Early and Mid-Term Outcomes of Females Treated with t-Branch off the Shelf Device.

Background: Female sex has been characterized as a risk factor of increased mortality in patients managed for complex aortic aneurysm using endovascular means. This study aimed to present the perioperative and follow-up outcomes of females managed electively or urgently with the t-Branch device and investigate factors affecting the early outcomes.

Methods: A 2-center retrospective observational study was conducted including elective and urgent female patients managed with the t-Branch device (Cook Medical, Bjaeverskov, Denmark) for thoracoabdominal and pararenal aneurysms between January 1, 2018 and September 30, 2020. Primary early outcomes included technical success and 30-day mortality and morbidity [spinal cord ischemia (SCI) and acute kidney injury]. Follow-up survival and freedom from reintervention rates were assessed using Kaplan-Meier estimates.

Results: In total, 153 females were included; 81 (52.9%) treated urgently. Urgent patients were older (73.2 ± 8.6 vs. 68.5 ± 6.8 years; P < 0.001) and presented higher previous coronary angioplasty/stenting (16.0% vs. 5.6%, P = 0.005) and lower double antiplatelet therapy (DAPT, 46.3% vs. 53.7%, P = 0.04) rates. Technical success was 97.4%. Early mortality was 16.3% (22% in urgent; 12% in elective; P = 0.2) and SCI and acute kidney injury were diagnosed in 13.7% (11% in urgent; 16% in elective; P = 0.2) and 18.3% (22.2% in urgent; 13.9% in elective; P = 0.18), respectively. Multivariate regression analyses showed that DAPT and b-blockers were related to lower 30-day mortality. DAPT was also preventive for SCI. Survival rates were 68.4% [standard error (SE) 0.07] at 12 months for the urgent and 75.6% (SE 0.09) at 24 months for the elective group (P = 0.14). Freedom from reintervention rates were 81.4% (SE 0.06) at 6 months and 64.7% (SE 0.09) at 18 months for the urgent and 81.7% (SE 0.06) at 6 months and 75.4% (SE 0.081) at 18 months for the elective group (P = 0.94).

Conclusions: Female patients managed with the t-Branch device for thoracoabdominal and pararenal aneurysms in elective and urgent setting presented similar 30-day mortality and SCI rates.