Eagleton, Matthew J.

Objective: To assess patient radiation exposure as reflected by cumulative air kerma (CAK) and dose area product (DAP) during fenestrated-branched endovascular aortic repair (FB-EVAR). Background: Patient radiation exposure during FB-EVAR has been reported inconsistently. Methods: Data from 2,111 patients enrolled in 10 physician-sponsored investigational device exemption studies (2012-2022) were analyzed from the United States Aortic Research Consortium database. Procedures were performed using seven fixed imaging systems (A to G). Patients were classified into three groups by imaging era: 2012-2015 (Group 1), 2016-2018 (Group 2), and 2019-2022 (Group 3). Primary endpoints were CAK and DAP risk factors, assessed using linear mixed-effect models. Secondary endpoints were diagnostic reference levels (DRL) for FB-EVAR. Results: Of the 2,111 patients (71% males; mean 74±9 years years-old) treated by FB-EVAR; 263 (12%) were in Group 1, 541 (26%) in Group 2, and 1,307 (62%) in Group 3. Use of ≥4 vessel stent-graft designs increased from 69% (Group 1) to 79% (Group 3) ( P <0.001). Median CAK decreased from 3,644 mGy (Group 1) to 1,753 mGy (Group 3), and DAP from 441 Gy.cm² to 208 Gy.cm² ( P <0.001). Higher BMI, iliac branch device (IBD) use, and longer fluoroscopy time (FT) were associated with increased CAK and DAP, while experienced operators and systems D, F, and G were protective ( P <0.05). DRLs for Group 3 were 2,800 mGy (CAK) and 340 Gy.cm² (DAP). Conclusions: Radiation exposure during FB-EVAR significantly decreased over time. Higher BMI, IBD use, and FT were linked to increased exposure, while experienced operator and System D, F or G were protective. Trial registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02043691 NCT00583817 NCT00483249 NCT01937949 NCT02050113 NCT02323581 NCT01874197 NCT01654133 NCT02266719.

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.

Objective: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). Background: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. Methods: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006–2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. Results: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P<0.001) and rates of MAEs (34% vs 20%, P<0.001). Median follow-up was 15 months (interquartile range, 7–37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P<0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50–2.44; P<0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63–3.62; P<0.001). Conclusions: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Objective: To report mid-term outcomes of renal-mesenteric target arteries (TAs) after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal and thoracoabdominal aortic aneurysm. Background: TA instability (TAI) is the most frequent indication for reintervention after FB-EVAR. Methods: Data from consecutive patients enrolled in 9 prospective nonrandomized physician-sponsored investigational device exemption studies between 2005 and 2020 were reviewed. TA outcomes through 5 years of follow-up were analyzed for vessels incorporated by fenestrations or directional branches (DBs), including TA patency, endoleak, integrity failure, reintervention, and instability. Results: A total of 1681 patients had 6349 renal-mesenteric arteries were targeted using 3720 fenestrations (59%), 2435 DBs (38%), and 194 scallops (3%). Mean follow was 23 ± 21 months. At 5 years, TAs incorporated by fenestrations had higher primary (95 ± 1% vs 91 ± 1%, P < 0.001) and secondary patency (98 ± 1% vs 94 ± 1%, P < 0.001), and higher freedom from TAI (87 ± 2% vs 84 ± 2%, P = 0.002) compared with TAs incorporated by DBs, with no differences in other TA events. DBs targeted by balloon-expandable stent-grafts had significantly lower freedom from TAI (78 ± 4% vs 88 ± 1%, P = 0.006), TA endoleak (87 ± 3% vs 97 ± 1%, P < 0.001), and TA reintervention (83 ± 4% vs 95 ± 1%, P < 0.001) compared with those targeted by self-expandable stent-grafts Conclusions: Incorporation of renal and mesenteric TA during FB-EVAR is safe and durable with high 5-year patency rates and low freedom from TAI. DBs have lower patency rates and lower freedom from TAI than fenestrations, with better performance for self-expandable stent grafts as compared with balloon-expandable stent grafts.