2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.

AIM: The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS: A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE: Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.

Health Disparities in Peripheral Artery Disease: A Scientific Statement From the American Heart Association.

Peripheral artery disease (PAD) affects 200 million individuals worldwide. In the United States, certain demographic groups experience a disproportionately higher prevalence and clinical effect of PAD. The social and clinical effect of PAD includes higher rates of individual disability, depression, minor and major limb amputation along with cardiovascular and cerebrovascular events. The reasons behind the inequitable burden of PAD and inequitable delivery of care are both multifactorial and complex in nature, including systemic and structural inequity that exists within our society. Herein, we present an overview statement of the myriad variables that contribute to PAD disparities and conclude with a summary of potential novel solutions.

Association between socioeconomic deprivation and presentation with a ruptured abdominal aortic aneurysm.

OBJECTIVE: Given the ongoing nature of research in the social determinants space and urges to improve United States Preventive Services Task Force screening efforts for abdominal aortic aneurysms (AAAs), this project aims to characterize the association between the level of socioeconomic deprivation, rurality, and ruptured AAA (rAAA) presentation across the United States. METHODS: We queried the Vascular Quality Initiative registry (2010-2019) for patients with AAAs. The area deprivation index (ADI) is an index from 1 to 100 used to capture socioeconomic status. ADI was grouped into quintiles, with the most deprived regions being quintile 5 and having the highest ADI index. Multivariable logistic regression assessed the association between ADI, rurality, and rAAA presentation overall and before age 65. RESULTS: Of the 82,909 patients included, 11,458 patients (14%) resided in the most socioeconomically deprived regions, and 18,083 patients (22%) lived in rural regions. Overall, 6831 patients (8.2%) experienced an rAAA, with 4696 patients (69%) residing in the three most deprived quintiles. Most patients underwent endovascular repair (n = 67,933; 82%), followed by open repair (n = 14,976; 18%). On multivariable analysis, residence in the most socioeconomically deprived region was associated with a near 1.5-fold increased odds of presenting with an rAAA compared with a residence in the least deprived regions (odds ratio [OR], 1.46; 95% confidence interval [CI], 1.31-1.63; P < .001), whereas urban residence was associated with a decreased odds to present with an rAAA compared with rural residence (OR, 0.84; 95% CI, 0.79-0.89; P < .001). When stratifying the study population by the United States Preventive Services Task Force recommended age for AAA screening (65 years old), 14,147 patients (17%) were under 65. Of those under 65, 1381 patients (9.8%) experienced a rAAA, and 9955 patients (71%) resided in the three most deprived quintiles. Residence in the most socioeconomically deprived region was associated with an increased odds of presenting with an rAAA compared with residence in the least deprived region (OR, 1.31; 95% CI, 1.01-1.69; P = .042). However, there were no significant associations between rural residence and increased rAAA presentation among individuals under 65 (OR, 1.07; 95% CI, 0.93-1.23; P = .36). CONCLUSIONS: Among all patients in this study, patients residing in highly socioeconomically deprived or rural regions were more likely to present with an rAAA, but among those under 65, only residence in a socioeconomically deprived area was associated with increased odds of rAAA presentation. Understanding the effects of socioeconomic deprivation on rAAA presentation can identify at-risk populations for early AAA screening before rupture.

Implementing methods in the ELEGANCE registry to increase diversity in clinical research.

OBJECTIVE: Women and underrepresented minorities (URMs) who are at an increased risk of presenting with severe peripheral artery disease (PAD) and have different responses to treatment compared with non-Hispanic White males yet are underrepresented in PAD research. METHODS: ELEGANCE is a global, prospective, multi-center, post-market registry of PAD patients treated with drug-eluting device that aims to enroll at least 40% women and 40% URMs. The study design incorporates strategies to increase enrollment of women and URMs. Inclusion criteria are age ≥18 years and treatment with any commercially available Boston Scientific Corporation drug-eluting device marketed for peripheral vasculature lesions; exclusion criterion is life expectancy <1 year. RESULTS: Of 750 patients currently enrolled (951 lesions) across 39 sites, 324 (43.2%) are female and 350 (47.3%) are URMs (21.6% Black, 11.2% Asian, 8.5% Hispanic/Latino, and 5.3% other). Rutherford classification is distributed differently between sexes (P = .019). Treatment indication differs among race/ethnicity groups (P = .003). Chronic limb-threatening ischemia was higher for Black (38.3%) and Hispanic/Latino (28.1%) patients compared with non-Hispanic White (21.8%) and Asian patients (21.4%). De-novo stenosis was higher in Asian patients (92.3%) compared with Black, non-Hispanic White, and Hispanic/Latino patients (72.2%, 68.7%, and 77.8%, respectively; P < .001). Mean lesion length was longest for Black patients (162.7 mm), then non-Hispanic White (135.2 mm), Asian (134.8 mm), and Hispanic/Latino patients (128.1 mm; P = .008). CONCLUSIONS: Analyses of data from the ELEGANCE registry show that differences exist in baseline disease characteristics by sex and race/ethnicity; these may be the result of other underlying factors, including time to diagnosis, burden of undermanaged comorbidities, and access to care.

Natural history of superior mesenteric artery in-stent restenosis.

OBJECTIVE: Superior mesenteric artery (SMA) stenting is the preferred approach for patients with symptomatic SMA-associated chronic mesenteric ischemia (CMI). The durability of this modality is impacted by in-stent restenosis (ISR). Duplex ultrasound (DUS) and computed tomographic angiography (CTA)-measured ISR may be weakly correlated and not uniformly associated with recurrence of presenting symptoms. This study aims to analyze the association between the degree of ISR for patients with CMI and to develop a predictive model for symptom recurrence. METHODS: Single center, retrospective study included all patients with CMI with SMA stents from the period of 2003 to 2020. Follow-up period analysis included patients' symptoms recurrence, DUS, CTA, and angiography. A receiver operating characteristic (ROC) analysis was used to evaluate whether peak systolic velocity (PSV) was predictive of symptom recurrence. A subgroup analysis of patients (asymptomatic and symptomatic) with SMA ISR was identified; restenosis defined by DUS with peak systolic velocity (PSV) ≥350. RESULTS: The study included 186 patients with the ROC analysis obtained from 503 postoperative visits. PSV was not a predictor of symptoms return with area under the curve (AUC) = 0.49 (95% confidence interval [CI], 0.40-0.57). Agreement analysis between imaging modalities showed higher agreement between CTA and angiogram (AUC, 0.769; 95% CI, 0.688-0.849) vs CTA and DUS (AUC, 0.650; 95% CI, 0.589-0.711). The subgroup analysis of patients with ISR included 99 patients (asymptomatic n = 67; symptomatic n = 32). There was no statistical difference between median time (months) to ISR between both groups: 4.5 (asymptomatic group) and 7.6 (symptomatic group). The use of preoperative antiplatelet (86% vs 65%; P = .015) and P2Y12 receptor blockers (36% vs 13%; P = .016) was more prevalent in the asymptomatic group. There was no difference between the type or number of stents placed, stent diameter, or concomitant celiac artery intervention between both groups. CONCLUSIONS: The natural history of SMA and multimodality defined ISR in CMI has not previously been described. Elevated PSV was a poor predictor of symptoms recurrence. Both asymptomatic and symptomatic patients with ISR did not differ in type of stent placed, time to ISR, or involvement of celiac artery. Antiplatelet use pre- and postoperatively appears protective against symptoms recurrence. Our findings underscore the need for long-term surveillance integrating clinical evaluation and multimodality imaging when indicated.

Effectiveness of bedside investigations to diagnose peripheral artery disease among people with diabetes mellitus: A systematic review.

As a progressive disease process, early diagnosis and ongoing monitoring and treatment of lower limb peripheral artery disease (PAD) is critical to reduce the risk of diabetes-related foot ulcer (DFU) development, non-healing of wounds, infection and amputation, in addition to cardiovascular complications. There are a variety of non-invasive tests available to diagnose PAD at the bedside, but there is no consensus as to the most diagnostically accurate of these bedside investigations or their reliability for use as a method of ongoing monitoring. Therefore, the aim of this systematic review was to first determine the diagnostic accuracy of non-invasive bedside tests for identifying PAD compared to an imaging reference test and second to determine the intra- and inter-rater reliability of non-invasive bedside tests in adults with diabetes. A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective and retrospective investigations of the diagnostic accuracy of bedside testing in people with diabetes using an imaging reference standard and reliability studies of bedside testing techniques conducted in people with diabetes were eligible. Included studies of diagnostic accuracy were required to report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio (NLR) which were the primary endpoints. The quality appraisal was conducted using the Quality Assessment of Diagnostic Accuracy Studies and Quality Appraisal of Reliability quality appraisal tools. From a total of 8517 abstracts retrieved, 40 studies met the inclusion criteria for the diagnostic accuracy component of the review and seven studies met the inclusion criteria for the reliability component of the review. Most studies investigated the diagnostic accuracy of ankle -brachial index (ABI) (N = 38). In people with and without DFU, PLRs ranged from 1.69 to 19.9 and NLRs from 0.29 to 0.84 indicating an ABI <0.9 increases the likelihood of disease (but the extent of the increase ranges from a small to large amount) and an ABI within the normal range (≥0.90 and <1.3) does not exclude PAD. For toe-brachial index (TBI), a threshold of <0.70 has a moderate ability to rule PAD in and out; however, this is based on limited evidence. Similarly, a small number of studies indicate that one or more monophasic Doppler waveforms in the pedal arteries is associated with the presence of PAD, whereas tri- or biphasic waveform suggests that PAD is less likely. Several forms of bedside testing may also be useful as adjunct tests and 7 studies were identified that investigated the reliability of bedside tests including ABI, toe pressure, TBI, transcutaneous oxygen pressure (TcPO2 ) and pulse palpation. Inter-rater reliability was poor for pulse palpation and moderate for TcPO2. The ABI, toe pressure and TBI may have good inter- and intra-rater reliability, but margins of error are wide, requiring a large change in the measurement for it to be considered a true change rather than error. There is currently no single bedside test or a combination of bedside tests that has been shown to have superior diagnostic accuracy for PAD in people with diabetes with or without DFU. However, an ABI <0.9 or >1.3, TBI of <0.70, and absent or monophasic pedal Doppler waveforms are useful to identify the presence of disease. The ability of the tests to exclude disease is variable and although reliability may be acceptable, evidence of error in the measurements means test results that are within normal limits should be considered with caution and in the context of other vascular assessment findings (e.g., pedal pulse palpation and clinical signs) and progress of DFU healing.

Effectiveness of revascularisation for the ulcerated foot in patients with diabetes and peripheral artery disease: A systematic review.

INTRODUCTION: Peripheral artery disease (PAD) is associated with an increased likelihood of delayed or non-healing of a diabetes-related foot ulcer, gangrene, and amputation. The selection of the most effective surgical technique for revascularisation of the lower limb in this population is challenging and there is a lack of conclusive evidence to support the choice of intervention. This systematic review aimed to determine, in people with diabetes and tissue loss, if direct revascularisation is superior to indirect revascularisation and if endovascular revascularisation is superior to open revascularisation for the outcomes of wound healing, minor or major amputation, and adverse events including mortality. METHODS: Title and abstract searches of Medline, Embase, PubMed, and EBSCO were conducted from 1980 to 30th November 2022. Cohort and case-control studies and randomised controlled trials reporting comparative outcomes of direct (angiosome) revascularisation (DR) and indirect revascularisation (IR) or the comparative outcomes of endovascular revascularisation and open or hybrid revascularisation for the outcomes of healing, minor amputation, and major amputation in people with diabetes, PAD and tissue loss (including foot ulcer and/or gangrene) were eligible. Methodological quality was assessed using the Cochrane risk-of-bias tool for randomised trials, the ROBINS-I tool for non-randomised studies, and Newcastle-Ottawa Scale for observational and cohort studies where details regarding the allocation to intervention groups were not provided. RESULTS: From a total 7086 abstracts retrieved, 26 studies met the inclusion criteria for the comparison of direct angiosome revascularisation (DR) and indirect revascularisation (IR), and 11 studies met the inclusion criteria for the comparison of endovascular and open revascularisation. One study was included in both comparisons. Of the included studies, 35 were observational (31 retrospective and 4 prospective cohorts) and 1 was a randomised controlled trial. Cohort study quality was variable and generally low, with common sources of bias related to heterogeneous participant populations and interventions and lack of reporting of or adjusting for confounding factors. The randomised controlled trial had a low risk of bias. For studies of DR and IR, results were variable, and it is uncertain if one technique is superior to the other for healing, prevention of minor or major amputation, or mortality. However, the majority of studies reported that a greater proportion of participants receiving DR healed compared with IR, and that IR with collaterals may have similar outcomes to DR for wound healing. For patients with diabetes, infrainguinal PAD, and an adequate great saphenous vein available for use as a bypass conduit who were deemed suitable for either surgical procedure, an open revascularisation first approach was superior to endovascular therapy to prevent a major adverse limb event or death (Hazard Ratio: 0.72; 95% CI 0.61-0.86). For other studies of open and endovascular approaches, there was generally no difference in outcomes between the interventions. CONCLUSIONS: The majority of available evidence for the effectiveness of DR and IR and open and endovascular revascularisation for wound healing and prevention of minor and major amputation and adverse events including mortality in people with diabetes, PAD and tissue loss is inconclusive, and the certainty of evidence is very low. Data from one high quality randomised controlled trial supports the use of open over endovascular revascularisation to prevent a major limb event and death in people with diabetes, infrainguinal disease and tissue loss who have an adequate great saphenous vein available and who are deemed suitable for either approach.

Performance of non-invasive bedside vascular testing in the prediction of wound healing or amputation among people with foot ulcers in diabetes: A systematic review.

INTRODUCTION: The presence of peripheral artery disease (PAD) confers a significantly increased risk of failure to heal and major lower limb amputation for people with diabetes-related foot ulcer (DFU). Determining performance of non-invasive bedside tests for predicting likely DFU outcomes is therefore key to effective risk stratification of patients with DFU and PAD to guide management decisions. The aim of this systematic review was to determine the performance of non-invasive bedside tests for PAD to predict DFU healing, healing post-minor amputation, or need for minor or major amputation in people with diabetes and DFU or gangrene. METHODS: A database search of Medline and Embase was conducted from 1980 to 30 November 2022. Prospective studies that evaluated non-invasive bedside tests in patients with diabetes, with and without PAD and foot ulceration or gangrene to predict the outcomes of DFU healing, minor amputation, and major amputation with or without revascularisation, were eligible. Included studies were required to have a minimum 6-month follow-up period and report adequate data to calculate the positive likelihood ratio (PLR) and negative likelihood ratio for the outcomes of DFU healing, and minor and major amputation. Methodological quality was assessed using the Quality in Prognosis Studies tool. RESULTS: From 14,820 abstracts screened 28 prognostic studies met the inclusion criteria. The prognostic tests evaluated by the studies included: ankle-brachial index (ABI) in 9 studies; ankle pressures in 10 studies, toe-brachial index in 4 studies, toe pressure in 9 studies, transcutaneous oxygen pressure (TcPO2 ) in 7 studies, skin perfusion pressure in 5 studies, continuous wave Doppler (pedal waveforms) in 2 studies, pedal pulses in 3 studies, and ankle peak systolic velocity in 1 study. Study quality was variable. Common reasons for studies having a moderate or high risk of bias were poorly described study participation, attrition rates, and inadequate adjustment for confounders. In people with DFU, toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg were associated with a moderate to large increase in pretest probability of healing in people with DFU. Toe pressure ≥30 mmHg was associated with a moderate increase in healing post-minor amputation. An ABI using a threshold of ≥0.9 did not increase the pretest probability of DFU healing, whereas an ABI <0.5 was associated with a moderate increase in pretest probability of non-healing. Few studies investigated amputation outcomes. An ABI <0.4 demonstrated the largest increase in pretest probability of a major amputation (PLR ≥10). CONCLUSIONS: Prognostic capacity of bedside testing for DFU healing and amputation is variable. A toe pressure ≥30 mmHg, TcPO2 ≥25 mmHg, and skin perfusion pressure of ≥40 mmHg are associated with a moderate to large increase in pretest probability of healing in people with DFU. There are little data available evaluating the prognostic capacity of bedside testing for healing after minor amputation or for major amputation in people with DFU. Current evidence suggests that an ABI <0.4 may be associated with a large increase in risk of major amputation. The findings of this systematic review need to be interpreted in the context of limitations of available evidence, including varying rates of revascularisation, lack of post-revascularisation bedside testing, and heterogenous subpopulations.

The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes and a foot ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this guideline the IWGDF, the European Society for Vascular Surgery and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development, and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

Racial and Ethnic Representation in Peripheral Artery Disease Randomized Clinical Trials.

Clinical trial enrollment provides various benefits to study participants including early access to novel therapies that may potentially alter the trajectory of disease states. Trial sponsors benefit from enrolling demographically diverse trial participants enabling the trial outcomes to be generalizable to a larger proportion of the community at large. Despite these and other well-documented benefits, clinical trial enrollment for Black and Hispanic Americans as well as women continues to be low. Specific disease states such as PAD have a higher prevalence and clinical outcomes are relatively worse in Black Americans compared with non-Hispanic white Americans. The recruitment process for peripheral artery disease (PAD) clinical trials can be costly and challenging and usually comes at the expense of representation. Participant willingness and trust, engagement, and socioeconomic status play essential roles in the representation of underrepresented minority (URM) groups. Despite the contrary belief, URM groups such as Blacks and Hispanics are just as willing to participate in a clinical trial as non-Hispanic Whites. However, financial burdens, cultural barriers, and inadequate health literacy and education may impede URMs' access to clinical trials and medical care. Clinical trials' enrollment sites often pose transportation barriers and challenges that negatively impact creating a diverse study population. Lack of diversity among a trial population can stem from the stakeholder level, where corporate sponsors of academic readers do not consider diversity in clinical trials a priority due to false cost-benefit assumptions. The funding source may also impact the racial reporting or the results of a given trial. Industry-based trials have always been criticized for over-representing non-Hispanic White populations, driven by the desire to reach high completion rates with minimum financial burdens. Real efforts are warranted to ensure adequate minorities' representation in the PAD clinical trials and to the process toward the ultimate goal of developing more durable and effective PAD treatments that fit the needs of real-world populations.

No difference in midterm outcomes and complication rate between retroperitoneal and transperitoneal open aortic aneurysm repair in females.

OBJECTIVES: Abdominal Aortic Aneurysms (AAA) in females are less prevalent, have higher expansion rates and experience rupture at smaller diameters than in males. Studies have compared outcomes of the retroperitoneal (RP) and transperitoneal (TP) approach in open aortic aneurysm repair (OAR) with conflicting results. No study to date has compared the two approaches solely in females. In this study we compare midterm outcomes of the RP and TP approach in females undergoing OAR. METHODS: Single-center, retrospective review of all females undergoing OAR from 2010 to 2021. Patients undergoing elective, symptomatic and ruptured OAR were included. The cohort was stratified by surgical approach RP versus TP and midterm outcomes were compared amongst the groups. Outcomes included mortality, graft related, and non-graft related complications. RESULTS: A total of 244 patients (RP n = 133; TP n = 111) were identified. Follow-up period was 28 ± 30.7 months. Baseline perioperative characteristics were similar except that more people in the RP group had ejection fraction ((EF) > 50% (82% vs 68%), p = .037). Patients who underwent RP repair had longer visceral/renal ischemia time (p = .01), larger graft diameter (18 vs 16 mm; p = <0.001), were more likely to have a suprarenal clamp placed(70.5 vs 48.2; p < .001), and had decreased autotransfusion volume (611 vs 861 mL; p < .01) compared to those who underwent TP repair. Number of deaths was higher in the TP group during study follow-up period (36.4 vs 23.8; p = .035), but the difference of the time to event analysis was not significant. There was no difference in all-cause survival at 36 months between RP and TP (77.8 vs 76.8; p = .045). Overall midterm complications were 9.5% in both groups. Any graft related complication was 1.8% in TP versus 3% RP (p = .69). In a multivariable model, after adjusting for age, urgency, smoking, prior aneurysm repair, and ASA level, the hazard ratio decreases with the RP approach, however this did not reach significance (p = .052). CONCLUSION: In a 12-year period of OAR in females, TP and RP results were comparable at midterm analysis. The RP approach appeared to be used more often for OAR requiring suprarenal clamping. Although the TP group had increased mortality, the difference of the time to event analysis was not significant. Midterm postoperative complications in both groups were low. This suggests that both approaches are safe in the female population and decision should be driven by anatomy and surgeon's preference.

Management of patients with chronic mesenteric ischemia across three consecutive eras.

BACKGROUND: Endovascular intervention (EI) is the most commonly used modality for chronic mesenteric ischemia (CMI). Since the inception of this technique, numerous publications have reported the associated clinical outcomes. However, no publication has reported the comparative outcomes over a period of time in which both the stent platform and adjunctive medical therapy have evolved. This study aims to assess the impact of the concomitant evolution of both the endovascular approach and optimal guideline-directed medical therapy (GDMT) on CMI outcomes over three consecutive time eras. METHODS: A retrospective review at a quaternary center from January 2003 to August 2020 was performed to identify patients who underwent EIs for CMI. The patients were divided into three groups based on the date of intervention: early (2003-2009), mid (2010-2014), and late (2015-2020). At least one angioplasty/stent was performed for the superior mesenteric artery (SMA) and/or celiac artery. The patients' short- and mid-term outcomes were compared between the groups. Univariable and multivariable Cox proportional hazard models were also conducted to evaluate the clinical predictors for primary patency loss in SMA only subgroup. RESULTS: A total of 278 patients were included (early, 74; mid, 95; late, 109). The overall mean age was 71 years, and 70% were females. High technical success (early, 98.6%; mid, 100%; late, 100%; P = .27) and immediate resolution of symptoms (early, 86.3%; mid, 93.7%; late, 90.8%; P = .27) were noted over the three eras. In both the celiac artery and SMA cohorts, the use of bare metal stents (BMS) declined over time (early, 99.0%; mid, 90.3%; late, 65.5%; P < .001) with a proportionate increase in covered stents (CS) (early, 0.99%; mid, 9.7%; late, 28.9%; P < .001). The use of postoperative antiplatelet and statins has increased over time (early, 89.2%; mid, 97.9%; late, 99.1%; P = .003) and (early, 47%; mid, 68%; late, 81%; P = .001), respectively. In the SMA stent-only cohort, no significant differences were noted in primary patency rates between BMS and CS (hazard ratio, 0.95; 95% confidence interval, 0.26-2.87; P = .94). High-intensity preoperative statins were associated with fewer primary patency loss events compared to none/low- or moderate-intensity statins (hazard ratio, 0.30; 95% confidence interval, 0.11-0.72; P = .014). CONCLUSIONS: Consistent outcomes were observed for CMI EIs across three consecutive eras. In the SMA stent-only cohort, no statistically significant difference in early primary patency was noted for CS and BMS, making the use of CS at additional cost controversial and possibly not cost effective. Notably, the preoperative high-intensity statins were associated with improved SMA primary patency. These findings demonstrate the importance of guideline-directed medical therapy as an essential adjunct to EI in the treatment of CMI.

Effects of abdominal aortic aneurysm appropriateness dashboard on clinical practice.

OBJECTIVE: The Society for Vascular Surgery published abdominal aortic aneurysm (AAA) practice guidelines in 2003, 2009, and 2018 to improve the management and treatment of AAAs. In 2014, our vascular surgery department implemented a quarterly AAA dashboard (AAAdb) to record the perioperative outcomes and guideline compliance with a focus on intervention appropriateness and procedural follow-up, which supplemented our Vascular Quality Initiative data. From the available reported evidence and expert consensus opinions, nine additional criteria for the appropriate treatment of AAAs <5 cm in women and <5.5 cm in men were noted, when applicable. The purpose of our study was to assess the effects of AAAdb implementation on adherence to society and institutional guidelines, documentation of treatment rationale, and the quality of follow-up. METHODS: We performed a retrospective review of elective open and endovascular AAA repair at a single institution from 2010 to 2018. The AAAdb was implemented in the middle of this period in 2014. The patient demographics, aortic size, repair indication, repair type, 30-day mortality, and postoperative and 1-year follow-up imaging findings were analyzed. The primary outcome was adherence to intervention appropriateness and the follow-up guidelines. The categorical factors were summarized using frequencies and percentages and compared using the Pearson χ2 test or Fisher exact test. Continuous measures were summarized using the mean ± standard deviation and compared between study periods using two-sample t tests. RESULTS: From 2010 to 2018, 1549 patients had undergone elective AAA repair: 657 before and 892 after AAAdb implementation. No differences were found in AAA size after AAAdb (5.6 ± 1.2 cm vs 5.6 ± 1.1 cm; P = .88). However, the proportion of size-appropriate repairs increased (64.1% vs 71.3%; P = .003). The proportion of small AAA repairs with a documented rationale had increased (64.4% vs 80.5%; P < .001), with rapid disease progression cited most often. No difference was found in 30-day mortality (1.2% vs 1.5%; P = .69). Follow-up imaging after endovascular abdominal aortic aneurysm repair increased at <60 days postoperatively (76% vs 84%; P = .004) and at 1 year of follow-up (78% vs 86%; P = .0005). The proportion of patients with endoleak at <60 days postoperatively had increased in the post-AAAdb cohort (21% vs 29%; P = .012). CONCLUSIONS: The AAAdb served as a centerpiece for improving the appropriateness of care and compliance with national and institutional guidelines, including treatment of small AAAs in special circumstances. Its implementation was associated with higher quality follow-up and surveillance in a high-volume, regional aortic center. Consideration should be given to adding additional criteria to the Society for Vascular Surgery guidelines and Vascular Quality Initiative reporting.

The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes mellitus and a foot ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

The Intersocietal IWGDF, ESVS, SVS Guidelines on Peripheral Artery Disease in People With Diabetes Mellitus and a Foot Ulcer.

Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis, and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this updated guideline, the IWGDF, the European Society for Vascular Surgery, and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.

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.

Study protocol of a randomized controlled trial of fistula vs. graft arteriovenous vascular access in older adults with end-stage kidney disease on hemodialysis: the AV access trial.

BACKGROUND: Treatment of end-stage kidney disease (ESKD) with hemodialysis requires surgical creation of an arteriovenous (AV) vascular access-fistula (AVF) or graft (AVG)-to avoid (or limit) the use of a central venous catheter (CVC). AVFs have long been considered the first-line vascular access option, with AVGs as second best. Recent studies have suggested that, in older adults, AVGs may be a better strategy than AVFs. Lacking evidence from well-powered randomized clinical trials, integration of these results into clinical decision making is challenging. The main objective of the AV Access Study is to compare, between the two types of AV access, clinical outcomes that are important to patients, physicians, and policy makers. METHODS: This is a prospective, multicenter, randomized controlled trial in adults ≥ 60 years old receiving chronic hemodialysis via a CVC. Eligible participants must have co-existing cardiovascular disease, peripheral arterial disease, and/or diabetes mellitus; and vascular anatomy suitable for placement of either type of AV access. Participants are randomized, in a 1:1 ratio, to a strategy of AVG or AVF creation. An estimated 262 participants will be recruited across 7 healthcare systems, with average follow-up of 2 years. Questionnaires will be administered at baseline and semi-annually. The primary outcome is the rate of CVC-free days per 100 patient-days. The primary safety outcome is the cumulative incidence of vascular access (CVC or AV access)-related severe infections-defined as access infections that lead to hospitalization or death. Secondary outcomes include access-related healthcare costs and patients' experiences with vascular access care between the two treatment groups. DISCUSSION: In the absence of studies using robust and unbiased research methodology to address vascular access care for hemodialysis patients, clinical decisions are limited to inferences from observational studies. The goal of the AV Access Study is to generate evidence to optimize vascular access care, based on objective, age-specific criteria, while incorporating goals of care and patient preference for vascular access type in clinical decision-making. TRIAL REGISTRATION: This study is being conducted in accordance with the tenets of the Helsinki Declaration, and has been approved by the central institutional review board (IRB) of Wake Forest University Health Sciences (approval number: 00069593) and local IRB of each participating clinical center; and was registered on Nov 27, 2020, at ClinicalTrials.gov (NCT04646226).

A case series of image-guided percutaneous drainage of abdominal aortic graft infection as bridge therapy.

INTRODUCTION: Aortic graft infection (AGI) is a rare complication following endovascular aneurysm repair and is associated with substantial morbidity and mortality. The traditional management of AGI is intravenous antibiotic therapy and surgical explantation. In this case series, percutaneous drainage was used as a bridge therapy in the treatment of AGI. METHODS: We report two cases, 78-year-old male and 57-year-old female, in whom image-guided percutaneous drainage was used to treat AGI in two contrasting contexts. Informed consent was obtained from both cases/relatives for publication. RESULTS: Both cases underwent successful percutaneous drainage of AGI utilized as a bridge therapy before definitive surgical reconstruction and graft explantation. Each patient had a different outcome. In the first case, the patient's comorbidities and severe disease state could not be overcome, resulting in his death. The second patient benefitted from the percutaneous drainage by allowing her more time ameliorate her malnutrition before definitive surgery. CONCLUSION: Data on the outcomes of percutaneous drainage of AGI is limited. The successful procedure described in this case series emphasizes the need to conduct more research to evaluate the safety and efficacy of this treatment approach before the surgical explantation.

Outcomes and role of peripheral revascularization in type A aortic dissection presenting with acute lower extremity ischemia.

OBJECTIVE: Limited data exists on management and outcomes of patients presenting with type A aortic dissection (TAAD) and acute lower extremity ischemia (ALI). The role of limb-related revascularization and optimal treatment strategy remains undefined. The objective of this study was to analyze dissection characteristics, treatment modalities, and outcomes of patients undergoing proximal aortic repair for TAAD with ALI. METHODS: Consecutive patients who underwent proximal aortic repair for TAAD were identified from a prospectively maintained database. Clinical data, imaging, operative details, and outcomes of patients with TAAD and ALI were retrospectively analyzed. Kaplan-Meier methodology was used to estimate overall and amputation-free survival. Log-rank tests were used to compare overall curves. Predictors of revascularization and in-hospital mortality were determined using multivariable logistic regression analysis. RESULTS: From 2010 to 2018, 463 patients with TAAD underwent proximal aortic repair. A total of 81 patients (17%) presented with ALI; 48% (39/81) with isolated ALI, and 52% (42/81) with ALI and renovisceral malperfusion. Thirty percent (24/81) required revascularization in addition to proximal aortic repair. Revascularization strategies involved endovascular (46%; 11/24), open (33%; 8/24), and hybrid (21%; 5/24) interventions. The major amputation rate was 4% (3/81), and in-hospital mortality was 21% (17/81). Amputation-free survival was significantly lower in patients requiring revascularization compared with those who did not (log-rank P = .023). Overall survival did not significantly differ between the two groups (log-rank P = .095). Overall survival was significantly lower in patients with concomitant ALI and renovisceral malperfusion compared with those with isolated ALI (log-rank P = .0017). Distal extent of dissection flap into zone 11 (odds ratio [OR], 5.65; 95% confidence interval [CI], 1.58-20.2; P = .008) and partial/complete thrombosis of any iliac artery (OR, 3.94; 95% CI, 1.23-12.6; P = .021) were associated with increased risk of requiring an additional revascularization procedure. True lumen collapse at level of renovisceral aorta (OR, 8.84; 95% CI, 1.74-44.9; P = .0086) was associated with increased risk of in-hospital mortality. CONCLUSIONS: ALI resolves after proximal aortic repair of TAAD in most cases. Distal extent of aortic dissection into zone 11 and iliac thrombosis are risk factors for additional peripheral revascularization. True lumen collapse at the renovisceral aorta and TAAD with concomitant ALI and renovisceral malperfusion portends a poor prognosis. A multi-disciplinary team approach to manage these patients who present with ascending aortic dissection and distal malperfusion may improve outcomes in this complex population.

Comparison of Aortobifemoral Bypass to Aortoiliac Stenting with Bifurcation Reconstruction for TASC II D Aortoiliac Occlusive Disease.

BACKGROUND: Long-segment stenting of the infrarenal aorta and bilateral iliac arteries, with or without femoral endarterectomy for diffuse disease, has been adopted for treatment of severe aortoiliac occlusive disease (AIOD). The objective of this study was to compare outcomes of this reconstruction, termed aortoiliac stenting with bifurcation reconstruction (AISBR), to aortobifemoral bypass (ABF) in patients with comparable TASC II D lesions. METHODS: This is a single-center, retrospective review of patients treated with ABF or AISBR for comparable TASC II D lesions between 2010 and 2018. ABF patients were included only if they were deemed anatomic candidates also for AISBR after review of preoperative imaging. Patients treated for acute limb ischemia and bypass graft infection were excluded. Statistics included Fisher exact test, Kaplan-Meier analysis, and Cox proportional hazards regression. RESULTS: There were 24 ABF and 75 AISBR included in the study. The primary indication for treatment was claudication in 55 (55.6%) patients, rest pain in 28 (28.3%), and tissue loss in 16 (16.2%). Patients undergoing AISBR were more likely to be female. Femoral endarterectomies were performed in 37/75 (49.3%) AISBR and 14/24 (58.3%) ABF (P = 0.44). AISBR were performed percutaneously in 34/75 (45.1%). No AISBR required conversion to ABF. Intraoperative blood loss, procedure time and hospital length of stay (LOS) were significantly less for AISBR compared to ABF. Surgical site infections (SSI) were less common in patients undergoing AISBR (AISBR: 6/75 (8.0%) vs. ABF: 9/24 (37.5%), (P< 0.01). One AISBR and two 2 ABF developed late SSI >30 days postoperatively. The reductions in blood loss, LOS and SSI remained significant after excluding percutaneous AISBR from the analysis. Five-year primary patency was 50.8% (95% CI: 33.3, 68.4%) for AISBR and 88.1% (72.7, 100.0%) for ABF (P= 0.04). Five-year survival was 76.5% (95% CI: 63.6, 89.5) for AISBR and 100% (95% CI: 100.0, 100.0) for ABF (P = 0.07). Five-year primary assisted patency, secondary patency, freedom from reintervention and major adverse limb events did not differ significantly between groups. CONCLUSIONS: AISBR is a viable option for management of TASC II D AIOD, with lower morbidity and acceptable durability when compared to traditional ABF.