Sex-related Outcomes after Fenestrated-Branched Endovascular Aneurysm Repair for Thoracoabdominal Aortic Aneurysms in the U.S. Aortic Research Consortium.

OBJECTIVE Fenestrated-branched endovascular aneurysm repair (FBEVAR) has expanded the treatment of patients with thoracoabdominal aortic aneurysms (TAAA). Prior studies have demonstrated that women are less likely to be treated with standard infrarenal endovascular aneurysm repair due to anatomic ineligibility and have higher mortality following both infrarenal and thoracic aortic aneurysm repair. The purpose of this study was to describe sex-related outcomes after FBEVAR for treatment of TAAA. METHODS A total of 886 patients with extent I-IV TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in 8 prospective physician-sponsored investigational device exemption studies from 2007-19, were analyzed. All data were collected prospectively, audited and adjudicated by clinical events committees and/or data safety monitoring boards, and subject to FDA oversight. All patients were treated with Cook manufactured patient-specific FBEVAR devices or the Cook t-Branch off-the-shelf device. RESULTS Of 886 patients who underwent FBEVAR, 288 (33%) were women. Women had more extensive aneurysms and higher prevalence of diabetes (33% vs. 26%, p=0.043), but lower prevalence of coronary artery disease (33% vs 52%, p<0.0001) and prior infrarenal endovascular aneurysm repair (7.6% vs 16%, p<0.001). Women had longer OR time from incision to surgery end (5.0±1.8 vs. 4.6±1.7 hours, p<0.001) and lower technical success (93% vs 98%, p=0.002), and were less likely to be discharged to their home (72% vs. 83%, p=0.009). Despite smaller access vessels, women did not have increased access site complications, and 30-day outcomes were broadly similar between sexes. At 1 year, there were no differences between women and men in freedom from type 1 or 3 endoleak (91.4% vs. 92.0%, p=0.64), re-intervention (81.7% vs. 85.3%, p=0.10), target vessel instability (87.5% vs. 89.2%, p=0.31), and survival (89.6% vs. 91.7%, p= 0.26). Women had a higher incidence of postoperative sac expansion (12% vs 6.5%, p=0.006). Multivariable modeling adjusting for age, aneurysm extent, aneurysm size, urgent procedure, and renal function showed that patient sex was not an independent predictor of survival (HR 0.83, CI 0.50-1.37, p=0.46). CONCLUSIONS Women undergoing FBEVAR demonstrate metrics of increased complexity and have a lower level of technical success, particularly those with extensive aneurysms. Compared with men, women had similar 30-day mortality and 1-year outcomes, with the exception of an increased incidence of sac expansion. These data demonstrate that FBEVAR is safe and effective among women and men, but that further efforts to improve outcome parity are indicated.