Prospective Multi-Center Longitudinal Study to Validate Accuracy of the Global Anatomic Staging System (GLASS) Score in Predicting Major Acute Limb Events in Patients With Chronic Limb Threatening Ischemia Undergoing Endovascular Intervention: The PROMOTE-GLASS Study Protocol.

INTRODUCTION: Developed by the Global Vascular Guidelines committee, the Global Limb Anatomic Staging System (GLASS) is an angiographic scoring system used for quantifying infrainguinal disease extent and predicting treatment success with endovascular techniques (EVT). Currently, no other risk prediction model is available for patients with chronic limb threatening ischemia (CLTI) undergoing EVT. GLASS' validation and adoption outside academic institutions for research are limited. Thus, this longitudinal multicenter prospective study aims to examine GLASS' validity and reliability in predicting major acute limb events and overall survival (OS) in patients with CLTI undergoing EVT. METHODS AND ANALYSIS: This prospective, international, multicenter, observational study will include patients with CLTI undergoing EVT (PROMOTE-GLASS) (ClinicalTrials.gov; ID: NCT06186544) identified through routine clinical referrals and emergency visits to vascular units in participating centers. Only patients who are referred for EVT will be recruited. The primary outcomes are immediate technical success, immediate technical failure, and 1-year limb base patency. The secondary outcomes are major adverse limb events, major lower limb amputation, and OS in patients presenting with CLTI who undergo EVT up to 1 year after the procedure. Clinical and imaging data will be analyzed at the end of follow-up to validate risk prediction. This protocol outlines our approach for identifying cases, GLASS score calculation, outcome measures assessment, and a statistical analysis plan. ANTICIPATED IMPLICATIONS: PROMOTE-GLASS holds significant implications and can potentially revolutionize clinical decision-making by assisting clinicians in identifying patients who are likely to benefit from EVT. Ultimately, reduce the need for more invasive procedures and improve patient outcomes. Furthermore, PROMOTE-GLASS can provide useful information, including patient selection, for future randomized controlled trials (RCTs) investigating EVT for CLTI. PROMOTE-GLASS anticipated implications on the vascular community are rooted in its potential to improve patient care, inform future research, and address limitations in existing literature regarding CLTI treatment outcomes.

Progressive Acute Lower Extremity Ischemia Resulting From Cardiac Myxoma Embolization: A Case Report.

Cardiac myxomas are the most common primary benign tumors of the heart. The occlusion of peripheral arteries and complete obstruction of the abdominal aorta by a tumor embolus presents with distinct clinical manifestations. Herein, we present the case of a 38-year-old male with acute paresthesia, muscle weakness, erythematous, and violaceous changes in skin color localized to the dorsum of the left forefoot initially treated as cutaneous vasculitis. Further studies revealed the total occlusion of the terminal abdominal aorta by a saddle embolus from a cardiac myxoma. A multidisciplinary team consisting of cardiothoracic and vascular surgeons were involved in treating the patient, which resulted in full resolution of the case. This paper details the progression of acute bilateral limb ischemia to chronic limb threatening ischemia resulting from the total occlusion of the terminal abdominal aorta by a saddle embolus.

Prehabilitation for delirium prevention in elderly patients with chronic limb threatening ischemia.

OBJECTIVE: Elderly patients with Chronic Limb Threatening Ischemia (CLTI) undergoing revascularization are prone to delirium and prolonged hospitalization. Preoperative prehabilitation may prevent delirium and reduce the length of stay. This study investigates the effect of multimodal prehabilitation on delirium incidence in elderly CLTI patients undergoing revascularization. METHODS: A comparative observational cohort study conducted in a large teaching hospital (intervention cohort n=101, retrospective control cohort n=207) and a university hospital (prospective control cohort n=48) from 2020 to 2023. Patients aged ≥ 65 years undergoing revascularization were included, with acute treatment or severe cognitive impairment as exclusion criteria. The three-week prehabilitation program included screening of general health and presence of delirium risk factors by a vascular nurse practitioner, screening and provision of personalized, home-based exercises by a physiotherapist, provision of nutritional advice by a dietician, and if indicated comprehensive geriatric assessment by a geriatrician, assessment of self-reliance and home situation by a prearranged homecare nurse, guidance and support for smoking cessation by a quit smoking coach, and anaemia treatment. Primary outcome was 30-day delirium incidence, analysed using regression models adjusting for potential confounders (age, physical impairment, history of delirium, preoperative anaemia and revascularization type). Secondary outcomes were length of stay, postoperative complications, 30-day mortality, and patient experiences. RESULTS: Median age (IQR) was 76 years (71-82). Delirium incidence was lower in the prehabilitation cohort (n=2/101, 2%) compared to controls (n=23/255, 9%; OR=0.21, 95%CI 0.05-0.89, p=.04). Adjusted analysis showed a non-significant delirium reduction (OR=0.28, 95%CI 0.06-1.3, p=.097). The prehabilitation cohort had a significantly shorter length of stay (2 [1-5] vs 4 [2-9] days; p=<.001), and fewer minor complications (14% vs 26%, p=.01). No differences were present in major complications and 30-day mortality. Patients reported high compliance and satisfaction (median score 8/10, IQR 7-9). CONCLUSIONS: Prehabilitation among elderly CLTI patients is safe and has the potential to yield multiple beneficial effects on general outcomes following revascularization, while also achieving high levels of patient satisfaction. Further validation and considering implementation in surgical settings is recommended.

Popliteal-Distal Bypass Affords Better Limb Salvage than Tibial Angioplasty for Chronic Limb-Threatening Ischemia.

OBJECTIVE: Chronic limb-threatening ischemia (CLTI) due to isolated tibial occlusive disease is treated by either popliteal distal bypass or tibial angioplasty, although there is limited data directly comparing efficacy and outcomes between these two treatment modalities. This study compares 30-day mortality and major adverse limb events following infrapopliteal bypass and tibial angioplasty in patients with CLTI. METHODS: Patients who underwent popliteal distal bypass for CLTI were extracted from American College of Surgeons National Surgical Quality Improvement Program targeted lower extremity open database, whereas patient with CLTI who underwent isolated tibial angioplasty were identified in the targeted lower extremity endovascular database. Any case with more proximal angioplasty such as femoral/pop/iliac was excluded. The time interval was 2011-2022. The two groups were comparable in demographics and pre-operative comorbidities were obtained using propensity matching. Mortality, systemic complications, and major adverse limb events were measured. Multivariable logistic regression was used for data analysis. To obtain granular data on the angiographic characteristics of patients undergoing popliteal-distal bypass or tibial angioplasty, The George Washington University institutional data from 2014 to 2019 was used as supplement to the database. RESULTS: There were 1,947 and 3,423 cases identified in the bypass and endovascular groups, respectively. After propensity matching for all preoperative variables, 1,747 cases remained in each group. Although bypass was associated with higher major adverse cardiovascular events, pulmonary, renal, and wound complications, bypass had significantly better 30-day limb salvage when compared to tibial angioplasty (major amputation rate 3.32% vs. 6.12%; p<0.01). Institutional data identified 69 patients with CLTI due to isolated tibial occlusive disease; 25 (36.2%) underwent popliteal-distal bypass and 44 (63.8%) underwent tibial angioplasty. Reviewing of angiographic details revealed patients who underwent popliteal-distal bypass had better pedal targets (inframalleolar/pedal score of P0 [24.0% vs 15.9%] or P1 [68.0% vs 61.3%]) than tibial angioplasty patients (inframalleolar/pedal score of P2 [22.7% vs 8.0%]). CONCLUSION: Popliteal-distal bypass was associated with higher morbidity but better limb salvage than endovascular interventions. However, this could be explained by the association with better pedal targets in patients who underwent popliteal-tibial bypass. Prospective studies should be done comparing popliteal distal bypasses and tibial angioplasty in cases with similar pedal targets.

The Role of Intravascular Ultrasound in Limb Salvage: A Systematic Review and Meta-Analysis.

PURPOSE: The purpose of this study was to review the current literature of intravascular ultrasound (IVUS) use in real world cohorts inclusive of chronic limb threatening ischemia (CLTI) patients and compare the outcomes to patients imaged by angiography alone. METHODS: The systematic review was registered in Research Registry. A literature search was performed across 4 databases: PubMed, Medline/Embase, Cochrane Review, and Web of Science for eligible comparative studies. The primary outcomes examined were clinically driven target lesion revascularization (CD-TLR), amputation (including minor below the ankle and major above the ankle), all-cause mortality, limb salvage and mean balloon dilation. A random effects model was used when pooling outcomes to account for heterogeneity. Publication bias was determined using eggers test and illustrated on a funnel plot. MAIN FINDINGS: Six studies were included in this review, with a total of 1883 subjects with Rutherford 1-6. Among the 1883 subjects, 940 had Rutherford 4-6. IVUS was used in 1294 subjects and angiography alone was used in 589 subjects. Pooled analysis determined no significant association in IVUS + angiography with CD-TLR (O.R = 1.43 [CI: 0.80, 2.58]), all-cause amputation (O.R = 0.63 [CI: 0.34, 1.17]), and all-cause mortality (O.R = 0.63 [CI: 0.34, 1.17]). Sub analysis of subjects with CLTI, Rutherford classes 4-6 showed an association between IVUS + angiography use with limb salvage at 1 year, O.R = 2.22 [1.24, 3.97]. CONCLUSION: The use of IVUS + angiography compared to angiography alone showed larger reference vessel diameter in both all-inclusive Rutherford classifications and the CLTI subset. The use of IVUS + angiography compared to angiography alone showed no difference in CD-TLR at 12 months, lower extremity amputation, and all-cause mortality for Rutherford 1-6. The use of IVUS + angiography compared to angiography alone in the CLTI subset analysis improved limb salvage.

Magnetic Resonance Imaging - Derived Psoas Muscle Area and Survival in Patients Treated Invasively for Peripheral Arterial Disease.

BACKGROUND AND AIMS: Psoas muscle parameters estimated from computed tomography images, as surrogates for sarcopenia, have been found to be associated with post-interventional outcomes after a wide range of cardiovascular procedures. The pre-interventional assessment in patients undergoing invasive treatment for peripheral arterial disease is increasingly often carried out with magnetic resonance imaging (MRI), and we therefore sought to investigate the predictive potential of MRI-derived psoas muscle area in this cohort. METHODS: A total of 899 patients with available sufficient quality pre-interventional MRI conducted within 6 months prior to treatment undergoing open, endovascular, or hybrid revascularization procedures for claudication and/or limb-threatening ischemia at Tampere University hospital between 2010 and 2020 were retrospectively studied in this single-center cohort study. The follow-up lasted until 17 June 2021. Psoas muscle areas were measured from the magnetic resonance images at the L4 level, and the reliability of muscle parameter measurements was tested with intraclass correlation coefficient analysis. The average psoas muscle area values (mean of left and right psoas surface areas) were z-scored and analyzed separately for men and women. RESULTS: The median follow-up time was 5.9 years (interquartile range (IQR) = 2.7-7.8), and the overall mortality count was 259 (28.8%) (29.5% n = 168/569 for men and 27.6% n = 91/330 for women). The intraclass correlation coefficient analysis showed excellent interrater reliability for psoas muscle measurements. The muscle surface areas were larger in men (mean = 7.58 cm2) compared to women (mean = 5.27 cm2) (p < 0.001). Higher psoas muscle area was associated with better survival in women (p = 0.003, hazard ratio (HR) = 0.71, 95% confidence interval (CI) = 0.6-0.9 per 1 SD), whereas in men, an independent association of the muscle parameter with mortality was not found. CONCLUSIONS: MRI-derived psoas muscle area may be a prognostic factor for clinical use.

Perceptions, barriers and facilitators regarding nutritional care for patients with chronic limb threatening ischemia: a focus group study among healthcare professionals.

BACKGROUND: Nutrition and nutritional care are essential for optimal outcomes, and, therefore of importance for patients with chronic limb threatening ischemia (CLTI) given their high risk of complications. However, insight is lacking in how healthcare professionals directly involved in the care of patients with CLTI perceive nutritional care, as well as in the perceived barriers and facilitators regarding optimal nutritional care. METHODS: In this qualitative study with a phenomenological approach, three online focus groups were conducted with various healthcare professionals directly involved in the care of patients with CLTI. Sample size was guided by information power. Focus group recordings were transcribed verbatim, and reflexive thematic analysis was performed. RESULTS: Seventeen healthcare professionals participated, including vascular surgeons, fellows in vascular surgery, a medical doctor and researcher, nurse specialized in wound care, general nurse, physical therapists, dietitians, and nutrition assistants. Four themes were generated: (1) nutritional care is crucial for optimal clinical outcomes and a healthy life, (2) insufficient attention to undernutrition and nutritional care by healthcare professionals, (3) patient-related factors challenge healthcare professionals in providing nutritional care, and (4) need for optimizing the organizational process related to nutritional care. Perceived barriers regarding nutritional care included knowledge deficits, nutritional care not being part of the healthcare professionals' routine, missing tools to identify undernutrition, patient-related factors, and time constraints. Facilitators regarding nutritional care included more scientific evidence regarding the effect of nutritional care on clinical outcomes and optimization of organizational processes related to nutritional care. CONCLUSION: Healthcare professionals perceive nutritional care as important for optimal outcomes, but nutritional care is not routinely implemented in the care of patients with CLTI. This lack of implementation of nutritional care may be due to the barriers perceived in various domains. The findings of this study stress the need to optimize nutritional care, with the aim of improving outcomes in the CLTI population.

Impact of Housing Status on Surgical Management and Inpatient Outcomes of Chronic Limb-Threatening Ischemia in the United States.

INTRODUCTION: Chronic limb-threatening ischemia (CLTI) represents the most severe form of peripheral artery disease. While previous studies have focused on gender and racial disparities, there is lack of evidence regarding the impact of housing status. The aim of this analysis was to identify disparities in inpatient management and outcomes of CLTI based on housing status. METHODS: In this retrospective, descriptive study, we analyzed patients admitted with CLTI who underwent revascularization, as identified by ICD-10 codes, between 2016-2021, using the National Inpatient Sample database. The patients were stratified by their housing status and a detailed, propensity-matched analysis was conducted to compare the demographics, comorbidities, mortality rates, types of intervention, resource utilization, and inpatient outcomes. RESULTS: During the study, 2,667,294 patients were admitted with CLTI, and 17% (463,435) underwent revascularization. Among these, 0.4% (1,790) were unhoused. Males were overrepresented in the unhoused group (83.5% vs. 62.5%, p<0.001). Unhoused patients were more likely to receive endovascular revascularization (AOR 1.77, 0.45-0.90, p=0.003) but less likely to undergo open surgical intervention (AOR 0.64, 0.45-0.90, p=0.010). They were also more likely to undergo aortoiliac interventions, while housed patients underwent more distal interventions. The mean adjusted length of stay was four days longer and inflation-adjusted costs were $8,501 higher for unhoused patients (p<0.001). Unhoused patients were also more likely to leave against medical advice and be transferred to skilled nursing facilities. CONCLUSION: This study highlights significant disparities in CLTI management and outcomes between housed and unhoused patients, underscoring the need for targeted interventions to address these inequities.

Mid-term results of popliteal-pedal inframalleolar vein bypasses in CLTI patients after previous failed tibial endovascular recanalization.

OBJECTIVES: Inframalleolar bypass still preserves its role in the modern endovascular era. Aim of this study was to evaluate the mid-term outcomes of "short" inframalleolar vein bypasses in patients with chronic limb-threatening ischemia (CLTI) after previous failed tibial endovascular recanalization. METHODS: Between January 2015 and December 2021 107 CLTI patients in 3 Italian Departments of Vascular Surgery underwent "short" inframalleolar vein bypass after failed tibial endovascular recanalization. Early (30-day) and 3-year outcomes were evaluated in terms of survival, primary patency, primary assisted patency, secondary patency, and amputation-free survival. Univariate analysis of the perioperative factors affecting outcomes were performed by means of log-rank test. Associations of procedure variables were sought based on a multivariate Cox regression analysis. RESULTS: Distal anastomosis (inframalleolar) was mostly performed on dorsal pedis (64, 59.8%). At 30 days bypass occlusion was recorded in 5 cases (4.6%). Mean follow-up period was 20.5 ± 17.9 months. Estimated 3-year overall survival was 66.7%. Three-year estimates of primary patency, primary assisted patency, secondary patency, and amputation-free survival were 68.5%, 70.1%, 70.2%, and 76.7%, respectively. Multivariate analysis showed a negative association of insulin treatment with primary patency (HR 4.3, p = .04), primary assisted patency (HR 5.1, p = .02), and secondary patency (HR 5.1, p = .02). Negative association of long-term corticosteroid use was also found with primary patency (HR 7.8, p = .005), primary assisted patency (HR 8.7, p = .003), secondary patency (HR 8.7, p = .003), and amputation-free survival (HR 3.9, p = .05). CONCLUSIONS: "Short" vein bypasses to the foot arteries in CLTI patients yielded good mid-term overall patency, and limb salvage rates after a failed tibial endovascular recanalization. Insulin dependent diabetes mellitus, and long-term corticosteroid use seemed to affect the outcomes.

Purified CD34+ Cells Transplantation in Patients with Angiitis-induced Chronic Limb-threatening Ischemia: A Single-center Retrospective Study over A 10-year Period.

BACKGROUND: Angiitis-induced chronic limb-threatening ischemia (AICLTI) is defined as chronic limb-threatening ischemia (CLTI) caused by thromboangiitis obliterans (TAO) or other arteritis-related autoimmunological diseases. In the current study, we aimed to report the 10-year outcomes of AICLTI patients who underwent purified CD34+ cells (PCCs) transplantation. METHODS: AICLTI patients who underwent PCCs transplantation at our center from May 2009 to September 2011 were retrospectively enrolled. The main outcome was major amputation-free survival (MAFS); other outcomes included Rutherford classification, intolerable pain-free walking time (IPFWT), Wong-Baker Faces Pain Rating Scale (WBFPS), recurrence, new lesions, quality of life (QoL) and patients' posttransplantation work conditions. RESULTS: Twenty-four patients were enrolled with a mean age of 41.5±7.8 years. Three underwent major amputation during the follow-up, and the 10-year MAFS was 87.5%. Eight were observed to have recurrence, and 2 had new lesions; the 10-year recurrence-free rate was 66.1%. All patients were unable to work at admission, 17 (70.8%) patients were reemployed after transplantation. CONCLUSION: The current study further demonstrated satisfactory long-term efficacy of PCCs transplantation, with a 10-year MAFS of 87.5%. However, the 10-year recurrence-free rate of 66.1% suggested that strict and regular long-term follow-up is necessary.

Impact of High Lipoprotein(a) Levels on Delayed Wound Healing in Patients With Chronic Limb-Threatening Ischemia After Peripheral Endovascular Therapy.

BACKGROUND: Elevated lipoprotein(a) [Lp(a)] levels are a causal risk factor for peripheral artery disease. However, data on their effect on delayed wound healing in patients with chronic limb-threatening ischemia (CLTI) are limited. The present study assessed the association between elevated Lp(a) levels and delayed wound healing in patients with CLTI. METHODS AND RESULTS: This study included 280 patients who successfully received endovascular therapy for CLTI between September 2016 and August 2021. High Lp(a) levels were defined as those >30 mg/dL. The primary outcome was wound healing. During a median follow-up of 20.4 months (interquartile range 6.8-38.6 months), 146 patients achieved wound healing. The wound healing rate at 24 months was significantly lower in the high Lp(a) than low Lp(a) group (41.1% vs. 86.3%, respectively; P<0.001). The adjusted risk ratio was 0.19 (95% confidence interval 0.13-0.29, P<0.001). Lp(a) levels of 31-50 and >50 mg/dL, but not 16-30 mg/dL, were significantly associated with delayed wound healing relative to Lp(a) levels of ≤15 mg/dL. CONCLUSIONS: Elevated Lp(a) levels were independently associated with delayed wound healing in patients with CLTI treated with endovascular therapy.

Infrapopliteal Surgical and Endovascular Intervention.

Infrapopliteal revascularization is generally performed for patients with chronic limb-threatening ischemia. As with revascularization in other fields, the indications for endovascular treatment (EVT) have expanded in recent years due to advances in endovascular devices and techniques. However, the optimal revascularization method must be selected based on (1) patient risk, (2) limb severity, and (3) anatomical pattern of disease. Therefore, vascular surgeons need to understand the characteristics of EVT and surgical treatment and improve their technical skills in both procedures. Here is an overview of the current methods of revascularization. (This is a translation of Jpn J Vasc Surg 2024; 33: 61-65).

Clinical Outcomes After Distal Bypass in Patients With Chronic Limb-Threatening Ischemia due to Connective Tissue Disease.

OBJECTIVES: Chronic limb-threatening ischemia (CLTI) is mostly caused by arteriosclerosis, but is sometimes due to connective tissue disease. However, there is a limited knowledge of clinical outcomes of patients with CLTI with connective tissue disease. The objective of the study was to assess outcomes after distal bypass in these patients using global vascular guidelines. MATERIAL AND METHODS: Data from distal bypasses performed for CLTI at a single center from 2014 to 2023 were evaluated retrospectively. Clinical outcomes after distal bypass were compared for patients with CLTI with arteriosclerosis (AS group) and those with connective tissue disease (CD group). The primary endpoints were limb salvage and wound healing. RESULTS: Of the 282 distal bypasses performed for 222 patients with CLTI, 22 were conducted for 21 patients with connective tissue disease (CD group). The connective tissue disease was progressive systemic scleroderma (n = 11 patients), pemphigoid diseases (n = 2), polyarteritis nodosa (n = 2), rheumatoid arthritis (n = 2), and others (n = 4). Compared with the AS group, the CD group included more females (P = .007) and had greater oral steroid use (P < .001) and a higher Global Limb Anatomical Staging System (GLASS) inframalleolar (IM) modifier P2 (P < .001). The mean follow-up period of the whole cohort was 27 ± 22 months with no significant difference between the groups (P = .25), and 22 limbs required major amputation during this period. The 2-year limb salvage rate was significantly lower in the CD group compared to the AS group (75% vs 94%, P = .020). Wound healing was achieved in 220 (78%) limbs, and the 12-month wound healing rate was significantly lower in the CD group (52% vs 86%, P = .006). CONCLUSION: The low 2-year limb salvage and 12-month wound healing rates in patients with CLTI with connective tissue disease indicate that distal bypass may be challenging in these patients.

Weighted-Incidence Syndromic Combination Antibiogram (WISCA) to Support Empirical Antibiotic Therapy Decisions in Infected Ischemic Leg Ulcers-A Feasibility Study.

Objective: Patients with peripheral artery occlusive disease (PAD) are at risk of developing foot ulcers, which can subsequently lead to foot infections and an increased risk of amputation. In cases of severe ischemic foot infections (IFIs), the empirical use of antibiotics can be limb-saving. However, there is currently no evidence-based guidance on the choice of empirical antibiotic therapy for IFI. Methods and Design: This retrospective single-center cohort study included 216 hospitalized patients with severe IFI undergoing endovascular revascularization. Weighted-Incidence Syndromic Combination Antibiograms (WISCAs) were calculated to guide empirical antibiotic choice. Results: The two most common causative pathogens for IFI were S. aureus and P. aeruginosa, with frequencies of 19.8% and 6.1%, respectively. The calculation of WISCAs revealed a low empirical coverage of amoxicillin (AMX) or clindamycin (CLN) with 21.6% and 27.7%, respectively. The empirical coverage of amoxicillin/clavulanic-acid (AMC), trimethoprim/sulfmethoxazole (SXT), and ciprofloxacin (CIP) was 50.6%, 53.1%, and 55.4%, respectively. Piperacillin/tazobactam (PT) exhibited the highest empirical coverage, with 82.5% as calculated by WISCAs. The calculated WISCAs did not significantly alter when stratified by the clinical characteristics of the patients. Conclusions: The empirical antibiotic coverage of CLN and AMX was low. SXT represents a promising empirical alternative in the case of IFI, irrespective of comorbidities and the WIfI score. WISCAs can assist in the decision-making process regarding empirical antibiotic therapy choices in cases of IFI.

Midterm results of atherectomy as an adjunct to endovascular intervention in a population with chronic limb-threatening ischemia.

Introduction: The use of atherectomy in peripheral vascular intervention remains controversial. Aim: To review our experience with atherectomy as an adjunct to endovascular revascularization in a successive group of patients with chronic limb-threatening ischemia (CLTI). Material and methods: Consecutive patients with CLTI treated in a high-volume vascular center between 12/01/2019 and 12/31/2021 were reviewed. Follow-up data were abstracted from office and hospital records. Endpoints were death, all amputation, major amputation and target lesion revascularization (TLR). Secondary endpoints were relief of ischemic rest pain and healing of wounds. Results: During the study period 405 patients (447 limbs) underwent an endovascular procedure. Mean age was 77 ±11.7 years. Of the 447 limbs treated, 123 (27.5%) were Rutherford 4, 284 (63.5%) Rutherford 5 and 40 (8.9%) Rutherford 6. 1190 lesions (2.66 ±1.02 lesion per limb) underwent treatment, with 56.3% located in the femoral-popliteal distribution and 681 (57.2%) being total occlusion. During follow-up to 24 months, there were 76 deaths (18.8%) and 18 major amputations (4%). Surgical bypass was performed in 2% of cases. Estimated two-year amputation and major amputation-free survival probability was 88.4% and 94.5%, respectively. Estimated two-year TLR-free probability was 55%. Conclusions: Atherectomy facilitated treatment of patients with CLTI. These patients were elderly, with limited life expectancy and had multiple lesions per extremity with a high percentage of long occlusions and tibial disease. While TLR-free probability at 2 years was 55%, the overall amputation rate was low. This approach resulted in excellent limb salvage in a high-risk patient group with limited life expectancy and advanced disease.

Prognostic Nutritional Index as a New Prediction Tool for All-Cause Mortality in Patients with Chronic Limb-Threatening Ischemia Undergoing Endovascular Therapy.

Objectives: Chronic Limb-Threatening Ischemia (CLTI) represents a complex manifestation of peripheral artery disease distinguished by symptoms such as ischemic rest pain, non-healing ulcers on the lower limb or foot, and the development of gangrene. CLTI is associated with a high risk of limb amputation, decreased quality of life, and substantial morbidity and mortality. The Prognostic Nutritional Index (PNI), which is calculated using albumin and lymphocyte levels, reflects the immunological and nutritional status. The objective of this study was to investigate the correlation between PNI levels and mortality among patients diagnosed with CLTI who underwent endovascular therapy. Methods: Individuals diagnosed with CLTI who received endovascular therapy below the knee in our tertiary care center were enrolled in this retrospective study. The patients were divided into two groups: survivors and non-survivors. Logistic regression analyses were performed to detect independent predictors of mortality and using Cox regression model, we assessed the relationship between PNI and mortality. Survival curves were estimated using the Kaplan-Meier method. Results: The study comprised 113 patients diagnosed with PAD who underwent EVT. The non-survivor group (42 patients) was older (62.9±10.9 vs. 67.7±9.9, p=0.045) and had a higher prevalence of chronic renal failure (22.5% vs. 42.9%, p=0.023) and congestive heart failure (8.5% vs. 21.4%, p:0.049) than the survivor group (71 patients). The median PNI value was lower in the non-survivor group than in the survivor group (35.9±5 vs 38.2±4.4, p=0.012). Cox regression analyses showed that Low PNI was associated with increased mortality (HR=0.931, CI=0.872-0.995, p=0.035). PNI cut-off of 37.009 showed 64.3% sensitivity, 64.8% specificity, and AUC of 0.642 for predicting all-cause mortality. Kaplan-Meier analysis supported higher PNI correlating with better survival. Conclusion: The Prognostic Nutritional Index was independently associated with mortality among individuals diagnosed with Chronic Limb-Threatening Ischemia.

Atherectomy Followed by Drug-Coated Balloon Angioplasty Versus Surgery for Symptomatic Deep Femoral Artery Arteriosclerotic Disease.

PURPOSE: Limited data are available regarding endovascular therapy of arteriosclerotic lesions of the deep femoral artery (DFA). In this study, we compare the outcomes of atherectomy combined with drug-coated balloon (DCB) angioplasty and open repair of DFA lesions. METHODS: This is a multicenter retrospective registry of patients with peripheral artery occlusive disease Rutherford categories 2 to 5 treated by surgical profundaplasty (SP) or atherectomy followed by DCB for DFA lesions (symptomatic DFA). The primary endpoint was clinically driven target lesion revascularization (CD-TLR). Overall mortality, target limb reinterventions, major amputation, and major adverse limb events (MALEs) were additionally analyzed. RESULTS: A total of 373 patients treated for an arteriosclerotic lesion of the DFA between February 2015 and August 2021 were included, 301 treated by SP and 72 with atherectomy and DCB. The rates of chronic limb threatening ischemia (CLTI) were 42.2% and 22.2% (p<0.002) for the surgical and endovascular groups, respectively. A previous DFA intervention was more frequent in the endovascular group (30.6% vs 15.3%; p<0.003). Patients who had an open repair were more likely to have an occlusion of the profunda (34.9% vs 19.7%, p=0.014), severe calcified lesions (26.5% vs 5.6%, p=0.001), and lesions longer than 20 mm (95.7% vs 88.7%, p=0.024). After propensity score matching, no significant differences were found with regard to technical and hemodynamic success. At 24 months, no difference was found in terms of freedom from CD-TLR (95.7% vs 96.8%), freedom from all-cause mortality (94.2% vs 98.5%), freedom from MALE (90.4% vs 93.9%), and amputation-free survival (93.8% vs 97%). Following endovascular therapy, length of stay was significantly lower (p<0.001) and any reintervention on the index limb was more frequent (p=0.039). CONCLUSION: Patients with CLTI, occlusion of profunda, severe calcified lesions, and longer lesions are more frequently treated by open surgery, while reinterventions are more commonly treated by atherectomy and DCB. In patients with comparable clinical and lesion characteristics after matching, endovascular and surgical reconstruction of DFA lesions showed similar mid-term clinical outcomes. However, the risk of reintervention at the index limb is higher after endovascular treatment. Randomized studies are now warranted to compare both techniques in terms of medical and financial aspects. CLINICAL IMPACT: Atherectomy followed by DCB of symptomatic DFA is safe and effective. In patients with comparable clinical and lesion characteristics, outcomes are comparable with surgery. However, the risk of reintervention at the index limb is higher after endovascular treatment. Therefore, whenever possible an additional outflow vessel revascularization should be performed by the time of the primary intervention. Randomized studies are warranted to compare endovascular techniques and open surgery also under economic aspects.

Percutaneous Deep Venous Arterialization by Balloon Angioplasty without Stent Implantation for Patients with Chronic Limb-Threatening Ischemia Undergoing Hemodialysis: A Retrospective Cohort, Single-Center, Single-Arm Study.

PURPOSE: This retrospective, single-center study aimed to determine the efficacy of percutaneous deep venous arterialization in patients on hemodialysis with chronic limb-threatening ischemia. MATERIALS AND METHODS: Twenty-one consecutive limbs on hemodialysis with chronic limb-threatening ischemia were treated with percutaneous deep venous arterialization using balloon angioplasty following a failed pedal arterial reconstruction between May 2021 and June 2022. An arteriovenous fistula near the ankle joint was created to ensure sufficient venous flow reversal to the pedal veins. In case of occlusion of the tibial artery, a guidewire was advanced (subintimal) to the ankle joint vicinity was technically important. The primary outcome measures were the 6-month complete wound healing and freedom from major amputation rates; the secondary outcome measure was the 6-month amputation-free survival. RESULTS: Occlusion of all pedal arteries was observed in 17 limbs (81.0%). Arteriovenous fistulas were predominantly created at the distal portions of the posterior tibial artery and vein in 18 limbs (85.7%). No extravasation at the fistulas was observed. Re-intervention was required in 16 limbs (76.2%) due to tibial artery or deep vein occlusion. The 6-month complete wound healing rate was 42.9% (nine limbs), with a median healing time of 85 days (interquartile range: 58-151 days). The 6-month freedom from major amputation and amputation-free survival rates were 90.5% (19 limbs) and 61.9% (13 limbs), respectively. CONCLUSION: Balloon angioplasty without stent implantation for percutaneous deep venous arterialization is promising for improving the complete wound healing and amputation-free survival rates after pedal artery reconstruction failure. LEVEL OF EVIDENCE: Level 3b, retrospective cohort study.

Efficacy and safety of the needle rendezvous technique for infrainguinal arterial calcified lesions.

BACKGROUND: Lower extremity artery disease is increasingly prevalent, and complex lesions such as calcified chronic total occlusions pose significant challenges during endovascular therapy. The needle rendezvous technique, which involves puncturing a needle toward the guidewire within the lesion or lumen and advancing the guidewire into the needle lumen to achieve guidewire externalization, offers a potential solution. If device passage remains challenging, the Rendezvous-PIERCE technique can be subsequently employed by advancing the needle over the externalized guidewire to modify the lesion directly. This study aimed to evaluate the procedural outcomes of needle rendezvous in infrainguinal arterial occlusive lesions. METHODS: This single-center, retrospective, single-arm study included patients treated with needle rendezvous between August 2020 and March 2024. The primary outcome was technical success rate, defined as the device passage following guidewire externalization using needle rendezvous. Secondary outcomes included the rates of procedural success, complications, and 30-day clinical-driven target lesion revascularization (CDTLR). RESULTS: Twenty-five patients (25 limbs) with 52% on hemodialysis and 80% having chronic limb-threatening ischemia in 52% and 80% were enrolled. All cases involved bilateral calcified occlusions, and 72% targeted the infrapopliteal artery segment. The average needle rendezvous time was 3.7 ± 2.0 min. Rendezvous-PIERCE was performed in 28% of cases. All cases achieved 100% technical and procedural success, with no procedure-related complications. The 30-day CDTLR rate was 8%, limited to below-the-knee lesions. CONCLUSIONS: Needle rendezvous is a safe and effective technique for treating complex infrainguinal arterial occlusions, providing a viable alternative when conventional methods fail.

Outcomes after endovascular revascularization for chronic limb-threatening ischemia from the only Vascular Quality Initiative (VQI) center in Asia.

OBJECTIVE: This study compares chronic limb-threatening ischemia disease characteristics and endovascular revascularization outcomes in a multi-ethnic Asian cohort vs their North American counterparts. METHODS: The Society for Vascular Surgery Vascular Quality Initiative (VQI) registry database from the first and currently the only VQI center in Asia was reviewed to identify patients with chronic limb-threatening ischemia who underwent endovascular revascularization between July 2019 and April 2024. Standardized VQI reporting variables were compared against benchmarks derived from all participating centers in North America. RESULTS: A total of 2862 endovascular revascularization procedures from our center were benchmarked against 129,347 procedures from 406 North American centers. Our cohort had a higher burden of comorbidities (diabetes mellitus, end-stage renal disease, cardiac disease) and presented with more advanced Wound, Ischemia, and foot Infection stages. Our patients had more heavily calcified and longer (14.8 cm vs 6.0 cm) diseased vessels with higher prevalence of multi-level (87% vs 54.6%), infrapopliteal (52.6% vs 38.9%), and inframalleolar (9.6% vs 2.4%) disease. Rates of technical success (92.7% vs 93%) and symptom improvement (39.1% vs 40.4%) were comparable between cohorts. However, 1-year mortality rates (28.9% vs 25.1%) and major amputation rates (13.3% vs 7.8%) were significantly higher. CONCLUSIONS: Short-term outcomes of technical success and symptom relief in our center were comparable to benchmarked North American outcomes despite having a cohort with more diseased vessels, higher Wound, Ischemia, and foot Infection stages, and more comorbidities. However, this cohort fared worse in longer term outcomes of 1-year mortality and major amputation rates. Further studies are required to elucidate the causes to improve these outcomes.