Dr. Francis Murgatroyd of Kings College Hospital, London, presented the results at the 2024 ESC (European Society of Cardiology) Congress.
The medtech giant said the study evaluated its Aurora EV-ICD system. Aurora delivers defibrillation, anti-tachycardia pacing (ATP) and backup (pause-prevention) pacing therapies. It features a similar size, shape and longevity to traditional transvenous ICDs. However, the implant goes below the left armpit with the Epsila defibrillation lead placed under the breastbone. This helps avoid certain risks associated with transvenous ICDs.
Aurora also features anti-tachycardia pacing (ATP), a safe and effective feature for terminating ventricular tachycardia (VT). ATP restores the heart’s normal rhythm, briefly delivering pacing pulses to the heart at a faster rate than the tachycardia.
Medtronic received FDA approval for the Aurora EV-ICD MRI SureScan extravascular defibrillator in October 2023.
The EV ICD pivotal trial, a prospective, multicenter, single-arm, non-randomized, pre-market clinical study, assessed the safety and effectiveness of the Aurora system for patients at risk of sudden cardiac death. Investigators enrolled 356 patients across 46 sites in 17 countries across North America, Europe, the Middle East, Asia, Australia and New Zealand.
Investigators published primary results in The New England Journal of Medicine. Medtronic says it saw previously reported safety and effectiveness results sustained out to 18 months.
“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 Murgatroyd. “We also now have increased evidence for the effectiveness and tolerability of anti-tachycardia pacing, rather than just shocks.
“This is a fundamental feature built into the extravascular ICD, which offers my patients a less painful solution, improved quality of life, and peace of mind, knowing they are protected against sudden cardiac death.”
A look at the data shared by Medtronic
The final results showed that ATP proved successful in 37 out of 48 episodes (77%). That fell in line with transvenous ATP success. The EV-ICD effectively terminated ventricular tachycardia/ventricular fibrillation (VT/VF), delivering 100% shock success for discrete spontaneous episodes.
Medtronic also said ATP utilization increased significantly through the duration of the study follow-up (an average of 30.6 months). ATP, which is nominally programmed off, was reported as programmed on in a majority of patients (81.2%) at 24 months. No patient with successful ATP had the therapy programmed off subsequently.
In 299 patients with a successful implant, 24 patients experienced 82 spontaneous arrhythmic episodes appropriately treated with either ATP only (38), shock only (34) or both (10). The EV-ICD demonstrated a low major complication rate, Medtronic said, and a high success rate for appropriate therapy. Investigators reported avoided shocks in nearly half the episodes due to the availability of ATP.
Medtronic also reported positive patient-reported quality of life (QOL) metrics and patient acceptance of the device. Investigators evaluated this through a standardized, device-specific quality of life survey, 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 reported greater overall acceptance of their ICD than subcutaneous ICD patients.
“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. “These findings highlight our commitment to continuing to create innovative products that allow physicians to provide device therapy with the advantages of transvenous defibrillators, while remaining outside the heart and vascular space.”
Medtronic also has a global post-approval, prospective, non-randomized, observational, multicenter registry across more than 125 sites for the Aurora EV-ICD system. It expects to enroll a minimum of 500 patients, with follow-up data collected through the lifetime of the device.
