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 3–5 years postoperatively.
1
, 2
, 3
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 longer-term 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 contrast to a recent published overview in the United States.
4
On the other hand, the inclusion criteria for the Endurant are very liberal, based on extensive bench testing by the manufacturer. Necks as short as 10 mm length, and/or severe angulations are part of the IFU's. To demonstrate effectiveness and safety, patients with adverse anatomy (inside the liberalised IFU's and outside IFU's) treated with the Endurant should be studied separately and in the long term. In addition, one has to be careful not to send the wrong message to the community, because in the real ‘real world’, most cases are performed in low volume centres.5
, 6
Before treating patients outside these already liberal and not clinically proven IFU's, one needs to balance the risks of EVAR with the Endurant in challenging anatomy with other therapeutic options, such as open repair, fenestrated stent-grafting or even chimney techniques. Broadening eligibility is not a goal in itself and, more than ever, with so many options around, we must try hard to find the best solution for each individual patient, and not for the doctor.In conclusion, we absolutely recognise the magnitude of the registry and congratulate both the manufacturer and all investigators. We eagerly await longer-term results that could demonstrate safety and effectiveness of the Endurant, especially in challenging anatomy.
Competition of Interest
Eric Verhoeven has received educational grants and is a consultant for Cook Inc., W.L. Gore & Associates, Siemens and Atrium-Maquet.
References
- Long-term follow-up of secondary interventions after endovascular aneurysm repair with the AneuRx endoprosthesis: a single-center experience.J Endovasc Ther. 2010; 17: 408-415
- Late problems at the proximal aortic neck: migration and dilation.Semin Vasc Surg. 2004; 17: 288-293
- Thirty-day mortality and late survival with reinterventions and readmissions after open and endovascular aortic aneurysm repair in Medicare beneficiaries.J Vasc Surg. 2011; 53: 6-12
- Predictors of abdominal aortic aneurysm sac enlargement after endovascular repair.Circulation. 2011; 123: 2848-2855
- Introduction of endovascular aneurysm repair into community practice: initial results with a new Food and Drug Administration-approved device.J Vasc Surg. 2002; 36: 226-232
- Endoluminal stent-graft placement for repair of abdominal aortic aneurysms in the community setting.J Endovasc Ther. 2008; 15: 688-694
Article info
Publication history
Published online: August 06, 2012
Identification
Copyright
© 2012 European Society for Vascular Surgery. Published by Elsevier Inc.
User license
Elsevier user license | How you can reuse 
Elsevier's open access license policy
Elsevier user license
Permitted
For non-commercial purposes:
- Read, print & download
- Text & data mine
- Translate the article
Not Permitted
- Reuse portions or extracts from the article in other works
- Redistribute or republish the final article
- Sell or re-use for commercial purposes
Elsevier's open access license policy
ScienceDirect
Access this article on ScienceDirectLinked Article
- Early Results from the ENGAGE Registry: Real-world Performance of the Endurant Stent Graft for Endovascular AAA Repair in 1262 PatientsEuropean Journal of Vascular and Endovascular SurgeryVol. 44Issue 4Open Archive
Related Articles
Comments
Commenting Guidelines
To submit a comment for a journal article, please use the space above and note the following:
- We will review submitted comments as soon as possible, striving for within two business days.
- This forum is intended for constructive dialogue. Comments that are commercial or promotional in nature, pertain to specific medical cases, are not relevant to the article for which they have been submitted, or are otherwise inappropriate will not be posted.
- We require that commenters identify themselves with names and affiliations.
- Comments must be in compliance with our Terms & Conditions.
- Comments are not peer-reviewed.
