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Lucas Boersma, MD, PhD, discusses the 1-year results of the Enlighten study, highlighting effective defibrillation, low rate of complications, and high ATP success.
Medtronic’s Aurora EV-ICD system has demonstrated high anti-tachycardia pacing (ATP) success, effective defibrillation, and more in patients with dangerous arrhythmias, according to 1-year data from the Enlighten study, a Post Approval Registry of the device.1
These data were presented at Heart Rhythm 2026 in Chicago by Professor Lucas Boersma, MD, PhD, a cardiologist at St. Antonius Hospital Department of Cardiology and professor of cardiology at the Academic Medical Center, University of Amsterdam. The presentation built on the 6-month results presented at the Asia Pacific Heart Rhythm Society Scientific Session 2025. After the meeting, the editorial team at HCPLive spoke with Boersma in an exclusive video interview.1
00:00:01 Intro
00:00:08 Study Overview
00:00:54 Where does the EV-ICD fit?
00:02:45 Learning curves
00:04:56 Infection rates
00:06:26 Patient characteristics predisposing complications
00:07:28 Further refinement
00:10:01 Displacing S-ICD
00:12:43 Future innovation
“There are issues when you have to implant transvenous leads – they can become defective, there can be infections, you may have to remove the leads,” Boersma told HCPLive. “On the other hand, we already have the S-ICD, which is a subcutaneous ICD with the leads under the skin – but the downside of that is that there are no pacing capabilities. The EV-ICD is something in between, because it has all the diagnostic capabilities and the size and shape of a transvenous device, but it doesn’t have the lead in the vascular system.”
The Enlighten study is an ongoing global, prospective, observational, multi-site registry study conducted within Medtronic’s post-market surveillance platform. The trial aimed to confirm the safety and effectiveness of the EV-ICD in routine clinical practice following the device’s commercial release.2
Patients were eligible for inclusion if they were intended to receive or be treated with an EV-ICD device System and had been enrolled prior to the implant procedure. Patients who were or would be inaccessible to follow-up, as well as those currently enrolled in any concurrent drug and/or device study that could confound the Enlighten results, were excluded from the study.2
The study’s primary endpoint was complication-free survival rate, defined as 5-year Aurora EV-ICD major system-related complication-free survival >79%. Secondary endpoints included system and/or procedure-related complication-free survival, abnormal battery depletion complications, patient deaths, extracardiac pacing sensations, asystole pacing, lead location, and lead motion at implant, among others.2
A total of 787 patients were ultimately enrolled in the Enlighten study. In these patients, ATP successfully avoided 65 shocks in 22 patients, with a high termination rate (GEE-estimated success: 74.2%) consistent with both transvenous ICDs and the EV-ICD Pivotal Trial results. Additionally, the system displayed a low risk of complications, with 95.8% of patients free from chronic major system-related complications through 1 year and 100% of all spontaneous potentially lethal VT/VF episodes treated successfully.1
These benefits were also consistent across age groups – roughly 17% of enrolled patients were ≥65 years old, and 83% were <65. Boersma and colleagues noted no difference in safety or effectiveness between age groups.1
Boersma did address a potential learning curve for the new implant, emphasizing the relative novelty of implanting leads below the sternum. However, he also noted that all participating clinicians in Enlighten received sufficient training, showing that the process is absolutely replicable in a clinical setting.
“The implant under the sternum is still something new, so people will still need to get accustomed to that, and it is not devoid of risk,” Boersma said. “Proper training is needed, and it’s probably not as safe as putting the lead over the sternum under the skin. There is a tradeoff – but not all patients need placement under the sternum.”
Editors’ Note: Boersma reports consultant and proctor fees paid to Medtronic and Boston Scientific.
