Gender Related Access Complications after Tevar: Data Analisys from Gore Great Registry

Introduction - Women show an increased risk of worse outcome than men following endovascular procedures. Sheath size of TEVAR and challenging anatomy of women (smaller iliac arteries, tortuosity and associated occlusive disease) could lead to significant increasing risk of access complication. However, thoracic aortic diseases, primarily aneurysms and dissections, are less frequent in females, therefore a smaller sample of women are available to analyze their results compared to male population. The goal of this study was to assess the effect of gender on access complications after thoracic endovascular aortic aneurysm repair (TEVAR), using data from GORE GREAT (Global Registry Endovascular Aortic Treatment). Methods - All the patients with an aortic thoracic disease treated with TEVAR and enrolled in GREAT were collected, with particular attemption to those who developed access complication. GREAT is a global prospective observational study which enrolled 5000 patients treated with a GORE thoracic and abdominal stent graft, from August 2010 to September 2016. In this study, major endpoints were: types of access complication (bleeding, hematoma, sieroma, local infection, artery dissection, thrombosis) compared across gender, categorized also by age (< 75 vs > 75) and stent-graft sizing. Results - Total patients treated with thoracic stent graft and enrolled in GREAT were 963 patients, including both elective, acute and emergencies repair. Access complications occurred in 16 patients, 11/322 (3.4%) in females group versus 5/641 (0.8%) in males group (p 0.006). Type of complications were 2 incision hematoma (2F), 2 pseudoaneurysms (1M,1F), 3 artery dissection (2M, 1F), 3 thrombosis (3F), 1 seroma (M), 2 wound infections (2F), 2 arterial injury (2F), 1 bleeding (M). Considering age of the treatment, a cut off of 75 years old was used to categorize patients < 75 years (group 1) vs > 75 years (group 2). A significant difference in access complications was observed comparing gender in the patients < 75 yrs old (6/193 (3.1%) for females vs 3/456 (0.8%) for males, p 0.023). No differences were noted in the older group > 75 years (5/102 (4.9%) females vs males 2/136 (1.5%) p 0.142). Regarding stent-graft sizing , a significant difference in the access complications was observed for females who need stent-graft range 37-45, which necessitates sheat size 24 Fr (females 7/121 (5.8%) vs males 3/354 (0.8%), p 0.004). Conclusion - Access complications are significant higher in women than in men, in particular using a stent graft with increased diameters. Younger women showed more frequently access complications compared to those older than 75, reflecting that a women developing atherosclerotic disease in younger age could have a more aggressive disease in all arteries. These results suggest, as others studies in other cardiovascular area, a need for more gender dedicated research and therapy, with decreased device delivery size and improvements in endovascular technology.