Evaluation of short-term mortality in patients with Medicare undergoing endovascular interventions for chronic limb-threatening ischemia.

INTRODUCTION: Patients with chronic limb-threatening ischemia (CLTI) have high mortality rates after revascularization. Risk stratification for short-term outcomes is challenging. We aimed to develop machine-learning models to rank predictive variables for 30-day and 90-day all-cause mortality after peripheral vascular intervention (PVI). METHODS: Patients undergoing PVI for CLTI in the Medicare-linked Vascular Quality Initiative were included. Sixty-six preprocedural variables were included. Random survival forest (RSF) models were constructed for 30-day and 90-day all-cause mortality in the training sample and evaluated in the testing sample. Predictive variables were ranked based on the frequency that they caused branch splitting nearest the root node by importance-weighted relative importance plots. Model performance was assessed by the Brier score, continuous ranked probability score, out-of-bag error rate, and Harrell's C-index. RESULTS: A total of 10,114 patients were included. The crude mortality rate was 4.4% at 30 days and 10.6% at 90 days. RSF models commonly identified stage 5 chronic kidney disease (CKD), dementia, congestive heart failure (CHF), age, urgent procedures, and need for assisted care as the most predictive variables. For both models, eight of the top 10 variables were either medical comorbidities or functional status variables. Models showed good discrimination (C-statistic 0.72 and 0.73) and calibration (Brier score 0.03 and 0.10). CONCLUSION: RSF models for 30-day and 90-day all-cause mortality commonly identified CKD, dementia, CHF, need for assisted care at home, urgent procedures, and age as the most predictive variables as critical factors in CLTI. Results may help guide individualized risk-benefit treatment conversations regarding PVI.

Area Deprivation Index is not predictive of worse outcomes after open lower extremity revascularization.

OBJECTIVE: Prior research has shown that socioeconomic status (SES) is associated with higher rates of diabetes, peripheral vascular disease, and amputation. We sought to determine whether SES or insurance type increases the risk of mortality, major adverse limb events (MALE), or hospital length of stay (LOS) after open lower extremity revascularization. METHODS: We conducted a retrospective analysis of patients who underwent open lower extremity revascularization at a single tertiary care center from January 2011 to March 2017 (n = 542). SES was determined using state Area Deprivation Index (ADI), a validated metric determined by income, education, employment, and housing quality by census block group. Patients undergoing amputation in this same time period (n = 243) were included to compare rates of revascularization to amputation by ADI and insurance status. For patients undergoing revascularization or amputation procedures on both limbs, each limb was treated individually for this analysis. We performed a multivariate analysis of the association between ADI and insurance type with mortality, MALE, and LOS using Cox proportional hazard models, including confounding variables such as age, gender, smoking status, body mass index, hyperlipidemia, hypertension, and diabetes. The cohort with an ADI quintile of 1, meaning least deprived, and the Medicare cohort were used for reference. P values of <.05 were considered statistically significant. RESULTS: We included 246 patients undergoing open lower extremity revascularization and 168 patients undergoing amputation. Controlling for age, gender, smoking status, body mass index, hyperlipidemia, hypertension, and diabetes, ADI was not an independent predictor of mortality (P = .838), MALE (P = .094), or hospital LOS (P = .912). Controlling for the same confounders, uninsured status was independently predictive of mortality (P = .033), but not MALE (P = .088) or hospital LOS (P = .125). There was no difference in the distribution of revascularizations or amputations by ADI (P = .628), but there was higher proportion of uninsured patients undergoing amputation compared with revascularization (P < .001). CONCLUSIONS: This study suggests that ADI is not associated with an increased risk of mortality or MALE in patients undergoing open lower extremity revascularization, but that uninsured patients are at higher risk of mortality after revascularization. These findings indicate that individuals undergoing open lower extremity revascularization at this single tertiary care teaching hospital received similar care, regardless of their ADI. Further study is warranted to understand the specific barriers that uninsured patients face.

Updated estimates for the burden of chronic limb-threatening ischemia in the Medicare population.

OBJECTIVE: Estimates of chronic limb-threatening ischemia (CLTI) based on diagnosis codes of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) suggest a prevalence of 0.23%-0.32% and incidence of 0.20%-0.26% among Medicare patients. ICD-10-CM includes 144 CLTI diagnosis codes, allowing improved specificity in identifying affected patients. We sought to use ICD-10-CM diagnosis codes to determine the prevalence of CLTI among Medicare patients and describe the patient cohort affected by this condition. METHODS: Using two years of data from Centers for Medicare and Medicaid Services, we identified all patients that had at least one CLTI diagnosis code to determine prevalence and incidence rates. Sensitivity analyses were performed to compare our methodology to prior publications and quantify the extent of missed diagnoses. The number and type of vascular procedures that occurred after diagnosis were tabulated. A cohort of patients with two or more CLTI diagnosis codes were then identified for further descriptive analysis. Associations between patient demographics and survival were analyzed using Cox proportional hazards models. RESULTS: Over 65 million patients were enrolled in Medicare in 2017 to 2018. Of these, 480,227 had diagnosis of CLTI, with a corresponding to a 1-year incidence of 0.33% and a 2-year prevalence of 0.74%. Patients underwent an average of 43.6 vascular procedures per 100 person-years. Sensitivity analyses identified 89,805 additional patients that had a diagnosis code of peripheral arterial disease who underwent revascularization or amputation. Patients with CLTI were predominantly male (56.2%), white (76.4%), and qualified for Medicare due to age (64.0%). Thirty-seven percent were dual-eligible. One-year survival was 77.7%, significantly lower than estimated actuarial survival adjusted for age, sex, and race (95.1%; P < .001). Cox proportional hazards models demonstrate significantly increased mortality for men vs women (hazard ratio, 1.07; 95% confidence interval, 1.04-1.10; P < .001), but no association between race and overall survival (hazard ratio, 0.99; 95% confidence interval, 0.98-1.01; P = .83). CONCLUSIONS: Using ICD-10-CM diagnosis codes, we demonstrated slightly higher incidence and prevalence of CLTI than in published literature, reflecting our more complete methodology. Sensitivity analyses suggest that increased complexity of the highly specific ICD-10-CM coding may diminish capture of CLTI. Inclusion of patients with non-CLTI peripheral arterial disease diagnoses produces moderate increases in incidence and prevalence at the cost of decreased specificity in identifying patients with CLTI. Medicare patients with CLTI are older, and more commonly male, black, and dual eligible compared with the general Medicare population. Observed mid-term survival for patients with CLTI is significantly lower than actuarial estimates, confirming the importance of focused efforts on identifying and aligning goals of care in this complex patient population.

A Systematic Review of Cost-Utility Analyses in Chronic Limb-Threatening Ischemia.

BACKGROUND: To review and describe the available literature on cost-utility analysis of revascularization and non-revascularization treatment approaches in chronic limb-threatening ischemia. METHODS: A systematic review was performed on cost-utility analysis studies evaluating revascularization (open surgery or endovascular), major lower extremity amputation, or conservative management in adult chronic limb-threatening ischemia patients. Six bibliographic databases and online registries were searched for English language articles up to August 2021. The outcome for cost-utility analysis was quality-adjusted in life years. Procedures were compared using incremental cost-effectiveness ratios which were converted to 2021 United States dollars. Study reporting quality was assessed using the 2022 Consolidated Health Economic Evaluation Reporting Standards statement. The study was registered in International Prospective Register of Systematic Reviews (CRD42021273602). RESULTS: Three trial-based and five model-based studies were included for review. Studies met between 14/28 and 20/28 criteria of the Consolidated Health Economic Evaluation Reporting Standards CHEERS statement. Only one study was written according to standardized reporting guidelines. Most studies evaluated infrainguinal disease, and adopted a health care provider perspective. There was a large variation in the incremental cost-effectiveness ratios presented across studies. Open surgical revascularization (incremental cost-effectiveness ratios: $3,678, $58,828, and $72,937), endovascular revascularization (incremental cost-effectiveness ratios: $52,036, $125,329, and $149,123), and mixed open or endovascular revascularization (incremental cost-effectiveness ratio: $8,094) maybe more cost-effective than conservative management. CONCLUSIONS: The application of cost-utility analyses in chronic limb-threatening ischemia is in its infancy. Revascularization in infrainguinal disease may be favored over major lower extremity amputation or conservative management. However, data is inadequate to support recommendations for a specific treatment. This review identifies short and long-term considerations to address the current state of evidence. Cost-utility analysis is an important tool in healthcare policy and should be encouraged amongst the vascular surgical community.

From pay for performance to collaborative quality initiatives: quality care and implications for the limb salvage center.

Management of chronic wounds, specifically those of the lower extremity, varies considerably by geographic region. The consequences of low-quality care perpetuate poor outcomes and low value for patients and the health care system. The emergence of value-based health care has forced stakeholders to evaluate care from quality and cost perspectives. This review presents a replicable quality assessment model for limb salvage specialists to apply to their practices. This model will foster increased collaboration between caregivers across all disciplines in an effort to increase quality care assurances for patients with chronic wounds of the lower extremity. Current approaches to quality assessment in the management of such wounds are outlined, and areas for innovation, such as collaborative initiatives, are highlighted. Use of the Donabedian model to provide quality and value to patients undergoing treatment for chronic wounds at a tertiary limb salvage center is also described. A value-based care system can be comprehensively assessed using the Donabedian framework. A pay-for-performance approach has largely guided health care reform in the United States; however, the effects of this approach have been incongruent with its intent. Limb salvage centers work to rectify this imbalance and continually evaluate quality measures to improve care. Collaborative quality initiatives have resulted in improved outcomes and cost savings in multiple specialties, and multidisciplinary limb salvage centers may benefit from such infrastructure. Limb salvage specialists have an important role in determining whether health care quality improvements are internally or externally driven. Existing quality assessment tools are imperfect, and the consequences of low-quality care of chronic wounds can be devastating. Through collaboration across institutions and the use of validated quality assessment tools such as the Donabedian model, chronic wound specialists can be leaders in developing and implementing quality care measures.

Economic value of podiatry service in limb salvage alliance.

OBJECTIVE/BACKGROUND: Over the past decade, multidisciplinary "toe and flow" programs have gained great popularity, with proven benefits in limb salvage. Many vascular surgeons have incorporated podiatrists into their practices. The viability of this practice model requires close partnership, hospital support, and financial sustainability. We intend to examine the economic values of podiatrists in a busy safety-net hospital in the Southwest United States. METHODS: An administrative database that captured monthly operating room (OR) cases, clinic encounters, in-patient volume, and total work relative value units (wRVUs) in an established limb salvage program in a tertiary referral center were examined. The practice has a diverse patient population with >30% of minority patients. During a period of 3 years, there was a significant change in the number of podiatrists (from 1 to 4) within the program, whereas the clinical full-time employees for vascular surgeons remained relatively stable. RESULTS: The limb salvage program experienced >100% of growth in total OR volumes, clinic encounters, and total wRVUs over a period of 4 years. A total of 35,591 patients were evaluated in a multidisciplinary limb salvage clinic, and 5535 procedures were performed. The initial growth of clinic volume and operative volume (P < .01) were attributed by the addition of vascular surgeons in year one. However, recruitment of podiatrists to the program significantly increased clinic and OR volume by an additional 60% and >40%, respectively (P < .01) in the past 3 years. With equal number of surgeons, podiatry contributed 40% of total wRVUs generated by the entire program in 2019. Despite the fact that that most of the foot and ankle procedures that were regularly performed by vascular surgeons were shifted to the podiatrists, vascular surgeons continued to experience an incremental increase in operative volume and >10% of increase in wRVUs. CONCLUSIONS: This study shows that the value of close collaboration between podiatry and vascular in a limb salvage program extends beyond a patient's clinical outcome. A financial advantage of including podiatrists in a vascular surgery practice is clearly demonstrated.

Procedural and 12-month in-hospital costs of primary infra-popliteal bypass surgery, infrapopliteal best endovascular treatment, and major lower limb amputation for chronic limb threatening ischemia.

OBJECTIVE: Chronic limb-threatening ischemia (CLTI) is a growing global problem due to the widespread use of tobacco and increasing prevalence of diabetes. Although the financial consequences are considerable, few studies have compared the relative cost-effectiveness of different CLTI management strategies. The Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial is randomizing patients with CLTI to primary infrapopliteal (IP) vein bypass surgery (BS) or best endovascular treatment (BET) and includes a comprehensive within-trial cost-utility analysis. The aim of this study is to compare over a 12-month time horizon, the costs of primary IP BS, IP best endovascular treatment (BET), and major limb major amputation (MLLA) to inform the BASIL-2 cost-utility analysis. METHODS: We compared procedural human resource (HR) costs and total in-hospital costs for the index admission, and over the following 12-months, in 60 consecutive patients undergoing primary IP BS (n = 20), IP BET (n = 20), or MLLA (10 transfemoral and 10 transtibial) for CLTI within the BASIL prospective cohort study. RESULTS: Procedural HR costs were greatest for BS (BS £2551; 95% confidence interval [CI], £1934-£2807 vs MLLA £1130; 95% CI, £1046-£1297 vs BET £329; 95% CI, £242-£390; P < .001, Kruskal-Wallis) due to longer procedure duration and greater staff requirement. With regard to the index admission, MLLA was the most expensive due to longer hospital stay (MLLA £13,320; 95% CI, £8986-£18,616 vs BS £8714; 95% CI, £6097-£11,973 vs BET £4813; 95% CI, £3529-£6097; P < .001, Kruskal-Wallis). The total cost of the index admission and in-hospital care over the following 12 months remained least for BET (MLLA £26,327; 95% CI, £17,653-£30,458 vs BS £20,401; 95% CI, £12,071-£23,926 vs BET £12,298; 95% CI, £6961-£15,439; P < .001, Kruskal-Wallis). CONCLUSIONS: Over a 12-month time horizon, MLLA and IP BS are more expensive than IP BET in terms of procedural HR costs and total in-hospital costs. These economic data, together with quality of life data from BASIL-2, will inform the calculation of incremental cost-effectiveness ratios for different CLTI management strategies within the BASIL-2 cost-utility analysis.

Racial and ethnic disparities in lower extremity amputation: Assessing the role of frailty in older adults.

BACKGROUND: Frailty is a state of decreased physiologic reserve contributing to functional decline and is associated with adverse surgical outcomes, particularly in the elderly. Racial disparities have been reported previously both in frail individuals and in limb-salvage patients. Our goal was to assess whether race and ethnicity are disproportionately linked to frailty status in geriatric patients undergoing lower-limb amputation, leading to an increased risk of complications. METHODS: A 3-year analysis was conducted of the National Surgical Quality Improvement Program database and included all geriatric (age ≥65 years) patients who underwent amputation of the lower limb. The frailty index was calculated using the 11-factor modified frailty index with a cutoff limit of 0.27 defined for frail status. Outcomes were 30-day complications, mortality, and readmissions. Multivariate regression analysis was performed. RESULTS: A total of 4,218 geriatric patients underwent surgical amputation of a lower extremity (above knee: 41%; below knee: 59%). Of these patients, 29% were frail, 26% were African American, and 9% were Hispanic. Being African American (odds ratio: 1.6 [1.3-1.9]) and Hispanic (odds ratio: 1.1 [1.05-2.5]) was independently associated with frail status. Frail African Americans had a higher likelihood of 30-day complications (odds ratio: 3.2 [1.9-4.4]) and 30-day readmissions (odds ratio: 2.9 [1.8-3.6]) when compared with nonfrail individuals. Similarly, frail Hispanics had higher 30-day complications (odds ratio: 2.6 [1.9-3.1]) and 30-day readmissions (odds ratio: 1.4 [1.1-2.7]) compared with nonfrail Hispanics/Latinos. CONCLUSION: African American and Hispanic geriatric patients undergoing lower-limb amputation are at increased risk for frailty status and, as a result, increased associated operative complications. These disparities exist regardless of age, sex, comorbid conditions, and location of amputation. Further studies are needed to highlight disparities by race and ethnicity to identify potentially modifiable risk factors, decrease frailty, and improve outcomes.

Contemporary Treatment of Popliteal Artery Aneurysms in 14 Countries: A Vascunet Report.

OBJECTIVE: Popliteal artery aneurysm (PAA) is the second most common arterial aneurysm. Vascunet is an international collaboration of vascular registries. The aim was to study treatment and outcomes. METHODS: This was a retrospective analysis of prospectively registered population based data. Fourteen countries contributed data (Australia, Denmark, Finland, France, Hungary, Iceland, Italy, Malta, New Zealand, Norway, Portugal, Serbia, Sweden, and Switzerland). RESULTS: During 2012-2018, data from 10 764 PAA repairs were included. Mean values with between countries ranges in parenthesis are given. The incidence was 10.4 cases/million inhabitants/year (2.4-19.3). The mean age was 71.3 years (66.8-75.3). Most patients, 93.3%, were men and 40.0% were active smokers. The operations were elective in 73.2% (60.0%-85.7%). The mean pre-operative PAA diameter was 32.1 mm (27.3-38.3 mm). Open surgery dominated in both elective (79.5%) and acute (83.2%) cases. A medial surgical approach was used in 77.7%, and posterior in 22.3%. Vein grafts were used in 63.8%. Of the emergency procedures, 91% (n = 2 169, 20.2% of all) were for acute thrombosis and 9% for rupture (n = 236, 2.2% of all). Thrombosis patients had larger aneurysms, mean diameter 35.5 mm, and 46.3% were active smokers. Early amputation and death were higher after acute presentation than after elective surgery (5.0% vs. 0.7%; 1.9% vs. 0.5%). This pattern remained one year after surgery (8.5% vs. 1.0%; 6.1% vs. 1.4%). Elective open compared with endovascular surgery had similar one year amputation rates (1.2% vs. 0.2%; p = .095) but superior patency (84.0% vs. 78.4%; p = .005). Veins had higher patency and lower amputation rates, at one year compared with synthetic grafts (86.8% vs. 72.3%; 1.8% vs. 5.2%; both p < .001). The posterior open approach had a lower amputation rate (0.0% vs. 1.6%, p = .009) than the medial approach. CONCLUSION: Patients presenting with acute ischaemia had high risk of amputation. The frequent use of endovascular repair and prosthetic grafts should be reconsidered based on these results.

Current opinion on the role of the foot perfusion in limb amputation risk assessment.

The most important and consulted guidelines dealing with not healing foot ulcers suggest the measurement of the foot perfusion (FP) to exclude the critical limb ischemia (CLI), because of the high risk of limb amputation. But the recommended cut-off values of FP fail to include all the heterogeneity of patients of the real-life with a not healing ulcer. Often these patients are diabetics with a moderate PAD but with a high level of infection. To meet this goal, in 2014, the Society for Vascular Surgery has published the "Lower Extremity Threatened Limb Classification System: Risk stratification based on Wound, Infection, and foot Ischemia (WIfI)." This new classification system has changed the criteria of assessment of limb amputation risk, replacing the single cut-off value role with a combination of a spectrum of perfusion values along with graded infection and dimension levels of skin ulcers. The impact of this new classification system was remarkable so to propose the substitution of the CLI definition, with the new Critical limb-threatening ischemia (CLTI), that seems to define the limb amputation risk more realistically.

Who, What, Where: Demographics, Severity of Presentation, and Location of Treatment Drive Delivery of Diabetic Limb Reconstructive Services within the National Inpatient Sample.

BACKGROUND: Technical advances have been made in reconstructive diabetic limb salvage modalities. It is unknown whether these techniques are widely used. This study seeks to determine the role of patient- and hospital-level characteristics that affect use. METHODS: Admissions for diabetic lower extremity complications were identified in the 2012 to 2014 National Inpatient Sample using International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. The study cohort consisted of admitted patients receiving amputations, limb salvage without flap techniques, or advanced limb salvage with flap techniques. Multinomial regression analysis accounting for the complex survey design of the National Inpatient Sample was used to determine the independent contributions of factors expressed as marginal effects. RESULTS: The authors' study cohort represented 155,025 admissions nationally. White non-Hispanic patients had the highest proportion of reconstruction without and with flaps, whereas black patients had the lowest. Multinomial regression models revealed that controlling for nongas gangrene and critical limb ischemia, both of which have a much greater incidence in minorities, the effect of race against receipt of reconstructive modalities was attenuated. Access to urban teaching hospitals was the strongest protective factor against amputation (9 percent reduction; p < 0.01) and predictor of receiving limb salvage without flaps (5 percent increase; p < 0.01) and with flaps (3 percent increase; p < 0.01). CONCLUSIONS: This study identified multiple patient- and hospital-level factors associated with decreased access to the gamut of reconstructive limb salvage techniques. Disparity reduction will likely require a multifaceted strategy that addresses the severity of disease presentation seen in minorities and delivery system capabilities affecting access and use of reconstructive limb salvage procedures. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia.

GUIDELINE SUMMARY: Chronic limb-threatening ischemia (CLTI) is associated with mortality, amputation, and impaired quality of life. These Global Vascular Guidelines (GVG) are focused on definition, evaluation, and management of CLTI with the goals of improving evidence-based care and highlighting critical research needs. The term CLTI is preferred over critical limb ischemia, as the latter implies threshold values of impaired perfusion rather than a continuum. CLTI is a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration. Venous, traumatic, embolic, and nonatherosclerotic etiologies are excluded. All patients with suspected CLTI should be referred urgently to a vascular specialist. Accurately staging the severity of limb threat is fundamental, and the Society for Vascular Surgery Threatened Limb Classification system, based on grading of Wounds, Ischemia, and foot Infection (WIfI) is endorsed. Objective hemodynamic testing, including toe pressures as the preferred measure, is required to assess CLTI. Evidence-based revascularization (EBR) hinges on three independent axes: Patient risk, Limb severity, and ANatomic complexity (PLAN). Average-risk and high-risk patients are defined by estimated procedural and 2-year all-cause mortality. The GVG proposes a new Global Anatomic Staging System (GLASS), which involves defining a preferred target artery path (TAP) and then estimating limb-based patency (LBP), resulting in three stages of complexity for intervention. The optimal revascularization strategy is also influenced by the availability of autogenous vein for open bypass surgery. Recommendations for EBR are based on best available data, pending level 1 evidence from ongoing trials. Vein bypass may be preferred for average-risk patients with advanced limb threat and high complexity disease, while those with less complex anatomy, intermediate severity limb threat, or high patient risk may be favored for endovascular intervention. All patients with CLTI should be afforded best medical therapy including the use of antithrombotic, lipid-lowering, antihypertensive, and glycemic control agents, as well as counseling on smoking cessation, diet, exercise, and preventive foot care. Following EBR, long-term limb surveillance is advised. The effectiveness of nonrevascularization therapies (eg, spinal stimulation, pneumatic compression, prostanoids, and hyperbaric oxygen) has not been established. Regenerative medicine approaches (eg, cell, gene therapies) for CLTI should be restricted to rigorously conducted randomizsed clinical trials. The GVG promotes standardization of study designs and end points for clinical trials in CLTI. The importance of multidisciplinary teams and centers of excellence for amputation prevention is stressed as a key health system initiative.

Temporal trends and hospital costs associated with an endovascular-first approach for acute limb ischemia.

OBJECTIVE: Recent studies suggest similar perioperative outcomes for endovascular and open surgical management of acute limb ischemia (ALI). We sought to describe temporal trends, patient factors, and hospital costs associated with contemporary ALI management. METHODS: We used the weighted National Inpatient Sample to estimate primary ALI cases requiring open or endovascular intervention (2005-2014). We used multivariable regression models to examine temporal trends, patient factors, and hospital costs associated with endovascular-first vs open-first management. RESULTS: Of 116,451 admissions for ALI during the study period, 35.2% were treated by an endovascular-first approach. The percentage of admissions managed with an endovascular-first approach increased over time (P < .001). Independent predictors of endovascular-first management included younger age, male sex, renal insufficiency, and more recent calendar year of admission (P ≤ .02), whereas patients who underwent fasciotomy, those with Medicaid, and those admitted on a weekend were more likely to undergo open-first management (P ≤ .02). Endovascular-first management had higher mean hospital costs than open-first management ($29,719 vs $26,193; P < .001). After adjustment for patient, hospital, and admission characteristics, there was an increase of $981 in treatment costs per year in the endovascular-first group (95% confidence interval [CI], $571-$1392; P < .001), whereas the costs associated with an open-first approach remained relatively stable over time ($10 per year; 95% CI, -$295 to $315; P = .95; P < .001 for interaction). The risk-adjusted odds of in-hospital major amputation was similar in both groups (adjusted odds ratio, 0.99; 95% CI, 0.85-1.15; P = .88). CONCLUSIONS: Use of an endovascular-first approach for the treatment of ALI has significantly increased over time. Although major amputation rates are similar for both approaches, the costs associated with an endovascular-first approach are increasing over time, whereas the costs of open surgery have remained stable. The cost-effectiveness of modern ALI management warrants further investigation.

Low cost reconstructive options after musculoskeletal tumour resection in developing countries. Affordable, effective and durable alternatives.

Over the last two, three decades, the overall survival rates for non-metastatic malignant tumours of the bone have dramatically improved. This has become possible due to the recent advances and multidisciplinary approach towards these diseases, specifically the advent of multi-agent chemotherapy and radiotherapy. Limb salvage has now become the norm in the treatment of musculoskeletal tumours without compromising on the overall survival and recurrence of the disease. In the era of metal, prosthetic reconstruction has become the standard procedure specifically in the large tumours which involve the joints as this method of reconstruction helps in joint mobility and early weight-bearing. Considering the costs and resource constraints, multiple cost-effective, stable, durable reconstruction options have evolved over the last decade and these have also shown favourable func tional outcomes without compromising on the amount of resection and risk of local recurrence. The current literature review was planned to discuss various cost-effective, durable reconstructive options and their advantages and disadvantages. These include Van ness rotationplasty, allograft, autograft, devitalised tumour bone and Masqueletor induced membrane technique . .

Pilot Assessment of the Angiosome Concept by Intra-operative Fluorescence Angiography After Tibial Bypass Surgery.

OBJECTIVES: The "angiosome" concept as a model for decision making in revascularisation of patients with critical limb ischaemia (CLI) has been subject to lively discussion in recent years. The aim of this prospective pilot study was to use intra-operative fluorescence angiography to provide further data on the angiosome concept on the level of microcirculation after tibial bypass surgery. DESIGN, MATERIALS, AND METHODS: This was a prospective analysis of 40 patients presenting with CLI Rutherford stage IV to VI before and after tibial bypass surgery. The macrocirculation was measured by the ankle brachial index. Skin microcirculation was assessed by intra-operative fluorescence angiography. The alteration of microcirculation was compared in direct and indirect revascularised angiosomes. Clinical follow-up investigations were performed and the wound healing rate was compared between the different revascularisation methods. RESULTS: Cumulated microcirculation parameters showed a significant improvement after surgery (ingress, ingress rate p<.001). Likewise, general microcirculatory improvement was observed in each foot angiosome after revascularisation, regardless of the tibial artery revascularised. Furthermore, a comparison of the direct (DR) and the indirect revascularised (IR) angiosomes did not show a significant difference concerning the improvement of microcirculation (difference DR-IR, ingress: 1.69, 95% CI 71.73-75.11; ingress rate: 0.08, 95% CI -12.91 to 13.07). The wound healing rate was similar in both groups, although the time to wound healing was faster by on average 2.5 months in the DR group (p=.083). CONCLUSION: Microcirculatory improvement was seen over the whole foot after tibial bypass. Therefore, fluorescence angiography is a promising tool to evaluate the angiosome concept in future larger studies. Clinicaltrials.gov: NCT03012750.

Function and quality of life among primary osteosarcoma survivors in Iran: amputation versus limb salvage.

PURPOSE: This study aimed to evaluate the psychometric properties of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Iranian osteosarcoma patients and apply this to compare the functional level, quality of life, symptoms and financial burden of the patients who underwent amputation and limb-salvage operations. METHODS: This study was conducted at the main referral orthopedic centers in the southwest of Iran from 2006 to 2016. After complete review of medical records, 48 patients were invited to attend the outpatient clinic and participate in the study via initial telephone interview. All data were entered in the Statistical Package for the Social Sciences version 15.0, and p values <0.05 were considered statistically significant. RESULTS: In total, 48 patients with extremities osteosarcoma completed the study. Of these, 31 had been treated with limb-salvage operation and 17 had undergone amputation. In functioning subscale, all the mean score of items, except social function, were higher in the limb salvage group than the amputee group. The mean scores (SD) of global health and quality of life were 64.5(13.2) and 61.2± 12.4 in the limb salvage and amputee groups, respectively. In the financial impact subscale, the mean score (SD) in the limb salvage group was 68.8± (29.7) compared to 74.5(25.0) in the amputee group. CONCLUSION: Results support the responsiveness of the EORTC QLQ-C30 for Iranian osteosarcoma patients. Applying this questionnaire revealed similar functional outcome, quality of life, symptoms and financial burden between amputation and limb-salvage groups.

Impact of Two Attendings on the Outcomes of Microvascular Limb Reconstruction.

BACKGROUND: Free tissue transfers are routinely performed for extremity reconstruction. In an era of increasing economic pressure in many healthcare systems, efficiency needs to be optimized for any kind of operative procedure. This study is examining the possible benefit of a two-attending approach to microsurgical reconstruction of the limbs using antero-lateral thigh- (ALT) or gracilis-muscle flaps at a major academic microsurgical center. METHODS: 309 patients underwent 392 free ALT- (206) or gracilis-muscle (186) flaps for limb defect reconstruction at our institution (2009-2015). All available data was retrospectively screened for patients' demographics, perioperative details, surgical complications, and overall flap survival. The cases were divided into two groups according to the number of operating microsurgeons: one versus two attendings. RESULTS: No significant differences existed between the two groups (341 "one attending" versus 51 "two attendings") regarding preoperative comorbidities. Overall, there was no significant difference between both groups regarding operative times, revision surgery rates, total as well as partial flap loss, and hospital length of stay (p > 0.05) during the 3-month follow-up period. Further, evaluating ALT and gracilis flaps separately also showed no significant differences between both groups (one versus two attendings). CONCLUSION: The addition of a second operating attending does not significantly shorten surgery times, hospital length of stay, need for revision surgery, or complications rates. A two-operation surgeon approach may therefore only provide a marginal benefit in microsurgical limb reconstruction.

Endoprosthetic replacement versus cement spacer in reconstruction of proximal humerus after tumor resection: Cost and benefits.

BACKGROUND: Proximal end of the humerus is a common site for both primary and metastatic bone tumors. Limb salvage with endoprosthetic replacement is the most common means of reconstruction, but it has been proved that cement spacer are more beneficial for inferior shoulder function. Thus, limb salvage can be replaced by cheaper spacers especially in poor societies. PATIENTS AND METHODS: This study included 20 patients, of whom 14 were female, with a mean age of 40.4 years (range 12-60). Among the study population, six were diagnosed with osteosarcomas, two chondrosarcomas, two myeloma, two lymphoma, four metastatic carcinoma in the breast, two giant cell tumor, and two recurrent chondroplastoma. Limb salvage was successfully done in all patients: Tikhoff-Linberg type I in 12 cases and type V in 8. Endoprosthetic replacement was done in eight cases. An on-table fabricated cement spacer was used in 12 cases. RESULTS: Follow-up ranged from 12 to 75 months, with a mean of 25.9 months. Functional outcome was almost comparable in both types of reconstruction, especially patient's satisfaction, with a mean function of 65%. CONCLUSION: A relatively expensive endoprosthesis could be replaced by a much cheaper cement spacer if their function is comparable.

[Assessment of surgical risk in patients with lower limb chronic critical ischaemia]. / Otsenka khirurgicheskogo riska u bol'nykh s khronicheskoi kriticheskoi ishemiei nizhnikh konechnostei.

Analysed herein are both immediate and remote results of surgical treatment of 93 patients presenting with chronic atherosclerotic occlusion of the femoral-popliteal-tibial segment in the stage of critical ischaemia. The patients were subjected to autovenous femoropopliteal bypass grafting to the isolated arterial segment or balloon angioplasty with stenting of the superficial femoral artery. While choosing the method of arterial reconstruction we assessed concomitant diseases, primarily lesions of the coronary and cerebral circulation. In order to objectively evaluate the patient state, we worked out a scale for assessing surgical risk. Survival rate without amputation after three years in patients with low risk amounted to 71.4%, in those with moderate risk to 60.0%, and in high-risk patients to 43.3%. Patients with initially high risk were found to have a high incidence rate of cardiac and cerebrovascular complications, exceeding 40%. It was shown that the worked out system of assessing the level of surgical risk objectively reflects the prognosis of patient survival following a reconstructive operation. This system of assessment may be appropriate while choosing an optimal method of arterial reconstruction (bypassing operation or endovascular intervention) in patients with atherosclerotic lesions of arteries of the femoropopliteal-tibial segment and critical ischaemia accompanied by severe concomitant pathology. Patients with high surgical risk should preferably be subjected to endovascular reconstruction, while those with low surgical risk should better undergo open shunting bypassing operation, and for those with moderate risk it is acceptable to perform both methods of arterial reconstruction.

Infective complications in tumour endoprostheses implanted after pathological fracture of the limbs.

INTRODUCTION: Pathological fractures represent an adverse prognostic factor in primary and metastatic bone tumours. The purpose of this study was to evaluate the results of tumour silver-coated prosthesis implanted after pathological fractures. MATERIALS AND METHODS: A retrospective analysis was conducted on 30 patients with pathological limb fracture after primary or metastatic bone tumours treated by the same surgeon with wide margin resection and tumour prosthesis implant between 2005 and 2015. Silver-coated prostheses were implanted in 17 patients and uncoated prostheses were implanted in 13 patients. The primary outcome of the study was to evaluate the infective risk, the secondary outcomes were survival and functional level (visual analogue scale [VAS], 36-Item Short Form Health Survey [SF 36], and Musculoskeletal Tumour Society [MSTS] score) obtained at the longest follow-up available. A multivariate analysis was performed considering age, sex, tumour histology, grading and location, resection size, concomitant radiotherapy/chemotherapy, use of mesh for soft tissue reconstruction and local complications (dislocation, relapse, implant breakage). Scanning electron microscopy (SEM) analysis of explanted prosthesis was performed to study the residual silver-coating. RESULTS: The average age of patients in the study was 56.2 years (range 12-78 years). Silver-coated prostheses were implanted in 56.7% of patients, and uncoated tumour prostheses were used in the remaining 43.3%. The mean follow-up was 40.7 months. A total of 26.7% of patients died at a median time of 28.6 months after surgery. The overall rate of complications was 30%, with 16.7% due to infection. A total of 11.8% of the patients treated with silver-coated implants developed infection compared with 23.1% of the patients treated with uncoated tumour prostheses. There were no cases of early infection in the silver-coated prosthesis group, whereas early infection occurred in 66.7% of patients in the uncoated prosthesis group. All the functional outcomes were significantly improved after surgery. None of the other parameters analysed can be considered a significant negative prognostic factor for infection. The SEM analyses showed severe silver-coating degradation 2 years after first implant. No case of silver toxicity was demonstrated. DISCUSSION: There are few papers in the literature about infective complications in tumour prosthesis after pathological fracture. Silver-coated implants showed a protective action against early infection. Late infection rate was similar between the groups, thereby indicating a reduction of antimicrobial activity for the silver-coating over time. CONCLUSIONS: Silver-coated prostheses are a protective factor against early infections in limb salvage surgery after pathological fractures, so may represent the first-choice of implants in this type of surgery.