Huang, Ying

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.

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.

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.

Purpose: To report the use of modified ex vivo renal artery (RA) reconstruction in a patient with 2 small right RAs (RRAs) in anticipation of planned fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysm (TAAA). Case Report: A staged hybrid repair was utilized in a patient with Extent II TAAA involving celiac axis (CA), superior mesenteric artery (SMA), single left RA (LRA), and 2 small (<3 mm) RRAs. The first-stage operation consisted of hepato-renal bypass using modified ex vivo renal reconstruction with single end-to-end anastomosis to both RAs using a saphenous vein graft. A second stage FB-EVAR was performed using patient-specific manufactured stent-graft with 3 fenestrations for the CA, SMA, and LRA 6 weeks later. The patient recovered with no complications. At 4 years, the patient had widely patent hepato-renal bypass and target vessels with normal renal function. Conclusion: The use of adjunctive hybrid procedures may optimize or facilitate FB-EVAR. In this patient, salvage of 2 small RAs was not ideally suited for branch stenting but was possible using modified ex vivo RA reconstruction with preservation of kidney parenchyma and function. Clinical Impact This case report illustrates a hybrid approach to overcome one of the most frequent limitations to total endovascular incorporation of renal arteries, eg small diameter, early bifurcation and multiple vessels. The modified ex vivo technique allows meticulous renal artery reconstruction without the deleterious effect of warm ischemia and without the cumbersome reconstruction of ureter and vein that is needed with traditional on table ex vivo auto transplantation. The technique is used in a minority of cases and adds the morbidity of open approach. Case selection is of paramount importance.

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 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.

Background Aortic syndromes (ASs), including aortic dissection, intramural hematoma, and penetrating aortic ulcer, carry significant acute and long-term morbidity and mortality. However, the contemporary incidence and outcomes of AS are unknown. Methods and Results We used the Rochester Epidemiology Project record linkage system to identify all Olmsted County, MN, residents with AS (1995–2015). Diagnostic imaging, medical records, and death certificates were reviewed to confirm the diagnosis and AS subtype. Age- and sex-adjusted incidence rates were estimated using annual county-level census data. Survival for patients with AS was compared with age- and sex-matched controls using Cox regression to adjust for comorbid conditions. We identified 133 patients with AS (77, aortic dissection; 21, intramural hematoma; and 35, penetrating aortic ulcer). Average age was 71.8 years (SD=14.1), and 57% were men. The age- and sex-adjusted incidence was 7.7 per 100 000 person-years, was higher for men than women (10.2 versus 5.7 per 100 000 person-years), and increased with age. Among subtypes, the incidence of aortic dissection was highest (4.4 per 100 000 person-years), whereas the incidence of penetrating aortic ulcer and intramural hematoma was lower (2.1 and 1.2 per 100 000 person-years). Overall, the incidence of AS was stable over time ( P trend=0.33), although the incidence of penetrating aortic ulcer seemed to increase from 0.6 to 2.6 per 100 000 person-years ( P =0.008) with variability over the study interval. Patients with AS had more than twice the mortality rate at 5, 10, and 20 years when compared with population-based controls (5-, 10-, and 20-year mortality 39%, 57%, and 91% versus 18%, 41%, and 66%; overall adjusted mortality hazards ratio=2.1; P <0.001). Survival was lower than expected up to 90 days after AS diagnosis and did not differ significantly by subtype or by 5-year strata of diagnosis. Conclusions Overall, the incidence of aortic dissection and intramural hematoma has remained stable since 1995, despite the decline noted for other cardiovascular disease. AS confers increased early and long-term mortality that has not changed. These data highlight the need to improve long-term care to impact the prognosis of this patient group.

Objective Relationships between duplex findings and data on health-related quality of life (QoL) to assess long-term results of treatment of varicose veins and chronic venous insufficiency (CVI) are not well known. The goal of this review was to correlate duplex findings and QoL assessments in clinical studies with long-term follow-up. Methods A review of the English language literature on PUBMED revealed 17 clinical studies, including 9 randomized controlled trials (RCTs), 6 prospective, and 2 retrospective studies that included patients with at least 5-year follow-up after endovenous laser ablation (EVLA), radiofrequency ablation (RFA), ultrasound-guided foam sclerotherapy (UGFS), and traditional superficial venous surgery. Results At 5 years, great saphenous vein (GSV) occlusion rate on duplex ultrasound ranged from 66% to 82% for EVLA, from 62% to 92% for RFA, from 41% to 58% for UGFS and from 54% to 85% for surgery. Freedom from GSV reflux rates were 82% and 84%, respectively for EVLA and surgery, and ranged between 84% and 95% for RFA. Significant improvements were observed in several domains of generic QoL and in most domains of venous disease-specific QoL, irrespective of the treatment. In at least one RCT, CIVIQ scores correlated well with abnormal duplex findings in patients who underwent treatment with UGFS. In another RCT, long-term AVVQ was significantly better after surgery as compared with UGFS similar to results of duplex findings. Conclusions Analysis of the available literature confirmed that all four techniques were effective in the abolishment of reflux or obliteration of the GSV. Moreover, well-designed RCTs with large sample size are needed to produce robust long-term data on clinical outcome after treatment of varicose veins and CVI and to better understand the relationships between duplex-derived data and QoL assessments.