The association between device instructions for use adherence and outcomes after elective endovascular aortic abdominal aneurysm repair

Abstract

Objective: Aortic neck anatomy has a significant impact on the complexity of endovascular aortic aneurysm repair (EVAR), with concern that neck characteristics outside of the instructions for use (IFU) may result in worse outcomes. Therefore, this study determined the impact of neck characteristics outside of the IFU on perioperative and 1-year outcomes and mid-term survival after EVAR. Methods: We identified all patients undergoing elective infrarenal EVAR from December 2014 to May 2020 in the Vascular Quality Initiative database. Neck characteristics outside of the IFU were determined based the specific device IFU neck characteristics (neck diameter, length, and angulation). Patients without 1-year follow-up were excluded for the 1-year outcomes analyses (n = 6138 [40%]). We used multivariable adjusted logistic regression and Cox proportional hazard models to identify the independent associations between neck characteristics outside of the IFU and our outcomes. Results: Of the 15,448 patients identified, 22.1% had neck characteristics outside of the IFU, including 6.6% with a infrarenal angle, 6.8% with a neck length, 10.4% with a neck diameter, and 1.1% with a suprarenal angulation outside of the IFU. Of these, 2.4% had more than one neck characteristic outside of the IFU. Patients with neck characteristics outside of the IFU were more often female (27.9% vs 15.0%; P < .001) and were older (median age, 75 years vs 73 years; P < .001). EVAR patients with neck characteristics outside of the IFU had higher rates of type Ia endoleaks at completion (4.8% vs 2.5%; P < .001), perioperative mortality (1.2% vs 0.6%; P < .001), 1-year sac expansion (7.1% vs 5.3%; P = .017), and 1-year reinterventions (4.4% vs 3.2%; P = .03). In multivariable adjusted analyses, neck characteristics outside of the IFU were independently associated with type Ia completion endoleaks (OR, 1.6; 95% CI, 1.3-2.0; P < .001), perioperative mortality (OR, 1.8; 95% CI, 1.2-2.7; P = .005), 1-year sac expansion (OR, 1.4; 95% CI, 1.0-1.8; P = .025), and 1-year reinterventions (OR, 1.4; 95% CI, 1.0-1.9; P = .039). The unadjusted midterm survival was lower for patients with neck characteristics outside of the IFU than for patients without (5-year survival 84.0% vs 86.7%; log-rank P < .001). However, after adjustment, survival was similar for patients with neck characteristics outside of the IFU to those within (hazard ratio, 1.1; 95% CI, 1.0-1.3; P = .22). Conclusions: Neck characteristics outside of the IFU are independently associated with completion type Ia endoleaks, perioperative mortality, 1-year sac expansion, and 1-year reinterventions among patients undergoing elective EVAR. These results indicate that continued effort is needed to improve the proximal seal in patients with neck characteristics outside of the IFU undergoing EVAR. Also, in patients with severe hostile neck characteristics, alternative approaches such as open repair, use of a fenestrated or branched device, or endoanchors should be considered.