Five Year Patient Outcomes of Endovascular Abdominal Aortic Aneurysm Repair in the ENDURANT France Registry

Abstract

WHAT THIS PAPER ADDSThis analysis of the ENDURANT France registry provides five year outcomes from a French population treated under real life conditions. Patients experienced a 69.9% AE 3.5% KaplaneMeier overall survival, 97.6% AE 1.2% freedom from aneurysm related mortality, low rates of type IA endoleaks, few secondary procedures, and showed positive signs of remodelling. These outcomes are similar to other recent global registries and better than the outcomes with earlier generation devices. With the current focus on managing costs and reimbursements, these five year outcomes of a French specific cohort provide further evidence of the long term durability and success with the Endurant stent graft system.Objective: Endovascular repair is the preferred method of treatment for infrarenal abdominal aortic aneurysms with numerous publications from multiple geographic regions showing excellent patient outcomes. Since the original ACE (Anevrysme de l'aorte abdominale: Chirurgie versus Endoprothese) randomised control trial, studies of French specific population have also contributed significantly to the body of evidence in support of endovascular abdominal aortic repair. Methods: In the ENDURANT France registry, 180 patients were consecutively enrolled from 20 French centres starting in 2012. Investigational sites included public and private practice and differing centre volumes to be as representative of real world French experience as possible. The aim of this study was to present the five year outcomes from this registry. Results: Instructions for use (IFU) were respected in 97.8% (176/180) of patients. At five years, the KaplaneMeier overall survival was 69.9% AE 3.5% and the freedom from aneurysm related death was 97.6% AE 1.2%. The freedom from Type IA endoleaks was 94.5% AE 1.7%, freedom from endoleaks of any type was 70.1 AE 3.4%, and freedom from secondary endovascular procedure 90.4% AE 2.6%. In addition, 61.6% (45/73) of patients exhibited sac shrinkage at five years. Conclusion: In this five year report of the Endurant France registry, survival, re-intervention, and freedom from endoleak rates were comparable to recent EVAR registries and there was a high sac shrinkage rate. Secondary procedure and aneurysm rupture were lower than those of ACE, the French RCT which included older generation devices. This prospective registry demonstrates favourable five year outcomes of the Endurant stent graft used within IFU.

Five-year survival after elective open and endovascular aortic aneurysm repair

“…18,19 Our study showed significantly increased mortality in the EVAR group 5 years after the procedure, compared with OSR, and the 5-year overall survival of EVAR patients was somewhat lower than the data reported by others. 13,18,19 Although the EVAR procedure is an independent risk factor for 5-year mortality, we cannot ignore the imbalance in the baseline characteristics between the EVAR and OSR groups. Significantly higher mean age and greater proportion of renal and cerebrovascular comorbidities among EVAR patients may influence not only the choice of treatment modality, but also prognosis.…”

“…1 However, improvements in the design and delivery of modern stent grafts have reduced the frequency of those adverse events over 5 years and beyond. 12,13 Although EVAR has been widely adopted and the initial results have been promising, comparison of its long-term efficacy against OSR still remains elusive, and late-onset aortic complications need to be systematically evaluated. Usage of older-generation stent grafts on the on hand, and the relatively small number of patients in controlled trials with longterm results on the other hand, are the limitations to comparison of long-term survival after elective OSR and EVAR.…”

Has Endovascular Aortic Repair Reached a State of Perfection or is There Still Work to be Done?

“…In this issue, Becquemin et al 1 demonstrate promising long term results using the Endurant stent graft in a multicentre French single arm post-market registry, with a KaplaneMeier five year freedom from type IA endoleaks and secondary endovascular procedures of 94.5 AE 1.7% and 90.4 AE 2.6%, respectively. Proponents of endovascular aortic repair (EVAR) may use this study as another example that EVAR has almost reached a state of perfection.…”