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.

Living in high-poverty areas is associated with reduced survival in patients with thoracoabdominal aortic aneurysms.

OBJECTIVES: Studies have demonstrated that socioeconomic status, insurance, race, and distance impact clinical outcomes in patients with abdominal aortic aneurysms. The purpose of this study was to assess if these factors also impact clinical outcomes in patients with thoracoabdominal aortic aneurysms (TAAAs). METHODS: We conducted a retrospective review of patients with TAAAs confirmed by computed tomography imaging between 2009 and 2019 at a single institution. Patients' zip codes were mapped to American Community Survey Data to obtain geographic poverty rates. We used the standard U.S. Census definition of high-poverty concentration as >20% of the population living at 100% of the poverty rate. Our primary outcome was overall survival, stratified by whether the patient underwent repair. RESULTS: Of 578 patients, 575 had zip code data and were analyzed. In both the nonoperative (N = 268) and operative (N = 307) groups, there were no significant differences in age, race, comorbidities, clinical urgency, surgery utilization, or surgery modality between patients living in high-poverty areas (N = 95, 16.4%) vs not. In the nonoperative group, patients from high-poverty areas were more likely to have aneurysm due to dissection (37.5% vs 17.6%, P = .03). In multivariate analyses, patients from high-poverty zip codes had significantly worse nonoperative survival (hazard ratio [HR]: 1.9, 95% confidence interval [CI]: 1.1-3.3, P = .03). In the repair group, high poverty was also a significant predictor of reduced postoperative survival (HR: 1.65, 95% CI: 1-2.63, P = .04). Adding the Gagne Index, these differences persisted in both groups (nonoperative: HR: 1.93, 95% CI: 1.01-3.70, P = .05; operative: HR: 1.62, 95% CI: 1.03-2.56, P = .04). In Kaplan-Meier analysis, the difference in postoperative survival began approximately 1.5 years after repair. Private insurance was predictive of improved postoperative survival (HR: 0.42, 95% CI: 0.18-0.95, P = .04) but reduced nonoperative survival (HR: 2.05, 95% 1.01-4.14, P = .04). Data were insufficient to determine if race impacted survival discretely from poverty status. These results were found after adjusting for age, race, sex, maximum aortic diameter, coronary artery disease, distance from the hospital, insurance, and active smoking. Interestingly, in multivariate regression, traveling greater than 100 miles was correlated with increased surgery utilization (odds ratio: 1.58, 95% CI: 1.08-2.33, P = .02) and long-term survival (HR: 0.61, 95% CI: 0.41-0.92, P = .02). CONCLUSIONS: Patients with TAAAs living in high-poverty areas had significantly more dissections and suffered a nearly doubled risk of mortality compared with patients living outside such areas. These data suggest that these disparities are attributed to the overall impacts of poverty and highlight the pressing need for research into TAAA disparities.

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.

Early outcomes of endovascular repairs of the aortic arch using thoracic branch endoprosthesis.

OBJECTIVE: The only commercially available thoracic branched endoprosthesis (TBE) for treatment of the aortic arch was released in 2022. Limited data outside of clinical trial results have been reported. This study describes the demographics, anatomic details, and outcomes for patients treated for zone 0 to 2 using TBEs outside of a clinical trial. METHODS: All patients treated using TBEs for zone 0 to 2 were included. Patients treated as part of the clinical trial for zone 0 to 1 (n = 6) were excluded. Patient demographics, comorbidities, anatomic and operative details, and outcomes were reported. Outcomes and survival were then compared between groups. RESULTS: Of 40 patients, six patients underwent repair of zone 0, three of zone 1, and 31 of zone 2. There were no differences in demographics, comorbidities, or operative details by zone of treatment; however, the frequency of genetic aortopathy differed (zone 0: 0%; zone 1: 67%; and zone 2: 6.4%; P < .01). Seventy-three percent of patients were treated for dissection vs 27% with isolated aneurysms. Of the patients, 2.5% were treated for rupture, 22% were treated for symptomatic aneurysms, and 75% were treated electively. Forty-eight percent of repairs included a proximal cuff, and 83% received distal extension. Technical success was achieved in 100% of patients. Mean fluoroscopy time was 18 minutes, and median fluoroscopy dose was 416 mGy. Sixty percent of patients had prior aortic ascending/arch repair. TBE was planned as part of a complete thoracoabdominal repair in 45% of patients. Thirty-day mortality was 2.5% overall, with a single death in a zone 0 patient that occurred at day 1 due to a myocardial infarction. There were no reinterventions within 30 days. All other outcomes were similar. The 30-day stroke rate was 5.0%. The strokes occurred at day 6 (zone 1) and day 15 (zone 2); however, both were due to occlusion of a prior proximal surgical bypass and unrelated to the TBE side branch or embolization. Specifically, both patients had occlusion of a branch of their prior zone 1 or zone 2 arch replacement. An endoleak occurred in 7.5% of patients at 30-day follow-up (type II: 5.0%; unknown: 2.5%). At a mean follow-up of 6.6 months, 100% of side branches were patent. CONCLUSIONS: Repair of the aortic arch including TBE can be performed electively and urgently with acceptable stroke and death rates. TBE provides a valuable tool for patients requiring complete repair of a thoracoabdominal aneurysm. Continued investigation is underway to assess long-term safety and efficacy outside of the clinical trial.

A multidisciplinary multistage complete mega aorta replacement and utilization of extracorporeal membrane oxygenation in thoracoabdominal aneurysm repair.

A 49-year-old woman underwent a 11-month multistage complete replacement of a mega aorta. Replacement stages included ascending aorta and arch replacement in conjunction with a frozen elephant trunk thoracic endovascular aortic repair, extension of thoracic endovascular aortic repair to zone 5, and open repair of the thoracoabdominal aneurysm with the use of venoarterial extracorporeal membrane oxygenation for circulatory support. This case illustrates the complexity of repairing a mega aorta, the multidisciplinary care and staging needed for repair, and the use of peripheral venoarterial extracorporeal membrane oxygenation for circulatory perfusion during thoracoabdominal aneurysm repair.

Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms.

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

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.

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.

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.

Overhead arm support reduces radiation exposure during complex endovascular aortic repair.

BACKGROUND: Complex endovascular aortic surgery has been associated with increased fluoroscopic radiation exposure. The radiation dosage necessary for visualization is dependent on the amount of tissue penetration required. Elevation of a patient's arms above their head during endovascular surgery could improve visualization by removing the arms from the field of view. Furthermore, it might reduce the radiation dose required. In the present study, we sought to determine the effect of arm elevation on radiation exposure during endovascular treatment of thoracoabdominal aneurysms. METHODS: All patients enrolled in a single-institution, physician-sponsored investigational device exemption study for endovascular treatment of thoracoabdominal aneurysms (fenestrated/branched endovascular aortic repair [F/BEVAR]) from 2012 to 2022 were assessed. The first 30 patients treated were excluded to account for the learning curve required with treatment. Patients treated after December 2020 were positioned with their arms elevated above their head using an overhead arm support (OAS). These patients were compared with those who had undergone F/BEVAR before the practice change. The radiation dose, fluoroscopy time, and contrast volume used were compared. A subgroup analysis was performed to assess the effect for patients with brachial access. RESULTS: A total of 145 patients were included in the present study, of whom 43 (30%) had undergone F/BEVAR with their arms supported overhead. No differences were identified in age, body mass index, aneurysm size, or prior aortic intervention between the groups with and without the use of the OAS. A history of dissection (23% vs 7.8%; P = .01) was more frequent for the patients treated with their arms elevated. Arm elevation was associated with a significant reduction in the mean radiation exposure (2261 vs 3100 mGy; P = .01). No differences were observed in the fluoroscopy time or contrast volume used between the two groups. In addition, no patient experienced palsy of the brachial plexus. Of the 145 patients, 55 (38%) had required brachial arterial access, limiting their ability to elevate both arms. In the subgroup analysis, the patients without brachial access continued to show a significant reduction in radiation exposure with arm elevation (2159 vs 3179 mGy; P < .01). CONCLUSIONS: Elevation of a patient's arms above their head using an OAS during F/BEVAR offered a low-cost, simple strategy that resulted in a 30% reduction in radiation exposure without added complications. This technique improved visualization and reduced radiation exposure for patients and physicians and should be included in abdominal aortic and visceral procedures work to improve patient and surgeon safety.

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.

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.

Outcomes of endovascular repair of aortic aneurysms with the GORE thoracic branch endoprosthesis for left subclavian artery preservation.

OBJECTIVE: Thoracic endovascular aortic repair has emerged as the dominant paradigm for treatment of patients with descending thoracic aortic aneurysms. For aneurysms involving the aortic arch in the region of the left subclavian artery (LSA), branch vessel preservation to maintain blood flow to the LSA is recommended. Branched aortic endografts are an alternative to surgical revascularization of the LSA. METHODS: Across 34 investigative sites, 84 patients with zone 2 aneurysms were enrolled in a nonrandomized, prospective study of a single branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for left subclavian perfusion. RESULTS: More than one-half of the patients were male (63%). Their average age was 70 ± 11 years. The aneurysm morphology was fusiform in 43 and saccular in 41 patients. The mean aneurysm diameter at screening was 56.2 mm. The mean follow-up was 30 months (range, 2.6-50.7 months). Reported here are the patient outcomes at 1 and 12 months. Predefined technical success with implantation of the device in landing zone 2 was achieved in 92% of patients (n = 77). There were no cases of aortic rupture, lesion-related mortality, or new-onset renal failure. There was no perioperative (30-day) mortality. A single case each of permanent paraplegia and paraparesis occurred. Three patients experienced a procedure-related stroke. Through 12 months, four patients died; none of the deaths were adjudicated as related to the device or procedure. One aortic reintervention was required. A single case of aortic enlargement (core laboratory) was reported at 6 months. Type I (n = 3) and III (n = 5) endoleaks occurred in 9.8% of patients, of which one (type III) required reintervention. CONCLUSIONS: Results from this device study in patients with zone 2 aneurysms demonstrate that early safety and efficacy outcomes are maintained up to 12 months after the endovascular procedure with low mortality and reintervention rates and an acceptable frequency of procedural complications, including neurologic complications.

Women with thoracoabdominal aortic aneurysms have increased frailty and more complex aortic anatomy compared with men.

OBJECTIVE: Operative repair of thoracoabdominal aortic aneurysms (TAAAs) is high risk, and many patients will be unfit for intervention. Prior studies have noted lower rates of repair for women than for men. The reasons for this disparity have remained unknown but could include a greater burden of co-morbid illness or anatomic barriers. Frailty could also contribute to the lower intervention rates but has rarely been reported in preoperative risk assessments. The aim of the present study was to assess the sex-related differences in clinical comorbidities, anatomic suitability, and frailty among an unselected cohort of patients who had presented with TAAAs. METHODS: All patients with extent I to V TAAAs confirmed by computed tomography imaging between 2009 and 2019 at a single institution were reviewed. Patients were included regardless of whether they had undergone repair. Clinical comorbidities, anatomic details, and metrics of frailty were collected and used to determine operative risk. RESULTS: Of the 578 identified patients, 233 (40%) were women. The women were older than the men at diagnosis (71 years vs 68 years; P = .006) but had had similar comorbidities, with the exception of lower rates of coronary artery disease (37% vs 47%; P = .04) and higher rates of chronic obstructive pulmonary disease (45% vs 36%; P = .008). The Society for Vascular Surgery clinical comorbidity score was similar between the sexes. Women were less likely to have undergone prior aortic surgery (32% vs 53%; P < .0001) but had had more extensive aneurysms (P = .007) with greater rates of prohibitive anatomic risk factors (open repair, 31% vs 17% [P = .01]; endovascular repair, 33% vs 28% [P = .32]). The metrics of frailty were higher for the women, including recent unintentional weight loss (11% vs 5%; P = .002), limited physical activity tolerance (46% vs 31%; P < .0001), and the need for ambulatory assistance (13% vs 6%; P < .0001). Of the 578 patients, 55% of the women and 30% of the men had had at least one frailty metric that was prohibitive for open repair (P = .0006). The women had also scored higher on the modified frailty index (P = .009). For open repair, 74% of women and 61% of men had at least one prohibitive risk factor. The women were also more likely to have multiple types of prohibitive risk factors. Compared with the men, the women were less likely to be offered repair (60% vs 74%; P = .0009) and less likely to undergo repair (44% vs 62%; P = .0001). CONCLUSIONS: Women with TAAAs had increased metrics of frailty and anatomic risk that were not captured by comorbidity-based risk assessments. This suggests that frailty, together with complex anatomy, could explain the lower intervention rates for women with TAAAs.

Sarcopenia predicts for long-term survival in patients with thoracoabdominal aortic aneurysms undergoing operative and nonoperative management.

OBJECTIVE: Sarcopenia, defined as a loss of muscle mass or poor muscle quality, is a syndrome associated with poor surgical outcomes. The prognostic value of sarcopenia in patients with thoracoabdominal aortic aneurysms (TAAAs) is unknown. The present study was designed to define sarcopenia in this patient population and assess its impact on survival among patients who had undergone operative and nonoperative management of TAAAs. METHODS: We retrospectively reviewed all patients with a diagnosis of a TAAA at an academic hospital between 2009 and 2017 who had been selected for operative and nonoperative management. Sarcopenia was identified by measuring the total muscle area on a single axial computed tomography image at the third lumbar vertebra. The muscle areas were normalized by patient height, and cutoff values for sarcopenia were established at the lowest tertile of the normalized total muscle area. Long-term patient survival was assessed using Kaplan-Meier and Cox regression models. RESULTS: A total of 295 patients were identified, of whom 199 had undergone operative management and 96 nonoperative management for TAAAs. The patients selected for nonoperative management were more likely to be women and to have chronic kidney disease, coronary artery disease, cerebrovascular disease, a higher modified frailty index, and a larger aortic diameter. The Kaplan-Meier analyses revealed significantly lower long-term survival for the patients with and without sarcopenia in the operative and nonoperative groups. In Cox regression analyses, sarcopenia was a significant predictor of shorter survival for both operative (hazard ratio, 0.96; 95% confidence interval, 0.94-0.99; P = .006) and nonoperative (hazard ratio, 0.95; 95% confidence interval, 0.90-1.00; P = .05) groups after adjusting for age, race, sex, maximum aortic diameter, modified frailty index, chronic kidney disease, and active smoking. Additionally, age was a significant predictor of shorter survival in the operative group, and smoking and aortic diameter were significant in the nonoperative group. CONCLUSIONS: In our cohort of patients who had received operative and nonoperative management of TAAAs, the patients with sarcopenia had had significantly lower long-term survival, regardless of whether surgery had been performed. These data suggest that sarcopenia could be used as a predictor of survival for patients with TAAAs and might be useful for risk stratification and decision making in the management of TAAAs.

Secondary interventions after fenestrated/branched aneurysm repairs are common and nondetrimental to long-term survival.

OBJECTIVE: Secondary interventions are common after endovascular repair of aortic aneurysms. However, the frequency and procedural details of secondary interventions after fenestrated or branched endovascular abdominal aortic aneurysm repair (F/BEVAR) have been less well described, and the effects on long-term survival and aneurysm-related mortality are unknown. METHODS: Consecutive patients enrolled as a part of a multicenter research consortium in nine independent physician-sponsored investigational device exemption studies from 2005 to 2020 were evaluated. All secondary interventions performed after the initial procedure were classified as open or percutaneous and as major or minor in accordance with the Society for Vascular Surgery reporting standards. Secondary interventions were further classified as high or low magnitude according to the physiologic effects of the intervention. The demographics, procedural details, and perioperative outcomes were compared between those who had and those who had not undergone secondary interventions. Kaplan-Meier and Cox proportional hazard ratio (HR) analysis were used to evaluate long-term survival. RESULTS: Of 1681 patients who had undergone F/BEVAR, 385 (23%) had required a secondary intervention at any point during follow-up. Freedom from reintervention was 82% at 1 year and 59% at 5 years of follow-up. The mean follow-up period was 23 months. Most secondary interventions were percutaneous (84%), minor (70%), and of low magnitude (81%). Renal stenting (30%) and access-related procedures (24%) were the most frequent percutaneous and open procedures, respectively. High magnitude operations were required for 19% of the patients. Technical success was achieved for 94% of the secondary interventions, and mortality from the secondary interventions was <1%. Secondary interventions as a whole were associated with improved long-term survival (HR, 0.6; 95% confidence interval [CI], 0.5-0.7). In the subgroup analysis, major (HR, 0.6; 95% CI, 0.4-0.8), minor (HR, 0.6; 95% CI, 0.5-0.8), low magnitude (HR, 0.5; 95% CI, 0.4-0.7), and percutaneous (HR, 0.6; 95% CI, 0.5-0.7) secondary interventions were associated with improved survival. However, high magnitude (HR, 1.0; 95% CI, 0.7-1.5) and open (HR, 1.0; 95% CI, 0.7-1.5) secondary interventions were not. Similarly, when aneurysm-related survival was specifically assessed, low magnitude secondary interventions were found to improve survival (HR, 0.3; 95% CI, 0.1-0.7), and high magnitude secondary interventions (HR, 2.8; 95% CI, 1.4-5.8) and open secondary interventions (HR, 2.7; 95% CI, 1.3-5.5) were associated with increased mortality. CONCLUSIONS: Secondary interventions after F/BEVAR were frequent and were typically percutaneous, minor, and low magnitude procedures. Although uncommon, high magnitude and open secondary interventions were associated with decreased long-term survival and increased aneurysm-related mortality. These data highlight the importance of close, lifelong surveillance and suggest that a significant rate of secondary intervention should be anticipated but that these will not negatively affect survival.