Incidence Of Major Amputation Research Articles

Prognostic value of leukocyte-glycemic index in long-term evolution of diabetic patients with peripheral arterial disease following endovascular treatment

Abstract Objective: The aim of this article is to determine the predictive value of the leukocyte-glycemic index in the long-term evolution of diabetic patients with peripheral arterial disease following endovascular treatment. Methods: This retrospective observational study enrolled 127 diabetic patients diagnosed with peripheral arterial disease requiring endovascular treatment. Patients were categorized into two groups based on the severity of the infrapopliteal atherosclerotic lesions identified during the pre-operative Computer Tomography Angiography examination. Group 1 includes patients without severe damage to the infrapopliteal artery, while Group 2 includes patients with severe infrapopliteal artery damage, identified by stenosis greater than 70% on all infrapopliteal arteries. The primary outcome was to assess the association between leukocyte-glycemic index value at baseline and the severity of infrapopliteal atherosclerotic lesions and long-term major amputation after percutaneous transluminal angioplasty. Results: Patients in Group 2 had a higher incidence of cardiovascular events (p=0.009), stage IV Leriche-Fontaine (p=0.016), and incidence of major amputation (p<0.001), as well as an increased value of leukocyte-glycemic index (p=0.004). During the follow-up, patients with above-median leukocyte-glycemic index value have a higher risk of major amputation (p=0.034), as seen in the Kaplan-Meier analysis. Moreover, at cox-regression, elevated biomarker values were associated with long-term risk of major amputation, independent of age, sex, cardiovascular risk factors, and below-the-knee arterial occlusion (HR:2.69, p=0.001). Conclusions: Elevated values of leukocyte-glycemic index are associated with the severity of infrapopliteal atherosclerotic lesions and major amputation in the long term.

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.

The Clinical Utility of Lower Extremity Dual-Energy CT Angiography in the Detection of Bone Marrow Edema in Diabetic Patients with Peripheral Artery Disease.

(1) Background: Type 2 diabetes is a major cause of incidences and the progression of peripheral artery disease (PAD). Bone marrow edema (BME) is an important finding suggestive of underlying bone inflammation in non-traumatic diabetic patients with PAD. Our aim was to evaluate the presence, severity, and clinical implications of BME detected by virtual non-calcium application (VNCa) of dual-energy CT angiography (DE-CTA). (2) Methods: A consecutive series of 76 diabetic patients (55 men; mean age 71.6 ± 11.2 yrs) submitted to lower limb DE-CTA for PAD evaluation and revascularization planning, which were retrospectively analyzed. VNCa images were independently and blindly revised for the presence, location, and severity of BME by two radiologists with 10 years of experience. BME and non-BME groups were evaluated in terms of PAD clinical severity and 6-month secondary major amputation rate. (3) Results: BME was present in 17 (22%) cases, while 59 (78%) patients were non-BME. The BME group showed a significantly higher incidence of major amputation (p < 0.001) and a significantly higher number of patients with advanced clinical stages of PAD compared to the non-BME group (p = 0.024). (4) Conclusions: Lower limb DE-CTA with VNCa application is a useful tool in the detection of BME in diabetic patients with PAD, simultaneously enabling the evaluation of the severity and location of the arterial disease for revascularization planning. BME presence could be a marker of clinically severe PAD and a possible risk factor for revascularization failure.

Abstract 19137: Chronic Kidney Disease is an Important Predictor of 2-Year Mortality After Chronic Limb Ischemia Repair Using Either Endovascular or Bypass Graft Intervention

Introduction: Chronic kidney disease (CKD) and end-stage renal disease (ESRD) are associated with worse outcomes after both endovascular (PVI) and bypass graft intervention (OI) of critical limb ischemia (CLI). Research Question: Do surgical outcomes of CLI repair differ by approach and CKD severity? Methods: Patients undergoing elective CLI intervention with preoperative renal function data captured by the Vascular Quality Initiative between Jan 2003 and Dec 2018 were analyzed. Patients were stratified by CKD class: normal/mild (CKD stage 1-2), moderate (CKD stage 3a), moderate-severe (CKD stage 3b), severe (CKD stage 4-5), and dialysis. Primary outcomes were 30-day, 1-year, and 2-year mortality, and incidence of major amputation. Predictors of survival were identified by Cox multivariate regression. Results: Out of 18,399 patients who underwent elective CLI treatment, 13,366 had PVI and 5033 had OI. Table 1 demonstrates the distribution of patients and primary outcomes. On Kaplan Meier analysis, 2-year survival favored the normal/moderate CKD cohort after both PVI and OI. On Cox regression analysis, when compared to normal/ mild CKD, CKD Class 3b (HR 1.405, p&lt;0.001) and Class 4 (HR 1.712, p&lt;0.001), and Class 5 (HR, 1.649, p = 0.070) were associated with worse 2-year mortality after OI. When compared to normal/mild CKD, CKD Class 3b (HR, 1.427 [1.2-1.7], p&lt;0.001), Class 4 (HR, 2.256 [1.77-2.87], p&lt;0.001), and Class 5 (HR, 1.210 [.59-2.5], p = 0.603) were associated with worse 2-year mortality. 2-year amputation rates did not demonstrate statistically significant differences among CKD classes. Conclusion: CKD severity is an important predictor of 2-year mortality after CLI repair regardless of approach but does not predict 2-year major amputation rates. Overall, PVI is associated with lower mortality and major amputation.

Relationship of the Wound, Ischemia, and Foot Infection Stage With Frailty, Disability, and Quality of Life at Baseline, and 1-year Outcomes in All-comers With Chronic Limb-threatening Ischemia

The wound, ischemia, and foot infection (WIfI) classification system has been widely adopted in chronic limb-threatening ischemia (CLTI) management, but validation has predominantly been among patients undergoing revascularization. This study aimed to investigate the association of WIfI stage with baseline frailty, disability, and quality of life (QoL), in addition to 1-year major amputation and survival, in all-comers with CLTI. Single-center prospective cohort study (NCT04027244) of patients aged ≥18 with CLTI, between May 2019 and March 2022. Frailty (clinical frailty scale), disability (Barthel index), and QoL (vascular QoL questionnaire; EQ-5D-5L) assessments were performed at baseline. Interim analysis of 1-year outcomes was performed in January 2023. Amputation incidence was calculated for WIfI stages, and individual WIfI score combinations with five or more patients, and presented as percentages with 95% confidence intervals (CI) (Agresti-Coull method). Associations of WIfI stage with 1-year major amputation was investigated using Fine-Gray competing risk analysis (death as competing risk), reported as subdistribution hazard ratios (HR) with 95% sCI. Associations of WIfI stage with one-year mortality was investigated using Cox regression and reported as HR with 95% CI. A total of 434 patients were included. Fifty-two patients (12.0%) classified as WIfI stage 1, 112 (25.8%) stage 2, 107 (24.7%) stage 3, 92 (21.2%) stage 4, and 71 (16.4%) had incomplete WIfI scores. Increasing WIfI stage was associated with increasing prevalence and severity of frailty (P = .002) and greater disability (P < .001). QoL scores were similar for each WIfI stage (Table I). Major amputation incidence at one-year was 2% (95% CI, 0%-11%) for WIfI stage 1, 7% (95% CI, 3%-14%) stage 2, 8% (95% CI, 4%-15%) stage 3, 21% (95% CI, 14%-30%) stage 4, and 14% (95% CI, 9%–26%) in those with incomplete WIfI scores. Amputation incidence for individual WIfI scores was largely consistent with stage classification (Table II). Increasing WIfI stage was independently associated with one-year major amputation (subdistribution HR, 2.00; 95% CI, 1.34-3.00; P = .001). Increasing WIfI stage was also associated with 1-year mortality (HR, 1.31; 95% CI, 1.02-1.68; P = .031), with frailty (clinical frailty scale score ≥5) (HR, 2.48; 95% CI, 1.33-4.61; P = .004) and nonoperative management (HR, 5.35; 95% CI, 2.98-9.59; P < .001) the strongest predictors of mortality at 1 year. WIfI classification is predictive of major amputation at one-year in patients with CLTI, but frailty status is a better predictor of mortality. Although WIfI classification is associated with both frailty and disability, it is not associated with QoL at baseline.Table IBaseline assessment scores and management strategy by WIfI stageStage 1 (n = 52)Stage 2 (n = 112)Stage 3 (n = 107)Stage 4 (n = 92)Missing (n = 71)P valueFrailty status.002 No frailty (CFS 1-3)8 (15)16 (14)10 (9)6 (7)5 (7.) Vulnerable (CFS 4)22 (42)50 (45)40 (37)20 (22)20 (28) Mild/moderate (CFS 5-6)20 (38)44 (39)52 (49)55 (60)41 (58) Severe frailty (CFS 7-9)2 (4)2 (2)5 (5)11 (12)5 (7)Barthel index20 (18-20)19 (17-20)19 (16-20)17 (15-20)18 (15-20)<.001HADS Anxiety score4.5 (2-10)7 (3-11)5 (3-9)6 (3-9)6 (3-12).414 Depression score5 (3-8)5 (3.5-9.0)5 (3-10)6 (4-10)7 (3-10).423VascuQoL score3.3 ± 1.52.8 ± 1.12.9 ± 1.13.1 ± 1.23.1 ± 1.2.143EQ-5D-5L EQ-5D value0.557 ± 0.2410.480 ± 0.2740.456 ± 0.2510.462 ± 0.2550.418 ± 0.296.237 EQ VAS55.5 ± 22.050.8 ± 23.153.6 ± 24.156.4 ± 21.847.1 ± 21.6.319Initial management<.001 Endovascular21 (40)53 (47)44 (41)40 (43)27 (38) Open/hybrid7 (13)33 (29)27 (25)15 (16)22 (31) Major amputation0 (0)0 (0)2 (2)9 (10)2 (3) Minor amputation1 (2)2 (2)3 (3)10 (11)9 (13) Nonoperative23 (44)24 (21)31 (29)18 (20)11 (15)CFS, Clinical frailty scale; HADS, Hospital Anxiety and Depression Scale; VAS, visual analogue scale; VascuQoL, Vascular Quality of Life Questionnaire.Data are presented as number (%), mean ± standard deviation, or median (interquartile range) unless otherwise stated. P values in bold are statistically significant.aData presented as. Open table in a new tab Table IIOne-year major amputation rates of individual WIfI score combinationWoundIschemia – 0Ischemia – 1Ischemia – 2Ischemia – 30––––0 (0) [0-21]–––1 (5) [0-26]–––3 (5) [1-15]–––10 (0) [0-34]–––1 (5) [0-25]2 (20) [5-52]––1 (4) [0-23]1 (14) [1-53]––1 (2) [0-13]4 (19) [7-41]––2––0 (0) [0-49]–0 (0) [0-40]0 (0) [0-32]2 (15) [3-43]–1 (17) [1-58]0 (0) [0-34]––2 (15) [3-43]4 (27) [10-52]1 (17) [1-58]–3----------------Foot infection0123012301230123Data are presented as number (%) [95% confidence interval].Color of cells denotes WIfI stage classification (estimated risk of 1-year amputation): . Amputation rates only calculated for score combinations with five or more individual patients. Open table in a new tab

Diabetes Interacts with Latinx/Hispanic Ethnicity to Increase Major Amputations After Peripheral Vascular Intervention for Chronic Limb-threatening Ischemia

Latinx/Hispanic patients treated for chronic limb-threatening ischemia (CLTI) have higher amputation rates after controlling for presenting Wound, Ischemia, and foot Infection (WIfI) status. We hypothesize that a higher incidence of diabetes mellitus (DM) in Latinx/Hispanic patients may contribute to this disparity. The Vascular Quality Initiative peripheral vascular intervention dataset (2016-2022) was queried for CLTI. Inclusion criteria were reported WIfI stage and White race or Latinx/Hispanic ethnicity. The primary endpoint was 1-year major amputation (through tibia/fibula or more proximally). A multivariate hierarchical Fine Gray analysis was performed controlling for hospital-level variation and competing risk of death. The analysis was stratified by WIfI stage, and DM was treated as an interaction term with race and ethnicity. Overall, 38,079 (45%) cases met inclusion criteria and 3247 (12%) were Latinx/Hispanic with a higher incidence of DM in Latinx/Hispanic patients (77% vs 61%; P < .01). Proportions of WIfI stages were similar between White race and Latinx/Hispanic ethnicity, respectively: stage 1 (29% vs 30%), stage 2 (38% vs 32%), stage 3 (19% vs 21%), and stage 4 (14% vs 18%). The cumulative incidence of major amputation was highest for Latinx/Hispanic patients with DM (Figure). On multivariate analysis, the 1-year subdistribution hazard ratio (SHR) for amputation was highest for Latinx/Hispanic patients with DM at 1.8 (95% confidence interval [CI], 1.3-2.4; P < .01); and 1.4; 95% CI, 0.7-2.6; P = .29) for Latinx/Hispanic without DM, and 1.4 (95% CI, 1.1-1.6; P < .01) for White race with DM compared to White race without DM. When stratified by WIfI stage, the interaction of Latinx/Hispanic ethnicity with DM conferred the greatest increase in 1-year SHR for WIfI stages 2 (SHR, 1.9; 95% CI, 1.1-3.2; P = .03) and 3 (SHR, 2.1; 95% CI, 1.2-3.7; P < .01), compared to White race without DM. Latinx/Hispanic ethnicity requiring insulin treatment for DM had the highest hazard of amputation (SHR, 2.0; 95% CI, 1.4-2.7; P < .01) (Table). The increase in major amputations for Latinx/Hispanic patients after peripheral vascular intervention for CLTI is modified by the interaction with DM with a stepwise increase for those requiring insulin treatment. This study suggests that DM prevention and treatment is a cornerstone in addressing disparities for Latinx/Hispanic patients with limb threat and reducing their amputation risk.TableSubdistribution hazard ratios (SHR) by diabetes mellitus (DM) TreatmentSHR95% CIP valueWhite racea Diet controlled0.80.5-1.2.29 Noninsulin treatment1.20.9-1.6.07 Insulin treatment1.51.2-1.8<.01Latinx/Hispanic ethnicitya No DM diagnosis1.40.8-2.6.29 Diet controlled1.50.6-3.8.26 Noninsulin treatment1.50.9-2.5.09 Insulin treatment2.01.4-2.7<.01CI, Confidence interval.Model adjusted for age, primary insurer, WIfI stage, end-stage renal disease, prior amputation, and intervention level. Boldface entries indicate statistical significance.aReference group for all: White race with no DM diagnosis. Open table in a new tab

Lower Extremity Amputation Rates in People With Diabetes Mellitus: A Retrospective Population Based Cohort Study in Zwolle Region, The Netherlands

Lower extremity amputations are a major complication of diabetes mellitus (DM). In a previous Dutch study, the incident rate of major amputations was 89.2 per 100 000 person years. The primary aim of this study was to describe the lower extremity amputation rates in people with DM in the Zwolle region, where preventive and curative footcare is organised according to the guidelines of the International Working Group of the Diabetic Foot (IWGDF). The secondary aim was to evaluate outcomes and underlying characteristics of these people. This was a retrospective regional population based cohort study. Data from all people with DM treated in primary and secondary care, living in the region Zwolle were collected. All amputations in the period 2017 to 2019 were analysed. Comparisons were made between those with and without an amputation. In the analysis 5 915 people with DM were included, with a mean age of 67.8 (IQR 57.9, 75.9) years. Of those people, 47% were women and the median HbA1c was 53 (IQR 47, 62) mmol/mol. Over the three year study period 68 amputations were performed in 59 people: 46 minor, 22 major. This translated into an average annual crude amputation incidence rate of non-traumatic major and minor amputations of 41.5 and 86.9 per 100 000 person years among people with diabetes. Compared with those not undergoing amputations, those who underwent an amputation were more often men, older, mainly had T2DM, were treated in secondary care, had higher diastolic blood pressure, worse diabetic footcare profile, longer DM duration and higher HbA1c. At the end of the follow up, 111 people died: 96 (1.6%) without and 15 (25.4%) with amputations (p < .001). This retrospective study provides detailed insight into the rate of amputations in Dutch people with diabetes in the region Zwolle. Compared with previous Dutch estimates, these data suggest a considerable decrease in the major amputation incidence rate.

Differences in Biologic Drug Effects and Distal Particulate Embolization in Three Paclitaxel-Coated Balloons for Femoropopliteal Lesions in a Rabbit Model.

A recent meta-analysis of randomized control trials demonstrated a significantly higher risk of major amputation in patients treated with drug-coated balloons (DCBs) compared with standard treatment, especially in high-dose paclitaxel-coated DCBs. Distal particulate embolization after DCB use was considered a potential cause of the higher incidence of major amputation. The current study aimed to histologically and biologically compare biologic drug effect and distal particulate embolization in 3 DCBs (a high-dose paclitaxel-coated DCB [IN.PACT Admiral] and 2 low-dose paclitaxel-coated DCBs [Ranger and Lutonix]). The DCBs were inflated in the healthy descending aortas of 18 rabbits, followed by euthanasia 28 days after the procedure. The treated descending aorta and distal skeletal muscles were histopathologically evaluated, and paclitaxel concentrations were measured. The paclitaxel concentration of the treated lesion was highest for Ranger, followed by IN.PACT and Lutonix (Ranger vs IN.PACT vs Lutonix: 1089 [745-2170] pmol/mg vs 638 [160-2075] pmol/mg vs 25 [10-304] pmol/mg, respectively; p<0.0001). In the histopathological evaluation, the angle of severe medial smooth muscle cell loss was largest for Ranger followed by IN.PACT and Lutonix (12.8 [8.0-20.4] degree vs 1.4 [1.2-5.2] degree vs 0.8 [0.5-2.5] degree, respectively), with significant differences for Ranger vs IN.PACT (p=0.007) and Ranger vs Lutonix (p=0.002). However, paclitaxel concentrations of distal skeletal muscles were lowest for Lutonix, followed by Ranger and IN.PACT (12 [1-58] pmol/mg vs 15 [13-21] pmol/mg vs 42 [19-108] pmol/mg, respectively, p<0.0001). The numbers of arteries with downstream DCB effects were highest for IN.PACT, followed by Ranger and Lutonix (Ranger vs IN.PACT vs Lutonix, 3 [3-4] vs 4 [3-7] vs 2 [1-2], respectively), which was consistent with the measured tissue paclitaxel concentrations. These findings suggest that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization, making it a good treatment option for patients with peripheral artery disease among the 3 DCBs evaluated in the current study. Further clinical head-to-head comparisons with larger numbers of patients are needed to explore which DCB is the most effective and safe treatment option.Clinical Impact:The findings of the current preclinical study suggests that Ranger demonstrates the strongest paclitaxel effect, as well as the second-best effect regarding distal particulate embolization making it a good treatment for patients with intermittent claudication and chronic limb-threatening ischemia.

Demographics and Etiology for Lower Extremity Amputations-Experiences of an University Orthopaedic Center in Germany.

Background and Objectives: Currently, the worldwide incidence of major amputations in the general population is decreasing whereas the incidence of minor amputations is increasing. The purpose of our study was to analyze whether this trend is reflected among orthopaedic patients treated with lower extremity amputation in our orthopaedic university institution. Materials and Methods: We conducted a single-center retrospective study and included patients referred to our orthopaedic department for lower extremity amputation (LEA) between January 2007 and December 2019. Acquired data were the year of amputation, age, sex, level of amputation and cause of amputation. T test and Chi² test were performed to compare age and amputation rates between males and females; significance was defined as p < 0.05. Linear regression and multivariate logistic regression models were used to test time trends and to calculate probabilities for LEA. Results: A total of 114 amputations of the lower extremity were performed, of which 60.5% were major amputations. The number of major amputations increased over time with a rate of 0.6 amputation/year. Men were significantly more often affected by LEA than women. Age of LEA for men was significantly below the age of LEA for women (men: 54.8 ± 2.8 years, women: 64.9 ± 3.2 years, p = 0.021). Main causes leading to LEA were tumors (28.9%) and implant-associated complications (25.4%). Implant-associated complications and age raised the probability for major amputation, whereas malformation, angiopathies and infections were more likely to cause a minor amputation. Conclusions: Among patients in our orthopaedic institution, etiology of amputations of the lower extremity is multifactorial and differs from other surgical specialties. The number of major amputations has increased continuously over the past years. Age and sex, as well as diagnosis, influence the type and level of amputation.

Timing of minor and major amputation in patients with diabetes-related foot ulceration admitted to two public tertiary referral hospitals in Australia.

There is limited information regarding the number of patients with diabetes-related foot ulceration (DFU) who receive minor or major amputation, and how quickly these amputations occur. This study aimed to identify the incidence of index minor and major amputation among inpatients with DFU over 4 years, and where amputation occurred during the patient's index DFU-related admission, investigate prognostic factors. The incidence of index minor and major amputation, and the admission sequence during which amputation occurred were identified from DFU-related admissions to two public hospitals during 2014-2018. Where minor or major amputation occurred during the patient's index DFU-related admission, prognostic factors were investigated using logistic regression. DFU-related hospital admissions were required by 564 patients. The incidence of minor amputation over 4 years was 34% (n= 193). The incidence of minor amputation during the patient's index DFU-related admission was 28% (n= 155), which was associated with requiring revascularisation (odds ratio [OR] 2.33, 95% CI 1.53-3.55, P< 0.001). The incidence of major amputation over 4 years was 8% (n= 45). The incidence of major amputation during the patient's index DFU-related admission was 6% (n= 31), which was associated with having more comorbidities (OR 1.58, 95% CI 1.10-2.26, P= 0.01) and receiving care for a mental health condition (OR 3.85, 95% CI 1.48-10.01, P= 0.006). Most amputations occurred during the patient's index DFU-related hospital admission. Major amputation during a patient's index admission was associated with more comorbidities and mental health conditions.

Below Knee Angioplasty Using Drug-Eluting Balloons in Patients with Critical Limb Ischemia with Six Months Follow-Up: Single-Center Experience at Tertiary Care Hospital

Abstract Purpose The aim of this study was to evaluate 6 monthly safety and primary patency rates of drug-eluting balloons (DEB) angioplasty in below-the-knee (BTK) arteries in critical limb ischemia (CLI) patients. Methods A prospective observational study was conducted over 2 years in a tertiary care center. A total of 25 patients with CLI were enrolled in this study. Inclusion criteria were patients presenting with CLI (Rutherford class 4 or greater), equal to or more than 50% luminal stenosis or occlusion of at least one tibial artery, and agreement to 6-month evaluation. Exclusion criteria were life expectancy less than 1 year, allergy to paclitaxel, and contraindication to antiplatelet treatment.Follow-up was performed by clinical and Doppler assessment. The primary endpoint was a 6-month primary patency rate, and secondary endpoints were changes in the Rutherford class and incidence of major amputation. Restenosis rate is defined as a reduction in the luminal diameter by 50% or greater by duplex ultrasound. Results Six-month primary patency was achieved in 19 (76%) patients. Both Rutherford category improvement and reduction in the percentage of stenosis after angioplasty were statistically significant (p-value &lt;0.0001). At 6 months, better patency rates were seen among diabetics (88.8%) than smokers (69.2%). Limb salvage was observed in 24 (96%) patients with one major amputation (above the ankle). Conclusion DEBs have shown safe and promising clinical outcomes with successful performance in infrapopliteal arteries in the short-term follow-up. DEB had a substantial 6-month primary patency rate. DEB angioplasty is a safe and effective treatment option for CLI patients with BTK vascular disease.

Evaluation of Arterial and Venous Allografts in Subinguinal Bypasses

Autologous saphenous vein (ASV) is the preferred conduit for below-the-knee bypasses in patient with critical limb-threatening ischemia (CLTI). Alternative graft must be considered for patients without (ASV). The aim of this work is to evaluate the mid-term performance of arterial (AA) and venous allografts (VA) used as an alternative conduit. This retrospective study included patients with CLTI, with or without a history of homolateral femoropopliteal bypass and no autologous veins were available who underwent infra-inguinal arterial reconstructions using VA or AA from 2008 to 2018. Patients undergoing revision operations for infected bypasses were excluded. Primary patency (PP), primary assisted patency (PAP), secondary patency (SP), major amputation and death from any cause were the endpoints. For each event, a set of analyses were performed. Overall, 111 patients (63 VA and 48 AA) were included, with 108 having below-the-knee bypass. The median follow-up time was 27.8 months [15.6; 37.4]. The difference in PP between the two allograft types was significant (p=0.049) with 65.9% [43.7; 81.0], 44.1% [24.2; 62.3] and 44.1% [24.2; 62.3] in the AA group respectively at 6, 12 and 18 months while 55.6% [40.0; 68.6], 46.0% [30.6; 60.2] and 33.2% [18.2; 49.0] in the VA group. The choice of an AA over a VA was an independent factor associated with patency (for PP: HR=0.43 [0.24; 0.75] (p=0.003), PAP: HR=0.52 [0.30; 0.89] (p=0.018), SP: HR=0.49 [0.27; 0.88] (p=0.016). The allograft type did not affect neither the incidence of major amputation nor death from any cause (respectively, HR=1.20 [0.49; 2.93], and 0.88 [0.37; 2.14]). The nature of the allograft appears to influence the patency of infra-inguinal reconstruction, but not the course of the disease. Performant alternative grafts answering infectious issues are needed.

Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study

PurposeData on the long-term safety and effectiveness of drug-coated balloons (DCBs) for the treatment of long femoropopliteal atherosclerotic lesions in the real-world setting are rare. This study reports 3 year and 5 year outcomes of the pre-specified 150 mm balloon sub-cohort of the IN.PACT Global Study.MethodsThe IN.PACT Global Study was a prospective, multicentre, international, single-arm study evaluating the performance of the IN.PACT Admiral DCB in real-world patients with femoropopliteal atherosclerotic disease. This pre-specified 150 mm DCB cohort analysis comprised 107 participants (111 lesions) with all target lesions treated with at least one 150 mm DCB.ResultsMean lesion length was 20.3 ± 9.2 cm; 18.0% had in-stent restenosis, 58.6% were totally occluded, and 17.1% were severely calcified. Through 60 months, the Kaplan–Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) was 72.7% [95% confidence interval (CI):62.4%–80.5%]. The safety composite endpoint (freedom from device/procedure-related death through 30 days; freedom from target limb major amputation and clinically driven target vessel revascularization through 5 years) was 70.5%. The cumulative incidence of major amputation was 1.0% and all-cause mortality was 18.4% through 60 months. Freedom from CD-TLR rates in the provisional stented and non-stented subgroups through 36 months were 64.0% [95% CI: 46.1%–77.3%] and 81.9% [95% CI: 69.7%–89.6%] (log-rank p = 0.074), respectively.ConclusionsThe results demonstrate sustained long-term safety of the 150 mm IN.PACT Admiral DCB for long femoropopliteal atherosclerotic lesions in real-world patients. In particular, the results show that DCB angioplasty is an effective revascularization modality in long complex lesions. ClinicalTrials.gov identifier: NCT01609296.Level of Evidence.Level 3, Cohort Study.

Temporal trends in major, minor and recurrent lower extremity amputations in people with and without diabetes in Belgium from 2009 to 2018

AimsThis study assessed temporal trends in the incidence of lower extremity amputations (LEA) in Belgium from 2009 to 2018, and subsequent secondary amputation rates. MethodsNationwide data on LEA were collected. Sex- and age-adjusted annual incidence rates were calculated. Time trends were analysed in negative binomial models. The incidence of secondary interventions, defined as either any ipsilateral reamputation or any contralateral amputation, was studied with death as competing risk. Results41 304 amputations were performed (13 247 major, 28 057 minor). In individuals with diabetes, the amputation rate (first amputation per patient per year) decreased from 143.6/100.000 person-years to 109.7 (IRR 0.97 per year, 95 %CI 0.96–0.98, p < 0.001). The incidence of major LEAs decreased from 56.2 to 30.7 (IRR 0.93, 95 %CI 0.91–0.94, p < 0.001); the incidence of minor amputations showed a non-significant declining trend in women (54.3 to 45.0/100 000 person years, IRR 0.97 per year, 95 %CI 0.96–0.99), while this remained stable in men with diabetes (149.2 to 135.3/100 000 person years, IRR 1.00 per year, 95 %CI 0.98–1.01). In individuals without diabetes, the incidence of major amputation didn’t change significantly, whereas minor amputation incidence increased (8.0 to 10.6, IRR 1.04, 95 %CI 1.03–1.05, p < 0.001). In individuals with diabetes, one-year secondary intervention rates were high (31.3% after minor, 18.4% after major LEA); the incidence of secondary amputations didn’t change. ConclusionsA significant decline in the incidence rate of major LEA was observed in people with diabetes. This decline was not accompanied by a significant rise in minor LEA. The incidence of secondary interventions remained stable.

Population-Based Trends in Amputations and Revascularizations for Peripheral Artery Disease From 1990 to 2009

ObjectiveTo determine trends in amputations and revascularizations for peripheral artery disease (PAD) in a well-defined population. MethodsA population-based cohort study of Olmsted County, Minnesota, residents with PAD undergoing amputation or revascularization was conducted between January 1, 1990, and December 31, 2009. Population-level 5-year incidence trends for endovascular, open surgical, and hybrid revascularizations and major and minor amputations were determined. Limb-specific outcomes after revascularization, including major adverse limb events and amputation-free survival, were compared between initial surgical and endovascular or hybrid revascularization groups using Kaplan-Meier analysis. ResultsWe identified 773 residents who underwent 1906 limb-procedures, including 689 open revascularizations, 685 endovascular or hybrid revascularizations, and 220 major amputations. During the 20-year study period, the incidence of endovascular and hybrid revascularizations increased, whereas the incidence of open surgical revascularizations and major amputations decreased. Incidence of revascularizations for chronic limb-threatening ischemia (CLTI) did not change. Among residents with CLTI undergoing their first revascularization on a limb, endovascular revascularization was associated with more major adverse limb events and major amputations compared with surgical revascularization during the ensuing 15 years. ConclusionThe rising incidence of endovascular and hybrid revascularizations and the decreasing incidence of open surgical revascularizations for PAD were associated with a decreasing incidence of major amputations in this population between 1990 and 2009, despite a stable incidence of revascularizations for CLTI. With more major adverse limb events and major amputations after endovascular revascularization, these trends suggest that additional emphasis should be placed on improving limb salvage efforts beyond just mode of revascularization.

Lower Limb Amputation Rates in Germany.

Background and Objectives: The current epidemiology of lower limb amputations is unknown. Therefore, the purpose of this study was to determine (1) lower extremity amputation rates as a function of age, gender, and amputation level between 2015 and 2019, (2) main diagnoses indicating amputation, (3) revision rates after lower extremity amputation. Materials and Methods: Lower extremity amputation rates were quantified based on annual Operation and Procedure Classification System (OPS) and International Classifications of Disease (ICD)-10 codes from all German medical institutions between 2015 through 2019, provided by the Federal Statistical Office of Germany (Destatis). Results: In 2019, 62,016 performed amputations were registered in Germany. Out of these 16,452 procedures (26.5%) were major amputations and 45,564 patients (73.5%) underwent minor amputations. Compared to 2015, the incidence of major amputations decreased by 7.3% to 24.2/100,000 inhabitants, whereas the incidence of minor amputation increased by 11.8% to 67.1/100,000 inhabitants. Highest incidence was found for male patients aged 80–89 years. Patients were mainly diagnosed with peripheral arterial disease (50.7% for major and 35.7% for minor amputations) and diabetes mellitus (18.5% for major and 44.2% for minor amputations). Conclusions: Lower limb amputations remain a serious problem. Further efforts in terms of multidisciplinary team approaches and patient optimization strategies are required to reduce lower limb amputation rates.

Characteristics of Diabetic Foot Ulcer Patients Pre- and During COVID-19 Pandemic: Lessons Learnt From a National Referral Hospital in Indonesia.

Background:Diabetic foot ulcer (DFU) is one of the most terrifying diabetic complications for patients, due to the high mortality rate and risk for amputation. During the COVID-19 pandemic, many diabetic patients limited their visits to the hospital, resulting in delays for treatment especially in emergency cases.Objective:This study aimed to compare the characteristics of patients with DFU pre- and during COVID-19 pandemic period. Methods: This study was a retrospective cohort study using foot registry data. We compared our patients’ characteristics pre-COVID-19 pandemic period (1 March 2019-28 February 2020) and during COVID-19 pandemic period (1 March 2020-28 February 2021).Results:Cohorts of 84 and 71 patients with DFU pre- and during COVID-19 pandemic period, respectively, were included in this study. High infection grade (66.7% vs 83.1%, P = .032), osteomyelitis event (72.6% vs 87.3%, P = .04), leukocyte count (15 565.0/μL vs 20 280.0/μL, P = .002), neutrophil-to-lymphocyte ratio (7.7 vs 12.1, P = .008), waiting time-to-surgery (39.0 h vs 78.5 h, P = .034), and number of major amputation (20.2% vs 39.4%, P = .014) were significantly higher during the COVID-19 pandemic period.Conclusion:During the COVID-19 pandemic, patients with DFU had more severe infection, higher proportion of osteomyelitis, longer waiting time for getting surgical intervention, and higher incidence of major amputation.

Low-intensity pulsed ultrasound decreases major amputation in patients with critical limb ischemia: 5-year follow-up study.

Various therapeutic strategies for angiogenesis are performed to improve symptoms in patients with critical limb ischemia (CLI). Pre-clinical studies have shown that low-intensity pulsed ultrasound (LIPUS) exposure induces angiogenesis. LIPUS may be a new stratergy for treatment of CLI. The purpose of this pilot trial was to evaluate outcomes in patients with CLI who were treated with LIPUS. Fourteen patients with CLI, who were not candidates for angioplasty or surgical revascularization, were enrolled in this study. Historical control data were obtained from the Hiroshima University PAD database. The primary endpoints were major amputation and death. The outcomes were compared in 16 lower limbs of the 14 patients with CLI who were treated with LIPUS and in 14 lower limbs of 14 patients with CLI as historical controls. All patients were followed for after 5 years after treatment with LIPUS. The mean duration of LIPUS exposure in the LIPUS group was 381± 283 days. During the 5-year follow-up periods, there were 3 major amputations and 7 deaths in the LIPUS group and there were 14 major amputations and 7 deaths in the historical control group. The overall amputation-free survival rate was significantly higher in patients who were treated with LIPUS than in historical controls. There was no significant difference between overall mortality-free survival rates in the LIPUS group and historical control group. LIPUS is a noninvasive option for therapeutic angiogenesis with the potential to reduce the incidence of major amputations in patients with CLI.

Major amputation rates and outcomes for Aboriginal and Torres Strait Islander and non-Indigenous people in North Queensland Australia between 2000 and 2015

BackgroundThis study estimated the incidence of major amputation for people in North Queensland, Australia, examined changes in amputation rates over time and investigated survival after major amputation.MethodsThis was a retrospective study of patients who underwent a major amputation above the ankle between 2000 and 2015. Major amputation rates and incidence rate ratios (IRR) were calculated using census data to define the at-risk population. Associations between risk factors and calendar year with major amputation were assessed using quasipoisson regression. Kaplan-Meier survival and Cox-proportional hazard analyses estimated the incidence of and risk factors for all-cause mortality.ResultsThe annual incidence of major amputation was estimated to be greater in Aboriginal and Torres Strait Islanders than non-Indigenous people (IRR 2.75, 95 % CI 1.92 to 3.84). After adjusting for population growth, the annual incidence of major amputations did not change significantly over time for either groups. Aboriginal and Torres Strait Islander people were at greater risk of all-cause mortality after major amputation compared to non-Indigenous people, although this association was not significant after adjusting for other risk factors (hazard ratio 1.24, 95 % CI 0.82 to 1.90).ConclusionsThe incidence of major amputation in North Queensland has not reduced over time, indicating the need for better preventative treatments, particularly in Aboriginal and Torres Strait Islander people.

Effect of recanalization of anterior tibial artery and peroneal artery on targeted angiosomes of posterior tibial artery in the foot through different aspects

Objective The purpose of this study is to evaluate the outcome of percutaneous transluminal angioplasty of ipsilateral peroneal artery and the anterior tibial artery for revascularization of targeted angiosomes in the vascular territory of posterior tibial artery (PTA) in the foot, through interconnecting branches, and the resulting effect on existing wound healing and limb salvage, in comparison with the effect of percutaneous transluminal angioplasty on PTA alone on revascularization and wound healing in these angiosomes. Patients and methods We included 80 patients for 80 angioplasty procedure (80 limbs) who were divided into two equal groups. Group A included patients with peroneal and anterior tibial patent vessel runoff, who were fit for percutaneous transluminal angioplasty for both vessels, whereas group B were candidates for PTA angioplasty. We studied the arterial supply in 80 limbs with TASC C-D lesions with follow-up along 1 year, all with PTA occlusion. Patients with single-vessel or three-vessel runoff were excluded from the study. Outcome measures included wound healing of targeted angiosomes of PTA with complete epithelialization of the affected lesion with or without secondary interventions such as debridement or skin grafting and limb salvage with absence of major amputation. Conclusions We found that recanalization of peroneal artery together with anterior tibial artery can supply angiosomes of PTA and accelerate wound healing through communicating branches in the foot with comparable outcome on wound healing and decreased incidence of major amputation to single recanalization of PTA as primary and secondary outcome, obviating the need for lengthy and more risky interventional procedure.