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Outcome disparities mandate further research on F/BEVAR in women with TAAA

Ngày 06/04/1988 09:16 | Lượt xem: 859

In a large, multicentre study, women undergoing fenestrated or branched endovascular aneurysm repair (F/BEVAR) for thoracoabdominal aortic aneurysms (TAAA) demonstrated metrics of increased complexity and had a lower level of technical success. However, women had similar 30-day mortality and one-year outcomes to men, with the exception of an increased incidence of sac expansion. “These data demonstrate that F/BEVAR is safe and effective among women and men”, write Natasha I Edman (University of Washington Medical Center, Seattle, USA) and colleagues in the Journal of Vascular Surgery (JVS). However, they stress that “further efforts to improve outcome parity are indicated”.

Edman et al state that, while F/BEVAR has “expanded the treatment options of patients with TAAA”, women are underrepresented in the literature. They outline the extent of the issue: “Although approximately 40–50% of patients with TAAA are women, women comprise only 6–32% of cohorts in F/BEVAR studies”. Increased physiologic risk and anatomic unsuitability have been put forward as reasons for this disparity, but for those women who do receive F/BEVAR for TAAAs, the authors stress that outcomes are limited. It was therefore the aim of this study to describe sex-related outcomes after F/BEVAR for the treatment of TAAA.

The investigators analysed 886 patients with extent I-IV TAAA (excluding pararenal or juxtarenal aneurysms) who were enrolled in eight prospective, physician-sponsored, investigational device exemption studies in the US Aortic Research Consortium between 2007 and 2019. They state that 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 (FDA) oversight. They specify that all patients were treated with Cook manufactured patient-specific F/BEVAR devices or the Cook t-Branch off-the-shelf device.

Of the total patient cohort, 288 (33%) were women. Writing in JVS, Edman and colleagues report that these women had more extensive aneurysms and a higher prevalence of diabetes (33% vs. 26%; p=0.043) than the men included in the analysis, but lower prevalence of coronary artery disease (33% vs. 52%; p<0.0001) and prior infrarenal EVAR (7.6% vs. 16%; p<0.001).

In addition, the authors relay that women had longer operating room (OR) time from incision to surgery end (5±1.8 vs. 4.6±1.7 hours; p<0.001), 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, Edman et al reveal that women did not have increased access site complications, and 30-day outcomes were broadly similar between sexes. At one year, they add, there were no differences between women and men in freedom from type I or III endoleak (91.4% vs. 92%; p=0.64), reintervention (81.7% vs. 85.3%; p=0.1), target vessel instability (87.5% vs. 89.2%; p=0.31), and survival (89.6% vs. 91.7%; p=0.26). However, they communicate that women had a higher incidence of postoperative sac expansion (12% vs. 6.5%, p=0.006).

The authors acknowledge that their study has a few key limitations. They recognise, for example, that all patients were treated at high-volume centres by teams focused on complex endovascular repair, and so the present results “may not be generalisable to other clinical settings”. Furthermore, they write that patients had been selected for clinical fitness for surgical repair and anatomic suitability for a branched endograft by a surgeon with expertise in these devices. “The fact that women comprised only one-third of this cohort indicates that there remains some referral or selection bias that results in lower treatment rates,” they remark.

Edman and colleagues suggest that longer-term data will be needed to elucidate the long-term difference in safety and effectiveness of F/BEVAR in men and women, and that further research is needed to identify and address the specific causes for lower treatment rates in women with TAAA.

Source VascularNews

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