Death resulted from branch stent complications in only two patients
June 8, 2012 Contact: Sue Crosson-Knutson 312-334-2311 firstname.lastname@example.org
WASHINGTON, D.C. - Branches following complex aortic aneurysm repair appear to be durable and are rarely the cause of patient death following complex aortic aneurysm repair according to a study presented at the 66th Vascular Annual Meeting presented by the Society for Vascular Surgery®.
Tara Marie Mastracci, MD, a co-author from the department of vascular surgery at The Cleveland Clinic Foundation in Cleveland, OH, reviewed findings from her group’s study. The researchers gathered prospective data from 650 patients who underwent endovascular aortic repair with branched or fenestrated devices between 2001 and 2010.
“This physician-sponsored investigational device exemption trial included imaging studies and electronic records to supplement the dataset when necessary,” said Dr.Mastracci. “Branch stent reintervention, endoleak repair, stent fracture, migration, rupture and death were calculated. Time to event analysis was performed for a composite endpoint of reintervention for any branch. Univariable and multivariable analysis was performed to identify related variables and device failure was reported as a function of exponential decay to capture the loss of freedom from complications over time.”
Through nine years of follow up (mean 3 years, standard deviation SD [2.3]) secondary procedures were performed for 0.6 percent of celiac, 4 percent of superior mesenteric artery, 6 percent of right renal and 5 percent of left renal artery stents. Mean time to reintervention was 237 days (SD 354 days).
The 30 day, 1-year and 5-year freedom from any branch intervention was 98 percent (95 percent confidence interval [CI] 96-99 percent), 94 percent (95 percent CI 92-96 percent), 84 percent (95 percent CI 78-90 percent) respectively. Death resulted from branch stent complications in two patients, and was related to SMA thrombosis. Multivariable analysis revealed no factors as independent predictors of branch reintervention.
“The absence of long-term data on branch patency in open repair precludes comparison, yet the lower morbidity and mortality risk coupled with longer-term durability data will further alter the balance of repair options,” added Dr. Mastracci.
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