Major Lower Extremity Amputation Research Articles

Investigating Nonadherence in an Integrated Diabetic Limb Salvage Programme: Reasons, Associated Factors, and Impacts on Care Outcomes.

Adherence to treatment plans is crucial for patients with diabetic foot ulcers (DFUs) to achieve positive outcomes. With limited understanding of nonadherence and its impacts on care outcomes, this study aimed to explore the reasons and factors associated with nonadherence in an integrated diabetic limb salvage (DLS) programme and evaluate its effects on care outcomes. This study included 2798 DFU patients who were enrolled in an integrated DLS programme across multiple institutions in central and northern Singapore from 2020 to 2021. Reasons for nonadherence were obtained via telephone interviews. Factors associated with nonadherence were identified using multiple logistic regression. Differences in one-year outcomes, including minor and major lower extremity amputation (LEA), mortality, LEA-free survival, and healthcare utilisation between adherent and nonadherent patients, were examined based on a significance level of P < .05. Nonadherence was observed in 40.2% of patients, with higher rates among younger patients, Malays and Indians, and those with higher HbA1c levels. Patient-related factors were the most commonly reported reasons for missed appointments (50.4%). Compared to adherent patients, nonadherent patients exhibited a relatively higher minor LEA rate (13.0% vs 10.2%, OR = 1.18, 95% CI: 0.93, 1.51), lower mortality rate (8.6% vs18.1%, OR = 0.50, 95% CI: 0.39, 0.65), higher overall LEA-free survival (76.4% vs 71.1%, OR = 1.27, 95% CI: 1.06, 1.53), and more hospitalisations (IRR = 1.22, 95% CI: 1.11, 1.33) and emergency visits (IRR = 1.27, 95% CI: 1.16, 1.39). While nonadherent patients showed relatively higher minor LEA rates and more healthcare utilisation, they also exhibited lower mortality and higher LEA-free survival. This suggests that nonadherence in this population may be associated with complex patient characteristics and behaviours that warrant further investigation to tailor interventions effectively.

Dynamic Perioperative Platelet Activity and Cardiovascular Events in Peripheral Artery Disease

ObjectivePatients with peripheral artery disease (PAD) undergo lower extremity revascularization (LER) for symptomatic relief or limb salvage. Despite LER, patients remain at increased risk of platelet-mediated complications, such as major adverse cardiac and limb events (MACLE). Platelet activity is associated with cardiovascular events; yet little is known about the dynamic nature of platelet activity over time. We therefore investigated the change in platelet activity over time and its association with long-term cardiovascular risk. MethodsPatients with PAD undergoing LER were enrolled into the multicenter, prospective Platelet Activity and Cardiovascular Events (PACE) study. Platelet aggregation was assessed by light transmission aggregometry (LTA) to submaximal epinephrine (0.4μ M) immediately prior to LER, and on post-operative day 1 or 2 (POD1) and 30 (POD30). A hyperreactive platelet phenotype was defined as >60% aggregation. Patients were followed longitudinally for MACLE, defined as the composite of death, myocardial infarction, stroke, major lower extremity amputation, or acute limb ischemia leading to reintervention. ResultsAmong 287 patients undergoing LER, mean age was 70 ± 11 years, 33% were female, 61% were white, and 89% were on baseline antiplatelet therapy. Platelet aggregation to submaximal epinephrine induced a bimodal response; 15.5%, 16.8%, and 16.4% of patients demonstrated a hyperreactive platelet phenotype at baseline, POD1, and POD30, respectively. Platelet aggregation increased by 18.5% (P=0.001) from baseline to POD1, which subsequently returned to baseline at POD30. After a median follow-up of 19 months, MACLE occurred in 165 (57%) patients. After adjustment for demographics, clinical risk factors, procedure type, and antiplatelet therapy, platelet hyperreactivity at POD1 was associated with a significant hazard of long-term MACLE (aHR 4.61, 95% CI 2.08-10.20, P<0.001). ConclusionAmong patients with severe PAD, platelet activity increases following LER. Platelet hyperreactivity to submaximal epinephrine on POD1 is associated with long-term MACLE. Platelet activity following LER may represent a modifiable biomarker associated with excess cardiovascular risk.

Lower extremity amputation rates in patients with chronic kidney disease: A database study comparing patients with and without diabetes mellitus

Lower extremity amputation (LEA) is one of the most feared consequences of diabetes mellitus (DM). The purpose of this study was to evaluate the impact of DM on LEA rates in patients at various stages of chronic kidney disease (CKD).A commercially available de-identified database was searched for patients undergoing LEA and for CKD patients, from 2010 to 2023. Patients with DM and patients without DM who were followed for at least 5 years were included. LEA rates were then compared for patients at all 5 CKD stages in patients with and without diabetes.Rates of all LEA were found to be significantly higher at all CKD stages for patients with diabetes (overall, minor and major LEA). Compared to patients without DM who have CKD stage 5 (end stage renal disease), patients with DM and CKD stage 5 have a 30 fold increased likelihood of undergoing overall LEA [OR 30.2 (24.48–37.19), p < 0.001], 29 fold increased likelihood of undergoing minor LEA [28.9i (22.91–36.35), p < 0.001] and 40 times fold increased likelihood of undergoing major LEA [40.1 (26.59–60.42), p < 0.001]. For all stages of CKD, independent of diabetes status, minor LEA were performed with greater frequency than major LEA. In patients with DM, LEA rates significantly increased with CKD progression between stages 2–5 with a substantial jump between stages 4 and 5 [OR 2.6 (CI 2.49–2.74), p < 0.001]. However, CKD progression between stages 1 and 2 was not significantly associated with increased LEA rates (OR 1.1 (CI 0.92–1.21), p = 0.24) in patients with diabetes.Patients with comorbid diabetes have elevated risk for LEA at all stages of CKD compared to those without diabetes.

External validation of the DIAFORA system to predict lower-extremity amputations in a prospective Danish cohort.

A diabetes-related foot ulcer (DFU) is a major risk factor for lower-extremity amputation (LEA). To help clinicians predict the risk of LEA in people with DFU, the Diabetic Foot Risk Assessment (DIAFORA) system was developed but has never been externally validated. In this study, 317 people presenting with a new DFU were included. At baseline, participants were grouped into three groups based on their DIAFORA score: low-risk (<15), medium-risk (15-25), and high-risk (>25). Participants were followed until healing, LEA, death, or at least 3 months. Discriminative accuracy was evaluated using sensitivity, specificity, likelihood ratios (LRs) and the area under the curve (AUC). All 317 participants completed at least 3 months of follow-up for a median duration of 146 days, during which 12.6% underwent minor amputation and 2.5% major amputation. People in the low- and medium-risk categories had major amputation rates of 0.9% and 2.1%, respectively, and negative LR of major LEA of 0.10 and 0.38, respectively, while the people in the high-risk category had an amputation rate of 25.0% and a positive LR of 12.9. The DIAFORA risk groups had a sensitivity of 75.0% and a specificity of 65.7%, with a corresponding AUC of 0.78 (95% CI 0.68-0.87) for the prediction of major LEA. The DIAFORA score is a useful tool for risk stratification of people presenting with a newly occurred DFU, with the external validation presenting results similar to those presented in the original study. The DIAFORA score may guide clinicians towards more individualized DFU treatment regimens.

Evaluating Receipt of Optimal Medical Therapy Among Structurally Disadvantaged Groups Undergoing Amputation

Optimal medical therapy (OMT) for peripheral artery disease (PAD) is associated with decreased major amputation and mortality. OMT has several components, including antiplatelet and high-intensity statin therapy, blood pressure control, etc. While there are disparities in receipt of OMT among PAD patients, it is unknown if patients from disadvantaged neighborhoods, measured by the area deprivation index (ADI), are less likely to be on OMT. We performed a retrospective review of patients that underwent major lower extremity amputation between 2015 and 2019 at two large academic healthcare systems. Primary exposure was high ADI, defined as ADI ≥60th percentile, and secondary exposure was non-Hispanic Black (NHB) race. For each analysis, the primary outcome of interest was receipt of OMT, defined here as at least one antiplatelet agent and a high-intensity statin. The exposure outcome relationship was assessed using multivariable logistic regression. Among 354 patients with median age of 66 (interquartile range [IQR] 58-74), 267 (75.4%) were male, 219 (61.9%) identified as NHB and 116 (32.8%) as non-Hispanic White. Overall, 91 (25.7%) patients were on OMT at time of amputation despite 57.3% of the cohort being established with a vascular surgeon. Compared to those with low ADI, the category high ADI had a higher proportion of NHB patients (48.1% vs 70.3%, p= 0.001) and patients were more often hospitalized at the University-affiliated facilities (47.4% vs 63.0%, p= 0.004). High ADI was not associated with receipt of OMT prior to major amputation (adjusted odds ratio [aOR] 0.72, 95% confidence interval [CI] 0.42-1.24). In secondary analysis, NHB race was not associated with receipt of OMT. Stratification by facility type (Veterans Affairs and University-affiliated facilities) also showed no association between high ADI or race and receipt of OMT. Neighborhood economic well-being is not associated with receipt of OMT prior to major amputation. While the absence of socioeconomic disparities is notable, the proportion of patients on OMT is suboptimal. Care processes should be critically evaluated and quality measures potentially created to improve the rate of receipt of OMT among patients at risk for amputation.

Geographic Variation in First Lower Extremity Amputations Related to Diabetes and/or Peripheral Arterial Disease

BackgroundTo assess trends of first cases of lower extremity amputation (LEA) related to diabetes and/or peripheral arterial disease (PAD), according to areas of residency and neighbourhood material and social deprivation quintiles, in the province of Quebec, Canada. MethodsUsing the Quebec Integrated Chronic Disease Surveillance System, we calculated crude and age-standardized annual incidence rates of first LEA (total, minor, and major) among adults 40 years of age and older with diabetes and/or PAD in fiscal years 2006 and 2019. Area of residency was compiled in 3 categories: (1) Montreal and other census metropolitan areas; (2) midsize agglomerations (10,000-100,000 inhabitants); and (3) small towns and rural areas (< 10,000 inhabitants). We also stratified according to neighbourhood material and social deprivation quintiles. One-year and 5-year all-cause mortality after first LEA were compared according to area of residency. ResultsAmong the 10,275 individuals who had a first LEA, age-standardized LEA rates remained stable between 2006 and 2019, whereas major LEA rates declined in all geographical areas and minor LEA rates increased (31.6%) in small towns and rural areas. In 2019, age-standardized LEA rates were higher in midsize agglomerations and small towns and rural areas compared with census metropolitan areas. Age-standardized LEA rates in 2019 were higher among the most deprived quintile compared with the most privileged quintile for material and social deprivation. No difference was observed in mortality after first LEA according to area of residency. ConclusionsThere are health disparities in the burden of diabetes and PAD related to first LEA in the province of Quebec. To improve preventive care and reduce the burden of LEA, targeted actions should be taken among the most deprived groups and rural settings.

Declining Incidence of Major Lower-Extremity Amputations in the Northern Danish Region Between 2016 and 2021: The Impact of Diabetes and Preventive Vascular Procedures

BackgroundPreventing lower-extremity amputations (LEAs) is pivotal. In the present study we aimed to examine the recent trends in non-traumatic LEAs seen in the Northern Danish Region. MethodsUsing data from the regional Business Intelligence unit we identified all non-traumatic LEAs (n=689) performed in people above 50 years of age in the Northern Danish Region between January 2016 and December 2021 (approximately 600.000 inhabitants). Persons with diabetes (n=26,025) were identified based on ICD-10 codes and data from The National Health Insurance Service Registry, while preventive vascular procedures (n=1,097) were identified using surgical codes. Major LEA was defined as any amputation above the ankle. Incidence rates were expressed as events per 1.000 person-years. Trends were described as differences between the periods 2016-2018 and 2019-2021. ResultsA total of 249 (36%) major LEAs were performed in people with diabetes. People with diabetes were younger (71 vs 77 years, p<0.001) and more frequently male (70% versus 54%, p<0.001). Between 2016-2018 and 2019-2021 the incidence of major LEA declined from 1.76 (95% CI: 1.75-1.76) to 1.39 (1.39-1.39) in people with diabetes, and from 0.47 (0.47-0.47) to 0.20 (0.20-0.20) in people without diabetes (all p<0.001). Simultaneously, the incidence of preventive vascular surgery increased from 2.26 (2.26-2.26) to 3.48 (3.48-3.48) in people with diabetes and declined slightly in people without 0.49 (0.49-0.49) to 0.47 (0.47-0.47) (all p<0.001). ConclusionDespite significant declines in major LEA in both people with and without diabetes, most of the decline was driven by a large reduction in major LEAs in people without diabetes. Diabetic foot, lower extremity amputation, major amputation, minor amputation, preventive vascular procedures, revascularization, vascular surgery.

Racial disparities in prosthesis abandonment and mobility outcomes after lower limb amputation from a dysvascular etiology in a veteran population.

Non-Hispanic Black (NHB) individuals have higher rates of amputation and increased risk of a transfemoral amputation due to dysvascular disease than non-Hispanic White (NHW) individuals. However, it is unclear if NHB individuals have differences in prosthesis use or functional outcomes following an amputation. To determine if there are racial disparities in prosthesis abandonment and mobility outcomes in veterans who have undergone their first major unilateral lower extremity amputation (LEA) due to diabetes and/or peripheral artery disease. National cohort study that identified individuals retrospectively through the Veterans Affairs (VA) Corporate Data Warehouse (CDW) from March 1, 2018, to November 30, 2020, then prospectively collected their self-reported prosthesis abandonment and mobility. Multiple logistic regression was used to control for potential confounders and identify potential effect modifiers. The VA CDW, participant mailings and phone calls. Three hundred fifty-seven individuals who underwent an incident transtibial or transfemoral amputation due to diabetes and/or peripheral arterial disease. Not applicable. (1) Self-reported prosthesis abandonment. (2) Level of mobility assessed using the Locomotor Capabilities Index. Rurally located NHB individuals without a major depressive disorder (MDD) had increased odds of abandoning their prosthesis (adjusted odds ratios [aOR] = 5.3; 95% confidence interval [CI]: [1.3-21.1]). This disparity was nearly three times as large for rurally located NHB individuals with MDD diagnosis, compared with other races from rural areas and with MDD (aOR = 15.8; 95% CI, 2.5-97.6). NHB individuals living in an urban area were significantly less likely to achieve advanced mobility, both with MDD (aOR=0.16; 95% CI: [0.04-7.0]) and without MDD (aOR = 0.26; 95% CI: [0.09-0.73]). This study demonstrated that health care disparities persist for NHB veterans following a dysvascular LEA, with increased prosthesis abandonment and worse mobility outcomes.

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.

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.

Utilizing the Frailty Index to Predict Long-term Mortality in Patients Undergoing Major Lower Extremity Amputation

The 5-factor modified Frailty Index (mFI-5) is a risk-stratification tool utilized to predict complications and mortality following major lower extremity (LE) amputation. However, its prognostic value for long-term mortality is unknown. The study aim was to assess whether a high mFI-5 score relates to long-term mortality following major LE amputation for chronic wounds. Patients ≥60 years who underwent major LE amputation from 2017 to 2021 were retrospectively reviewed. Data regarding demographics, comorbidities, perioperative factors, amputation type, and postoperative complications was collected and mFI-5 was calculated. Survival analysis was performed with Kaplan-Meier curves and differences were assessed with Log-Rank test. A total of 172 patients were identified. Mean age was 70.7 ± 8.0 years. Median time to ambulation was 3.7 months (IQR 4.0). By final follow-up of 17.5 ± 15.9 months, ambulatory rate was 51.7% (n = 89), overall mortality 36.0% (n = 62), 1-year mortality 14.0% (n = 24), and 3-year mortality 27.9% (n = 48). Patients with an mFI-5 of ≥4 (26.7%, n = 46) compared with patients with mFI-5 <4 (73.3%, n = 126) had a higher rate of prolonged postoperative LOS (34.8% vs 19.8%, p = .042), overall mortality (52.2% vs 30.2%, p = .008), 1-year mortality (23.9% vs 10.3%, p = .023), and 3-year mortality (45.7% vs 21.4%, p = .002). Multivariate analysis demonstrated mFI-5 was an independent predictor of 3-year mortality (OR 2.35, p = .043). At a threshold ≥4, the mFI-5 demonstrated utility in predicting long-term mortality. The value of this prognostic indicator is in its preoperative application of assessing risk of mortality, which should be utilized in conjunction with other measures.

Mortality after major lower extremity amputation and association with index level: a cohort study based on 11,205 first-time amputations from nationwide Danish databases.

Mortality after major lower extremity amputations is high and may depend on amputation level. We aimed to examine the mortality risk in the first year after major lower extremity amputation divided into transtibial and transfemoral amputations. This observational cohort study used data from the Danish Nationwide Health registers. 11,205 first-time major lower extremity amputations were included from January 1, 2010, to December 31, 2021, comprising 3,921 transtibial amputations and 7,284 transfemoral amputations. The 30-day mortality after transtibial amputation was overall 11%, 95% confidence interval (CI) 10-12 (440/3,921) during the study period, but declined from 10%, CI 7-13 (37/381) in 2010 to 7%, CI 4-11 (15/220) in 2021. The 1-year mortality was 29% overall, CI 28-30 (1,140 /3,921), with a decline from 31%, CI 21-36 (117/381) to 20%, CI 15-26 (45/220) during the study period. For initial transfemoral amputation, the 30-day mortality was overall 23%, CI 22-23 (1,673/7,284) and declined from 27%, CI 23-31 (138/509) to 22%, CI 19-25 (148/683) during the study period. The 1-year mortality was 48% overall, CI 46-49 (3,466/7,284) and declined from 55%, CI 50-59 (279/509) to 46%, CI 42-50 (315/638). The mortality after major lower extremity amputation declined in the 12-year study period; however, the 1-year mortality remained high after both transtibial and transfemoral amputations (20% and 46% in 2021). Hence, major lower extremity amputation patients constitute one of the most fragile orthopedic patient groups, emphasizing an increased need for attention in the pre-, peri-, and postoperative setting.

The Utility of Sirolimus Eluting Balloons in the Setting of Chronic Limb Threatening Ischaemia in Asian Patients from Singapore – 12 Months Results of the PRISTINE Registry

PurposeThe aim of PRISTINE was to evaluate the 6 and 12 months safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon for treatment of complex lower limb occlusive lesions (TASC II C & D) in patients with chronic limb threatening ischemia (CLTI) from Singapore.MethodsPRISTINE was a prospective, non-randomized, single arm, observational, multi-investigator, single-center clinical study. Complication-free survival at 30 days was the safety clinical endpoint. Immediate technical success (ability to cross and dilate the lesion and achieve residual angiographic stenosis < 30%), 6-month primary vessel patency, limb salvage, clinically driven target lesion revascularization (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest.ResultsSeventy five patients were included. There were 50 (68.0%) males; mean age, 69.0 ± 10.7 years. CLTI severity was based on the Rutherford Scale (R5 = 51; R6 = 17). Significant co-morbidities included diabetes mellitus (n = 68; 91.0%) and end-stage renal failure (n = 28; 37.0%). 112 atherosclerotic lesions were treated (TASC II D = 58 (52%); 76 (67%) de novo). There was 100% technical success. Mean lesion length treated was 22.4 ± 13.9 cm. Primary vessel patencies at 6 and 12 months were 64/86 (74%) and 43/74 (58%) and freedom from clinically driven TLR were 72/86 (84%) and 55/74 (74%) respectively. AFS was 61/73 (84.0%; five deaths and seven major lower extremity amputation) at 6-months. Mean Rutherford score improved from 5.1 ± 0.55 at baseline to 1.1 ± 2.05 (p < 0.05) at one year and there was a wound healing rate of 38/48 (79%) at the same timepoint.ConclusionsThe Selution SLR™ drug eluting balloon is safe and efficacious in treating highly complex infra-inguinal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients with a high incidence of diabetes and end-stage renal failure. It is associated with highly satisfactory acute technical and clinical success, 12-month target lesion patency and AFS.Level of EvidenceLevel 2b, Individual Cohort Study.Graphical

The Sustained Impact of the COVID-19 Pandemic on Vascular Surgical Care Delivery

The COVID-19 pandemic necessitated postponement of vascular surgery procedures nationally. Whether procedure volumes have since recovered remains undefined. Therefore, our objective was to quantify changes in procedure volumes and determine whether surgical volume has returned to its prepandemic baseline. This study was a retrospective cross-sectional study between 2018 and 2023 using the US Fee-for-Service Medicare 5% National Sample as part of the VA Disrupted Care National Project. We studied patients who underwent 1 of 3 procedures: abdominal aortic aneurysm (AAA) repair for intact aneurysms, carotid endarterectomy (CEA), and major lower extremity amputation (LEA). The case volume of each quarter of 2020-2023 was compared to its corresponding prepandemic quarter in 2019. We then performed a subanalysis of these trends by sex, age, and race. We identified 21,031 procedures: 4,411 AAA repair, 8,361 CEA, and 8,259 LEA. The average percent change during the baseline prepandemic period from 2018 to 2019 was -4.3% for AAA repair, -8.5% for CEA, and -2.6% for LEA. Compared to Q2 of 2019, Q2 of 2020 demonstrated that AAA repair procedures decreased by 47%, CEA by 40%, and LEA by 14%. While procedures initially rebounded in Q3 of 2020, volumes did not return to their prepandemic baseline, demonstrating a persistent volume reduction (-16% AAA, -22% CEA, and -11% LEA). Thereafter, procedure counts again declined in Q1 of 2022 (-25% AAA, -34% CEA, and -25% LEA). Despite a perception that vascular surgical care was singularly disrupted at the outset of the pandemic, there has been a sustained reduction in vascular surgical volume since 2019. Not only have procedure volumes not returned to prepandemic baseline but it also appears that there has been a cumulative incremental impact on overall procedure volume. The impact of these findings on long-term population health remains uncertain and necessitates a better understanding of postpandemic care delivery.

The phenomenon of drug-coating embolism during lower extremity endovascular interventions with paclitaxel-coated balloon.

There is a risk of distal embolization lower extremity endovascular interventions. Possibly a drug-coating embolism caused by coating detachment from intravascular devices. This review focuses on providing updated information on distal embolism in endovascular revascularization of lower extremity arteries, including the use of drug-coated balloons. Drug-coating embolism is a special case of distal embolization during recanalization of the arteries of the lower extremities. Preclinical studies have demonstrated embolization of drug-coated balloons during angioplasty of lower extremity arteries. However, the clinical role of drug-coating embolism is not completely clear. A 2020 meta-analysis found an increased risk of major lower extremity amputation after drug-coated balloon angioplasty in patients with critical limb ischemia. But long-term research is emerging to support the safety of using these devices. Perhaps a more thorough assessment of the quality of life and the degree of compensation of lower limb ischemia with an intraoperative assessment of the frequency of peripheral embolizations using ultrasound emboli detection, as well as microcirculation with transcutaneous oximetry and laser Doppler flowmetry of the operated lower limb will allow a more detailed study of the phenomenon of drug-coating embolism and its impact on long-term clinical outcomes. According to the results of preclinical studies, the use of paclitaxel-coated balloons leads to an increase in the concentration of paclitaxel in distal skeletal muscles. However, paclitaxel concentration in skeletal muscle was significantly higher in first-generation DCBs. The non-target effects of drug-coating balloon are not fully understood and require further study. Understanding the phenomenon of drug-coating embolism can help physicians to better assess the patient risk and to minimize complications.

A scoping review of postoperative early rehabilitation programs after dysvascular-related amputations.

After amputation, people face challenges including wound healing and decreased functional mobility. Early mobilization in acute hospital care has proved safe, improved function, and sped discharge. Still, loss of a leg complicates standing and early mobilization after amputation. Approaches to early mobilization and rehabilitation after amputation surgery have not been widely studied. To map the evidence regarding early postoperative mobilization after dysvascular amputation. Specific aims included identifying research designs and populations, describing rehabilitation approaches, and identifying gaps within the literature. Scoping review following PRISMA-Sc guidelines. The a priori scoping review methodology conducted in June 2022 with English language and 20-year limits used the OVID Medline, OVID Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, Cochrane databases, and Journal of Prosthetics and Orthotics archive. Reviewer pairs used Covidence software to screen for inclusion (subjects with major lower limb dysvascular amputations, seen immediately postoperatively for hospital-based rehabilitation) with decisions by concurrence. Data for best practice scoping reviews were synthesized for analysis. Two hundred ninety-six citations were screened, 13 full texts reviewed, and 8 articles included: 2 cohort studies, 3 case-control studies, 2 single-group interventional studies, and 1 case study. There were no randomized control trials or prospective comparison group trials. Few studies were identified regarding acute rehabilitation after major lower extremity amputation. The limited evidence in this review suggested that early mobilization in the days after amputation was safe with or without use of temporary prostheses, although further research is certainly warranted.

Prosthetic fitting and mortality after major lower extremity amputation

BackgroundStudies suggest that ambulation after major lower extremity amputation (LEA) is low and mortality after LEA is high. Successful prosthetic fitting after LEA has a significant quality of life benefit; however, it is unclear if there are benefits in post-LEA mortality. Our objective was to examine a contemporary cohort of patients who underwent LEA and determine if there is an association between fitting for a prosthetic and mortality. MethodsWe reviewed all patients who underwent LEA between 2015 and 2022 at two academic health care systems in a large metropolitan city. The exposure of interest was prosthetic fitting after LEA. The primary outcomes were mortality within 1 and 3 years of follow-up. Ambulation after LEA was defined as being ambulatory with or without an assistive device. Patients with prior LEA were excluded. Extended Cox models with time-dependent exposure were used to evaluate the association between prosthetic fitting and mortality at 1 and 3 years of follow-up. ResultsAmong 702 patients who underwent LEA, the mean (SD) age was 64.3 (12.6) years and 329 (46.6%) were fitted for prosthetic. The study population was mostly male (n = 488, 69.5%), predominantly non-Hispanic Black (n = 410, 58.4%), and nearly one-fifth were non-ambulatory before LEA (n = 139 [19.8%]). Of note, 14.3% of all subjects who were nonambulatory at some point after LEA, and 28.5% of patients not ambulatory preoperatively were eventually ambulatory after LEA. The rate of death among those fitted for a prosthetic was 12.0/100 person-years at 1 year and 5.8/100 person-years at 3 years of follow-up; among those not fitted for a prosthetic, the rate of death was 55.7/100 person-years and 50.7/100 person-years at 1 and 3 years of follow-up, respectively. After adjusting for several sociodemographic data points, comorbidities, pre- or post- coronavirus disease 2019 pandemic timeframe, and procedural factors, prosthetic fitting is associated with decreased likelihood of mortality within 1 year of follow-up (adjusted hazard ratio, 0.24; 95% confidence interval, 0.14-0.40) as well as within 3 years (adjusted hazard ratio, 0.40; 95% confidence interval, 0.29-0.55). ConclusionsProsthetic fitting is associated with improved survival, and preoperative functional status does not always predict postoperative functional status. Characterizing patient, surgical, and rehabilitation factors associated with receipt of prosthetic after LEA may improve long-term survival in these patients. Process measures employed by the Department of Veterans Affairs, such as prosthetic department evaluation of all amputees, may represent a best practice.

Rapid Access From Primary Care to a Multidisciplinary Clinic at Tertiary Care Improves Clinical Outcomes for Patients With Diabetic Foot Ulcers: Results From Diabetic Foot in Primary and Tertiary (DEFINITE) Care's Lower Extremity Amputation Prevention Program (LEAPP) Clinic.

Diabetic Foot in Primary and Tertiary (DEFINITE) Care is an inter-institutional, multidisciplinary team (MDT) program for patients with diabetic foot ulcers (DFU) within a healthcare cluster in Singapore. This is one of our subgroup analyses within DEFINITE Care, assessing clinical outcomes of lower extremity amputation prevention program (LEAPP), a multidisciplinary diabetic foot clinic, and non-LEAPP patients within the program. From June 2020 to June 2022, 2798 patients within the DEFINITE cohort completed a minimum of 12-month follow up. Of these patients, 20.6% were managed by LEAPP, whereas 79.4% were non-LEAPP patients. Patients in the LEAPP cohort were older with co-existing metabolic conditions and complications of diabetes. Using non-LEAPP cohort as the reference group and after adjusting for age, gender, ethnicity, comorbidities, and medications, there was a significantly lower risk of death (odds ratio [OR] 0.60, P = .001) and composite major lower extremity amputation (LEA) or death (OR 0.66, P = .002) among LEAPP patients at 1 year with longer mean days from enrollment to minor LEA, major LEA, and death. The adjusted 1-year healthcare utilization outcomes for LEAPP patients demonstrated an increase in inpatient admissions, primary care polyclinic visits, hospital specialist outpatient clinic (SOC) visits and elective day surgery procedures. Despite the increased in inpatients admissions, cumulative hospital length of stay in LEAPP patients were lower. This subgroup analysis has demonstrated that the MDT approach to caring for patients with DFU in tertiary centers not only improves mortality by 40%, but also delayed the incidence of minor LEA, major LEA, and death.

Association Between Diagnosis-to-Limb Revascularization Time and Clinical Outcomes in Outpatients With Chronic Limb-Threatening Ischemia: Insights From the CLIPPER Cohort.

The extent and consequences of ischemia in patients with chronic limb-threatening ischemia (CLTI) may change rapidly, and delays from diagnosis to revascularization may worsen outcomes. We sought to describe the association between time from diagnosis to endovascular lower extremity revascularization (diagnosis-to-limb revascularization [D2L] time) and clinical outcomes in outpatients with CLTI. In the CLIPPER cohort, comprising patients between 66 and 86 years old diagnosed with CLTI betweeen 2010 and 2019, we used Medicare claims data to identify patients who underwent outpatient endovascular revascularization within 180 days of diagnosis. We described the risk-adjusted association between D2L time and clinical outcomes. Among 1 130 065 patients aged between 66 and 86 years with CLTI, 99 221 (8.8%) underwent outpatient endovascular lower extremity revascularization within 180 days of their CLTI diagnosis. Among patients with D2L time <30 days, there was no association between D2L time and all-cause death or major lower extremity amputation. However, among patients with D2L time >30 days, each additional 10-day increase in D2L time was associated with a 2.5% greater risk of major amputation (hazard ratio, 1.025 [95% CI, 1.014-1.036]). There was no association between D2L time and all-cause death. A delay of >30 days from CLTI diagnosis to lower extremity endovascular revascularization was associated with an increased risk of major lower extremity amputation among patients undergoing outpatient endovascular revascularization. Improving systems of care to reduce D2L time could reduce amputations.

Five-Year Trends of Vascular Disease-Related Amputations in Romania: A Retrospective Database Study.

Background/Objectives: Lower extremity amputations (LEAs) are a burdensome complication of peripheral artery disease (PAD) and/or arterial embolism and thrombosis (AET). We assessed the trends in PAD- and/or AET-related LEAs in Romania. Methods: This retrospective study (2015-2019) analyzed data on minor and major LEAs in hospitalized patients recorded in the National School for Public Health, Management, and Health Education database. The absolute numbers and incidences of LEAs were analyzed by diagnosis type, year, age, sex, and amputation level. Results: Of 38,590 vascular disease-related amputations recorded nationwide, 36,162 were in PAD and 2428 in AET patients. The average LEA incidence in the general population was 34.73 (minimum: 31.96 in 2015; maximum: 36.57 in 2019). The average incidence of major amputations, amputations above the knee, hip amputations, amputations below the knee, and minor amputations was 16.21 (15.62 in 2015; 16.84 in 2018), 13.76 (13.33 in 2015; 14.28 in 2018), 0.29 (0.22 in 2017; 0.35 in 2019), 2.15 (2.00 in 2015; 2.28 in 2019), and 18.52 (16.34 in 2015; 20.12 in 2019), respectively. Yearly PAD- and/or AET-related amputations were significantly higher in men versus women. The overall number of LEAs increased with age, particularly in patients ≥ 70 years. The increase in the total number of amputations was mainly due to a constant rise in minor amputations for both groups, regardless of gender. Conclusions: PAD- and/or AET-related LEAs in Romania increased from 2015 to 2019, with men having a greater incidence than women. Raising awareness and effective management strategies are needed to prevent LEAs.