Spectrum Health Seeks to Be Among First to Offer Recently FDA-Approved Heart Attack Alert System
Spectrum Health was top enrolling site in clinical trials testing the device for detection of acute coronary syndromes
GRAND RAPIDS, Mich., Aug. 27, 2019 – An implantable monitoring device may benefit those suffering from high-risk cardiac disease and Spectrum Health hopes to be among the first in the nation to offer the treatment to its patients.
An acute coronary syndrome (ACS) event occurs when one or more of the coronary arteries supplying the heart with oxygen-rich blood becomes blocked. Because it is often difficult for people at risk of ACS events to know when they need to seek medical attention, the inventors of the AngelMed Guardian® System designed a system to notify patients when an ACS event may be imminent.
The Guardian System includes a cardiac monitoring and alerting device that is implanted like a pacemaker, which monitors the heart’s electrical signal 24 hours a day. The system can detect ACS events even when a person has no symptoms or has symptoms that are not typical.
David Wohns, MD, cardiology division chief at Spectrum Health, was principal investigator at the top enrolling site of the ALERTS study (AngelMed for Early Recognition and Treatment of STEMI), a multicenter, randomized trial of the device. ST-Elevation Myocardial Infarction (STEMI) is a very serious type of heart attack during which one of the heart’s major arteries is blocked.
“The study found that the alarms significantly reduced the time from onset of symptoms to arrival for treatment at a medical facility,” Wohns said. “And previous studies have shown that the more quickly we can offer treatment to the patient the greater the chances of survival.”
According to a 2018 report from the American Heart Association, of the 1.2 million annual heart attacks in the nation, roughly one third of victims will die within a year, and half of those will die before reaching the hospital. Delays in treatment contribute to the high level of mortality and morbidity from heart attacks.
“We know that each 30-minute delay in treatment equates to a 7.5 percent increase in mortality,” Wohns added. “So, time really is of the essence.”
Another factor complicating diagnosis and treatment is the poor reliability of self-reported symptoms of an ACS event. Symptoms such as chest pain are a poor predictor, with less than 20 percent of patients presenting to the emergency room having a true positive ACS event and more than one third of heart attacks having atypical or no symptoms.
The ALERTS study demonstrated a reduced rate over time of patient presentations without ACS events (false positives) and better identified asymptomatic ACS events, prompting the user to seek medical attention.
The Guardian System is designed with the Quadruple Aim of the Institute for Healthcare Improvement and National Institutes of Health in mind. These include: Improve Health Care by prompting treatment of undetectable silent symptoms, reducing symptom to door time and detecting other heart anomalies; Improve Clinical Experience by producing less stress when patients arrive for treatment earlier and having data for more informed decision-making; Improve Population Health by improving quality of life, increasing likelihood for exercise and lowering anxiety and improving sleep; and Reduce Cost by reducing false positive ED visits, reducing length of stay for acute events and by reducing costs associated with heart failure and chronic cardiovascular disease.
“We look forward to adding another tool to our arsenal in our continued efforts to provide the best care for our patients,” Wohns said.
The Guardian received U.S. Food and Drug Administration (FDA) Premarket approval on April 9, 2018.
Results of the ALERTS study were published April 23, 2019 in the Journal of the American College of Cardiology as Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction.
Spectrum Health System, a not-for-profit, integrated health system, is committed to improving the health and wellness of our communities. We live our mission every day with 31,000 compassionate professionals, 4,300 medical staff experts, 3,300 committed volunteers and a health plan serving 1 million members. Our talented physicians and caregivers are privileged to offer a full continuum of care and wellness services to our communities through 14 hospitals, including Helen DeVos Children’s Hospital, 155 ambulatory sites and telehealth offerings. We pursue health care solutions for today and tomorrow that diversify our offerings. Locally-governed and based in Grand Rapids, Michigan, our health system provided $585 million in community benefit in fiscal year 2019. Thanks to the generosity of our communities, we received $30 million in philanthropy in the most recent fiscal year to support research, academics, innovation and clinical care. Spectrum Health has been recognized as one of the nation’s 15 Top Health Systems by Truven Health Analytics®, part of IBM Watson HealthTM.