Sex-related Outcomes After Fenestrated-Branched Endovascular Aneurysm Repair for Thoracoabdominal Aortic Aneurysms in the US Fenestrated and Branched Aortic Research Consortium

Abstract

Fenestrated-branched endovascular aneurysm repair (F-BEVAR) has expanded the treatment of patients with thoracoabdominal aortic aneurysms (TAAAs). Prior studies have demonstrated that women are less likely to be treated with routine endovascular aneurysm repair due to anatomic ineligibility and experience higher mortality following both infrarenal and thoracic aortic aneurysm repair. The purpose of this study was to describe sex-related outcomes after F-BEVAR for treatment of TAAA. A total of 886 patients with extent I to V TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in eight prospective physician-sponsored investigational device exemption studies from 2007 to 2019, were analyzed. All data were collected prospectively, audited and adjudicated by clinical events committees and/or data safety monitoring boards, and subject to US Food and Drug Administration oversight. All patients were treated with Cook manufactured patient-specific F-BEVAR devices or the Cook t-Branch off-the-shelf device. Of 886 patients who underwent F-BEVAR, 288 (33%) were women (Table I). Women had more extensive aneurysms, higher prevalence of diabetes, lower prevalence of coronary artery disease, and lower prevalence of prior endovascular aneurysm repair. Women had longer operative times, lower technical success (93 vs 98%; P = .002), and longer length of stay (Table II). Women were more commonly treated with low-profile devices and had smaller target vessels with no difference in access site complications. Thirty-day mortality was 2% in both men and women. Early outcomes were equivalent except women experienced increased risk of permanent paralysis 2.9% versus 0.9% (P < .05). Multivariable model adjusting for age, aneurysm extent, aneurysm size, urgent procedure and renal function demonstrated that patient sex was not an independent predictor of survival (hazard ratio, 0.9; 95% confidence interval, 0.53-1.53; P = .69). At 1 year, freedom from type I or III endoleak (92.5% vs 92.5%; P = .91), reintervention (82.8% vs 85.8%; P = .19), branch vessel instability (86.4% vs 89.7%; P = .54), and survival (89.9% vs 91.6%; P = .37) did not differ between men and women. Women experienced a higher incidence of postoperative sac expansion (13% vs 6.4%; P = .006). F-BEVAR performed on women demonstrate metrics of increased complexity and have a lower level of technical success. Women experienced a higher risk of perioperative spinal cord injury but no increase in 30-day mortality. Female sex is not associated with disadvantaged 1-year outcomes; however, they did experience twice the rate of sac expansion at last follow-up. These data demonstrate that F-BEVAR is safe and effective among women despite being slightly higher risk. Further efforts to improve outcome parity are indicated.Table IPatient demographicsWomen (n = 276)Men (n = 568)P valueAge74 (7.4)74 (7.4).98Medical comorbidities Coronary artery disease33%53%<.0001 Cerebrovascular disease23%19%.18 Hypertension89%91%.41 Hyperlipidemia66%71%.14 Diabetes mellitus33%26%.043 Chronic obstructive pulmonary disease35%35%.85 Renal failure requiring dialysis3%10%.56 Prior aortic surgery44%46%.68 Prior endovascular aneurysm repair7.6%16%<.001 Dissection5.7%7.5%.99 Smoking status87%89%.46TAAA extent<.0001 I9.4%7.2% II36%20% III25%18% IV28%53% V1%0.5%Aneurysm size (cm)6.4 (1.3)6.5 (1.1).20Symptomatic/urgent presentation2.3%1.4%.39TAAA, Thoracoabdominal aortic aneurysm.Data are reported as mean (standard deviation) or as percentage where indicated. Open table in a new tab Table IIDevice and operative detailsWomen (n = 276)Men (n = 568)P valueDevice design Target vessels3.4 (0.9)3.4 (0.9).50 t-Branch14%13%.58 No. of branches1.4 (1.6)1.2 (1.6).08 No. of fenestrations1.7 (1.6)2.0 (1.8).002 Low profile55%46%.034 Preloaded system26%23%.22 Distal landing zone in the infrarenal aorta42%24%<.0001 Distal landing zone in the iliac arteries58%76%<.0001 Celiac stent diameter, mm7.3 (1.9)7.1 (2.6).33 SMA stent diameter, mm7.5 (0.9)8.2 (1.1)<.0001 RRA stent diameter, mm5.9 (0.7)6.3 (0.8)<.0001 LRA stent diameter, mm5.9 (0.9)6.1 (1.1)<.0001Operative details Operative time, hours5.0 (1.8)4.6 (1.7)<.001 Examination dose, mGy1882 (2397)3606 (2418).10 Contrast volume, mL117 (56)111 (59).20 Technical success93%98%.002 ICU Length of stay, days3.8 (3.3)3.0 (3.5).004 Hospital length of stay, days9.5 (25)6.9 (18).14ICU, Intensive care unit; LRA, left renal artery; RRA, right renal artery; SMA, superior mesenteric artery.Data are reported as mean (standard deviation) or as percentage where indicated. Open table in a new tab