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Multicenter Study
. 2024 Oct 22;150(17):1343-1353.
doi: 10.1161/CIRCULATIONAHA.123.068234. Epub 2024 Jul 11.

Early and Late Aortic-Related Mortality and Rupture After Fenestrated-Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysms: A Prospective Multicenter Cohort Study

Gustavo S Oderich  1 , Ying Huang  1 , William S Harmsen  2 , Emanuel R Tenorio  1 , Andres Schanzer  3 , Carlos H Timaran  1 , Darren B Schneider  4 , Bernardo C Mendes  5 , Matthew J Eagleton  6 , Mark A Farber  7 , Warren J Gasper  8 , Adam W Beck  9 , Matthew P Sweet  10 , W Anthony Lee  11 ; United States Aortic Research Consortium
Collaborators, Affiliations
Multicenter Study

Early and Late Aortic-Related Mortality and Rupture After Fenestrated-Branched Endovascular Aortic Repair of Thoracoabdominal Aortic Aneurysms: A Prospective Multicenter Cohort Study

Gustavo S Oderich et al. Circulation. .

Abstract

Background: Fenestrated-branched endovascular aortic repair (FB-EVAR) has been used as a minimally invasive alternative to open surgical repair to treat patients with thoracoabdominal aortic aneurysms (TAAAs). The aim of this study was to evaluate aortic-related mortality (ARM) and aortic aneurysm rupture after FB-EVAR of TAAAs.

Methods: Patients enrolled in 8 prospective, nonrandomized, physician-sponsored investigational device exemption studies between 2005 and 2020 who underwent elective FB-EVAR of asymptomatic intact TAAAs were analyzed. Primary end points were ARM, defined as any early mortality (30 days or in hospital) or late mortality from aortic rupture, dissection, organ or limb malperfusion attributable to aortic disease, complications of reinterventions, or aortic rupture. Secondary end points were early major adverse events, TAAA life-altering events (defined as death, permanent spinal cord injury, permanent dialysis, or stroke), all-cause mortality, and secondary interventions.

Results: A total of 1109 patients were analyzed; 589 (53.1%) had extent I-III and 520 (46.9%) had extent IV TAAAs. Median age was 73.4 years (interquartile range, 68.1-78.3 years); 368 (33.2%) were women. Early mortality was 2.7% (n=30); congestive heart failure was associated with early mortality (odds ratio, 3.30 [95% CI, 1.22-8.02]; P=0.01). Incidence of early aortic rupture was 0.4% (n=4). Incidence of early major adverse events and TAAA life-altering events was 20.4% (n=226) and 7.7% (n=85), respectively. There were 30 late ARMs; 5-year cumulative incidence was 3.8% (95% CI, 2.6%-5.4%); older age and extent I-III TAAAs were independently associated with late ARM (each P<0.05). Fourteen late aortic ruptures occurred; 5-year cumulative incidence was 2.7% (95% CI, 1.2%-4.3%); extent I-III TAAAs were associated with late aortic rupture (hazard ratio, 5.85 [95% CI, 1.31-26.2]; P=0.02). Five-year all-cause mortality was 45.7% (95% CI, 41.7%-49.4%). Five-year cumulative incidence of secondary intervention was 40.3% (95% CI, 35.8%-44.5%).

Conclusions: ARM and aortic rupture are uncommon after elective FB-EVAR of asymptomatic intact TAAAs. Half of the ARMs occurred early, and most of the late deaths were not aortic related. Late all-cause mortality rate and the need for secondary interventions were 46% and 40%, respectively, 5 years after FB-EVAR.

Registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02089607, NCT02050113, NCT02266719, NCT02323581, NCT00583817, NCT01654133, NCT00483249, NCT02043691, and NCT01874197.

Keywords: aortic aneurysm, thoracoabdominal; aortic rupture; aortic-related mortality; fenestrated-branched endovascular aneurysm repair.

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Conflict of interest statement

Dr Oderich has received consulting fees and grants from Cook Medical, W.L. Gore, Centerline Biomedical, and GE Healthcare (all paid to Mayo Clinic and the University of Texas Health Science at Houston with no personal income). Dr Schanzer received funding from Cook Medical, Philips, and Artivion. Dr Timaran received funding from Cook Medical and W.L. Gore. Dr Schneider reports funding from Cook Medical, W.L. Gore, Endologix, and Medtronic. Dr Mendes received funding from Cook Medical, W.L. Gore, and Medtronic. Dr Farber reports funding from Cook Medical, W.L. Gore, ViTaaa, Centerline, and Getinge. Dr Beck received funding from Artivion, Cook Medical, Medtronic, W.L. Gore, and Terumo (all paid to his university). Dr Sweet received funding from Artivion. Dr Lee received funding from Terumo Aortic, W.L. Gore, and Cook Medical. The other authors report no conflicts.

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