5-Year Outcomes of Endovascular Treatment for Aortic Dissection From the Global Registry for Endovascular Aortic Treatment

Abstract

Global Registry for Endovascular Aortic Treatment (GREAT) is an International prospective multicenter registry collecting real-world data on performance of W. L. Gore (Flagstaff, AZ) aortic endografts. The purpose is to analyze long term outcomes/patient survival and device performance in patients undergoing thoracic endovascular aortic repair (TEVAR) for acute/chronic and complicated/uncomplicated Type B aortic dissection (TBAD). From August 2010 to October 2016, 5014 patients were enrolled in the GREAT registry. The study population were patients treated with TEVAR for TBAD through 5-year follow-up (day 0-2006). The primary outcomes for this analysis were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, and any reintervention through 5-years. 265 patients were identified. Mean age was 60.9 ± 11.9 years [range, 19-84 years; 211 (79.6%) males]. Devices used were GORE® TAG® and Conformable GORE® TAG® Thoracic Endoprosthesis (TAG/CTAG) (W.L. Gore, Flagstaff, AZ). 228 patients (86.0%) underwent primary endovascular treatment [144 (54.3%) off-label]. 22 (8.3%) underwent reintervention after prior endovascular procedure, 15 (5.7%) underwent reintervention after prior open procedure. Kaplan-Meier estimated freedom from all-cause mortality at 5 years was 71.1%. Freedom from aortic-related mortality through 5 years was 95.8%. There was no significant difference in freedom from all-cause mortality during the follow-up period in complicated or uncomplicated disease. At 30 days and through 5 years respectively for all following outcomes, aortic rupture rate was 1.1% (n=3) and 1.9% (n=5). Stroke rate was 1.1% (n=3) and 4.2% (n=11). Spinal cord ischemic event rate was 1.5% (n=4) and 2.6% (n=7). Re-interventions were required in 6.4% (n=17) and 21.1% (n=56) of patients. Need for conversion to open repair was 0.4% (n=1) and 2.6% (n=7). Additional graft placement was required in 3 patients (1.1%) and 16 patients (6.0%). Endoleak rate at 30 days was 3.4% [n=9; Type IA (n=1; 0.4%), Type IB (n=4; 1.5%), Type II (n=1; 0.4%), Type III (n=1; 0.4%) and unspecified (n=4; 1.6%)]. Through 5 years, endoleak rate was 12.1% [n=32; Type IA (n=7; 2.6%), Type IB (n=10; 3.8%), Type II (n=9; 3.4%), Type III (n=2; 0.8%) and unspecified (n-12, 4.5%)]. There were no cases of stent migration, compression or fracture through 5 years. Results at 5-year follow-up demonstrate that the use of TAG/CTAG can be supported in treatment of TBAD (acute, chronic, complicated and uncomplicated). These data demonstrate strong device durability, beneficial patient outcomes, and support for treatment of thoracic aortic dissection with an endovascular approach. Complete 10-year follow-up in GREAT as planned will be advantageous.