Greenberg, Roy K.

The purpose of this study was to analyze the effect of gender on deployment, early morbidity, and survival after endovascular aortic aneurysm repair (EVAR) using the Zenith Endovascular Graft. Data were obtained from the U.S. Multicenter Zenith Endograft trial and complemented with results from the Zenith female registry, including 40 women (10.9%) and 326 men (89.1%). Data analysis included preoperative medical risk factors, aneurysm morphology, deployment, and postoperative morbidity data, and 30-day and 1-year results. Preoperatively, women more often had experienced thromboembolic events (13% vs 4.3%; P = 0.04), but less angina pectoris (24% vs 49%; P = 0.002) or myocardial infarction (18% vs 38%; P = 0.01) compared with men. Women had more angulated aneurysm necks and narrower iliac arteries compared with men. Procedural success, cardiovascular, pulmonary, renal, bowel-related, neurologic, or other adverse events were comparable, as were 30-day and 1-year survival. Females experienced more wound dehiscences (5.0% vs 0.0%; P = 0.01) and open surgical conversions in the first year (5%) compared with men (0.31%) ( P = 0.03). With more challenging aneurysm morphologies, women were found to be at a higher risk for conversion in the first year after EVAR using the Zenith endograft. This however does not translate into inferior survival or higher overall morbidity compared with men.

Purpose: To analyze the 2-year outcomes of female patients after endovascular aortic aneurysm repair (EVAR) with the Zenith AAA Endovascular Graft. Methods: A retrospective analysis was conducted of data from the US Zenith multicenter trial and the Zenith female registry on 40 women (10.9%, study group) and 326 men (89.1%, control group) enrolled. All patients had completed their 2-year follow-up. Primary study endpoints were survival, aneurysm rupture, and conversion rate. Significance was assumed if p<0.05. Results: Overall rates of mortality (12.5% for women versus 13.2% for men, p=0.94) and aneurysm rupture (2.5% for women versus 0% for men, p=0.11) were comparable between groups. Conversion to open repair within 2 years was significantly more frequent in women compared to men (7.5% versus 0.6%, p=0.01). The incidence of endoleaks of any type was equivalent between groups at 2 years (13.3% for women versus 6.9% for men, p=0.30). No difference was observed in the need for secondary interventions (15% for women versus 13.5% for men, p=0.81) or aneurysm dilatation >5 mm (10.5% for women versus 2.3% for men, p=0.10). None of the patients developed device migration .10 mm or required intervention for migration. Conclusion: While women underwent conversion to open repair more frequently compared to men at 2 years post EVAR, there was no difference in survival, freedom from aneurysm rupture, or need for secondary interventions between groups. As in men, the Zenith AAA Endovascular Graft provides reliable protection from aneurysm rupture and aneurysm-related death in women in a midterm follow-up.