A Review of WIfI Clinical Staging to Predict Outcomes in Patients With Threatened Limbs.

The Society for Vascular Surgery Wound, Ischemia, and foot Infection's (WIfI's) threatened limb classification system serves to comprehensively assess the severity of disease in patients with chronic limb-threatening ischemia by identifying and grading the main factors that place the threatened limb at greatest risk: wound severity, ischemic burden, and presence of infection. Each of these 3 factors is graded and the limb placed into a clinical stage, with increasing stage associated with severity of limb threat and predicted risk of major limb amputation at 1 year. Globally, there is a growing body of evidence reported from multiple institutions that has assessed amputation rates and wound-healing outcomes following revascularization in patients with WIfI clinical staging. Risk of major amputation at 1 year is low in clinical stage 1, moderate in stages 2 and 3, and high in stage 4. Higher clinical stages are associated with prolonged time to wound healing, while 1-year wound healing rates consistently decrease with increasing clinical stage. Additional avenues of investigation utilizing WIfI as an objective clinical staging tool have yielded new insights into which patients benefit from revascularization, complexity of care, hospital length of stay, quality of life, ethnic and socioeconomic disparities, as well as spurred interest in other modalities of assessing limb perfusion and their possible clinical utility. Ongoing study and refinement of WIfI grading and clinical staging will continue to improve its prognostic utility.

Persistent under-representation of female patients in United States trials of common vascular diseases from 2008 to 2020.

BACKGROUND: Women have been historically under-represented in vascular surgery and cardiovascular medicine trials. The rate and change in representation of women in trials of common vascular diseases over the last decade is not understood completely. METHODS: We used publicly available data from ClinicalTrials.gov to evaluate trials pertaining to carotid artery stenosis (CAS), peripheral arterial disease (PAD), thoracic and abdominal aortic aneurysms (TAA and AAA), and type B aortic dissections (TBAD) from 2008 to the present. We evaluated representation of women in these trials based on the participation-to-prevalence ratios (PPR), which are calculated by dividing the percentage of women among trial participants by the percentage of women in the disease population. Values of 0.8 to 1.2 reflect similar representation. RESULTS: The sex distribution was reported in all 97 trials, including 11 CAS trials, 68 PAD trials, 16 TAA/AAA trials, and 2 TBAD trials. The total number of participants in these trials was 41,622 and the median number of participants per trial was 150.5 (interquartile range [IQR], 50-252). The percentage of women in the disease population was 51.9% for CAS, 53.1% for PAD, 34.1% for TAA/AAA, and 30.9% for TBAD. Industry sources funded 76 of the trials (77.6%), and the Veterans Affairs Administration (n = 4 [4.1%]), unspecified university (n = 7 [7.1%]), and extramural sources (n = 11 [11.2%]) funded the remainder of the trials. The overall median PPR for all four diseases was 0.65 (IQR, 0.51-0.80). Women were under-represented for all four conditions studied (CAS, 0.73 [IQR, 0.62-0.96]; PAD, 0.65 [IQR, 0.53-0.77]; TAA/AAA, 0.59 [IQR, 0.38-1.20]; and TBAD, 0.74 [IQR, 0.65-0.84]). There was no significant difference in PPR among the diseases (P = .88). From 2008 to the present, there was no significant change in PPR values over time overall (r2 = 0.002; P = .70). When examined individually, PPR did not change significantly over time for any of the diseases studied (for each, r2 < 0.04; P > .45). The PPR did not vary significantly over time for any of the funding sources (for each, r2 < 0.85, P > .08). There was appropriate representation (PPR of 0.8-1.2) in a minority of trials for each disease except TBAD (CAS, 27.3%; PAD, 15.9%; TAA/AAA, 18.8%; and TBAD, 50%). Trials that were primarily funded from university sources had the highest median PPR (1.04; IQR, 0.21-1.27), followed by industry-funded (0.67; IQR, 0.54-0.81), and extramurally funded (0.60; IQR, 0.34-0.73). Studies funded by Veterans Affairs had the lowest PPR (0.02; IQR, 0.00-0.11; P = .004). CONCLUSIONS: Participation of women in US trials of common vascular diseases remains low and has not improved since 2008. Therefore, the generalizability of recent trial results to women with these vascular diseases remains unknown. An improved understanding of the underlying root causes for poor female trial participation, advocacy, and education are required to improve the generalizability of trial results for female vascular patients.

The impact of foot infection on infrainguinal bypass outcomes in patients with chronic limb-threatening ischemia.

BACKGROUND: Despite advances in endovascular therapy, infrainguinal bypass continues to play a major role in achieving limb salvage. In this study, we sought to compare outcomes of infrainguinal bypass in patients with limb-threatening ischemia who presented with or without foot infection. METHODS: We conducted a retrospective cohort study of patients who underwent infrainguinal bypass for chronic limb-threatening ischemia at a single institution. End points of interest included long-term mortality, 45-day readmission, postoperative length of stay (LOS), major amputation, and time to wound healing. Multivariable Cox, logistic, and robust regressions were used to model time to event outcomes, readmission rates, and LOS. RESULTS: There were 454 infrainguinal bypass procedures analyzed. Demographics and baseline characteristics were similar, except congestive heart failure and diabetes were more common in the infection group. Presence of foot infection had no impact on mortality (hazard ratio [HR], 0.78; P = .243). Significant predictors of long-term mortality included increasing age, hypoalbuminemia, and congestive heart failure; preoperative use of clopidogrel was protective. Presence of foot infection was an independent predictor of major amputation. In the multiple regression model, the presence of foot infection was independently associated with amputation rate (HR, 2.14; 95% confidence interval, 1.42-3.22; P < .001); use of venous conduit and increasing age and body mass index were protective. Foot infection was an independent predictor of prolonged LOS (mean LOS was 1.54 days longer in patients with vs those without infection; P = .001). Other independent predictors of prolonged LOS included intraoperative blood loss and reoperation; history of continuous preoperative aspirin use and normal baseline renal function and albumin levels were associated with decreased LOS. Readmission was influenced by reoperation (odds ratio [OR], 2.51; P < .001) but not by presence of foot infection (OR, 1.21; P = .349). There was a strong trend for prolonged wound healing time in patients with diabetes (HR, 1.58; P = .05) but not in those with foot infection (OR, 0.74; P = .36). CONCLUSIONS: Among patients requiring infrainguinal bypass for limb-threatening ischemia, infection was more common in patients with diabetes and was a significant predictor of major amputation and prolonged LOS. Infection was not predictive of mortality, wound healing time, or readmission. These findings lend support to the inclusion of infection in risk stratification schemes for patients with chronic limb-threatening ischemia, as recommended in the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system, because of its adverse impacts on limb salvage.

Sex-Based Differences in Ten-Year Nationwide Outcomes of Carotid Revascularization.

BACKGROUND: We compared the rates of stroke, death, and/or MI between men and women, stratified by symptomatic status and procedure type (carotid endarterectomy [CEA] or carotid artery stent [CAS]). STUDY DESIGN: Using the Nationwide Inpatient Sample, crude and propensity-matched rates of the composite end point of stroke/death/MI were estimated. Multivariable logistic regression was used to calculate the odds of stroke/death/MI associated with sex. RESULTS: Between 2005 and 2015, there were 1,242,688 carotid interventions performed (1,083,912 CEA; 158,776 CAS; 515,789 [41.5%] were female patients). Symptomatic admissions comprised 11.3% of the cohort. In-hospital stroke/death/MI rates were more prevalent in men compared with women (4.2% vs 3.9%; p < 0.01). Subgroup analysis revealed symptomatic women vs men had higher rates of stroke after CEA (7.7% vs 6.2%; p < 0.01) and CAS (9.9% vs 7.6%; p < 0.01). Asymptomatic women experienced the same rates of stroke after either CEA (0.3% vs 0.3%; p = 0.051) or CAS (0.4% vs 0.5%; p = 0.09). Propensity-matched logistic regression revealed that symptomatic males vs females had lower odds of stroke after CEA (odds ratio [OR] 0.81; 95% CI 0.72 to 0.91) and CAS (OR 0.72; 95% CI 0.57 to 0.90). Asymptomatic men and women had similar odds of stroke after both CEA (OR 0.95; 95% CI 0.79 to 1.14) and CAS (OR 0.70; 95% CI 0.43 to 1.13). CONCLUSIONS: This is the largest cohort study to date that demonstrates asymptomatic women undergoing CEA or CAS do not have a higher risk of perioperative stroke, death, or MI. Symptomatic men experience lower rates of stroke after CEA or CAS.

Air Leak Management Program With Digital Drainage Reduces Length of Stay After Lobectomy.

BACKGROUND: Air leaks can impede recovery from lung resection. To help prevent and manage air leaks, we developed a comprehensive program that includes using precompression of lung staple lines, sealant, fissureless video-assisted thoracoscopic (VATS) lobectomy, a digital drainage system, and endobronchial valve placement for prolonged air leak. We assessed the effectiveness of this program on air leak duration, hospital length of stay (LOS), and chest tube duration in our high-risk veteran population. METHODS: Using a prospectively maintained database, we retrospectively analyzed data from 226 patients who underwent lung resection for cancer by VATS lobectomy in a Veterans Affairs center. Patients were divided into two groups. Group A (n = 134; historical controls) underwent lobectomy from July 2009 through October 2013; group B (n = 92; intervention group) underwent lobectomy from November 2013 through July 2016 and received care per the comprehensive program. RESULTS: The median hospital LOS was significantly shorter in group B than in group A patients (5 days versus 6 days, respectively; p = 0.0001). Group B had a shorter median chest tube duration (2 days versus 3 days, p = 0.027). Prolonged air leak (more than 5 days) occurred in 5.4% of group B and 9.7% of group A patients (p = 0.24). Prolonged LOS (more than 14 days) was less frequent in group B (1.1%) than in group A (8.2%, p = 0.030). Multivariable analysis showed that predictors of decreased air leak duration, chest tube duration, and LOS included undergoing surgery in the later period (group B). CONCLUSIONS: Our comprehensive program was associated with reduced chest tube days and hospital LOS.