Benefits of the GUARDIAN's real-time alerts
Despite education and public healthcare campaigns patients still delay going to the hospital when they experience symptoms of a possible heart attack. The GUARDIAN monitors a patient’s heart 24/7 and alerts the patient upon detection of signals related to acute coronary syndrome (ACS) events alerting the patient to seek medical care without delay. By getting to the hospital quickly the patient is likely to have better outcomes.
ALERTS1,2 GUARDIAN pivotal randomised study for safety and efficacy of the GUARDIAN and highlighted a broad range of benefits to patients, clinicians and the healthcare system.
The GUARDIAN reduces time to door
90% of MI patients presented symptom to door under 2 hours. The overall reduction in symptom to door time was reduced from a median of 8 hours to 1.7 hours in the treatment group.
With STEMI and NSTEMI patients – a reduction was seen from a median of 12.7 hours to 1.6 hours2.
The GUARDIAN detected 42 silent ACS events in the study, that is an ASC event where the patient did not experience any symptoms. These patients arrived to door in a medium time of 1.4 hours, prompting early myocardial saving treatment.
The GUARDIAN reduces myocardial damage
After an alert and once the patient reaches the Emergency Department accepted international cardiac clinical pathways are implemented. The GUARDIAN reduces delays to treatment to improve outcomes for patients. In the ALERTS study GUARDIAN patients that had an occlusive event were less likely to have new onset LV dysfunction at discharge (35% v 4%).
Detects other co-morbidities
During the ALERTS study, the GUARDIAN revealed a need for a therapeutic device in 5% of study patients with an overall detection of new serious medical conditions in 8.68% of the study population1.
In addition to the EMERGENCY alarm, the GUARDIAN also has a SEE DOCTOR alert which indicates a detection of cardiac activity that should be evaluated by a medical professional.
Reduces impact on hospital resources
In the ALERTS study, it was demonstrated that the GUARDIAN prompted patients to seek medical attention for asymptomatic ACS events. There was a 26% reduction in the False Positive Rate and unnecessary tests compared to patient symptoms as a trigger for ED visits.
References:
1. Gibson, M., Holmes, D., Mikdadi, G., et al. Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction. JACC. 2019; 73(15):1919-1927.
2. Holmes, D.R., Krucoff, M.W., Mullin, C., et al. Implanted Monitor Alerting to Reduce Treatment Delay in Patients with Acute Coronary Syndrome Events. JACC. 2019; 74(16):2047-2055.