July 1, 2020
ENCORE Database of Endologix Ovation EVAR Device Shows Similar 5-year Outcomes by Sex
July 1, 2020—Five-year freedom from endoleaks and overall survival of patients undergoing endovascular aneurysm repair (EVAR) with the Ovation abdominal stent graft platform (Endologix, Inc.) did not differ between sexes even though women present with substantially more adverse proximal neck characteristics, concluded Rens R.B. Varkevisser, BS, et al in a study published in Journal of Vascular Surgery (JVS; 2020;72:11-121).
According to the investigators, women undergoing EVAR for infrarenal abdominal aortic aneurysms (AAAs) present with more challenging anatomy and historically have worse outcomes compared with men. The Ovation device is designed with a polymer-filled proximal sealing ring and a low-profile delivery system that potentially is beneficial in women. The investigators sought to determine differences in long-term outcomes between men and women treated with this device.
The study used data collected prospectively in the Effectiveness of Custom Seal with Ovation: Review of the Evidence (ENCORE) database, which is composed of five trials and the European Postmarket Registry. Anatomic characteristics of the proximal aneurysm neck and iliac arteries were compared between men and women.
Outcomes were 5-year freedom from type IA and type I/III endoleaks, AAA-related reinterventions, and overall survival. The investigators used Kaplan-Meier analysis to estimate survival proportions, Log-rank tests to determine univariate differences in survival, and Cox proportional hazards modeling to adjust for baseline differences.
As summarized in JVS, the investigators identified 1,045 (81%) men and 251 (19%) women undergoing EVAR.
Patient characteristics included the following:
- Women were older (mean age, 75 ± 8.4 vs 73 ± 8.1 years; P < .006).
- Women had smaller aneurysm diameter (52 ± 7.5 vs 55 ± 9.2 mm; P < .001) and proximal neck diameter (21 ± 3.3 vs 23 ± 2.9 mm; P < .001), but adjusted for body surface area, women had relatively larger aneurysms and aneurysm necks.
- Women presented with shorter proximal necks, smaller iliac artery diameters, more angulated necks, and higher rates of reverse-tapered necks.
The investigator found the following similar results at 5 years between men versus women:
- Freedom from type IA endoleaks (97% vs 96%; P = .38)
- Freedom from type I/III endoleaks (91% vs 94%; P = .37)
- Freedom from reinterventions (91% vs 93%; P = .67)
- Survival (79% vs 81%; P = .55)
- Aneurysm-related death (0.8% vs 0.4%; P = .76)
Risk-adjusted analyses showed no association between sex and type IA endoleak (hazard ratio [HR], 1.4; 95% CI, 0.6-3.1; P = .41), type I/III endoleak (HR, 1.4; 95% CI, 0.7-2.8; P = .33), reintervention (HR, 1; 95% CI, 0.6-2.0; P = .77), or overall mortality (HR, 0.7; 95% CI, 0.4-1.1; P = .14), reported the investigators in JVS.
On June 15, Endologix issued a voluntary correction notice for the Ovation iX abdominal stent graft system that identifies the root cause of polymer leaks. More details about the correction notice can be found here.