Retroperitoneal vs. Transperitoneal Approach for Non-Ruptured Open Conversion after Endovascular Aneurysm Repair.

OBJECTIVE: Several studies comparing the transperitoneal (TP) and retroperitoneal (RP) approach for AAA repair suggest that the RP approach may result in lower rates of perioperative mortality and morbidity. However, data comparing these approaches for open conversion are lacking. This study aims to evaluate the association between the type of approach and outcomes following open conversion after EVAR. METHODS: We included all patients who underwent open conversion after EVAR between 2010-2022 in Vascular Quality Initiative (VQI). Patients presenting with rupture were excluded. The primary outcome was perioperative mortality. The secondary outcomes included perioperative complications and 5-year mortality. Inverse probability weighting (IPW) was used to adjust for factors with statistical or clinical significance. Logistic regression was used to assess perioperative mortality and complications in the weighted cohort. 5-year mortality was evaluated using Kaplan-Meier and Cox regression. RESULTS: We identified 660 patients (39% RP) who underwent open conversion after EVAR. Compared with TP, RP patients were older (75 [IQR, 70-79] years vs. 73.5 [IQR, 68-79] years, p<.001), and more frequently had prior myocardial infarction (33% vs. 22%, p=.002). Compared with the TP approach, the RP approach was less frequently used in case of associated iliac aneurysm (19% vs. 27%, p=.026), but more frequently with associated renal bypass (7.8% vs. 1.7%, p<.001) and by high volume physicians (highest quintile, >7 AAA annually: 41% vs. 17%, p<.001) and in high volume centers (highest quintile, >35 AAA annually: 36% vs. 20%, p<.001). RP patients, compared with TP patients, were less likely to have external iliac or femoral distal anastomosis (8.2% vs. 21%, p<.001), and an infrarenal clamp (25% vs. 36%, p<.001). Unadjusted perioperative mortality was not significantly different between approaches (RP vs. TP: 3.8% vs. 7.5%; p=.077). After risk adjustment, RP patients had similar odds of perioperative mortality (aOR, 0.49; 95%CI, 0.22-1.10; p=.082), and lower odds of intestinal ischemia (aOR, 0.26; 95%CI, 0.08-0.86; p=.028) and in-hospital reintervention (aOR, 0.43; 95%CI, 0.22-0.85; p=.015). No significant differences were found in the other perioperative complications, and 5-year mortality (aHR, 0.79; 95%CI, 0.47-1.32; p=.37). CONCLUSIONS: - Our findings suggest that the RP approach may be associated with lower adjusted odds of perioperative complications compared with the TP approach. The RP approach should be considered for open conversion after EVAR when feasible.

Impact of Chronic Kidney Disease on Outcomes following Vascular Procedure in the Vascular Quality Initiative.

BACKGROUND: Chronic kidney disease (CKD) increases morbidity and mortality in most vascular procedures. However, a binary classification of estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, which is often used in both modeling and clinical trials, may not be optimal for predicting clinical outcomes. OBJECTIVE: Determine the optimal eGFR cutoff for use in risk stratification and prediction models. METHODS: Vascular Quality Initiative (VQI) data for non-emergent, first-time OAR, EVAR, TEVAR, CEA, CAS, PVI, Supra- and infra-inguinal bypass were analyzed from to 2013-2023 and divided into cohorts based on eGFR (≥60, 45-59, 30-44, <30, and preoperative dialysis). χ2 and logistic regression were used to evaluate perioperative outcomes. RESULTS: Compared to patients with eGFR ≥60, those with eGFR 45-59 had similar odds of mortality following all procedures, except TEVAR. Driven by this group, the combined cohort showed a slight increase in the odds of mortality for eGFR 45-59 (0.6% vs. 0.7%, aOR 1.16, P=0.002). Those in the 30-44 group demonstrated increased odds of mortality both overall and in the individual procedure groups (0.6% vs. 1.2%, aOR 1.78, P<0.001). The odds of mortality continued to increase with worsening eGFR. The overall rate of new permanent dialysis was low for all eGFR cohorts, with a 0.02% difference between those with eGFR >60 and those in the 45-59 cohort (0.04% vs. 0.06%; a OR 1.65, P<0.001). The odds of permanent dialysis likewise continued to increase with decreasing eGFR. CONCLUSIONS: Rather than a binary eGFR cutoff of ≥60 and <60 to stratify patient risk, better risk stratification may be achieved by using five groups of ≥60, 45-59, 30-44, <30, and preoperative dialysis.

Factors Associated with and Outcomes of Respiratory Adverse Events Following Thoracic Endovascular Aortic Repair.

OBJECTIVE: Respiratory adverse events (RAEs) after thoracic endovascular aortic repair (TEVAR) remain poorly characterized due to the lack of comprehensive studies that identify individuals prone to these complications. This study aims to determine the incidence, factors associated with, and outcomes of RAEs after TEVAR. METHODS: We identified Vascular Quality Initiative patients undergoing TEVAR isolated to zones 0-5 from 2010 to 2023 for non-traumatic pathologies. After determining the incidence of post-operative RAEs, we assessed baseline characteristics, pathology, procedural details, and postoperative complications stratified by respiratory complication status: none, pneumonia only, reintubation only, or both. We then examined pre- and intra-operative variables independently associated with the development of postoperative RAEs using multivariable modified Poisson regression. Kaplan-Meier analysis and Cox proportional hazards regression model were used to determine associations between postoperative RAEs and 5-year survival adjusting for preoperative variables and other non-respiratory post-operative complications in a separate model. RESULTS: Of 10,708 patients, 8.3% had any RAE (pneumonia only: 2.1%, reintubation only: 4.8%, both: 1.4%). Patients with any RAE were more likely to present with aortic dissection (any respiratory complication: 46% vs no respiratory complication: 35%; p<.001), and be symptomatic (58% vs 48%;p<.001). Developing RAEs post-TEVAR was associated with male sex (aRR: 1.19 [95% CI: 1.01-1.41]; p=0.037), obesity (1.31[1.07-1.61]; p=0.009), morbid obesity (1.68[1.20-2.32]; p=0.002), renal dysfunction (eGFR 30-45: 1.45[1.15-1.82]; p=0.002; eGFR <30/hemodialysis: 1.7[1.37-2.11]; p<0.001), anemia (1.31[1.09-1.58]; p=0.003), aortic diameter >65mm (1.54[1.25-1.89]; p<0.001), proximal disease in the aortic arch (1.23[1.03-1.48]; p=0.025) or ascending aorta (1.61[1.19-2.14]; p=0.002), acute aortic dissection (2.13[1.72-2.63]; p<0.001), ruptured presentation (3.07[2.43-3.87]; p<0.001), same-day surgical thoracic branch treatment (1.51[1.25-1.82]; p<0.001), COPD on home oxygen (1.58[1.08-2.25]; p=0.014), limited self-care or bed-bound status (2.12[1.45-3.03]; p<0.001), and intraoperative transfusion (1.88[1.47-2.40]; p<0.001). Patients who developed post-operative RAEs had higher 30-day mortality (27% vs 4%; p<.001) and 5-year mortality than patients without respiratory complications (46% vs 20%; p<0.001). After adjusting for pre-operative and post-operative variables, 5-year mortality was higher in patients who developed any post-operative RAE (aHR: 1.8[1.6, 2.1]; p<.001), post-operative pneumonia only (1.4[1.0, 1.8];p=.046), reintubation only (2.2[1.8, 2.6]; p<.001) or both (1.5[1.1, 2.0]; p=.008). CONCLUSIONS: RAEs after TEVAR are common, more likely to occur in male patients with obesity, renal dysfunction, anemia, COPD on home oxygen, acute aortic dissection, ruptured presentation, same-day surgical thoracic branch treatment, who received intra-operative transfusion, and are associated with a two-fold increase in 5-year mortality regardless of the development of other post-operative complications. Considering these factors in assessing risks and benefits of TEVAR procedures, along with implementing customized post-operative care, can potentially improve clinical outcomes.

Association between diabetes status and long-term outcomes following open and endovascular repair of infrarenal abdominal aortic aneurysms.

OBJECTIVE: Current literature reports conflicting findings regarding the effect of diabetes mellitus (DM) on outcomes of abdominal aortic aneurysm (AAA) repair. In this study we examined the effect of DM and its management on outcomes after open AAA repair (OAR) and endovascular AAA repair (EVAR). METHODS: We identified all patients undergoing OAR or EVAR for infrarenal AAA between 2003 and 2018 in the Vascular Quality Initiative registry data linked with Medicare claims. We excluded patients with missing DM status. Patients were stratified by their preoperative DM status, and then further stratified by DM management: dietary, noninsulin antidiabetic medications (NIMs), or insulin. Outcomes of interest included 1-year aneurysm sac dynamics, 8-year aneurysm rupture, reintervention, and all-cause mortality. These outcomes were analyzed with the χ2 test, Kaplan-Meier methods, and multivariable Cox regression analyses. RESULTS: We identified 34,021 EVAR patients and 4127 OAR patients, of whom 20% and 16% had DM, respectively. Of all DM patients, 22% were managed by dietary management, 59% by NIM, and 19% by insulin. After EVAR, DM patients were more likely to have stable sacs, whereas non-DM patients were more likely to have sac regression at 1 year. Compared with non-DM, DM was associated with a significantly lower risk for 8-year rupture in EVAR (EVAR hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.51-0.92). Compared with non-DM, NIM was associated with lower risk of rupture within 8-years for both EVAR and OAR (EVAR HR, 0.64; 95% CI, 0.44-0.94; OAR HR, 0.29; 95% CI, 0.41-0.80), whereas dietary control and insulin had a similar rupture risk compared with non-DM. However, compared with non-DM, DM was associated with a higher risk of 8-year all-cause mortality after EVAR and OAR (DM vs non-DM: EVAR HR, 1.17; 95% CI, 1.11-1.23; OAR HR, 1.16; 95% CI, 1.00-1.36). After further DM management substratification, compared with non-DM, management with NIM and insulin were associated with a higher 8-year mortality in EVAR and OAR (EVAR: NIM HR, 1.12; 95% CI, 1.05-1.20; insulin: HR, 1.40; 95% CI, 1.26-1.55; OAR: NIM HR, 1.27; 95% CI, 1.06-1.54; and insulin: HR, 1.57; 95% CI, 1.15-2.13). Finally, there was a similar risk of reintervention across the DM and non-DM populations for EVAR and OAR. CONCLUSIONS: DM was associated with a lower adjusted risk of rupture after EVAR as well as OAR in patients managed with NIM. Nevertheless, just as in patients without AAA, preoperative DM was associated with a higher adjusted risk of all-cause mortality. Further study is needed to evaluate for differences in aneurysm-related mortality between DM and non-DM patients, and studies are planned to evaluate the independent effect of NIM on aneurysm-related outcomes.

Outcomes following carotid revascularization in patients with prior ipsilateral carotid artery stenting in the Vascular Quality Initiative.

OBJECTIVE: The outcomes of carotid revascularization in patients with prior carotid artery stenting (CAS) remain understudied. Prior research has not reported the outcomes after transcarotid artery revascularization (TCAR) in patients with previous CAS. In this study, we compared the peri-operative outcomes of TCAR, transfemoral CAS (tfCAS) and carotid endarterectomy (CEA) in patients with prior ipsilateral CAS using the Vascular Quality Iniatitive. METHODS: Using Vascular Quality Initiative data from 2016 to 2023, we identified patients who underwent TCAR, tfCAS, or CEA after prior ipsilateral CAS. We included covariates such as age, race, sex, body mass index, comorbidities (hypertension, diabetes, prior coronary artery disease, prior coronary artery bypass grafting/percutaneous coronary intervention, congestive heart failure, renal dysfunction, smoking, chronic obstructive pulmonary disease, and anemia), symptom status, urgency, ipsilateral stenosis, and contralateral occlusion into a regression model to compute propensity scores for treatment assignment. We then used the propensity scores for inverse probability weighting and weighted logistic regression to compare in-hospital stroke, in-hospital death, stroke/death, postoperative myocardial infarction (MI), stroke/death/MI, 30-day mortality, and cranial nerve injury (CNI) after TCAR, tfCAS, and CEA. We also analyzed trends in the proportions of patients undergoing the three revascularization procedures over time using Cochrane-Armitage trend testing. RESULTS: We identified 2137 patients undergoing revascularization after prior ipsilateral carotid stenting: 668 TCAR patients (31%), 1128 tfCAS patients (53%), and 341 CEA patients (16%). In asymptomatic patients, TCAR was associated with a lower yet not statistically significant in-hospital stroke/death than tfCAS (TCAR vs tfCAS: 0.7% vs 2.0%; adjusted odds ratio [aOR], 0.33; 95% confidence interval [CI], 0.11-1.05; P = .06), and similar odds of stroke/death with CEA (TCAR vs CEA: 0.7% vs 0.9%; aOR, 0.80; 95% CI, 0.16-3.98; P = .8). Compared with CEA, TCAR was associated with lower odds of postoperative MI (0.1% vs 14%; aOR, 0.02; 95% CI, 0.00-0.10; P < .001), stroke/death/MI (0.8% vs 15%; aOR, 0.05; 95% CI, 0.01-0.25; P < .001), and CNI (0.1% vs 3.8%; aOR, 0.04; 95% CI, 0.00-0.30; P = .002) in this patient population. In symptomatic patients, TCAR had an unacceptably elevated in-hospital stroke/death rate of 5.1%, with lower rates of CNI than CEA. We also found an increasing trend in the proportion of patients undergoing TCAR following prior ipsilateral carotid stenting (2016 to 2023: 14% to 41%), with a relative decrease in proportions of tfCAS (61% to 45%) and CEA (25% to 14%) (P < .001). CONCLUSIONS: In asymptomatic patients with prior ipsilateral CAS, TCAR was associated with lower odds of in-hospital stroke/death compared with tfCAS, with comparable stroke/death but lower postoperative MI and CNI rates compared with CEA. In symptomatic patients, TCAR was associated with unacceptably higher in-hospital stroke/death rates. In line with the postprocedure outcomes, there has been a steady increase in the proportion of patients with prior ipsilateral stenting undergoing TCAR over time.

Ten years of physician-modified endografts.

OBJECTIVES: Physician-modified endografts (PMEGs) have expanded the scope of endovascular abdominal aortic repair beyond the infrarenal aorta. Patients with prohibitively high surgical risk and visceral segment disease are often candidates for this intervention, which mitigates much of the morbidity and mortality associated with conventional open repair. Here we present the institutional PMEG experience of a high-volume aortic center. METHODS: We studied all PMEGs performed at our institution from 2012 to 2023. We included cases that were submitted to the US Food sand Drug Administration in support of an investigational device exemption (IDE) trial, as well as those in the subsequently approved IDE trial. Over this 11-year period, we assessed the changes in operative characteristics and perioperative outcomes over time. Additionally, we compared the outcomes from PMEG cases to those of Zenith fenestrated (ZFEN) grafts (done by the surgeon with the PMEG IDE), an alternative device used for aneurysms involving the lower visceral segment. Here we assessed operative characteristics, perioperative outcomes, and 5-year survival and reintervention rates. RESULTS: When assessing the change over time for PMEG operative characteristics, we found a trend toward decreased fluoroscopy time and decreased proportions of completion type I and type III endoleaks (all P < .05). Perioperative outcomes have remained stable over this period, with an overall perioperative mortality rate of 4.9% (noting that this registry also includes cases that were urgent and emergent). Despite the increased complexity of PMEGs relative to ZFENs, we found comparable perioperative outcomes with regard to mortality (4.9% vs 4.3%; P = .86), permanent spinal cord ischemia (1.1% vs 0%; P = .38), postoperative myocardial infarction (4.3% vs 2.9%; P = .60), postoperative respiratory failure (7.1% vs 4.3%; P = .43), and new dialysis use (2.2% vs 4.3%; P = .35). Additionally, 5-year survival (PMEG 54% vs ZFEN 65%; P = .15) and freedom from reintervention (63% vs 74%; P = .07) were similar between these cohorts. CONCLUSIONS: Throughout our >10-year experience with PMEGs, we have noted improvements in operative outcomes, which can likely be attributed to technological advances and increased physician experience. Additionally, we have found that PMEGs perform well when compared with ZFENs, despite being a more complicated repair that is able to treat a larger segment of the aorta. PMEGs are crucial for the comprehensive care of vascular patients with complex aortic disease. As further operative advancements are made, we only expect the use of this intervention to increase.

Management and outcomes of venous thoracic outlet decompression: A transition to the infraclavicular approach.

OBJECTIVE: Venous thoracic outlet syndrome (vTOS) is caused by compression of the subclavian vein at the costoclavicular space, which may lead to vein thrombosis. Current treatment includes thoracic outlet decompression with or without venolysis. However, given its relatively low prevalence, the existing literature is limited. Here, we report our single-institution experience in the treatment of vTOS. METHODS: We performed a retrospective review of all patients who underwent rib resection for vTOS at our institution from 2007 to 2022. Demographic, procedural details, and perioperative and long-term outcomes were reviewed. RESULTS: A total of 76 patients were identified. The mean age was 36 years. Swelling was the most common symptom (93%), followed by pain (6.6%). Ninety percent of patients had associated deep vein thrombosis, with 99% of these patients starting anticoagulation preoperatively. A total of 91% of patients underwent rib resection via the infraclavicular approach, 2% via the paraclavicular approach (due to a neurogenic component), and 7% via the transaxillary approach. Eighty-three percent of patients had endovascular intervention before or at the time of the rib resection, with catheter-directed thrombolysis (87%), followed by angioplasty (71%) and rheolytic thrombectomy (57%) being the most common interventions. The median time from endovascular intervention to rib resection was 14 days, with 25% at the same admission. The median postoperative stay was 3 days (2-5 days). There was no perioperative mortality or nerve injury. Fourteen percent of patients had postoperative complications, with bleeding complications (12%) being the most common. Waiting more than 30 days between initial endovascular intervention and rib resection was not associated with decreased risk of bleeding complications. Patients were seen postoperatively at 1-month (physical examination) and 6-month (duplex) intervals or for any new or recurrent symptoms. Twenty-two percent of our overall patient population underwent reintervention, most commonly angioplasty (21%). At last follow-up, 97% of subclavian veins were patent, and 93% of patients were symptom free. CONCLUSIONS: Over the last decade, we have transitioned to an infraclavicular approach for isolated vTOS, with low perioperative morbidity and good patency rates. These results support the adoption of the infraclavicular approach with adjunct endovascular techniques as a safe and efficacious treatment of vTOS.

An international, expert-based, Delphi consensus document on controversial issues in the management of abdominal aortic aneurysms.

OBJECTIVE: As a result of conflicting, inadequate or controversial data in the literature, several issues concerning the management of patients with abdominal aortic aneurysms (AAAs) remain unanswered. The aim of this international, expert-based Delphi consensus document was to provide some guidance for clinicians on these controversial topics. METHODS: A three-round Delphi consensus document was produced with 44 experts on 6 prespecified topics regarding the management of AAAs. All answers were provided anonymously. The response rate for each round was 100%. RESULTS: Most participants (42 of 44 [95.4%]) agreed that a minimum case volume per year is essential (or probably essential) for a center to offer open or endovascular AAA repair (EVAR). Furthermore, 33 of 44 (75.0%) believed that AAA screening programs are (probably) still clinically effective and cost effective. Additionally, most panelists (36 of 44 [81.9%]) voted that surveillance after EVAR should be (or should probably be) lifelong. Finally, 35 of 44 participants (79.7%) thought that women smokers should (or should probably/possibly) be considered for screening at 65 years of age, similar to men. No consensus was achieved regarding lowering the threshold for AAA repair and the need for deep venous thrombosis prophylaxis in patients undergoing EVAR. CONCLUSIONS: This expert-based Delphi consensus document provides guidance for clinicians regarding specific unresolved issues. Consensus could not be achieved on some topics, highlighting the need for further research in those areas.

The impact of travel distance in patient outcomes following revascularization for chronic limb-threatening ischemia.

BACKGROUND: Patient travel distance to the hospital is a key metric of individual and social disadvantage and its impact on the management and outcomes following intervention for chronic limb-threatening ischemia (CLTI) is likely underestimated. We sought to evaluate the effect of travel distance on outcomes in patients undergoing first-time lower extremity revascularization at our institution. METHODS: We retrospectively reviewed all consecutive patients undergoing first-time lower extremity revascularization, both endovascular and open, for CLTI from 2005 to 2014. Patients were stratified into 2 groups based on travel distance from home to hospital greater than or less than 30 miles. Outcomes included reintervention, major amputation, restenosis, primary patency, wound healing, length of stay, length of follow-up and mortality. Kaplan-Meier estimates were used to determine event rates. Logistic and cox regression was used to evaluate for an independent association between travel distance and these outcomes. RESULTS: Of the 1293 patients were identified, 38% traveled >30 miles. Patients with longer travel distances were younger (70 years vs 73 years; P = .001), more likely to undergo open revascularization (65% vs 41%; P < .001), and had similar Wound, Ischemia, foot Infection stages (P = .404). Longer distance travelled was associated with an increase in total hospital length of stay (9.6 days vs 8.6 days; P = .031) and shorter total duration of postoperative follow-up (2.1 years vs 3.0 years; P = .001). At 5 years, there was no definitive difference in the rate of restenosis (hzard ratio [HR], 1.3; 95% confidence interval [CI], 0.91-1.9; P = .155) or reintervention (HR, 1.4; 95% CI, 0.96-2.1; P = .065), but longer travel distance was associated with an increased rate of major amputation (HR, 2.1; 95% CI, 1.2-3.7; P = .011), and death (HR, 1.6; 95% CI, 1.2-2.2; P = .002). Longer travel distance was also associated with higher rate of nonhealing wounds (HR, 2.3; 95% CI, 1.5-3.5; P = .001). CONCLUSIONS: Longer patient travel distance was found to be associated with a lower likelihood of limb salvage and survival in patients undergoing first-time lower extremity revascularization for CLTI. Understanding and addressing the barriers to discharge, need for multidisciplinary follow-up, and appropriate postoperative wound care management will be key in improving outcomes at tertiary care regional specialty centers.

An Expert Delphi Consensus on Risk Factors for Adverse Events After Endovascular Aortic Aneurysm Repair: Tier 1 Study From the International RIsk Stratification in EVAR (IRIS-EVAR) Working Group.

PURPOSE: Tier 1 of the International RIsk Stratification in EndoVascular Aneurysm Repair (IRIS-EVAR) project aimed to identify important risk factors for adverse events following endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Initially, the steering committee proposed a number of risk factors for adverse events following EVAR. A Delphi consensus was performed as expert panelists were presented with risk factors and provided the opportunity to propose additional risk factors during the process. Experts in EVAR completed an online survey via 3 structured rounds. The first round opened in July 2022, and the third round closed in December 2022. Panelists rated risk factors using a 4-point Likert scale. Consensus was defined as >70% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing with a statement in each round. RESULTS: Thirty-five panelists from 12 countries completed the 3 rounds of surveys. Of a total of 64 individual risk factors assessed by the panelists, 37 (58%) had consensus that they were important for adverse events following EVAR. Risk factors were stratified in 4 domains: 14 (38%) were related to preoperative anatomy, 3 (8%) related to the aortic device selection, 8 (22%) related to the procedure performance, and 12 (32%) related to postoperative surveillance. Factors with the highest consensus in each domain were as follows: proximal aortic neck length <15 mm (98% consensus), anatomy non-compliant with instructions for use (94% consensus), length of achieved proximal aortic neck post implantation <10 mm (98% consensus), and non-satisfactory seal at landing or overlapping zones/sac expansion/kink or stenosis (100% consensus each), respectively. CONCLUSIONS: Clinically important risk factors for adverse events after EVAR were identified via expert consensus. These factors will be used to develop an expert consensus-informed risk stratification and surveillance strategies. CLINICAL IMPACT: This is the first study to apply an in-depth Delphi methodology to achieve an expert consensus on risk factors for adverse events after endovascular aneurysm repair (EVAR). Important risk factors were stratified in 4 domains: preoperative anatomy (14 factors), aortic device (3 factors), EVAR procedure (8 factors), and postoperative surveillance (12 factors). This study will potentially influence future clinical practice by providing evidence informed by experts regarding predictors of adverse events following EVAR that can be taken into account during decision making and developing post-EVAR surveillance strategies. These findings will inform a risk stratification tool for everyday use by vascular surgeons.

The Effect of One Year Aneurysm Sac Dynamics on Five Year Mortality and Continued Aneurysm Sac Evolution.

OBJECTIVE: One year aneurysm sac dynamics after endovascular abdominal aortic aneurysm repair (EVAR) were independently associated with a greater all cause mortality risk in prior registry studies but were limited in completeness and granularity. This retrospective analysis aimed to study the impact of sac dynamics on survival within the Endurant Stent Graft Global Registry (ENGAGE) with five year follow up. METHODS: A total of 1 263 subjects were enrolled in the ENGAGE Registry between March 2009 and April 2011. One year aneurysm sac changes were calculated between the one month post-operative imaging scans and the scan closest to the time of one year follow up. Sac regression was defined as a sac decrease of ≥ 5 mm and sac expansion as aneurysm sac growth ≥ 5 mm. The primary outcome was the five year all cause mortality rate. Kaplan-Meier estimates for freedom from all cause death were calculated. Multivariable Cox regression was used to determine the association between sac dynamics and all cause death. RESULTS: At one year, 441 of the 949 study participants with appropriate imaging (46%) had abdominal aortic aneurysm sac regression, 462 (49%) remained stable, and 46 (4.8%) had sac expansion. For patients with sac regression, the five year all cause mortality rate was 20%, compared with 28% for stable sac (p = .007) and 37% for the sac expansion (p = .010) cohorts. After adjustment, the sac expansion and stable sac cohorts were associated with a greater all cause mortality rate (expansion: hazard ratio [HR] 1.8; 95% CI 1.1 - 3.2; p = .032; stable: HR 1.4; 95% CI 1.1 - 1.9; p = .019). CONCLUSION: In the ENGAGE Global Registry, the one year rate of sac regression was 46%, and one year sac regression was observed to be associated with greater five year survival, corroborating prior findings using data from vascular registries. Sac regression could become the new standard for success after EVAR.

A national census for the off-label treatment of complex aortic aneurysms.

OBJECTIVE: Despite regulatory challenges, device availability, and rapidly expanding techniques, off-label endovascular repair of complex aortic aneurysms (cAAs) has expanded in the past decade. Given the lack of United States Food and Drug Administration-approved endovascular technology to treat cAAs, we performed a national census to better understand volume and current practice patterns in the United States. METHODS: Targeted sampling identified vascular surgeons with experience in off-label endovascular repair of cAAs. An electronic survey was distributed with institutional review board approval from the University of Rochester to 261 individuals with a response rate of 38% (n = 98). RESULTS: A total of 93 respondents (95%) reported off-label endovascular repair of cAAs. Mean age was 45.7 ± 8.3 years, and 84% were male. Most respondents (59%) were within the first 10 years of practice, and 69% trained at institutions with a high-volume of off-label endovascular procedures for complex aortic aneurysms with or without a physician-sponsored investigational device exemption (PS-IDE). Twelve respondents from 11 institutions reported institutional PS-IDEs for physician-modified endografts (PMEGs), in-situ laser fenestration (ISLF), or parallel grafting technique (PGT), including sites with PS-IDEs for custom-manufactured devices. Eighty-nine unique institutions reported elective off-label endovascular repair with a mean of 20.2 ± 16.5 cases/year and ∼1757 total cases/year nationally. Eighty reported urgent/emergent off-label endovascular repair with a mean of 5.7 ± 5.4 cases/year and ∼499 total cases/year nationally. There was no correlation between high-volume endovascular institutions (>15 cases/year) and institutions with high volumes of open surgical repair for cAAs (>15 cases/year; odds ratio, 0.7; 95% confidence interval, 0.3-1.5; P = .34). Elective techniques included PMEG (70%), ISLF (30%), hybrid PMEG/ISLF (18%), and PGT (14%), with PMEG being the preferred technique for 63% of respondents. Techniques for emergent endovascular treatment of complex aortic disease included PMEG (52%), ISLF (40%), PGT (20%), and hybrid-PMEG/ISLF (14%), with PMEG being the preferred technique for 41% of respondents. Thirty-nine percent of respondents always or frequently offer referrals to institutions with PS-IDEs for custom-manufactured devices. The most common barrier for referral to PS-IDE centers included geographic distance (48%), longitudinal relationship with patient (45%), and costs associated with travel (33%). Only 61% of respondents participate in the Vascular Quality Initiative for complex endovascular aneurysm repair, and only 57% maintain a prospective institutional database. Eighty-six percent reported interest in a national collaborative database for off-label endovascular repair of cAA. CONCLUSIONS: Estimates of off-label endovascular repair of cAAs are likely underrepresented in the literature based on this national census. PMEG was the most common technique for elective and emergent procedures. Under-reported off-label endovascular repair of cAA outcomes data appears to be limited by non-standardized PS-IDE reporting to the United States Food and Drug Administration, and the lack of Vascular Quality Initiative participation and prospective institutional data collection. Most participants are interested in a national collaborative database for endovascular repair of cAAs.

The association between sex and outcomes after thoracic endovascular repair for acute type B aortic dissection.

OBJECTIVE: Prior literature has found worse outcomes for female patients after endovascular repair of abdominal aortic aneurysm and mixed findings after thoracic endovascular aortic repair (TEVAR) for thoracic aortic aneurysm. However, the influence of sex on outcomes after TEVAR for acute type B aortic dissection (aTBAD) is not fully elucidated. METHODS: We identified patients who underwent TEVAR for aTBAD (<30 days) in the Vascular Quality Initiative from 2014 to 2022. We excluded patients with an entry tear or stent seal within the ascending aorta or aortic arch and patients with an unknown proximal tear location. Included patients were stratified by biological sex, and we analyzed perioperative outcomes and 5-year mortality with multivariable logistic regression and Cox regression analysis, respectively. Furthermore, we analyzed adjusted variables for interaction with female sex. RESULTS: We included 1626 patients, 33% of whom were female. At presentation, female patients were significantly older (65 [interquartile range: 54, 75] years vs 56 [interquartile range: 49, 68] years; P = .01). Regarding indications for repair, female patients had higher rates of pain (85% vs 80%; P = .02) and lower rates of malperfusion (23% vs 35%; P < .001), specifically mesenteric, renal, and lower limb malperfusion. Female patients had a lower proportion of proximal repairs in zone 2 (39% vs 48%; P < .01). After TEVAR for aTBAD, female sex was associated with comparable odds of perioperative mortality to males (8.1 vs 9.2%; adjusted odds ratio [aOR]: 0.79 [95% confidence interval (CI): 0.51-1.20]). Regarding perioperative complications, female sex was associated with lower odds for cardiac complications (2.3% vs 4.7%; aOR: 0.52 [95% CI: 0.26-0.97]), but all other complications were comparable between sexes. Compared with male sex, female sex was associated with similar risk for 5-year mortality (26% vs 23%; adjusted hazard ratio: 1.01 [95% CI: 0.77-1.32]). On testing variables for interaction with sex, female sex was associated with lower perioperative and 5-year mortality at older ages relative to males (aOR: 0.96 [0.93-0.99] | adjusted hazard ratio: 0.97 [0.95-0.99]) and higher odds of perioperative mortality when mesenteric malperfusion was present (OR: 2.71 [1.04-6.96]). CONCLUSIONS: Female patients were older, less likely to have complicated dissection, and had more distal proximal landing zones. After TEVAR for aTBAD, female sex was associated with similar perioperative and 5-year mortality to male sex, but lower odds of in-hospital cardiac complications. Interaction analysis showed that females were at additional risk for perioperative mortality when mesenteric ischemia was present. These data suggest that TEVAR for aTBAD overall has a similar safety profile in females as it does for males.

Outcomes of carotid revascularization stratified by procedure in patients with an estimated glomerular filtration rate of <30 and dialysis patients.

OBJECTIVE: Renal failure is a predictor of adverse outcomes in carotid revascularization. There has been debate regarding the benefit of revascularization in patients with severe chronic kidney disease or on dialysis. METHODS: Patients in the Vascular Quality Initiative undergoing transcarotid artery revascularization (TCAR), transfemoral carotid artery stenting (tfCAS), or CEA between 2016 and 2023 with an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2 or on dialysis were included. Patients were divided into cohorts based on procedure. Additional analyses were performed for patients on dialysis only and by symptomatology. Primary outcomes were perioperative stroke/death/myocardial infarction (MI) (SDM). Secondary outcomes included perioperative death, stroke, MI, cranial nerve injury, and stroke/death. Inverse probability of treatment weighting was performed based on treatment assignment to TCAR, tfCAS, and CEA patients and adjusted for demographics, comorbidities, and preoperative symptoms. The χ2 test and multivariable logistic regression analysis were used to evaluate the association of procedure with perioperative outcomes in the weighted cohort. Five-year survival was evaluated using Kaplan-Meier and weighted Cox regression. RESULTS: In the weighted cohort, 13,851 patients with an eGFR of <30 (2506 on dialysis) underwent TCAR (3639; 704 on dialysis), tfCAS (1975; 393 on dialysis), or CEA (8237; 1409 on dialysis) during the study period. Compared with TCAR, CEA had higher odds of SDM (2.8% vs 3.6%; adjusted odds ratio [aOR], 1.27; 95% confidence interval [CI], 1.00-1.61; P = .049), and MI (0.7% vs 1.5%; aOR, 2.00; 95% CI, 1.31-3.05; P = .001). Compared with TCAR, rates of SDM (2.8% vs 5.8%), stroke (1.2% vs 2.6%), and death (0.9% vs 2.4%) were all higher for tfCAS. In asymptomatic patients CEA patients had higher odds of MI (0.7% vs 1.3%; aOR, 1.85; 95% CI, 1.15-2.97; P = .011) and cranial nerve injury (0.3% vs 1.9%; aOR, 7.23; 95% CI, 3.28-15.9; P < .001). Like in the primary analysis, asymptomatic tfCAS patients demonstrated higher odds of death and stroke/death. Symptomatic CEA patients demonstrated no difference in stroke, death, or stroke/death. Although tfCAS patients demonstrated higher odds of death, stroke, MI, stroke/death, and SDM. In both groups, the 5-year survival was similar for TCAR and CEA (eGFR <30, 75.1% vs 74.2%; aHR, 1.06; P = .3) and lower for tfCAS (eGFR <30, 75.1% vs 70.4%; aHR, 1.44; P < .001). CONCLUSIONS: CEA and TCAR had similar odds of stroke and death and are both a reasonable choice in this population; however, TCAR may be better in patients with an increased risk of MI. Additionally, tfCAS patients were more likely to have worse outcomes after weighting for symptom status. Finally, although patients with a reduced eGFR have worse outcomes than their healthy peers, this analysis shows that the majority of patients survive long enough to benefit from the potential stroke risk reduction provided by all revascularization procedures.

The rise of endovascular repair for abdominal, thoracoabdominal, and thoracic aortic aneurysms.

BACKGROUND: Given changes in intervention guidelines and the growing popularity of endovascular treatment for aortic aneurysms, we examined the trends in admissions and repairs of abdominal aortic aneurysms (AAAs), thoracoabdominal aortic aneurysms (TAAAs), and thoracic aortic aneurysms (TAAs). METHODS: We identified all patients admitted with ruptured aortic aneurysms and intact aortic aneurysms repaired in the Nationwide Inpatient Sample between 2004 and 2019. We then examined the use of open, endovascular, and complex endovascular repair (OAR, EVAR, and cEVAR) for each aortic aneurysm location (AAA, TAAA, and TAA), alongside their resulting in-hospital mortality, over time. cEVAR included branched, fenestrated, and physician-modified endografts. RESULTS: 715,570 patients were identified with AAA (87% intact repairs and 13% rupture admissions). Both intact AAA repairs and ruptured AAA admissions decreased significantly between 2004 and 2019 (intact 41,060-34,215, P < .01; ruptured 7175-4625, P = .02). Of all AAA repairs performed in a given year, the use of EVAR increased (2004-2019: intact 45%-66%, P < .01; ruptured 10%-55%, P < .01) as well as cEVAR (2010-2019: intact 0%-23%, P < .01; ruptured 0%-14%, P < .01). Mortality after EVAR of intact AAAs decreased significantly by 29% (2004-2019, 0.73%-0.52%, P < .01), whereas mortality after OAR increased significantly by 16% (2004-2019, 4.4%-5.1%, P < .01). In the study, 27,443 patients were identified with TAAA (80% intact and 20% ruptured). In the same period, intact TAAA repairs trended upward (2004-2019, 1435-1640, P = .055), and cEVAR became the most common approach (2004-2019, 3.8%-72%, P = .055). A total of 141,651 patients were identified with ascending, arch, or descending TAAs (90% intact and 10% ruptured). Intact TAA repairs increased significantly (2004-2019, 4380-10,855, P < .01). From 2017 to 2019, the mortality after OAR of descending TAAs increased and mortality after thoracic endovascular aneurysm repair decreased (2017-2019, OAR 1.6%-3.1%; thoracic endovascular aneurysm repair 5.2%-3.8%). CONCLUSIONS: Both intact AAA repairs and ruptured AAA admissions significantly decreased between 2004 and 2019. The use of endovascular techniques for the repair of all aortic aneurysm locations, both intact and ruptured, increased over the past two decades. Most recently in 2019, 89% of intact AAA repairs, infrarenal through suprarenal, were endovascular (EVAR or cEVAR, respectively). cEVAR alone increased to 23% of intact AAA repairs in 2019, from 0% a decade earlier. In this period of innovation, with many new options to repair aortic aneurysms while maintaining arterial branches, endovascular repair is now used for the majority of all intact aortic aneurysm repairs. Long-term data are needed to evaluate the durability of these procedures.

Comparison of open and endovascular left subclavian artery revascularization for zone 2 thoracic endovascular aortic repair.

OBJECTIVE: In patients undergoing elective thoracic endovascular aortic repair (TEVAR) and left subclavian artery (LSA) coverage, routine preoperative LSA revascularization is recommended. However, in the current endovascular era, the optimal surgical approach is debated. We compared baseline characteristics, procedural details, and perioperative outcomes of patients undergoing open or endovascular LSA revascularization in the setting of TEVAR. METHODS: Adult patients undergoing TEVAR with zone 2 proximal landing and LSA revascularization between 2013 and 2023 were identified in the Vascular Quality Initiative. We excluded patients with traumatic aortic injury, aortic thrombus, or ruptured presentations, and stratified based on revascularization type (open vs any endovascular). Open LSA revascularization included surgical bypass or transposition. Endovascular LSA revascularization included single-branch, fenestration, or parallel stent grafting. Primary outcomes were stroke, spinal cord ischemia (SCI), and perioperative mortality (Pearson's χ2 test). Multivariable logistic regression was used to evaluate associations between revascularization type and primary outcomes. Secondarily, we studied other in-hospital complications and 5-year mortality (Kaplan-Meier, multivariable Cox regression). Sensitivity analyses were performed in patients undergoing concomitant LSA revascularization to TEVAR. RESULTS: Of 2489 patients, 1842 (74%) underwent open and 647 (26%) endovascular LSA revascularization. Demographics and comorbidities were similar between open and endovascular cohorts. Compared with open, endovascular revascularization had shorter procedure times (median, 135 minutes vs 174 minutes; P < .001), longer fluoroscopy times (median, 23 minutes vs 16 minutes; P < .001), lower estimated blood loss (median, 100 mL vs 123 mL; P < .001), and less preoperative spinal drain use (40% vs 49%; P < .001). Patients undergoing endovascular revascularization were more likely to present urgently (24% vs 19%) or emergently (7.4% vs 3.4%) (P < .001). Compared with open, endovascular patients experienced lower stroke rates (2.6% vs 4.8%; P = .026; adjusted odds ratio [aOR], 0.50 [95% confidence interval (CI), 0.25-0.90]), but had comparable SCI (2.9% vs 3.5%; P = .60; aOR, 0.64 [95% CI, 0.31-1.22]) and perioperative mortality (3.1% vs 3.3%; P = .94; aOR, 0.71 [95% CI, 0.34-1.37]). Compared with open, endovascular LSA revascularization had lower rates of overall composite in-hospital complications (20% vs 27%; P < .001; aOR, 0.64 [95% CI, 0.49-0.83]) and shorter overall hospital stay (7 vs 8 days; P < .001). After adjustment, 5-year mortality was similar among groups (adjusted hazard ratio, 0.85; 95% CI, 0.64-1.13). Sensitivity analyses supported the primary analysis with similar outcomes. CONCLUSIONS: In patients undergoing TEVAR starting in zone 2, endovascular LSA revascularization had lower rates of postoperative stroke and overall composite in-hospital complications, but similar SCI, perioperative mortality, and 5-year mortality rates compared with open LSA revascularization. Future comparative studies are needed to evaluate the mid- to long-term safety of endovascular LSA revascularization and assess differences between specific endovascular techniques.

Using Administrative Data to Better Treat Chronic Limb Threatening Ischemia.

Chronic limb threatening ischemia (CLTI) is the most severe manifestation of peripheral arterial disease and represents a particularly high-risk subgroup of patients. As such, efforts to better understand this complex patient population through well-designed clinical research studies are critical to improving CLTI care. Prospective randomized clinical trials (RCTs) remain the gold standard in clinical research, but these trials are resource-intensive and have highly selective patient populations, which limit their feasibility and generalizability. Alternatively, retrospective studies are less expensive than RCTs, have a larger sample size, and are more generalizable owing to a broader patient population. Health care administrative data provide rich sources of information that may be used for research purposes and are increasingly being used for the study of vascular surgery conditions, including CLTI. Although administrative data are collected for billing purposes, they may be leveraged to study a broad range of topics in vascular surgery including those related to health care delivery, epidemiology, health disparities, and outcomes. This review provides an overview of administrative data available for CLTI research, the strengths and limitations of these data sources, current areas of investigation, and future opportunities for further study with the goal of improving outcomes in this high-risk population.

Predictors of prolonged length of stay after elective carotid revascularization.

OBJECTIVE: Postoperative day-one discharge is used as a quality-of-care indicator after carotid revascularization. This study identifies predictors of prolonged length of stay (pLOS), defined as a postprocedural LOS of >1 day, after elective carotid revascularization. METHODS: Patients undergoing carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR), and transfemoral carotid artery stenting (TFCAS) in the Vascular Quality Initiative between 2016 and 2022 were included in this analysis. Multivariable logistic regression analysis was used to identify predictors of pLOS, defined as a postprocedural LOS of >1 day, after each procedure. RESULTS: A total of 118,625 elective cases were included. pLOS was observed in nearly 23.2% of patients undergoing carotid revascularization. Major adverse events, including neurological, cardiac, infectious, and bleeding complications, occurred in 5.2% of patients and were the most significant contributor to pLOS after the three procedures. Age, female sex, non-White race, insurance status, high comorbidity index, prior ipsilateral CEA, non-ambulatory status, symptomatic presentation, surgeries occurring on Friday, and postoperative hypo- or hypertension were significantly associated with pLOS across all three procedures. For CEA, additional predictors included contralateral carotid artery occlusion, preoperative use of dual antiplatelets and anticoagulation, low physician volume (<11 cases/year), and drain use. For TCAR, preoperative anticoagulation use, low physician case volume (<6 cases/year), no protamine use, and post-stent dilatation intraoperatively were associated with pLOS. One-year analysis showed a significant association between pLOS and increased mortality for all three procedures; CEA (hazard ratio [HR],1.64; 95% confidence interval [CI], 1.49-1.82), TCAR (HR,1.56; 95% CI, 1.35-1.80), and TFCAS (HR, 1.33; 95%CI, 1.08-1.64) (all P < .05). CONCLUSIONS: A postoperative LOS of more than 1 day is not uncommon after carotid revascularization. Procedure-related complications are the most common drivers of pLOS. Identifying patients who are risk for pLOS highlights quality improvement strategies that can optimize short and 1-year outcomes of patients undergoing carotid revascularization.