Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia.

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. RESULTS: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

Long-term outcomes of great saphenous vein harvest techniques for infrainguinal arterial bypass in a Medicare-matched registry database.

OBJECTIVE: Long-term outcomes for harvesting techniques for great saphenous vein (GSV) and its impact on the outcomes of infrainguinal arterial bypass remains largely unknown. Endoscopic GSV harvesting (EVH) has emerged as a less invasive alternative to conventional open techniques. Using the Vascular Quality initiative Vascular Implant Surveillance & Interventional Outcomes Network (VQI-VISION) database, we compared the long-term outcomes of infrainguinal arterial bypass using open and endoscopic GSV harvest techniques. METHODS: Patients who underwent infrainguinal GSV bypass between 2010 and 2019 were identified in the VQI-VISION Medicare linked database. Long-term outcomes of major/minor amputations, and reinterventions up to 5 years of follow-up were compared between continuous incisions, skip incision, and EVH, with continuous incisions being the reference group. Secondary outcomes included 30- and 90-day readmission, in addition to surgical site infections and patency rates at 6 months to 2 years postoperatively. Survival analysis using Kaplan-Meier curves and Cox regression hazard models were utilized to compare outcomes between groups. To adjust for multiple comparisons between the study groups, a P value of 2.5% was considered significant. RESULTS: Among the 8915 patients included in the study, continuous and skip vein harvest techniques were used in 44.4% and 43.4% of cases each, whereas 12.3% underwent EVH. The utilization of EVH remained relatively stable at around 12% throughout the study period. Compared with GSV harvest using continuous incisions, EVH was associated with higher rates of reintervention at 1 year (46.5% vs 41.3%; adjusted hazard ratio [aHR], 1.22; 95% confidence interval [CI], 1.06-1.41; P = .01]. However, no significant difference was observed between EVH and continuous incisions, and between skip and continuous incisions in terms of long-term reintervention or major and minor amputations on adjusted analysis. Compared with continuous incision vein harvest, both EVH and skip incisions were associated with lower surgical site infection rates within the first 6 months post-bypass (aHR, 0.53; 95% CI, 0.35-0.82 and aHR, 0.68; 95% CI, 0.53-0.87, respectively). Loss of primary, primary-assisted, and secondary patency was higher after EVH compared with continuous incision vein harvest. Among surgeons performing EVH, comparable long-term outcomes were observed regardless of low (<4 cases/year), medium (4-7 cases/year), or high procedural volumes (>7 cases/year). CONCLUSIONS: Despite higher 1-year reintervention rates, EVH for infrainguinal arterial bypass is not associated with a significant difference in long-term reintervention or amputation rates compared with other harvesting techniques. These outcomes are not influenced by procedural volumes for EVH technique.

How multidisciplinary clinics may mitigate socioeconomic barriers to care for chronic limb-threatening ischemia.

OBJECTIVE: Although multidisciplinary clinics improve outcomes in chronic limb-threatening ischemia (CLTI), their role in addressing socioeconomic disparities is unknown. Our institution treats patients with CLTI at both traditional general vascular clinics and a multidisciplinary Limb Preservation Program (LPP). The LPP is in a minority community, providing expedited care at a single facility by a consistent team. We compared outcomes within the LPP with our institution's traditional clinics and explored patients' perspectives on barriers to care to evaluate if the LPP might address them. METHODS: All patients undergoing index revascularization for CLTI from 2014 to 2023 at our institution were stratified by clinic type (LPP or traditional). We collected clinical and socioeconomic variables, including Area Deprivation Index (ADI). Patient characteristics were compared using χ2, Student t, or Mood median tests. Outcomes were compared using log-rank and multivariable Cox analysis. We also conducted semi-structured interviews to understand patient-perceived barriers. RESULTS: From 2014 to 2023, 983 limbs from 871 patients were revascularized; 19.5% of limbs were treated within the LPP. Compared with traditional clinic patients, more LPP patients were non-White (43.75% vs 27.43%; P < .0001), diabetic (82.29% vs 61.19%; P < .0001), dialysis-dependent (29.17% vs 13.40%; P < .0001), had ADI in the most deprived decile (29.38% vs 19.54%; P = .0061), resided closer to clinic (median 6.73 vs 28.84 miles; P = .0120), and had worse Wound, Ischemia, and foot Infection (WIfI) stage (P < .001). There were no differences in freedom from death, major adverse limb event (MALE), or patency loss. Within the most deprived subgroup (ADI >90), traditional clinic patients had earlier patency loss (P = .0108) compared with LPP patients. Multivariable analysis of the entire cohort demonstrated that increasing age, heart failure, dialysis, chronic obstructive pulmonary disease, and increasing WIfI stage were independently associated with earlier death, and male sex was associated with earlier MALE. Ten traditional clinic patients were interviewed via convenience sampling. Emerging themes included difficulty understanding their disease, high visit frequency, transportation barriers, distrust of the health care system, and patient-physician racial discordance. CONCLUSIONS: LPP patients had worse comorbidities and socioeconomic deprivation yet had similar outcomes to healthier, less deprived non-LPP patients. The multidisciplinary clinic's structure addresses several patient-perceived barriers. Its proximity to disadvantaged patients and ability to conduct multiple appointments at a single visit may address transportation and visit frequency barriers, and the consistent team may facilitate patient education and improve trust. Including these elements in a multidisciplinary clinic and locating it in an area of need may mitigate some negative impacts of socioeconomic deprivation on CLTI outcomes.

Secondary interventions following open vs endovascular revascularization for chronic limb threatening ischemia in the BEST-CLI trial.

OBJECTIVES: Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints. METHODS: In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396). We also compared the cumulative number of major and all index limb reinterventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models. RESULTS: In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb reintervention (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.28-0.49; P < .001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P < .001), or any reintervention, amputation, or death (HR, 0.68; 95% CI, 0.60-0.78; P < .001). Findings were similar in cohort 2 for major reintervention (HR, 0.53; 95% CI, 0.33-0.84; P = .007) or any reintervention (HR, 0.71; 95% CI, 0.52-0.98; P = .04). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to ENDO as compared with OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio [MR], 0.45; 95% CI, 0.34-0.58; P < .001) or any target limb reinterventions (MR, 0.67; 95% CI, 0.57-0.80; P < .001) per year was significantly less in the OPEN arm of cohort 1. The mean number of reinterventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR, 0.45; 95% CI, 0.35-0.57; P < .001 and MR, 0.66; 95% CI, 0.55-0.79; P < .001 for major and all, respectively). The majority of index limb reinterventions occurred during the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial. CONCLUSIONS: Reintervention is common following revascularization for chronic limb-threatening ischemia. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions.

Educating Trainees to Treat Peripheral Arterial Disease: Challenges and Opportunities.

Educating trainees to treat Peripheral Artery Disease (PAD) carries specific contemporary challenges. The national increase of the prevalence of PAD combined with a significant shortage of vascular surgeons creates a need for concern for future management of this complex disease. Over the past 2 decades, traditional (5 + 2) and integrated (0 + 5) paradigms have fostered trainee annual growth and comparable case distribution and volumes in endovascular and open surgical treatment options have been maintained. Close evaluation into not only the absolute numbers of surgical cases, but the level of trainee involvement in each logged case is recommended. Future implementation of the Entrustable Professional Activity (EPA) modules will hopefully assist in ensuring linear development of surgical skill and judgment. Additionally, advances in individual and systems level techniques to enhance skill acquisition in the form of "off-the job training" and simulation-based training may provide an enhancement to traditional technical training methods. Finally, the possibility and role of artificial intelligence in vascular surgery skill training must not be ignored, but carefully explored and utilized to modernize cognitive and technical skill preparation for trainees in the and delivery of care for PAD patients. Overall, the training residents for the treatment of PAD patients will be associated with new challenges that vascular surgery must embrace and surmount to advance our specialty.

Impact of neighborhood social disadvantage on the presentation and management of peripheral artery disease.

OBJECTIVE: Studies examining the relationship between socioeconomic disparities and peripheral artery disease (PAD) often focus on individual social health determinants and fail to account for the complex interplay between factors that ultimately impact disease severity and outcomes. Area deprivation index (ADI), a validated measure of neighborhood adversity, provides a more comprehensive assessment of social disadvantage. Therefore, we examined the impact of ADI on PAD severity and its management. METHODS: We identified all patients who underwent infrainguinal revascularization (open or endovascular) or amputation for symptomatic PAD in the Vascular Quality Initiative registry between 2003 and 2020. An ADI score of 1 to 100 was assigned to each patient based on their residential zip code, with higher ADI scores corresponding with increasing adversity. Patients were categorized by ADI quintiles (Q1-Q5). The outcomes of interest included indication for procedure (claudication, rest pain, or tissue loss) and rates of revascularization (vs primary amputation). Multinomial logistic regression was used to evaluate for an independent association between ADI quintile and these outcomes. RESULTS: Among the 79,973 patients identified, 9604 (12%) were in the lowest ADI quintile (Q1), 14,961 (18.7%) in Q2, 19,800 (24.8%) in Q3, 21,735 (27.2%) in Q4, and 13,873 (17.4%) in Q5. There were significant trends toward lower rates of claudication (Q1: 39% vs Q5: 34%, P < .001), higher rates of rest pain (Q1: 12.4% vs Q5: 17.8%, P < .001) as the indication for intervention, and lower rates of revascularization (Q1: 80% vs Q5: 69%, P < .001) with increasing ADI quintiles. In adjusted analyses, there was a progressively higher likelihood of presenting with rest pain vs claudication, with patients in Q5 having the highest probability when compared with those in Q1 (relative risk: 2.0; 95% confidence interval: 1.8-2.2; P < .001). Patients in Q5, when compared with those in Q1, also had a higher likelihood of presenting with tissue loss vs claudication (relative risk: 1.4; 95% confidence interval: 1.3-1.6; P < .001). Compared with patients in Q1, patients in Q2-Q5 had a lower likelihood of undergoing any revascularization procedure. CONCLUSIONS: Among patients who underwent infrainguinal revascularization or amputation in the Vascular Quality Initiative, those with higher neighborhood adversity had more advanced disease at presentation and lower rates of revascularization. Further work is needed to better understand neighborhood factors that are contributing to these disparities in order to identify community-level targets for improvement.

Vascular surgery integrated resident selection criteria in the pass or fail era.

OBJECTIVES: Vascular surgery integrated residency (VSIR) programs are highly competitive; however, criteria for resident selection remain opaque and non-standardized. The already unclear selection criteria will be further impacted by the impending transition of the United States Medical Licensing Examination (USMLE) Step 1 from numeric scores to a binary pass/fail outcome. The purpose of this study was to investigate the historical and anticipated selection criteria of VSIR applicants. METHODS: This was a cross-sectional, nationwide, 59-item survey that was sent to all VSIR program directors (PDs). Data was analyzed using the Fisher exact test if categorical and the Mann-Whitney U test and the Kruskal-Wallis test if ordinal. RESULTS: Forty of 69 PDs (58%) responded to the survey. University-based programs constituted 85% of responders. Most VSIR PDs (65%) reported reviewing between 101 to 150 applications for 1 to 2 positions annually. Forty-two percent of the responding PDs reported sole responsibility for inviting applicants to interview, whereas 50% had a team of faculty responsible for reviewing applications. On a five-point Likert scale, letters of recommendation (LOR) from vascular surgeons or colleagues (a person the PD knows) were the most important objective criteria. Work within a team structure was rated highest among subjective criteria. The majority of respondents (72%) currently use the Step 1 score as a primary method to screen applicants. Regional differences in use of Step 1 score as a primary screening method were: Midwest (100%), Northeast (76%), South (43%), and West (40%) (P = .01). PDs responded that that they will use USMLE Step 2 score (42%) and LOR (10%) to replace USMLE Step 1 score. The current top ranked selection criteria are letters from a vascular surgeon, USMLE Step 1 score and overall LOR. The proposed top ranked selection criteria after transition of USMLE Step 1 to pass/fail include LOR overall followed by Step 2 score. CONCLUSIONS: This is the first study to evaluate the selection criteria used by PDs for VSIR. The landscape of VSIR selection criteria is shifting and increasing transparency is essential to applicants' understanding of the selection process. The transition of USMLE Step 1 to a pass/fail report will shift the attention to Step 2 scores and elevate the importance of other relatively more subjective criteria. Defining VSIR program selection criteria is an important first step toward establishing holistic review processes that are transparent and equitable.

Relationship between WIfI stage and quality of life at revascularization in the BEST-CLI trial.

OBJECTIVE: The WIfI (Wound, Ischemia, foot Infection) stage measures the extent of wounds, ischemia, and foot infection in patients with chronic limb threatening ischemia (CLTI) and has been associated with the risk of major amputation. Patients with CLTI have impaired health-related quality of life (HRQoL), which can be multifactorial. We hypothesized that the severity of the limb threat (WIfI stage) would be associated with poor HRQoL among patients with CLTI presenting for revascularization. METHODS: The dataset of the BEST-CLI (best endovascular versus best surgical therapy in patients with CLTI) trial, a prospective, randomized trial comparing open and endovascular revascularization strategies, was queried for HRQoL assessments at patient enrollment. The HRQoL assessments included (1) Vascular Quality of Life; (2) 12-item short form survey (SF-12), containing the utility index score (short-form six-dimension R2 utility index, incorporating physical, emotional, and mental well-being) and mental and physical components; and (3) the EQ-5D. Multivariable regression analysis was used to identify the independent associations with the baseline HRQoL assessments. RESULTS: A total of 1568 patients with complete WIfI data were analyzed, of whom 71.5% were men. The WIfI distribution was 35.5% with stage 4, 29.6% with stage 3, 28.6% with stage 2, and 6.3% with stage 1. Patients presenting with WIfI stage 4, compared with stage 1 to 3, were more often men (74.9% vs 69.6%) and current smokers (25.4% vs. 17.6%), had had end-stage renal disease (13.3% vs 8.5%) and diabetes (83.6% vs 60.2%), were not independently ambulatory (56.8% vs 38.5%), and had had higher median morbidity scores (4 vs 3; P < .05 for all). On multivariable analysis, WIfI stage 4, compared with stage 1 to 3, was associated with lower SF-12 mental component scale scores (estimate, -2.43; 95% confidence interval, -3.73 to -1.13; P < .001) and short-form six-dimension R2 utility index scores (estimate, -0.02; 95% confidence interval, -0.03 to 0.001; P = .04). The WIfI stage was not independently associated with the baseline Vascular Quality of Life, SF-12 physical component scale, or EQ-5D assessments. CONCLUSIONS: WIfI stage was independently associated with poorer quality of life because of mental, rather than physical, health for patients with CLTI. Clinicians should be aware of the burden of mental stress borne by those with the greatest limb impairment.

Paradigm Shift in Vascular Surgery Training: Independent versus Integrated Match Outcomes.

BACKGROUND: Currently, 2 predominant pathways exist for vascular surgery training: integrated and independent training pathways. We hypothesized that match rates would increase with time and be higher in the independent pathway than in the integrated pathway. METHODS: The National Resident Matching Program provided data from the Vascular Surgery Match (VSM) (2008-2021). Match rates were defined as the percentage of applicants who matched. Chi-squared tests were used to evaluate temporal trends and interpathway differences. RESULTS: Over the study period, the annual number of training positions increased for both the independent (119 to 129, 8% increase) and integrated (9 to 79, 778% increase) training pathways. From 2008 to 2021, the annual match rate was stable in the independent pathway (97% to 96%, P > 0.05). In the integrated pathway, the annual match rate increased from 29% to 44% (P < 0.001). During each year, match rates in the independent pathway exceeded those in the integrated pathway (P < 0.001). US allopathic graduates had higher match rates than non-US allopathic graduates in both the independent (92% vs. 82%, P < 0.001) and the integrated pathway (70% vs. 17%, P < 0.001). In the independent pathway, the percentage of applicants that matched at 1 of their top 3 choices decreased from 67% to 58% (P < 0.001). Over the study period, more training positions went unmatched in the Independent (n = 130, 8%) versus the Integrated (n = 17, 3%) pathway (P < 0.001). CONCLUSIONS: VSM match rates have increased for the integrated pathway and remains competitive especially for non-US allopathic graduates. More research is needed to understand applicant variables that modulate match rates.

The USMLE® STEP 1 Pass or Fail Era of the Vascular Surgery Residency Application Process: Implications for Structural Bias and Recommendations.

United States Medical Licensing Examination® (USMLE®) STEP 1 score reporting has been changed to a binary pass/fail format since January 26, 2022. The motives behind this change were (1) the questionable validity of using USMLE STEP 1 as a screening tool during the candidate selection process and (2) the negative impact of using standardized examination scores as an initial gatekeeping threshold for the underrepresented in medicine (URiM) candidates applying to graduate medical education programs, given their generally lower mean standardized exams scores compared to non-URiM students. The USMLE administrators justified this change as a tactic to enhance the overall educational experience for all students and to increase the representation of URiM groups. Moreover, they advised the program directors (PDs) to give more attention to other important qualities and components such as the applicant's personality traits, leadership roles and other extracurricular accomplishments, as part of a holistic evaluation strategy. At this early stage, it is unclear how this change will impact Vascular Surgery Integrated residency (VSIR) programs. Several questions are outstanding, most importantly, how VSIR PDs will evaluate applicants absent the variable which heretofore was the primary screening tool. Our previously published survey showed that VSIR PDs will move their attention to other measures such as USMLE STEP 2 Clinical Knowledge (CK) and letters of recommendation during the VSIR selection process. Furthermore, more emphasis on subjective measures such as the applicant's medical school rank and extracurricular student activities is expected. Given the expected higher weight of USMLE STEP 2CK in the selection process than ever, many anticipate that medical students will dedicate more of their limited time to its preparation at the expense of both clinical and nonclinical activities. Potentially leaving less time to explore specialty pathways and to determine whether Vascular Surgeons  is the appropriate career for them. The critical juncture in the VSIR candidate evaluation paradigm presents an opportunity to thoughtfully transform the process via current (Standardized Letter of Recommendation, USMLE STEP 2CK, and clinical research) and future (Emotional Intelligence, Structure Interview and Personality Assessment) measures which constitute a framework to follow in the USMLE STEP 1 pass/fail era.

The vascular surgery in-training examination predicts performance on qualifying examination.

OBJECTIVE: Vascular surgery trainees participate in the vascular surgery in-training examination (VSITE) during each year of their training. Although the VSITE was developed as a low-stakes, formative examination, performance on that examination might correlate with the pass rates for the Vascular Surgery Board written qualifying examination (VQE) and oral certifying examination (VCE) and might, therefore, guide both trainees and program directors. The present study was designed to examine the ability of the VSITE to predict trainees' performance on the VQE and VCE. METHODS: All first-time candidates of the Vascular Surgery Board VQE and VCE were analyzed from 2016 to 2020, including those from both the integrated and independent training pathways. VSITE scores from the final year of training were associated with the VQE scores and the probability of passing the VQE and VCE both. Linear and logistic regression models were used to determine the ability of VSITE results to predict the VQE scores and the probability of passing each board examination. RESULTS: VSITE scores available for the 559 candidates (69.3% male; 30.7% female) who had completed the VQE and 369 candidates (66.7% male; 33.3% female) who had completed both the VQE and the VCE. The linear regression model results for the final year of training showed that the VSITE scores explained 34% of the variance in the VQE scores (29% for the integrated and 37% for the independent trainees). Logistic regression demonstrated that the final year VSITE scores were a significant predictor of passing the VQE for both integrated and independent trainees (P < .001). A VSITE score of 500 during the final year of training predicted a VQE passing probability of >90% for each group of candidates. The probability of passing the VQE decreased to 73% for candidates from integrated programs, 61% for candidates from independent programs, and 64% for the whole cohort when the score was 400. The VSITE scores were a significant predictor of passing the VCE only for the candidates from independent programs (odds ratio, 1.01; 95% confidence interval, 1.00-1.02; P < .01), for whom a VSITE score of 400 correlated with an 82% probability of passing the VCE. CONCLUSIONS: VSITE performance is predictive of passing the VQE for trainees from both integrated and independent training paradigms. Vascular surgery trainees and training programs should optimize their preparation and educational efforts to maximize performance on the VSITE during their final year of training to improve the likelihood of passing the VQE. Further analysis of the predictive value of VSITE scores during the earlier years of training might allow the board certification examinations to be administered earlier in the final year of training.

Impact of Perioperative Blood Transfusion in Anemic Patients Undergoing Infra Inguinal Bypass.

OBJECTIVE: Patients who present with lower extremity ischemia are frequently anemic and the optimal transfusion threshold for this cohort remains controversial. We sought to evaluate the impact of blood transfusion on postoperative major adverse cardiac events (MACE), including myocardial infarction, dysrhythmia, stroke, congestive heart failure, and 30-day mortality for these patients. METHODS: All consecutive patients who underwent infra-inguinal bypass at our institution from 2011 to 2020 were included. Perioperative red blood cell transfusion was the primary exposure, and the primary outcome was MACE. Univariate and multivariable analyses were performed to assess the impact of patient and procedural variables, including red blood cell transfusion, stratified by hemoglobin (Hgb) nadir: <7, 7-8, and >8 g/dL. RESULTS: Of the 287 patients reviewed for analysis, 146 (50.9%) had a perioperative transfusion (mean: 1.6 ± 3 units). Patients who received a transfusion had a mean nadir Hgb of 8.3 ± 1.0 g/dL, compared to 10.1 ± 1.7 g/dL without a transfusion. The overall incidence of MACE was 15.7% (45 of 287 patients). Univariate analysis demonstrated that MACE was associated with blood transfusion (P = 0.009), lower Hgb nadir (P = 0.02), and higher blood loss (P = 0.003). On multivariate analysis, transfusion was independently associated with MACE for patients with a Hgb nadir >8 g/dL (OR: 3.09; P = 0.006), but not for patients with Hgb nadir 7-8 g/dL (OR: 0.818; P = 0.77). Additionally, patients with MACE had significantly longer length of hospital stay than for patients without (13 vs. 7.7 days, P = 0.001). CONCLUSIONS: For patients undergoing infra-inguinal bypass, receiving a red blood cell transfusion with a Hgb nadir >8 g/dL was associated with a 3-fold increase in MACE, with nearly twice the length of stay. For patients with a Hgb 7-8 g/dL, transfusion did not increase or reduce the incidence of MACE. These findings suggest no benefit of blood transfusion for patients with Hgb nadir >7 g/dL and harm for Hgb >8 g/dL, however causation cannot be proven due to the retrospective nature of the study and randomized studies are needed to confirm or refute these findings.

Management strategy for lower extremity malperfusion due to acute aortic dissection.

OBJECTIVE: Aortic dissection can result in devastating cerebral, visceral, renal, spinal, and extremity ischemia. We describe the management and outcomes of patients presenting with aortic dissection and lower extremity malperfusion (LEM). METHODS: A single-center institutional aortic database was queried for patients with aortic dissection and LEM from 2011 to 2019. The primary end point was resolution of LEM after aortic repair. Secondary end points were amputation, in-hospital mortality, time to intervention, and postoperative complications. RESULTS: Of 769 patients with aortic dissection, 42 (5.5%) presented acutely with LEM: 16 with Stanford type A and 26 Stanford type B aortic dissection (age 55 ± 13 years; 90% men). Most presented as Rutherford IIB symptoms, but patients with type A had Rutherford III more often, compared with those with type B. Aortic repair was performed before limb interventions in 36 patients (86%; 19 TEVAR, 16 open arch and ascending repair, and 1 open descending aortic repair with fenestration). Seven (19%) had immediate failure with persistent malperfusion recognized in the operating room and underwent additional limb intervention, including extra-anatomic revascularization (n = 4), iliac stenting (n = 2), and femoral patch with septal fenestration or tacking (n = 2). Three patients (8%) had early delayed failure requiring extra-anatomic bypass in two and amputation in one. In contrast, six patients had limb-first intervention with extra-anatomic revascularization. None had immediate failure, but one-half had early delayed failure requiring proximal aortic intervention: two TEVAR and one open aortic fenestration. Limb-first patients were more likely to have early delayed failure compared with aortic dissection treated first patients (50% vs 8%; P = .029). The amputation rate was 2%, occurring in one type A patient. The overall in-hospital mortality was 7% (n = 3), with no difference between type A and type B aortic dissection. There was no difference in surgical site infection, postoperative dialysis need, stroke, and myocardial infarction. CONCLUSIONS: In patients presenting with acute aortic dissection with limb ischemia, resolution of the malperfusion occurs in the majority of cases after primary aortic dissection intervention, emphasizing the usefulness of urgent TEVAR for complicated type B and open repair of type A before lower extremity intervention. Limb-first interventions have a higher early delayed failure rate and thus require more frequent reoperation. However, the overall amputation rate in LEM owing to aortic dissection remains low.

Effect of infrainguinal bypass tunneling technique on patency and amputation in patients with limb ischemia.

OBJECTIVE: We investigated the association of tunneling technique on patency and amputation in patients undergoing lower extremity bypass for limb ischemia. METHODS: The National Vascular Quality Initiative database infrainguinal bypass module from 2008 to 2017 was queried for analysis. We excluded cases with non-great saphenous vein grafts, grafts using multiple segments, aneurysmal disease indications, bypass locations outside the femoral to below the knee popliteal artery or tibial arteries, and missing data on tunneling type and limb ischemia. The main exposure variable was the tunneling type, subcutaneously vs subfascially. Our primary outcomes were primary patency and amputation. The secondary outcomes included primary-assisted patency and secondary patency. Univariate and multivariate logistic regression models were used. RESULTS: A total of 5497 bypass patients (2835 subcutaneous and 2662 subfascial) were included. Age, race, graft orientation (reversed vs not reversed), bypass donor and recipient vessels, harvest type, end-stage renal disease, smoking, coronary artery bypass graft, congestive heart failure, P2Y12 inhibitor at discharge, surgical site infection at discharge, and indication (rest pain vs tissue loss vs acute ischemia) were analyzed for an association with the tunneling technique (P < .05). Multivariate analyses demonstrated that the tunneling type was not associated with primary patency, primary-assisted patency, secondary patency, or major amputation (P > .05). CONCLUSIONS: Compared with subfascial tunneling, the superficial tunneling technique was not associated with primary patency or major amputation in limb ischemia patients undergoing infrainguinal bypass with a single-segment great saphenous vein.

Endovascular versus open repair of isolated superficial femoral and popliteal artery injuries.

OBJECTIVE: Despite the increasing use of endovascular therapy for traumatic arterial injuries, little is known about the outcomes of endovascular repair of superficial femoral artery (SFA) and popliteal artery (PA) injuries. In the present study, we compared the characteristics and outcomes of endovascular vs open repair of traumatic SFA and PA injuries. METHODS: We performed a retrospective National Trauma Data Bank analysis of trauma patients with a blunt or penetrating injury of the SFA and/or PA who had undergone endovascular or open repair from 2007 to 2014. Multivariate logistic regression was used to compare the outcomes, with propensity score matching used for sensitivity analysis. RESULTS: The incidence of SFA and PA injuries was 0.2%, with an overall increase in the annual use of endovascular stent repair from 3.2% in 2007 to 7.6% in 2014 (P = .002). A total of 2,873 patients with an isolated SFA and/or PA injury were included in the present study, of whom 163 (5.7%) had undergone endovascular repair. SFA injuries were more frequently treated with endovascular repair (70% vs 27%) and PA injuries were more often associated with open repair (41.1% vs 54.7%). Open repair was more frequently associated with a concomitant femur fracture or knee dislocation (30.7% vs 38.8%; P = .039). Endovascular repair was not associated with worse in-hospital amputation-free survival (AFS) compared with open repair on univariate analysis (91.1% vs 89.7%; P = .573) or multivariate logistic regression (odds ratio [OR], 1.053; 95% confidence interval [CI], 0.551-2.012; P = .876). Propensity score matching revealed that in-hospital mortality was higher (OR, 3.69; 95% CI, 1.37-9.82; P = .01) and fasciotomy was lower (OR, 0.23; 95% CI, 0.14-0.37; P < .001) in the endovascular repair group, with no significant differences in AFS (OR, 0.86; 95% CI, 0.48-1.67; P = .65). CONCLUSIONS: Endovascular repair of SFA and PA injuries has in-hospital AFS comparable to that for open repair, supporting the increasing use of endovascular repair for traumatic SFA and PA injuries in appropriately selected cases. Given the unexpected finding of increased in-hospital mortality after endovascular repair, further studies are necessary to determine the appropriate patient selection and the durability of endovascular repair.

Complications associated with lumbar drain placement for endovascular aortic repair.

OBJECTIVE: We reviewed the complications associated with perioperative lumbar drain (LD) placement for endovascular aortic repair. METHODS: Patients who had undergone perioperative LD placement for endovascular repair of thoracic and thoracoabdominal aortic pathologies from 2010 to 2019 were reviewed. The primary endpoints were major and minor LD-associated complications. Complications that had resulted in neurological sequelae or had required an intervention or a delay in operation were defined as major. These included intracranial hemorrhage, symptomatic spinal hematoma, cerebrospinal fluid (CSF) leak requiring intervention, meningitis, retained catheter tip, arachnoiditis, and traumatic (or bloody) tap resulting in delayed operation. Minor complications were defined as a bloody tap without a delay in surgery, asymptomatic epidural hematoma, and CSF leak with no intervention required. Isolated headaches were recorded separately owing to the minimal clinical impact. RESULTS: A total of 309 LDs had been placed in 268 consecutive patients for 222 thoracic endovascular aortic repairs, 85 complex endovascular aortic repairs (EVARs; fenestrated branched EVAR/parallel grafting), and 2 EVARs (age, 65 ± 13 years; 71% male) for aortic pathology, including aneurysm (47%), dissection (49%), penetrating aortic ulcer (3%), and traumatic injury (0.6%). A dedicated neurosurgical team performed all LD procedures; most were performed by the same individual, with a technical success rate of 98%. Radiologic guidance was required in 3%. The reasons for unsuccessful placement were body habitus (n = 2) and severe spinal disease (n = 3). Most were placed prophylactically (96%). The overall complication rate was 8.1% (4.2% major and 3.9% minor). Major complications included spinal hematoma with paraplegia in 1 patient, intracranial hemorrhage in 2, meningitis in 2, arachnoiditis in 3, CSF leak requiring a blood patch in 3, bloody tap delaying the operation in 1, and a retained catheter tip in 1 patient. Patients who had undergone previous LD placement had experienced significantly more major LD-related complications (12.2% vs 3%; P = .019). The rate of total LD-associated complications did not differ between prophylactic and emergent therapeutic placements (8.1% vs 7.7%; P = 1.00) nor between major or minor complications. On multivariate analysis, previous LD placement and an overweight body mass index were the only independent predictors of major LD-related complications. CONCLUSIONS: The complications associated with LD placement can be severe even when performed by a dedicated team. Previous LD placement and overweight body mass index were associated with a significantly greater risk of complications; however, emergent therapeutic placement was not. Although these risks are justified for therapeutic LD placement, the benefit of prophylactic LD placement to prevent paraplegia should be weighed against these serious complications.

Ensuring equity, diversity, and inclusion in the Society for Vascular Surgery: A report of the Society for Vascular Surgery Task Force on Equity, Diversity, and Inclusion.

Diversity, equity, and inclusion represent interconnected goals meant to ensure that all individuals, regardless of their innate identity characteristics, feel welcomed and valued among their peers. Equity is achieved when all individuals have equal access to leadership and career advancement opportunities as well as fair compensation for their work. It is well-known that the unique backgrounds and perspectives contributed by a diverse workforce strengthen and improve medical organizations overall. The Society for Vascular Surgery (SVS) is committed to supporting the highest quality leadership, patient care, surgical education, and societal recommendations through promoting diversity, equity, and inclusion within the SVS. The overarching goal of this document is to provide specific context and guidance for enhancing diversity, equity, and inclusion within the SVS as well as setting the tone for conduct and processes beyond the SVS, within other national and regional vascular surgery organizations and practice settings.

Use of Inner Branches During Physician-Modified Endografting for Complex Abdominal and Thoracoabdominal Aortic Aneurysms.

OBJECTIVES: Endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms have been performed widely in an increasing number of centers, utilizing custom-manufactured or physician-modified stent grafts containing fenestrations and side-arm branches for visceral and renal artery incorporation. Alternatively, inner branch configurations may be useful in complex anatomy, where application of fenestrations or side-arm branches can be challenging. Our study aims to evaluate the incidence of target vessel instability when incorporated with inner branch configurations, and report clinical outcomes of patients who underwent fenestrated/branched endovascular aortic repairs (F-BEVAR) containing one or more inner branches. METHODS: We reviewed patients who underwent F-BEVAR with at least one inner branch configuration for complex abdominal or thoracoabdominal aortic aneurysms at Keck Hospital of University of Southern California from 2014 to 2020. Endpoints were mortality, major adverse events (MAE), technical success, and target vessel instability. Target vessel instability was assessed using follow-up computed tomography (CT) and duplex imaging. RESULTS: Out of the 175 patients who underwent F-BEVAR for complex abdominal and TAAA during the study period, 17 patients had at least one inner branch configuration. All were deemed high-risk for open repair with multiple cardiovascular and/or pulmonary comorbidities. Eight (47%) patients had extent I, II, III thoracoabdominal aortic aneurysms, and 10 (59%) had prior aortic repairs. A total of 68 target vessels were incorporated (mean = 4 vessels/patient, range=1~6), of which 40% were inner branch configurations, most commonly for renal arteries. Technical success was 94.1%. There was one perioperative mortality due to massive myocardial infarction, as well as one patient who needed temporary hemodialysis. No device-related mortalities were observed. At 30 days, primary inner branch patency was 100% with no target vessel instability or reintervention. At mean follow-up of 5.8 months, the overall survival was 94% with one patient who expired from unknown cause. Overall primary inner branch patency was 96.3%, due to occlusion of a long lumbar artery branch with no clinical sequelae. CONCLUSION: Inner branch configurations can provide a safe alternative technique of branch incorporation during complex endovascular aortic repair.

Functional ambulatory status as a potential adjunctive decision-making tool following wound, level of ischemia, and severity of foot infection assessment.

The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System has been developed to stratify amputation risk on the basis of extent of the wound, level of ischemia, and severity of foot infection (WIfI). However, there are no currently validated metrics to assess, grade, and consider functional status, especially ambulatory status, as a major consideration during limb salvage efforts. Therefore, we propose an adjunct to the current WIfI system to include the patient's ambulatory functional status after initial assessment of limb threat. We propose a functional ambulatory score divided into grade 0, ambulation outside the home with or without an assistive device; grade 1, ambulation within the home with or without an assistive device; grade 2, minimal ambulation, limbs used for transfers; and grade 3, a person who is bed-bound. Adding ambulatory function as a supplementary assessment tool can guide clinical decision making to achieve optimal future functional ambulatory outcome, a patient-centered goal as critical as limb preservation. This adjunct may aid limb preservation teams in rapid, effective communication and clinical decision making after initial WIfI assessment. It may also improve efforts toward patient-centered care and functional ambulatory outcome as a primary objective. We suggest a score of functional ambulatory status should be included in future trials of patients with chronic limb-threatening ischemia.

Improved survival with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in chronic limb-threatening ischemia.

OBJECTIVE: Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) reduce the risk of cardiovascular events in patients with peripheral artery disease. However, their effect on limb-specific outcomes is unclear. The objective of this study was to assess the effect of ACE inhibitors/ARBs on limb salvage (LS) and survival in patients undergoing peripheral vascular intervention (PVI) for chronic limb-threatening ischemia (CLTI). METHODS: The Vascular Quality Initiative registry was used to identify patients undergoing PVI for CLTI between April 1, 2010, and June 1, 2017. Patients with complete comorbidity, procedural, and follow-up limb and survival data were included. Propensity score matching was performed to control for baseline differences between the groups. LS, amputation-free survival (AFS), and overall survival (OS) were calculated in matched samples using Kaplan-Meier analysis. RESULTS: A total of 12,433 limbs (11,331 patients) were included. The ACE inhibitors/ARBs group of patients had significantly higher prevalence of coronary artery disease (31% vs 27%; P < .001), diabetes (67% vs 57%; P < .001), and hypertension (94% vs 84%; P < .001) and lower incidence of end-stage renal disease (7% vs 12%; P < .001). Indication for intervention was tissue loss in 64% of the ACE inhibitors/ARBs group vs 66% in the no ACE inhibitors/ARBs group (P = .005). Postmatching survival analysis at 5 years showed improved OS (81.8% vs 79.9%; P = .01) and AFS (73% vs 71.5%; P = .04) with ACE inhibitors/ARBs but no difference in LS (ACE inhibitors/ARBs, 88.3%; no ACE inhibitors/ARBs, 88.1%; P = .56). After adjustment for multiple variables in a Cox regression model, ACE inhibitors/ARBs were associated with improved OS (hazard ratio, 0.89; 95% confidence interval, 0.80-0.99; P = .03) and AFS (hazard ratio, 0.92; 95% confidence interval, 0.84-0.99; P = .04). CONCLUSIONS: ACE inhibitors/ARBs are independently associated with improved survival and AFS in patients undergoing PVI for CLTI. LS rates remained unaffected. Further research is required to investigate the use of ACE inhibitors/ARBs in this population of patients, especially CLTI patients with other indications for therapy with ACE inhibitors/ARBs.