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Large Endograft Diameter is Associated with Poor Short- and Mid-term Outcomes following Thoracic Endovascular Aortic Aneurysm Repair
Dean J Arnaoutakis
1, Trung Nguyen
1, Xinyan Zheng
2, Jialin Mao
2, Andrew H. Matar
1, Benjamin S. Brooke
3, Jean Bismuth
1, David H. Stone
4, Salvatore T. Scali
5 1University of South Florida, Tampa, FL;
2Weill Cornell Medical College, New York, NY;
3University of Utah, Salt Lake City, UT;
4Dartmouth-Hitchcock Medical Center, Lebanon, NH;
5University of Florida, Gainesville, FL
Objective: Multiple factors contribute to early and/or late failure after endovascular aortic repair. Notably, the impact of device-related parameters, specifically diameter, on postoperative outcomes following thoracic endovascular aortic aneurysm repair (TEVAR) has not been thoroughly explored. This study aimed to determine whether there is an increased risk of adverse outcomes among patients who received large diameter (≥40mm) endografts at the time of TEVAR.
Methods: All TEVAR procedures involving proximal Ishimaru zones 0-7 in the SVS-VQI from 2016-2019 were identified. Patients were linked to the Medicare claims data (VQI-VISION) to provide long-term follow-up. The cohort was stratified based on endograft diameter, specifically identifying those with at least one endograft ≥40mm (vs. <40mm). Preoperative characteristics, operative variables, and postoperative outcomes were compared between groups. The primary outcome measure was a composite of aortic-related reintervention, rupture, and all-cause mortality. Unadjusted and adjusted Cox regression analyses were performed across outcome measures.
Results: A total of 2,259 patients met inclusion criteria, with 681 (30.1%) receiving at least one ≥40mm diameter endograft. The overall cohort was elderly (74±9.1 years), predominantly white (n=1760, 78%) and a majority had hypertension (n=2059, 91%). Patients receiving large endografts (≥40mm) were more likely to be men (n=412, 61% vs. n=828, 53%; p=.0004) with larger preoperative aneurysm diameters (60mm [IQR54-67mm] vs. 54mm [IQR40-61]; p<.0001) who had prior aortic surgery (n=306, 45% vs. n=390, 25%; p<.0001). Patients with large endografts were more likely to have aneurysmal pathology (n=528, 78% vs. n=935, 59%; p<.0001) as opposed to acute dissection/IMH/PAU. Large endograft deployments were more likely to occur for disease extent involving the aortic arch and descending thoracic aorta (n=463, 71% vs. n=873, 58%; p<.0001) rather than more distal thoracoabdominal disease. Procedures tended to be more complex for patients with large endografts, as evidenced by longer procedure times, increased fluoroscopy exposure, and higher contrast volume use. Patients with large endografts had significantly worse 30-day mortality and complication rates (
Table). The 1-year and 3-year composite rate of aortic-related reintervention, rupture, and all-cause mortality were significantly worse in those with large endografts (
Figure). This finding was primarily driven by differences in aortic-related reintervention and all-cause mortality. Independent predictors of aortic-related reintervention included endograft ≥40mm (HR 1.38;[95%CI 1.104-1.730]), aneurysm size (HR 1.02;[95%CI 1.01-1.02]), and female sex (HR 1.24;[95%CI 1.00-1.54]).
Conclusions: Large endograft diameters (≥40mm) are associated with worse short- and mid-term outcomes following TEVAR. Although there was no significant difference in late rupture events, aortic-related reintervention and all-cause mortality were significantly worse at 3-years. Treatment success should be heavily scrutinized when using large diameter endografts, as these results identify a device-specific parameter that is strongly associated with longitudinal risks. Device regulators may need to reassess the efficacy of large diameter thoracic endografts.
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