Medtronic Has Positive Long-Term Extravascular ICD Study Data

Medtronic shared long-term results from its global Extravascular Implantable Cardioverter Defibrillator (EV ICD) pivotal trial. They were presented as late-breaking clinical science at this year’s ESC (European Society of Cardiology) Congress.
 
The Aurora EV-ICD system is implanted below the left armpit with the Epsila defibrillation lead placed under the breastbone, helping avoid risks associated with transvenous ICDs.
 
The EV ICD trial found that the device’s anti-tachycardia pacing (ATP) was successful in 37 of 48 episodes (77%), which is in line with transvenous ATP success. The EV-ICD effectively stopped ventricular tachycardia/ventricular fibrillation (VT/VF), with 100% shock success of discrete spontaneous episodes.
 
ATP usage also grew significantly through the duration of study follow-up (average 30.6 months), Medtronic reported.
 
ATP, which is nominally OFF, was reported as programmed ON in most patients (81.2%) at 24 months. In 299 patients with a successful implant, 24 patients experienced 82 spontaneous arrhythmic episodes that were appropriately treated with either ATP only (38), shock only (34), or both (10). The EV-ICD showed a low major complication rate and high success rate for appropriate therapy, with shocks avoided in nearly half of the episodes due to ATP’s availability.
 
The trial also examined quality of life metrics and patients’ acceptance of the EV-ICD. EV-ICD patients reported fewer body image concerns and less device-related distress from baseline to six-month follow-up, Medtronic said.
 
“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 Alan Cheng, MD, chief medical officer of Medtronic’s Cardiac Rhythm Management business. “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.”