Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia.

BACKGROUND: Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation. METHODS: We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure. RESULTS: We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported. CONCLUSIONS: We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).

Current Status and Principles for the Treatment and Prevention of Diabetic Foot Ulcers in the Cardiovascular Patient Population: A Scientific Statement From the American Heart Association.

Despite the known higher risk of cardiovascular disease in individuals with type 2 diabetes, the pathophysiology and optimal management of diabetic foot ulcers (DFUs), a leading complication associated with diabetes, is complex and continues to evolve. Complications of type 2 diabetes, such as DFUs, are a major cause of morbidity and mortality and the leading cause of major lower extremity amputation in the United States. There has recently been a strong focus on the prevention and early treatment of DFUs, leading to the development of multidisciplinary diabetic wound and amputation prevention clinics across the country. Mounting evidence has shown that, despite these efforts, amputations associated with DFUs continue to increase. Furthermore, due to increasing patient complexity of management secondary to comorbid conditions, such as cardiovascular disease, the management of peripheral artery disease associated with DFUs has become increasingly difficult, and care delivery is often episodic and fragmented. Although structured, process-specific approaches exist at individual institutions for the management of DFUs in the cardiovascular patient population, there is insufficient awareness of these principles in the general medicine communities. Furthermore, there is growing interest in better understanding the mechanistic underpinnings of DFUs to better define personalized medicine to improve outcomes. The goals of this scientific statement are to provide salient background information on the complex pathogenesis and current management of DFUs in cardiovascular patients, to guide therapeutic and preventive strategies and future research directions, and to inform public policy makers on health disparities and other barriers to improving and advancing care in this expanding patient population.

Multi-Level Thrombotic/Embolic Burden and Its Role in Sex-Related Outcomes in Acute Limb Ischemia (ALI).

INTRODUCTION: The impact of sex upon outcomes in acute limb ischemia (ALI) remains disputed. We aim to quantify the effect of sex upon amputation-free survival (AFS) after a percutaneous-first approach for ALI. METHODS: Two-center retrospective review of ALI managed via a percutaneous-first approach. Demographics, comorbidities, and clinical characteristics were analyzed (Table I). The Kaplan-Meier and Cox regression were used to estimate AFS, limb-salvage and overall survival. RESULTS: Over nine years, 170 patients (87, 51% males; median age 67 IQR 59, 77 years) presented with ALI. Rutherford Classification was I in 56 (33%); IIa in 85 (50%); IIb in 20 (12%) and III in 9 (5%). Thirty-day mortality, major amputation rate and fasciotomy rates were 8% (N=13); 6.5% (N=11), and 4.7% (N=8), respectively. Among revascularized limbs, 92% were patent at 30 days. Length of stay was 7 (IQR 3-11) days. Complications included 13 bleeding episodes (8%), 4 cases of atrial fibrillation (2%), and 3 re-thrombosis/clot extension events (1.7%). No differences were noted in complication rates when stratified by sex. Females were older than males (median age 70 IQR 62, 79 vs 65 IQR 56, 76 years; p=0.02) and more likely to present with atrial fibrillation (20.5% vs 8%, p 0.02); and hyperlipidemia (72% vs 57%, p = 0.04). Females also more frequently presented with multi-level thrombotic/embolic burden compared to males (56% vs 43%; p=0.03), and required both aspiration thrombectomy and thrombolysis (27% versus 14%; p 0.02). Kaplan-Meier estimated median AFS, limb salvage, and overall survival were 425 (IQR 140, 824 days); 314 (IQR 72, 727 days); and 342 (IQR 112, 762 days). When stratified by sex, females had worse survival (median 270 IQR 92, 636 versus 406 IQR 140, 937 days; p=0.005); and limb salvage (median 241 IQR 88, 636 versus 363 IQR 49, 822 days; p=0.04) compared to males. Univariate Cox regression showed female sex (HR = 1.46 95% CI 1.04-2.05; p=0.03); multi-level thrombotic/embolic burden (HR 1.64 95% CI 1.17-2.31; p=0.004) and Rutherford Class (HR 1.37 95% CI 1.08-1.73; p=0.009) predicted major amputation/death. By multivariable Cox regression, multi-level thrombotic/embolic burden (HR 1.54 95% CI 1.09-2.17; p=0.01), Rutherford Class (HR 1.34 95% CI 1.07-1.69; p=0.01), and female Sex (HR = 1.45 95% CI 1.03-2.05; p=0.03) were each independently predictive of major amputation/death. CONCLUSIONS: A percutaneous-first strategy is safe and efficacious in the overall ALI population. Similar to prior works, female versus male ALI patients in our cohort have higher rates of mortality and major amputation. In our multivariable model, multi-level thrombotic/embolic burden was independently associated with a greater than 45% increased hazard of major amputation/ death at last follow up. Further prospective analysis is warranted to elucidate the underlying factors contributing to the higher prevalence of multi-level thrombotic/embolic burden in female ALI patients, and to further define the optimal percutaneous-first approach for ALI in consideration of patient sex and extent of clot burden.

Guidelines on the classification of foot ulcers in people with diabetes (IWGDF 2023 update).

BACKGROUND: This publication represents a scheduled update of the 2019 guidelines of the International Working Group of the Diabetic Foot (IWGDF) addressing the use of systems to classify foot ulcers in people with diabetes in routine clinical practice. The guidelines are based on a systematic review of the available literature that identified 28 classifications addressed in 149 articles and, subsequently, expert opinion using the GRADE methodology. METHODS: First, we have developed a list of classification systems considered as being potentially adequate for use in a clinical setting, through the summary of judgements for diagnostic tests, focussing on the usability, accuracy and reliability of each system to predict ulcer-related complications as well as use of resources. Second, we have determined, following group debate and consensus, which of them should be used in specific clinical scenarios. Following this process, in a person with diabetes and a foot ulcer we recommend: (a) for communication among healthcare professionals: to use the SINBAD (Site, Ischaemia, Bacterial infection, Area and Depth) system (first option) or consider using WIfI (Wound, Ischaemia, foot Infection) system (alternative option, when the required equipment and level of expertise is available and it is considered feasible) and in each case the individual variables that compose the systems should be described rather than a total score; (b) for predicting the outcome of an ulcer in a specific individual: no existing system could be recommended; (c) for characterising a person with an infected ulcer: the use of the IDSA/IWGDF classification (first option) or consider using the WIfI system (alternative option, when the required equipment and level of expertise is available and it is considered as feasible); (d) for characterising a person with peripheral artery disease: consider using the WIfI system as a means to stratify healing likelihood and amputation risk; (e) for the audit of outcome(s) of populations: the use of the SINBAD score. CONCLUSIONS: For all recommendations made using GRADE, the certainty of evidence was judged, at best, as being low. Nevertheless, based on the rational application of current data this approach allowed the proposal of recommendations, which are likely to have clinical utility.

Classification of foot ulcers in people with diabetes: A systematic review.

BACKGROUND: Classification and scoring systems can help both clinical management and audit the outcomes of routine care. AIM: This study aimed to assess published systems used to characterise ulcers in people with diabetes to determine which should be recommended to (a) aid communication between health professionals, (b) predict clinical outcome of individual ulcers, (c) characterise people with infection and/or peripheral arterial disease, and (d) audit to compare outcomes in different populations. This systematic review is part of the process of developing the 2023 guidelines to classify foot ulcers from the International Working Group on Diabetic Foot. METHODS: We searched PubMed, Scopus and Web of Science for articles published up to December 2021 which evaluated the association, accuracy or reliability of systems used to classify ulcers in people with diabetes. Published classifications had to have been validated in populations of >80% of people with diabetes and a foot ulcer. RESULTS: We found 28 systems addressed in 149 studies. Overall, the certainty of the evidence for each classification was low or very low, with 19 (68%) of the classifications being assessed by ≤ 3 studies. The most frequently validated system was the one from Meggitt-Wagner, but the articles validating this system focused mainly on the association between the different grades and amputation. Clinical outcomes were not standardized but included ulcer-free survival, ulcer healing, hospitalisation, limb amputation, mortality, and cost. CONCLUSION: Despite the limitations, this systematic review provided sufficient evidence to support recommendations on the use of six particular systems in specific clinical scenarios.

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.

Lower-extremity pressure, staging, and grading thresholds to identify chronic limb-threatening ischemia.

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.

Frailty in People with Chronic Limb Threatening Ischemia and Diabetes-Related Foot Ulcers: A Systematic Review.

BACKGROUND: Frailty represents a state of multisystem impairment that may adversely impact people presenting with chronic limb-threatening ischemia (CLTI) and diabetes-related foot ulcers (DFUs). The aim of this systematic review was to explore the association between frailty and outcomes from CLTI and DFUs. METHODS: We performed a systematic literature search of electronic databases to find studies using a validated measure of frailty in individuals with CLTI and/or DFUs. The primary outcomes were the impact of frailty on the severity of initial clinical presentation and unfavorable follow-up outcomes including readmissions, major limb amputation, cardiovascular events, revascularization, and wound healing. RESULTS: Ten cohort studies were included. Two studies had a low risk of bias, 1 was unable to be assessed, 5 had moderate risk of bias, and 2 high risk of bias. The prevalence of frailty in people presenting with CLTI ranged from 27% to 88% and was 71% in people with DFUs. The presence of frailty in both people with CLTI and DFUs was associated with substantially increased severity at presentation (severity of ischemia and tissue loss) and poorer outcomes at follow-up (risk of readmission, limb amputation, and all-cause mortality). CONCLUSIONS: The presence of frailty in both people with CLTI and DFUs is likely associated with substantially higher complexity at presentation followed by a greater risk for readmission, amputation, and death during follow-up. Heterogeneity in the tools used to screen for frailty, poor definition of frailty, and unclear evaluation of exposure and outcomes limit further interpretation of findings.

Most individuals with diabetes-related foot ulceration do not meet dietary consensus guidelines for wound healing.

The inaugural expert consensus and guidance for Nutrition Interventions in Adults with Diabetic Foot Ulcers (DFU) have been welcomed by clinicians internationally. This short report aimed to determine how the macronutrient and micronutrient status of individuals living with DFU compared to the American Limb Preservation Society Nutrition Interventions in Adults with DFU expert consensus and guidance. Descriptive analysis was conducted as a secondary analysis of an existing dataset. Mean (SD) dietary intake, the proportion meeting the nutrition recommendations and the proportion exceeding the upper limit (UL) for specific vitamins and minerals were reported. Most individuals with DFU do not meet current consensus guidelines for optimal dietary intake for wound healing, with inadequacies evident for fibre, zinc, protein, vitamin E and vitamin A. Future iterations of the consensus guideline should consider using evidence-informed recommendations for clinical practice, with the inclusion of all nutrients that are essential for wound healing in DFU.

Racial and ethnic disparities in abdominal aortic aneurysm evaluation and treatment rates in Texas.

BACKGROUND: Screening identifies intact abdominal aortic aneurysms (iAAAs) before progression to ruptured AAAs (rAAAs). However, screening efforts have been limited by the low overall diagnostic yield and unequal screening among minority populations. The goal of the present study was to identify equitable AAA screening strategies for both majority and minority populations. METHODS: We performed epidemiologic and geospatial analyses of inpatient and outpatient procedures for iAAAs and rAAAs at Texas hospitals from 2006 through 2014 at all nonfederal hospitals and clinics in Texas. The data were aggregated by area (metropolitan statistical area vs rural region) and then supplemented by six additional data sources to estimate the AAA repair incidence rates, rates of AAA-related clinic and ultrasound visits, travel distance to providers, and the location and number of unrecognized AAAs. RESULTS: Most AAA repairs had occurred among men aged 65 to 84 years and categorized as White in large metropolitan areas. The area procedure rates for rAAAs and iAAAs were strongly correlated (R2 = 0.47). Two other variables-the proportions of persons categorized as White and those aged ≥65 years in a region-identified subgroups within the majority population with a high risk of iAAAs (R2 = 0.46). Lower rates of clinic visits and AAA ultrasound scans were seen among persons categorized as Black. Several areas with disproportionately higher rAAA/iAAA repair ratios were found, mainly affecting persons categorized as Black. CONCLUSIONS: Multiple focused AAA screening strategies could be required to address the disproportionately lower AAA identification among persons categorized as Black.

Early experience with venous arterialization for limb salvage in no-option patients with chronic limb-threatening ischemia.

OBJECTIVE: Chronic limb-threatening ischemia (CLTI) is associated with adverse limb outcomes and increased mortality. However, a small subset of the CLTI population will have no feasible conventional methods of revascularization. In such cases, venous arterialization (VA) could provide an alternative for limb salvage. The objective of the present study was to review the outcomes of VA at our institution. METHODS: We performed a single-institution review of 41 patients who had been followed up prospectively and had undergone either superficial or deep VA. The data collected included patient demographics, comorbidities, VA technique (endovascular vs hybrid), and WIfI (wound, ischemia, and foot infection) limb staging. Data were collected at 1-month, 6-month, and 1-year intervals and included the following outcomes: patency, wound healing, major adverse limb events, major amputation, and death. Descriptive statistics were used for analysis. RESULTS: The study group included 41 patients who had undergone successful open hybrid superficial or deep endovascular VA; 21 (51.2%) had undergone a purely endovascular procedure and 20 (48.8%), hybrid VA. The WIfI clinical stage was as follows: stage 4, 33 (80.5%); stage 3, 6 (14.6%); and stage 2, 1 (2.4%). Of the 41 patients, 24 (58.5%) had completed follow-up at 6 months and 16 (39%) at 1 year. At 1 year, the VA primary patency was 28.6% (95% confidence interval [CI], 0.15%-0.43%), primary assisted patency was 44.3% (95% CI, 0.27%-0.60%), and secondary patency was 67% (95% CI, 0.49%-0.80%). The complete wound healing rate was 2.7% (n = 1) at 1 month, 62.5% (n = 15) at 6 months, and 18.8% (n = 3) at 1 year. Overall wound healing at 1 year was 46.3% (n = 19). The number of major adverse limb events at 1 year was 15 (36.5%) and included 8 reinterventions (19.5%) and 7 major amputations (17%). The number of deaths was zero (0%) at 1 month and four (19%) at 6 months. Two deaths (9.5%) were attributed to COVID-19 (coronavirus disease 2019). No further deaths had occurred within 1 year. The limb salvage survival probability at 1 year was 81%. CONCLUSIONS: These findings suggest that for a select subset of CLTI patients presenting with a high WIfI clinical limb stage and no viable options for conventional open or endovascular arterial revascularization, superficial and deep VA are feasible options to achieve limb salvage.

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.

Society for Vascular Surgery appropriate use criteria for management of intermittent claudication.

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.

Guillotine Transmetatarsal Amputations With Staged Closure Promote Early Ambulation and Limb Salvage in Patients With Advanced Chronic Limb-Threatening Ischemia.

PURPOSE: Transmetatarsal amputation (TMA) with primary closure has long been an option for limb salvage in patients with advanced chronic limb-threatening ischemia (CLTI) with extensive tissue loss of the forefoot. However, TMA healing and closure techniques are challenging, specifically in high-risk patients. Guillotine transmetatarsal amputations (gTMA) with staged closure may provide an alternative treatment in this population. We report long-term outcomes of such technique. MATERIALS AND METHODS: A single-center retrospective cohort study of CLTI patients undergoing gTMA between 2017 and 2020 was performed. Limb salvage, wound healing, and survival rates were quantified using Kaplan-Meier (KM) analysis. Multivariate regression was used to identify the effect of patient characteristics on the outcomes. RESULTS: Forty-four gTMA procedures were reviewed. Median follow-up was 381 (interquartile range [IQR], 212-539.75) days. After gTMA, 87.8% (n=36) of the patients were able to ambulate after a median interval of 2 (IQR, 1-3) days. Eventual coverage was achieved in a personalized and staged approach by using a combination of skin substitutes (88.6%, n=39) ± split thickness skin grafts (STSG, 61.4%, n=27). KM estimates for limb salvage, wound healing, and survival were 84.1%, 54.5%, and 88.6% at 1 year and 81.8%, 63.8%, and 84.1% at 2 years. Wound healing was significantly associated with STSG application (p=0.002, OR=16.5, 95% CI 2.87-94.81). CONCLUSION: gTMA resulted in high limb salvage rates during long-term follow-up in CLTI patients. Adjunctive STSG placement may enhance wound healing at the gTMA site, thus leading to expedited wound closure. Surgeons may consider gTMA as an alternative to reduce limb loss in CLTI patients at high risk of major amputation. CLINICAL IMPACT: Currently, the clinical presentation of CLTI is becoming more complex to deal with due to the increasing comorbidities as the society becomes older. The data shown in this article means for clinicians that when facing diffused forefoot gangrene and extensive tissue loss, limb preservation could still be considered instead of major amputation. Guillotine transmetatarsal amputations in the setting of an aggressive multidisciplinary group, can be healed by the responsibly utilization of dermal substitutes and skin grafts leading to the preservation of the extremity, allowing mobility, avoiding of sarcopenia, and decreasing frailty. This will equate to maintenance of independent living and preservation of lifespan.

Angiosarcoma of the Pancreas in a Pediatric Patient With an Activating KDR-Internal Tandem Duplication: A Case Report and Review of the Literature.

Pancreatic angiosarcoma is an exceedingly rare malignancy accounting for <1% of pancreatic neoplasms. A very limited number of pancreatic angiosarcomas have been reported in the literature without any cases described in children. We present the case of a 17-year-old female diagnosed with angiosarcoma of the pancreas following pancreaticoduodenectomy for a pancreatic mass, initially presumed to be a solid pseudopapillary neoplasm of the pancreas. The angiosarcoma was found to have a novel activating internal tandem duplication in the KDR gene (KDR-internal tandem duplication). We discuss the current literature on this disease process. This is the first reported case of pancreatic angiosarcoma in a pediatric patient and the first with an activating KDR-internal tandem duplication.

Gender, Racial and Ethnic Disparities in Iatrogenic Vascular Injuries among the Ten Most Frequent Surgical Procedures in the United States.

OBJECTIVE: Iatrogenic vascular injuries (IaVI's) appear to be increasing, with disparate prevalence across gender, race and ethnicity. We aim to assess the risk of IaVI's across these characteristics. METHODS: Using the Nationwide Inpatient Sample for the years 2008 to 2015, we identified rates of IaVI's among the top ten most frequently performed inpatient procedures in the United States. Joint point regression was employed to examine the trends in the rates of IaVI's. We also calculated the adjusted odds ratios for IaVI's using survey logistic regression. RESULTS: During the eight-year study period, a total of 29,877,180 procedures were performed (33.6% hip replacement, 14% knee arthroplasty, 11.2% cholecystectomy, 10.3% spinal fusion, 8.9% lysis of adhesions, 8% colorectal resection, 7.9% partial bone excision, 5% appendectomy, 0.6% percutaneous coronary angioplasty, 0.6% laminectomy). A total of 194,031 (0.65%) IaVI's were associated with these procedures. The incidence of IaVI's increased over time with an average annual percentage change (AAPC) of 4.2% (95% CI: 3.1, 5.4; P < 0.01). More females (105,747; 54.5%) than males (88,284; 45.5%) suffered IaVI's during their hospital admission (P < 0.01). Patients 70 years of age and older had the highest incidence of IaVI's (12,244,082; 34.3%; P ≤ 0.01). Among the ten index procedures, Non-Hispanic (NH) Whites underwent the highest proportion of procedures (14.1 procedures/100 hospitalizations; P < 0.01) and cholecystectomy was associated with the highest rate of IaVI's (19.4 per 1000 hospitalizations, P ≤ 0.01). Overall, patients from the lowest income quartile were least likely to suffer IaVI's (0.83 95% CI 0.79-0.88, P < 0.01) compared to the highest income quartile. All form of healthcare coverage increased the odds of IaVI's: Medicaid (1.07 95% CI 1.07-1.13, P < 0.01); Private insurance (1.35 95% CI 1.3-1.39, P < 0.01); Self-pay or no charge (1.45 95% CI 1.38-1.52, P < 0.01). IaVI's increased the odds of in-hospital mortality in all groups (1.25 95% CI 1.14-1.35, P < 0.01) and more pronounced in NH-Blacks (1.51 95% CI 1.15-1.99, P < 0.01). In the overall cohort, urban teaching hospitals observed the highest odds of in-hospital mortality (1.11 95% CI 1.07-1.15, P < 0.01). CONCLUSION: Between 2008 to 2015, IaVI's rates for the top ten most frequently performed inpatient procedures increased by 33.6% (4.2% annually; P < 0.01). The elderly, females, and Hispanics more frequently had hospitalizations complicated by IaVI's. Overall, IaVI's independently increased the adjusted odds of mortality by 25%. IaVI's were most fatal among Blacks, about 50% elevated risk of death compared to NH-Whites. These benchmarks will be critical to future efforts to reduce IaVI, and associated healthcare disparities.

Safety and efficacy of an endovascular-first approach to acute limb ischemia.

BACKGROUND: The optimal techniques to manage acute limb ischemia (ALI) remain unclear. Previous reports have suggested that the decreased morbidity and mortality of endovascular approaches are mitigated by the limited technical success rates relative to open or hybrid approaches for ALI. However, these data failed to include newer technologies that might improve the technical success rates. We, therefore, sought to describe the current outcomes for an endovascular-first approach to ALI. METHODS: We performed a single-center, single-arm, retrospective cohort study of consecutive patients with ALI from 2015 to 2018. Technical success, limb salvage, survival, patency, and length of stay were quantified using Kaplan-Meier (KM) analysis. Cox regression analysis was used to identify the predictors of amputation-free survival. RESULTS: During the 3 years, 60 consecutive patients (39 men [65%]; median age, 65 years) presented with ALI. The Rutherford class was I in 15 patients (25%), IIa in 23 (38%), IIb in 13 (22%), and III in 9 patients (15%). Of the 60 patients, 34 had a history of previous failed ipsilateral revascularization (56%), including open bypass for 8 (13%), endovascular for 8 (13%), and both open and endovascular intervention for 18 (30%). The endovascular-first approach procedures included catheter-directed thrombolysis only (n = 19; 3%), catheter-directed thrombolysis plus aspiration and/or rheolytic thrombectomy (n = 19; 32%), and aspiration and/or rheolytic thrombectomy (n = 16; 26%). Six patients (10%) underwent covered stent placement only. The underlying occlusive process was most often thrombosis of a previous bypass graft or stent in 32 patients (53%), followed by native vessel thrombosis in 15 (25%). ALI had resulted from embolism in 13 patients (21.7%), including 2 (3%) with embolization to occlude a previous bypass graft or stent. Technical success was achieved in 58 patients (97%), with open conversion required in two patients (3%). At 30 days postoperatively, 52 patients (87%) survived, and 53 (88%) had successful limb salvage. Five patients (8%) had required four-compartment fasciotomy. No major hemorrhagic complications developed. The median length of stay overall and in the intensive care unit was 9 days (interquartile range, 4-14 days) and 2 days (interquartile range, 1-5 days), respectively. At 1 year, the KM estimates were as follows: amputation-free survival, 58% ± 0.08%; limb salvage, 74.3% ± 0.07%; and survival, 73.3% ± 0.07%. The 1-year KM estimates for primary and secondary patency were 39.4% ± 0.08% and 78.2% ± 0.07%, respectively. On multivariable Cox regression analysis, only age independently predicted for death and/or amputation at the last follow-up (hazard ratio, 1.06; 95% confidence interval, 1.01-1.10; P = .01). CONCLUSIONS: The current endovascular approaches to ALI have high technical success rates. Survival, limb salvage, perioperative complications, and length of stay were similar to those from previous reports of historical open cohorts. Further prospective, appropriately powered, multicenter cohort studies are warranted to evaluate the efficacy of endovascular vs open approaches to ALI.

Engaging patients and caregivers to establish priorities for the management of diabetic foot ulcers.

OBJECTIVE: Effective diabetic foot ulcer (DFU) care has been stymied by a lack of input from patients and caregivers, reducing treatment adherence and overall quality of care. Our objectives were to capture the patient and caregiver perspectives on experiencing a DFU and to improve prioritization of patient-centered outcomes. METHODS: A DFU-related stakeholder group was formed at an urban tertiary care center. Seven group meetings were held across 4 months, each lasting ∼1 hour. The meeting facilitator used semistructured questions to guide each discussion. The topics assessed the challenges of the current DFU care system and identified the outcomes most important to stakeholders. The meetings were audio recorded and transcribed. Directed and conventional content analyses were used to identify key themes. RESULTS: Six patients with diabetes (five with an active DFU), 3 family caregivers, and 1 Wound Clinic staff member participated in the stakeholder group meetings. The mean patient age was 61 years, four (67%) were women, five (83%) were either African American or Hispanic, and the mean hemoglobin A1c was 8.3%. Of the five patients with a DFU, three had previously required lower extremity endovascular treatment and four had undergone at least one minor foot amputation. Overall, stakeholders described how poor communication between medical personnel and patients made the DFU experience difficult. They felt overwhelmed by the complexity of DFU care and were persistently frustrated by inconsistent medical recommendations. Limited resources further exacerbated their frustrations and barriers to care. To improve DFU management, the stakeholders suggested a centralized healthcare delivery pathway with timely access to a coordinated, multidisciplinary DFU team. The clinical outcomes most valued by stakeholders were (1) avoiding amputation and (2) maintaining or improving health-related quality of life, which included independent mobility, pain control, and mental health. From these themes, we developed a conceptual model to inform DFU care pathways. CONCLUSIONS: Current DFU management lacks adequate care coordination. Multidisciplinary approaches tailored to the self-identified needs of patients and caregivers could improve adherence. Future DFU-related comparative effectiveness studies will benefit from direct stakeholder engagement and are required to evaluate the efficacy of incorporating patient-centered goals into the design of a multidisciplinary DFU care delivery system.

Society for Vascular Surgery best practice recommendations for use of social media.

The use of social media (SoMe) in medicine has demonstrated the ability to advance networking among clinicians and other healthcare staff, disseminate research, increase access to up-to-date information, and inform and engage medical trainees and the public at-large. With increasing SoMe use by vascular surgeons and other vascular specialists, it is important to uphold core tenets of our commitment to our patients by protecting their privacy, encouraging appropriate consent and use of any patient-related imagery, and disclosing relevant conflicts of interest. Additionally, we recognize the potential for negative interactions online regarding differing opinions on optimal treatment options for patients. The Society for Vascular Surgery (SVS) is committed to supporting appropriate and effective use of SoMe content that is honest, well-informed, and accurate. The Young Surgeons Committee of the SVS convened a diverse writing group of SVS members to help guide novice as well as veteran SoMe users on best practices for advancing medical knowledge-sharing in an online environment. These recommendations are presented here with the goal of elevating patient privacy and physician transparency, while also offering support and resources for infrequent SoMe users to increase their engagement with each other in new, virtual formats.

Outcomes after Endovascular Stent Placement for Long-Segment Superficial Femoral Artery Lesions.

BACKGROUND: Endovascular intervention is commonly pursued as first-line management of symptomatic, long-segment superficial femoral artery (SFA) disease. The relative effectiveness and comparative long-term outcomes among bare metal stents (BMS), covered stents (CS), and drug-eluting stents (DES) for long-segment SFA lesions remain uncertain. METHODS: A retrospective cohort study identified patients with symptomatic SFA lesions measuring at least 15 cm in length who successfully received an endovascular stent (BMS, CS, or DES). The outcomes were patency, patient presentation upon stent occlusion, amputation-free survival (AFS), and all-cause mortality. Proportional hazards regressions and a multinomial logistic regression model were used to control for significant confounders. RESULTS: A total of 226 procedures were analyzed (BMS: 95 [42%]; CS: 74 [33%]; DES: 57 [25%]). There were no significant differences among the 3 stent types with respect to age, prevalence of either diabetes or end-stage renal disease, or smoking history. The median length of the SFA lesion varied across the cohorts (BMS: 28 cm [interquartile range, IQR 20-30]; CS: 26 cm [IQR 20-30]; DES: 20 cm [IQR 16-25]; P = 0.002). The unadjusted primary patency of BMS at 12, 24, and 48 month following index stent placement was 57%, 47%, and 44%, respectively. This is compared to 62%, 49%, and 42% for CS, and 81%, 66%, and 53% for DES, respectively (log-rank P = 0.044). In adjusted models, however, there were no significant differences in primary patency among the stent types. Compared to CS however, DES was associated with improved primary-assisted patency (hazard ratio [HR] for patency loss: 0.35, P = 0.008) and secondary patency (HR: 0.32, P = 0.011). Across the entire follow-up period, stent occlusions occurred in 38 (40%) BMS cases, 42 (57%) CS, and 11 (19%) DES (P < 0.001). Of these, acute limb ischemia (ALI) occurred in 2 (5%) BMS cases, 14 (33%) CS, and 1 (9%) DES (P = 0.010). After adjustment, the relative risk of presenting with ALI as opposed to claudication was 27 times greater among patients re-presenting with occluded CS compared to BMS (P = 0.020). There were no significant differences in AFS or all-cause mortality across the 3 cohorts. CONCLUSIONS: For long-segment SFA lesions, DES is associated with improved primary-assisted and secondary patency over long-term follow-up. In the event of stent occlusion, CS is associated with an increased risk of ALI.