Medtronic has announced that its investigational EV ICD system—a defibrillator with the lead placed under the breastbone, outside of the heart and veins—achieved a defibrillation success rate of 98.7% and met its safety endpoints in a global clinical trial.
Findings from the Extravascular implantable cardioverter defibrillator (EV ICD) pivotal study were presented as late-breaking science at the European Society of Cardiology (ESC) congress (26 – 29 August, Barcelona, Spain) and simultaneously published in the New England Journal of Medicine. Worldwide, the EV ICD system is investigational and not yet approved for sale or distribution.
The Medtronic EV ICD system is designed to treat fast heart rhythms that can lead to sudden cardiac arrest (SCA), while avoiding certain risks of traditional, transvenous ICDs because its lead is placed outside the heart and veins, under the sternum using a minimally invasive approach. Placing the lead in this location is designed to help avoid long-term complications that may be associated with leads in the heart and veins, such as vessel occlusion and risks for blood infections.
The lead is connected to a device that is implanted in the left mid-axillary region. Clinical trial participants received the same therapies provided by traditional ICDs, including defibrillation, anti-tachycardia pacing (ATP), and back-up pacing therapies with this single implanted device that is similar in size, shape, and longevity to traditional ICDs.
“We are very encouraged by the high defibrillation effectiveness and strong safety profile of the EV ICD system seen in the study, as we look to deliver less-invasive treatment options for patients at risk of sudden cardiac arrest,” said Ian Crozier (Christchurch Hospital, Christchurch, New Zealand), who presented the results at ESC Congress 2022. “These results demonstrate the potential for this novel technology to be used as a safe, successful approach for patients with life-threatening arrhythmias.”
In the study, the device’s effectiveness in delivering defibrillation therapy at implant was 98.7% (298 of 302 patients), surpassing the prespecified performance goal of 88%.
Further, the efficacy of ATP in the EV ICD study was comparable to ATP efficacy in transvenous defibrillators. In total, 33 shocks were avoided by having ATP programmed “on.”
The study also exceeded its safety endpoint: at six months, 92.6% of patients (Kaplan-Meier estimate) were free from major system and/or procedure-related major complications such as hospitalization, system revision, or death (compared to the performance goal of 79%; p<0.001). There were no major intraprocedural complications, nor any unique complications observed related to the EV ICD procedure or system (compared to transvenous and subcutaneous ICDs).
The EV ICD Pivotal study is a prospective, multicentre, single-arm, non-randomised, pre-market clinical study that assessed the safety and effectiveness of the Medtronic EV ICD system for patients at risk of sudden cardiac death. The EV ICD Pivotal study enrolled 356 patients at 46 sites in 17 countries in North America, Europe, the Middle East, Asia, Australia and New Zealand. Medtronic has received FDA approval for a Continued Access Study while the agency reviews the company’s EV ICD pre-market application.