Effect Of Fenestration Configuration On Renal Artery Outcomes During Fenestrated-Branched Endovascular Aortic Repair.

OBJECTIVES: To evaluate the effect of fenestration configuration and fenestration gap on renal artery outcomes during fenestrated-branched endovascular aortic repair (F/BEVAR). METHODS: A retrospective multicenter analysis was performed, including patients with complex aortic aneurysms treated with F/BEVAR that incorporated at least one small fenestration to a renal artery. The renal fenestrations were divided into groups 1 (8x6 mm) and 2 (6x6 mm). Primary patency, target vessel instability (TVI), freedom from secondary interventions (SIs), occurrence of type IIIc endoleak, all related to the renal arteries, were analyzed at 30-day, 1-year, and 5-year landmarks. The fenestration gap (FG) distance was analyzed as a modifier, and clustering was addressed at the patient level. RESULTS: Seven hundred and ninety-six patients were included in this study, 71.7% male, with a mean age of 73.3±8.1 years. The mean follow-up was 30.0±20.6 months. Of the 1474 small renal fenestrations analyzed, 47.6% were 8x6, and 52.4% were 6x6mm. At the 30-day landmark, primary patency (99.9% vs 98.0%, p-value <0.001 for groups 1 and 2, respectively), freedom from TVI (99.6% vs 97.1%, p-value <0.001 for groups 1 and 2, respectively), and freedom from SI (99.8% vs 98.4%, p-value = .022 for groups 1 and 2, respectively) were higher in 8x6 compared to 6x6 fenestrations, and the incidence of AKI was similar across the groups (92.6% vs 92.7%, p-value = .953 for groups 1 and 2 respectively). The primary patency at 1 and 5 years was higher in 8x6 fenestrations (1-year: 98.8% vs 96.9%; 5-year: 97.8% vs 95.7%, for groups 1 and 2, respectively, p values = .010 and 0.021 for 1 and 5 year comparisons, respectively). The freedom from SIs was significantly higher among 6x6 fenestrations at 5 years (93.1% vs 96.4%, for groups 1 and 2, respectively, p value = .007). The groups were equally as likely to experience a type Ic endoleak (1.3 % and 1.6% for 8x6 and 6x6mm fenestrations, respectively, p = .689). The 6x6 fenestrations were associated with higher risk of kidney function deterioration (17.8%) when compared with 8x6 fenestrations (7.6%) at 5 years (p <.001). The risk of type IIIc endoleak was significantly higher among 8x6 fenestrations at 5 years (4.9% and 2% for 8x6 and 6x6 mm fenestrations, respectively, p= .005). A FG ≥5 mm negatively impacted the cumulative 5-year freedom from TVI (group 1: FG ≥5 mm = 0.714, FG <5 mm = 0.857, p<.001; group 2: FG ≥5 mm = 0.761, FG <5 mm = 0.929, p<.001) and the cumulative 5-year freedom from type IIIc endoleak (group 1: FG ≥5 mm = 0.759, FG <5 mm = 0.921, p=.034; group 2: FG ≥5 mm = 0.853, FG <5 mm = 0.979, p<.001) in both groups and the cumulative 5-year patency in group 2 (group 1: FG ≥5 mm = 0.963, FG <5 mm = 0.948, p=.572; group 2: FG ≥5 mm = 0.905, FG <5 mm = 0.938, p=.036). CONCLUSIONS: Fenestration configuration for the renal arteries impacts outcomes. The 8x6 small fenestrations have better patency at 30-days, 1 year, and 5 years, while 6x6 small fenestrations are associated with lower rates of secondary interventions, primarily due to a lower incidence of type IIIc endoleaks. Fenestration gap ≥ 5 mm at the level of the renal arteries significantly impacts the freedom from TVI, freedom from type IIIc endoleak and 5-year patency independently of the fenestration size or vessel diameter.

Practice Patterns of Antiplatelet and Anticoagulant Therapy After Fenestrated/Branched Endovascular Aortic Repair.

OBJECTIVE: Antiplatelet and/or anticoagulant therapy are commonly prescribed after fenestrated/branched endovascular aortic repair (F/BEVAR). However, the optimal regimen remains unknown. We sought to characterize practice patterns and outcomes of antiplatelet and anticoagulant use in patients who underwent F/BEVAR. METHODS: Consecutive patients enrolled (2012-2023) as part of the United States Aortic Research Consortium (US-ARC) from ten independent physician-sponsored investigational device exemption (PS-IDE) studies were evaluated. The cohort was characterized by medication regimen on discharge from index F/BEVAR: 1. Aspirin alone OR p2y12 alone (single-antiplatelet therapy, SAPT), 2. Anticoagulant Alone, 3. Aspirin+p2y12 (dual-antiplatelet therapy, DAPT), 4. Aspirin+anticoagulant OR p2y12+anticoagulant (SAPT+Anticoagulant), 5. Aspirin+p2y12+anticoagulant (triple therapy, TT), and 6. No Therapy. Kaplan-Meier analysis and Cox proportional hazards modeling were used to compare 1-year outcomes including survival, target artery patency, freedom from bleeding complication, freedom from all reinterventions, and freedom from stent-specific reintervention. RESULTS: Of the 1525 patients with complete exposure and outcome data, 49.6% were discharged on DAPT, 28.8% on SAPT, 13.6% on SAPT+Anticoagulant, 3.2% on TT, 2.6% on Anticoagulant Alone, and 2.2% on No Therapy. Discharge medication regimen was not associated with differences in 1-year survival, bleeding complications, composite reintervention rate, or stent-specific reintervention rate. However, there was a significant difference in 1-year target artery patency. On multivariable analysis comparing to SAPT, DAPT conferred a lower hazard of loss of target artery patency (HR 0.48, 95% CI 0.27-0.84, p=0.01). On sub-analyses of renal stents alone or visceral stents alone, DAPT no longer had a significantly lower hazard of loss of target artery patency (Renal: HR 0.66, 95% CI 0.35-1.27, p=0.22. Visceral: HR 0.31, 95% 0.05-1.9, p=0.21). Lastly, duration of DAPT therapy (1 month, 6 months, or 1 year) did not significantly affect target artery patency. CONCLUSIONS: Practice patterns for antiplatelet and anticoagulant regimens after F/BEVAR vary widely across the US-ARC. There were no differences in bleeding complications, survival or reintervention rates among different regimens, but higher branch vessel patency was noted in the DAPT cohort. These data suggest there is a benefit in DAPT therapy. However, the generalizability of this finding is limited by the retrospective nature of this data, and the clinical significance of this finding is unclear, as there is no difference in survival, bleeding, or reintervention rates amongst the different regimens. Hence, an "optimal" regimen, including the duration of such regimen, could not be clearly discerned. This suggests equipoise for a randomized trial, nested within this cohort, to identify the most effective antiplatelet/anticoagulant regimen for the growing number of patients being treated globally with F/BEVAR.

Five-year outcomes of fenestrated and branched endovascular repair of complex aortic aneurysms based on aneurysm extent.

OBJECTIVE: The aim of this study was to evaluate the 5-year outcomes of fenestrated/branched endovascular aortic repair (F/BEVAR) for the treatment of complex aortic aneurysms stratified by the aneurysm extent. METHODS: Patients with the diagnosis of complex aortic aneurysm, who underwent F/BEVAR at a single center were included in this study and retrospectively analyzed. The cohort was divided according to the aneurysm extent, comparing group 1 (types I-III thoracoabdominal aneurysms [TAAAs]), group 2 (type IV TAAAs), and group 3 (juxtarenal [JRAAs], pararenal [PRAAs], or paravisceral [PVAAs] aortic aneurysms). The primary endpoints were 30-day and 5-year survival. The secondary endpoints were technical success, occurrence of spinal cord ischemia, primary patency of the visceral arteries, freedom from target vessel instability, and secondary interventions. RESULTS: Of 436 patients who underwent F/BEVAR between July 2012 and May 2023, 131 presented with types I to III TAAAs, 69 with type IV TAAAs, and 236 with JRAAs, PRAAs, or PVAAs. All cases were treated under a physician-sponsored investigational device exemption protocol with a patient-specific company-manufactured or off-the-shelf device. Group 1 had significantly younger patients than group 2 or 3 respectively (69.6 ± 8.7 vs 72.4 ± 7.1 vs 73.2 ± 7.3 years; P < .001) and had a higher percentage of females (50.4% vs 21.7% vs 17.8%; P < .001). Prior history of aortic dissection was significantly more common among patients in group 1 (26% vs 1.4% vs 0.9%; P < .001), and mean aneurysm diameter was larger in group 1 (64.5 vs 60.7 vs 63.2 mm; P = .033). Comorbidities were similar between groups, except for coronary artery disease (P < .001) and tobacco use (P = .003), which were less prevalent in group 1. Technical success was similar in the three groups (98.5% vs 98.6% vs 98.7%; P > .99). The 30-day mortality was 4.5%, 1.4%, and 0.4%, in groups 1, 2, and 3, respectively, and was significantly higher in group 1 when compared with group 3 (P = .01). The incidence of spinal cord ischemia was significantly higher in group 1 compared with group 3 (5.3% vs 4.3% vs 0.4%; P = .004). The 5-year survival was significantly higher in group 3 when compared with group 1 (P = .01). Freedom from secondary intervention was significantly higher in group 3 when compared with group 1 (P = .003). At 5 years, there was no significant difference in freedom from target vessel instability between groups or primary patency in the 1652 target vessels examined. CONCLUSIONS: Larger aneurysm extent was associated with lower 5-year survival, higher 30-day mortality, incidence of secondary interventions, and spinal cord ischemia. The prevalence of secondary interventions in all groups makes meticulous follow-up paramount in patients with complex aortic aneurysm treated with F/BEVAR.

Current outcomes following upper and lower extremity arterial trauma from the National Trauma Data Bank.

OBJECTIVE: The modern treatments of trauma have changed in recent years. We aim to evaluate the factors associated with limb salvage and mortality after extremity arterial trauma, especially with respect to the type of conduit used in revascularization. METHODS: The National Trauma Data Bank was queried to identify patients with upper and lower extremity (UE and LE) arterial injuries between 2016 and 2020. The patients were stratified by the types of arterial repair. The primary outcome was in-hospital mortality. RESULTS: 8780 patients were found with 5054 (58%) UE and 3726 (42%) LE injuries. Eighty-three percent were men, and the mean age was 34 ± 15 years. Penetrating mechanism was the predominant mode of injury in both UEs and LEs (73% and 67%, respectively) with a mean injury severity score of 14 ± 8. For UEs, the majority underwent primary repair (67%, P < .001), whereas the remainder received either a bypass (20%) or interposition graft (12%). However, LEs were more likely to receive a bypass (52%, P < .00001) than primary repair or interposition graft (34% and 14%, respectively). Compared with the extremely low rates of amputation and mortality among UE patients (2% for both), LE injuries were more likely to result in both amputation (10%, P < .001) and death (6%, P < .001). Notably, compared with primary repair, the use of a prosthetic conduit was associated with a 6.7-fold increase in the risk of amputation in UE and a 2.4-fold increase in LE (P < .0001 for both). Synthetic bypasses were associated with a nearly 3-fold increase in return to the operating room (OR) in UE bypasses (P < .05) and a 2.4-fold increase in return to the OR in LE bypasses (P < .0001). CONCLUSIONS: In recent years, most extremity vascular trauma was due to penetrating injury with a substantial burden of morbidity and mortality. However, both limb salvage rates and survival rates have remained high. Overall, LE injuries more often led to amputation and mortality than UE injuries. The most frequently used bypass conduit was vein, which was associated with less risk of unplanned return to the OR and limb loss, corroborating current practice guidelines for extremity arterial trauma.

Gender disparities in patients with aortoiliac disease requiring open operative intervention.

OBJECTIVE: Peripheral artery disease is known to affect males and females in different proportions. Disparate surgical outcomes have been quantified after endovascular aortic aneurysm repair, arteriovenous fistula creation, and treatment of critical limb ischemia. The aim of this study is to objectively quantify the sex differences in outcomes in patients undergoing open surgical intervention for aortoiliac occlusive disease. METHODS: Patients were identified in the aortoiliac occlusive disease Vascular Quality Initiative database who underwent aorto-bifemoral bypass or aortic thromboendarterectomy as determined by Current Procedural Terminology codes between 2012 and 2019. Patients with a minimum of 1-year follow-up were included. Risk differences (RDs) by sex were calculated using a binomial regression model in 30-day and 1-year incidence of mortality and limb salvage. Additionally, incidence of surgical complications including prolonged length of stay (>10 days), reoperation, and change in renal function (>0.5 mg/dl rise from baseline), were recorded. Inverse probability weighting was used to standardize demographic and medical history characteristics. Multivariate logistic regression models were employed to conduct analyses of the before mentioned clinical outcomes, controlling for known confounders. RESULTS: Of 16,218 eligible patients from the VQI data during the study period, 6538 (40.3%) were female. The mean age, body mass index, and race were not statistically different between sexes. Although there was no statistically significant difference detected in mortality between males and females at 30 days postoperatively, females had an increased crude 1-year mortality with an RD of 0.014 (95% confidence interval, 0.01-0.02; P value < .001. Males had a higher rate of a postoperative change in renal function with an RD of -0.02 (95% confidence interval, -0.03 to -0.01; P < .001). CONCLUSIONS: Although there was no sex-based mortality difference at 30 days, there was a statistically significant increase in mortality in females after open aortoiliac intervention at 1 year based on our weighted model. Male patients are statistically significantly more likely to have a decline in renal function after their procedures when compared with females. Postoperative complications including prolonged hospital stay, reoperation, and wound disruption were similar among the sexes, as was limb preservation rates at 1 year. Further studies should focus on elucidating the underlying factors contributing to sex-based differences in clinical outcomes following aortoiliac interventions.

Comparison of Landmark-Guided Versus Fluoroscopy-Guided Cerebrospinal Fluid Drain-Related Complications After Aortic Repairs.

OBJECTIVE: Cerebrospinal fluid drains (CSFDs) are efficacious in preventing spinal cord injury after thoracic or thoracoabdominal aortic repair with extensive coverage. Increasingly, fluoroscopy is used to guide placement instead of the traditional landmark-based approach, but it is unknown which approach is associated with fewer complications. DESIGN: A retrospective cohort study. SETTING: In the operating room. PARTICIPANTS: Patients having undergone thoracic or thoracoabdominal aortic repair with a CSFD over a 7-year period at a single center. INTERVENTIONS: No intervention. MEASUREMENTS AND MAIN RESULTS: Groups were reviewed and statistically compared with respect to baseline characteristics, ease of CSFD placement, and major and minor complications directly related to placement. A total of 150 CSFDs were placed with landmark guidance as opposed to 95 with fluoroscopy guidance. Compared to the landmark group, patients with fluoroscopy-guided CSFDs were older (p < 0.008), had lower American Society of Anesthesiologists physical status scores (p = 0.008), required fewer CSFD placement attempts (p = 0.011), had the CSFD in place for longer duration (p < 0.001), and had a similar incidence of CSFD-related complications (p > 0.999). Composites of both major (4.5% of cases) and minor CSFD-related complications (6.1% of cases), the primary outcomes of the study, occurred with similar incidences between the 2 groups (p > 0.999 for both comparisons) after adjusting potential confounders. CONCLUSIONS: In patients undergoing thoracic or thoracoabdominal aortic repairs, there were no significant differences in the risk of major and minor CSFD-related complications between fluoroscopic guidance and the landmark approach. Although the authors' institution is a high-volume center for this type of procedure, the study was limited by a small sample size. Hence, regardless of the technique used for the placement of CSFD, the risks related to the placement should be balanced carefully against the potential benefits resulting from spinal cord injury prevention. Fluoroscopy-aided insertion of CSFD requires fewer attempts and, hence, may be better tolerated by patients.

Effect of bridging stent graft selection for directional branches on target artery outcomes of fenestrated-branched endovascular aortic repair in the United States Aortic Research Consortium.

OBJECTIVE: The purpose of this study was to evaluate the effect of directional branches (DBs) bridging stent choice on target artery (TA) outcomes during fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. METHODS: Patients enrolled in nine prospective physician-sponsored investigational device exemption studies in the United States between 2005 and 2020 were analyzed. All patients who had at least one TA incorporated by DB using either self-expandable (SESGs), balloon-expandable (BESGs), or hybrid stent graft combinations (HSGs). Endpoints were TA patency and freedom from TA endoleak, instability, and reintervention. RESULTS: There were 800 patients with 2426 renal-mesenteric arteries incorporated by DBs. DB stent selection was SESGs in 1205 TAs (50%), BESGs in 1095 TAs (45%), and HSGs in 126 TAs (5%). SESGs were predominantly used in the first three quartiles of the study period, whereas BESGs comprised 75% of all stents between 2017 and 2020. The median follow-up was 15 months (interquartile range, 6-35 months). At 5 years, BESGs had significantly lower freedom from TA instability (78% ± 4% vs 88% ± 1% vs 96% ± 2%; log-rank P =.010), freedom from TA endoleaks (87% ± 3% vs 97% ± 1% vs 99% ± 1%; log-rank P < .001), and freedom from TA reintervention (83% ± 4% vs 95% ± 1% vs 99% ± 2%; log-rank P <.001) compared with SESGs or HSGs, respectively. For renal arteries, there was no difference in freedom from TA instability for BESGs, SESGs, or HSGs. However, freedom from TA endoleaks and reintervention were lower for renal arteries targeted by BESGs compared with DBs targeted by SESGs and HSGs (83% ± 6% vs 98% ± 1% vs 100%; log-rank P < .001; and 70% ± 10% vs 92% ± 1% vs 96% ± 4%; log-rank P = .022). For mesenteric arteries, DBs targeted by BESGs had lower freedom from TA instability, endoleak, and reintervention than SESGs or HSGs. In stent-specific analysis, iCAST BESGs had the lowest freedom from TA instability either for renal or mesenteric arteries, primarily due to higher rates of TA endoleaks. There was no difference in patency in any scenario. Independent predictors of TA instability were age (+1-year: hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.94-0.99), stent diameter (+1 mm: HR, 0.67; 95% CI, 0.57-0.80), and BESG (HR, 1.8; 95% CI, 1.1-2.9). CONCLUSIONS: DBs incorporated using BESGs had lower freedom from TA instability, TA endoleak, and TA reintervention compared with SESGs and HSGs. The patency of DBs was not affected by the type of stent construction. The observed performance disadvantage associated with BESGs appears to have largely been driven by iCAST usage.

Comparison of upper extremity and transfemoral access for fenestrated-branched endovascular aortic repair.

OBJECTIVE: The use of upper extremity (UE) access is an accepted and often implemented approach for fenestrated/branched endovascular aortic aneurysm repair (F-BEVAR). The advent of steerable sheaths has enabled the performance of F-BEVAR using a total transfemoral (TF) approach without UE access, potentially decreasing the risks of cerebral embolic events. The purpose of the present study was to assess the outcomes of F-BEVAR using UE vs TF access. METHODS: Prospectively collected data from nine physician-sponsored investigational device exemption studies at U.S. centers were analyzed using a standardized database. All patients were treated for complex abdominal aortic aneurysms (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs) using industry-manufactured fenestrated and branched stent grafts between 2005 and 2020. The outcomes were compared between patients who had undergone UE vs total TF access. The primary composite outcome was stroke or transient ischemia attack (TIA) and 30-day or in-patient mortality during the perioperative period. The secondary outcomes included technical success, local access-related complications, and perioperative mortality. RESULTS: Among 1681 patients (71% men; mean age, 73.43 ± 7.8 years) who had undergone F-BEVAR, 502 had had CAAAs (30%), 535 had had extent IV TAAAs (32%), and 644 had had extent I to III TAAAs (38%). UE access was used for 1103 patients (67%). The right side was used for 395 patients (24%) and the left side for 705 patients (42%). UE access was preferentially used for TAAAs (74% vs 47%; P < .001). In contrast, TF access was used more frequently for CAAAs (53% vs 26%; P < .01). A total of 38 perioperative cerebrovascular events (2.5%), including 32 strokes (1.9%) and 6 TIAs (0.4%), had occurred. Perioperative cerebrovascular events had occurred more frequently with UE access than with TF access (2.8% vs 1.2%; P = .036). An individual component analysis of the primary composite outcome revealed a trend for more frequent strokes (2.3% vs 1.2%; P = .13) and TIAs (0.54% vs 0%; P = .10) in the UE access group. On multivariable analysis, total TF access was associated with a 60% reduction in the frequency of perioperative cerebrovascular events (odds ratio, 0.39; P = .029). No significant differences were observed between UE and TF access in the technical success rate (96.5% vs 96.8%; P = .72), perioperative mortality (2.9% vs 2.6%; P = .72), or local access-related complications (6.5% vs 5.5%; P = .43). CONCLUSIONS: In the present large, multicenter, retrospective analysis of prospectively collected data, a total TF approach for F-BEVAR was associated with a lower rate of perioperative cerebrovascular events compared with UE access. Although the cerebrovascular event rate was low with UE access, the TF approach offered a lower risk of stroke and TIA. UE access will continue to play a role for appropriately selected patients requiring more complex repairs with anatomy not amenable to the TF approach.

Choice of optimal bridging stent and methods of visceral vessel incorporation during fenestrated/branched endovascular aortic repair for thoracoabdominal and complex abdominal aortic aneurysms.

Techniques for endovascular repair of thoracoabdominal and complex abdominal aortic aneurysms have evolved in the last few decades, elucidating the variable facets for optimal bridging stent selection for visceral vessel incorporation. One must consider different stent-graft types with their relative strengths and weaknesses before implantation in target vessels. Target anatomic criteria, such as vessel diameters, tortuosity, and the presence of an early bifurcation, should also play a role in decision making. Renal arteries require special consideration, as they are associated with higher target-vessel event rates compared with the mesenteric targets. Although the overall reintervention rates after fenestrated and branched endovascular aortic repair approach nearly 20%, the technical success and target vessel patency rates remain encouragingly high at approximately 95%. More long-term outcomes studies are needed for optimization of aortic stent-graft design in the treatment of these complex aortic aneurysms.

The development and potential implications of the US Fenestrated and Branched Aortic Research Consortium.

The endovascular repair of thoracoabdominal aortic aneurysms has evolved during the last 2 decades, making fenestrated and branched endovascular aortic repair the preferred method to repair thoracoabdominal aortic aneurysms in high-risk patients. Single-center publications have given vascular specialists a significant amount of data, but patient numbers and clinical event rates remain limited. Statistical power to answer important clinical questions is often limited in the single-center studies published to date. In 2018, the principal investigators at the 10 physician-sponsored Investigational Device Exemption centers in the United States decided to coordinate and collect their data in a similar fashion. This effort would allow for the development of the largest cohort of patients in the world treated with complex endovascular devices. By combining efforts and resources, a much larger dataset was compiled to help resolve some of the unanswered questions about patients with complex aortic pathology. To date, the US Aortic Research Consortium has collected data from 2,281 patients and 9,124 target vessel treatment with complex aortic aneurysms treated with custom-manufactured fenestrated and branched endovascular aortic repair devices. These data have resulted in the publication of seven peer-reviewed articles describing various aspects and outcomes of complex endovascular aortic treatment.

Multicenter global early feasibility study to evaluate total endovascular arch repair using three-vessel inner branch stent-grafts for aneurysms and dissections.

OBJECTIVE: We evaluated the outcomes of total endovascular aortic arch repair using three-vessel inner branch stent-grafts for aneurysms and chronic dissections. METHODS: We reviewed the clinical data and outcomes of consecutive patients treated by total endovascular aortic arch repair at eight academic centers using three-vessel inner branch stent-grafts (William Cook Europe, Bjaeverskov, Denmark) from 2016 to 2019. All patients received three-vessel designs with two antegrade and one retrograde inner branch, which was used to incorporate the innominate, left common carotid, and left subclavian arteries. The antegrade inner branches were accessed via a carotid or an upper extremity approach. A preloaded catheter was used for access to the retrograde left subclavian artery branch via a transfemoral approach. The endpoints were technical success, mortality, major adverse events, any stroke (minor or major) or transient ischemia attack, secondary interventions, target vessel patency, target vessel instability, aneurysm-related mortality, and patient survival. RESULTS: A total of 39 patients (31 men [79%]; mean age, 70 ± 7 years) had undergone treatment of 14 degenerative (36%) and 25 chronic (64%) postdissection arch aneurysms. The clinical characteristics included American Society of Anesthesiologists class ≥III in 28 patients (95%) and previous median sternotomy for ascending aortic repair in 28 patients (72%). The technical success rate was 100%. Two patients had died in-hospital or within 30 days (5%), and two patients had experienced a stroke (one minor). The combined mortality and any stroke rate was 8% (n = 3). Major adverse events occurred in 10 patients (26%), including respiratory failure in 4 (10%) and estimated blood loss >1 L, myocardial infarction, and acute kidney injury in 2 patients each (5%). The median follow-up was 3.2 months (interquartile range, 1-14 months). Of the 39 patients, 12 (31%) required secondary interventions to treat vascular access complications in 5, endoleak in 6 (three type II, one type Ic, one type Ia/Ib, one type IIIa), and target vessel stenosis in 1 patient. At 1 year, the primary and secondary patency rates and freedom from target vessel instability were 95% ± 5%, 100%, and 91% ± 5%, respectively. Freedom from aortic-related mortality and patient survival was 94% ± 4% and 90% ± 6%, respectively. CONCLUSIONS: The findings from the present multicenter global experience have demonstrated the technical feasibility and safety of total endovascular aortic arch repair for aneurysms and chronic dissections using three-vessel inner branch stent-grafts. The mortality and stroke rates compare favorably with those after open surgical repair in a higher risk group of patients. However, the rate of secondary interventions was high (31%), emphasizing need for greater experience and longer follow-up.

Performance of Viabahn balloon-expandable stent compared with self-expandable covered stents for branched endovascular aortic repair.

OBJECTIVE: The objective of this study was to compare the performance between the Viabahn balloon-expandable stent (VBX; Viabahn [W. L. Gore & Associates, Flagstaff, Ariz]) and a covered self-expandable stent (SES; Fluency [Bard Peripheral Vascular, Tempe, Ariz]) used as bridging stents for directional branches during fenestrated or branched endovascular aneurysm repair of complex aortic aneurysms. METHODS: Patients with thoracoabdominal aortic aneurysms (type I-IV) or pararenal aortic aneurysms either at high risk for open repair or unsuitable for endovascular repair with commercially available devices were prospectively enrolled in a physician-sponsored investigational device exemption trial. Descriptive statistics of the cohort included demographics, risk factors, and anatomic and device characteristics. Individual branches were grouped as either VBX or SES and had data analyzed for primary patency, branch-related type I or type III endoleaks, branch instability, branch-related secondary intervention, and branch-related aortic rupture or death. Categorical variables were expressed as total and percentage, and continuous variables were expressed as median (interquartile range). Kaplan-Meier curves were used to estimate long-term results. Groups were compared with the log-rank test. P value <.05 was considered statistically significant. RESULTS: During the period from July 2012 through June 2019, there were 263 patients treated for complex aortic aneurysm (thoracoabdominal aortic aneurysm) with fenestrated or branched endografts. The devices used were either custom-manufactured devices or off-the-shelf p-Branch or t-Branch (Cook Medical, Bloomington, Ind) devices. The median age was 71 years (interquartile range, 66-79 years); 70% were male, and 81% were white. The most common cardiac risk factors were smoking (92%), hypertension (91%), hyperlipidemia (78%), and chronic obstructive pulmonary disease (52%). The total number of vessels incorporated into the repair was 977, with branches representing 18.4% (179 branches). Among these 179 branches, the celiac artery, superior mesenteric artery, right renal artery, and left renal artery received 54 (30%), 56 (31%), 38 (21%), and 31 (18%) branches, respectively. VBX and SES groups represented 96 (54%) and 81 (46%) of the branches implanted. The celiac artery, superior mesenteric artery, right renal artery, and left renal artery received VBX as a bridging stent in 40%, 46.7%, 33.8%, and 32.2% respectively. The overall cohort survival rate was 78.5% at 24 months. There was no branch-related rupture or mortality. Primary patency at 24 months (VBX, 98.1%; SES, 98.6%; log-rank, P = .95), freedom from endoleak (VBX, 95.6%; SES, 98.6%; log-rank, P = .66), freedom from secondary intervention (VBX, 94.7%; SES, 98.1%; log-rank, P = .33), and freedom from branch instability (VBX, 95.6%; SES, 97.2%; log-rank, P = .77) were similar between groups. CONCLUSIONS: This initial experience with VBX stents demonstrated excellent primary patency and similarly low rates of branch-related complications and endoleaks, with no branch-related aortic rupture or death. Our results demonstrate that in a high-volume, experienced aortic center, the VBX stent is a safe and effective bridging stent option during branched endovascular aortic repair. Multicenter studies with a larger cohort and longer follow-up are necessary to validate these findings.

Incidence and management of iliac artery aneurysms associated with endovascular treatment of juxtarenal and thoracoabdominal aortic aneurysms.

BACKGROUND: This study reports the clinical impact of iliac artery aneurysms (IAAs) in a population of patients with juxtarenal and thoracoabdominal aortic aneurysms being treated with fenestrated or branched aortic endografts. METHODS: Data from 364 patients with IAA (33%) were extracted from the 1118 patients treated for juxtarenal or thoracoabdominal aortic aneurysms with a fenestrated or branched aortic endograft in a physician-sponsored investigational device exemption trial (2001-2016). IAAs were defined as ≥21 mm in diameter, as measured by an imaging core laboratory. Outcomes were assessed by univariate and multivariable analysis. RESULTS: IAAs were unilateral in 219 (60%) and bilateral in 145 (40%) of the 364 patients. Treatment was iliac leg endoprosthesis without coverage of the hypogastric artery (seal distal to the IAA in the common iliac artery), placement of a hypogastric branched endograft in 105 (21%), and hypogastric artery coverage with extension into the external iliac artery in 103 (20%); 67 (13%) were untreated. Procedure duration was longer for those with IAA (5.3 ± 1.79 hours vs 4.6 ± 1.74 hours; P < .001), although hospital stay was not. There was no difference in aneurysm-related mortality and all-cause mortality for patients with unilateral and bilateral IAAs compared with those without an IAA. Treatment of patients with a hypogastric branched endograft had similar all-cause mortality compared with treatment of patients without a hypogastric branched endograft but also with an IAA. Reintervention rates were significantly higher in those with bilateral IAAs compared with no IAA (hazard ratio, 1.886; P < .001). Spinal cord ischemia trended higher in patients with bilateral IAA. CONCLUSIONS: IAA management at the time of fenestrated or branched endovascular aneurysm repair increases procedure time without increasing hospitalization. The reintervention rate and spinal cord ischemia rate are higher in patients with bilateral IAA compared with those with no IAA.

Improving midterm results justify the continued use of bare-metal stents for endovascular therapy for chronic mesenteric ischemia.

OBJECTIVE: The objective of this study was to evaluate the contemporary results of interventions in the celiac axis (CA) and superior mesenteric artery (SMA) for chronic mesenteric ischemia (CMI) and factors associated with patency and symptom-free survival. METHODS: A retrospective review of patients with CMI treated with angioplasty and stenting with bare-metal stents from 2003 to 2014 was conducted. Demographic, history, risk factor, preoperative testing, and technical variables were collected and subject to univariate analysis, with end points of patency loss. The patients were divided into early (2003-2008) and late (2009-2014) groups to compare early and contemporary results. Correlates of patency were then subject to further univariate and multivariable analysis. RESULTS: From 2003 to 2014, there were 150 patients (39 men, 111 women; age, 70.7 ± 11.1 years) with CMI who underwent interventions on the CA (56 vessels) and the SMA (133 vessels); 38 patients had both CA and SMA intervention. Primary patency for the CA was 86% (95% confidence interval [CI], 73-99) at 1 year and 66% (95% CI, 46-87) 3 years; for the SMA, primary patency was 81% (95% CI, 72-89) at 1 year and 69.0% (95% CI, 58-81) at 3 years. Increased age was associated with improved results in the SMA (hazard ratio [HR], 0.96; 95% CI, 0.92-1.00; P = .028). Chronic total occlusion in the SMA conferred worse patency compared with stenosis (HR, 2.38; 95% CI, 1.03-5.47; P = .042), and younger patients (<70 years) had a higher proportion of SMA occlusion (38.9% vs 22.8; P = .045). In the SMA, comparing early (2003-2008; 68 patients) vs late (2009-2014; 65 patients), primary patency was better in the late experience (3 years, 59% vs 77%; P = .016). The late cohort was older (early, 68.1 ± 12.5 years vs 72.5 ± 9.7 years; P = .024). The late cohort had a higher incidence of ostial flaring of the stent (early, 44.1%; late, 72.3%; P < .001). Multivariable analysis revealed only ostial flaring to be associated with improved patency in the SMA (HR, 0.29; 95% CI, 0.12-0.69; P = .006). CONCLUSIONS: Intervention for CMI has acceptable midterm results, and with experience and adoption of newer techniques, the results appear to be improving. Patients older than 70 years have better results than younger patients, and this may reflect a more malignant presentation in the younger patients. Ostial flaring proved to be the single factor on multivariate analysis associated with improved patency and was adopted in the late group. These data support the continued use of bare-metal stents in the treatment of CMI.

Survival affects decision making for fenestrated and branched endovascular aortic repair.

OBJECTIVE: Repair options for complex abdominal and thoracoabdominal aortic aneurysms (TAAAs) are evolving with increased experience and availability of less invasive endovascular techniques. Identifying risk factors for mortality after fenestrated and branched endovascular aortic repair (F/B-EVAR) could improve patient selection and facilitate decision making regarding who may benefit from prophylactic F/B-EVAR. METHODS: We evaluated 1091 patients in a prospective investigational device exemption trial who underwent F/B-EVAR from August 2001 to June 2015 for complex aortic aneurysms (CAAs). Multivariable analysis of risk factors for death was performed using a nonproportional hazards model and a nonparametric analysis using random survival forest technology. RESULTS: Operative mortality after F/B-EVAR was low (3.7%), with high CAA-related survival at 30 day and 5 years (96.8% and 94.0%, respectively). All-cause 5-year survival, however, was 46.2% and older age, heart failure, chronic obstructive pulmonary disease, renal disease, anemia, and coagulation disorders were risk factors. Risk was highest for those undergoing type I/II TAAA repairs and those with larger aneurysms. CONCLUSIONS: Patients with multiple comorbidities and those undergoing type I or II TAAA repair are at greatest risk of mortality; however, in this high-risk population, F/B-EVAR offers greater survival compared with that reported for the natural history of untreated aneurysms. Operative and early mortality is lower than the best-reported open repair outcomes, even in this high-risk population, suggesting a potential benefit in extending the use of F/B-EVAR to low-to-average risk CAA patients.

Durability of iliac artery preservation associated with endovascular repair of infrarenal aortoiliac aneurysms.

OBJECTIVE: This study evaluated and compared the long-term clinical outcomes of endovascular repair of infrarenal aortoiliac aneurysms (EVAR) vs EVAR with preservation of antegrade internal iliac artery (IIA) perfusion using iliac branched devices (EVAR-IBDs). METHODS: From October 1998 to August 2015, patients with infrarenal aortoiliac aneurysmal (AIA) disease at high risk for conventional open surgery were enrolled in a prospective physician-sponsored investigational device exemption trial. Clinical data of 75 patients treated with EVAR-IBD and 255 with standard EVAR were analyzed. Technical success, perioperative outcomes, mortality, device patency, endoleak rates, and reinterventions during a follow-up of 10 years were analyzed. RESULTS: There were 87 IBDs deployed in 75 patients. Technical success rate was 97%. Mortality at 30 days was 1.3%. Freedom from aneurysm-related mortality at 3, 5, and 10 years was 99%. Freedom from a type I or III endoleak at 3, 5, and 10 years was 99%. Freedom from secondary reinterventions at 3, 5, and 10 years was 86%, 81%, and 81%, respectively. Primary patency of the IBDs at 3, 5, and 10 years was 94%, 94%, and 77%, respectively. Twenty-four percent of patients underwent EVAR for concomitant AIA disease (EVAR-AIA), and 78% were managed by staged IIA embolization before EVAR. No statistically significant difference in freedom from aneurysm-related mortality, limb occlusions, or endoleak rates was identified in patients with EVAR-AIA vs EVAR-IBD (P > .05). There were significantly more secondary reinterventions in the EVAR-AIA group compared with the EVAR-IBD group (hazard ratio, 0.476, 95% confidence interval, 0.226-1.001; P = .045). CONCLUSIONS: EVAR of infrarenal AIAs with preservation of antegrade flow to the IIA using IBDs is feasible with long-term sustained durability. Serious considerations should be given to the use of IBDs in patients with infrarenal AIAs meeting appropriate anatomic criteria.