Superficial Femoral Artery Angioplasty Research Articles

JET+PCB strategy in the treatment of superficial femoral artery occlusion: a case report

Сritical limb ischemia (CLI) is becoming more and more common among patients worldwide. This is a comorbid condition, which is accompanied by chronic pain, sometimes trophic ulcers and gangrene, as well as a decrease in the quality of life. Despite the chronic nature of ischemia, the absence of treatment is accompanied by a high incidence of limb amputation and death. Patients with lower limb atherosclerosis had the higher risk of cardiovascular events and death. This publication proposes to consider minimally invasive interventional arterial revascularization in a 63-year-old patient with intermittent claudication, stage III critical limb ischemia, with a history of bilateral superficial femoral artery (SFA) stenting. Control lower limb angiography showed bilateral SFA occlusion and thrombosis. Taking into account the restenosis of the previously implanted stent, JET+PCB strategy was considered: first stage — rotational atherectomy followed by SFA angioplasty with a drug-eluting balloon catheter. The correct choice of minimally invasive surgery method in combination with non-pharmacological (smoking cessation, training walking) and pharmacological methods made it possible to restore viability and preserve the lower limb without negative consequences for the patient's health.

Primary Patency Rate of Superficial Femoral Artery Angioplasty in Patients with Stenosis/Occlusion of Femoropopliteal Artery

Background: The primary patency rate (PPR) is still controversial in angioplasty and heart bypass surgery for blood vessel repair and reconstruction in patients with femoropopliteal disease. Objectives: This study aimed to investigate the prolonged PPR rate in patients with stenosis/occlusion of the femoropopliteal artery undergoing superficial femoral artery (SFA) and popliteal angioplasty. Methods: A case series study population consisted of patients demonstrating femoropopliteal artery occlusion referred to Sina Hospital, Tehran, Iran for angiography during 2016-2018. After angiography, patients underwent either stent placement or balloon angioplasty in the case of stenosis/occlusion of femoropopliteal arteries. After angioplasty, patients were followed up in the 3rd, 12th, and 24th months for re-examination, and color Doppler ultrasonography of femoropopliteal arteries was also performed to measure the patency rate. The SPSS Statistics version 21.0 was used to analyze the data. The Kaplan–Meier method and a log-rank test were utilized to evaluate this rate. Results: Sixty patients were included in the study, from which 44 were women (73.3%) and 16 were men (26.6%) with a mean age of 69.9 years. Fifty-two, 41, and 29 patients were examined at intervals of 3, 12, 24 months, with PPRs of 86%, 79%, and 68%, respectively. There was a significant relationship between claudication degree and procedure success (P = 0.02). Conclusion: The prolonged PPR rate of patients after femoropopliteal artery angioplasty was acceptable and was a safe and effective treatment. For future studies, an increase in the number of study variables, a more comprehensive classification, and PPR-related variables are suggested.

Case of successful hybrid revascularization and limb salvage in patient with CLI after multiply ABF thrombosis and absence of outflow arteries

Patients with CLI often present multilevel disease. They underwent multiply revascularization procedures aiming to save thelimb. The main obstacle is absence or poor outflow arteries. Inability to restore bloodflow usuallyleads to ischemia progression and consequent amputation. We describe two cases of successful treatment of patient with CLI after multiply ABF thrombosis and absence of outflow arteries.The first 63 years old patient developed the third case of ABF thrombosis as a result of profunda and superficial femoral arteries chronic occlusion. We performed mechanical recanalization and angioplasty of anterior tibial, popliteal, subintimal recanalization and angioplasty of superficial femoral arteries. After that the ABFleg was sutured to subintimal space of femoral artery. The next case was another 63 years old patient with total chronic occlusion of iliac, femoral, popliteal and tibioperoneal trunk. We performed mechanical recanalization and angioplasty of anterior tibial, popliteal, subintimal recanalization and angioplasty of superficial femoral arteries. And then extra anatomy femoro-femoral autovenous bypass, distal anastomosis was performed by using subintimal artery space also. Thelong term period was 27 months for the first case and 20 months - for the second one. All bypasses were patient.Therefore this described above approach of hybrid open and endovascular surgery could give additional chance forlowlimb revascularization in this so-called hopeless group with criticallimb ischemia.

Influence of Infrapopliteal Runoff Vessels on Primary Patency after Superficial Femoral Artery Angioplasty with Stenting in Patients with Claudication.

PurposeThe number of infrapopliteal runoff vessels seems to be one of the factors influencing arterial patency in patients who had undergone superficial femoral artery (SFA) angioplasty with stenting. However, the effectiveness of infrapopliteal runoff vessels in predicting patency during SFA angioplasty remains unclear. This study aimed to determine whether the number and quality of infrapopliteal runoff vessels affect the primary patency after SFA angioplasty with stenting in patients with claudication.MethodsMaterials and This study reviewed a retrospective database of patients with claudication who underwent SFA angioplasty with stenting between March 2011 and December 2016. The preoperative computed tomography findings of all patients were reviewed to assess infrapopliteal runoff vessels. The Trans-Atlantic Inter-Society (TASC) II classification and modified Society for Vascular Surgery (SVS) runoff score were used for subsequent analysis. Kaplan–Meier survival curves were constructed, and Fisher’s exact and chi-square tests were used for data analysis.ResultsA total of 153 limbs of 122 patients (88.2% male, mean age: 69.1 years) underwent SFA angioplasty with stenting. The overall primary patency rates of TASC II A/B and C/D cases were 77.1% and 31.2%, respectively, at 36 months (P<0.001). The primary patency rates at 36 months using the modified SVS runoff scoring system were 64.6% and 49.8% for the good-to-compromised (≤9 points) and poor (≥10 points) runoff groups, respectively (P=0.011).ConclusionThe modified SVS runoff scoring system is effective in predicting primary patency after SFA angioplasty with stenting in patients treated for claudication.

POOR PROGNOSTIC DETERMINANTS FOR PATIENTS UNDERGOING SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY

Introduction: Aim is to study the poor prognostic determinants for patients undergoing superficial femoral artery angioplasty . Material and Methods: It is a Prospective observational study done in fifty patients who has undergone superficial femoral artery angioplasty for lower limb ischemia. Results: 22% had reocclusion of lesion, 10% required reintervention and 8% underwent major limb amputation .These three were considered major negative impact conditions. These were found in majority of patients with renal insufficiency, critical limb ischemia, smoker and drug defaulters. Conclusion: Thus poor prognostic determinants in the study were renal insufficiency, critical limb ischemia , smoker and drug defaulters.

Clinical outcomes from profundoplasty performed as a sole procedure for revascularization in critically ischaemic limbs

The aim of this study is to investigate the durability and clinical efficacy of profundoplasty as a sole procedure in patients presenting with critical limb ischaemia associated with profunda femoral artery disease and superficial femoral artery occlusion. Retrospective analysis of outcomes from all patients who underwent surgical profundoplasty in a single tertiary referral centre was performed. Patients who presented with either rest pain or tissue loss and had combined profunda femoral artery disease and superficial femoral artery occlusion were included in the study. Outcomes were compared between the rest pain and the tissue loss groups. Between 2009 and 2019, 51 procedures were performed in 49 patients; 27 (53%) procedures were performed for rest pain and 24 (47%) for tissue loss. Technical success was 100% in both groups. Procedure success was significantly better in the rest pain group owing to lower procedure-related complications (p = 0.037). Incidence of major adverse cardiovascular events was higher in the tissue loss group with five reported cases compared to only one in the rest pain group (p = .05); 85.2% of patients with rest pain experienced clinical improvement compared to only 33.3% in the tissue loss group (p < .001). Higher rates of re-intervention were recorded in the tissue loss group, but this was not statistically significant. Amputation-free survival at 3, 6 and 12 months was 96%, 96% and 92% in the rest pain group, respectively, compared to 77%, 67% and 54% in the tissue loss group (p = .004). At one-year, freedom from major adverse limb events was lower in patients with tissue loss at 43% compared to 81% in patients with rest pain (p = .009). Profundoplasty performed as a sole procedure for revascularisation of the critically ischaemic limb is a viable straightforward option. However, our results suggest that it may be more effective in the treatment of rest pain rather than in the setting of tissue loss when a combined superficial femoral artery angioplasty or distal bypass may be required.

Patient and Institutional Costs of Failure of Angioplasty of the Superficial Femoral Artery

Debate surrounds the optimal management of superficial femoral artery (SFA) disease. Randomized trial data rarely reflect real world findings, specifically the consequences to the patient of angioplasty failure. We observed the effect of a failed SFA angioplasty on the need for repeated clinic visits, hospital readmissions, imaging requirements, and reinterventions. We reviewed a consecutive series of 148 patients (94 men, median age 72years) undergoing solely SFA angioplasty over a 2-year period. Patient preangioplasty demographics and 2-year post-PTA follow-up data were collated, including hospital attendances (inpatient/outpatient), further imaging (including radiation exposure) and revascularization attempts. We defined "failed angioplasty" as presence of clinical symptoms with radiological evidence of significant restenosis after an initial successful primary SFA angioplasty. Fifty-four patients represented with a failed angioplasty (median time of 4months after index PTA). In this group, failure of index angioplasty resulted in a further 185 restenosis-related clinic visits and a total of 537 bed days of inpatient stay. This group underwent a further 149 imaging events and required a further 34 endovascular revascularization procedures and 12 infrainguinal bypass procedures. These interventions and investigations corresponded to overall effective radiation dose across all patients of 190.69mSv. Of the cohort of 99 patients who did not have a "failed angioplasty," they required 100 clinic visits, 21 further scans (total radiation dose 6.42mSv), and 36 bed days of inpatient admission. Failed angioplasty results in significant additional consequences for patients and health-care systems. Further work should focus on refining decision-making, providing the right procedure to the right patient at the right time.

Endovascular Interventions to Superficial Femoral Artery Occlusion: Different Approaches, Technique, and Follow-up.

Background:Superficial femoral artery lesion is one of the main causes for intermittent claudication or critical limb ischemia. Percutaneous transluminal angioplasty is one of the approved therapies for this medical entity. Anatomical factors should be considered in choosing the right approach and puncture.The purpose of this study is to discuss the anatomical, radiological, and technical factors which determine the preference of various approaches and to determine its safety, efficacy, and mid-term clinical and radiological outcome.Methods:Retrospectively, data were collected from patients who underwent angioplasty to superficial femoral arteries for total occlusion from January 2015 and June 2018 in our center, we performed angioplasty to 59 occluded superficial femoral artery patients at our center. The ipsilateral femoral artery, ipsilateral popliteal artery, contralateral femoral artery, or upper limb approaches were used depending on the various anatomical factors determined by radiological imaging before the procedure.Results:Acute success rate was 91.52%. There were no significant periprocedural complications. At the latest clinical follow-up of mean 25.8 months (10–51), a restenosis rate of 16.67% in infrainguinal arteries and 5.88% in suprainguinal arteries were noted.Conclusions:Percutaneous transluminal angioplasty of superficial femoral artery is a proven, viable, safer, and effective option, with good mid-term clinical results and patency rates. Different approaches to be chosen depends on the anatomical and technical factors to get the best possible outcome.

Evolution of the cardiovascular profile after renal transplantation in type 1 diabetic

Renal transplantation is the best treatment for end-stage renal disease (ESRD). Diabetes and chronic kidney disease (CKD) are major cardiovascular (CV) risk factors. Our study focuses on the initial CV profile and its evolution after renal transplantation (RT) in type 1 diabetes (DT1) patients. This is a retrospective study of 4 DT1 patients who benefited from a renal transplantation over the period from 2010 to 2017. In our series of 74 patients receiving a kidney from a living donor, 4 patients (5.4%) had DT 1. Our study concerned these 4 patients: 3 men and 1 woman, mean age: 36.25 years [30–43]. The average duration of diabetes was 25.25 years [13–33]. All patients were hypertensive, one had dyslipidemia and none of them was overweight. Diabetic nephropathy was the cause of end-stage renal failure in all 4 cases and patients were treated with kidney replacement therapy for 2 years (hemodialysis in 2 cases and peritoneal dialysis in 2 cases). Prior to RT, all patients had normal echocardiography and stress testing, 2 patients underwent myocardial scintigraphy without abnormality. None of the patients had coronary angiography. Doppler ultrasonography of the iliac and aortic axes was normal in 1 case, atheromatous infiltration was noticed in 2 patients, and distal mediacalcosis with tight stenosis of both tibial axes was discovered in one case. All patients underwent immunosuppressive therapy with corticosteroids, ciclosporine and mycophenolate mofetil, and followed for an average of 3.25 years. The post RT evolution was marked by an immediate resumption of graft function. Echocardiography control was normal for all 4 patients. One patient presented 2 years later a gangrene of the foot that had been treated by angioplasty of the left superficial femoral artery and amputation of one toe. In DT1 patients, renal transplantation is the best treatment for ESRD despite the use of corticosteroids and anticalcineurins. However, prior explorations of good cardiac function and adequate vascular compliance are essential to reduce the risk of CV.

RS01. Mortality After Paclitaxel-Coated Balloon Angioplasty and Stenting of Superficial Femoral and Popliteal Artery

A recent meta-analysis of 4663 patients reported higher 2- and 5-year mortality in patients with femoral-popliteal artery occlusive disease treated with paclitaxel-coated balloons and stents compared with plain balloon angioplasty and bare metal stenting. Our aim was to compare mortality after similar treatments using a multicenter vascular registry. Patients (n = 6992) without prior peripheral vascular intervention undergoing endovascular treatment of superficial femoral-popliteal artery occlusive disease in the Vascular Quality Initiative (VQI) were studied from September 2016 to September 2017. All-cause mortality was compared between patients treated with nondrug-coated devices (n = 3905) versus paclitaxel-coated balloons and/or eluting stents (paclitaxel group; n = 3087). Mortality rates with hazard ratios (HR) and 95% confidence intervals (CI) were compared between unadjusted and propensity matched cohorts and illustrated by Kaplan-Meier analysis. Subgroup analysis was performed for intermittent claudication and critical limb ischemia (CLI). Mortality was higher in the nondrug group (13.4%) compared with the paclitaxel group (10.8%) in the unmatched cohorts (HR, 0.80; 95% CI, 0.69-0.93; P < .01). After 1:1 propensity matching the paclitaxel (n = 2440) and nondrug-coated device (n = 2440) groups were similar except for differences at the extremes of age and symptom status (CLI 54% vs 59% respectively; P < .01). Mortality was similar for the nondrug group (13.2%) and paclitaxel group (11.5%) after propensity matching (HR, 0.87; 95% CI, 0.73-1.04; P = .12) at a mean follow-up of 509 days (17 months; range, 0-813 days [0-27 months]). Subgroup analysis of patients with claudication showed no mortality difference in the matched cohorts; nondrug coated device (5.1%; n = 41/804) and paclitaxel (3.8%; n = 32/842; HR, 0.74; 95% CI, 0.46-1.17; P = .20). Subgroup analysis of patients with CLI showed no mortality difference in the matched cohorts; nondrug-coated device (18.9%; n = 191/1012) and paclitaxel (18.5%; n = 200/1081) groups (HR, 0.99; 95% CI, 0.81-1.20; P = .90). By Kaplan-Meier analysis mortality was similar in the paclitaxel versus nondrug device group (Fig). At a mean follow-up of 17 months, mortality is similar for patients with claudication and CLI after treatment of femoral-popliteal occlusive disease with paclitaxel coated and nondrug coated devices. Additional VQI analysis is planned for 2019 to assess for mortality differences at later time points. This work highlights the potential use of the VQI for surveillance of the safety of new peripheral arterial devices.

Successful surgical retrieval of Celt ACD\xae vascular closure device embolised in the tibioperoneal trunk

BackgroundThis report presents a case of surgical retrieval of a Celt ACD® vascular closure device (VCD) situated in the tibioperoneal trunk, following a failed attempt at deployment. Existing literature mostly recommends an endovascular approach when attempting to retrieve embolised VCDs.Case presentationA 55 year old male presented with right sudden right lower limb pain and numbness 1 week following a successful left retrograde superficial femoral artery (SFA) angioplasty. Computed tomography (CT) angiogram revealed that the Celt ACD® VCD had embolised in the right tibioperoneal trunk. An endovascular approach was initially attempted to retrieve the VCD; however, this was unsuccessful due to the small diameter of the target artery. Due to the failure of the endovascular approach, surgical exploration of the right tibioperoneal trunk was undertaken, which led to the successful retrieval of the embolised VCD.ConclusionThe case presented herein demonstrates the critical need for swift and decisive surgical exploration of patients with suspected embolisation of Celt ACD® devices in smaller distal arteries. Our experience has led to the recommendation that, due to the sharp edges of the Celt ACD® accompanied with the small diameter of the occluded vessels, surgical exposure and retrieval is the safest option if endovascular retrieval is unsuccessful.

Effects of Percutaneous Transluminal Angioplasty of Superficial Femoral Artery on Photoplethysmographic Pulse Transit Times.

We analyze the changes in upper and lower limb pulse transit times (PTT) caused by peripheral artery disease (PAD) and its treatment with percutaneous transluminal angioplasty (PTA) of the superficial femoral artery. PTTs were extracted from the photoplethysmograms (PPG) recorded from an index finger and 2nd toes. PTTs were defined between the R-peaks of the ECG and different reference points of the PPG: foot and peak points, maxima of 1st and 2nd derivative, and by means of intersecting tangents method. Also the PTTs between the toe and finger pulses were analyzed. Our sample consists of 24 subjects examined before and after the PTA and in 1-month follow-up visit. Also 28 older than 65 years controls having normal ankle-to-brachial pressure index (ABI) and no history in cardiovascular diseases as well as 21 younger subjects were examined. The differences between the groups and pre- and post-treatment phases were analyzed by means of non-parametric statistical tests. The changes in the PTTs of upper limb and non-treated lower limb were negligible. The agreement with the reference values, ABI and toe pressures, was studied by kappa-analysis, resulting in kappa-values of 0.33-0.91. Differences in PTTs were found between pre-treatment state of the treated limb, post-treatment state and the follow-up visit, as well as between the pre-treatment state and controls. If patients' age and systolic blood pressure were taken into consideration, the method of lower limb PTT calculation from the peak point turns out feasible in finding the markers of PAD and monitoring post-treatment vascular remodellation.

The effect of percutaneous transluminal angioplasty of superficial femoral artery on pulse wave features

We aimed to analyze the effects of percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) on arterial pulse waves (PWs). Altogether 24 subjects i.e. 48 lower limbs were examined including 26 treated lower limbs having abnormal ankle-to-brachial pressure index (ABI) (ABI<0.9 or ABI>1.3) and 22 non-treated lower limbs. The measurements were conducted in pre-, peri- and post-treatment phases as well as in follow-up visit after 1 month. Both ABI and toe pressures measured by standard equipment were used as reference values. PW-derived parameters include ratios of different peaks of the PW and time differences between them as well as aging index. Both treated and non-treated limbs were compared in pre- and post-treatment as well as follow-up visit conditions. The results were evaluated in terms of statistical tests, Bland-Altman-plots, free-marginal multirater κ-analysis and multiple linear regression analysis. PTA was found to cause small changes to the studied PW-derived parameters of the treated limb which were observed immediately after the treatment, but the changes were more pronounced in the follow-up visit. In addition, we observed that the endovascular instrumentation itself does not cause significant changes to the PW-derived parameters. The results show that PW-analysis could be a useful tool for monitoring the treatment-effect of the PTA. However, because the pre-treatment differences of the treated and non-treated limb were small, further studies with subjects having no arterial diseases are required. The study demonstrates the potential of the PW analysis in monitoring vascular abnormalities.

USE OF DRUG-ELUTING STENTS VERSUS STANDARD NITINOL STENTS AFTER DRUG-COATED BALLOON ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY: INSIGHTS FROM THE MULTICENTER EXCELLENCE IN PERIPHERAL ARTERY DISEASE (XLPAD) REGISTRY

Paclitaxel drug-coated balloon (DCB) angioplasty in superficial femoral artery (SFA) interventions has steadily increased since its introduction in 2014. After SFA angioplasty, adjunctive stenting with drug-eluting (DES) or nitinol stents can be used to treat residual dissection or recoil. There is

P21-Activated Kinase 4 Promotes Intimal Hyperplasia and Vascular Smooth Muscle Cells Proliferation during Superficial Femoral Artery Restenosis after Angioplasty.

The aim of this study is to explore the function of p21-activated kinase 4 (PAK4) in intimal hyperplasia (IH) and vascular smooth muscle cells (VSMCs) proliferation. We choose vascular samples from patients undergoing angioplasty in superficial femoral artery (SFA) as the experimental group and vascular samples from donors without clinical SFA restenosis as the control group, respectively. We draw from the results that both levels of mRNA and protein of PAK4 in the experimental group increased dramatically compared with the control group. IH arose from angioplasty of SFA. Moreover, overexpression of PAK4 dramatically contributed to cell proliferation of VSMCs and promoted cell cycle progression from G0/G1 phase (71.12 ± 0.69% versus 58.77 ± 0.77%, P < 0.001) into S phase (23.99 ± 0.21% versus 31.35 ± 0.33%, P < 0.001). Besides, PAK4 downregulated the level of p21 and enhanced the activity of Akt as well. And we conclude that PAK4 acts as a regulator of cell cycle progression of VSMC by mediating Akt signaling and controlling p21 levels, which further modulate IH and VSMCs' proliferation.

Retrograde Use of Frontrunner Catheter in Superficial Femoral Artery for Flushing Long Segment Occlusions Involving Distal Common Femoral Artery

We present the case of an 81-year-old female with flush occlusion of the superficial femoral artery (SFA) and percutaneous transluminal angioplasty. Initially, the antegrade approach failed due to flush occlusion without stump. Hard, round surfaced, calcific, and eccentric plaque of the ostium of SFA was also present, which involved distal common femoral artery (CFA). Thus, we successfully used a Frontrunner catheter for retrograde reentry at the lower position of the CFA. Various treatment strategies involving Frontrunner and atherectomy devices could make percutaneous procedures possible in femoropopliteal occlusive disease, involving the CFA.

Serum Cholinesterase Levels Are Associated With 2-Year Ischemic Outcomes After Angioplasty and Stenting for Peripheral Artery Disease

Purpose: To prospectively investigate the associations of serum cholinesterase (CHE) levels with ischemic outcomes after angioplasty and stenting for lower limb peripheral artery disease (PAD). Methods: A prospective cohort study enrolled 108 patients with Rutherford category 2–3 ischemia who had successful primary unilateral angioplasty and self-expanding bare metal stent implantation for superficial femoral artery (SFA) stenosis. The primary endpoint was a composite of nonfatal myocardial infarction, nonfatal stroke or transient ischemic attack, cardiovascular death, or >80% target lesion restenosis within 2 years after peripheral angioplasty. Target lesion restenosis (restenosis endpoint) and the composite of the aforementioned atherothrombotic events (atherothrombotic endpoint) within 2-year follow-up were defined as secondary endpoints. Results: CHE levels were not available in 4 patients due to technical problems and 4 patients were lost to follow-up. The remaining 100 patients (median age 65 years; 62 men) met the minimum sample size requirement for statistical analysis. Median CHE levels were significantly lower in patients who subsequently experienced the primary endpoint compared with patients without ischemic events [7.1 (IQR 6.3–8.1) vs 8 (IQR 7–9.3) kU/L, p=0.007]. A CHE level <8.3 kU/L was identified as the best cutoff value to predict the primary endpoint, providing an 82.1% sensitivity and 44.3% specificity. The primary endpoint occurred significantly more often in patients with low CHE <8.3 kU/L than in patients with higher CHE levels (32 vs 7 patients, p=0.01). In multivariable Cox regression analysis, low CHE was associated with a 2.6-fold increased risk (95% CI 1.1 to 5.9, p=0.03) of the primary endpoint. Moreover, patients who suffered the secondary restenosis endpoint had significantly lower median CHE levels than patients without restenosis [7.1 (IQR 6.3–8.2) vs 7.9 (IQR 7–8.9) kU/L, p=0.02], and restenosis occurred more frequently in patients with low CHE compared with those with higher CHE levels (27 vs 7 patients, p=0.04). Conclusion: Low CHE is associated with an increased risk of long-term adverse ischemic events following SFA angioplasty with stent implantation for PAD.

SS10. Advanced Vascular Surgery Surgical Skills and Simulated Assessment Program for Senior Vascular Surgery Trainees

Cognitive competence in vascular surgery is determined by oral and written examinations administered by the Vascular Surgery Board. Technical competence of vascular surgery trainees is determined solely by subjective assessment from faculty members of the trainee's institution. This program represents the first attempt to objectively evaluate the advanced vascular surgical skills of senior vascular trainees using high-fidelity simulation models by an independent faculty proctor. Nineteen senior vascular trainees were evaluated over a 3-day period. Twenty-five board-certified vascular surgeons served as assessment proctors. Assessment stations included thoracic and abdominal aortic aneurysm endograft repair, open abdominal aortic aneurysm repair, carotid endarterectomy, femoral-popliteal bypass, arteriovenous fistula creation, mismatched end-to-side anastomosis at depth, carotid, renal, iliac, and superficial femoral artery angioplasty and stenting, and use of a percutaneous closure device. Trainees were given 1 hour to complete each station. Technical performances were evaluated by a single faculty member using global rating scales, critical task and time assessment metrics, and a global rating summary. Competency was defined as achieving >80% global rating scale score, 100% achievement of all critical task metrics, or attainment of a level 4 (proficient) or level 5 (advanced) global rating summary score. Immediate feedback was provided after each performance. Six simulation stations were videotaped for future assessment metrics validation. A total of 202 skill and simulation assessments were performed. Vascular trainees were graded as being proficient for 83% (global rating scale), 75% (global rating summary), and 49% (critical task metrics) of all surgical skills and simulated performances. Similar patterns of trainee technical and procedural errors were noted to occur for each simulated procedure. The performance results identified a range of technical skills among the trainees. Faculty assessment was inconsistent with reporting errors or omissions occurring in 18%. Endovascular simulator malfunction occurred in just 4% of procedures. No malfunctions occurred in the open vascular simulators. These preliminary results indicate that it is feasible to perform objective assessment of senior vascular trainees by board-certified vascular surgery faculty using multiple objective assessment metrics. Simulation models overall exhibited good durability and consistency, and therefore appear to be useful in the assessment of advanced vascular surgical skills. Data from this initial feasibility study can be used to determine reproducible objective assessment metrics. These metrics, once validated, can than serve as a foundation for a technical competence examination in vascular surgery.

A randomized phase II study of Xilonix, a targeted therapy against interleukin 1α, for the prevention of superficial femoral artery restenosis after percutaneous revascularization

The purpose of this study was to evaluate an anti-interleukin 1α antibody for its ability to reduce acute postprocedural inflammation, thereby reducing neointimal hyperplasia and restenosis after superficial femoral artery (SFA) angioplasty. Restenosis of the SFA after endovascular intervention is a common problem leading to 1-year primary patency as low as 40%. These failures are primarily due to the development of neointimal hyperplasia, resulting from arterial wall inflammation. This was a randomized, phase II trial examining SFA restenosis in patients after percutaneous revascularization. Randomization occurred after successful revascularization, and patients were assigned to either the standard of care arm or the Xilonix (XBiotech USA, Inc, Austin, Tex) plus standard of care arm (N = 43). Xilonix was administered immediately after revascularization, every 2 weeks intravenously for four doses, and monthly subcutaneously until month 12. The major efficacy end points were target vessel event-free survival and incidence of major adverse cardiovascular events (MACEs). At 12 months of follow-up, MACE (43% vs 36%; P = .76) and target vessel restenosis (24% vs 27%; log-rank, P = .79) rates were not significantly different between the groups. At 3-month follow-up, which covers the intravenous dosing period, a trend toward lower incidence of restenosis (0 of 22 [0%] vs 2 of 21 [10%]; P = .14) and MACE (2 of 22 [9%] vs 5 of 21 [24%]; P = .22) was observed in the Xilonix cohort. Adverse events were equally distributed in both arms. Xilonix was well tolerated. Observed tendency to improved vessel patency with intravenous dosing suggests Xilonix could potentially represent a safe and effective therapeutic approach to preserving vessel patency.

A Review of Superficial Femoral Artery Angioplasty and Stenting

Introduction: Peripheral arterial disease (PAD) of the superficial femoral artery (SFA) is the most common cause of intermittent claudication. Several endovascular treatment options exist; the most frequent are angioplasty or angioplasty with stent placement. The aim of this review is to clarify the role of angioplasty alone vs. angioplasty with stent placement. Methods: A literature review was conducted reviewing the topic of SFA angioplasty and SFA angioplasty with stenting. Three notable randomized trials were included in addition to other available studies on the topic. Results: When a residual stenosis or flow limiting dissection is visualized, stenting is clearly necessary. Current literature favors the use angioplasty for short (~4 cm) SFA stenoses or occlusions due to comparable patency and results. Primary stenting using Nitinol stents may be a superior initial treatment for intermediate (6-8 cm) and long (>10 cm) length lesions. In these intermediate and long length lesions, the use of stents appears to reduce the restenosis rates and improves patency. Conclusion: Angioplasty works best for short SFA stenoses or occlusions. However, angioplasty with stenting using is likely superior initial treatment for intermediate and long length lesions.