Medtronic's Aurora EV-ICD system, an extravascular implantable cardioverter defibrillator, has demonstrated sustained long-term safety and efficacy in patients at risk of sudden cardiac death. The results, presented at the 2024 ESC Congress by Dr. Francis Murgatroyd of Kings College Hospital, London, underscore the device's ability to deliver defibrillation, anti-tachycardia pacing (ATP), and backup pacing therapies while avoiding risks associated with traditional transvenous ICDs.
Pivotal Trial Results
The global pivotal trial enrolled 356 patients across 46 sites in 17 countries. The study assessed the Aurora system's safety and effectiveness. Primary results, previously published in The New England Journal of Medicine, have been sustained over an average follow-up of 30.6 months. The device is implanted below the left armpit, with the Epsila defibrillation lead placed under the breastbone.
"The final results from the EV ICD pivotal trial confirm the ongoing safety of the procedure and system and consolidate the benefits of the extravascular implantable cardioverter defibrillator," said Dr. Murgatroyd. He also noted the increased evidence for the effectiveness and tolerability of anti-tachycardia pacing, which offers patients a less painful solution and improved quality of life.
Anti-Tachycardia Pacing (ATP) Success
The data revealed that ATP was successful in 77% of episodes (37 out of 48), aligning with transvenous ATP success rates. The EV-ICD effectively terminated ventricular tachycardia/ventricular fibrillation (VT/VF), achieving 100% shock success for discrete spontaneous episodes. ATP utilization significantly increased throughout the study, with 81.2% of patients having ATP programmed on at 24 months. No patient with successful ATP had the therapy subsequently turned off.
In 299 patients with successful implants, 24 experienced 82 spontaneous arrhythmic episodes appropriately treated with ATP only (38), shock only (34), or both (10). The study reported a low major complication rate and high success rate for appropriate therapy. Investigators noted that nearly half the episodes avoided shocks due to ATP availability.
Patient Quality of Life
Medtronic also reported positive patient-reported quality of life (QOL) metrics, evaluated through the Florida Patient Acceptance Survey. EV-ICD patients reported fewer body image concerns and less device-related distress from baseline to six-month follow-up. They also indicated greater overall acceptance of their ICD compared to subcutaneous ICD patients.
Industry Impact
"The final results of the EV ICD Pivotal Trial presented at ESC 2024 underscore the longer-term benefits for patients at risk of sudden cardiac death who receive a Medtronic extravascular defibrillator," said Dr. Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business at Medtronic. He emphasized the company's commitment to creating innovative products that provide device therapy with the advantages of transvenous defibrillators while remaining outside the heart and vascular space.
Medtronic is also conducting a global post-approval registry across more than 125 sites for the Aurora EV-ICD system, expecting to enroll a minimum of 500 patients with follow-up data collected throughout the device's lifetime. The FDA approved the Aurora EV-ICD MRI SureScan in October 2023.
