How Sac Regression at 1 Year Affects All-Cause Mortality Through 8 Years: Key Insights From the ENGAGE Registry

Background

The ENGAGE registry is prospective real world clinical study about the performance of Endurant endograft from Medtronic. This stent-graft is a very well-known device for abdominal endografting since 2008. It is a self-expandable modular stent-graft with nitinol alloy as stent wiring, and polyester as fabric. One of the unique features is related to the stent strut configuration at the level of the proximal sealing zone. It has a M-shape, 5 mm tall and with a 2 mm gap distance between two rows of struts.

It is the first time knowing long-term data about the behavior of this graft in terms of sac reduction after endovascular aneurysm repair (EVAR). Sac reduction is the clearest indicator for a successful EVAR. Sac shrinkage during follow up indicates successful exclusion of the aneurysm from arterial pressure, and has been shown to be a predictor of low risk of EVAR failure. In other words, sac growth during the surveillance period represents a big concern for any endovascular operator.

ENGAGE

ENGAGE, with 1,263 enrolled patients, reported different relevant information about the Endurant performance over the years. Now, it is time to know data concerning sac reduction behavior.  

We observe that just after one-year follow-up we can predict the posterior clinical consequences at 8 years. For instance, sac increase after one-year EVAR follow-up represents more risk for aneurysm-related mortality if it is compared with stable or reduced sacs. Moreover, stable and increased sacs are more prone to develop any endoleak that needs secondary procedures at 8-year follow-up. Any reintervention is associated with potential complications that could contribute to an increase all-cause mortality rates.

What’s Next?

We will continue collecting and analyzing data up to 10-year follow-up. After 10 years, we want to compare ENGAGE findings with some coming from old randomized trials like EVAR-1. We should scientifically demonstrate that newer devices, like Endurant, perform better than previous generations.

Take-Home Message

My most practical message for the global audience is to look for aneurysm sac shrinkage. It is the most important indicator for EVAR success over further follow-up. Stable sacs are not as benign as was previously expected. Growing sacs should be actively corrected whenever possible.