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Introduction: The Society for Vascular Surgery Threatened Limb Classification System (‘WIfI’) is used to predict risk of limb loss and identify peripheral artery disease in patients with foot ulcers or gangrene. We estimated the diagnostic sensitivity of multiple clinical and noninvasive arterial parameters to identify chronic limb-threatening ischemia (CLTI). Methods: We performed a single-center review of 100 consecutive patients who underwent angiography for foot gangrene or ulcers. WIfI stages and grades were determined for each patient. Toe, ankle, and brachial pressure measurements were performed by registered vascular technologists. CLTI severity was characterized using Global Limb Anatomic Staging System (GLASS stages) and angiosomes. Medial artery calcification in the foot was quantified on foot radiographs. Results: GLASS NA (not applicable), I, II, and III angiographic findings were seen in 21, 21, 23, and 35 patients, respectively. A toe–brachial index < 0.7 and minimum ipsilateral ankle–brachial index < 0.9 performed well in identifying GLASS II and III angiographic findings, with sensitivity rates 97.8% and 91.5%, respectively. The diagnostic accuracy rates of noninvasive measures peaked at 74.7% and 89.3% for identifying GLASS II/III and GLASS I+ angiographic findings, respectively. The presence of medial artery calcification significantly diminished the sensitivity of most noninvasive parameters. Conclusions: The use of alternative noninvasive arterial testing parameters improves sensitivity for detecting PAD. Abnormal noninvasive results should suggest the need for diagnostic angiography to further characterize arterial anatomy of the affected limb. Testing strategies with better accuracy are needed.

Patients undergoing open or endovascular infrainguinal revascularization are at an elevated risk for postoperative cardiovascular complications due to high rates of comorbidities and the physiologic stress of surgery. Transfusions are known to be associated with adverse events but knowledge of specific risks associated with transfusion timing, product type, and long-term outcomes while accounting for preoperative cardiovascular risk factors is not well understood in this population. This study aimed to characterize the association of intraoperative and perioperative transfusion, anemia, and cardiovascular risk factors with cardiovascular events and mortality in patients undergoing infrainguinal revascularization.A single-center retrospective study was performed on 564 infrainguinal revascularization procedures, including both open (n = 250) and endovascular (n = 314) approaches (2016-2020). Comprehensive clinical data were collected including patient demographics, cardiovascular risk factors, preoperative hemoglobin, and detailed transfusion data. Multivariable logistic regression tested the association of transfusions with composite 30-day outcomes of cardiac complications (postoperative myocardial infarction [postop-MI], congestive heart failure, or dysrhythmia) and with major adverse cardiovascular events (MACE-postop-MI or death). Kaplan-Meier analysis and Cox proportional hazard modeling examined the association of transfusions, anemia, and cardiovascular risk factors with mortality up to 1 year.Intraoperative transfusion was performed in 15% of cases and 13% underwent transfusion in the early postoperative period. Intraoperative transfusion was associated with higher Revised Cardiac Risk Index (RCRI), lower preoperative hemoglobin, increased blood loss, and open procedures (all P 0.05). Within each RCRI score, intraoperative transfusion was associated with 2-4-fold increased MACE at 30 days. Intraoperative packed red blood cells transfusion and early postoperative packed red blood cells transfusion was associated with more than 2-fold adjusted odds of any cardiovascular complication and intraoperative transfusion was also associated with MACE (all P 0.05). Intraoperative transfusion was associated with mortality at 1 year on unadjusted analysis, but after adjustment for RCRI, age, and preoperative hemoglobin, only RCRI scores of 2 and 3+ and preoperatively hemoglobin remained significant risk factors for mortality.Intraoperative and early perioperative transfusions are strongly associated with worse cardiovascular outcomes after infrainguinal revascularization. These findings may have a prognostic value for further risk stratifying patients perioperatively at a high risk for complications. However, prospective studies are needed to elucidate whether optimizing transfusion strategies mitigates these risks.

Different renin-angiotensin-aldosterone system inhibitor (RAASI) usage patterns exist among patients undergoing lower extremity bypass (LEB) for peripheral arterial disease. We studied the association of RAASI usage patterns with LEB outcomes to determine which pattern is associated with improved survival after LEB.We evaluated peripheral arterial disease patients who underwent LEB between January 2014 and December 2018 in the Vascular Quality Initiative-Medicare matched database. Study cohorts included no RAASI use, preoperative RAASI use only, postoperative RAASI use only, and continuous RAASI use both preoperatively and postoperatively. Logistic and Cox regression was used to adjust for potential confounders. Primary outcome was 2-year amputation-free survival (AFS).Of 19,012 patients included, 1,574 (8.3%) were on RAASIs preoperatively only, 1,051 (5.5%) postoperatively only, and 8,484 (45.2%) continuously. Compared to no RAASI use, isolated preoperative RAASI use was associated with 2.8-fold increased odds of 30-day mortality (adjusted Odds Ratio, 2.75; 95% confidence interval [CI], 2.15-3.51; P 0.001) whereas continuous RAASI use had 56% lower odds of 30-day mortality (adjusted Odds Ratio, 0.44; 95% CI, 0.34-0.58; P 0.001). Two-year AFS was 63.2% for no RAASI use and 60.4%, 66.2%, and 73.4% for preoperative, postoperative, and continuous RAASI use, respectively (P 0.001). While no RAASI use and postoperative RAASI use had comparable adjusted risks of 2-year major amputation or death (adjusted Hazard Ratio [aHR], 0.94; 95% CI, 0.83-1.06; P = 0.312), this risk was 14% higher for preoperative RAASI use only (aHR, 1.14; 95% CI, 1.04-1.26; P = 0.006) and 23% lower for continuous RAASI use (aHR, 0.77; 95% CI, 0.72-0.82; P 0.001).Isolated preoperative RAASI use was associated with worse 30-day mortality and 2-year AFS, while continuous RAASI use was associated with improved 30-day mortality and 2-year AFS. Optimum survival benefit may be derived from continuous RAAS inhibition in the preoperative and postoperative periods.

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.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.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; P0.001). 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.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.).

Volume and quality benchmarks for open abdominal aortic surgery and particularly open aortic aneurysm repair (OAR) in the endovascular era are guided by the Society for Vascular Surgery guidelines, but the Vascular Quality Initiative (VQI) OAR module fails to capture the full spectrum of complex OAR. We hypothesized that VQI-ineligible complex OAR would be the dominant form of open repairs performed at a VQI-participating tertiary center.All OAR cases performed at a single tertiary care center from 2007 to 2020 were reviewed. The VQI OAR criteria were applied with exclusions (non-VQI) defined as concomitant renal bypass, clamping above the superior mesenteric artery or celiac artery, repairs performed for trauma, anastomotic aneurysm, isolated iliac aneurysm, or infected aneurysms. Linear regression was used to assess temporal trends.Among a total of 481 open abdominal aortic operations, 355 (74%) were OAR. The average annual OAR volume remained stable over 14 years (25 ± 6; P = .46). Non-VQI OAR comprised 54% of all cases and persisted over time (RComplex OAR comprises a majority of OAR cases in a contemporary tertiary referral hospital, yet these cases are not accounted for in the VQI. Creation of a "complex OAR" VQI module would capture these cases in a quality-driven national registry and help to better inform benchmarks for volume and outcomes in aortic surgery.

Post-operative delirium (POD) is common yet often underdiagnosed following vascular surgery. Elderly patients with advanced peripheral artery disease may be at particular risk for POD yet understanding of the clinical predictors and impact of POD is incomplete. We sought to identify POD predictors and associated resource utilization after infrainguinal lower extremity bypass.This single center retrospective analysis included all infrainguinal bypass cases performed for peripheral arterial disease from 2012-2020. The primary outcome was inpatient POD. Delirium sequelae were also evaluated. Key secondary outcomes were length of stay, nonhome discharge, readmission, 30-day amputation, post-operative myocardial infarction, mortality, and 2-year survival. Regression analysis was used to evaluate risk factors for delirium in addition to association with 2-year survival and amputation free survival.Among 420 subjects undergoing infrainguinal lower extremity bypass, 105 (25%) developed POD. Individuals with POD were older and more likely to have non-elective surgery (P 0.05). On multivariable analysis, independent predictors of POD were age 60-89 years old, chronic limb threatening ischemia, female sex, and nonelective procedure. Consultations for POD took place for 25 cases (24%); 13 (52%) were with pharmacists, and only 4 (16%) resulted in recommendations. The average length of stay for those with POD was higher (17 days vs. 9 days; P 0.001). POD was associated with increased non-home discharge (61.8% vs. 22.1%; P 0.001), 30-day major amputation (6.7% vs. 1.6%; P 0.01), 30-day postoperative myocardial infarction (11.4% vs. 4.1%; P 0.01), and 90-day mortality (7.6% vs. 2.9%; P = 0.03). Survival at 2 years was lower in those with delirium (89% vs. 75%; P 0.001). In a Cox proportional hazards model, delirium was independently associated with decreased survival (HR = 2.0; 95% CI = 1.15-3.38; P = 0.014) and decreased major-amputation free survival (HR = 1.9; 95% CI = 1.18-2.96; P = 0.007).POD is common following infrainguinal lower extremity bypass and is associated with other adverse post-operative outcomes and increased resource utilization, including increased hospital length of stay, nonhome discharge, and worse 2-year survival. Future studies should evaluate the role of routine multidisciplinary care for high-risk patients to improve perioperative outcomes for vulnerable older adults undergoing infrainguinal lower extremity bypass.

OBJECTIVE: Although the use of closure devices (CD) for femoral artery antegrade access (AA) is not in the instructions for use (IFU) for many devices, AA has been reported to be associated with a lower incidence of access site complications compared to manual compression alone. We hypothesized that CD use for AA would not be associated with a clinically significant increased odds of access site complications compared to CD use for retrograde access (RA). METHODS: This was a retrospective review of the Vascular Quality Initiative from 2010 to 2019 for infrainguinal peripheral vascular interventions with common femoral artery access closed with a CD. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether access was antegrade or retrograde. Hierarchical multivariable logistic regressions controlling for hospital level variation were used to examine the independent association between AA and access site complications. The primary outcomes were access site hematoma, stenosis, or occlusion as defined in the VQI. The secondary outcome was the development of an access site hematoma requiring an intervention, which was defined as transfusion, thrombin injection, or surgery. Sensitivity analyses after coarsened exact matching were performed to reduce residual bias. RESULTS: Overall, 72,463 cases were identified and 6,070 (8.4%) had AA. Patients with AA were less likely to be smokers (27.2% vs 33.0%) or obese (31.5% vs 35.6%; all P

The multidisciplinary Superficial Femoral Artery-Popliteal EvidencE Development (SPEED) Study Group, under the auspices of the Registry Assessment of Peripheral Interventional Devices (RAPID) partnership, recently published objective performance goals for peripheral vascular interventions in the femoropopliteal arteries. Retrospective outcomes from the Vascular Quality Initiative provided the sole study data source. Strengths and weaknesses of this landmark effort are examined. Critical concerns include the substantial risks of ascertainment bias, flawed end point selection, sparse and variable capture of midterm follow-up data, and lack of expected discrimination between treatment modalities. The current Vascular Quality Initiative registry data thus appear insufficiently robust for the generation of objective performance goals and practice benchmarks; suggestions for redesign are provided. The impact of the statutory framework of the US Food and Drug Administration on device approval pathways and the maturation of an evidence-based approach to peripheral vascular intervention is explored.

To describe contemporary outcomes from a single center capable of both complex open and endovascular aortic repair for paravisceral aortic aneurysms (PVAAA).Data on all patients receiving open or endovascular (endo) treatment for aortic aneurysms with proximal extent at or above the renal arteries and distal to the inferior pulmonary ligament (IPL) were reviewed. Coarsened exact matching (CEM) on age, aneurysm type, gender, coronary artery disease (CAD), previous aortic surgery and symptomatic status created balanced cohorts for outcomes comparisons.Between October, 2006 and February, 2018, 194 patients were treated for juxtarenal (40%), pararenal (21%), paravisceral (6%) and Type 4 thoracoabdominal (34%) aortic aneurysms with open (81, 42%) or endo (113, 58%) at a single tertiary center. Endo repairs included renal coverage with a bifurcated graft (2%), unilateral (13%) or bilateral (4%) renal snorkels, Z-fen (15%), multi-branched graft (IDE protocol; 62%) and unique complex configurations (4%). On multivariable analysis, patients selected for open surgery were more likely to be symptomatic, whereas older patients, female patients and those with Type 4 TAAA extent were more often selected for endovascular treatment. Matching based on the significant independent covariates reduced the open and endovascular groups by one-third. Survival at 30 days was 97% for endo and 94% for open repair, 98% for both subgroups when excluding symptomatic cases, and was not different between the matched groups (98% vs 89%; P=0.23). Hospital and ICU stays were longer in open patients (8 vs. 10 days, 2 vs. 4, both P≤0.001). Post-op CVA, MI, lower extremity ischemia, surgical site infections and reoperation were not different between matched groups (all p0.05), while pulmonary and intestinal complications, as well as grade 1/2 renal dysfunction by RIFLE criteria, were more common after open repair (all P0.05). Spinal cord ischemia was significantly more frequent in the unmatched Endo group (11% vs. 1%, P=0.02), but this difference was not significant after matching. Composite major aortic complications was no different between treatment groups (unmatched P=0.91, matched P=0.87). Endo treatment resulted in patients more frequently discharged to home (84% vs. 66%, P=0.02). Reintervention after 30 days occurred more frequently in the endo group (P=0.002). Estimated survivals at 1 and 5 years for endo and open are 96% vs. 81% and 69% vs. 81% respectively (Log-rank P=0.57).Contemporary repair of PVAAA demonstrates safe outcomes with durable survival benefit when patients are well-selected for open or complex endovascular repair. We believe these data have implications for off-label device use in the treatment of PVAAA, and that open repair remains an essential option for younger, good risk patients in experienced centers.

Background Mental health's impact on vascular surgical patients has long been overlooked. While outside the expertise of most surgeons, understanding the role that depression plays in the postoperative course could provide additional insight into opportunities to improve surgical outcomes and healthcare value. Additionally, non-home discharge (NHD) to a rehabilitation or skilled nursing facility after surgery is associated with impaired quality of life and higher postdischarge complications, readmissions, and mortality. We hypothesized that depression would be associated with an increased risk for NHD following abdominal aortic aneurysm (AAA) repair. Methods Nonruptured AAA repair cases were identified from the National Inpatient Sample (NIS) using ICD-9 codes between 2005 and 2014. Depression, comorbidities, postoperative complications, and discharge destination were evaluated using statistical tests as appropriate to the data. A hierarchical multivariable logistic regression controlling for hospital level variation was used to examine the independent association between depression, and the primary outcome of NHD controlling for median income and confounders meeting P Results There were 99,934 total cases analyzed, of which 4,755 (4.8%) were diagnosed with depression and 10,618 (11.9%) required NHD. Patients with depression were younger, more likely to be women, white, have diabetes, chronic obstructive pulmonary disease, hypertension, tobacco use, and more likely to experience a postoperative complication. On adjusted multivariable analysis, patients with depression were more likely to require NHD (odds ratio [OR] 1.87, 95% confidence interval [CI]: 1.68–2.08, c-statistic = 0.82). On stratified analysis by operative approach, depression had a larger effect estimate in endovascular repair (OR 2.19; 95% CI: 1.90–2.52) versus open repair (OR 1.60; 95% CI: 1.38–1.87). Conclusions In a nationally representative sample, patients with depression were more likely to require NHD after AAA repair. This study highlights the importance that depression plays in postoperative outcomes after AAA repair. Furthermore, addressing mental health preoperatively has the potential to improve outcomes in patients undergoing AAA repair.

Racial and ethnic disparities have been well-documented in the outcomes for chronic limb threatening ischemia (CLTI). One purported explanation has been the disease severity at presentation. We hypothesized that the disparities in major adverse limb events (MALE) after peripheral vascular intervention (PVI) for CLTI would persist despite controlling for disease severity at presentation using the WIfI (wound, ischemia, foot infection) stage.The Vascular Quality Initiative PVI dataset (2016-2021) was queried for CLTI. Patients were excluded if they were missing the WIfI stage. The primary end point was the incidence of 1-year MALE, defined as major amputation (through the tibia or fibula or more proximally) or reintervention (endovascular or surgical) of the initial treatment limb. A multivariate hierarchical Fine-Gray analysis was performed, controlling for hospital variation, competing risk of death, and presenting WIfI stage, to assess the independent association of Black/African American race and Latinx/Hispanic ethnicity with MALE. A Cox proportional hazard regression model was used for the 1-year survival analysis.Overall, 47,830 patients (60%) had had WIfI scores reported (73% White, 20% Black, and 7% Latinx). The 1-year unadjusted cumulative incidence of MALE was 13.1% (95% confidence interval [CI], 12.6%-13.5%) for White, 14.3% (95% CI, 13.5%-15.3%) for Black, and 17.0% (95% CI, 15.3%-18.9%) for Latinx patients. On bivariate analysis, the occurrence of MALE was significantly associated with younger age, Black race, Latinx ethnicity, coronary artery disease, cerebrovascular disease, congestive heart failure, hypertension, diabetes, dialysis, intervention level, any prior minor or major amputation, and WIfI stage (P .001). The cumulative incidence of 1-year MALE increased by increasing WIfI stage: stage 1, 11.7% (95% CI, 10.9%-12.4%); stage 2, 12.4% (95% CI, 11.8%-13.0%); stage 3, 14.8% (95% CI, 13.8%-15.8%); and stage 4, 15.4% (95% CI, 14.3%-16.6%). The cumulative incidence also increased by intervention level: inflow, 10.7% (95% CI, 9.8%-11.7%), femoropopliteal, 12.3% (95% CI, 11.7%-12.9%); and infrapopliteal, 14.1% (95% CI, 13.5%-14.8%). After adjustment for WIfI stage only, Black race (subdistribution hazard ratio [SHR], 1.30; 95% CI, 1.17-1.44; P .001) and Latinx ethnicity (SHR, 1.58; 95% CI, 1.37-1.81; P .001) were associated with an increased 1-year hazard of MALE compared with White race. On adjusted multivariable analysis, MALE disparities persisted for Black/African American race (SHR, 1.12; 95% CI, 1.01-1.25; P = .028) and Latinx/Hispanic ethnicity (SHR, 1.34; 95% CI, 1.16-1.54; P .001) compared with White race.Black/African American and Latinx/Hispanic patients had a higher associated hazard of MALE after PVI for CLTI compared with White patients despite an adjustment for WIfI stage at presentation. These results suggest that disease severity at presentation does not account for disparities in outcomes. Further work should focus on better understanding the underlying mechanisms for disparities in historically marginalized racial and ethnic groups presenting with CLTI.

There have been no data to support the use of tibial interventions in the treatment of claudication to date. We aimed to characterize the practice patterns surrounding tibial peripheral vascular interventions (PVI) in patients with claudication in the United States.Using 100% Medicare fee-for-service claims from 2017 to 2019, we conducted a retrospective analysis of all patients undergoing an index PVI for claudication. Patients who had any previous PVI, acute limb ischemia, or chronic limb-threatening ischemia in the preceding 12 months were excluded. The primary outcome was the receipt or delivery of tibial revascularization during index PVI for claudication, defined as tibial PVI with or without concomitant femoropopliteal PVI. Univariable comparisons and a multivariable hierarchical logistic regression were used to assess patient and physician characteristics associated with the use of tibial PVI for claudication.Of 59,930 Medicare patients who underwent index PVI for claudication between 2017 and 2019, 16,594 (27.7%) received a tibial PVI (38.5% isolated tibial PVI and 61.5% tibial PVI with concomitant femoropopliteal PVI). Of 1,542 physicians included in the analysis, the median physician-level tibial PVI rate was 20.0% (IQR 9.1%-37.5%). Hierarchical logistic regression suggested that patient-level characteristics associated with tibial PVI for claudication included male sex (adjusted odds ratio [aOR] 1.23), increasing age (aOR1.30-1.96), Black race (aOR 1.47), Hispanic ethnicity (aOR 1.86), diabetes (aOR 1.36), no history of hypertension (aOR 1.12), and never-smoking (aOR 1.64; all, P0.05). Physician-level characteristics associated with tibial PVI for claudication included early-career status (aOR 2.97), practice location in the West (aOR 1.75), high-volume PVI practice (aOR 1.87), majority practice in an ASC/OBL setting (aOR 2.37), and physician specialty; vascular surgeons had significantly lower odds of performing tibial PVI compared to radiologists (aOR 2.98) and cardiologists (aOR 1.67; all, P0.05). Average Medicare reimbursement per patient was dramatically higher for physicians performing high rates of tibial PVI (quartile 4 vs. quartile 1-3: $12,023.96 vs. $692.31 per patient, P0.001).Tibial PVI for claudication are performed more commonly by non-vascular surgeons, in high-volume practices, and in high-reimbursement settings. This reveals a critical need to reevaluate the indications, education, and reimbursement policies surrounding these procedures.

The SVS Wound, Ischemia, foot Infection (WIfI) limb staging system was established to estimate risk of major amputation in chronic limb-threatening ischemia (CLTI) and better stratify outcomes comparisons. There is little data on treatment outcomes beyond one year based on presenting WIfI stage.This is a single-institution retrospective study of 413 patients who underwent infrainguinal revascularization for CLTI (2011-2021) with data available for WIfI staging. Patient characteristics and outcomes were gathered from the electronic medical record. Data were analyzed based on presenting WIfI stage and initial treatment received at our center.Presenting WIfI stages were 1-2 (23%), 3 (27%) and 4 (50%). Index revascularization approach was endoluminal (59%), autogenous vein bypass (29%), or non-autogenous bypass (13%). Operative mortality within 30 days was 2.9% and was not associated with WIfI stage or revascularization approach. Median limb follow-up time was 502 days (IQR 112-1256), and median survival follow-up time was 932 days (IQR 343-1770). Major amputation or death occurred in 19% and 46% of patients at median times of 119 days (IQR 28-314) and 739 days (IQR 204-1475), respectively. WIfI stage was independently associated with major amputation (p=0.001), as was initial revascularization approach (p=0.01). In a Cox proportional hazards model, factors independently associated with major amputation were male sex [HR 1.4 (1.04-2.0), p=0.03], diabetes [HR1.8 (1.3-2.5), p=0.001], WIfI stage 4 [HR 2.3 (1.5-3.5), p0.001], and non-autogenous bypass [HR 2.9 (2.1-4.2) p0.001]. In a Cox proportional hazards model for mortality, independently associated factors were age [HR 1.04 (1.02-1.05), p0.001], ESRD [HR 2.8 (1.9-4.0), p0.001], CHF [HR 1.9 (1.4-2.5), p0.001], COPD [HR 1.5 (1.1-2.1, p=0.02), and WIfI stage 4 [HR 1.6 (1.04-2.2), p=0.03]. Among those presenting with WIfI stage 4 limbs, Kaplan-Meier estimated rates of freedom from major amputation or death at 2 years were 71% ± 3.7% and 68% ± 3.5%, respectively. In an inverse propensity weighted Cox proportional hazards model, non-white race [HR 1.5 (1.01-2.2), p=0.047], diabetes [HR 2.0 (1.2-3.3), p=0.008], GLASS IP grade [HR 1.2 (1.05-1.3), p=0.005], non-autogenous bypass [HR 3.2 (1.9-5.3), p0.001], and endoluminal revascularization [HR 2.6 (1.6-4.3), p0.001] were independently associated with major amputation in the WIfI stage 4 subgroup.Presenting WIfI stage is strongly associated with long-term risks of major amputation and death following infrainguinal revascularization for CLTI and should be used to stratify outcomes comparisons. Effective revascularization is critical in WIfI stage 4 disease, and autogenous vein bypass provides durable long-term limb preservation.

Transmetatarsal amputation (TMA) allows for maintenance of ambulatory function in patients with significant forefoot tissue loss. Effective revascularization is key to optimizing limb salvage in patients with chronic limb threatening ischemia (CLTI). We hypothesize that CLTI patients requiring TMA have better healing and functional outcomes with open bypass (OPEN) compared with endovascular (ENDO) revascularization.Consecutive TMAs performed at three affiliated centers between 2008 and 2020 were retrospectively reviewed. Baseline characteristics including WIfI stage, non-invasive vascular studies, healing, and ambulatory outcomes were collected. Catheter-based angiographic images were evaluated using the GLASS system. Primary outcomes were TMA healing and community ambulation, with secondary outcomes of TMA healed at end of study, any ambulatory function postoperatively, major amputation, and mortality. Descriptive statistics, univariate, multivariable, and Kaplan-Meier analyses were performed.346 TMAs were performed in 318 patients, 209 of whom had peripheral artery disease (PAD). Median follow up was 2. 5 years. Patients with PAD had significantly lower rates of healing compared to those without (64% vs. 77%, p=0.007). Revascularization was performed in 185 limbs with 102 treated ENDO and 83 OPEN. Patients who underwent ENDO were significantly less likely to heal their TMA at any time (55% vs. 76%, p=0.003) and less likely to remain healed at the end of study (49% vs 66%, p=0.02). Patients with GLASS stage 3 anatomy were significantly more likely to heal with OPEN (75% vs 45%, p=0.003). Long term ambulation data was available for 72% of revascularized patients. ENDO was associated with lower likelihood of community ambulation after TMA (34% vs 57%, p=0.002). In multivariable analysis, OPEN was significantly associated with TMA healing (OR 2.8, p=0.007) and ambulation (OR 2.9, p=0.001).In patients with CLTI and significant tissue loss requiring TMA, initial OPEN approach to revascularization was associated with improved healing and higher rates of ambulation than ENDO. The metabolic requirement to heal a TMA in CLTI patients may be better met by open revascularization.

Patients with peripheral artery disease (PAD) requiring lower extremity revascularization (LER) are at high risk of adverse limb and cardiovascular events. VOYAGER PAD demonstrated that rivaroxaban significantly reduced this risk with an overall favorable net benefit in patients undergoing surgical revascularization; however, the efficacy and safety in those treated by surgical bypass including stratified by bypass conduit (venous or prosthetic) has not been described.In the VOYAGER PAD trial, patients with PAD after surgical and endovascular infrainguinal LER were randomized to rivaroxaban 2.5 mg twice daily or placebo and followed for a median of 28 months. The primary endpoint was a composite of acute limb ischemia (ALI), major amputation of vascular etiology, myocardial infarction, ischemic stroke, or cardiovascular death. The principal safety outcome was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. Index procedure details including conduit type (venous or prosthetic) were collected at baseline.Among 6564 randomized, 2185 (33%) underwent surgical LER. Of these, surgical bypass was performed in 1448 (66%), using prosthetic conduit in 773 (53%) and venous in 646 (45%). Adjusting for baseline differences and anatomic factors, the risk for unplanned limb revascularization in the placebo arm was 2.5-fold higher for those receiving prosthetic versus venous conduits (adjHR 2.53, 95% CI 1.65-3.90; p0.001) while the risk for ALI was 3 times greater (adjHR 3.07, 95% CI 1.84-5.11; p0.001). Rivaroxaban reduced the primary outcome in patients treated with bypass surgery (HR 0.78, 95% CI 0.62-0.98) with consistent benefits in those receiving venous (HR 0.66, 95% CI 0.49-0.96) and prosthetic (HR 0.87, 95% CI 0.66-1.15) conduits (pSurgical bypass with prosthetic conduit is associated with significantly higher rates of major adverse limb events relative to venous conduits even after adjusting for patient and anatomic characteristics. Adding rivaroxaban 2.5 mg twice daily to aspirin or dual antiplatelet therapy significantly reduces this risk, increases bleeding, but has a favorable benefit risk in patients treated with bypass surgery and regardless of conduit type. Rivaroxaban should be considered after lower extremity bypass for symptomatic PAD to reduce ischemic complications of the heart, limb, and brain.

Background Living in a food desert has been associated with increased cardiovascular risk; however, its impact on vascular surgery outcomes is unknown. This study hypothesized that living in a food desert would be associated with increased postoperative complications in patients undergoing revascularization for chronic limb-threatening ischemia (CLTI). Methods This was a single-center retrospective analysis of open and endovascular infrainguinal revascularization for CLTI between April 2013 and December 2015. A food desert was defined using the US Department of Agriculture's Food Access Research Atlas. Bivariate analyses were performed appropriate to the data. Binary logistic regression was performed assessing the association of food desert status with 30-day postoperative complications. Results In total, 152 cases were included, of which 17% (n = 26) resided in food deserts. Patients in the food desert cohort were less likely to be low income (27% vs. 54%, P = 0.01). Living in a food desert was associated with increased 30-day readmission [(39% vs. 20%, P = 0.04), unadjusted OR: 2.5 (CI: 1.0–6.2)]. FD cases also had a higher proportion of wound complications [12 (46%) vs. 28 (22%), P = 0.01)]. The overall wound complication rate was 27% with the majority being due to infections (63%). On multivariable analysis, food desert status remained associated with increased odds of 30-day readmission (OR: 2.7, CI: 1.2–8.4, P = 0.047). Reasons for readmission in the food desert group were all due to wound complications (100% vs. 72%, P = 0.08). Conclusions Living in a food desert was associated with nearly three times the odds of 30-day readmission after lower extremity revascularization for CLTI. This increase in readmission may be explained through increased wound complications. These findings support considering access to healthy food as a potential modifiable risk factor for adverse outcomes, particularly in CLTI revascularization.

Objective Acute iliofemoral artery thrombosis (IFAT) can occur in critically ill neonates and infants who require indwelling arterial cannulas for monitoring or as a consequence of cardiac catheterization. Guidelines suggest treatment with anticoagulation, but evidence supporting the optimal duration of therapy and the role of surveillance ultrasound is limited. The objectives of this study were to characterize the kinetics of thrombus resolution and to define an appropriate duration of anticoagulation and interval for surveillance ultrasound. Methods This was a single-center retrospective cohort study of pediatric patients with acute IFAT from 2011 to 2019. Medical records and vascular laboratory studies were reviewed. Patients with one or more surveillance ultrasound examinations were included. Thrombus resolution was defined as multiphasic flow throughout the index limb without evidence of echogenic intraluminal material by ultrasound. Time to resolution of thrombus was assessed using Kaplan-Meier analysis. Results Fifty-four limbs in 50 patients were identified with acute IFAT. The median age was 9.9 weeks (interquartile range, 3.1-21.7 weeks), with a median weight of 4.2 kg (interquartile range, 3.3-5.5 kg). The majority of limbs (65%) with acute IFAT presented with a diminished pedal Doppler signal, commonly after cardiac catheterization (55%). Forty-eight (89%) limbs had complete arterial occlusion on index ultrasound, and flow could not be detected below the ankle in 48%. The median number of ultrasound examinations per limb was three (range, two to seven), and 61% of limbs had a surveillance ultrasound within 7 days of diagnosis. At 14 and 30 days, 33% and 64% of patients, respectively, treated with anticoagulation had an estimated complete resolution of thrombus. Nine (17%) patients did not receive anticoagulation, and only two of these patients experienced IFAT resolution. At the time of diagnosis, one patient underwent open thrombectomy because of a contraindication to anticoagulation, and one patient was treated with thrombolysis. There were no instances of tissue loss or amputation Conclusions Management of IFAT with anticoagulation resulted in successful short-term outcomes. Based on the observed rate of resolution, management should start with anticoagulation, followed by surveillance ultrasound at 2-week intervals. With treatment by anticoagulation, resolution can be expected to occur in one-third of patients every 2 weeks.

Objective: Tissue perfusion measurement remains a fundamental challenge in management of peripheral arterial disease (PAD) patients. Better measurement of baseline and dynamic changes after revascularization would aid clinical judgement. The Wireless Lumee® Oxygen System represents a novel approach to tracking tissue oxygen via a subcutaneous hydrogel that provides noninvasive optical oxygen measurements. This study’s objective was to assess the correlation of the Lumee sensor with transcutaneous oximetry (tcpO2) in PAD patients. Methods: The Lumee® Oxygen System is a subcutaneously placed hydrogel (0.5x0.5x5mm). Optical signals are captured with a skin surface reader sensing extravascular oxygenation. A pilot study assessed in vivo performance with inclusion criteria of peripheral arterial disease (Rutherford I-IV). Sensors were injected in the arm and foot and oxygenation measured before, during, and after proximal blood pressure cuff inflation (Figure) and Buerger’s Test modulation. The correlation (R) of oxygenation between tcpO2 and Lumee® was assessed following sensor placement at 2, 10, 90, 180, and 365 days. Results: Eleven subjects had 148 occlusion modulations over 199 days. Mean age was 67 years (range: 55-88), with 9% females, 45% White and 55% Black Race, Rutherford class I: 36%, II: 36%, III:27%. The median ABI was 0.83 (IQR0.69-1.14). In the arm, modulation was 56.9±24.6% (Lumee) and 84.7±9.2% (tcpO2), R:0.81. In the foot, modulation was 63.4±22.7% (Lumee) and 80.4±15.5% (tcpO2), R:0.79. No injection related adverse events occurred. Conclusion: Occlusion related changes in tissue oxygen can be detected by both tcpO2 and the Lumee sensor which strongly correlate in both the arm and foot. This pilot phase study supports expansion of the trial. The Lumee sensor shows promise for future evaluation of tissue oxygenation in PAD patients, which could be used to assess changes in tissue oxygenation over time and following revascularization.

Despite the shared pathogenesis of peripheral arterial disease (PAD) and vascular dementia, there is little data on cognitive impairment in PAD patients. We hypothesized that cognitive impairment will be common and previously unrecognized.Cognitive impairment screening was prospectively performed for Veterans presenting to a single Veterans Affairs outpatient vascular surgery clinic from 2020-2021 for PAD consultation or disease surveillance. Overall, 125 Veterans were screened. Cognitive impairment was defined as a score of26 on the Montreal Cognitive Assessment (MoCA) survey. A multivariable logistic regression assessed for independent risk factors for cognitive impairment.Overall, 77 (61%) had cognitive impairment, 92% was previously unrecognized. Cognitive impairment was associated with increased age (74.4 vs. 71.8 years, p=0.03), Black vs. White race (94% vs. 54%, p0.01), hypertension (66% vs. 31%, p=0.01), prior stroke/TIA (79% vs. 58%, p=0.03), diabetes treated with insulin (79% vs. 58%, p=0.05), and post-traumatic stress disorder (PTSD) (80% vs. 57%, p=0.04). On multivariable analysis, risk factors for newly diagnosed cognitive impairment included age ≥ 70 years, diabetes treated with insulin, PTSD, and Black race.Many Veterans with PAD have evidence of cognitive impairment and is overwhelmingly underdiagnosed. This study suggests cognitive impairment is an unrecognized issue in a VA population with PAD, requiring more study to determine cognitive impairment's impact on surgical outcomes, and how it can be mitigated and incorporated into clinical care.

The Society for Vascular Surgery appropriate use criteria (AUC) for the management of intermittent claudication were created using the RAND appropriateness method, a validated and standardized method that combines the best available evidence from medical literature with expert opinion, using a modified Delphi process. These criteria serve as a framework on which individualized patient and clinician shared decision-making can grow. These criteria are not absolute. AUC should not be interpreted as a requirement to administer treatments rated as appropriate (benefit outweighs risk). Nor should AUC be interpreted as a prohibition of treatments rated as inappropriate (risk outweighs benefit). Clinical situations will occur in which moderating factors, not included in these AUC, will shift the appropriateness level of a treatment for an individual patient. Proper implementation of AUC requires a description of those moderating patient factors. For scenarios with an indeterminate rating, clinician judgement combined with the best available evidence should determine the treatment strategy. These scenarios require mechanisms to track the treatment decisions and outcomes. AUC should be revisited periodically to ensure that they remain relevant. The panelists rated 2280 unique scenarios for the treatment of intermittent claudication (IC) in the aortoiliac, common femoral, and femoropopliteal segments in the round 2 rating. Of these, only nine (0.4%) showed a disagreement using the interpercentile range adjusted for symmetry formula, indicating an exceptionally high degree of consensus among the panelists. Post hoc, the term "inappropriate" was replaced with the phrase "risk outweighs benefit." The term "appropriate" was also replaced with "benefit outweighs risk." The key principles for the management of IC reflected within these AUC are as follows. First, exercise therapy is the preferred initial management strategy for all patients with IC. Second, for patients who have not completed exercise therapy, invasive therapy might provide net a benefit for selected patients with IC who are nonsmokers, are taking optimal medical therapy, are considered to have a low physiologic and technical risk, and who are experiencing severe lifestyle limitations and/or a short walking distance. Third, considering the long-term durability of the currently available technology, invasive interventions for femoropopliteal disease should be reserved for patients with severe lifestyle limitations and a short walking distance. Fourth, in the common femoral segment, open common femoral endarterectomy will provide greater net benefit than endovascular intervention for the treatment of IC. Finally, in the infrapopliteal segment, invasive intervention for the treatment of IC is of unclear benefit and could be harmful.

Valid risk stratification schemes are key to performing comparative effectiveness research; however, for chronic limb-threatening ischemia (CLTI), risk stratification schemes have limited efficacy. Improved, accurate, comprehensive, and reproducible risk stratification models for CLTI are needed.To evaluate the use of topic model cluster analysis to generate an accurate risk prediction model for CLTI.This multicenter, nested cohort study of existing Project of Ex Vivo Vein Graft Engineering via Transfection (PREVENT) III clinical trial data assessed data from patients undergoing infrainguinal vein bypass for the treatment of ischemic rest pain or ischemic tissue loss. Original data were collected from January 1, 2001, to December 31, 2003, and were analyzed in September 2021. All patients had 1 year of follow-up.Supervised topic model cluster analysis was applied to nested cohort data from the PREVENT III randomized clinical trial. Given a fixed number of clusters, the data were used to examine the probability that a patient belonged to each of the clusters and the distribution of the features within each cluster.The primary outcome was 1-year CLTI-free survival, a composite of survival with remission of ischemic rest pain, wound healing, and freedom from major lower-extremity amputation without recurrent CLTI.Of the original 1404 patients, 166 were excluded because of a lack of sufficient feature and/or outcome data, leaving 1238 patients for analysis (mean [SD] age, 68.4 [11.2] years; 800 [64.6%] male; 894 [72.2%] White). The Society for Vascular Surgery Wound, Ischemia, and Foot Infection grade 2 wounds were present in 543 patients (43.8%), with rest pain present in 645 (52.1%). Three distinct clusters were identified within the cohort (130 patients in stage 1, 578 in stage 2, and 530 in stage 3), with 1-year CLTI-free survival rates of 82.3% (107 of 130 patients) for stage 1, 61.1% (353 of 578 patients) for stage 2, and 53.4% (283 of 530 patients) for stage 3. Stratified by stage, 1-year mortality was 10.0% (13 of 130 observed deaths in stage 1) for stage 1, 13.5% (78 of 578 patients) for stage 2, and 20.2% (105 of 521 patients) for stage 3. Similarly, stratifying by stage revealed major limb amputation rates of 4.2% (5 of 119 observed major limb amputations in stage 1) for stage 1, 10.8% (55 of 509 patients) for stage 2, and 18.4% (81 of 440 patients) for stage 3. Among survivors without a major amputation, the rates of CLTI recurrence were 9.2% (11 of 119 observed recurrences in stage 1) for stage 1, 24.9% (130 of 523 patients) for stage 2, and 29.6% (132 of 446 patients) for stage 3.The topic model cluster analysis in this cohort study identified 3 distinct stages within CLTI. Findings suggest that CLTI-free survival is an end point that can be accurately and reproducibly quantified and may be used as a patient-centric outcome.