The Impact Of Device Instructions For Use Adherence On Outcomes After Elective Endovascular Aortic Abdominal Aneurysm Repair
Livia de Guerre1, Thomas O'Donnell1, Rens Varkevisser1, Nicholas Swerdlow1, Chun Li1, Kirsten Dansey1, Joost van Herwaarden2, Marc Schermerhorn1, Virendra Patel3.
1Beth Israel Deaconess Medical Center, Boston, MA, USA, 2UMC Utrecht, Utrecht, Netherlands, 3New York Presbyterian/Columbia University, New York, NY, USA.
OBJECTIVES: We assessed the impact of neck characteristics outside of IFU on perioperative and one-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 VQI. Neck characteristics outside of IFU were determined based the specific device IFU neck characteristics (neck diameter, neck length, neck angle). The outcomes of this study were type Ia endoleaks at completion of the index procedure, perioperative mortality, one-year endoleaks, sac behavior, reinterventions, and five-year survival.RESULTS: Of the 15,448 patients identified, 22.1% had neck characteristics outside of IFU, including 6.6% with a neck angle and 6.8% with a neck length outside of IFU, 3.4% with a neck diameter larger than the IFU and 7% with a neck diameter lower than the IFU. Of these, 2.4% had more than one neck characteristic outside of IFU. Patients with neck characteristics outside of IFU were more often female (27.9% vs. 15.0%, P<.001) and were older (median age 75 vs. 73, P<.001). EVAR patients with neck characteristics outside of 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), one-year sac expansion (7.1% vs. 5.3%, P=.017), and one-year reinterventions (4.4% vs. 3.2%, P=.03). In multivariable adjusted analyses, neck characteristics outside of IFU were independently associated with type Ia completion endoleaks (OR:1.6, [1.3-2.0], P<.001), perioperative mortality (OR:1.8; [1.2-2.7]; P=.005), one-year sac expansion (OR:1.4; [1.0-1.8]; P=.025) and one-year reinterventions (OR:1.4; [1.0-1.9]; P=.039). Neck angle outside of IFU had the most impact on these adverse outcomes, follow by larger neck diameter (Table). Unadjusted mid-term survival was lower for patients with neck characteristics outside of IFU than for patients without (5-year survival 84.0% vs. 86.7%, log-rank<.001). However, after adjustment, survival was similar for patients with neck characteristics outside of IFU to those within (HR:1.1; [1.0-1.3]; P=.22).CONCLUSIONS: Neck characteristics outside of IFU are independently associated with worse outcomes among patients undergoing elective 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.
Back to 2021 ePosters