You can address sac regression with Endurant™ AAA stent graft system1–4,7
Why sac regression?
- Sac regression is defined by the SVS as the reduction in maximum diameter of the aneurysm sac by ≥ 5 mm.5
- Latest data suggests aneurysm sac regression is associated with better long-term outcomes.6
Addressing sac regression factors with Endurant stent graft
Endurant AAA stent graft has demonstrated low type I and type II endoleaks in broad patient anatomies,7 with:
- Accurate placement and controlled deployment2
- Continuous seal, fixation, and graft conformability3
- Durable hemostatic barrier and resistance against type II endoleaks4
Sac regression features and benefits - (02:35)
Endurant II/IIs is designed to provide continuous seal in a dynamic environment*,3
Methodology:
Radial force was tested and micro-CT scans were evaluated by an independent lab to model the Endurant stent graft performance in the proximal seal zone through the cardiac cycle.
Results:
M-stent maintains even distribution of contact pressure, resulting in optimal conformability in a pulsatile environment.3
See the Endurant II/IIs system perform in a dynamic environment.*
Normalized contact pressure in systole (120 mm Hg)*
EVAR success
Aneurysm sac regression is a key indicator6 for EVAR success.
Dr. Ross Milner, M.D., Professor of Surgery, Co-director, Center for Aortic Diseases at the University of Chicago, discusses his thoughts on aneurysm sac regression post-EVAR.
Dr. Ross Milner discusses post-EVAR success - (02:08)
A new paradigm shift
Hear physicians’ thoughts on aneurysm sac regression post-EVAR ― watch the on-demand webcast.
- Moderated by Prof. Jean-Pierre Becquemin, M.D.
- Panel includes Prof. Hence Verhagen, M.D., Ph.D., Prof. Michel Reijnen, M.D., Ph.D., and Dr. Apostolos Tassiopoulos, M.D.
"If you have sac shrinkage in the first year, the need for secondary interventions and therefore the need for intensive follow-up is different than those that don’t shrink."
–Prof. Hence Verhagen, M.D., Ph.D.
Aneurysm sac regression post-EVAR webinar - (05:37)
Clinical evidence VQI data
Latest data suggests aneurysm sac regression is associated with better long-term outcomes.6
Cohort that demonstrated sac regression at 1 year had significantly better outcomes than stable and expanding sac cohorts.
Endurant stent graft sac regression data associated with better long-term outcomes
ENGAGE OUS Registry confirms sac regression link to better long-term outcomes. Patients with regressing sacs at one year had statistically significant better freedom from (FF) all-cause mortality (ACM) and FF secondary endovascular reinterventions than patients with stable or expanding sacs.8
The Endurant AAA stent graft is the standard of EVAR durability.9
Endurant data shows consistent high sac regression rates
Endurant demonstrates consistent and high sac regression rates across straightforward and complex anatomies. New data suggests that patients with sac regression at 1 year appear to continue to have sac regression at 5 years.*
10-year sac regression rates‡
1-year sac regression is indicative of 5-year sac dynamics
Of those with sac regression at 1 year:
- 86% of patients with images at 5 years continue to have sac regression.
- 2% have sac increase at 5 years.
One-year sac regression is indicative of 5-year sac dynamics
Of those with sac regression at one year8:
- 86% of patients with images at five years continue to have sac regression
- 2% have sac increase at five years
Sac dynamics at follow-up time points8
Challenging EVAR procedure video case study
Dr. Ross Milner, M.D., reviews the case of a challenging EVAR patient that resulted in a regressing aneurysm sac.
Case study of aneurysm sac regression with the Endurant II/IIs AAA stent graft - (04:11)
*
Bench test data may not be indicative of clinical performance. Performance may vary upon use.
†
P < 0.01 for comparisons to the regression group.
‡
Data reported at 5-year time frame is full-cohort; n=1,263 patients. Data reported at 10-year time frame is extended-cohort; n=390 patients due to reconsent for extended 10-year follow-up.
References
1
Lalys F, Daoudal A, et al. (2016). Influencing factors of sac shrinkage after endovascular aneurysm repair. J Vasc Surg. 65(6),1830–1838
2
Endurant™ US IDE trial: Makaroun M. One-year outcomes of the US regulatory trial of the Endurant™ stent graft system. J Vasc Surg. 2011; 54:601–608
3
Based on internal test report DVR7245 Design Verification Report: Endurant Stent Graft System conducted January - July 2007.
4
Wakefield, T. W., Shulkin, B. L., et al. (1989). Platelet reactivity in human aortic grafts: a prospective, randomized midterm study of platelet adherence and release products in Dacron and polytetrafluoroethylene conduits. J Vasc Surg. 9(2), 234–243
5
Ahn SS, Rutherford RB, Johnston KW, et al. Reporting standards for infrarenal endovascular abdominal aortic aneurysm repair. Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/International Society for Cardiovascular Surgery. J Vasc Surg. February 1997;25(2):405–410.
6
O’Donnell TFX, Deery SE, Boitano LT, et al. Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long-term survival. J Vasc Surg. February 2019;69(2):414–422.
7
Singh MJ, Fairman R, Anain P, et al. Final Results of the Endurant Stent Graft System in the United States regulatory trial. J Vasc Surg. July 2016;64(1):55–62.
8
Bӧckler D, Li C, Dansey K, et al. Sac regression is associated with lower all-cause mortality after contemporary endovascular aneurysm repair — a new paradigm for success. Presented online at ESVS 34th Annual Meeting, October 6, 2020.
9
Verhagen H, et al. The ENGAGE Registry: Ten-Year Outcomes with the Endurant Stent Graft for Endovascular Abdominal Aortic Aneurysm Repair. Presented at: Charing Cross 2023 International Symposium; April 26, 2023; London, UK.