Mendes, Bernardo C.

Objective: The aim of this study was to evaluate outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysms (TAAAs) and complex abdominal aortic aneurysms (CAAAs) in patients actively smoking at the time of repair compared with previous smokers and non-smokers. Methods: Single-center retrospective review of elective FB-EVARs for TAAA and CAAAs between 2007 and 2023 was conducted. Demographics, comorbidities, aneurysm extent/ morphology, technical details, and peri-operative outcomes were collected. Patients were grouped into 1 of 3 groups: active smokers, prior smokers, and never smokers. Patients who stopped smoking within 6 weeks to surgery were considered active smokers. Rupture and symptomatic aneurysms were excluded. Endpoints included early (<30 days) mortality and major adverse events (MAEs). Results: There were 676 patients (73% male, mean age 74 ± 7.8). There were 141 (21%) active smokers, 455 (67%) prior smokers, and 80 (12%) never smokers. Active smokers were significantly younger than prior or never smokers (71 ± 6.7, 75 ± 6.9, and 76 ± 12, respectively; P < .001). Cardiovascular risk factors were similar, except active smokers were significantly more likely to have chronic obstructive pulmonary disease (60% vs 42% vs 6.2%, P < .001) and peripheral arterial disease (31% vs 24% vs 10%, P = .002) when compared to prior and never smokers, respectively. Patients who never smoked had significantly more extent II aneurysms (34%) than prior (18%) and active (15%) smokers, P = .001. Univariable and multivariable logistic regression analyses showed no statistically significant associations between smoking status and any specific peri-operative adverse events following surgery. Conclusion: Active smoking status does not appear to affect peri-operative outcomes after FB-EVAR for complex aortic aneurysms. Although smoking cessation must be strongly encouraged, repair should not be delayed due to active smoking status. Clinical Impact These data suggest that active smoking, in isolation, should not be considered a contraindication to elective FB-EVAR when anatomy is suitable and patients are otherswise optimized. This is particularly relevant for high-risk patients who may have limited alternative treatment options. Proceeding with FB-EVAR in active smokers does not appear to compromise early safety or procedural efficacy.

Purpose: Familial history of aortic disease has been associated with increased risk of aneurysm-related complications after standard endovascular aortic repair. The aim of this study was to evaluate outcomes of fenestrated-branched endovascular aortic repair (FB-EVAR) for complex aortic aneurysms in patients with or without familial aortic aneurysms (FAAs). Materials and Methods: We reviewed the clinical data of consecutive patients enrolled in a prospective non-randomized study to investigate outcomes after FB-EVAR for treatment of complex aortic aneurysms between 2013 and 2022. Familial aortic aneurysm was defined as occurrence of an aortic aneurysm or dissections in a first- or second-degree relative and compared with patients with sporadic aortic aneurysms (SAAs). Endpoints included procedural metrics, 30-day mortality and major adverse events (MAEs), mid-term patient survival, freedom from reintervention and endoleak, and aneurysm sac shrinkage. Results: There were 499 patients treated with FB-EVAR (70% males, mean age was 74±7.7 years) including 66 (13%) patients with FAAs and 434 (87%) with SAAs. Both groups had similar demographics, clinical characteristics, aneurysm extent, and prior history of aortic dissection or aortic repair. Patients with FAAs had longer fluoroscopy time (82 vs 71 minutes) and radiation exposure (1856 vs 1213 mGy; each p<0.05), with no difference in technical success (FAA, 94% vs SAA, 97%; p=0.51). There was no difference in 30-day mortality (1.5% vs 0.9%; p=1.00) and MAEs (23% vs 18%; p=0.44) among patients with FAA and SAA, respectively. Median follow-up was 28 months. At 3 years, patient survival, freedom from secondary interventions, and cumulative incidence of sac shrinkage were 76±2.5%, 74±2.5%, and 32±2.6% for all patients, respectively, with no difference between FAA and SAA groups. Conclusion: Fenestrated-branched endovascular aortic repair was performed with high technical success, low mortality, and low incidence of MAEs regardless of the presence of FAA. There was no difference in mid-term patient survival, secondary interventions, and sac changes among patients with or without family history of aortic disease. Clinical Impact This study demonstrates that fenestrated-branched endovascular aortic repair (FB-EVAR) can be performed with high technical success and comparable early and mid-term outcomes in patients with or without a familial history of aortic aneurysm, after exclusion of genetically triggered aortic diseases. These findings challenge the assumption that family history alone should preclude complex endovascular repair. Clinically, this supports broader use of FB-EVAR in carefully selected patients with familial aortic disease, emphasizing anatomical suitability rather than pedigree alone. The innovation lies in validating FB-EVAR as a safe alternative to open repair for this understudied population, informing patient selection, counseling, and surveillance strategies.

Purpose: Fenestrated stent-grafts with proximal bare-metal fixation stent (BMFS) may provide better rotational movement to facilitate vessel catheterization, but novel designs with covered fixation stents (CFSs) have been increasingly utilized with lower profile fabric. This study aimed to evaluate procedural metrics and outcomes of fenestrated endovascular repair (FEVAR) using BMFS and CFS devices. Methods: Clinical data of 502 consecutive patients enrolled in a prospective, non-randomized investigational device exemption (IDE) study were reviewed. Patients with 4-vessel fenestrated stent-grafts with BMFS or CFS for treatment of complex abdominal aortic aneurysms (CAAAs) and Extent IV thoracoabdominal aortic aneurysms (TAAAs) were included. Patients with Extent I-III TAAAs and stent-grafts designed with <4 fenestrations or scallops were excluded. Endpoints were technical success, radiation exposure, major adverse events (MAEs), patient survival, freedom from secondary interventions, and target artery instability (TAI). Results: There were 147 patients (29%; 85% male, median 75 years old) treated by FEVAR using 4-vessel fenestrated stent-grafts with BMFS in 79 patients or CFS in 68 patients. Patients treated with BMFS designs had significantly (p<0.05) higher prevalence of cigarette smoking and peripheral artery disease and less often had Extent IV TAAAs. Use of BMFS designs decreased from 88% (64/73) to 20% (15/74) after 2018 (p<0.001). Technical success was similar in patients treated with or without BMFS designs (99% vs 100%, p=0.47), but total operating time and cumulative air karma were significantly lower (p<0.05) in patients with CFS designs. Overall 30-day mortality was 1%, with no difference in mortality and MAEs among patients treated with or without BMFS (1% vs 1%, p=1.0 and 15% vs 12%, p=0.59), respectively. Patient survival at 1 and 3 years was 95%±2%, and 85%±4% for all patients with no difference between groups (p=0.51). Freedom from secondary interventions was 88%±3.6% for patients with BMFS and 86%±4.6% for those with CFS at 1 year (p=0.71), with also no difference at 3 years (p=0.55). Conclusion: FEVAR for CAAAs and Extent IV TAAAs was performed with high technical success, low mortality, and MAEs, independent of the use of BMFS. There is no difference in patient survival and freedom from secondary interventions in patients treated with or without BMFS. Clinical Impact One hundred forty-seven patients were treated with bare-metal fixation-stent (79) or covered fixation stents (68). Technical success was similar (p=.47). Overall 30-day mortality was 1%, with no difference in major adverse events (MAEs; p=.59). At 1- and 3-year, there was no difference in patient survival (p=.51), freedom from secondary intervention (p=.71). In conclusion, FEVAR for CAAAs and Extent IV TAAAs was performed with high technical success, low mortality and MAEs, independent of the use of bare-metal fixation stent.

Objective: Target vessel stenosis or occlusion is a common indication for secondary intervention after fenestrated-branched endovascular aortic repair requiring long-term imaging surveillance including duplex ultrasound (DUS). This study aimed to describe and compare longitudinal changes in peak systolic velocity (PSV) measurements for renal and mesenteric arteries targeted by directional branches (DBs) or reinforced fenestrations (RFs). Methods: Patients enrolled in a prospective, nonrandomized study (2013-2020) had DUS of celiac axis, superior mesenteric artery, and renal arteries (RAs) obtained preoperatively, at 6 to 8 weeks, 6 months, and annually. Vessels with preprocedural stenosis were excluded. Outcomes were variations in PSV over time for target vessels incorporated by DBs or RFs, differences in balloon-expandable stent-grafts (BESGs) and self-expandable stent-grafts (SESGs), PSV measurements prior to secondary interventions related to vessel stenosis, and a predictive value of PSV for stenosis requiring secondary intervention. Results: A total of 419 patients (292 male, mean age 74 ± 8 years old) were enrolled, with 1,311 target vessels analyzed preoperatively, including 607 mesenteric and 704 RAs. Over a median follow-up of 23 months (interquartile range [IQR], 7-36), PSV measurements decreased in the first 6 to 8 weeks after DB incorporation, remained stable, followed by a nonsignificant increase at 5 years. PSV increased in the first 6 months using RFs with postoperative velocities significantly higher ( P < .05) for RFs compared to DBs. Branched mesenteric vessels stented with BESGs had higher velocities than SESGs ( P < .05). Of the 23 target vessels treated by secondary intervention for stenosis, 19 (83%) had velocities above the thresholds for native, nonstented vessels. Furthermore, in RAs (n = 20) PSV effectively predicted clinically relevant stenosis, AUC was 0.98, with a 231 cm/s threshold offering 84% sensitivity with 100% specificity. Conclusion: Longitudinal follow-up shows that velocity changes vary depending on the type of incorporation, vessel, and bridging stent. For DBs, PSV decreased initially, stabilized, and showed a nonsignificant increase at 5 years. In contrast, PSV increased with RFs and remained higher than DBs. Despite these variations, velocities remained below established thresholds for clinically significant stenosis in nonstented vessels. Criteria for in-stent stenosis may differ, and PSV alone should not be the sole indicator for reintervention. Clinical Impact This study provides new insight into duplex ultrasound (DUS) surveillance after fenestrated and branched endovascular aneurysm repair (FB-EVAR). Peak systolic velocity (PSV) trends differed between fenestrations and branches, and stent type influenced flow dynamics. Importantly, most vessels with secondary interventions had elevated PSVs, but many others exceeded native stenosis thresholds without clinical consequence. Despite these variations, velocities remained below established thresholds for clinically significant stenosis in non-stented vessels. Criteria for in-stent stenosis may differ, and PSV alone should not be the sole indicator for reintervention.The reported PSV measurements served as a benchmark for DUS surveillance following FB-EVAR.

Objective: To evaluate treatment trends and compare outcomes following fenestrated-branched endovascular aortic repair (FB-EVAR) versus open surgical repair (OSR) of thoracoabdominal aortic aneurysms (TAAA). Background: FB-EVAR has been increasingly utilized as a less invasive alternative to OSR for treatment of TAAAs. Methods: We studied patients who underwent elective FB-EVAR or OSR of TAAAs (2008-2020), since the initiation of an Advanced Endovascular Aortic Program. Primary endpoints were early major adverse events (MAE) and early and late all-cause mortality. Propensity score overlap weighting analysis was performed to adjust for measured confounders between groups. Results: There were 357 (70.8%) patients treated by FB-EVAR and 147 (29.2%) with OSR. The use of FB-EVAR increased from 16.7% in 2008 to >80% since 2017 ( P <0.001). Incidences of early MAEs were 25.8% and 49.0%, respectively; early mortality rates for FB-EVAR and OSR were 2.5% and 6.8%, respectively. In the weighted cohort, FB-EVAR patients had decreased early MAEs (weight-adjusted odds ratio [aOR], 0.28; 95% confidence interval [CI], 0.18-0.41; P <0.001) and mortality (aOR, 0.35; 95% CI, 0.17-0.73; P =0.005) versus OSR patients. Five-year survival estimates were 52.2% (95% CI, 45.2-60.4%) and 78.0% (95% CI, 70.6-86.2%), respectively. In the weighted cohort, there was no significant difference in late survival between groups (weight-adjusted hazard ratio, 1.33; 95% CI, 0.74-2.39; P =0.34). Conclusions: This study confirmed the change in practice from OSR to FB-EVAR for treatment of TAAAs over the past decade. Incidences of early MAEs and mortality were lower with FB-EVAR, with no significant difference in late survival in the weighted cohort.

Recurrent coarctation of the aorta (reCoA) can be treated via redo surgical or endovascular means with the latter option providing a shorter hospitalization, expedient recovery, and a lower incidence of early morbidity and mortality. A common barrier to endovascular repair with standard thoracic endografts is the proximity of the left subclavian artery (LSA) to the reCoA which has previously necessitated adjunctive open revascularization or additional off-label endovascular techniques. This case describes percutaneous endovascular repair of postsurgical reCoA and a poststenotic descending thoracic aortic aneurysm with an off-the-shelf thoracic branched endograft incorporating the LSA with successful resolution of aortic pressure gradient and complete aneurysm exclusion. Clinical Impact This case highlights the use of a commercially available, off-the-shelf endograft to treat thoracic aortic coarctation and associated aortic aneurysm. The paper highlights unique technical points for use of the Gore Thoracic Branch Endoprosthesis in the off-label treatment of thoracic aortic coarctation which is an ideal endovascular option for lesions in proximity to the left subclavian artery.

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.

ImportanceFenestrated and branched endovascular aortic repairs (F/BEVAR) have been adopted by many centers. However, national trends of F/BEVAR use remain unclear, particularly at sites who perform them without an US Food and Drug Adminstration (FDA)–approved investigational device exemption (IDE).ObjectiveTo quantify the use of F/BEVAR in the US and to determine if mortality was different at IDE vs non-IDE sites.Design, Setting, and ParticipantsThis retrospective cohort study examined 100% fee-for-service Medicare claims data from 2016 to 2023. Participants were patients who underwent endovascular treatment of the visceral aorta incorporating 2 or more visceral artery endoprostheses. Hospitals with vs without an IDE were identified using hospitals’ Employer Identification Number as a time varying exposure.ExposureF/BEVAR.Main Outcomes and MeasuresTrends in the center-level F/BEVAR case volume stratified by IDE status were assessed using cumulative incidence curves. Mortality outcomes at 30 days and 3 years were compared using Kaplan-Meier methods and Cox proportional hazards models with adjustment for baseline patient characteristics.ResultsFrom 2016 to 2023, 8017 patients were treated with F/BEVAR at 549 hospitals. The median (IQR) age was 75.8 (71.3-80.8) years; 5795 patients (72.3%) were male and 2222 (27.7%) female. A total of 2226 F/BEVAR (27.8%) were performed at 22 hospitals with an IDE. The number of patients treated with F/BEVAR increased from 771 in 2016 to 1251 in 2023. The median (IQR) annual case volume per hospital was significantly higher at IDE sites (22.3 [11.0-30.4] vs 1.2 [1.0-2.0] cases/y; P &amp;lt; .001); 18 IDE sites (90.0%) and 20 non-IDE sites (3.7%) completed 9 or more cases per year. The 30-day mortality (3.0% vs 4.9%) but not 3-year mortality (26.0% vs 27.1%) was lower for patients treated at hospitals with vs without an IDE. After risk adjustment, both 30-day (odds ratio, 0.47; 95% CI, 0.32-0.69) and midterm mortality (hazard ratio, 0.81; 95% CI, 0.69-0.95) were lower for patients treated at IDE sites.Conclusions and RelevanceThe use of F/BEVAR is increasing across the United States, with the majority of cases being performed outside of IDE studies and at low-volume centers. F/BEVAR performed at non-IDE centers are associated with higher adjusted 30-day and midterm mortality. Transparent outcome reporting and identification of process measures from IDE sites may help achieve more equity in patient outcomes.

Objective: To compare target artery (TA) outcomes after fenestrated or branched endovascular aortic repair (FB-EVAR) versus open surgical repair (OSR) of thoracoabdominal aortic aneurysms (TAAAs). Background: Few studies have compared TA outcomes after endovascular incorporation and open reconstruction. Methods: Among consecutive patients who underwent elective OSR or FB-EVAR of TAAAs (2008–2020), we reviewed those who had postoperative imaging studies evaluating TA. Data of FB-EVAR patients were obtained from a prospectively maintained institutional database. TAs included celiac, superior mesenteric, right, and left renal arteries treated during TAAA repairs. The primary endpoint was TA patency (primary and secondary). Results: There were 131 patients (487 TAs) treated by OSR and 350 (1300 TAs) by FB-EVAR. In the OSR group, 440 TAs (90.3%) were reconstructed by bypasses, and 47 (9.7%) by reimplantation. In the FB-EVAR group, 841 TAs (64.7%) were incorporated by fenestrations and 459 (35.3%) by directional branches. Thirty-day TA primary patency rates were not significantly different between FB-EVAR and OSR (99.4%% vs 99.0%, P = 0.36), but the secondary patency rate was higher after FB-EVAR (99.8% vs 99.0%, P = 0.02). Three-year primary patency rates were 95.9% (95% CI: 94.7%–97.2%) and 94.7% (95% CI: 92.2%–97.2%), respectively; secondary patency rates were 98.5% (95% CI: 97.7%–99.2%) and 94.7% (95% CI: 95.7%–99.2%), respectively. There were no significant differences in late primary patency and secondary patency between groups (each P < 0.05). Conclusions: TA primary and secondary patency rates following elective OSR or FB-EVAR were high. Endovascular repair was not associated with loss of primary patency and late secondary patency.

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.