F-BEVAR performed on women shows ‘lower’ level of technical success

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U.S. Fenestrated and Branched Aortic Research Consortium

Fenestrated-branched endovascular aneurysm repair (F-BEVAR) for thoracoabdominal aortic aneurysms (TAAAs) carried out on women “demonstrate metrics of increased complexity and have a lower level of technical success, particularly among patients with higher extent aneurysms,” a research team in Seattle found.

“Compared with men, women had similar 30-day mortality and one-year outcomes, with the exception of an increased rate of sac expansion,” the investigators discovered. “These data demonstrate that F-BEVAR is safe and effective among women and men, but that further efforts to improve outcome parity between the sexes are indicated.”

The findings were part of study on sex-related outcomes after F-BEVAR and presented at the Pacific Northwest Vascular Society (PNWVS) virtual annual meeting (Oct. 30) by Natasha Edman, MA, a medical student at the University of Washington School of Medicine.

The researchers approached the study by referencing prior inquiries demonstrating that women are less likely to be eligible for F-BEVAR due to anatomic barriers. “Few data are available to determine whether their outcomes differ from those of men,” Edman told attendees. “Women are known to experience higher mortality after infrarenal and thoracic aortic aneurysm repair but it is unknown whether the same is true for women with TAAA.”

Edman and colleagues aimed to describe sex-related outcomes after F-BEVAR for TAAA. They studied 886 patients with extent IV TAAAs (excluding pararenal or juxtarenal aneurysms) enrolled in eight prospective physician-sponsored investigational device exemption studies—part of the U.S. Fenestrated and Branched Aortic Research Consortium—from 2007–19 using either a Cook Medical patient-specific device or an off-the-shelf Cook Zenith t-Branch. Of the cohort, 288 (33%) were women.

Women had more extensive aneurysms and higher prevalence of diabetes, but lower prevalence of coronary artery disease and prior EVAR. They also had longer operating room times, lower technical success and longer length of stay. Women and men had similar 30-day mortality (2.4% vs. 1.7%) and early outcomes, though spinal cord injury was more common in women, the researchers found. “At one 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), branch vessel instability (87.5% vs. 89.2%; p=0.31), and survival (89.6% vs. 91.7%; p= 0.26).”

Women also had a higher incidence of postoperative sac expansion (12% vs 6.5%; p=0.006), the team said. 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 (hazard ratio 0.83, confidence interval 0.50–1.37; p=0.46), they added.

Edman concluded: “Thirty-day adverse events and one-year outcomes were broadly similar between women and men undergoing F-BEVAR. Women experienced higher rates of non-home discharge and postoperative sac expansion, and women with extensive aneurysms were more likely to experience technical failure.”

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