Effect of EVAR on International Ruptured AAA Mortality-Sex and Geographic Disparities.

Background: We sought to investigate the differential impact of EVAR (endovascular aneurysm repair) vis-à-vis OSR (open surgical repair) on ruptured AAA (abdominal aortic aneurysm) mortality by sex and geographically. Methods: We performed a retrospective study of administrative data on EVAR from state statistical agencies, vascular registries, and academic publications, as well as ruptured AAA mortality rates from the World Health Organization for 14 14 states across Australasia, East Asia, Europe, and North America. Results: Between 2011-2016, the proportion of treatment of ruptured AAAs by EVAR increased from 26.1 to 43.8 percent among females, and from 25.7 to 41.2 percent among males, and age-adjusted ruptured AAA mortality rates fell from 12.62 to 9.50 per million among females, and from 34.14 to 26.54 per million among males. The association of EVAR with reduced mortality was more than three times larger (2.2 vis-à-vis 0.6 percent of prevalence per 10 percentage point increase in EVAR) among females than males. The association of EVAR with reduced mortality was substantially larger (1.7 vis-à-vis 1.1 percent of prevalence per 10 percentage point increase in EVAR) among East Asian states than European+ states. Conclusions: The increasing adoption of EVAR coincided with a decrease in ruptured AAA mortality. The relationship between EVAR and mortality was more pronounced among females than males, and in East Asian than European+ states. Sex and ethnic heterogeneity should be further investigated.

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.

Complications of Carotid Interventions for Symptomatic Lesions after Systemic Thrombolysis.

OBJECTIVE: Series detailing complications after carotid endarterectomy (CEA) and transfemoral carotid stenting (tfCAS) for patients presenting with neurologic symptoms that are treated with systemic thrombolysis (ST) are sparse. We sought to determine if treatment with ST was associated with a higher rate of post-carotid intervention complications. METHODS: A multispecialty, institutional, prospectively maintained database was queried for symptomatic patients treated with CEA or tfCAS from 2007-2019. The primary outcomes of interest were bleeding complications (access/wound complications, hematuria, intracranial hemorrhage) or need for reintervention, stroke, and death. We compared rates of these outcomes between patients who were and were not treated with ST. To adjust for preoperative patient factors and confounding variables, propensity scores for assignment to ST and no ST were calculated. RESULTS: There were 1,139 patients included (949 [82%] CEA and 190 [17%] tfCAS. All treated lesions were symptomatic (550 [48%] stroke, 603 [52%] TIA). Fifty-six patients (5%) were treated with ST. Fifteen of 56 patients also underwent catheter-based intervention for stroke. ST was administered 0 to 1 day preoperatively in 21 (38%) patients, 2 to 6 days preoperatively in 27 (48%) patients, and greater than 6 days preoperatively in 8 (14%) patients. ST patients were more likely to present with stroke (93% vs. 45%; p<0.001) and have higher preoperative Rankin Scores. Unadjusted rate of bleeding/return to OR was 3% for ST group and 3% for non-ST group (p=0.60). Unadjusted rate of stroke was 4% for ST group and 3% for the non-ST group (p=0.91) while perioperative mortality was 5% for ST group and 1% for non-ST group (p=0.009). After adjusting for patient factors, preoperative antiplatelet/anticoagulation, and operative factors, ST was not associated with an increased odds of perioperative bleeding/return to OR (OR 0.37; 95%CI: 0.02-1.63; p=0.309) or stroke (OR 0.62; 95%CI: 0.16-2.40; p=0.493). CONCLUSIONS: ST does not convey a higher risk of complications after CEA or tfCAS. After controlling for other factors, patients that received ST had similar rates of local complications and stroke when compared to non-ST patients. Early carotid intervention is safe in patients that have received ST, and delays should be avoided in symptomatic patients given the high risk of recurrent stroke.

Preoperative risk factors for 1-year mortality in patients undergoing fenestrated endovascular aortic aneurysm repair in the US Aortic Research Consortium.

BACKGROUND: Early survival (1-year) after elective repair of complex abdominal aortic aneurysms (AAA) or thoracoabdominal aortic aneurysms (TAAA) can be used as an indicator of successful repair and provides a reasonable countermeasure to the annual rupture risk based on diameter. We aimed to identify preoperative factors associated with 1-year mortality after fenestrated or branched endovascular aortic repair (F/BEVAR) and develop a predictive model for 1-year mortality based on patient-specific risk profiles. METHODS: The US-Aortic Research Consortium database was queried for all patients undergoing elective F/BEVAR for complex AAA (cAAA) or TAAA from 2005 to 2022. The primary outcome was 1-year survival based on preoperative risk profile. Multivariable Cox regression was used to determine preoperative variables associated with 1-year mortality overall and by extent of aortic pathology. Logistic regression was performed to build a predictive model for 1-year mortality based on number of risk factors present. RESULTS: A total of 2099 patients met the inclusion criteria for this study (cAAA: n = 709 [34.3%]; type 1-3 TAAA: n = 777 [37.6%]; type 4-5 TAAA: n = 580 [28.1%]). Multivariable Cox regression identified the following significant risk factors associated with 1-year mortality: current smoker, chronic obstructive pulmonary disease, congestive heart failure (CHF), aortic diameter >7 cm, age >75 years, extent 1-3, creatinine >1.7 mg/dL, and hematocrit <36%. When stratified by extent of aortic involvement, multivariable Cox regression revealed risk factors for 1-year mortality in cAAA (CHF maximum aortic diameter >7 cm, hematocrit <36 mg/dL, and current smoking status), type 1-3 TAAA (chronic obstructive pulmonary disease, CHF, and age >75 years), and type 4-5 TAAA (age >75 years, creatinine >1.7 mg/dL, and hematocrit <36 mg/dL). Logistic regression was then used to develop a predictive model for 1-year mortality based on patient risk profile. Appraisal of the model revealed an area under the curve of 0.64 (P < .001), and an observed to expected ratio of 0.85. CONCLUSIONS: This study describes multiple risk factors associated with an increase in 1-year mortality after F/BEVAR. Given that elective repair of cAAA or TAAA is offered to some patients in whom future rupture risk outweighs operative risk, these findings suggest that highly comorbid patients with smaller aneurysms may not benefit from repair. Descriptive and predictive models for 1-year mortality based on patient risk profiles can serve as an adjunct in clinical decision-making when considering elective F/BEVAR.

Prospective randomized pilot trial comparing prophylactic vs therapeutic cerebrospinal fluid drainage during complex endovascular thoracoabdominal aortic aneurysm repair.

BACKGROUND: Endovascular techniques have transformed the management of thoracoabdominal aortic aneurysms (TAAAs). However, spinal cord ischemia (SCI) remains a prevalent and devastating complication. Prophylactic drainage of cerebrospinal fluid (CSF) is among the proposed strategies for prevention of SCI. Although prophylactic CSF drainage is widely used and conceptually attractive, prophylactic CSF drains have not been demonstrated to definitively prevent the occurrence nor mitigate the severity of SCI in endovascular TAAA repair. Whether or not outcomes of prophylactic drains are superior to therapeutic drains remains unknown. This pilot study was performed to determine the feasibility of a randomized clinical trial designed to investigate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair using branched and fenestrated endovascular aortic repair (FBEVAR). METHODS: This was a prospective multicenter randomized pilot clinical trial conducted at The University of Alabama at Birmingham and The University of Massachusetts. Twenty patients were enrolled and randomized to either the prophylactic drainage or therapeutic drainage groups, prior to undergoing FBEVAR for extensive TAAAs and arch aortic aneurysms. This was a pilot feasibility study that was not powered to detect statistical differences in clinical outcomes. The primary outcome was feasibility of randomization and compliance with a shared lumbar drain protocol. Secondary outcomes included rate of drain complications and SCI. RESULTS: Twenty patients were enrolled and successfully randomized, without any crossovers, to either the control cohort (n = 10), without prophylactic drains, or the experimental cohort (n = 10), with prophylactic drains. There were no differences in age, comorbidities, or history of prior aortic surgery across the cohorts. All patients were treated with FBEVAR. Aneurysm classifications were as follows: Extent I (10%), Extent II (50%), Extent III (35%), and Extent IV (5%). The average length of aortic coverage was 207 ± 21.6 mm. The length of aortic coverage did not vary across cohorts, nor did procedural times or blood loss volume. Compliance with the SCI prevention protocol was 100% across both groups. Within the prophylactic drain cohort, one patient experienced an adverse event related to lumbar drain placement, manifested as an epidural hematoma requiring laminectomy, without neurologic deficit (n = 1/10; 10%). There was one SCI event (n = 1/20; 5%), which occurred in the prophylactic drain cohort on postoperative day 9 following an episode of hypotension related to a gastrointestinal bleed. CONCLUSIONS: The role of prophylactic CSF drains for the prevention of SCI following endovascular TAAA repair is a topic of ongoing research, with many current practices based on expert opinion and experience, rather than rigorous scientific data. This study demonstrates the feasibility of a multicenter randomized clinical trial to evaluate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair.

Assessment of fitness for open repair in patients with infrarenal abdominal aortic aneurysms.

OBJECTIVE: Endovascular aortic repair (EVAR) was originally designed as a treatment modality for patients with abdominal aortic aneurysms (AAAs) deemed unfit for open repair. However, the definition of "unfit for open repair" is largely subjective and heterogenous. The purpose of this study was to compare patients deemed unfit for open repair who underwent EVAR to a matched cohort who underwent open repair for infrarenal AAAs. METHODS: The Vascular Quality Initiative of the Society for Vascular Surgery was queried for patients who underwent EVAR and open infrarenal AAA repair from 2003 to 2022. Patients that underwent EVAR were included if they were deemed unfit for open repair by the operating surgeon. EVAR patients deemed unfit because of a hostile abdomen were excluded. Patients in both the open and EVAR datasets were excluded if their repair was deemed non-elective or if they had prior aortic surgery. EVAR patients were matched to a cohort of open patients. The primary outcome for this study was 1-year mortality. Secondary outcomes included 30-day mortality, major adverse cardiac events, pulmonary complications, non-home discharge, reinterventions, and 5-year survival. RESULTS: A total of 5310 EVAR patients were identified who were deemed unfit for open repair. Of those, 3028 EVAR patients (57.0%) were able to be matched 1:1 to a cohort of open patients. Open patients had higher rates of major adverse cardiac events (20.2% vs 4.4%; P < .001), pulmonary complications (12.8% vs 1.6%; P < .001), non-home discharges (28.5% vs 7.9%; P < .001), and 30-day mortality (4.5% vs 1.4%; P < .001). There were no differences in early survival, but open repair had better middle and late survival compared with EVAR over the course of 5 years. A total of 74 EVAR patients (2.4%) had reinterventions during the study period. EVAR patients that required interventions had higher 1-year (40.5% vs 7.3%; P < .001) and 5-year mortality (43.2% vs 14.1%; P < .001) compared with those that did not require reinterventions. EVAR patients who had reinterventions had higher 1-year (40.5% vs 6.3%; P < .001) and 5-year (43.2% vs 20.3%; P = .006) mortality compared with their matched open cohort. CONCLUSIONS: Patients undergoing EVAR for AAAs who are deemed unfit for open repair have better perioperative morbidity and mortality compared with open repair. However, patients who had an open repair had better middle and late survival over the course of 5 years. The categorization of unfitness for open surgery may be inaccurate and re-evaluation of this terminology/concept should be undertaken.

Room for improvement in patient compliance during peripheral vascular interventions.

Introduction: For patients receiving Procedural Sedation and Analgesia (PSA), patient cooperation is crucial as patients remain continuously aware of operating room activity and can be asked to perform tasks such as prolonged breath-holds. This survey aimed to collect information on patient compliance with on-table instructions and its relation to periprocedural outcomes from surgeons nationwide performing peripheral vascular interventions (PVI) under PSA. Methods: A 9-question online survey was sent to 383 vascular surgeons (including both vascular surgery attendings and trainees) across the United States through REDCap from August 30 to September 21, 2021, with responses closed on October 30, 2021. The survey response was analyzed with descriptive statistics. Results: 83 (21.6%) vascular surgeons responded to the survey, of which 67 (80.7%) were attending vascular surgeons and 16 (19.3%) were vascular surgery trainees. 41 (49.4%) respondents performed 11-20 PVI cases under PSA every month, while 31 (41.0%) respondents performed 1-10 PVI cases under PSA every month. 41 (49.4%) respondents reported that in 1-10% of their cases, additional contrast and/or radiation was administered because patient moved on the table or did not cooperate with breath holds; 25 (30.1%) reported that this occurred in 11-20% of their cases, 12 (14.5%) reported that this occurred in 21-50% of their cases and 4 (4.8%) reported that this occurred in over 50% of their cases. In such cases, the majority of respondents reported a 1-10% increase in contrast volume (59.0%), radiation dosage (62.7%), sedative/analgesia administration (46.3%) and procedural time (54.9%). Of cases being converted to general anesthesia due to inadequate patient cooperation, 35 (42.2%) respondents reported between 1-5 per month, and 3 (3.6%) respondents reported between 6-10 per month. Of cases being aborted due to inadequate patient cooperation, 25 (30.1%) respondents reported between 1-5 per month, and 1 (1.2%) respondents reported between 6-10 per month. Conclusion: A significant fraction of PVI cases performed under PSA result in increased radiation and contrast exposure, sedative administration and procedural time due to inadequate patient cooperation. In certain cases, conversion to general anesthesia or case abortion is required. Further research should be performed to investigate strategies to minimize such adverse patient safety events.

Iliac artery aneurysm endoleak management in a patient with vascular Ehlers-Danlos syndrome.

Endovascular repair has traditionally been avoided in patients with connective tissue disorders. We describe successful treatment of multiple endoleaks of an expanding common iliac artery aneurysm previously treated with an endograft in a patient with vascular Ehlers-Danlos syndrome. The modalities used to treat the endoleaks were transgluteal embolization of the internal iliac artery and proximal and distal extension of the prior endograft. This case demonstrates endovascular management of endoleaks in patients with vascular Ehlers-Danlos syndrome can be safe and feasible.

Severity of acute kidney injury is associated with decreased survival after fenestrated and branched endovascular aortic aneurysm repair.

OBJECTIVE: Acute kidney injury (AKI) occurs frequently in complex aortic surgery and has been implicated in perioperative and long-term survival. This study sought to characterize the relationship between AKI severity and mortality after fenestrated and branched endovascular aortic aneurysm repair (F/B-EVAR). METHODS: Consecutive patients enrolled by the US Aortic Research Consortium in 10, prospective, nonrandomized, physician-sponsored investigational device exemption studies evaluating F/B-EVAR, between 2005 and 2023, were included in this study. Perioperative AKI during hospitalization was defined by and staged using the 2012 Kidney Disease Improving Global Outcomes criteria. Determinants of AKI were evaluated with backward stepwise mixed effects multivariable ordinal logistic regression. Survival was analyzed with conditionally adjusted survival curves and backward stepwise mixed effects Cox proportional hazards modelling. RESULTS: In the study period, 2413 patients with a median (interquartile range [IQR]) age of 74 years (IQR, 69-79 years) underwent F/B-EVAR. The median follow-up duration was 2.2 years (IQR, 0.7-3.7 years). The median baseline estimated glomerular filtration rate (eGFR) and creatinine were 68 mL/min/1.73 m2 (IQR, 53-84 mL/min/1.73 m2) and 1.1 mg/dL (IQR, 0.9-1.3 mg/dL), respectively. Stratification of AKI identified 316 patients (13%) with stage 1 injury, 42 (2%) with stage 2 injury, and 74 (3%) with stage 3 injury. Renal replacement therapy was initiated during the index hospitalization in 36 patients (1.5% of cohort, 49% of stage 3 injuries). Thirty-day major adverse events were associated with AKI severity (all P ≤ .0001). Multivariable predictors of AKI severity included baseline eGFR (proportional odds ratio, 0.9 per 10 mL/min/1.73 m2 [95% confidence interval (CI), 0.85-0.95 per 10 mL/min/1.73 m2]; P < .0001), baseline serum hematocrit (0.58 per 10% [95% CI, 0.48-0.71 per 10%]; P < .0001), renal artery technical failure during aneurysm repair (3 [95% CI,1.61-5.72]; P = .0006), and total operating time (1.05 per 10 minutes [95% CI, 1.04-1.07 per 10 minutes]; P < .0001). One-year unadjusted survivals for AKI severity strata were 91% (95% CI, 90%-92%) for no injury, 80% (95% CI, 76%-85%) for stage 1 injury, 72% (95% CI, 59-87%) for stage 2 injury, and 46% (95% CI, 35-59%) for stage 3 injury (P<.0001). Multivariable determinants of survival included AKI severity (stage 1, hazard ratio [HR], 1.6 [95% CI, 1.3-2]); stage 2, HR, 2.2 [95% CI, 1.4-3.4]); stage 3 HR, 4 [95% CI, 2.9-5.5]; P < .0001), decreased eGFR (HR, 1.1 [95% CI, 0.9-1.3]; P = .4), patient age (HR, 1.6 per 10 years [95% CI, 1.4-1.8 per 10 years]; P < .0001), baseline chronic obstructive pulmonary disease (HR, 1.5 [95% CI, 1.3-1.8]; P < .0001), baseline congestive heart failure (HR, 1.7 [95% CI, 1.6-2.1]; P < .0001), postoperative paraplegia (HR, 2.1 [95% CI, 1.1-4]; P = .02), and procedural technical success (HR, 0.6 [95% CI, 0.4-0.8]; P = .003). CONCLUSIONS: AKI, as defined by the 2012 Kidney Disease Improving Global Outcomes criteria, occurred in 18% of patients after F/B-EVAR. Greater severity of AKI after F/B-EVAR was associated with decreased postoperative survival. The predictors of AKI severity identified in these analyses suggest a role for improved preoperative risk mitigation and staging of interventions in complex aortic repair.

Outcomes After Endovascular Aortic Intervention in Patients With Connective Tissue Disease.

Importance: Endovascular treatment is not recommended for aortic pathologies in patients with connective tissue diseases (CTDs) other than in redo operations and as bridging procedures in emergencies. However, recent developments in endovascular technology may challenge this dogma. Objective: To assess the midterm outcomes of endovascular aortic repair in patients with CTD. Design, Setting, and Participants: For this descriptive retrospective study, data on demographics, interventions, and short-term and midterm outcomes were collected from 18 aortic centers in Europe, Asia, North America, and New Zealand. Patients with CTD who had undergone endovascular aortic repair from 2005 to 2020 were included. Data were analyzed from December 2021 to November 2022. Exposure: All principal endovascular aortic repairs, including redo surgery and complex repairs of the aortic arch and visceral aorta. Main Outcomes and Measures: Short-term and midterm survival, rates of secondary procedures, and conversion to open repair. Results: In total, 171 patients were included: 142 with Marfan syndrome, 17 with Loeys-Dietz syndrome, and 12 with vascular Ehlers-Danlos syndrome (vEDS). Median (IQR) age was 49.9 years (37.9-59.0), and 107 patients (62.6%) were male. One hundred fifty-two (88.9%) were treated for aortic dissections and 19 (11.1%) for degenerative aneurysms. One hundred thirty-six patients (79.5%) had undergone open aortic surgery before the index endovascular repair. In 74 patients (43.3%), arch and/or visceral branches were included in the repair. Primary technical success was achieved in 168 patients (98.2%), and 30-day mortality was 2.9% (5 patients). Survival at 1 and 5 years was 96.2% and 80.6% for Marfan syndrome, 93.8% and 85.2% for Loeys-Dietz syndrome, and 75.0% and 43.8% for vEDS, respectively. After a median (IQR) follow-up of 4.7 years (1.9-9.2), 91 patients (53.2%) had undergone secondary procedures, of which 14 (8.2%) were open conversions. Conclusions and Relevance: This study found that endovascular aortic interventions, including redo procedures and complex repairs of the aortic arch and visceral aorta, in patients with CTD had a high rate of early technical success, low perioperative mortality, and a midterm survival rate comparable with reports of open aortic surgery in patients with CTD. The rate of secondary procedures was high, but few patients required conversion to open repair. Improvements in devices and techniques, as well as ongoing follow-up, may result in endovascular treatment for patients with CTD being included in guideline recommendations.

Update of T-branch use from the US Aortic Research Consortium.

Aortic endograft evolution has altered our approach to treating patients with both standard and complex aortic disease. In particular, fenestrated and branched aortic endografts have allowed for the expansion of therapy to include those patients with extensive thoracoabdominal aortic aneurysms (TAAAs). The fenestrations and branches allow for the aortic endografts to achieve a seal in the proximal and distal aspects of the aorto-iliac tree, to exclude the aneurysm, while maintaining perfusion to the renal and visceral vessels. Historically, many of the grafts used for this purpose are custom made devices designed for a specific patient based on their preoperative computed tomography imaging. One downside to this approach is the time it takes to construct these grafts. Given this, much effort has been directed towards developing "off-the-shelf" grafts which may be applicable to many patients in an immediate-need bases. The Zenith T-Branch device offers an off-the-shelf graft with four directional branches. Its utilization is not applicable to all patients, but can be applied to many patients with TAAAs. Large reported series on outcomes for these devices is limited to centers in Europe as well as within the United States Aortic Research Consortium. While early outcomes appear excellent, long-term outcomes related to aneurysm exclusion, branch patency, and freedom from reintervention are needed and will be forthcoming.

Implementation of a Consensus-Driven Quality Improvement Protocol to Decrease Length of Stay after Elective Carotid Endarterectomy.

BACKGROUND: National guidelines stipulate that postoperative length-of-stay (LOS) after elective carotid endarterectomy (CEA) should not exceed 1 day on average, yet perioperative care coordination gaps may limit the ability for institutions to achieve this goal. Internal review determined that increased LOS after CEA at our institution was frequently attributable to urinary retention or postoperative hypertension. We designed and implemented a quality improvement (QI) protocol aiming to better our institutional performance in postoperative LOS after CEA, consisting of 2 Plan-Do-Study-Act (PDSA) cycles. METHODS: In the first PDSA cycle, a division-wide standardized protocol was developed by which antihypertensive medications were managed preoperatively and through postoperative day (POD) 1. This protocol included dedicated patient outreach with instructions for at-home antihypertensive management through the morning of POD 0. Second, alpha-1-blockade was administered to all male patients preoperatively. All patients receiving an elective CEA performed at our institution by vascular surgeons were included in the protocol. The primary outcome measure was defined percent failure of the LOS >1 day metric, with raw LOS as a secondary outcome measure. Process measures included adherence to the antihypertensive medication protocol and adherence to preoperative alpha-1 blockade. Balance measures included documented intraoperative hypotension and 30-day readmission. Fisher's exact test was used to evaluate relationships between preintervention and postintervention cohorts and the outcome measure. Wilcoxon rank-sum tests were used to evaluate relationships between cohorts and total LOS. RESULTS: Baseline performance on the LOS >1 day metric after elective CEA was 58.3% in the 8 months prior to intervention, across 48 patients. Both PDSA interventions were implemented simultaneously. In the 12 months after intervention, 64 patients met protocol inclusion criteria, including 19 symptomatic patients (29.7%). Process measure success for preoperative antihypertensive regimen adherence was 89.8%. For males not chronically prescribed alpha-1 blockade preoperatively, process measure success for adherence to preoperative alpha-1 blockade was 78.8%. The intraoperative hypotension balance measure occurred in 1 patient (1.6%). Performance on the LOS >1 day outcome measure was improved to 32.8% (P = 0.01). Performance on the raw LOS outcome measure was similar between the preintervention cohort (median 2 days, interquartile range [IQR] 1-2) and postintervention cohort (median 1 day, IQR 1-2, P = 0.07). Performance on the 30-day readmission balance measure was similar between preintervention (6.3%) and postintervention cohorts (9.4%, P = 0.73). CONCLUSIONS: The consensus-driven development and implementation of a QI protocol to reduce postoperative LOS after CEA showed promising results in our institution, with approximately 40% improvement in the primary outcome measure. Wider efforts to improve LOS after CEA should include a focus on minimization of postoperative hypertension and urinary retention.

Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium.

OBJECTIVE: Spinal cord ischemia (SCI) is a well-known complication of thoracoabdominal aortic aneurysm repair and is associated with profound morbidity and mortality. The purpose of this study was to describe predictors for the development of SCI, as well as outcomes for patients who develop SCI, after branched/fenestrated endovascular aortic repair in a large cohort of centers with adjudicated physician-sponsored investigational device exemption studies. METHODS: We used a pooled dataset from nine US Aortic Research Consortium centers involved in investigational device exemption trials for treatment of suprarenal and thoracoabdominal aortic aneurysms. SCI was defined as new transient weakness (paraparesis) or permanent paraplegia after repair without other potential neurological etiologies. Multivariable analysis was performed to identify predictors of SCI, and life-table analysis and Kaplan-Meier methodologies were used to evaluate survival differences. RESULTS: A total of 1681 patients underwent branched/fenestrated endovascular aortic repair from 2005 to 2020. The overall rate of SCI was 7.1% (3.0% transient and 4.1% permanent). Predictors of SCI on multivariable analysis were Crawford Extent I, II, and III distribution of aortic disease (odds ratio [OR], 4.79; 95% confidence interval [CI], 4.77-4.81; P < .001), age ≥70 years (OR, 1.64; 95% CI, 1.63-1.64; P = .029), packed red blood cell transfusion (OR, 2.00; 95% CI, 1.99-2.00; P = .001), and a history of peripheral vascular disease (OR, 1.65; 95% CI, 1.64-1.65; P = .034). The median survival was significantly worse for patients with any degree of SCI compared with those without SCI (any SCI, 40.4 vs no SCI, 60.3 months; log-rank P < .001), and also worse in those with a permanent deficit (24.1 months) vs those with a transient deficit (62.4 months) (log-rank P < .001). The 1-year survival for patients who developed no SCI was 90.8%, compared with 73.9% in patients who developed any SCI. When stratified by degree of deficit, survival was 84.8% at 1 year for those who developed paraparesis and 66.2% for those who developed permanent deficits. CONCLUSIONS: The overall rates of any SCI at 7.1% and permanent deficit at 4.1% observed in this study compare favorably with those reported in contemporary literature. Our findings confirm that increased length of aortic disease is associated with SCI and those with Crawford Extent I to III thoracoabdominal aortic aneurysms are at highest risk. The long-term impact on patient mortality underscores the importance of preventive measures and rapid implementation of rescue protocols if and when deficits develop.

Mid-term Renal and Mesenteric Artery Outcomes During Fenestrated and Branched Endovascular Aortic Repair for Complex Abdominal and Thoracoabdominal Aortic Aneurysms in the United States Aortic Research Consortium.

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.

Women of Childbearing Age Have Higher Mortality Rates Following Inpatient Interventions for Splenic Artery Aneurysms.

BACKGROUND: Splenic artery aneurysms (SAAs) are the most common type of splanchnic aneurysms. Current guidelines recommend repair of SAAs in women of childbearing age because maternal mortality is high. The purpose of this study was to evaluate treatment modalities and outcomes following inpatient SAA repair in women. METHODS: The National Inpatient Sample database from 2012 to 2018 was queried. Patients with SAAs were identified using International Classification of Diseases (ICD) 9 and 10 codes. Childbearing age was defined as 14-49 years. The primary outcome was in-hospital mortality. RESULTS: A total of 561 patients were admitted with a diagnosis of SAA between the years of 2012 and 2018. There were 267 (47.6%) female patients and of these 103 (38.6%) were of childbearing age. The overall in-hospital mortality rate was 2.7% (n = 15). There were no differences in rates of elective admissions or type of repair (open versus endovascular) between women of childbearing age and the remainder of the cohort. However, women of childbearing age were significantly more likely to undergo a splenectomy compared to the remainder of the cohort (32.0% vs. 21.4%, P = 0.028). Women of childbearing age had higher rates of in-hospital mortality compared to the remainder of the cohort (5.8% vs. 2.0%, P = 0.040). Subset analysis of the women of childbearing age revealed that those undergoing a splenectomy versus no splenectomy (14.8% vs. 2.6%, P = 0.039) and those treated in the nonelective versus elective setting (10.5% vs. 0%, P = 0.032) had higher rates of in-hospital mortality. There was 1 patient with an ICD code associated with pregnancy and they survived. CONCLUSIONS: Women of childbearing age had higher in-hospital mortality following inpatient interventions for SAAs with all of the deaths occurring in the nonelective setting. These data support the pursuit of aggressive elective treatment of SAAs in women of childbearing age.

Infectious Aortitis of Thoracic Aortic Aneurysm From Clostridium Septicum.

A 71-year-old male presented with 1-day history of back pain. Imaging displayed an enlarging thoracic aortic aneurysm with gas in the aortic wall. Blood cultures grew Clostridium septicum. He underwent resection, debridement, and in situ aortic replacement with a rifampin-soaked graft under deep hypothermic circulatory arrest. His recovery was uncomplicated. (Level of Difficulty: Beginner.).

Aneurysm extent-based mortality differences in complex endovascular repair of thoracoabdominal aneurysms in the Vascular Quality Initiative and the United States Aortic Research Consortium.

BACKGROUND: Endovascular management of thoracoabdominal aneurysms (TAAA) is becoming more common. Technological advances including custom devices under the Physician-Sponsored Investigational Device Exemption (PS-IDE), physician-modified endografts (PMEG), and parallel stenting techniques have expanded the extent of disease that is amenable to endovascular treatment. Patients within the PS-IDE studies are a highly selected group of patients, whereas patients treated with PMEG as captured within the Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) represent a real-world experience. Research within both the SVS VQI on PMEG and the US Aortic Research Consortium (US-ARC) has demonstrated a relationship between extent of aneurysmal disease and mortality after complex endovascular TAAA repair, but no direct comparison of these cohorts has been conducted. In this study, we sought to compare outcomes of custom PS-IDE devices with off-label uses of commercially available devices for the endovascular management of TAAAs. METHODS: A retrospective review of patients presenting for elective endovascular TAAA repair for asymptomatic disease between 2011 and 2019 was conducted within both the SVS VQI registry and the US-ARC. Patients within the SVS VQI registry were treated with either PMEG or with parallel stenting techniques. Patients within the US-ARC were treated with PS-IDE custom devices. The extent of aneurysm disease was defined by the deployment zones documented for the devices entered in the registry using Crawford extents I to V. Primary outcomes were 30-day and 1-year mortality rates. RESULTS: A total of 3212 patients were included in the study: 1571 PMEG/parallel stenting within the VQI registry and 1641 with PS-IDE within the US-ARC database. The majority of patients presented with extent IV aneurysms (n = 1827 [57%]), with extent IV aneurysms being slightly more prevalent within the US-ARC cohort. Maximal aneurysm diameter within each extent did not vary between the US-ARC and VQI cohorts. Across all patients, the 30-day mortality was 4.4% and the 1-year mortality was 12.2%. Unadjusted mortality at 30-days was 6.7% within the VQI, and 2.2% in the US-ARC (P < .001). The unadjusted 1-year mortality was 14.3% within the VQI and 10.2% within the US-ARC (P < .001). When adjusted for aneurysm extent, similar differences in 30-day and 1-year survivals were identified. CONCLUSIONS: Patients treated in PS-IDE studies had better 30-day and 1-year survival rates compared with those treated with a similar extent of disease using off-label approaches in a real-world registry. These differences are complex and likely associated with a number of factors, including arterial anatomy, patient comorbidities, device construct, and volume outcomes, as well as complex and unmeasurable surgeon- and patient-specific factors.

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.