Commentary on ‘Early Results from the ENGAGE Registry: Real World Performance of the Endurant Stent Graft for Endovascular AAA Repair in 1262 Patients’

Abstract

The Endurant (Medtronic, Santa Rosa, California, USA) Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) is unprecedented because of its magnitude. In this report, the authors describe early results in 1262 patients treated with the Endurant stent-graft in 79 sites around the world. This large registry clearly demonstrates the commitment of the manufacturer to provide ‘real world’ data to the vascular community. We seem to move away from randomised trials comparing open and endovascular repair (EVAR) to focus on advances in EVAR. Clearly, we have reached a point of acceptance between two validated techniques in the treatment of infrarenal abdominal aortic aneurysms. The authors document perioperative (30 days) outcomes for the total patient cohort, but also provide 1-year follow-up results for 39.6% (500/1262) of the patients. It is no surprise that the results are excellent. Most of the currently available third-generation stent-grafts would probably match these outcomes. Complications leading to higher re-intervention rates compared to open repair usually occur after the first year or even only after 3e5 years postoperatively.1e3 We do not contest the quality of the results, and the authors do acknowledge that longer-term results need to be awaited, but the conclusion is overrated. As mentioned, we completely agree with the magnitude of the effort (unprecedented), but not that the results are (already?) promising (what?) or that the graft is safe and effective yet. Not that we doubt on the quality of the graft, but technically speaking we just need longerterm outcomes before having proven safety and effectiveness. Unfortunately, such premature conclusions are drawn too easy with new generation stent-grafts (or with current new concept stent-grafts). The ENGAGE registry aims at reporting ‘real world’ results, by its magnitude and the many centres throughout the world. Nevertheless, we would argue that these are still larger and experienced centres. It actually positively surprises us that only 17.9% of the patients were treated outside instructions for use (IFU) criteria, in