HRS Congress 2026 – Prof Lucas Boersma (St. Antonius Hospital, Nieuwegein, NL) joins us to discuss real-world periprocedural outcomes from the Enlighten post-market registry study evaluating the extravascular implantable cardioverter-defibrillator (EV-ICD) system, and how these compare to findings from pre-market clinical trials.

The Enlighten study is an ongoing, global, prospective post-market registry enrolling patients with a class I or IIa ICD indication planned for EV-ICD implantation. This analysis examined 228 patients implanted between September 2023 and June 2024 across 81 implanters, performing a meta-analysis against a pooled pre-market cohort of 370 patients from the EV-ICD Pilot, Pivotal, and Continued Access studies. Outcomes assessed included procedural success, defibrillation testing efficacy, and major complication rates through discharge.

Interview Questions:

1. What unmet need does the EV-ICD system address, and what do we know about its performance from the pre-market trial programme?
2. What were the aims of the Enlighten post-market registry, and how was this analysis designed?
3. How did the real-world patient population compare to the pre-market cohort, and did any baseline differences influence how you interpreted the results?
4. What were the key periprocedural outcomes, and how did they compare between the Enlighten and pre-market groups?
5. What do these findings tell us about the readiness of the EV-ICD for broader real-world adoption?
6. What are the next steps for the Enlighten registry, and what longer-term questions remain?

Recorded on-site at HRS Congress 2026, Chicago.
Editors: Jordan Rance
Videographer: Oliver Miles
Support: This is an independent interview produced by Radcliffe Cardiology.