Rutherford Category Research Articles

Diabetes mellitus and femoropopliteal in-stent restenosis.

Background: The influence of diabetes mellitus (DM) on recurrent in-stent restenosis (ISR) of femoropopliteal arteries remains understudied. We investigated whether DM has an impact on recurrent restenosis after femoropopliteal stenting in patients included in the dRug-coatEd balloon angioPlasty for femoropopliteAl In-stent Restenosis (REPAIR) cooperation. Patients and methods: The REPAIR cooperation pooled the patient-level data from 3 randomized trials in which patients with ISR of femoropopliteal arteries received either drug-coated balloon (DCB) or plain balloon angioplasty. For this analysis, patients were divided in two groups based on whether they had or had not a DM diagnosis at the time of enrollment. The primary outcome was target lesion revascularization (TLR). The main secondary outcome was recurrent ISR. Other outcomes of interest were death, Rutherford class improvement and ankle-brachial index at follow-up. Results: 256 patients (DM, n=99 vs. non-DM, n=157) with 12-month follow-up were included in the analysis. Compared to non-DM patients, DM patients displayed no difference in terms of TLR [adjusted hazard ratio (95% Confidence intervals): 0.96 (0.55, 1.69), p=0.89] and recurrent ISR [1.04 (0.61, 1.77), p=0.88], whilst mortality was higher [9.38 (1.06, 83.11), p=0.044]. There were no differences between groups with respect to other secondary outcomes. The percutaneous treatment with DCB as compared to plain balloon angioplasty significantly reduced the risk of TLR and recurrent ISR without an excess risk of death irrespective of DM (p for interaction ≥0.70). Conclusions: In patients with femoropopliteal ISR, diabetes has a neutral effect on the risk of recurrence, but increases mortality at 12-month follow-up. DCB as compared to plain balloon angioplasty is associated with superior efficacy without trade-off in safety, regardless of diabetes.

Endovascular Intravascular Lithotripsy in the Treatment of Calcific Common Femoral Artery Disease: A Case Series With an 18-Month Follow-Up

BackgroundIntravascular lithotripsy (IVL) is a novel endovascular treatment for calcified common femoral artery disease (CFA). Data on midterm effectiveness for clinically driven target lesions revascularization (CD-TLR) is lacking. This study investigated CD-TLR during 18-month follow-up in patients requiring IVL for CFA disease treatment. MethodsIn a single-center retrospective cohort study, electronic medical record of patients undergoing IVL for CFA disease from January 2018 to March 2020 were reviewed. Primary outcome was CD-TLR estimated by Kaplan-Meier method during 18-month follow-up. Univariate logistic regression was used to compare differences in CD-TLR by the type of adjunct therapy used. ResultsAmong 54 CFA lesions in 50 patients, mean age (SD) was 75(8) years, gender and race were predominantly male (74%, n = 37) and white (94%, n = 47), respectively. Rutherford class III claudication was most common (70%, n = 35) with mean ABI of 0.66 (0.26) and mean angiographic stenosis of 77% (13%). Adjunct use of drug-coated balloon (DCB) angioplasty was 83% (n = 45) and atherectomy was 39% (n = 21). Residual angiographic stenosis was <30% in all cases. Complications included dissection requiring stent placement (2%, n = 1). After 18-months, 18% (n = 9) died unrelated to procedural complications and 6% (n = 3) were lost to follow-up. 18-month cumulative freedom from CD-TLR was 80.6% (95% CI: 69.1%, 92%). Univariate logistic regression did not reveal a statistically significant difference in CD-TLR with type of adjunct therapy used (p > 0.05). ConclusionIVL with adjunct use of DCB and/or atherectomy is safe and effective in treatment of calcified CFA disease. Randomized studies are required to confirm these findings.

The Predictive Role of NLR and PLR in Outcome and Patency of Lower Limb Revascularization in Patients with Femoropopliteal Disease.

Background: Peripheral arterial disease (PAD) changes the arterial structure and function, and is the most common manifestation of the atherosclerotic process, except for the coronary and cerebral arterial systems. Inflammation is well known to have a role in the progression of atherosclerosis and, by extension, in PAD. Among the recently studied markers in the literature, we list the neutrophil–lymphocyte ratio (NLR) and platelet–lymphocyte ratio (PLR). This study aims to analyze the preoperative role of NLR and PLR in the medium-term outcome of patients surgically revascularized for femoropopliteal disease. Methods: A retrospective study included patients admitted to the Vascular Surgery Clinic of the County Emergency Clinical Hospital of Târgu-Mureș, Romania, between January 2017 and December 2019, diagnosed with femoropopliteal disease and having presented an indication for surgical revascularization. The patients included in the study were classified according to the 12 months primary patency in two groups: “patency” and “nonpatency”. Results: Depending on the Rutherford classification (RC), there was a higher incidence of stages II and III in the patency group and a higher incidence of stage V in the nonpatency group. Depending on the optimal cut-off value according to ROC for the 12 months primary patency, obtained from Youden’s index (3.95 for NLR (82.6% sensitivity and 89.9% specificity), and 142.13 for PLR (79.1% sensitivity and 82.6% specificity)), in all high-NLR and high-PLR groups, there was a higher incidence of all adverse outcomes. Moreover, a multivariate analysis showed that a high baseline value for NLR and PLR was an independent predictor of all outcomes for all recruited patients. Furthermore, for all hospitalized patients, RC 5 was an independent predictor of poor prognosis. Conclusions: Our findings establish that a high value of preoperative NLR and PLR determined at hospital admission is strongly predictive of primary patency failure (12 months after revascularization). Additionally, elevated ratio values are an independent predictor for a higher amputation rate and death for all patients enrolled in the study, except for mortality in RC 2, and both amputation and mortality in RC 5.

Clinical Outcomes of Additional Below-The-Ankle Intervention Compared to Below-The-Knee Intervention Alone: A Post-Hoc Analysis of a Prospective Multicenter Study.

To investigate the clinical implication of additional below-the-ankle (BTA) intervention in patients with chronic limb-threatening ischemia (CLTI) undergoing below-the-knee (BTK) intervention. A sub-analysis was performed using data from the LIBERTY trial (ClinicalTrials.gov identifier NCT01855412), a prospective, observational, core-laboratory adjudicated, multicenter study of endovascular intervention in 1204 patients. Patients with CLTI (Rutherford Classification 4-6) who underwent BTK intervention were included in this sub-analysis. Participants were then stratified into 2 treatment groups according to whether at least one lesion intervened on was BTA (n=66) or not (n=273). The decision on whether and where to intervene was made during the procedure. The main outcome measures included major amputation, target vessel revascularization (TVR), major adverse events (MAE), survival, amputation-free survival, major adverse limb events or peri-operative death (MALE-POD), and all-cause death. Other outcome measures included procedural success, procedural complications, and wound healing rate. There were no differences in procedural success or severe angiographic complications between the 2 groups. At 1-year post-procedure, patients in the BTK group had a higher rate of freedom from major amputation (95.0% vs. 86.9%, respectively; HR: 2.87, 95% CI: 1.17-7.03), a higher rate of freedom from TVR (80.1% vs. 66.9%, respectively; HR: 1.94, 95% CI: 1.14-3.32), a higher rate of freedom from MALE-POD (94.6% vs. 86.9%, respectively; HR: 2.65, 95% CI: 1.10-6.41), and a higher rate of freedom from MAE at both 1 (76.0% vs. 60.1%, respectively; HR: 2.00, 95% CI: 1.24-3.22) and 3 years post procedure (67.5% vs. 55.8%, respectively; HR: 1.69, 95% CI: 1.08-2.65). There was a significantly lower rate of survival in the BTK group at 3 years (74.3% vs. 91.1%, respectively; HR: 0.35, 95% CI: 0.14-0.87). After risk adjustment, there was a higher rate of all-cause death in the BTK group at 3 years (19.4% vs. 9.1%, respectively; p=0.023) post-intervention. Patients with disease requiring intervention to BTA lesions have a potential increased amputation rate in the short term, but BTA intervention carries a potential survival benefit in the long term when compared to BTK intervention alone.

Abstract 303: Monitoring Tissue Oxygen Dynamics With A Novel Implantable Hydrogel Sensor In Patients With Pad

Objective: Tissue perfusion measurement remains a fundamental challenge in management of peripheral arterial disease (PAD) patients. Better measurement of baseline and dynamic changes after revascularization would aid clinical judgement. The Wireless Lumee® Oxygen System represents a novel approach to tracking tissue oxygen via a subcutaneous hydrogel that provides noninvasive optical oxygen measurements. This study’s objective was to assess the correlation of the Lumee sensor with transcutaneous oximetry (tcpO2) in PAD patients. Methods: The Lumee® Oxygen System is a subcutaneously placed hydrogel (0.5x0.5x5mm). Optical signals are captured with a skin surface reader sensing extravascular oxygenation. A pilot study assessed in vivo performance with inclusion criteria of peripheral arterial disease (Rutherford I-IV). Sensors were injected in the arm and foot and oxygenation measured before, during, and after proximal blood pressure cuff inflation (Figure) and Buerger’s Test modulation. The correlation (R) of oxygenation between tcpO2 and Lumee® was assessed following sensor placement at 2, 10, 90, 180, and 365 days. Results: Eleven subjects had 148 occlusion modulations over 199 days. Mean age was 67 years (range: 55-88), with 9% females, 45% White and 55% Black Race, Rutherford class I: 36%, II: 36%, III:27%. The median ABI was 0.83 (IQR0.69-1.14). In the arm, modulation was 56.9±24.6% (Lumee) and 84.7±9.2% (tcpO2), R:0.81. In the foot, modulation was 63.4±22.7% (Lumee) and 80.4±15.5% (tcpO2), R:0.79. No injection related adverse events occurred. Conclusion: Occlusion related changes in tissue oxygen can be detected by both tcpO2 and the Lumee sensor which strongly correlate in both the arm and foot. This pilot phase study supports expansion of the trial. The Lumee sensor shows promise for future evaluation of tissue oxygenation in PAD patients, which could be used to assess changes in tissue oxygenation over time and following revascularization.

The Impact of the First 11 Months of the COVID-19 Pandemic on Vascular Patients’ Care and Hospitalisation Rate in the Vascular Surgery Divisions of Southern Italy

The Impact of the First 11 Months of the COVID-19 Pandemic on Vascular Patients’ Care and Hospitalisation Rate in the Vascular Surgery Divisions of Southern Italy

Improvement in walking impairment following surgical and endovascular revascularization: Insights from VOYAGER PAD.

Peripheral artery disease (PAD) affects 200 million people worldwide and is associated with impaired quality of life, increased morbidity, and mortality. Supervised exercise therapy (SET) and lower-extremity revascularization (LER) are both proven strategies to improve patient symptoms. Short and long-term functional outcomes after LER for symptomatic PAD in a large, international cohort have not previously been described. The VOYAGER PAD trial (ClinicalTrials.gov identifier: NCT02504216) enrolled subjects after LER for symptomatic PAD (Rutherford category 2-6). Participants completed the Walking Impairment Questionnaire (WIQ) at baseline, 1, 3 and 6 months, and every 6 months thereafter. The primary outcome analysis was degree of difficulty walking two blocks at each of the aforementioned time points. Difficulty walking three blocks and climbing one flight of stairs at these time points was also analyzed. Data about supervised and home exercise therapy before or after revascularization were not collected in the VOYAGER PAD trial. Of the 5614 VOYAGER PAD participants completing the WIQ at baseline, three-quarters presented with claudication and one-quarter with critical limb ischemia. Of these, the majority (62% with claudication and 74% with CLI) reported inability or much difficulty walking two blocks prior to LER. Walking improved after LER regardless of revascularization strategy, but one-fifth with claudication and one-third with CLI reported continued inability or much difficulty walking two blocks 1 month after LER. Participants who reported improved walking ability 1 month after LER experienced a durable functional result out to 3 years. Although the proportion of participants reporting significant baseline difficulty climbing one flight of stairs or walking three blocks differed, the trend in immediate and sustained improvement after LER was similar to that observed for walking two blocks. In this large, international cohort undergoing LER for symptomatic PAD, nearly two-thirds reported inability or much difficulty walking two blocks at baseline. Although many participants reported improved walking ability after LER, a substantial proportion remained severely disabled. These observations may help motivate providers, patients, and medical systems to improve awareness and engagement in SET referral after LER.

Excimer laser atherectomy combined with drug-coated balloon angioplasty for the treatment of femoropopliteal arteriosclerosis obliterans.

It has been reported that excimer laser atherectomy combined with a drug-coated balloon (ELA+DCB) can achieve better results than simple balloon angioplasty, especially for the treatment of femoropopliteal in-stent restenosis. However, reports on the application of ELA+DCB in China for femoropopliteal arteriosclerosis obliterans are lacking. This study focuses on analysing the effectiveness and safety of ELA+DCB. This was a single-centre retrospective study that enrolled patients from November 2016 to January 2019 who had femoropopliteal arteriosclerosis obliterans treated by ELA+DCB. Preoperative demographics, operative details and postoperative follow-up outcomes were analysed statistically. There were 43 patients with an average patient age of 68.0±8.6 years; 79.1% were male. In 30 cases, the lesions were de novo and the others were in-stent restenosis (ISR). During the procedure, flow-limiting dissection (48.8%) was the main adverse event and there were 17 bailout stent implantations due to dissection. Mean (±sd) ankle-brachial index (ABI) in the patients was 0.42±0.31 before the operation and 0.83±0.13 before discharge. The mean (±sd) follow-up time was 29.35±9.71 months. The primary patency rate was 66.8%, 64.3% and 60.9% at 12, 24 and 36 months. Freedom from target lesion revascularisation (TLR) was 85.7%, 80.7% and 75.3% at 12, 24 and 36 months. Rutherford categories also greatly improved during follow-up. Overall mortality was 6.9% (3/48), and no deaths were related to the intervention. The use of ELA+DCB had good clinical benefit for femoropopliteal arteriosclerosis obliterans, which had good primary patency and freedom from TLR, although intraoperative complications still required attention. Multicentre randomised controlled trials with long-term follow-up are needed.

Sex-Related Outcomes Following Drug Balloon Angioplasty in Patients from the BIOLUX P-III Registry: A Subgroup Analysis

PurposeTo evaluate the use of drug-coated balloons in a real-world patient population with peripheral arterial disease and analyse the impact of sex on mid-term outcomes following their utilisation.MethodsThe BIOLUX P-III is a prospective, international, multi-centre, registry of patients with infra-inguinal lesions treated using the Passeo-18 Lux, a drug-coated balloon. Our study is a 24-month subgroup analysis of these patients; primary endpoints were freedom from major adverse events and clinically driven target lesion re-vascularisation within 12 months post-intervention.ResultsOf the 877 patients in the registry, 561 (64.0%) were male and 316 (36.0%) were female. Chronic limb threatening ischaemia (Rutherford class ≥ 4) occurred in 35.7% of males and 40.6% of females. Rates of freedom from major adverse events and clinically driven target lesion re-vascularisation at 12 months were 87.3% (95% confidence interval [CI] 84.2–89.9) and 90.4% (95% CI 86.5–93.3), and 92.3% (95% CI 89.9–94.1) and 92.9% (95% CI 89.7–95.1) in males and females, respectively. All-cause mortality at 24 months was 12.0% (95% CI 9.4–15.3) in males and 11.9% (95% CI 8.6–16.5) in females. The major target limb amputation rate at 24 months was 9.1% (95% CI 6.9–11.9) in males and 4.0% (95% CI 2.3–7.0) in females.ConclusionTreatment with the Passeo-18 Lux DCB demonstrated high efficacy and low complication rates. Despite the greater proportion of chronic limb threatening ischaemia observed in females, males were at a greater risk of ipsilateral major limb amputation and major adverse events following drug-coated balloon utilisation.Clinical Trial RegistrationNCT02276313.Level of EvidenceLevel 4.

Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study).

First-generation drug-coated balloons (DCBs) have significantly reduced the rate of restenosis compared with balloon angioplasty alone; however, high rates of bailout stenting and dissections persist. The Chocolate Touch DCB is a nitinol constrained balloon designed to reduce acute vessel trauma and inhibit neointima formation and restenosis. Patients with claudication or ischemic rest pain (Rutherford class 2-4) and superficial femoral or popliteal disease (≥70% stenosis) were randomized 1:1 to Chocolate Touch or Lutonix DCB at 34 sites in the United States, Europe, and New Zealand. The primary efficacy end point was DCB success, defined as primary patency at 12 months (peak systolic velocity ratio <2.4 by duplex ultrasound without clinically driven target lesion revascularization in the absence of clinically driven bailout stenting). The primary safety end point was freedom from major adverse events at 12 months, a composite of target limb-related death, major amputation, or reintervention. Both primary end points were tested for noninferiority, and if met, sequential superiority testing for efficacy followed by safety was prespecified. An independent clinical events committee, and angiographic and duplex ultrasound core laboratories blinded to treatment allocation reviewed all end points. A total of 313 patients were randomized to Chocolate Touch (n=152) versus Lutonix DCB (n=161). Follow-up at 1 year was available in 94% of patients. The mean age was 69.4±9.5 years, the average lesion length was 78.1±46.9 mm, and 46.2% had moderate-to-severe calcification. The primary efficacy rates of DCB success at 12 months was 78.8% (108/137) with Chocolate Touch and 67.7% (88/130) with Lutonix DCB (difference, 11.1% [95% CI, 0.6-21.7]), meeting noninferiority (Pnoninferiority<0.0001) and sequential superiority (Psuperiority=0.04). The primary safety event rate was 88.9% (128/144) with Chocolate Touch and 84.6% (126/149) with Lutonix DCB (Pnoninferiority<0.001; Psuperiority=0.27). In this prospective, multicenter, randomized trial, the second-generation Chocolate Touch DCB met both noninferiority end points for efficacy and safety and was more effective than Lutonix DCB at 12 months for the treatment of femoropopliteal disease. URL: https://www. gov; Unique identifier: NCT02924857.

Comparison of pharmaco-mechanical thrombolysis and catheter-directed thrombolysis for treating thrombotic or embolic arterial occlusion of the lower limb.

Whether pharmaco-mechanical thrombolysis (PMT) results in superior outcomes to catheter-directed thrombolysis (CDT) in treating thrombotic or embolic arterial occlusion of the lower limbs is unclear. We enrolled 94 patients with Rutherford class I-IIb due to thrombotic or embolic arterial occlusion in the lower limbs and who received emergency endovascular treatment. Baseline demographics, laboratory data, angiography and clinical outcomes were collected through chart reviews and fluoroscopic imaging. The procedural characteristics (thrombolytic drug dosage, treatment duration, and additional procedures), immediate angiographic outcomes (patency of calf vessels, and complete lysis), complications (major bleeding, and fasciotomy), and primary composite end-points (30-day mortality, amputation, and reocclusion) were compared between patients who received CDT versus PMT. Compared with CDT, PMT was independently associated with lower total UK dosage (standardized coefficient β=- 0.44; P<0.01) and higher prevalence of complete lysis (odds ratio =1.78, 95% confidence interval: 1.03-3.06; P=0.04) after adjustments of covariates. The PMT group had significantly shorter treatment duration (23.00 [7.25-39.13] vs. 41.00 [27.00-52.50]; P<0.01). No significant intergroup differences were observed for the primary composite end point (10.7% vs. 9.1%; P=0.81), or prevalence of the major bleeding (9.1% vs. 0.0%; P=0.10) despite the PMT group comprising patients with more advanced chronic kidney disease and more diffuse thrombosis. PMT with a Rotarex is a safe and effective strategy for treating thrombotic or embolic lower limb ischemia. It significantly reduced the thrombolytic drug dosage, and resulted in the complete lysis being more likely.

The Impact of Atrial Fibrillation on One-Year Mortality in Patients with Severe Lower Extremity Arterial Disease.

Atrial fibrillation (Afib) is associated with the presence of lower extremity arterial disease (LEAD), but its effect on a severe LEAD prognosis remains unclear. We investigated the association between Afib and clinical outcomes. We retrospectively enrolled consecutive severe LEAD patients undergoing percutaneous transluminal angioplasty between 1 January 2013 and 31 December 2018. Patients were divided according to the history of any type of Afib and followed for at least one year. The primary outcome was all-cause mortality. Secondary outcomes were cardiac-related mortality and major adverse cardiovascular events (MACEs). The study included 222 patients aged 74 ± 11 years (54% male), and 12.6% had acute limb ischemia. The Afib group had significantly higher rates of all-cause mortality (42.9% vs. 20.1%, p = 0.014) and MACEs (32.1% vs. 14.4%, p = 0.028) than the non-Afib group. Afib was independently associated with all-cause mortality (adjusted HR: 2.153, 95% CI: 1.084–4.276, p = 0.029) and MACEs (adjusted HR: 2.338, 95% CI: 1.054–2.188, p = 0.037). The other factors associated with all-cause mortality included acute limb ischemia (adjusted HR: 2.898, 95% CI: 1.504–5.586, p = 0.001), Rutherford classification, and heart rate. Afib was significantly associated with increased risks of one-year all-cause mortality and MACEs in patients with severe LEAD. Future studies should investigate whether oral anticoagulants benefit these patients.

Technical Success of the GoBack™ Crossing Catheter in Chronic Total Occlusion in Patients with Chronic Limb Threatening Ischemia.

To assess the technical success of GoBack™ crossing catheter in chronic total occlusion. A retrospective review of chronic limb threatening ischemia (CLTI) patients treated for chronic total occlusions (CTO) with the application of the GoBack™ crossing catheter (Upstream Peripheral Technologies, Haifa, Israel) between May 2020 and January 2021 was performed. Sixteen GoBack catheters were applied in twelve limbs in 12 patients (ten men, average age 75.7years). Treated limbs were classified as Rutherford Category 5 and 6 in ten patients and four in two patients. Average occlusion length was 287mm (62-466). All occluded arteries were heavily calcified. Technical success was defined as successful application of the GoBack catheter for lesion crossing or luminal reentry. Successful application of the four French catheter was achieved in 11 of the 12 cases (92%) for reentry in external iliac (1), superficial femoral (2), popliteal (2) and posterior tibial (1) arteries in six out of six cases (100%) and lesion crossing in popliteal (4), peroneal (1) and posterior tibial arteries in five out of six cases (83%). The 2.9 Fr catheter was successfully applied once out of four (25%) in lesion crossing in the posterior tibial artery. The GoBack™ 4 Fr crossing catheter in revascularization of CLI patients with CTO could be valuable when manual crossing or reentry is unsuccessful and is applicable from any access site.

Relationships between Indicators of Lower Extremity Artery Disease and miRNA Expression in Peripheral Blood Mononuclear Cells.

Lower extremity artery disease (LEAD) is an underdiagnosed and globally underestimated vascular disease caused by the progressive and chronic formation of atherosclerotic plaques in the arteries of the lower limbs. Much evidence indicates that the abnormal course of pathophysiological processes underlying LEAD development is associated with altered miRNA modulatory function. In the presented study, relationships between miRNA expression and clinical indicators of this disease (ABI, claudication distance, length of arterial occlusion, Rutherford category, and plaque localization) were identified. MiRNA expression profiles were obtained using next-generation sequencing in peripheral blood mononuclear cells (PBMCs) of 40 LEAD patients. Correlation analysis performed using the Spearman rank correlation test revealed miRNAs related to ABI, claudication distance, and length of arterial occlusion. In the DESeq2 analysis, five miRNAs were found to be dysregulated in patients with Rutherford category 3 compared to patients with Rutherford category 2. No miRNAs were found to be differentially expressed between patients with different plaque localizations. Functional analysis performed using the miRNet 2.0 website tool determined associations of selected miRNAs with processes underlying vascular pathology, such as vascular smooth muscle cell differentiation, endothelial cell apoptosis, response to hypoxia, inflammation, lipid metabolism, and circadian rhythm. The most enriched functional terms for genes targeted by associated miRNAs were linked to regulation of the cell cycle, regulation of the transcription process, and nuclear cellular compartment. In conclusion, dysregulations of miRNA expression in PBMCs of patients with LEAD are indicative of the disease and could potentially be used in the prediction of LEAD progression.

Detecting Changes in Tissue Perfusion With Hyperspectral Imaging and Thermal Imaging Following Endovascular Treatment for Peripheral Arterial Disease

Purpose Hyperspectral imaging (HSI) and thermal imaging allow contact-free tissue perfusion measurements and may help determine the effect of endovascular treatment (EVT) in patients with peripheral arterial disease. This study aimed to detect changes in perfusion with HSI and thermal imaging peri-procedurally and determine whether these changes can identify limbs that show clinical improvement after 6 weeks. Methods Patients with Rutherford class 2–6 scheduled for EVT were included prospectively. Hyperspectral imaging and thermal imaging were performed directly before and after EVT. Images were taken from the lateral side of the calves and plantar side of the feet. Concentrations of (de)oxyhemoglobin, oxygen saturation, and skin temperature were recorded. Angiographic results were determined on completion angiogram. Clinical improvement 6 weeks after EVT was defined as a decrease ≥ one Rutherford class. Peri-procedural changes in perfusion parameters were compared between limbs with and without good angiographic results or clinical improvement. To identify limbs with clinical improvement, receiver operating characteristic (ROC) curves were used to determine cutoff values for change in HSI. Results Included were 23 patients with 29 treated limbs. Change in HSI values and temperature was not significantly different between limbs with good and poor angiographic results. Change in peri-procedural deoxyhemoglobin, determined by HSI, at the calves and feet was significantly different between limbs with and without clinical improvement at 6 week follow-up (p=0.027 and p=0.017, respectively). The ROC curve for change in deoxyhemoglobin at the calves showed a cutoff value of ≤1.0, and ≤−0.5 at the feet, which were discriminative for clinical improvement (sensitivity 77%; specificity 75% and sensitivity 62%; specificity 88%, respectively). Conclusions HSI can detect changes in perfusion at the calves after EVT in patients with Rutherford class 2–6. Peri-procedural deoxyhemoglobin changes at the calves and feet are significantly different between limbs with and without clinical improvement. Decrease in deoxyhemoglobin directly after EVT may identify limbs that show clinical improvement 6 weeks after EVT.

2-Year Results With a Sirolimus-ElutingSelf-Expanding Stentfor Femoropopliteal Lesions: The First-in-Human ILLUMINA Study.

The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics. DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating. Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes. At 24months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95%CI: 73.9%-89.6%) and 93.1% (95%CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24months, which was associated with preserved improvements in all walking disability questionnaire scores. The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676).

Risk factors for major amputation after arterial vascular trauma of the lower extremity.

Arterial vascular trauma bears a great risk of poor functional outcome or limb loss. The aim of this study was to analyze amputation rates of patients after vascular trauma and to perform a predictor analysis for the risk of major amputation. In a single-center retrospective analysis of 119 extremities treated for arterial vascular injury between 1990 and 2018 amputation rates and factors associated with limb loss were assessed. All patients were treated for traumatic vascular injuries; iatrogenic injuries were not included in the study. During the study period, a total of 119 legs in 118 patients were treated after arterial vascular trauma. The in-hospital major amputation rate was 16.8% and the mortality rate was 2.5%. In the predictors analysis, vascular re-operation (amputation rate 53.8% vs 12%, odds ratio = 8.56), a Rutherford category ⩾IIb (25.4% vs 4.2%, odds ratio = 6.43), work-related or traffic accidents (28.2% vs 0%, odds ratio = 4.86), concomitant soft tissue or bone injuries (26.7% vs 7.3%, odds ratio = 4.64), polytrauma (33.3% vs 12%, odds ratio = 3.68), and blunt trauma (18.9% vs 0% for penetrating trauma, odds ratio = 1.64) were found to be associated with amputation. Lower extremity arterial vascular trauma was associated with a significant major amputation rate. Several predictors for limb loss were identified, which could aid in identifying patients at risk and adapting their treatment.

Prospective Study of Serration Angioplasty in the Infrapopliteal Arteries Using the Serranator Device: PRELUDE BTK Study

A prospective, multicenter, single-arm feasibility study (dates not included). Forty-six patients with limb-threatening ischemia (80%; n = 37) or claudication (20%; n = 9) with 53 “infrapopliteal” artery stenotic (72%) or occluded (28%) lesions underwent treatment with the Serranator device (Cagent Vascular, Wayne, Pa). Device success was 92%. Freedom from major adverse limb events plus death was 96% after 30 days. One lesion (2%) required a bailout stent for dissection. The Rutherford classification score had improved by one or more levels for 70% of the patients, with 42% having a score of 0, at 6 months. Serrations were present in all treated lesions in nine patients who had undergone optical coherence tomography or intravascular ultrasound. Serranator treatment of “infrapopliteal” artery stenoses showed excellent lumen gain with minimal evidence of arterial injury and good clinical results. Imaging studies showed serrations without significant dissection, supporting the device's proposed mechanism of action.

Treatment of Long Femoropopliteal Lesions With Self-Expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA Trial

Purpose: The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD). Methods: The STELLA SUPERA (STEnting Long de L’Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2–6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months. Results: Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months. Conclusion: The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.

Systematic review of atherectomy of inguinal arteries for atherosclerotic lesions.

Surgical endarterectomy represents the gold standard for the treatment of atherosclerotic lesions of the groin vessels. Endovascular treatment such as atherectomy with or without drug coated angioplasty (DCA) of the so called no stenting zones, i.e. inguinal and popliteal vessels, is gaining growing acceptance as alternative option to open surgery. This systematic review aims to scrutiny the current clinical evidence regarding atherectomy and DCA for the common artery (CFA). We conducted an exhaustive research in multiple platforms (Medline, PubMed, Cochrane, Google Scholar, Embase) on studies over atherectomy and angioplasty for inguinal atherosclerotic lesions published between 2000 and 2021. As search strategy we used a wide list of MeSH items, words, synonyms. Bibliographies of review articles were checked for further relating studies regarding atherectomy of CFA. A qualitative and quantitative data analysis was carried out. Fifteen studies were included in the qualitative review. Not all studies were focused only on atherectomy of inguinal vessels, despite including such treatment. Hence, data regarding this treatment were not exhaustive. A fairly homogeneous data analysis was possible in 7 of 15 studies. The remaining 8 studies were qualitatively analyzed but not included in the statistical analysis. In all 7 included studies directional atherectomy and DCA under filter protection were carried out. In this subgroup, overall, 497 patients were treated with atherectomy. Sixty-eight percent of the patients were males. Rutherford class from 1-3 dominated against 4-6 (63% vs. 37%). Mean technical success rate was 96%, with a primary and secondary patency rate of 92% and 98% respectively at one year. Procedure related vascular complications ranged from 1% to 6%. Current literature about atherectomy for inguinal arteries is scant, data are inhomogeneous and so are treatment modalities. Nevertheless, the results of this systematic review suggest that this endovascular strategy is feasible with good short and midterm results. Prospective trials with larger patient cohorts are necessary to confirm these preliminary results.