PURPOSE: This study evaluated the differences between male and female patients undergoing thoracic endovascular aneurysm repair (TEVAR) in a pivotal Food and Drug Administration (FDA)-approved trial. METHODS: The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) study was a prospective, nonrandomized, multicenter, pivotal trial conducted in the United States. Patients were enrolled between December 2003 and June 2005. Follow-up was conducted at 30 and 365 days. RESULTS: VALOR enrolled 115 men (58.9%; 69.3 ± 11.7 years old), and 80 women (41.1%; 71.6 ± 10.1 years old). Iliac conduits were used more often in women, who had smaller diameter external iliac arteries, than in men (38.8% vs 8.8%, P < .001). Women required more blood transfusions and had a longer hospital length of stay. At 30 days, more major adverse events occurred in women than in men (52.5% vs 33.0%, P = .008), with more vascular access-related and respiratory complications. No gender-based differences were seen in all-cause mortality or in aneurysm-related death. The composite end point of 365-day "successful aneurysm treatment," defined as no aneurysm growth >5 mm at the 365-day follow-up visit compared with the 30-day follow-up visit and absence of any type I endoleak requiring a secondary procedure, favored women over men (98.2% vs 82.4%, P = .004). CONCLUSIONS: TEVAR with the Talent device provided similar rates of 365-day mortality and morbidity for men and women. Although female patients had higher rates of periprocedural complications, they also more often had successful aneurysm treatment at the 1-year follow-up.
PURPOSE: This study evaluated the differences between male and female patients undergoing thoracic endovascular aneurysm repair (TEVAR) in a pivotal Food and Drug Administration (FDA)-approved trial. METHODS: The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) study was a prospective, nonrandomized, multicenter, pivotal trial conducted in the United States. Patients were enrolled between December 2003 and June 2005. Follow-up was conducted at 30 and 365 days. RESULTS: VALOR enrolled 115 men (58.9%; 69.3 ± 11.7 years old), and 80 women (41.1%; 71.6 ± 10.1 years old). Iliac conduits were used more often in women, who had smaller diameter external iliac arteries, than in men (38.8% vs 8.8%, P < .001). Women required more blood transfusions and had a longer hospital length of stay. At 30 days, more major adverse events occurred in women than in men (52.5% vs 33.0%, P = .008), with more vascular access-related and respiratory complications. No gender-based differences were seen in all-cause mortality or in aneurysm-related death. The composite end point of 365-day "successful aneurysm treatment," defined as no aneurysm growth >5 mm at the 365-day follow-up visit compared with the 30-day follow-up visit and absence of any type I endoleak requiring a secondary procedure, favored women over men (98.2% vs 82.4%, P = .004). CONCLUSIONS: TEVAR with the Talent device provided similar rates of 365-day mortality and morbidity for men and women. Although female patients had higher rates of periprocedural complications, they also more often had successful aneurysm treatment at the 1-year follow-up.
Authors: Sarah E Deery; Peter A Soden; Sara L Zettervall; Katie E Shean; Thomas C F Bodewes; Alexander B Pothof; Ruby C Lo; Marc L Schermerhorn Journal: J Vasc Surg Date: 2016-12-13 Impact factor: 4.268
Authors: Sarah E Deery; Katie E Shean; Grace J Wang; James H Black; Gilbert R Upchurch; Kristina A Giles; Virendra I Patel; Marc L Schermerhorn Journal: J Vasc Surg Date: 2017-03-01 Impact factor: 4.268
Authors: Nathan L Liang; Elizabeth A Genovese; Georges E Al-Khoury; Eric S Hager; Michel S Makaroun; Michael J Singh Journal: Ann Vasc Surg Date: 2016-08-10 Impact factor: 1.466
Authors: Salvatore T Scali; Catherine K Chang; Robert J Feezor; Philip J Hess; Thomas M Beaver; Tomas D Martin; Thomas S Huber; Adam W Beck Journal: J Vasc Surg Date: 2012-07-25 Impact factor: 4.268