Endovascular treatment for thoracic aortic disease from the Global Registry for Endovascular Aortic Treatment

Abstract

ObjectiveGlobal Registry for Endovascular Aortic Treatment (GREAT) is an international prospective multicenter registry collecting real-world data on performance of W. L. Gore thoracic and abdominal aortic endografts. This analysis evaluated the long-term differences in patient survival and device performance in patients undergoing thoracic endovascular aortic repair (TEVAR) for any thoracic aortic pathology. MethodsFrom August 2010 to October 2016, 5014 patients were enrolled in GREAT. The population of interest was comprised of only patients treated for thoracic aortic pathologies. Through 5 years, primary outcomes were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, paraplegia, and any reintervention through 5 years, grouped by pathology. Secondary outcomes were reintervention rate and freedom from serious device- and aortic-related events. ResultsThe 578 patients with thoracic aortic pathologies enrolled in GREAT and identified for this analysis were categorized by common pathologies: thoracic aneurysm (n = 239), thoracic dissection (n = 203), arch (n = 26), and other (n = 110). The mean age of this population was 66.1 ± 12.8 years, and 64.7% were male. Procedure survival was 99.7%. In the overall group, at index procedure to 30 days and 31 days to 5 years, Kaplan-Meier estimates of freedom from all-cause mortality were 99.6% and 66.4%, respectively, and for aortic-related mortality were 97.7% and 94.6%, respectively. Aortic rupture rate was 0.5% (n = 3) at 30 days and 1.4% (n = 8) through 5 years. Stroke and spinal cord ischemic events were 1.9% (n = 11) and 1.6% (n = 9) at 30 days and at 5 years were 3.6% (n = 20), 0.5% (n = 3), respectively. Reinterventions were required in 7.3% (n = 42) at 30 days and 12.4% (n = 69) through 5 years. The number of patients with endoleaks at 30 days was 2.1% (n = 12): n = 3 (1.1%) for each of types IA, 1B, and II; n = 2 (0.3%) for type III; and n = 4 (0.7%) for unspecified. Through 5 years, the percentage of patients was 8.3% (n = 40): n = 15 (3.1%) for type IA; n = 10 (2.1%) for type IB; n = 11 (2.3%) for type II; and n = 9 (1.9%) for unspecified. One patient (0.2%) had stent migration at 30 days (aneurysm group); none were reported through 5 years. There were no incidents of stent compression or fracture from index procedure through 5 years. ConclusionsData herein demonstrates durability and support for treatment of thoracic aortic disease with the GORE TAG conformable thoracic stent graft, including no incidents of stent compression/fracture and high freedom from aortic-related mortality. The planned analysis of follow-up to 10 years in GREAT will be beneficial.