One-Year Outcomes From an International Multicenter Study of Zenith TX2 Low Profile Endovascular Graft for Thoracic Endovascular Repair

Abstract

OPG cohort were stratified into low-risk and high-risk groups based on age, distal target, poor conduit quality, and procedures performed for tissue loss. However, in the era of endovascular revascularization, few patients who undergo LEB fall into the low-risk OPG category. Therefore, the goal of this study was to determine safety and efficacy measures for those patients who do not fall into the OPG cohort. Methods: All patients who underwent LEB for CLI in the Vascular Study Group of New England database from 2003 to 2013 were identified. Patients were stratified by OPG criteria into OPG and non-OPG cohorts, and the OPG cohort was divided into high-risk and low-risk strata. Outcomes included 30-day major adverse limb event, 30-day major adverse cardiac event (MACE), 1-year survival, 1-year limb salvage, and 1-year primary patency rates. Results: We identified 4190 patients: 2649 (63%) OPG and 1541 (37%) non-OPG. Of the OPG cohort, 2506 (95%) were high risk, 143 (5%) were low risk. A total of 1467 (35%) had a previous bypass (43% non-OPG, 30% OPG; P < .001). The 30-day major adverse limb event was 5.6% (6% non-OPG, 5.4% OPG; P 1⁄4 .36), and the MACE was 8.3% (10.3% non-OPG, 7.1% OPG; P < .001). At 1 year, limb salvage was 85% (77% non-OPG, 89% OPG; P < .001), survival was 83% (75% nonOPG, 87% OPG; P < .001), and primary patency was 70% (72% OPG, 66% non-OPG; P 1⁄4 .009). Conclusions: In contemporary practice, 97% of patients undergoing LEB for CLI would be excluded or considered high risk based on the Society for Vascular Surgery OPG criteria and therefore cannot be held to this standard. For the non-OPG group, the 30-day MACE of 10.3%, 1-year limb salvage of 77%, and 1-year survival of 75% are lower than OPG metrics but are more realistic in this high-risk cohort of patients.