The company designed Guardian to improve the long-term management and outcomes of recurrent vents in high-risk patients who have survived one or more heart attacks. It alerts patients to rapidly progressive ST-segment deviation associated with coronary occlusion.
Eatontown, New Jersey-based Avertix presented the data at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. The study found an increase of more than 150% in new administration or titration of medications related to rate and rhythm normalities. These occurred in patients with activated Guardian alarms, compared to those with the alarms turned off.
Guardian, an FDA-approved implantable system, alerts patients in real-time of abnormal heart rates and rhythms. It also provides a recent history of intracardiac recordings. Avertix shared data from the first 12 months of each subject, with Dr. Andrew J. Kaplan presenting at TCT. Kaplan serves as an electrophysiologist and director of electrophysiology at Phoenix Heart, Vein and Vascular.
“This data has provided us with valuable insights into addressing the care needs of high-risk Acute Coronary Syndrome (ACS) patients,” said Kaplan. “Our findings demonstrate that the use of the Guardian System, with its continuous intracardiac monitoring and patient-alerting capabilities, offers physicians a powerful tool to proactively manage cardiac events, enabling appropriate medication management as part of providing responsive, long-term care.”
More about the Avertix ALERTS trial
ALERTS evaluated the safety and efficacy of the Guardian implantable cardiac monitor in 907 patients. In addition to assessing acute coronary syndrome (ACS) events, the trial collected data on medication usage and adjustments.
Patients with active Guardian alarms exhibited an increase in new medication prescriptions or adjustments. Avertix reported 29% receiving changes, compared to 13.2% of patients without active alarms.
The study observed no differences concerning antiplatelets, anticoagulants, antihypertensives, or other non-cardiac medications. Avertix said the correlation comes from the notion that poorly regulated AFib rates and elevated sinus rhythm rates may relate to increased ischemia and decreased left ventricular (LV) function.
“Improving medical management of rate and rhythm irregularities presents the prospect of better long-term outcomes and a reduction in downstream sequelae for ACS patients,” Avertix says. “The forthcoming post-market studies for the Guardian System will provide further evaluation of these findings.”
