Abstract

Females remain underrepresented in studies of endovascular aneurysm repair (EVAR) owing to anatomic ineligibility for EVAR devices. The aim of the LUCY study is to explore the comparative safety and effectiveness of EVAR using a low-profile stent graft (Ovation; Endologix, Inc, Irvine, Calif) in females as well as males.The LUCY registry was a prospective, nonrandomized, multicenter study where patient enrollment was stratified by sex in a two-to-one ratio (male-to-female). Main outcomes were procedural data, 30-day major adverse events, device-related adverse events confirmed with contrast-enhanced computed tomography scans, secondary interventions, and hospital readmissions. Adverse events were adjudicated by a clinical events committee. Patients were followed at their 1-month and 1-year follow-up visits.A total of 225 patients (76 females, 149 males) were enrolled at 39 U.S. centers. No statistically significant sex differences were observed in demographics or medical history. Females presented with smaller access vessels (6.2 vs 7.7 mm; P < .001), statistically smaller neck diameter (22 mm vs 23 mm; P = .001), similar neck angulation (11% vs 9% angulation >45°; P = .81), and smaller maximum abdominal aortic aneurysm (AAA) diameter (50 mm vs 53 mm; P = .01), however, these factors do not seem to be clinically significant. Technical success was 99%, and the median hospital stay was 1 day. The incidence of MAE through 30 days was 1.3% in females and 2.0% in males. There were no differences between sexes observed among the 30-day perioperative outcomes. The 30-day secondary intervention rate was 0.4%. The all-cause readmission rate through 30 days was 5.3% in females and 6.7% in males. There were no reports of limb occlusion or deaths within the first 30 days. At 1 year, there were no deaths in the female arm but nine deaths (6.0%) were observed in males, two of which were AAA related (1.3%). Through 1 year, there were eight type IA endoleaks (one female, seven males; P = .27) and three cases with limb occlusion (one female, two males). There were no reports of migration, AAA rupture, or surgical conversion through the end of follow-up.Despite more complex aortic morphology in females than males, EVAR with a low-profile stent graft was associated with comparable procedural and perioperative outcomes through 1 year between the sexes.

View details for DOI 10.1016/j.jvs.2019.10.080

View details for PubMedID 31918999