Major Amputation Research Articles

The Impact of Sociodemographic Variables on Functional Recovery following Lower Extremity Amputation

ObjectiveWe hypothesize that sociodemographic variables, particularly disadvantaged financial environments, impact both rate of prosthetic utilization and the achievement of ambulation post major amputation. MethodsAll cases in the Vascular Quality Initiative (VQI) amputation module were queried between April 2013 and January 2024. Inclusion was limited to patients who underwent below knee, through knee, and above knee amputation. Two primary outcomes were investigated : Non-ambulatory status after amputation (minimum of 120 days follow up); and, not having obtained a prosthetic limb (minimum of 90 days follow up). The ambulation status and prosthetic status analyses had 6984 and 6793 patients meet inclusion respectively. Multivariable binary logistic regression analysis was performed utilizing variables which achieved univariable significance (P<.05) for the outcomes. ResultsMean follow up for those meeting inclusion was 432 days. Amongst all patients meeting inclusion, 46.7% of patients did not acquire a prosthetic limb and 44.1% were non-ambulatory. Sociodemographic factors with significant multivariable association for the outcome of no prosthetic limb acquisition in follow up were : advancing age (aOR 1.011/year (1.006-1.016), P<.001); female sex (aOR 1.43 (1.28-1.61), P<.001); top 20% ADI representing highest deprivation (aOR 1.24 (1.09-1.41) P=.001); race (P=.002) Insurance status (P=.028) with protective status for commercial insurance (39% rate of no prosthetic) and non US insurance (33%) versus Medicare (51%), Medicaid (48%), VA insurance (49%), Self Pay (42%) and Medicare Advantage (51%). There were numerous co-morbidities which also had association with lack of prosthetic limb acquisition.Sociodemographic variables which achieved multivariable significance (P<.05) for the outcome of non-ambulatory status after major amputation were : female sex (aOR 1.37 (1.23-1.54), P<.001); Medicare insurance (P=.016); advancing age (aOR 1.009/year (1.004-1.014), P<.001); CHF (aOR 1.15 (1.02-1.31), P=.028); and, not living at home in follow up (aOR (3.53 (2.99-4.17) P<.001). Physical therapy at any point after surgery (aOR .742 (.662-.832), P<.001) and commercial insurance (aOR .839 (.737-.956), P=.008) were protective. There were numerous co-morbidities which also had association with non-ambulatory status in follow up. ConclusionsLiving within the most financially disadvantaged areas and race both have a significant independent association with lack of prosthetic limb acquisition following major amputation. Black, Native American and Pacific Islander demographic patients experience lack of acquisition at a higher rate than White and Asian patients independent of co-morbidities and socioeconomic co-variables. Female patients obtain a prosthetic limb and ambulate less frequently than males after major amputation, largely due to a higher rate of above knee amputation. Co-morbidities, and not socioeconomic variables are the leading drivers of non-ambulation.

Discrepancy in opioid prescription patterns for Black or African American patients following lower extremity bypass surgery for chronic limb-threatening ischemia

BackgroundDisparity in the allocation of medical services and resources based on race is present within the health care industry today, including the prescription of postoperative analgesics. The purpose of this study was to evaluate the presence of race-based disparity in the prescription of postdischarge opioids after lower extremity bypass (LEB) surgery for chronic limb-threatening ischemia (CLTI). MethodsRetrospective analysis was conducted on adult CLTI patients who underwent LEB from 2000 to 2023 in the TrinetX database. Patients were stratified into two groups based on race: White (group I) and black or African American (AA) (group II). Primary outcomes were defined as oral opioid prescriptions at 7 days and 30 days after discharge, and mortality at 1 year postoperatively. Secondary outcomes included length of stay and 30-day postoperative outcomes, including myocardial infarction, pulmonary embolism, cerebral vascular accident, deep vein thrombosis, acute kidney injury, major amputation, minor amputation, major adverse cardiac events, and major adverse limb events. Stratified analysis was conducted based on disease stage (rest pain vs lower extremity ulcer vs gangrene). Univariate analysis was performed via two-sample t test and χ2 test. Logistic regression was performed to estimate the association of Black or AA (vs White) race while controlling for pertinent preoperative potential confounders. ResultsThere were 3345 patients who met the inclusion criteria. Group I included 2661 White patients and group II included 684 Black or AA patients. Group II patients were more likely to be younger, female, present with gangrene, and have a history of hypertension, diabetes, chronic kidney disease, or diabetic neuropathy. At both 7 and 30 days after discharge, the Black or AA cohort had significantly lower rates of opioid prescriptions (33.2% vs 42.5% and 35.8% vs 47.2%, respectively) (all P < .05). Stratification by indication showed that opioid prescription disparity persisted despite black or AA patients presenting at worse stages of disease both at 7 and 30 days after discharge (7 days: rest pain 43.4% vs 33.7% [P = .013], ulcer 41.4% vs 31.7% [P = .027], gangrene, 42.7% vs 33.6% [P = .006] and 30 days: rest pain 47.8% vs 37.1% [P = .007], ulcer 45.4% vs 33.5% [P = .007], gangrene, 48.2% vs 36.1% [P < .001]). Adjusted analysis confirmed that Black or AA race was associated with lower rates of 7- (adjusted odds ratio, 0.607; P = .001) and 30-day (adjusted odds ratio, 0.56; P = .001) postdischarge opioid prescriptions. ConclusionsBlack or AA patients were less likely to receive postdischarge opioid prescriptions compared with their White counterparts at 7 and 30 days after LEB for CLTI.

Validated German PROMs for People with Major Amputation of the Lower Extremity - A Narrative Review Based on the Final Report of the LEAD and COMPASS Initiative of the ISPO

Patient-reported outcome measures (PROMs) play an important role in the rehabilitation of people with major limb amputations. Patient-completed questionnaires help collect specific constructs on this patient population. The COMPASS and LEAD initiatives, carried out by the International Society for Prosthetics and Orthotics (ISPO), underscore the importance of regularly collecting high-quality PROMs. These are essential for the evaluation of rehabilitation needs, progress, and success. In the final report of ISPO's major international initiative, PROMs recommendations of the expert panel are tabulated. In Table 3.2 of the report, ISPO lists n=12 PROMs that were included in the narrow consensus process were considered to be of acceptable quality, and therefore recommended. The aim of this systematic review was to specifically search for these recommended PROMS regarding their availability in a German and validated version in order to identify potential gaps. All PROMs that were available in a German and validated version were then examined further with regard to the quality of the validation study, using the checklist of COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). Through a systematic literature search, six validated German-language versions were found. Only four of these met the quality standards of the COSMIN checklist sufficiently. Overall, this review shows serious gaps in the availability in the German language of validated versions of PROMs used internationally and recommended as standard by the ISPO. This gap needs to be closed by guideline-oriented translation and subsequent validation studies in order to be able to offer and collect the PROMS recommended by the ISPO also for German-speaking patient populations.

Contemporary outcomes after endoscopic vein harvesting for lower extremity bypass in a multicenter subspecialty practice

BackgroundEndoscopic vein harvesting (EVH) is considered the standard of care for coronary bypass procedures given the lower early morbidity from surgical wound complications. However, the use of EVH for lower extremity (LE) bypass remains controversial owing to concerns about decreased graft patency. In 2022, the BEST-CLI Trial (Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia) demonstrated patients undergoing surgical bypass with adequate great saphenous vein quality experienced a lower incidence of major adverse limb events and mortality than those who underwent endovascular repair. Despite these results, wound complications from large harvest site incisions remain a significant barrier preventing surgical bypass as being the preferred initial treatment. To mitigate wound complications, our practice has adopted EVH as the standard approach for harvesting bypass conduit. Here, we report our recent 5-year experience using EVH for LE bypass. MethodsOne hundred sixty-eight LE bypasses with EVH were evaluated from 2017 to 2022. The cohort included 14 vascular surgeons in 8 hospitals. The primary end point was 30-day surgical wound complications. Secondary end points included bypass patency, need for major amputation, 30-day morbidity and mortality, length of operation, and length of hospitalization. Wound complications were measured using Szilagyi's method, with class I characterized by erythema necessitating antibiotics, class II having drainage or superficial dehiscence, and class III threatening graft integrity and requiring surgical intervention. ResultsA total of 168 LE bypasses with EVH were performed on 166 patients. Of these, 65.48% were male with a median age of 68.4 ± 9.7 years. There were no wound complications related to saphenectomy. Surgical site infections occurred in 22 patients (13.10%). Seven patients (4.17%) had class I complications, 12 (7.14%) had class II complications, and 3 (1.79%) had class III complications. Primary patency at 30 days was 96.10% and 86.84% at 1 year). Seven patients (4.17%) required major amputation at 30 days. The 1-year amputation-free survival was 89.39%. The 30-day postoperative stroke, myocardial infarction, and death rates were 0.60%, 0.60%, and 2.38%, respectively. The median operative time was 3.30 ± 1.18 hours. The median length of hospitalization was 3.00 ± 3.56 days. ConclusionsEVH minimizes saphenectomy wound complications without compromising patency and limb salvage rates. Older studies suggesting lower patency rates after EVH may have been limited by older technology and inexperienced operators. Whether EVH should be the standard of care for LE bypass warrants further investigation.

Treatment of chronic limb-threatening ischemia (CLTI) based on BEST-CLI and BASIL-2

The rate of vascular recanalizations in CLTI is increasing worldwide. Safety and efficacy of surgical versus endovascular treatment in CLTI patients was investigated in 2 prospective randomized trials with contrasting results. The BEST-CLI trial randomized 1830 patients with CLTI, the Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL-2) trial included 345 patients with CLTI. Best-CLI evaluated outcome events as the primary endpoint, which includes major reinterventions in addition to major amputations and death. Only half of the CLTI patients received a crural intervention or surgery. There were no differences in major amputations or death. After a median follow-up (FU) of 2,7 years, the surgery group showed significantly better results compared to the endovascular group, due to fewer re-interventions. BASIL-2 used amputation-free survival as the primary outcome and only included patients with lower leg lesions. After a median FU of 40 months, endovascular therapy was found to be superior. The extremely high mortality rate was remarkable in both studies. The BEST-CLI study represents CLTI patients only to a limited degree, whereas the BASIL-2 study presents the treatment of CLTI patients with below-the-knee-lesions quite well. Both studies confirm that patients with CLTI should be treated in specialized centers that offer both crural surgery and endovascular therapy. Cardiovascular risk factor management must play a more important role in reducing the high mortality associated with CLTI.

Prosthetic fitting and mortality after major lower extremity amputation: Presented at the Forty-eighth Annual Meeting of the Southern Association for Vascular Surgery, Scottsdale, Arizona, January 27, 2024.

Prosthetic fitting and mortality after major lower extremity amputation: Presented at the Forty-eighth Annual Meeting of the Southern Association for Vascular Surgery, Scottsdale, Arizona, January 27, 2024.

Impact of operative approach and patient frailty on outcomes for aorto-iliac occlusive disease with critical limb threatening ischemia.

Multiple treatment modalities exist for the management of aorto-iliac occlusive disease (AIOD) including endovascular (endo), extra-anatomic bypass (EAB), and anatomic bypass (AB). The goal of this study was to examine the impact of revascularization strategy and patient frailty on outcomes for AIOD in patients with critical limb threatening ischemia (CLTI). Patients undergoing revascularization for CLTI and AIOD were identified from the NSQIP database over 5years. Demographics, procedural characteristics, and outcomes were recorded. Modified frailty index (mFI-5) was calculated for each patient. Patients were compared based on the type of procedure and frailty (mFi>0.6). From 2017 to 2021, 1777 patients underwent revascularization for CLTI from AIOD. Patients were majority male (56%) with a mean age of 68. A total of 1346 patients (76%) underwent an open operation of which 669 were EAB. When endo (431 patients) was compared with open repair, endo was associated with a higher incidence of tissue loss at presentation (42% vs 33%, p < 0.001), lower rates of bleeding (6.5% vs 15.5%, p < 0.001), fewer MI/stroke (1.6% vs 4.6%, p = 0.004), and fewer wound complications (2.6% vs 11.2%, p < 0.001). There was no difference in re-intervention, amputation, or death based on frailty. For frail patients (184 patients), type of repair did not impact re-intervention, major amputation, or mortality, though there was increased MI/stroke with EAB and increased wound complications with AB/EAB. AIOD revascularization strategies for patients with CLTI have similar 30-day re-intervention, major amputation, and mortality rates. Endovascular repair has less surgical wound complications and is better suited for frail patients.

Perioperative Risk Factors for Early Major Amputation Following First-Time Diabetic Forefoot Amputation.

Despite a meticulous multidisciplinary team approach, limb salvage remains uncertain even after the initial forefoot amputation in patients with end-stage diabetes. Which of many factors strongly influence the early failure of the limb salvage strategy remains unknown. This study aimed to analyze perioperative independent risk factors for major amputation within 1 year following first-time diabetic forefoot amputation. Perioperative variables of 808 diabetic forefoot amputations performed in a tertiary referral center specialized for organ transplantation and end-stage diabetes were analyzed. Major amputations were performed in 104 patients (12.9%) throughout follow-up, and 77 (74%) of 104 patients had their major amputation within 1 year. Cox proportional hazards were examined to assess the risk factors for major amputation performed within 1 year. In univariate analysis, 18 possible risk factors significantly differed between patients with and without early major amputation. In stepwise multivariable analysis, chronic renal failure (CRF), peritoneal dialysis, and bilateral initial amputation were strong risk factors for early major amputation, with hazard ratios of 2.973 (95% CI 1.805-4.896, P < .0001), 2.558 (95% CI 1.113-5.881, P = .027), and 2.515 (95% CI 1.318-4.798, P = .005), respectively. Regardless of kidney transplantation (KT) status, CRF strongly predicts >20% chance of major amputation within 1 year after the first diabetic forefoot amputation.

The association of chronic obstructive pulmonary disease and 30-day outcomes of infrainguinal bypass surgery: A propensity-score matching study.

Infrainguinal bypass surgery is an effective treatment for peripheral artery disease (PAD). While chronic obstructive pulmonary disease (COPD) has been linked to heightened risks of mortality and morbidity in major surgery, a thorough investigation into COPD's impact on infrainguinal bypass outcomes remained underexplored. Thus, this study aimed to assess the 30-day outcomes for COPD patients undergoing infrainguinal bypass surgery. COPD and non-COPD patients who underwent infrainguinal bypass were identified in American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database from 2011 to 2022. Patients of age<18 were excluded. A 1:1 propensity-score matching was used to match demographics, baseline characteristics, symptomatology, procedure, conduit, and anesthesia. Thirty postoperative outcomes were compared. There were 3,183 (12.64%) and 22,004 (87.36%) patients with and without COPD, respectively, who underwent infrainguinal bypass. COPD patients had a higher comorbid burden. After propensity-score matching, COPD patients had higher sepsis (3.55% vs 2.42%, p = 0.01), wound complications (18.94% vs 16.40%, p = 0.01), and 30-day readmission (18.00% vs 14.92%, p < 0.01). However, COPD and non-COPD patients had comparable 30-day mortality (2.54% vs 2.67%, p = 0.81), and organ system complications including cardiac (3.58% vs 3.99%, p = 0.43), pulmonary (3.96% vs 3.20%, p = 0.12), and renal complications (1.70% vs 1.82%, p = 0.78). Limb-specific outcomes including major amputation (2.95% vs 2.50%, p = 0.30), untreated loss of patency (1.85% vs 1.38%, p = 0.16), and patent graft (98.24% vs 98.65%, p = 0.27) were also comparable between the cohorts. While COPD might be associated with the development of PAD due to potentially shared pathophysiology, it may not be an independent risk factor for the major 30-day outcomes in infrainguinal bypass surgery.

Patients Experience Significant Long-Term Social and Health Challenges After Major Lower Extremity Amputation

Major lower extremity amputation is a significant life-changing event that can have long-term implications. The goal of this study was to assess long-term medical outcomes and social determinants of health (SDH) challenges in this population. A retrospective review of major lower extremity (previously mentioned ankle) amputations (2018-2022) was performed at a safety-net tertiary care center. Patients who participated in an SDH survey between 6 months and 1.5years postoperatively were included for survey analysis. Patient demographics, comorbidities, and perioperative and long-term outcomes were analyzed. There were 100 patients included. Mean age was 61.5years and 23% were of female gender. The majority (57%) were Black race, 20% White race, and 21% Hispanic ethnicity. Comorbidities included diabetes (78%), chronic kidney disease (51%), coronary artery disease (31%), congestive heart failure (23%), previous cerebrovascular events (19%), and 37% used opioids preadmission. At baseline, the majority (62%) lived at home. Guillotine amputation was performed in 24%, with definitive amputation in the following and previously mentioned knee in 67% and 33%, respectively. Median length of stay was 7days. Readmission at 30 days, 90days, and 1 year was 13%, 30%, and 43% respectively. The average follow up was 839days. At long-term follow up, 55% lived at home, 25% used opioids, and only 25% were independently ambulatory. In the SDH survey at follow up, 32% identified at least one SDH challenge, with younger patients more often affected (58 vs. 63years, P=0.031). SDH challenges consisted of food insecurity (17%), housing insecurity (13%), transportation challenges (13%), seeking employment (8%), difficulty paying for utilities (5%) and medications (4%), seeking further education (5%), and difficulty caring for family/friends (4%). On multivariable analysis, having at least one SDH challenge was independently associated with 1-year readmission (odds ratio 6.7, 95% confidence interval 1.3-35.8, P<0.001). Older age was associated with lower long-term independent ambulation (odds ratio 0.92, 95% confidence interval 0.85-0.99, P=0.025). After major lower extremity amputation, patients have significant medical and social challenges with fewer living at home, the majority were not independently ambulatory, and one-third having at least one SDH challenge. Improvements in long-term support including medical, social, and rehabilitation services are required for this vulnerable population.

Clinical Comparison of Drug-Coated Balloon and Drug-Eluting Stent for Femoropopliteal Lesions in Chronic Limb-Threatening Ischemia With Wounds.

Endovascular therapy (EVT) with devices such as drug-coated balloons (DCBs) and drug-eluting stents (DESs) for atherosclerotic disease in the femoropopliteal (FP) artery has been established. However, EVT using drug-based devices for chronic limb-threatening ischemia (CLTI) remains challenging. The optimal device for FP lesions in patients with CLTI remains unknown. This study compared the clinical efficacy of DCB and DES in patients with CLTI and FP lesions.Methods and Results: This retrospective single-center study included 539 consecutive patients (562 lesions) treated with EVT between January 2018 and December 2022; 166 patients with CLTI and Rutherford Class 5 or 6 wounds underwent EVT with DCB or DES. Clinical outcomes were compared between 53 pairs after propensity score matching. There were no significant differences between the DCB and DES groups in the incidence of complete wound healing without death or major amputation (84.8% vs. 80.2%, respectively; P=0.99), primary patency (69.4% vs. 75.6%, respectively; P=0.65), and freedom from target lesion revascularization at 1 year (78.6% vs. 78.0%, respectively; P=0.92). Multivariate analysis showed that complete wound healing at 1 year is negatively associated with hemodialysis and Wound, Ischemia, and foot Infection Stage 4, but positively associated with Global Limb Anatomic Staging System FP Grade 3 or 4. No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.

Impact of multidisciplinary management via special clinic for the outcome of diabetic foot disease: A prospective observational study.

Diabetic foot is a common complication of diabetes mellitus, affecting approximately 15-20% of individuals with diabetes. It is a comorbid condition that significantly impacts the routine life of patients. This study aimed to assess multidisciplinary management strategies and their impact on the outcomes of patients with diabetic foot. A prospective observational study was conducted on 56 patients with diabetic foot. Outcome measures included the type of surgery, frequency of surgery, morbidity, mortality, patient satisfaction, return to work, and the number of patients using prostheses. The majority of the patients (87%) received surgical treatment. The most common type of surgery performed was debridement (55%), followed by minor amputations (toes amputation/forefoot amputation) (28%) and major amputations (below-knee (B/K) or above-knee (A/K)) (15%). More than 70% of patients had multiple surgeries. The mortality rate was low (7%), and 71% of surviving patients were satisfied with their treatment. Sixty-seven percent of patients had an early return to work. The number of patients using prostheses was also high (73% of major amputation cases). Multidisciplinary management is the most effective approach for diabetic foot patients. These patients may experience less morbidity and an early return to work. A specialized care clinic for diabetic foot patients is essential to prevent treatment failure, loss of follow-up records, permanent limb loss, and economic burdens on society.

Illness Trajectories After Revascularization in Patients With Peripheral Artery Disease: A Unified Approach to Understanding the Risk of Major Amputation and Death.

The aim of this study was to investigate the illness trajectories of patients with peripheral artery disease (PAD) after revascularization and estimate the independent risks of major amputation and death (from any cause) and their interaction. Data from Hospital Episode Statistics Admitted Patient Care were used to identify patients (≥50 years of age) who underwent lower limb revascularization for PAD in England from April 2013 to March 2020. A Markov illness-death model was developed to describe patterns of survival after the initial lower limb revascularization, if and when patients experienced major amputation, and survival after amputation. The model was also used to investigate the association between patient characteristics and these illness trajectories. We also analyzed the relative contribution of deaths after amputation to overall mortality and how the risk of mortality after amputation was related to the time from the index revascularization to amputation. The study analyzed 94 690 patients undergoing lower limb revascularization for PAD from 2013 to 2020. The majority were men (65.6%), and the median age was 72 years (interquartile range, 64-79). One-third (34.8%) of patients had nonelective revascularization, whereas others had elective procedures. For nonelective patients, the amputation rate was 15.2% (95% CI, 14.4-16.0) and 19.9% (19.0-20.8) at 1 and 5 years after revascularization, respectively. For elective patients, the corresponding amputation rate was 2.7% (95% CI, 2.4-3.1) and 5.3% (4.9-5.8). Overall, the risk of major amputation was higher among patients who were younger, had tissue loss, diabetes, greater frailty, nonelective revascularization, and more distal procedures. The mortality rate at 5 years after revascularization was 64.3% (95% CI, 63.2-65.5) for nonelective patients and 33.0% (32.0-34.1) for elective patients. After major amputation, patients were at an increased risk of mortality if they underwent major amputation within 6 months after the index revascularization. The illness-death model provides an integrated framework to understand patient outcomes after lower limb revascularization for PAD. Although mortality increased with age, the study highlights patients <60 years of age were at increased risk of major amputation, particularly after nonelective revascularization.

Racial and Ethnic Underserved Populations Prescription Analgesic Use Before and After Lower Extremity Amputation in US Medicare.

Racial disparities exist in access to health care and management of multiple health conditions including chronic pain; however, racial disparities in pre- and postoperative pain management in lower extremity amputation are not well-studied. Our objective was to examine the association between different racial and ethnic groups and prescription opioid and other analgesics use before and after lower extremity amputation. We hypothesize prescription opioid and other analgesic use among Black, Hispanic, and Native American US Medicare beneficiaries undergoing lower extremity amputations will be lower compared to White US Medicare beneficiaries. This retrospective cohort study included a 5% national sample of all Medicare beneficiaries from 2011 to 2015 and 15% national sample of fee-for-service Medicare beneficiaries from 2016 to 2018 undergoing nontraumatic, lower extremity amputations. The exposure of interest was racial and ethnic group membership (ie, Black, Hispanic, Native American, White, and others-with others being the combination of the categories Asian and other) as provided in Medicare claims data. Using multivariable generalized estimating equations with a logistic link to account for repeated measurements over time, we estimated the odds of prescription opioid use within 6 months before and after lower extremity amputation across different racial and ethnic groups separately, adjusting for sociodemographic and health status factors (eg, Elixhauser index). Adjusted odds ratios (aORs) and 95% confidence intervals (95% CI) were reported. Among 16,068 eligible beneficiaries who underwent major and minor amputations (mean age = 65.1 ± 12.7 years; female = 36.1%), 10,107 (62.9%) were White, 3462 (21.5%) were Black, 1959 (12.2%) were Hispanic, 247 (1.5%) were Native American, and 151 (2.9%) were beneficiaries of other races. During the 6 months before lower extremity amputation, Hispanic beneficiaries (aOR, 0.71, 95% CI, 0.65-0.78) and beneficiaries of other races (aOR, 0.60, 95% CI, 0.47-0.76) had significantly lower odds of using prescription opioids compared to White beneficiaries. Similarly, Hispanic beneficiaries (aOR, 0.78, 95% CI, 0.71-0.84) and beneficiaries of other races (aOR, 0.63, 95% CI, 0.51-0.78) were associated with lower odds of opioid use in the 6 months after amputation compared to White beneficiaries. Among fee-for-service Medicare beneficiaries, Hispanic and other (eg, Asian) fee-for-service Medicare beneficiaries had lower odds of prescription opioid use than their White counterparts before and after nontraumatic, lower extremity amputations. Efforts to determine the underlying reasons are needed to ensure equitable health care access.

Diabetic Foot Osteomyelitis in Patients with and without Peripheral Arterial Disease: Two Different Diseases?

The aim of the current study was to evaluate the outcomes of patients with diabetic foot osteomyelitis (DFO), comparing subjects with and without peripheral arterial disease (PAD). The study is a prospective study including a population of patients affected by a DFO located in the forefoot. All patients were managed by a surgical conservative approach defined by the removal of the infected bone, in association with the antibiotic therapy. Patients were divided into two groups: those with PAD (neuro-ischaemic DFO) and those without (neuropathic DFO). After 1 year of follow-up, the following outcome were evaluated and compared between groups: healing, healing time, minor amputation, major amputation, hospitalization, need for surgical re-intervention. Overall, 166 patients were included, 87(52.4%) of them had neuro-ischaemic DFO and 79 (47.6%) neuropathic DFO. Patients with neuro-ischaemic DFO in comparison to neuropathic DFO were older (72.5 ± 9 vs 64.1 ± 15.5 years, P < .0001), had longer diabetes duration (21.8 ± 5.6 vs 16.4 ± 7.6 years, P < .0001), higher rate of dialysis (13.8 vs 1.3%, P = .001) and ischaemic heart disease (79.3 vs 12.7%, P < .0001). Outcomes for neuro-ischaemic DFO and neuropathic DFO were: healing (96.5 vs 97.5%, P = .7), healing time (7.8 ± 6.2 vs 5.7 ± 3.7 weeks, P = .01), minor amputation (16.1 vs 3.8%, P = .006), major amputation (0 vs 0%, ns), hospitalization (90.8 vs 51.9%, P < .0001), surgical re-intervention (14.9 vs 8.8%, P = .004) respectively. In addition, PAD resulted in an independent predictor of minor amputation, hospitalization, and surgical re-intervention. DFO in patients with PAD was characterized by longer healing time, more cases of minor amputation, hospitalization, and surgical re-intervention. PAD independently predicted the risk of minor amputation, hospitalization, and surgical re-intervention, while it was not associated with the healing rate.

Efficacy of Supera Stent in the Treatment of Complex Femoropopliteal Artery Lesions: A Short-Term Result Analysis of Real-World Evidence

When dealing with complex femoropopliteal lesions, there is a growing preference for the utilization of drug-coated balloons (DCB) or stents. However, in real-world scenarios, a greater number of elderly patients with longer lesion lengths are encountered. The purpose of our study was to compare the efficacy and safety of different interventional strategies, including the utilization of Supera stent and DCB, in a real-world setting. This was a retrospective study that collected treatment and follow-up data of patients with complex femoropopliteal artery lesions treated between January 2019 and March 2022. All patients were categorized into three groups: "non-Supera stent group,""Supera stent group," and "Supera stent + DCB group." The primary effectiveness outcome was primary patency at 12 months, defined as duplex ultrasound peak systolic velocity ratio<2.5 at the 12-month visit. Other outcomes included improvements in Rutherford categories and safety. A total of 162 patients were enrolled in this study. Compared to non-Supera group (47.6%) in the primary patency rate at 12 months, Supera group (58.7%) or Supera + DCB group (60.0%) showed no significant difference. There were no significant differences in all-cause death, major amputation of the target limb, and target lesion revascularization (TLR) between the groups. Supera group showed a significant improvement in Rutherford category without TLR at 12 months compared to non-Supera group (73.3% vs. 54.8%, P=0.041). In 12-month follow-up, over 65% of patients maintained a Rutherford category of 3 or below, particularly in Supera group where 74.7% of patients had mild symptoms. The Supera stent has demonstrated its efficacy and safety in treating complex peripheral artery disease. However, combining Supera stent with DCB did not provide a significant advantage. Further research is necessary to validate these findings in a larger patient population.

Long-term outcomes of below-the-knee bypass surgery using heparin-bonded expanded polytetrafluoroethylene grafts.

To report the outcomes of below-the-knee (BK) bypass surgery using heparin-bonded expanded polytetrafluoroethylene (ePTFE) grafts, performed in two centers since its launch in Japan. We conducted a retrospective analysis of databases from two medical centers, evaluating 51 limbs in 42 consecutive patients with peripheral arterial disease (PAD), who underwent BK bypass surgery using heparin-bonded ePTFE grafts between October, 2013 and April, 2023. Thirty-three limbs (64.7%) were classified as Rutherford category 4-6 and 33 limbs (64.7%) had a history of ipsilateral revascularization. Technical success was achieved in 98% of the patients. The 30day mortality rate was 2.4% (n = 1) and the overall 30day complication rate was 9.5% (n = 4). The median follow-up period was 38 (interquartile range 13-67) months. Three patients required major amputation and 14 died during follow-up. Primary patency rates at 1, 3, and 5years were 67.8%, 57.5%, and 46.5%, respectively, while secondary patency rates for these periods were 84.6%, 70.0%, and 66.0%, respectively. Overall survival rates at 1, 3, and 5years were 90.1%, 74.5%, and 70.9%, respectively. BK bypass surgery using heparin-bonded ePTFE graft is a viable and durable option for patients with PAD, who are deemed unsuitable for autologous vein bypass surgery.

Clinical efficacy of endovascular revascularization combined with vacuum-assisted closure for the treatment of diabetic foot.

The diabetic foot is a common cause of disability and death, and comorbid foot infections usually lead to prolonged hospitalization, high healthcare costs, and a significant increase in amputation rates. And most diabetic foot trauma is complicated by lower extremity arteriopathy, which becomes an independent risk factor for major amputation in diabetic foot patients. To establish the efficacy and safety of endovascular revascularization (ER) combined with vacuum-assisted closure (VAC) for the treatment of diabetic foot. Clinical data were collected from 40 patients with diabetic foot admitted to the Second Affiliated Hospital of Soochow University from April 2018 to April 2022. Diabetic foot lesions were graded according to Wagner's classification, and blood flow to the lower extremity was evaluated using the ankle-brachial index test and computerized tomography angiography of the lower extremity arteries. Continuous subcutaneous insulin infusion pumps were used to achieve glycemic control. Lower limb revascularization was facilitated by percutaneous tran-sluminal balloon angioplasty (BA) or stenting. Wounds were cleaned by nibbling debridement. Wound granulation tissue growth was induced by VAC, and wound repair was performed by skin grafting or skin flap transplantation. Of the 35 cases treated with lower limb revascularization, 34 were successful with a revascularization success rate of 97%. Of these, 6 cases underwent stenting after BA of the superficial femoral artery, and 1 received popliteal artery stent implantation. In the 25 cases treated with infrapopliteal artery revascularization, 39 arteries were reconstructed, 7 of which were treated by drug-coated BA and the remaining 32 with plain old BA. VAC was performed in 32 wounds. Twenty-four cases of skin grafting and 2 cases of skin flap transplantation were performed. Two patients underwent major amputations, whereas 17 had minor amputations, accounting for a success limb salvage rate of 95%. ER in combination with VAC is a safe and effective treatment for diabetic foot that can significantly improve limb salvage rates. The use of VAC after ER simplifies and facilitates wound repair.

Long-Term Outcome of Lower Extremity Bypass Surgery in Patients with Chronic Kidney Disease and Critical Limb Ischemia in Germany

The aim of this study is to present short- and long-term outcomes after lower extremity bypass (LEB) surgery in patients with chronic limb-threatening ischemia (CLTI) and chronic kidney disease (CKD), differentiated by peripheral artery disease (PAD) Fontaine stage III and IV. Methods: Retrospective analysis of anonymized data from a nationwide German health insurance company (AOK). Data from 22,633 patients (14,523 men) who underwent LEB from 2010 to 2015, were analyzed, presenting 18,271 with CKD stage 1/2, 2,483 patients with CKD stage 3 and 1,879 with CKD stage 4/5. Results: Perioperative mortality (60-day mortality) was 7.2% for CKD stage 1/2, 12.4% for CKD stage 3, and 18.0% for CKD stage 4/5. Patients with PAD stage IV had a significantly higher perioperative mortality (43.2%) than patients with PAD stage III (22.7%). The perioperative major amputation rate depended significantly on PAD stage IV (Odds Ratio (OR): 2.57 CI: 2.16 – 3.05, p < .001), the LEB level below the knee and crural/pedal (OR: 2.49 CI: 2.14 – 2.90, p < .001), CKD stage 4/5 (OR: 1.28, CI: 1.06 – 1.54, p = .009), and the presence of diabetes mellitus type 2 (OR: 1.19, CI: 1.05 – 1.36, p = .007). Kaplan-Meier estimated long-term survival of up to 9 years after surgery was 31.7% for patients with CKD stage 1 and 2, 14.3% for CKD stage 3, and only 10.1% for CKD stage 4 and 5 (p < .001). PAD Fontaine stage IV vs. III (Hazard Ratio (HR): 1.64, CI: 1.56 – 1.71, p < .001), but not bypass level had an independent adverse influence on long-term survival. Conclusion: CKD and PAD stage were equally significant independent predictors of patient survival and MACE with higher PAD and CKD stages associated with less favorable long-term outcomes.

Development of a major amputation prediction model and nomogram in patients with diabetic foot.

Diabetes mellitus, as one of the world's fastest-growing diseases, is a chronic metabolic disease that has now become a public health problem worldwide. The purpose of this research was to develop a predictive nomogram model to demonstrate the risk of major amputation in patients with diabetic foot. A total of 634 Type 2 Diabetes Mellitus (T2DM) patients with diabetic foot ulcer hospitalized at the Air Force Medical Center between January 2018 and December 2023 were included in our retrospective study. There were 468 males (73.82%) and 166 females (26.18%) with an average age of 61.64 ± 11.27years and average body mass index of 24.45 ± 3.56kg/m2. The predictive factors were evaluated by single factor logistic regression and multiple logistic regression and the predictive nomogram was established with these features. Receiver operating characteristic (subject working characteristic curve) and their area under the curve, calibration curve, and decision curve analysis of this major amputation nomogram were assessed. Model validation was performed by the internal validation set, and the receiver operating characteristic curve, calibration curve, and decision curve analysis were used to further evaluate the nomogram model performance and clinical usefulness. Predictors contained in this predictive model included body mass index, ulcer sites, hemoglobin, neutrophil-to-lymphocyte ratio, blood uric acid (BUA), and ejection fraction. Good discrimination with a C-index of 0.957 (95% CI, 0.931-0.983) in the training group and a C-index of 0.987 (95% CI, 0.969-1.000) in the validation cohort were showed with this predictive model. Good calibration were displayed. The decision curve analysis showed that using the nomogram prediction model in the training cohort and validation cohort would respectively have clinical benefits. This new nomogram incorporating body mass index, ulcer sites, hemoglobin, neutrophil-to-lymphocyte ratio, BUA, and ejection fraction has good accuracy and good predictive value for predicting the risk of major amputation in patients with diabetic foot.