and atypical symptomatic heart attacks. At AdventHealth Celebration, we became the first in Central Florida to successfully implant the Guardian System on June 13, 2023.
How the Guardian System Works
The Guardian System includes a cardiac monitoring and alerting device that is implanted using the same surgical procedure as a single chamber pacemaker. This is typically performed on an outpatient basis under conscious sedation. Once implanted, the Guardian starts collecting heart data every 90 seconds. About 10 to 14 days later, the patient comes in for a follow-up visit where the Guardian is programmed according to the signals it has collected. The device 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.
When the Guardian System detects a potential ACS event, it vibrates inside the patient’s chest and sends a message through a pager-sized accessory, alerting them to call 9-1-1. Upon arrival at the hospital, the patient’s physician 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. The device also detects non-emergency irregularities, sending the patient an alert to see their physician for a follow-up visit.
Improving Clinical Outcomes and Saving Lives
The Guardian System introduces a significant advancement in cardiac care, potentially transforming how we detect heart attacks.
We know that early identification and prompt treatment of a myocardial infarction is critical to achieving the best possible clinical outcome. Some of the specific benefits include the following:
- Detecting silent or asymptomatic heart attacks, which occur more often in women, diabetics and the elderly
- Improving how quickly patients experiencing a heart attack seek emergency care
- Providing patients with peace of mind and a sense of control knowing that their device will detect any signs of another ACS event
- Reducing false positive emergency room (ER) visits
I am excited to be involved in an innovative approach to cardiac care and look forward to witnessing how it can improve the well-being of patients in need of continuous heart monitoring.
