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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, MD, MBA
1, Trung Nguyen, DO
1, Xinyan Zheng, MS
2, Jialin Mao, MD, PhD
2, Andrew H. Matar, MD
1, Benjamin S. Brooke, MD, PhD
3, Jean Bismuth, MD
1, David H. Stone, MD
4, Salvatore T. Scali, MD
5.
1University of South Florida, Tampa, FL, USA,
2Weill Cornell Medical College, New York, NY, USA,
3University of Utah, Salt Lake City, UT, USA,
4Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA,
5University of Florida, Gainesville, FL, USA.
Objective: Multiple factors contribute to failure after thoracic endovascular aortic repair (TEVAR). The impact of device diameter on TEVAR outcomes is unknown. This study aimed to determine whether there is an increased risk of adverse outcomes among patients undergoing TEVAR with large diameter (≥40mm) endografts.
Methods: All TEVAR procedures involving Ishimaru zones 0-7 in the SVS-VQI from 2016-2019 were identified and linked to VQI-VISION Medicare claims data to provide long-term follow-up. The cohort was stratified based on endograft diameter, identifying those with at least one endograft ≥40mm (vs. <40mm). Pre-, intra-, and post-operative variables were compared between groups. The primary outcome measure was an aggregate of freedom from aortic-related reintervention, rupture, and all-cause mortality. Cox regression was performed across outcome measures.
Results: A total of 2,259 patients were analyzed, 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%) with hypertension(n=2059, 91%). Patients receiving ≥40mm endografts were more likely to be men(n=412, 61% vs. n=828, 53%; p=.0004) with larger 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 ≥40mm endografts were more likely to have aneurysmal pathology(n=528, 78% vs. n=935, 59%; p<.0001) compared to acute dissection/IMH/PAU and more likely to have disease involving the arch/descending thoracic aorta(n=463, 71% vs. n=873, 58%; p<.0001) rather than more distal thoracoabdominal aorta. Procedure time, fluoroscopy exposure, and contrast volume were greater in the ≥40mm endograft group. Patients with large endografts had significantly worse 30-day mortality(n=76, 11% vs. n=126, 8%; p=.02) and complication rates(n=214, 32% vs. n=386, 25%; p=.0006). The 1-year and 3-year aggregate rates of freedom from aortic-related reintervention, rupture, and all-cause mortality were significantly worse in those with large endografts (
Figure). 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 1.010-1.024]), and female sex(HR 1.24;[95%CI 1.001-1.539]).
Conclusions: Endograft diameters ≥40mm are associated with worse outcomes following TEVAR. Aortic-related reintervention and all-cause mortality were significantly worse at 3-years. Device regulators may need to reassess the efficacy of ≥40mm endografts as these results identify a device-specific parameter that is strongly associated with longitudinal risks.
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