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.

Using the Society for Vascular Surgery Wound, Ischemia, and foot Infection classification to identify patients most likely to benefit from revascularization.

BACKGROUND: The Society of Vascular Surgery Wound Ischemia foot Infection (WIfI) classification system for chronic limb-threatening ischemia was intended to predict 1-year major lower extremity amputation (LEA) risk and to identify which patients benefit most from revascularization. We aimed to identify which WIfI presentations benefited most from revascularization to explore whether a cluster analysis could identify a more data-driven WIfI score, and to quantify which component of the WIfI score was most strongly associated with 1-year LEA after revascularization. METHODS: Composite multi-institutional nested cohort data from centers who previously validated WIfI were reviewed retrospectively. We collected each patient's WIfI component grades and whether LEA was performed. To examine the benefit of revascularization, the predicted LEA rates were subtracted from observed LEA rates. We used k-means cluster analysis to model predicted vs observed LEA rates after revascularization. Multivariable linear regression analysis was performed to quantify which WIfI score component(s) best predicted LEA. RESULTS: Data from 10 centers, accumulated between 2005 and 2015 were collated (2878 limbs at risk; 314 LEAs performed). The subset of patients who underwent revascularization comprised the study base (1654 limbs; 169 LEAs). Of 64 potential WIfI grade combinations, 15 were never reported and were excluded from the analysis. By original WIfI stages, the observed LEA rate after revascularization was: stage 1, 10.8% (14/130); stage 2, 4.9% (5/103); stage 3, 5.1% (25/487); and stage 4, 13.4% (125/934). Based on the difference between predicted and observed LEA risk for those who underwent revascularization, the WIfI scores were placed into quartiles from greatest to no benefit of revascularization. Cluster analysis identified four clusters with the following 1-year LEA rates: cluster 1, 4.4% (46/1038); cluster 2, 14.8% (66/447); cluster 3, 28.1% (36/128); and cluster 4, 51.2% (21/41). The between sum of squares/total sum of squares was 93.9%. Multiple linear regression revealed the wound grade most strongly predicted LEA (F-value, 17.25; P < .001). Ischemia (F-value, 6.51; P = .001) and infection (F-value, 5.7; P = .003) were similarly associated with LEA risk. Interaction terms between each component of the WIfI score were not statistically significant. CONCLUSIONS: WIfI can identify which patients with chronic limb-threatening ischemia are most likely to benefit from revascularization and may provide improved prognostication, risk stratification, and equitable outcome assessments. After revascularization, wound severity is most strongly associated with LEA risk. Ischemic and infectious grades confer additive, but not synergistic, risk. Future cluster analyses comparing specific WIfI presentations treated with and without revascularization will be required to further refine WIfI.

Outcome Comparison between Open and Endovascular Management of TASC II D Aortoiliac Occlusive Disease.

BACKGROUND: Endovascular management of complex aortoiliac occlusive disease (AIOD) has been described as a viable alternative to open surgical reconstruction. To date, few studies have directly compared the 2 techniques. We therefore, evaluated short and mid- term outcomes of open and endovascular therapy in TASC II D AIOD patients. METHODS: TASC II D patients undergoing treatment between January 2009 and December 2016 were retrospectively reviewed. Patient demographics, clinical data, and outcomes (complications [technical and systemic] and graft patency) were collected. The primary outcome of this study was primary graft patency. Patients were compared according to treatment group (open versus endovascular). Kaplan-Meier curves were used to analyze follow up results. RESULTS: A total of 75 consecutive patients (open: 30; endovascular: 45) were included in this analysis. In the endovascular group, 25 (55.6%) patients were managed using a hybrid approach with 100% technical success. Critical limb ischemia was the indication for intervention in 16.0% of this cohort (open, 13.3% vs. endovascular, 17.8%, P = 0.397). Overall, there were no significant differences in gender (male: open, 50.0% vs. endovascular, 55.6%, P = 0.637) or age (54.5 ± 5.9 years vs. 57.0 ± 8.7 years, P = 0.171). No in hospital deaths occurred in this cohort. The overall complication rate was significantly higher in the open group (43.3% vs. 17.8%, OR 3.5, 95% CI [1.2-10.1], P = 0.016) with peri-operative systemic complications being more likely in the open cohort (40.0% vs. 6.7%, OR 9.3, 95% CI [2.3-37.3], P < 0.001) while technical complications did not differ between the 2 groups (6.7% vs. 11.1%, OR 0.6, 95% CI [0.1-3.1], P = 0.517). Follow up data was available for 68 patients (90.7%), for a mean of 21.3 ± 17.1 months (range: 1-72 months). Re-intervention rates were significantly higher in the endovascular group (3.3% vs. 20.0%, OR 7.2, 95% CI [1.1-14.3], P = 0.038). The overall primary patency at 2 years was significantly higher in the open group (96.7% vs. 80.0%, OR 7.2, 95% CI [1.2-60.5], P = 0.038). Cox regression analysis revealed separation of the primary outcome for open therapy relative to endovascular repair (log rank, P = 0.320). CONCLUSIONS: In this comparison of open and endovascular therapy for complex AIOD, endovascular therapy was associated with high initial technical success and fewer in-hospital systemic complications but also high re-intervention rates when compared to open repair. Further prospective studies aimed at reduction of complications, optimization of patency, and patient selection for such procedures is warranted.

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.

Neurotoxins and fillers for skin rejuvenation.

The ephemeral effects of neurotoxins and fillers are well described for facial remodeling and rejuvenation. Less is known about their long-term effects on skin rejuvenation and neocollagenesis. This article aims to review current available science and literature to support the use of these cosmetic procedures as lasting antiaging treatments.

Intraoperative ultrasound evidence of accidental simultaneous cannulation of the common carotid artery and internal jugular vein: illustrative case.

BACKGROUND: Establishing central venous access is important to provide fluid resuscitation or medications intravenously to patients. OBSERVATIONS: Although accidental cannulation of the internal carotid artery has been reported in the literature, to our knowledge this report is the first documented intraoperative ultrasound video demonstrating accidental and simultaneous common carotid artery and internal jugular cannulation during central line placement in the internal jugular vein. LESSONS: Ultrasound use minimizes accidental carotid cannulation during central line placement in the internal jugular vein. Carotid artery puncture can be managed by external application of pressure or surgical reexploration.

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.

Video-assisted thoracoscopic lobectomy is associated with greater recurrence-free survival than stereotactic body radiotherapy for clinical stage I lung cancer.

OBJECTIVE: Stereotactic body radiotherapy is the standard treatment for medically inoperable early-stage non-small cell lung cancer. Recent data suggest that in operable patients, stereotactic body radiotherapy produces outcomes comparable to those of surgical resection. In veterans with early non-small cell lung cancer, we compared the outcomes of stereotactic body radiotherapy and video-assisted thoracoscopic lobectomy. METHODS: We retrospectively reviewed data from 183 patients (94.0% male) with clinical stage I non-small cell lung cancer who underwent stereotactic body radiotherapy (n = 56) or video-assisted thoracoscopic lobectomy (n = 127) from 2009 to 2014. Propensity matching was used to produce more comparable groups. Primary end points were tumor control and overall, recurrence-free, and lung-cancer-specific survival, as estimated by Kaplan-Meier actuarial analysis. Multivariable analysis was used to identify independent predictors. RESULTS: In the overall cohort, the patients who received stereotactic body radiotherapy were older than the patients who received video-assisted thoracoscopic lobectomy (median age, 79.5 vs 64 years) and had more comorbidities. In the 37 propensity-matched pairs, the 3-year actuarial tumor control rate was 54.3% after stereotactic body radiotherapy and 90.6% after video-assisted thoracoscopic lobectomy (P = .0038). Actuarial lung cancer-specific 3-year survival was 78.1% (stereotactic body radiotherapy) versus 93.6% (video-assisted thoracoscopic lobectomy) (P = .055). One-year overall, 3-year overall, and 3-year recurrence-free survivals were 89.2%, 52.9%, and 38.5% after stereotactic body radiotherapy and 94.6%, 85.7%, and 82.8% after video-assisted thoracoscopic lobectomy (P < .005 for all), respectively. In multivariable analysis, stereotactic body radiotherapy independently predicted recurrence and poorer survival. CONCLUSIONS: In veteran patients with early-stage non-small cell lung cancer, video-assisted thoracoscopic lobectomy resulted in better disease control and survival than stereotactic body radiotherapy. Although prior reports suggest that stereotactic body radiotherapy is a suitable alternative to surgery in early-stage lung cancer, a prospective randomized trial is needed. Nevertheless, stereotactic body radiotherapy remains a suitable option for medically inoperable patients.

The Stent Is Not to Blame: Lessons Learned With a Simplified US Version of the Frozen Elephant Trunk.

BACKGROUND: We analyzed trends, assessed outcomes and lessons learned, and investigated whether using a simplified US version of the frozen elephant trunk (FET) technique to treat complex arch pathology poses additional risk. METHODS: From 2010 to 2015, we performed 129 consecutive ET procedures (traditional ET [t-ET], n = 92 [71.3%]; FET, n = 37 [28.7%]) for chronic dissecting (n = 62 [48.1%]) and atherosclerotic aneurysms (n = 67 [51.9%]). A stepwise logistic regression model using preoperative and intraoperative variables was created to analyze the outcomes. RESULTS: Thirty-day mortality was 12.4% (t-ET, n = 9 [9.8%]; FET, n = 7 [18.9%]; p = 0.24). The rate of persistent (at the time of discharge) stroke was 5.4% (t-ET, n = 5 [5.4%]; FET, n = 2 [5.4%]; p =1.00). The rate of persistent spinal cord deficit was 3.9% (t-ET, n = 3 [3.3%]; FET, n = 2 [5.4%]; p = 0.62). In the multivariable analyses, the addition of FET was not an independent predictor of mortality, permanent stroke, or spinal cord deficit. CONCLUSIONS: With the advent of endovascular technology, there is a clinical shift toward increased use of FET to eliminate or facilitate the second surgical stage in treating patients with extensive aortic pathology. The addition of FET to the surgical armamentarium does not seem to pose additional risk (although larger studies are needed), but judicious use is advised nonetheless. A single-piece endoprosthesis for FET instead of a customized one should be considered.

The impact of temperature in aortic arch surgery patients receiving antegrade cerebral perfusion for >30 minutes: How relevant is it really?

OBJECTIVE: We examined the early outcomes and the long-term survival associated with different degrees of hypothermia in patients who received antegrade cerebral perfusion (ACP) for >30 minutes. METHODS: During a 10-year period, 544 consecutive patients underwent proximal and total aortic arch surgery and received ACP for >30 minutes and 1 of 3 levels of hypothermia: deep (14.1°C-20°C; n = 116 [21.3%]), low-moderate (20.1°C-23.9°C; n = 262 [48.2%]), and high-moderate (24°C-28°C; n = 166 [30.5%]). A variable called "predicted temperature" was used in propensity-score analysis. Multivariate analysis was done to evaluate the effect of actual temperature on outcomes. RESULTS: The operative mortality rate was 12.5% (n = 68) overall and was 15.5%, 11.8%, and 11.5% in the deep, low-moderate, and high-moderate hypothermia patients, respectively (P = .54). The persistent stroke rate was 6.6% overall and 12.2%, 4.6%, and 6.0% in these 3 groups, respectively (P = .024 on univariate analysis). On multivariate analysis, actual temperature was not associated with mortality, but lower temperatures predicted persistent stroke and reoperation for bleeding. In the propensity-matched subgroups, the patients with predicted deep hypothermia had (nonsignificantly) greater rates of persistent stroke (12.2% vs 4.9%; relative risk, 1.08; 95% CI, 0.87-1.15) and reoperation for bleeding (14.6% vs 2.4%; relative risk, 1.14; 95% CI, 0.87-1.15) than the patients with predicted moderate hypothermia. On long-term follow-up (mean duration, 5.12 years), 4- and 8-year survival rates were 62.3% and 55.7% in the deep hypothermia group and 75.4% and 74.2% in the moderate hypothermia group (P = .0015). CONCLUSIONS: In proximal and arch operations involving ACP for >30 minutes, greater actual temperatures were associated with less stroke and reoperation for bleeding. There were no significant differences among the predicted hypothermia levels, although a trend toward a higher rate of adverse events was noticed in the deep hypothermia group. Long-term survival was better in the moderate hypothermia group.

Congenital airway anomaly of double aortic arch in a 2-day-old infant.

Double aortic vascular ring is a complete vascular ring that is formed when the distal portion of the right dorsal aorta fails to regress and the ascending aorta bifurcates to surround and compress both trachea and esophagus and rejoins to form the descending aorta.