Major Limb Amputation Research Articles

Safety and Efficacy of the Passeo-18 Lux Drug-Coated Balloon Catheter in Atherosclerotic Femoropopliteal Lesions: The Multicenter BIOLUX P-IV China Study

The purpose of this trial was to assess the safety and effectiveness of a paclitaxel-coated balloon catheter in Chinese patients with de novo or nonstented restenotic femoropopliteal atherosclerotic lesions. BIOLUX P-IV China is a prospective, independently adjudicated, multicenter, single-arm trial conducted in China. Patients with Rutherford class 2-4 were eligible, excluded were patients in which predilation resulted in severe (≥ grade D) flow-limiting dissection or residual stenosis > 70%. Follow-up assessments were conducted at 1, 6, and 12months. The primary safety end point was 30-day major adverse event rate and the primary effectiveness end point was primary patency at 12months. We enrolled 158 patients with 158 lesions. Mean age was 67.6±9.6years, diabetes was present in 53.8% (n=85), and previous peripheral intervention/surgeries in 17.1% (n=27). Lesions were 4.1±0.9mm in diameter and 74±50mm long with a mean diameter stenosis of 91±13%; 58.2% (n=92) were occluded (core laboratory analysis). Device success was achieved in all patients. The rate of major adverse events was 0.6% (95% confidence interval: 0.0; 3.5) at 30days, consisting of 1 target lesion revascularization. At 12months, binary restenosis was present in 18.7% (n=26) and target lesion revascularization was performed in 1.4% (n=2, all clinically driven), resulting in a primary patency of 80.0% (95% confidence interval: 72.4, 85.8); no major target limb amputation occurred. Clinical improvement at 12months, defined as improvement of at least 1 Rutherford class, was 95.3% (n=130). The median walking distance per 6-minute walk test was 279m at baseline and improved by 50m at 30days and by 60m at 12months; the visual analogue scale changed from 76.6±15.6 at baseline to 80.0±15.0 at 30days and 78.6±14.6 at 12months. Our results confirmed the clinical effectiveness and safety of a paclitaxel-coated peripheral balloon dilatation catheter for the treatment of de novo and nonstented restenotic lesion of the superficial femoral and proximal popliteal artery in Chinese patients (NCT02912715).

Surgical Technique for Targeted Muscle Reinnervation in Knee Disarticulation Amputation for Nonambulatory Patients.

Chronic neuropathic pain following major limb amputation has historically been difficult to treat. In patients undergoing lower extremity amputation, "preemptive" targeted muscle reinnervation (TMR) nerve transfers may be performed concurrently with the amputation to help mitigate the risk of chronic neuropathic postoperative pain. Despite clinical studies demonstrating efficacy of TMR in lower extremity amputations, few procedural descriptions have been written, and none have been written regarding performing TMR at the knee disarticulation (KD) level of amputation. Although uncommonly utilized, the KD amputation has clear functional benefits over other levels of amputation for nonambulatory patients. As nonambulatory patients are also subject to the occurrence of chronic neuropathic postamputation pain, it stands to reason that the addition of TMR to KD surgery could be an improvement to standard techniques. In this report, we provide a technical description for concurrent TMR with KD and describe the rationale for its use.

Endothelial Progenitor Cells May Be Related to Major Amputation after Angioplasty in Patients with Critical Limb Ischemia.

Critical limb ischemia represents an advanced stage of peripheral arterial disease. Angioplasty improves blood flow to the limb; however, some patients progress irreversibly to lower limb amputation. Few studies have explored the predictive potential of biomarkers during postangioplasty outcomes. To evaluate the behavior of endothelial progenitor cells in patients with critical limb ischemia, in relation to their postangioplasty outcome. Twenty patients with critical limb ischemia, candidates for angioplasty, were enrolled. Flow-mediated dilation, as well as endothelial progenitor cells (subpopulations CD45+/CD34+/CD133+/CD184+ and CD45+/CD/34+/KDR[VEGFR-2]+ estimated by flow cytometry) from blood flow close to vascular damage, were evaluated before and after angioplasty. Association with lower limb amputation during a 30-day follow-up was analyzed. Endothelial progenitor cells were related with flow-mediated dilation. A higher number of baseline EPCs CD45+CD34+KDR+, as well as an impaired reactivity of endothelial progenitor cells CD45+CD34+CD133+CD184+ after angioplasty, were observed in cases further undergoing major limb amputation, with a significant discrimination ability and risk (0.75, specificity 0.83 and RR 4.5 p < 0.05). Endothelial progenitor cells were related with endothelial dysfunction, whereas a higher baseline number of the subpopulation CD45+CD34+KDR+, as well as an impaired reactivity of subpopulation CD45+CD34+CD133+CD184+ after angioplasty, showed a predictive ability for major limb amputation in patients with critical limb ischemia.

Effect of a continuous perineural levobupivacaine infusion on pain after major lower limb amputation: a randomised double-blind placebo-controlled trial

ObjectivesRandomised controlled trial of the effect of a perineural infusion of levobupivacaine on moderate/severe phantom limb pain 6 months after major lower limb amputation.SettingSingle-centre, UK university hospital.ParticipantsNinety patients undergoing above-knee...

A scoping review on nutritional intake and nutritional status in people with a major dysvascular lower limb amputation

Purpose To systematically review literature on nutritional intake, nutritional status and nutritional interventions, and to study their association with short- and long-term clinical outcomes in people with a major dysvascular lower limb amputation. Methods PubMed, Ovid, CINAHL, and The Cochrane Library were searched. Studies were included if nutritional intake, nutritional status, or nutritional interventions in people with a major dysvascular lower limb amputation were analyzed. Results Of the 3038 unique papers identified, 30 studies were included. Methodological quality was moderate (1 study) or weak (29 studies). Limited information was available on nutritional intake (2 studies) and nutritional interventions (1 study). Nutritional intake and nutritional status were assessed by diverse methods. The percentage of people with a poor nutritional status ranged from 1% to 100%. In some studies, measures of poor nutritional status were associated with adverse short- and long-term clinical outcomes. Conclusions The percentage of people with a poor nutritional status is inconclusive in the major dysvascular lower limb amputation population, because of the heterogeneity of the assessment methods used. Some included studies reported a negative association between poor nutritional status and clinical outcomes. However, these results should be interpreted with caution, because of the limited quality of the studies available. Studies high in methodological quality and high in hierarchy of evidence are needed. IMPLICATIONS FOR REHABILITATION The proportion of people with a poor nutritional status in the major dysvascular lower limb amputation population is inconclusive. Poor nutritional status seems to affect clinical outcomes negatively. More uniformity in assessment of malnutrition in the major dysvascular lower limb amputation population is needed.

The influence of simultaneous pancreas-kidney transplantation on the evolution of diabetic foot lesions and peripheral arterial disease.

Simultaneous pancreas-kidney transplantation (SPKT) remains the best treatment option in patients with type 1 diabetes and chronic kidney failure. There are only a few studies addressing the potential ischemic deterioration of peripheral arterial disease (PAD) due to blood diverting from the iliac artery to the kidney graft. We aimed to evaluate diabetic foot lesions and PAD evolution in SPKT recipients and investigate if they are more frequent in ipsilateral lower limb of kidney graft. We developed a retrospective cohort, including patients submitted to SPKT in our tertiary center, between 2000 and 2017. Diabetic foot lesions and PAD frequencies were compared in the period before and after transplantation. Two hundred and eleven patients were included, 50.2% (n = 106) female, with a median age at transplantation of 35years (IQR 9). After a median follow-up period of 10years (IQR 7), patient, kidney, and pancreatic graft survival were 90.5% (n = 191), 83.4% (n = 176), and 74.9% (n = 158), respectively. Before transplant, 2.8% (n = 6) had PAD and 5.3% (n = 11) had history of foot lesions. In post-transplant period, 17.1% (n = 36) patients presented PAD and 25.6% (n = 54) developed diabetic foot ulcers, 47.6% (n = 35) of which in the ipsilateral and 53.3% (n = 40) in the contralateral lower limb of the kidney graft (p = 0.48). Nine patients (4.3%) underwent major lower limb amputation, 3 (30%) ipsilateral and 7 (70%) contralateral to the kidney graft (p = 0.29). Diabetic foot lesions were not more frequent in the ipsilateral lower limb of the kidney graft, therefore downgrading the 'steal syndrome' role in these patients.

What is the cost, impact, and willingness to pay for an Amputee Peer Support Program?

The provision of peer support from those who have already made positive adjustments to amputation is recommended for people incurring a major limb amputation; however, few receive this service. From a program perspective, determine the cost, impact, and willingness to pay for an Amputee Peer Support Program. Cost analysis. Cost of the Amputee Peer Support Program included a cost analysis of program data over a 5-year time horizon (2013-2018) reported in Australian Dollars 2018/2019. Impact and willingness to pay for an Amputee Peer Support Program was determined through surveys of the 3 participant groups: referring health professionals, program volunteers, and program participants. Over 5 years, there were 793 program participants, serviced by 256 program volunteers, for a cost of $631,497. The cost per program participant was $796. Thirty-eight health professionals, 86 program volunteers, and 12 program participants reported on impact and willingness to pay. The Program was reported to have a positive impact on all participant groups. The themes of access to resources and information and the provision of social and emotional well-being were identified across all 3 groups as being important. All 3 groups reported a higher willingness to pay for the health service (range $113-$450), National Disability Insurance Scheme ($156-$432), and private health insurance ($153-$347), and a lower willingness to pay for the program participant ($23-$49). Amputee peer support had a positive impact on those receiving and providing the service. Amputee peer support is likely to be a powerful yet inexpensive addition to routine care.

Spinal cord stimulation in non-reconstructable critical limb ischemia: a retrospective study of 71 cases

BackgroundSpinal cord stimulation (SCS) is a therapeutic option for patients with a peripheral arterial disease with critical limb ischemia (CLI) and consequent ischemic rest pain. Neuromodulation is chosen when vascular reconstruction is not possible or failed. Data about the effect of SCS over limb salvage rates are dissonant.MethodWe report on a retrospective cohort of CLI patients who were implanted with SCS systems between July 2010 and December 2013 in a single center. Major amputation, postoperative complications, and death were recorded.ResultsSeventy-two CLI patients underwent SCS implantation, with 35 of them classified as non-reconstructable and 37 with previous but failed or only partially successful vascular procedures. A total of 21 subjects were at Fontaine’s stage III (29.2%), and the remaining 51 were at stage IV (70.8%). In total, 26.4% of the patients had diabetes (n = 19), two of them at Fontaine’s stage III. The mean follow-up was 17.1 ± 10.5 months. At the last follow-up, 59.2% of all patients (42/71), 85.7% of Fontaine’s stage III (18/21), 48.0% of Fontaine’s stage IV (24/50), and 52.6% of diabetic patients (10/19) were alive without major amputation. The probability of limb survival at 12 months was 72% for all patients, 94% for Fontaine’s stage III, 62% for Fontaine’s stage IV, and 61% for diabetic patients. The probability of survival at 12 months for patients who underwent major limb amputation (n = 25) was 86% with a mean survival time of 31.03 ± 4.63 months.ConclusionsNon-reconstructable CLI patients treated with SCS can achieve meaningful clinical outcomes with few procedure-related complications. The therapy may be more beneficial in patients classified as Fontaine’s Stage III.

Outcome of covered stents for severe aorto-iliac occlusive disease (AIOD) in patients with chronic limb-threatening ischaemia

Objective: To determine early and medium-term outcomes in patients with chronic limb-threatening ischaemia (CLTI) due to Transatlantic Inter-Society Consensus (TASC) C/D aorto-iliac occlusive disease (AIOD) treated with covered stents (CS). Design: A retrospective single-centre case series. Methods: Analysis of consecutive patients treated with CS for TASC C/D AIOD and CLTI between 2006 and 2017. The primary outcome was amputation-free survival (AFS). Secondary outcomes were survival, major limb amputation (MLA), patency, complications and freedom from re-intervention. Results: Eighty-eight patients (61 men; 7 TASC C; 81 TASC D) were treated for CLTI (54 rest pain; 34 tissue loss). One hundred and twenty limbs were revascularised with 99.8% technical success. The 30-day mortality was 4.5%. Postoperative complications occurred in 30 (34%) patients. Seven (8%) patients underwent MLA. AFS was 76.0% (95% CI 65.6 to 83.6) and 66.6% (95% CI 55.2 to 75.7), primary patency 83.9% (95% CI 71.0 to 91.4) and 70.5% (95% CI 52.8 to 82.6), and freedom from re-intervention 92.4% (95% CI 83.8 to 96.5) and 83.2% (95% CI 71.2 to 90.5) at 1 and 3 years, respectively. MLA was not associated with target lesion revascularisation (OR 4.35, 95% CI 0.89 to 21.18, p=0.073) or CS patency (OR 0.33, 95% CI 0.03 to 3.43, p=0.360). Age (HR 1.10, 95% CI 1.05 to 1.14, p&lt;0.001), creatinine (HR 1.01, 95% CI 1.00 to 1.02, p&lt;0.001), urgency (emergency: HR 3.10, 95% CI 0.97 to 9.98, p=0.057; urgent: HR 3.71, 95% CI 1.25 to 10.97, p=0.018), tissue loss (HR 5.34, 95% CI 2.36 to 12.07, p&lt;0.001), postoperative respiratory complications (HR 5.37, 95% CI 1.44 to 20.01, p=0.012), congestive cardiac failure (HR 0.23, 95% CI 0.05 to 0.99, p=0.049) and implantation of bilateral CS (HR 0.38, 95% CI 0.15 to 0.94, p=0.036) were independently associated with AFS. Conclusions: Covered stents in patients with TASC C/D AIOD presenting with CLTI are associated with acceptable early and medium-term outcomes in these multi-morbid patients with reduced life expectancy. CS patency was not associated with MLA or AFS and may therefore represent a poor surrogate endpoint for assessing the efficacy of endovascular intervention for AIOD.

An index to prevent major limb amputations in diabetic foot.

Objective. Besides the early detection and treatment of diabetic foot ulcers, being aware of the risk factors for major amputation plays a crucial role in preventing the major lower limb amputations. Major lower limb amputations are not just mentally and physically hard for patients, but also have an effect on patient's survival and are a financial burden on both patients and healthcare systems. Subjects and Methods. We defined 37 potential risk factors for major amputation and these risk factors were investigated among 507 patients who had ulcers in their feet and were seen by the diabetic foot ulcer council at Ege University Faculty of Medicine. In our study, 106 (20.9%) patients ended up undergoing major lower limb amputation. Results. The univariate analysis showed that 24 defined risk factors were statistically significant. In the multivariate analysis using the Cox regression model, 6 risk factors remained statistically significant. Multivariate-adjusted hazard ratios were 4.172 for hyperlipidemia, 3.747 for albumin <3.365 g/dL, 3.368 for C-reactive protein (CRP) >2.185 mg/L, 2.067 for presence of gangrenous Wagner stage, 1.931 for smoking tobacco >30 pack/year, and 1.790 for hematocrit (HCT) <31.5%. Most patients with major amputation presented with a neuroischemic foot (58%). Gender and age were not found to be risk factors for major amputation. Having less than 7% of hemoglobin A1c (HbA1c) levels had a direct proportion with major amputation numbers. The mortality rates in one year, two and three years after the major amputation operations were 24.6%, 30%, and 35.9%, respectively. Conclusion. Being familiar with these risk factors for major amputation is crucial for multi-disciplinary teams to take good care of patients with diabetic foot ulcers and to lower the need for major amputations.

Limb Loss: Facts and Statistics – Diabetes Mellitus and Vascular Insufficiency, a Real Harbinger of Major Limb Amputations – A Cross-sectional Study among Amputees Reporting to a Tertiary Care Center

Abstract Background: Limb loss to amputation is a major problem, especially in developing countries where the majority of the cases are preventable. It is a burden, not just for the patient but also for their caregivers. Today, when amputation is necessary, surgery is undertaken with consideration for the functional aspects of the residual limb. The purpose of this study was to describe the etiology and characteristics of major limb amputees at a tertiary care center in North India. Methods: This prospective observational study was conducted by the Government Medical College Jammu, for 2 years. Eighty-one patients underwent major limb amputations in our hospital during the study. In this study, we studied several variables including age, sex, side of the limb, level of the amputation, and etiology. Results: In this study, dysvascular disease was the major reason of amputation, diabetes mellitus being the most common cause (39.5%), followed by trauma, with a male preponderance, with peaking at the age of 51–70 years. Lower limb is the most common with the predominance of transtibial amputation. Younger individuals who underwent amputation were mostly due to the trauma. The most common postoperative complication was surgical site infection (21%) and the most common organism cultured from the wound was Pseudomonas (50%). The most common additional procedure done was wound debridement. The mortality rate was 10% and the mean duration of hospital stay was 23 days. Conclusion: In contrast to declining rates of trauma-related and cancer-related amputations, we found evidence of a significant increase in the incidence of amputations due to diabetic foot syndrome. Overall, the risk of amputations increased with age. This was true for all etiologies and for both sexes. Males with an average age of 50 years are generally at higher risk for limb loss than women.

Functional results and mortality in elderly patients with major lower limb amputation

Functional results and mortality in elderly patients with major lower limb amputation

Fast-Access Multidisciplinary Approach to Management of Diabetic Foot Ulcers: The Diabetic Rapid Evaluation and Lower Limb Amputation Management (DREAM) Clinic.

Diabetic foot ulcers (DFUs) are debilitating to the patient and costly for the healthcare system. We set up the Diabetic Rapid Evaluation and lower limb Amputation Management (DREAM) clinic with the aim of providing early directed specialist care to patients with DFUs. With early management, we hope to treat DFUs in its early stages, reducing the need for and associated morbidity of major and minor lower limb amputations. We evaluated the outcomes of the fast-access DREAM clinic with multi-disciplinary evaluation for patients with DFUs. Outcomes include time from the point of referral to DREAM clinic evaluation, amputation rates and wound healing rates. Patients presenting with DFU to the DREAM clinic were enrolled. A podiatrist made the first assessment, followed by immediate specialist consultation with Endocrinologists, Vascular surgeons or Orthopaedic surgeons as required. Data on baseline demographics and DFU characteristics were collected. Outcomes evaluated were wound healing at 12 weeks, wound salvage rates, time to DREAM clinic access and time to specialist referral. Sixty-eight patients were enrolled, with 57.3% males, and mean age of 63 ± 13.0 years. Majority of ulcers were classified as neuropathic (41.3%) and located at the digits (40%). At 12-weeks follow-up, 1 had undergone major amputation, 9 minor amputations and 4 surgical debridements. The median time to DREAM clinic evaluation from first presentation was 3 days (IQR 7). Eleven (16.2%) required >1 specialist consult. Twenty (29.4%) were hospitalised for treatment. Twelve underwent revascularisation within 4 days (IQR 3.5). Twenty-four patients (35.3%) continued podiatry follow-up, having 28 DFUs in which 20 (71.4%) healed within 12 weeks. The fast-access multidisciplinary DREAM clinic shows promising outcomes with lower major amputation rates and exemplary DFU healing outcomes.

Targeted Muscle Reinnervation: A Brief History of a Promising Procedure for Effective Management of Amputation Pain

Each year, 27.5% of the 150 000 people in the United States who require lower extremity amputation experience significant postoperative complications, including pain, infection, and need for reoperation. Postamputation pain, including RLP and PLP, is debilitating. While the causes of such pain remain unknown, neuroma formation following sensory nerve transection is believed to be a major contributor. Various techniques exist for management of a symptomatic neuroma, but few data exist on which technique is superior. Furthermore, there are few data on primary prevention of neuroma formation following injury or intentional transection. The TMR technique shows promise for both management of PLP and RLP and prevention of neuroma formation. Following amputation, transected sensory nerves are coapted to nearby motor nerve supplying remaining extremity musculature. Not only does this procedure generate increased myoelectric signals for improved prosthesis control, TMR appears to neurophysiologically alter sensory nerves, preventing formation of painful sensory neuromas. The sole RCT to date evaluating the efficacy of TMR showed statistically significant reduction in PLP. TMR is not limited to use in the setting of major limb amputation. It has also been used in the setting of post-mastectomy pain, abdominal wall neuromas, digital amputations, and headache surgeries. This article reviews the origin of TMR and provides a brief description of histologic changes following the procedure, as well as current data regarding the efficacy of TMR with regard to postoperative pain relief. It also seeks to provide a concise, comprehensive resource for providers to facilitate better discussions with patients about treatment options.

Ceramides in peripheral arterial plaque lead to endothelial cell dysfunction

BackgroundPeripheral arterial atheroprogression is increasingly prevalent, and is a risk factor for major limb amputations in individuals with risk factors such as diabetes. We previously demonstrated that bioactive lipids are significantly altered in arterial tissue of individuals with diabetes and advanced peripheral arterial disease. MethodsHere we evaluated whether sphingolipid ceramide 18:1/16:0 (C16) is a cellular regulator in endothelial cells and peripheral tibial arterial tissue in individuals with diabetes. ResultsWe observed that C16 is the single most elevated ceramide in peripheral arterial tissue from below the knee in individuals with diabetes (11% increase, P < .05). C16 content in tibial arterial tissue positively correlates with sphingomyelin (SPM) content in patients with and without diabetes (r2 = 0.5, P < .005; r2 = 0.17, P < .05; respectively). Tibial arteries of individuals with diabetes demonstrated no difference in CERS6 expression (encoding ceramide synthase 6; the predominate ceramide synthesis enzyme), but higher SMPD expression (encoding sphingomyelin phosphodiesterase that catalyzes ceramide synthesis from sphingomyelins; P < .05). SMPD4, but not SMPD2, was particularly elevated in maximally diseased (Max) tibial arterial segments (P < .05). In vitro, exogenous C16 caused endothelial cells (HUVECs) to have decreased proliferation (P < .03), increased apoptosis (P < .003), and decreased autophagy (P < .008). Selective knockdown of SMPD2 and SMPD4 decreased native production of C16 (P < .01 and P < .001, respectively), but only knockdown of SMPD4 rescued cellular proliferation (P < .005) following exogenous supplementation with C16. ConclusionsOur findings suggest that C16 is a tissue biomarker for peripheral arterial disease severity in the setting of diabetes, and can impact endothelial cell viability and function. Clinical relevancePeripheral arterial disease and its end-stage manifestation known as chronic limb-threatening ischemia (CLTI) represent ongoing prevalent and intricate medical challenges. Individuals with diabetes have a heightened risk of developing CLTI and experiencing its complications, including wounds, ulcers, and major amputations. In the present study, we conducted a comprehensive examination of the molecular lipid composition within arterial segments from individuals with CLTI, and with and without diabetes. Our investigations unveiled a striking revelation: the sphingolipid ceramide 18:1/16:0 emerged as the predominant ceramide species that was significantly elevated in the peripheral arterial intima below the knee in patients with diabetes. Moreover, this heightened ceramide presence is associated with a marked impairment of endothelial cell function and viability. Additionally, our study revealed a concurrent elevation in the expression of sphingomyelin phosphodiesterases, enzymes responsible for catalyzing ceramide synthesis from sphingomyelins, within maximally diseased arterial segments. These findings underscore the pivotal role of ceramides and their biosynthesis enzymes in the context of CLTI, offering new insights into potential therapeutic avenues for managing this challenging disease process.

National Treatment Patterns and Outcomes for Hospitalized Patients with Chronic Limb-Threatening Ischemia and End-Stage Kidney Disease.

Chronic limb-threatening ischemia (CLTI) can be associated with dismal outcomes but there are limited real-world data to further define the impact of end-stage kidney disease (ESKD) on outcomes nationally in this subset of patients. We sought to characterize national patterns of inpatient treatment of CLTI and compare outcomes in patients without ESKD. The National Inpatient Sample was queried from 2015-2018 for all hospital admissions including treatment for CLTI. Mixed-effects linear and logistic regression models were used to estimate the effect of ESKD on outcomes and treatment choice. We identified 11652 hospital admissions with CLTI alone and 2705 with CLTI + ESKD. Hospital admissions with CLTI + ESKD patients included patients who were younger (66 vs 69years, P < .0001), less likely to be white (39% vs 63%, P < .0001), and more likely to reside in lower income large metropolitan areas. Admissions for CLTI + ESKD patients had a lower likelihood of open arterial reconstruction (OR .40, P < .0001) and a higher likelihood of endovascular revascularization or major limb amputation (OR 1.70, P < .0001). Admissions for CLTI + ESKD also had a 4.5- and 1.5-fold higher odds of in-hospital death and complications. These findings were associated with a longer LOS (P < .0001), increased probability of discharge to rehabilitation facility (50% vs 41%, P < .0001), and greater hospital charges (median, $107K vs $85K, P < .0001). Compared to hospital admissions for patients without ESKD, admissions for patients with CLTI + ESKD demonstrated distinctive demographic characteristics, a lower likelihood of open revascularization and a higher likelihood of endovascular revascularization and major limb amputation. Chronic limb-threatening ischemia + ESKD hospital admissions showed worse overall outcomes and greater resource utilization compared to CLTI admissions without ESKD.

Retracted: Quality of Life Following Major Limb Amputation in a Rural Community in Cameroon.

Amputation is considered the last resort when a limb is no longer salvageable, a limb is dead or dying, is viable but non-functional, or is endangering the patient's life. Limb amputation is associated with profound economic, social, and psychological effects on patients. The aim of this study is to evaluate quality of life following major limb amputation in a rural setting in west Cameroon. This was a cross-sectional descriptive, analytical study. Participants were interviewed and data collected using a pre-defined accredited questionnaire of the WHOQOL-BREF to assess quality of life. There were 63 participants, and a majority (60.32% ) reported trauma as the cause of amputation. Participants with a prosthesis had better quality of life. Quality of life of people following major limb amputation in this study was generally fair according to the World Health Organization (WHO) quality of life tool.

ANMCO Position paper: Evidence and practical indications for the use of low-dose rivaroxaban in stable coronary artery disease and peripheral artery disease

In patients with atherosclerotic disease, the occurrence of atherothrombotic events is the main determinant of morbidity and mortality. Growing evidence suggests the involvement of the coagulation pathway in the atherosclerotic process and the benefit of antithrombotic agents, such as direct oral anticoagulants, which interfere with both platelet aggregation and the coagulation cascade. The COMPASS trial has shown that in patients with stable coronary artery disease (CAD) or peripheral artery disease (PAD), low-dose rivaroxaban (2.5 mg twice daily) added to acetylsalicylic acid (ASA) 100 mg reduces major vascular events and mortality, with an increase in major bleeding but not in fatal bleeding or involving a critical organ. The reduction in major cardiovascular events has been confirmed in the overall population with CAD and in both patients with and without a previous percutaneous coronary revascularization, and also in patients with previous coronary bypass surgery. In patients with PAD, the combination of rivaroxaban 2.5 mg twice daily and ASA was found to reduce both major adverse cardiovascular events and major adverse limb events, including major limb amputations. In clinical practice, the use of rivaroxaban 2.5 mg co-administered with ASA has been approved in both patients with CAD and symptomatic PAD at high risk of ischemic events. However, in Italy, the national health system reimbursement is provided only for patients with PAD. In patients treated with rivaroxaban 2.5 mg, assessment and monitoring of bleeding risk is crucial to achieve the maximum clinical benefit.

A Community and Hospital cAre Bundle to improve the medical treatment of severe cLaudIcation and critical limb iSchaemia (CHABLIS).

Patients with peripheral artery disease (PAD) often do not receive optimal best medical therapy (BMT). Through interaction with patients and healthcare-professionals (HCPs) we developed the LEaflet Gp letter Structured checklist (LEGS) complex clinical intervention to support HCPs in providing guideline-compliant PAD BMT. This was a prospective multicentre study assessing the feasibility and fidelity of delivering the LEGS intervention in primary and secondary care over six months. Intervention fidelity was scored based on the proportion of intervention components used correctly at discharge, 30 days, and six months. Overall, 129 individuals were screened and 120 took part (33% female, 74% with chronic limb threatening ischaemia; 93% recruitment rate). Of those, 118 (98% retention rate) completed follow-up. Mean intervention fidelity score at discharge (primary outcome measure) was 63% [95% Confidence Interval (CI): 39-68%, SD: 5%], exceeding the success criteria set at 60% by a panel of HCPs and patients. This, however, declined to 51% at six months. Eight patients (6.7%) died (all cardiovascular deaths), four (3.3%) had a major lower limb amputation, 12 (10%) had a cardiovascular event, and 13 (11%) were admitted due to limb ischaemia at six months. Incomplete lipid therapy prescriptions and LEGS intervention documents not received by primary care CHPs were the most common reasons for not complying with the LEGS intervention. The LEGS intervention can be delivered in PAD care pathways across different hospitals, primary, and community healthcare settings with acceptable fidelity, to streamline and improve PAD BMT short- and medium-term.

Effectiveness and Safety of Atherectomy versus Plain Balloon Angioplasty for Limb Salvage in Tibioperoneal Arterial Disease

PurposeTo evaluate the effectiveness and safety of atherectomy versus plain balloon angioplasty (POBA) for treatment of critical limb ischemia (CLI) due to tibioperoneal arterial disease (TPAD). Materials and MethodsPatients enrolled in the Vascular Quality Initiative registry who had CLI (Rutherford Class 4–6) and underwent atherectomy versus POBA alone for isolated TPAD were retrospectively identified. Of eligible patients, a cohort of 2,908 patients was propensity matched 1:1 by clinical and angiographic characteristics. The atherectomy group comprised 1,454 patients with 2,183 arteries treated, and the POBA group comprised 1,454 patients with 2,141 arteries treated. The primary study endpoint was major ipsilateral limb amputation. Secondary endpoints were minor ipsilateral amputations, any ipsilateral amputation, primary patency, target vessel reintervention (TVR), and wound healing at 12 months. ResultsThe median follow-up period was 507 days, the mean patient age was 69 years ± 11.7, and the mean occluded length was 6.9 cm ± 6.5. There was a trend toward higher technical success rates with atherectomy than with POBA (92.9% vs 91.0%, respectively; P = .06). The rates of major adverse events during the procedure were not significantly different. The 12-month major amputation rate was similar in the atherectomy and POBA groups (4.5% vs 4.6%, respectively; P = .92; odds ratio, 0.97; 95% CI, 0.68–1.37). There was no difference in 12-month TVR (17.9% vs 17.8%; P = .97) or primary patency (56.4% vs 54.5%; P = .64) between the atherectomy and POBA groups. ConclusionsIn a large national registry, treatment of CLI from TPAD using atherectomy versus POBA showed no significant differences in procedural adverse events, major amputations, TVR, or vessel patency at 12 months.