Symptomatic infrapopliteal arterial disease often requires challenging endovascular interventions. Percutaneous transluminal angioplasty with stent placement to settle residual stenosis or dissections remains the standard of care for infrapopliteal endovascular intervention. Concerns have been raised about permanent artery rigidification by stainless steel stents. Drug-eluting resorbable scaffolds combine the mechanical support in the acute phase and the delivery of an antirestenotic drug overtime, then fully resorb leaving the vessel free from permanent metallic implant. This study investigated the performance of the Magmaris sirolimus-eluting resorbable magnesium scaffold (RMS) in the management of infra-popliteal, severely diseased leg arteries.

This investigator-initiated single-center retrospective study, analyzed all patients with symptomatic peripheral arterial occlusive disease (Rutherford class of symptoms 2-5) treated with the Magmaris RMS from 2016 to 2023, for the treatment of infrapopliteal arterial lesions with postangioplasty 50% or more residual stenosis. Technical success, degree of residual stenosis after scaffold implantation, incidences of target lesion primary patency, clinically driven target lesion revascularization (CDTLR), major limb amputation, and all-cause mortality are provided up to 36 months.

Hundred eleven patients (69.4% male, age 79 ± 10) were treated with 141 Magmaris RMS for infrapopliteal lesions (92.3% proximal third of leg). Target lesions had a mean degree of stenosis of 92%, with 52.2% of occlusion and 58.5% of moderate or severe calcification. The mean degree of stenosis after angioplasty remained 60.1% ± 15.8% and fell to 4.8% ± 9.6% after scaffold implantation. Freedom from CDTLR was 95.5%, 93.4%, 90.4%, and 87.9% at 6, 12, 24, and 36 months. Freedom from limb major amputation was 98.2%, 98.1%, 96.4%, and 95.5% and mortality was 7.6%, 10.6%, 24.2%, and 28.8% at 6, 12, 24, and 36 months.

This study suggests that the Magmaris RMS has adequate mechanical properties, drug elution, and resorption time to be safely applied to atherosclerotic infrapopliteal arteries with promising clinical results. These data show that metallic resorbable scaffold may constitute a valuable addition to current option for infrapopliteal arteries management.Clinical ImpactResorbable magnesium scaffold (RMS) are an innovation in the treatment of residual stenoses or dissections after angioplasty in the infrapopliteal arteries. They offer mechanical support and drug elution during the healing phase of the artery wall; and then disappear, leaving the artery free of any rigid implant, once the resorption is completed. RMS thus allow the restoration of artery motion and endothelial function. This study provides efficacy and safety information up to 3 years after RMS implantation in severe lesions of the leg arteries and is the largest study in the field of resorbable scaffold for below the knees arteries, as well as the first evaluating magnesium-based alloy scaffolds. It shows immediate and long-term clinical success, well beyond the entire resorption of the RMS.

Peripheral arterial disease (PAD) is a major complication in individuals with diabetes and is increasingly prevalent in those with diabetic foot ulcers (DFUs). Despite this, the characterisation of PAD in diabetic patients remains insufficiently refined, leading to suboptimal management and outcomes. This review underscores the necessity for a more nuanced understanding of PAD's anatomical and biological aspects in diabetic patients. The distribution of atherosclerotic plaques varies significantly among individuals, influencing prognosis and treatment efficacy. We describe three key patterns of PAD in diabetes: pattern 1 PAD-below-the-knee (BTK) disease (with infrageniculate disease where present); pattern 2-below-the-ankle (BTA) disease; and pattern 3-small artery disease (SAD), each presenting unique challenges and require tailored therapeutic approaches. BTK PAD, characterised by occlusions in the anterior tibial, posterior tibial, and peroneal arteries, necessitates targeted revascularisation to improve foot perfusion. BTA PAD, involving the pedal and plantar arteries, is associated with higher risks of amputation and requires advanced revascularisation techniques. SAD, affecting the small arteries of the foot, remains an enigma and is challenging to treat with the current mechanical methods, highlighting the potential of autologous cell therapy as a promising alternative. A refined characterisation of PAD in diabetes is crucial for developing effective, individualised treatment strategies, ultimately improving patient outcomes, and reducing the burden of diabetic foot complications. In light of these complexities, it is incredulous that we often use a single term, "peripheral arterial disease", to describe such a diverse array of disease patterns. This oversimplification can be perilous, as it may lead to inadequate therapeutic approaches and suboptimal patient care.

The aim of study was to confirm the hypothesis that advanced medial arterial calcification (MAC)/ small artery disease (SAD), much like the progression of peripheral arterial disease (PAD) stages can adversely impact the outcomes in DFU patients, even after successful endovascular procedures. In retrospective study, we enrolled 54 patients with DFUs who underwent percutaneous transluminal angioplasty (PTA). MAC was quantified using a three-level scoring system based on radiographs. Patients were categorized based on their MAC score into three groups. Study groups were compared in terms of primary DFU outcomes (healing, amputations) and secondary DFU outcomes (mortality, changes in transcutaneous oxygen pressure (TcPO2)) three and six months after PTA. The MAC/SAD score increased significantly with age (p = 0.014). The MAC/SAD score was't associated with the risk of amputation or the healing of DFUs up to three months after revascularization. However, a significant association was observed after six months (p = 0.043). The MAC/SAD score correlated significantly with severity of PAD, as classified by the Global Limb Anatomic Staging System (p = 0.042) and the Graziani system (p = 0.019). We found a negative correlation between the MAC/SAD score and absolute levels of TcPO2 after PTA. MAC/SAD score was significantly associated with long-term unhealed DFUs and the risk of lower limb amputations.

Diagnostic angiography of peripheral arteries using carbon dioxide (CO2) is feasible in nearly all areas below the diaphragm. Using carbon dioxide as a contrast material in angiography provides the highest quality diagnostic results in the vascular segments above the knee. However, its diagnostic reliability decreases as it moves toward the distal side of the vessels below the knee. This study investigated the diagnostic accuracy and consistency between CO2 and iodine contrast angiography in patients with peripheral vascular disease (PVD) with chronic limb ischemia (CLI).

The study prospectively enrolled 35 patients with PVD and CLI and performed both CO2 and iodine contrast angiography, comparing the results for each patient. Image quality, stenosis severity, and anatomical location were analyzed.

In this study, a total of 35 patients (19 male) with an average age of 56.91 ± 10.73 were examined. Among them, 13 patients (37.1%) had involvement in the femoral region, 8 patients (22.9%) in the popliteal region, 8 patients (22.9%) in the tibial region, and 6 patients (17.1%) in the foot region. CO2 angiography produced excellent image quality in 40% of cases, with good quality in another 25.7%. The quality decreased in the popliteal and foot regions. While stenosis assessment was comparable between the two methods in the femoral, popliteal, and tibial regions, there was a significant difference in the foot region. The sensitivity, specificity, positive predictive value, and negative predictive value of CO2 angiography were all 100% in the femoral and popliteal areas. However, these values were lower in the tibial and foot areas.

The study concluded that the use of CO2 angiography, particularly for vascular lesions above the popliteal cavity, is a valuable and safe method for peripheral vascular examination of the lower limbs. It can serve as an alternative to iodine contrast angiography, especially in patients with kidney failure.

To compare the consolidation quality between the anteromedial aspect of regenerated bone (AMRB) and the other areas of regenerated bone (TORB) following the induced membrane technique (IMT) for managing critical-sized tibial shaft bone defects, and determine the factors affecting consolidation quality in the AMRB.

Retrospective comparative study.

Academic Level I trauma center.

Included were patients who underwent IMT with only an intramedullary nail for tibial shaft segmental defects and serial computed tomography immediately, 6 months, and 1 year postoperatively.

Comparison were made of regenerative bone volume, density, and corticalization between AMRB and TORB.

This study enrolled 37 patients with a mean age of 47.7 years (range 20-79). Twenty-eight (75.7%) patients were men. Postoperatively, the AMRB exhibited significantly more negative volumetric change than TORB at 0-1 year (-20.01% ± 25.59% vs. -13.32% ± 22.48%, P = 0.028), less positive density change 0-6 months (+197.84 ± 107.95 vs. +290.14 ± 131.74 Hounsfield unit (HU), P < 0.001) and 0-1 year (+377.51 ± 150.71 HU vs. +455.48 ± 135.04 HU, P < 0.001), and lower corticalization rate in 1 year (49.77% ± 29.42% vs. 82.27 ± 19.73%, P < 0.001). Significant factors included fracture-related infection (FRI) ( P = 0.047 and P = 0.048 at 0-6 months and 0-1 year, respectively) and longer defect length ( P = 0.032 and P = 0.020) for the negative volumetric AMRB changes; older age ( P = 0.004 and P = 0.016) for the AMRB negative density changes; higher percentage of mixed recombinant human bone morphogenetic protein-2 in graft material ( P = 0.013 in 0-6 months) for the AMRB positive density change; FRI ( P = 0.024) for the inferior corticalization rate of the AMRB; FRI ( P = 0.026 in 0-1 year), longer defect length ( P = 0.017 in 0-6 months), and higher mixed demineralized bone matrix percentage ( P = 0.010 in 0-1 year) for the difference in density change between the AMRB and TORB; higher mixed demineralized bone matrix percentage ( P = 0.023) for the difference between the AMRB and TORB in corticalization rates.

The tibial shaft's anteromedial aspects demonstrated significantly inferior consolidation after IMT, especially in terms of volume at 6 months, density at 6 months and 1 year, and corticalization at 1 year postoperatively.

Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Cell therapy has had satisfactory safety and efficacy outcomes for no-option critical limb ischaemia (NO-CLI) patients. In the current study, we aimed to compare the image quality of ischaemic lower limb blood vessels shown on volumetric CT-based time maximum intensity projection CT perfusion (t-MIP CTP) versus single-phase CTA (sCTA). We also tried to quantify the blood flow of the ischaemic lower extremity based on the t-MIP technique, not only to precisely show the dynamic change in blood flow from before to after cell therapy but also to detect any relationship between this change and patient prognosis.

A total of 31 patients with thromboangiitis obliterans (TAO)-induced NO-CLI who had been referred from the department of vascular surgery to undergo autologous stem cell transplantation into a single limb from January 2020 to March 2021 were prospectively enrolled in this study. Preoperative sCTA or t-MIP CTP and postoperative 1-month t-MIP CTP were performed in all patients. Clinical outcomes, including the 1-month ankle-brachial index (ABI) and 3-month CLI status, were also analysed. Image quality, including objective scores (attenuation, signal-to-noise ratio [SNR] and contrast-to-noise ratio [CNR]), subjective scores and collateral scores, was compared between preoperative sCTA and t-MIP CTP. Vascular volume was calculated as the total volume (mL) of lower limb arteries within the scanning range. All images and calculations were performed by 2 separate radiologists. Receiver operating characteristic curves were drawn to reveal the sensitivity and specificity of vascular volume and ABI in predicting prognosis.

Both sCTA and t-MIP CTP images exhibited good quality for diagnosis. t-MIP CTP images showed significantly higher attenuation, SNR and CNR in all arterial segments (popliteal artery, anterior tibial artery, posterior tibial artery and peroneal artery). In subjective and collateral score evaluations, t-MIP CTP images were also significantly better than sCTA images (both p < .05). At 1 month after transplantation, both vascular volume and ABI showed significant improvement (both p < .01). At 3 months after transplantation, 38.71% of patients (12/31) achieved CLI relief (Rutherford class < 4). Through the receiver operating characteristic (ROC) curve, the 1-month vascular volume increase ratio showed better ability to predict the 3-month prognosis (radiologist 1: AUC, 0.757; sensitivity, 0.750; specificity, 0.840; radiologist 2: AUC, 0.803; sensitivity, 0.500; specificity, 1.000) than the 1-month ABI increase ratio (AUC, 0.607; sensitivity, 0.230; specificity, 0.820) or 1-month ABI (AUC, 0.410; sensitivity, 0.080; specificity, 0.580).

t-MIP CTP showed significantly higher-quality images of ischaemic limb vascularity than sCTA. t-MIP CTP can reveal the anatomical information of collaterals more accurately, which is of great importance for NO-CLI patients undergoing cell transplantation. The 1-month vascular volume increase ratio can predict the 3-month prognosis more precisely on this basis.

The aim of this classification system is to provide vascular surgeons with a simple tool that categorises disease severity by anatomical segment in aortoiliac occlusive disease and thus guide decision making and management strategies. Disease of the common femoral arteries is included as the distal extent of disease with respect to access for both open and endovascular intervention is essential to management planning.

The classification system designates diseased segment letters and numbers to guide treatment planning. The degree of disease other than stenotic or occluded is not required. In a similar manner to the TNM classification, anatomy and disease severity - based on angiography, CTA, and MRA - are categorised using a simple, user-friendly method. Two clinical cases are presented to exemplify the clinical application of this classification system.

A simple and useful classification system is presented and ease of use exemplified by two clinical cases.

Management strategies for peripheral artery disease in general, aortoiliac occlusive disease specifically, have evolved rapidly in recent years. Existing classification systems, such as TASC II, steer the clinician towards specific treatment approaches. However, the first step in the management decision-making process is the accurate identification of the arterial segments that require treatment. None of the existing classification systems specifically address anatomy as an entity in itself. This classification system provides an intuitive framework, based on letters and numbers, that provides specific information on arterial segments and disease severity in aortoiliac occlusive disease on which clinicians can base management decisions. It has been developed to bolster this aspect of the vascular surgery armamentarium; to be used as a decision making and management planning tool, in partnership with, not instead of, existing classification systems.

Chronic limb-threatening ischemia (CLTI) in patients with end-stage renal disease (ESRD) poses significant challenges in clinical management due to its unique pathology and poor treatment outcomes. This review calls for a tailored classification and risk assessment for these patients to guide better revascularization choices with early minor amputation as a first-line strategy in advanced stages.

This review consolidates key findings from recent literature on CLTI in ESRD, focusing on disease mechanisms, treatment options, and patient outcomes. It evaluates the literature to clarify the decision-making process for managing CLTI in ESRD.

CLTI in ESRD patients often results in worse clinical outcomes, such as nonhealing wounds, increased limb loss, and higher mortality rates. While the literature reveals ongoing debates regarding the optimal revascularization method, recent retrospective studies and meta-analyses suggest potential benefits of endovascular treatment (EVT) over open bypass surgery (OB) in reducing mortality and wound complications, with comparable amputation-free survival rates.

The selection of revascularization methods in ESRD patients with CLTI is complex, necessitating individualized strategies. The importance of early detection and timely intervention is critical to decelerate disease progression and improve revascularization outcomes. There is a shift in these treatment strategies toward less invasive endovascular procedures, acknowledging the limitations these patients face with open revascularization surgeries. Considering early minor amputations after revascularization could prevent worse consequences, reflecting a shift in the approach to managing CLTI in ESRD patients.

Peripheral artery disease (PAD) is an atherosclerotic condition commonly complicating type 2 diabetes (T2D), leading to poor quality of life and increased risk of major adverse lower-limb (MALE) and cardiovascular (CV) events (MACE). Therapeutic management of PAD in T2D patients is much more arduous, often due to bilateral, multi-vessel, and distal vascular involvement, in addition to increased systemic polyvascular atherosclerotic burden. On the other hand, the pathophysiological link between PAD and T2D is very complex, involving mechanisms such as endothelial dysfunction and increased subclinical inflammation in addition to chronic hyperglycemia. Therefore, the clinical approach should not ignore vascular protection with the aim of reducing limb and overall CV events besides a mere glucose-lowering effect. However, the choice of the best medications in this setting is challenging due to low-grade evidence or lacking targeted studies in PAD patients. The present review highlighted the strong relationship between T2D and PAD, focusing on the best treatment strategy to reduce CV risk and prevent PAD occurrence and worsening in patients with T2D. The Medline databases were searched for studies including T2D and PAD up to June 2024 and reporting the CV effectiveness and safety of the most used glucose-lowering agents, with no restriction on PAD definition, study design, or country. The main outcomes considered were MACE-including nonfatal acute myocardial infarction, nonfatal stroke, and CV death-and MALE-defined as lower-limb complications, amputations, or need for revascularization. To the best of our current knowledge, GLP-1 receptor agonists and SGLT2 inhibitors represent the best choice to reduce CV risk in T2D and PAD settings, but a personalized approach should be considered. GLP-1 receptor agonists should be preferred in subjects with prevalent atherosclerotic burden and a history of previous MALE, while SGLT2 inhibitors should be used in those with heart failure if overall CV benefits outweigh the risk of lower-limb complications.

Peripheral arterial disease is the third leading cause of cardiovascular morbidity after coronary artery disease and stroke. Lower limb peripheral arterial disease commonly involves infrainguinal arteries, may impair walking ability (intermittent claudication) and may confer a significant risk of limb loss (chronic limb-threatening ischaemia), depending on the severity of ischaemia. Endovascular treatment has become the mainstay revascularisation option in both the femoropopliteal and the below-the-knee arterial segments. After crossing and preparing the lesion, treatment results in these arterial segments can be enhanced by using drug-coated devices (drug-eluting stents and drug-coated balloons) that mitigate the occurrence of restenosis. As for other medical devices, the use of drug-eluting devices is based on their demonstrated safety and efficacy profiles when applied in the distinct segments of the lower limb vasculature. In this state-of-the-art narrative review we provide an overview of the safety and efficacy of drug-coated devices when used in the femoropopliteal and below-the-knee arterial segments.

Diabetic foot ulcer (DFU) and the resulting lower extremity amputation are associated with a poor survival prognosis. The objective of this study is to generate a model for predicting the probability of major amputation in hospitalized patients with DFU.

The National Inpatient Sample (NIS) database from 2008 to 2014 was used to select patients with DFU, who were then further divided by major amputation status. International Classification of Diseases, Ninth Edition, Clinical Modification (ICD-9-CM) and Agency for Healthcare Research and Quality (AHRQ) comorbidity codes were used to compare patient characteristics. For the descriptive statistics, the Student t test, the χ2 test, and the Spearman correlation were utilized. The five most predictive variables were identified. A decision tree model (CTREE) based on conditional inference framework algorithm and a random forest model were used to develop the algorithm.

A total of 326 853 inpatients with DFU were identified, and 5.9% underwent major amputation. The top five contributory variables (all with P < .001) were gangrene (odds ratio [OR] = 11.8, 95% confidence interval [CI] = 11.5-12.2), peripheral vascular disease (OR = 2.9, 95% CI = 2.8-3.0), weight loss (OR = 2.6, 95% CI = 2.5-2.8), systemic infection (OR = 2.5, 95% CI = 2.4-2.53), and osteomyelitis (OR = 1.7, 95% CI = 1.6-1.73). The model performance of the training data was 77.7% (76.1% sensitivity and 79.3% specificity) and of the testing data was 77.8% (76.2% sensitivity and 79.4% specificity). The model was further validated with boosting and random forest models which demonstrated similar performance and area under the curve (AUC) (0.84, 95% CI = 0.83-0.85).

Utilizing machine learning methods, we have developed a clinical algorithm that predicts the risk of major lower extremity amputation for inpatients with diabetes with 77.8% accuracy.

This retrospective observational registry trial combines national registries for vascular surgical procedures and diabetes mellitus to clarify results of drug eluting technology in treating diabetic subjects with intermittent claudication or chronic limb threatening ischemia compared to treatment of non-diabetic subjects. As earlier proposed and showed in this trial, there may be an implication for a beneficial treatment efficacy with drug eluting therapy in the diabetic population with PAD compared to the non-diabetic population. A finding worth further exploration.

Background: Anatomy is critical in risk stratification and therapeutic decision making in coronary disease. The relationship between anatomy and outcomes is not well described in PAD. We sought to develop an angiographic core lab within the VOYAGER-PAD trial. The current report describes the methods of creating this core lab, its study population, and baseline anatomic variables. Methods: Patients undergoing lower-extremity revascularization for symptomatic PAD were randomized in VOYAGER-PAD. The median follow up was 2.25 years. Events were adjudicated by a blinded Clinical Endpoint Committee. Angiograms were collected from study participants; those with available angiograms formed this core lab cohort. Angiograms were scored for anatomic and flow characteristics by trained reviewers blinded to treatment. Ten percent of angiograms were evaluated independently by two reviewers; inter-rater agreement was assessed. Clinical characteristics and the treatment effect of rivaroxaban were compared between the core lab cohort and noncore lab participants. Anatomic data by segment were analyzed. Results: Of 6564 participants randomized in VOYAGER-PAD, catheter-based angiograms from 1666 patients were obtained for this core lab. Anatomic and flow characteristics were collected across 16 anatomic segments by 15 reviewers. Concordance between reviewers for anatomic and flow variables across segments was 90.5% (24,417/26,968). Clinical characteristics were similar between patients in the core lab and those not included. The effect of rivaroxaban on the primary efficacy and safety outcomes was also similar. Conclusions: The VOYAGER-PAD angiographic core lab provides an opportunity to correlate PAD anatomy with independently adjudicated outcomes and provide insights into therapy for PAD. (ClinicalTrials.gov Identifier: NCT02504216).

Infrapopliteal lesions are generally complex to treat due to small vessel diameter, long lesion length, multilevel disease, and severe calcification. Therefore, different vessel preparation devices have been developed to contribute to better peri- and postprocedural outcomes. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug-coated balloon (DCB) angioplasty with POBA or DCB alone in infrapopliteal arterial disease.

Medline, EMBASE, and Cochrane databases were searched for studies published between 2000 and 2022 assessing the value of adjunctive vessel preparation in infrapopliteal arterial disease. The primary outcomes were 12-month primary patency and limb salvage.

A total of 1685 patients with 1913 lesions were included in 11 POBA studies. Methodological quality was assessed as poor to moderate in these studies. Only 2 studies with 144 patients assessed vessel preparation in conjunction with DCB angioplasty. These randomized trials were assessed as high quality and found no significant benefit of adjunctive atherectomy to DCB angioplasty. The pooled Kaplan-Meier estimates of 12-month primary patency and limb salvage in the POBA studies were 67.8% and 80.9% for POBA, 62.1% and 86.4% for scoring balloons, 67.9% and 79.6% for mechanical atherectomy (MA), and 79.7% and 82.6% for laser atherectomy, respectively. Within the pooled data only scoring balloons and MA demonstrated significantly improved 12-month limb salvage compared to POBA.

Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and MA. However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation.

Infrapopliteal arterial disease is associated with chronic limb-threatening ischemia (CLTI) and generally complex to treat due to small vessel diameter, long lesion length, multilevel disease and severe calcification. A wide range of vessel preparation devices have been developed to contribute to improved peri- and postprocedural outcomes in these complex lesions. This systematic review aims to compare different vessel preparation techniques prior to plain old balloon angioplasty (POBA) or drug coated balloon (DCB) angioplasty with POBA or DCB angioplasty alone in infrapopliteal arterial disease. Different forms of adjunctive vessel preparation demonstrate similar 12-month outcomes compared to POBA and DCB angioplasty alone in infrapopliteal disease, with the exception of improved 12-month limb salvage in scoring balloons and mechanical atherectomy (MA). However, since the included studies were heterogeneous and assessed as poor to moderate methodological quality, selection bias may have played an important role. Main conclusion is that this systematic review found no additional value of standard use of vessel preparation.

Patients with chronic limb-threatening ischemia, the terminal stage of peripheral artery disease, are frequently afflicted by below-the-knee disease. Although all patients should receive guideline-directed medical therapy, restoration of inline flow is oftentimes necessary to avoid limb loss. Proper patient selection and proficiency in endovascular techniques for below-the-knee revascularization are intended to prevent major amputation and promote wound healing. This review, a consensus among an international panel of experienced operators, provides guidance on these challenges from an endovascular perspective and offers techniques to navigate this complex disease process.

Diabetic foot ulcer complicated with lower extremity vasculopathy is highly prevalent, slow healing and have a poor prognosis. The final progression leads to amputation, or may even be life-threatening, seriously affecting patients' quality of life. The treatment of lower extremity vasculopathy is the focus of clinical practice and is vital to improving the healing process of diabetic foot ulcers. Recently, a number of clinical trials on diabetic foot ulcers with lower extremity vasculopathy have been reported. A joint group of Chinese Medical Association (CMA) and Chinese Medical Doctor Association (CMDA) expert representatives reviewed and reached a consensus on the guidelines for the clinical diagnosis and treatment of this kind of disease. These guidelines are based on evidence from the literature and cover the pathogenesis of diabetic foot ulcers complicated with lower extremity vasculopathy and the application of new treatment approaches. These guidelines have been put forward to guide practitioners on the best approaches for screening, diagnosing and treating diabetic foot ulcers with lower extremity vasculopathy, with the aim of providing optimal, evidence-based management for medical personnel working with diabetic foot wound repair and treatment.

Peripheral artery disease (PAD) is associated with an increased likelihood of delayed or non-healing of a diabetes-related foot ulcer, gangrene, and amputation. The selection of the most effective surgical technique for revascularisation of the lower limb in this population is challenging and there is a lack of conclusive evidence to support the choice of intervention. This systematic review aimed to determine, in people with diabetes and tissue loss, if direct revascularisation is superior to indirect revascularisation and if endovascular revascularisation is superior to open revascularisation for the outcomes of wound healing, minor or major amputation, and adverse events including mortality.

Title and abstract searches of Medline, Embase, PubMed, and EBSCO were conducted from 1980 to 30th November 2022. Cohort and case-control studies and randomised controlled trials reporting comparative outcomes of direct (angiosome) revascularisation (DR) and indirect revascularisation (IR) or the comparative outcomes of endovascular revascularisation and open or hybrid revascularisation for the outcomes of healing, minor amputation, and major amputation in people with diabetes, PAD and tissue loss (including foot ulcer and/or gangrene) were eligible. Methodological quality was assessed using the Cochrane risk-of-bias tool for randomised trials, the ROBINS-I tool for non-randomised studies, and Newcastle-Ottawa Scale for observational and cohort studies where details regarding the allocation to intervention groups were not provided.

From a total 7086 abstracts retrieved, 26 studies met the inclusion criteria for the comparison of direct angiosome revascularisation (DR) and indirect revascularisation (IR), and 11 studies met the inclusion criteria for the comparison of endovascular and open revascularisation. One study was included in both comparisons. Of the included studies, 35 were observational (31 retrospective and 4 prospective cohorts) and 1 was a randomised controlled trial. Cohort study quality was variable and generally low, with common sources of bias related to heterogeneous participant populations and interventions and lack of reporting of or adjusting for confounding factors. The randomised controlled trial had a low risk of bias. For studies of DR and IR, results were variable, and it is uncertain if one technique is superior to the other for healing, prevention of minor or major amputation, or mortality. However, the majority of studies reported that a greater proportion of participants receiving DR healed compared with IR, and that IR with collaterals may have similar outcomes to DR for wound healing. For patients with diabetes, infrainguinal PAD, and an adequate great saphenous vein available for use as a bypass conduit who were deemed suitable for either surgical procedure, an open revascularisation first approach was superior to endovascular therapy to prevent a major adverse limb event or death (Hazard Ratio: 0.72; 95% CI 0.61-0.86). For other studies of open and endovascular approaches, there was generally no difference in outcomes between the interventions.

The majority of available evidence for the effectiveness of DR and IR and open and endovascular revascularisation for wound healing and prevention of minor and major amputation and adverse events including mortality in people with diabetes, PAD and tissue loss is inconclusive, and the certainty of evidence is very low. Data from one high quality randomised controlled trial supports the use of open over endovascular revascularisation to prevent a major limb event and death in people with diabetes, infrainguinal disease and tissue loss who have an adequate great saphenous vein available and who are deemed suitable for either approach.

Arterial perfusion is a key factor in diabetic foot ulcer (DFU) healing. Although it is associated with pedal arch patency, not all patients are amenable to pedal artery angioplasty. This study aims to determine the impact of angiographic improvement of the pedal arch quality after proximal arterial inflow revascularization (PAIR) and its association with wound healing.

One hundred and fifty diabetic patients with tissue loss in 163 limbs who had digital subtraction angiography were studied. Cox regression analysis was used to determine independent predictors of wound healing. Wound healing rates in association with pedal arch patency were calculated by Kaplan-Meier analysis.

End-stage renal disease, minor amputation, and complete pedal arch patency were significant independent predictors of wound healing following PAIR with hazard ratios for failure: 3.02 (P = 0.008), 0.54 (P = 0.023), and 0.40 (P = 0.039), respectively. The prevalence of complete pedal arches increased by 24.1% with successful intervention (P < 0.001). The overall rates of wound healing at 6, 12, and 24 months were 36%, 64%, and 72%, respectively. The wound healing rate at 1 year in patients with a complete pedal arch was 73% compared to 45% in those with an absent pedal arch (P = 0.017).

PAIR increases complete pedal arch patency, a significant predictor of wound healing in DFU.

To analyze the outcomes of heparin-bonded expanded polytetrafluoroethylene (HePTFE) graft as an alternative conduit in infrapopliteal revascularization of chronic limb-threatening ischemia (CLTI) in the absence of an autologous vein conduit.

A single-center retrospective analysis of patients with CLTI submitted to infrapopliteal bypasses with autologous vein graft (VEIN group) or HePTFE graft (HePTFE group) was implemented. Primary end points were freedom from CLTI at 12 months and recurrence of CLTI at 3 years. Secondary end points included freedom from major amputation, amputation-free survival (AFS), survival, and primary (PP) and secondary patency (SP) rates at 3 years of follow-up.

A total of 348 limbs submitted to infrapopliteal bypasses, 214 with venous graft and 134 with HePTFE graft, were followed-up for a median of 25 months. Most patients of the HePTFE group were male (69%), with a median age of 76 years (interquartile range [IQR] 15). Fifty-nine percent of the limbs of the HePTFE group had Wound grade ≥2, being 46% of them infected. Eighty-eight percent were GLASS stage III. Freedom from CLTI was not significantly different between HePTFE and VEIN groups (75% vs. 84%, adjusted hazard ratio [aHR] 0.88, confidence interval [CI] 0.66-1.18, P = 0.401). Recurrence of CLTI was higher in the HePTFE group (42% vs.18% at 3 years; aHR 2.82, CI 1.59-5.00, P < 0.001). The VEIN group achieved higher rates of freedom from major amputation (87% vs.69% at 3 years; aHR 2.21, CI 1.31-3.75, P = 0.003) and AFS (59% vs. 37% at 3 years; aHR 1.39, CI 1.02-1.88, P = 0.036), but no significance in survival (aHR 1.10, CI 0.72-1.66, P = 0.667). Patency rates were inferior in the HePTFE group, with 2-year PP and SP rates of 52% vs. 74%, and 76% vs. 90%, respectively (PP: aHR 1.70, CI 1.11-2.59, P = 0.014; SP: aHR 2.51, CI 1.42-4.42, P = 0.001).

Infrapopliteal bypass with autologous vein graft is the gold standard to treat CLTI limbs. HePTFE graft should be regarded as an alternative for complex infrapopliteal revascularization when lacking an autologous vein conduct.

To compare the results of endovascular therapy for chronic limb-threatening ischemia (CLTI) in patients categorized under the gray and yellow zones of the patient risk, limb severity, and anatomic pattern (PLAN) concept over a 2-year follow-up period.

Patients who underwent endovascular therapy for peripheral artery disease and presented with CLTI from February 2017 to February 2019 were retrospectively reviewed. The patients were grouped into yellow and gray zones based on the PLAN concept. Preoperative and postoperative walking distances, Rutherford classes, and postoperative target vessel patency rates were recorded and compared between the groups. Follow-up evaluations were performed at 1, 6, 12, and 24 months post-procedure.

Of the 387 patients evaluated, the yellow and gray groups comprised 88 patients each. The overall patency rates were similar between the groups (84 (95.45%) vs. 81 (92.05%), respectively). The occlusion-/stenosis-free survival times, amputation-free survival time, and mean survival time were not significantly different. However, the gray group had a significantly higher number of atherectomy interventions (74 vs. 59) and crosser devices used (62 vs. 42).

Endovascular therapy is an effective treatment option for patients in the gray zone of the PLAN color coding system.

High incidence of superficial femoral artery (SFA) restenosis after percutaneous transluminal angioplasty (PTA) poses a persistent challenge in peripheral arterial disease (PAD) treatment. We studied how the patients' and lesions' characteristics, thrombin generation, overall haemostatic potential (OHP), and single nucleotide polymorphisms (SNPs) of the NR4A2 and PECAM1 genes affected the likelihood of restenosis. In total, 206 consecutive PAD patients with limiting intermittent claudication due to SFA stenosis who were treated with balloon angioplasty with bailout stenting when necessary were included. Patients' clinical status and patency of the treated arterial segment on ultrasound examination were assessed 1, 6, and 12 months after the procedure. Restenosis occurred in 45% of patients, with less than 20% of all patients experiencing symptoms. In the multivariate analysis, predictors of restenosis proved to be poor infrapopliteal runoff, higher lesion complexity, absence of treated arterial hypertension, delayed lag phase in thrombin generation, and higher contribution of plasma extracellular vesicles to thrombin concentration. Poor infrapopliteal runoff increased the risk of restenosis in the first 6 months, but not later. The negative effect of poor infrapopliteal runoff on SFA patency opens questions about the potential benefits of simultaneous revascularisation of below-knee arteries along with SFA revascularisation.

An increasing proportion of patients with chronic limb-threatening ischemia are older and have multiple comorbidities, including diabetes and renal failure. For those who are not candidates for a surgical bypass, this set of patients presents a challenge to vascular surgeons and interventionalists owing to the complex below-the-knee and increasingly below-the-ankle disease pattern that can fail traditional approaches for endovascular intervention. Two techniques, the retrograde pedal access and the pedal-plantar loop technique, can be useful in these settings and in skilled hands can be used safely, with a high technical success rate. In patients with chronic limb-threatening ischemia who are not candidates for a single-segment saphenous vein bypass, the retrograde pedal access technique can be used not only in the setting of failed antegrade treatment, but also primarily when faced with a difficult groin or as an adjunct during a planned antegrade-retrograde intervention. The pedal plantar loop technique allows for retrograde access to tibial vessels without retrograde vessel puncture and additionally offers the ability to treat the pedal-plantar arch, which may have added benefit in wound healing. We describe the tips and tricks for these two techniques used in our limb salvage practice.

This work sought to develop a robust and clinically relevant swine model of critical limb ischemia (CLI) involving the onset of ischemic muscle necrosis. CLI carries about 25-40% risk of major amputation with 20% annual mortality. Currently, there is no specific treatment that targets the ischemic myopathy characteristic of CLI. Current swine models of CLI, with tolerable side-effects, fail to achieve sustained ischemia followed by a necrotic myopathic endpoint. Such limitation in experimental model hinders development of effective interventions. CLI was induced unilaterally by ligation-excision of one inch of the common femoral artery (CFA) via infra-inguinal minimal incision in female Yorkshire pigs (n = 5). X-ray arteriography was done pre- and post-CFA transection to validate successful induction of severe ischemia. Weekly assessment of the sequalae of ischemia on limb perfusion, and degree of ischemic myopathy was conducted for 1 month using X-ray arteriography, laser speckle imaging, CTA angiography, femoral artery duplex, high resolution ultrasound and histopathological analysis. The non-invasive tissue analysis of the elastography images showed specific and characteristic pattern of increased muscle stiffness indicative of the fibrotic and necrotic outcome expected with associated total muscle ischemia. The prominent onset of skeletal muscle necrosis was evident upon direct inspection of the affected tissues. Ischemic myopathic changes associated with inflammatory infiltrates and deficient blood vessels were objectively validated. A translational model of severe hindlimb ischemia causing ischemic myopathy was successfully established adopting an approach that enables long-term survival studies in compliance with regulatory requirements pertaining to animal welfare.

Diabetic foot is a clinical manifestation of diabetes with a wide range of symptoms, including ulceration, osteomyelitis, osteoarticular destruction, and gangrene, as a consequence of advanced disease. Some diabetic foot cases present general indications for amputation, including dead limb, threat to the patient's life, pain, loss of function, or nuisance. Various tools have been introduced to help decision-making in amputation for diabetic foot. However, it remains a conundrum because diabetic foot involves multiple pathomechanisms and factors that hinder its outcomes. Sociocultural issues often impede treatment from the patient's side. We reviewed different perspectives in diabetic foot management, particularly related to amputation. In addition to deciding whether to amputate, physicians should address amputation level, timing, and ways to avoid patient deconditioning. Surgeons should not be autocratic in these circumstances and should be aware of beneficence and maleficence when considering whether to amputate. The main goal should be improving the patients' quality of life rather than preserving the limb as much as possible.

To describe a crossing technique of stenotic/occluded and tortuous highly calcific ankle vessels during complex percutaneous limb salvage intervention in diabetic patients with ischaemic foot ulcers (Rutherford 5 and 6).

We propose a simple technique to achieve "straightening" of the tortuous vessel and allow safe devices passage into the foot arteries, Patients were asked to hold their foot in plantar or dorsal flexion, accordingly to the treated artery. If unable to do so, an equipe member executed the manoeuvre on their behalf.

The technique was applied in 148 cases, with a success rate of 81% (120/148). No complications related to the manoeuvre were observed.

Crossing of tortuous distal crural vessels can be challenging in diabetic patients; in our experience, this technique can be a useful tool to obtain a successful recanalization in complex procedures with high risk of failure.

This study aimed to examine the feasibility and impact of extra-vascular ultrasound (EVUS)-guided intervention for infrapopliteal (IP) artery occlusive disease.

A retrospective analysis was performed using data collected from patients who underwent endovascular treatment (EVT) for IP artery occlusive disease between January 2018 and December 2020 at our institution. A total of 63 consecutive de novoocclusive lesions were compared according to the recanalization method utilized. Propensity score matching analysis was performed to compare the clinical outcomes of the methods utilized. The prognostic value was analyzed based on the technical success rate, distal puncture rate, radiation exposure, amount of contrast media, postprocedural skin perfusion pressure (SPP), and procedural complication rate.

Eighteen matched pairs of patients were analyzed using propensity score-matched analysis. Radiation exposure was significantly lower in the EVUS-guided group than in the angio-guided group, with 135 and 287 mGy (p = 0.04) exposure on average, respectively. There were no significant differences between the two groups in terms of technical success rate, distal puncture rate, the amount of contrast media, postprocedural SPP, and procedural complication rate.

EVUS-guided EVT for IP occlusive disease achieved a feasible technical success rate and significantly reduced radiation exposure.

Diabetics are at 5-15 times greater risk of developing peripheral arterial disease (PAD) and few studies have compared risk factors and distribution and severity of arterial changes in diabetics compared with non-diabetics.

To compare angiographic changes between diabetic and non-diabetic patients with advanced PAD and correlate them with risk factors.

A retrospective cross-sectional study was conducted of consecutive patients undergoing lower limb arteriography for PAD (Rutherford 3-6) using TASC II and Bollinger et al. angiographic scores. Exclusion criteria were upper limb angiographies, unclear images, incomplete laboratory test results, and previous arterial surgeries. Statistical analyses included chi-square tests, Fisher's test for discrete data, and Student's t test for continuous data (significance level: p < 0.05).

We studied 153 patients with a mean age of 67 years, 50.9% female and 58.2% diabetics. A total of 91 patients (59%) had trophic lesions (Rutherford 5 or 6) and 62 (41%) had resting pain or limiting claudication (Rutherford 3 and 4). Among diabetics, 81.7% were hypertensive, 29.4% had never smoked, and 14% had a history of acute myocardial infarction. According to the Bollinger et al. score, infra-popliteal arteries were more affected in diabetics, especially the anterior tibial artery (p = 0.005), while the superficial femoral artery was more affected in non-diabetics (p = 0.008). According to TASC II, the most severe angiographic changes in the femoral-popliteal segment occurred in non-diabetic patients (p = 0.019).

The most frequently affected sectors were the infra-popliteal sectors in diabetics and the femoral sector in non-diabetics.

To evaluate the fluorescence angiography (FA) parameters with Indocyanine green (ICG) and their dynamics in diabetic foot patients after endovascular treatment.

A single-center prospective non-blinded study was conducted with the inclusion of 47 diabetic foot patients with Chronic limb-threatening ischemia (CLTI). TcPO2 and FA-ICG were done before and after angioplasty. Zones of interest were selected for FA-ICG: the area of minimum and maximum fluorescence, the area of of the largest part of the foot. Also presented are the parameters of FA ICG: Tstart (sec) - the time of occurrence of min fluorescence (Istart, unit) in the zone of interest after the introduction of ICG; Tmax (sec) - the time to achieve max fluorescence (Imax, unit) after the introduction of ICG; Tmax -Tstart (sec) - the difference in the time of reaching Imax and Istart.

The median TcPO2 values indicated the presence of CLTI before revascularization. Technical success of revascularization was achieved in 45 patients. In the postoperative period, statistically significant changes in TcPO2 and Tstart, Tmax, Tmax-Tstar were obtained. A reduction in the time to reach the ICZ to the zones of interest was noted.

FA-ICG evaluate the visual and quantitative characteristics of perfusion of soft tissues of the foot. Reducing the time to reach the fluorescent substance in the areas of interest makes it possible to assume the restoration of the main blood flow to the foot. Further investigations are warranted to determine threshold values to predict wound healing and indications for revascularization.

This subgroup analysis aimed to evaluate the effect of comorbidities on infrapopliteal angioplasty outcomes in patients with chronic limb-threatening ischemia (CLTI).

This was an observational study evaluating eligible CLTI patients aged >18 years who underwent infrapopliteal angioplasty between April 2014 and May 2017 at a tertiary care center. Subgroup analyses were based on (1) baseline glycated hemoglobin (HbA1c ≤6.5% vs >6.5%), (2) presence/absence of chronic kidney disease (CKD), and (3) control of lipid parameters.

A total of 231 patients with 332 infrapopliteal vessels were treated. While diabetes was prevalent in all participants, hypertension, coronary artery disease, and CKD were reported in 76.6%, 46.3%, and 25.5% of patients at baseline, respectively. The overall technical success rate was 84.4%, and the patency rate at 6 months was 82.04%. Patency at 6 months, wound healing, in-line flow, and complete plantar arch formation were numerically higher in patients with HbA1c ≤6.5% versus >6.5%, but all comparisons were nonsignificant. According to multivariable analysis, the odds of wounds not healing was 2.38 times higher (odds ratio [OR] = 2.4, 95% confidence interval [CI]: 1.2 to 4.5) and developing plantar arch was 5.88 times higher (OR = 5.9, 95% CI: 1.3 to 25) among patients with CKD compared with patients without CKD.

The 6-month outcomes of infrapopliteal angioplasty may be better in patients with controlled versus uncontrolled glycemic levels. Control of lipid parameters may not have a significant influence on outcomes, especially in patients on statin therapy. The short-term outcomes may be similar in patients with and without CKD.

Endovascular revascularization strategies have advanced tremendously over the years and are now often considered first line for treatment of peripheral arterial disease. Drug-eluting stents (DESs) have been developed as one of the tools to overcome the limitations of elastic recoil and neointimal hyperplasia observed with balloon angioplasty and bare metal stents. While these stents have been extremely successful in coronary revascularization, they have not translated as effectively to the peripheral arteries which differ in their unique mechanical environments and differences in vessel and lesion composition. DESs, through their embedded pharmaceutical agent, seek to inhibit vascular smooth muscle cell (VSMC) proliferation and migration. Paclitaxel, sirolimus, and its derivatives (-limus family) achieve VSMC inhibition through unique mechanisms. Several clinical trials have been performed to evaluate the use of DES in the femoropopliteal and infrapopliteal territory and have demonstrated overall decrease in revascularization rates and improved clinical outcomes.

Patients with diabetes mellitus (DM) have a more extensive distal arterial occlusive disease compared to non-diabetic patients. Diagnostic imaging is a necessity to identify the location and extent of the arterial occlusion in acute limb ischemia (ALI). Computed tomography angiography (CTA) is the most commonly used modality and the diagnostic performance with CTA of calf arteries may be questioned.

To evaluate diagnostic performance of CTA of calf arteries in ALI and to compare patients with and without DM.

All thrombolytic treatments performed during 2001-2018 in patients with ALI were included. Initial digital subtraction angiography (DSA) and CTA of all patients were classified according to the Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) below-the-knee arteries and compared to CTA. Two raters assessed the CTA images independently. Inter-rater reliability was expressed as intraclass correlation (ICC) with 95% confidence intervals (CI).

Patients with (n = 23) and without (n = 85) DM had lower (P = 0.006) glomerular filtration rate. ICC between CTA and DSA was 0.33 (95% CI -0.22 to 0.56) and 0.71 (95% CI 0.38-0.68) in patients with and without DM, respectively. Sensitivity with CTA for TASC D lesions in patients with and without DM was 0.14 (95% CI -0.12 to 0.40) and 0.64 (95% CI 0.48-0.80), respectively.

The sensitivity of CTA for assessment of infra-popliteal TASC D lesions in patients with ALI was not acceptable in patients with DM in contrast to those without DM. Another imaging option at present times should be considered for patients with DM.

Chronic limb-threatening ischemia (CLTI) carries a high risk of amputation and warrants urgent intervention. CLTI involving the infrageniculate vessels, in particular, carries a considerably higher risk of major limb amputation. Open surgical bypass is the historical gold standard for the treatment of tibial arterial disease; however, endovascular therapy provides an attractive alternative in this high-risk patient population. In this article, we review the existing literature regarding distal bypass and infrageniculate endovascular intervention in patients with CLTI.

To report 24 month safety and efficacy of the Tack Endovascular System for treatment of post-percutaneous transluminal angioplasty (PTA) infrapopliteal dissections in patients with critical limb-threatening ischemia (CLTI).

The Tack-Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) study was a prospective, multicenter, single-arm evaluation of the Tack Endovascular system for post-PTA infrapopliteal dissection repair. Patients with Rutherford Clinical Category (RC) 3 to 5 and a post-PTA dissection(s) of the BTK arteries were enrolled. The 30 day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary effectiveness endpoint was a composite of MALE at 6 months and 30 day POD. Outcomes were assessed as observational endpoints at 24 months.

Tack-Optimized Balloon Angioplasty II BTK enrolled 233 patients; all patients had a post-PTA dissection(s) and received ≥1 Tack implant (range, 1-16). Mean age was 74.4±10.0 years and 67.4% were men. Most patients had CLTI (RC 3: 16.3%; RC 4/5: 83.7%). Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions and total occlusions were present in 118 (47.6%) lesions. Kaplan-Meier freedom from MALE at 24 months + POD at 30 days was 92.2% and 24 month freedom from clinically-driven target lesions revascularization was 73.6%. Kaplan-Meier target limb salvage was 95.7% and amputation-free survival was 75.4%. Improvements in functional status and quality of life were observed through 24 months.

The TOBA II BTK study demonstrated sustained safety and efficacy through 24 months in patients treated for post-PTA dissection(s) of BTK lesions.

ClinicalTrials.gov identifier NCT02942966.

The aim of this study is to evaluate the 5-year clinical outcome of the DEBATE-BTK (Drug-eluting balloon for below-the-knee angioplasty evaluation) trial.

The DEBATE-BTK was a single-center, randomized trial that enrolled 132 diabetic patients with critical limb ischemia. Subjects were randomized 1:1 to DCB or plain old balloon angioplasty (POBA). Major clinical endpoints were, freedom from all-cause death, freedom from clinically driven target lesion revascularization (CDTLR) and the occurrence of major amputation. Additional analysis were conducted to assess overall survival in patients treated with DCB compared to those treated with only POBA in the entire 5-years period and to test the correlation between paclitaxel dose exposure (in terciles) and overall survival.

Freedom from all-cause death at 5 years was 63.1% (41/65) in DCB vs. 53.7%(35/67) POBA patients (p = 0.4). Freedom from CDTLR was 82% in DCB and 63% in POBA patients (p = 0.002) at 1 year and 63 versus 54% at 5 years respectively P = 0.07. One patient in DCB and 2 patients in POBA underwent a major amputation of the target limb. During the 5-year follow-up, 24 patients originally randomized to POBA received DCB treatment for additional limb revascularization. According to DCB treatment in all the 5 years period, overall survival was 66.3.% (30/89) in DCB versus 40%(26/43) in POBA patients, p = 0.003.

Overall survival at 5-year was similar in DCB treated patients compared to POBA. Moreover, survival was higher in patients that received DCB angioplasty at any time of the 5 years period.

Level 1b, Individual inception cohort study with > 80% follow-up.

To assess a specific classification of the foot atherosclerotic disease concerning the angiosomal source arteries, the connected foot arches and attached collaterals for Rutherford 5, CLTI patients. To compare eventual analogies of this novel grading system with previously reported GLASS/GVG inframalleolar patterns of occlusive disease (P0-P2).

A series of 336 ischemic feet (221 diabetics) were selected and retrospectively analyzed. For each angiographic pattern of inframalleolar atherosclerotic disease, 4 severity classes of targeted angiosomal artery path (TAAP), associating 4 other classes concerning linked foot arches (LFA) and collaterals occlusive disease were described. By associating the 4 TAAP with the 4 others parallel LFA and collaterals classes, 4 novel anatomical "Grades" (A-D) of occlusive disease were described. Limb salvage was studied between groups of diabetic and non-diabetic patients.

Using a primary endovascular approach, limb preservation comparison of grade A/B proved without significance for diabetics (P = 0.032) and non-diabetics (P = 0.226). Comparison in diabetics and/or non-diabetics between A/C (P = 0.045 and 0.046), A/D (P = 0.027 and 0.030, B/C (P = 0.009 and 0.038), and B/D (P = 0.006 and P = 0.042), as well as C/D groups (P = 0.048 and P = 0.034) proved ponderous. Parallel analysis of similar grades (A/A, B/B, etc.) with, or without diabetes appeared without significance (P > 0.05). Further comparison between grades A+B (assigned as P0/GVG), versus C (P1), and D (P2), proved significant (P < 0.0001).

The present grading system proposes a useful correlation between the severity of foot angiosomal arteries, arches, and collaterals disease and limb salvage, confirming the clinical significance of P0-P2 GVG severity score. This analysis also points the limits of EVT to be probably avoided in grade D patients.

Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease. It is estimated that 60% of all nontraumatic lower-extremity amputations performed annually in the United States are in patients with diabetes and CLTI. The consequences of this condition are extraordinary, with substantial patient morbidity and mortality and high socioeconomic costs. Strategies that optimize the success of arterial revascularization in this unique patient population can have a substantial public health impact and improve patient outcomes. This article provides an up-to-date comprehensive assessment of management strategies for patients afflicted by both diabetes and CLTI.

Atherosclerosis is a systemic disease with different faces. Despite identical or similar pathogenetic mechanisms, atherosclerotic lesions and their clinical manifestations vary in different parts of the vascular system. Peripheral arterial disease (PAD) represents one of the most frequent clinical manifestations of atherosclerosis with predominant location in the superficial femoral artery (SFA). Morphological characteristics of atherosclerotic plaques in peripheral arteries differ from lesions in the coronary and carotid arteries. Plaques in SFA have more fibrotic components, less lipids and inflammatory cells, which makes them more stable and less prone to rupture. Factors that determine the different structure of plaques in SFA compared to coronary arteries include hemodynamic forces, vasa vasorum and calcification. Low shear stress in SFA in the adductor canal is one of the factors which determines frequent atherosclerotic lesions in this region. Lower lipid content and fewer inflammatory cells explain higher stability of SFA plaques. The specific structure of SFA plaques may require preventive and therapeutic measures, which to some extent differ from prevention of coronary atherosclerosis and may include inhibition of fibrotic proliferation in SFA plaques and calcification. Revascularization of PAD differs from procedures used in coronary arteries and requires specific technical expertise and devices.

Anatomic grading systems have historically been poor predictors of patency after endovascular tibial interventions. The Global Vascular Guidelines proposed a new Global Anatomic Staging System (GLASS) to estimate one-year limb-based patency (LBP). The purpose of this study was to determine the association of GLASS with LBP following endovascular tibial interventions.

We included all patients presenting to our multidisciplinary diabetic limb preservation service between 01/2012 and 8/2020 who underwent first-time endovascular tibial revascularization for chronic limb-threatening ischemia. Diagnostic angiograms were reviewed to define the preferred target artery pathway and assign a GLASS stage to each treated limb. One-year LBP was calculated and compared across GLASS stages using Kaplan-Meier curves with log-rank tests and Cox proportional hazards models.

We performed tibial revascularization in 96 limbs (5.2% rest pain, 56.3% ulcer, 37.5% gangrene), including isolated tibial interventions in 61.5% and tibial + femoropopliteal interventions in 38.5%. 15.6% of limbs were GLASS stage 1, 28.1% were GLASS stage 2, and 56.3% were GLASS stage 3. Overall, one-year LBP was 43.2 ± 6.3%, and did not differ significantly across GLASS stages (P = 0.42). The hazard ratio for failed LBP was 1.94 (95% CI 0.70-5.41) for GLASS stage 2 and 1.49 (95% CI 0.56-3.94) for GLASS stage 3 limbs (versus GLASS stage 1). When analyzed excluding the calcium modifier, LBP remained similar across GLASS stages (P = 0.72). Major amputation was uncommon, occurring in 9.3 ± 3.4% of limbs at one year, and did not significantly differ by GLASS stage (P = 0.98).

The Global Anatomic Staging System did not predict limb-based patency following tibial endovascular interventions. Given the low major amputation rates in this cohort, anatomic complexity should not preclude endovascular limb salvage efforts below the knee.

The aim of this study was to evaluate the influence of pedal arch quality on 5-year survival and limb salvage in diabetic patients with foot wounds undergoing peripheral angiography.

Between January 2014 and December 2014, 153 diabetic patients with foot wounds underwent peripheral angiography. Final foot angiograms were used to allocate patients according to pedal arch: complete pedal arch (CPA), incomplete pedal arch (IPA), and absent pedal arch (APA). Five-year survival and limb salvage rates were analyzed with Kaplan-Meier curves and compared by means of Gehan-Breslow-Wilcoxon test. Associations of patient and procedure variables with overall survival and limb salvage outcomes were sought with univariate and multivariate analyses.

A below-the-knee (BTK) artery was the target vessel in 80 cases (52.3%). Five-year Kaplan-Meier rates of survival were similar in all groups (p = 0.1): CPA 30%, IPA 27.5%, and APA 26.4%. Five-year limb salvage rates were significantly better in patients with CPA/IPA (p < 0.001): CPA 95.1%, IPA 94.3%, and APA 67.3%. In the whole population study, multivariate analysis showed significant association of smoking (p = 0.01), chronic renal failure (p = 0.02), and severity of foot wounds (p < 0.001) with survival. Coronary artery disease (p = 0.03), severity of foot wounds (p = 0.001), and pedal arch status (p = 0.05) showed strong association with limb salvage.

Pedal arch quality significantly affected limb salvage but not survival at 5 years in patients with diabetic foot ulcers. Smoking, chronic renal failure, and severity of foot wounds affected overall survival, whilst coronary artery disease, and severity of foot wounds limb salvage.

Osteomyelitis represents a challenging condition in the diabetic foot with an associated high risk of major amputation. S53P4 Bioactive Glass (BG) has bacterial inhibiting properties on the market and indicated to be used in osteomyelitis. The objective of the study was to test the efficacy and safety of BG in treating diabetic foot osteomyelitis. This was an observational, retrospective, single-centre study involving subjects with diabetes affected by osteomyelitis of the foot who underwent surgical debridement from 01/2016 to 10/2018. Overall, 44 diabetic patients (14 [31.8%] female, aged 68.0 ± 10.2 years, diabetes duration 26.8 ± 11.9 years) were studied: 22 (50%) treated with surgical debridement and a local application of BG; 22 (50%) treated by means of surgical debridement. The primary outcome was the osteomyelitis resolution. Revascularization was performed before surgical procedure in 31 (70.5%) of patients. Systemic antibiotics were used in both groups. The osteomyelitis resolution rate was significantly higher in subjects treated with BG than in subjects treated with traditional procedure (18 [90%] vs 13 [61.9%], respectively p = .03). The odds of BG to reach osteomyelitis resolution was 5.54 times greater than for traditional treatment (odds ratio 5.54, 95% confidence interval 1.10-30.5). The use of BG was associated with an 81% lower probability to need additional antibiotic therapy compared to subjects treated with traditional procedure (odds ratio 0.19, 95% confidence interval 0.04-0.87). The debridement of osteomyelitis followed by application of BG could be an effective and safe option in the treatment of osteomyelitis of the diabetic foot.

Effective revascularization of the patient with peripheral artery disease is about more than the procedure. The approach to the patient with symptom-limiting intermittent claudication or limb-threatening ischemia begins with understanding the population at risk and variation in clinical presentation. The urgency of revascularization varies significantly by presentation; from patients with intermittent claudication who should undergo structured exercise rehabilitation before revascularization (if needed) to those with acute limb ischemia, a medical emergency, who require revascularization within hours. Recent years have seen the rapid development of new tools including wires, catheters, drug-eluting technology, specialized balloons, and biomimetic stents. Open surgical bypass remains an important option for those with advanced disease. The strategy and techniques employed vary by clinical presentation, lesion location, and lesion severity. There is limited level 1 evidence to guide practice, but factors that determine technical success and anatomic durability are largely understood and incorporated into decision-making. Following revascularization, medical therapy to reduce adverse limb outcomes and a surveillance plan should be put in place. There are many hurdles to overcome to improve the efficacy of lower extremity revascularization, such as restenosis, calcification, microvascular disease, silent embolization, and tools for perfusion assessment. This review highlights the current state of revascularization in peripheral artery disease with an eye toward technologies at the cusp, which may significantly impact current practice.