EVAR may not benefit patients outside instructions for use criteria

Patients with abdominal aortic aneurysms who fell outside the instructions for use criteria of endovascular aneurysm repair devices had better survival when undergoing open repair vs. EVAR, researchers reported at the Society for Vascular Surgery Vascular Annual Meeting.

The researchers analyzed 426 patients with AAA and at least one anatomic violation for EVAR use who underwent EVAR (n = 202) or open repair (n = 224) at three centers between 2003 and 2016. In the EVAR group, the violation was based on the instructions for use of the device used in the procedure. In the open-repair group, violations of generic instructions for use criteria were applied.

The outcome of interest was mortality. Median follow-up was 5.4 years in the open-repair group and 5.2 years in the EVAR group.

Patients in the open-repair group were younger (71 years vs. 78 years) and more likely to be hypertensive (80% vs. 69%) than patients in the EVAR group, Philippe Charbonneau, MD, from McGill University, Longueuil, Quebec, Canada, said during a presentation.

Instructions for use violations related to the proximal aortic neck were more common in the open-repair group (75% vs. 47%), whereas violations related to the iliac artery were more common in the EVAR group (79% vs. 65%), according to the researchers.

The mortality rate in the overall cohort was 30%.

In a Kaplan-Meier analysis, increased long-term survival was associated with open repair (log-rank P < .0001), Charbonneau and colleagues found.

After propensity matching and adjustment for confounders, open repair remained associated with lower risk for mortality (HR = 0.6; 95% CI, 0.4-0.9), Charbonneau said.

Among those with instructions for use violations related to the proximal aortic neck, mortality did not differ by procedure type (HR = 1.3; 95% CI, 0.6-2.7), according to the researchers.

“When adjusted for important clinical variables and propensity to undergo EVAR vs. [open repair], our study identified that patients with [instructions for use] violations have improved overall long-term survival with open treatment,” Charbonneau and colleagues wrote in an abstract. “When evaluating AAA patients with anatomic [instructions for use] violations, caution should be applied when considering EVAR.” – by Erik Swain

Reference:

Charbonneau P, et al. S6: Scientific Session 6. Presented at: Society for Vascular Surgery Vascular Annual Meeting; June 20-23, 2018; Boston.

Disclosure: The authors report no relevant financial disclosures.