Trans-Atlantic Inter-Society Consensus Document Research Articles

Employing magnetic resonance histology for precision chronic limb-threatening ischemia treatment planning

ObjectiveRecent randomized controlled trials have demonstrated a notable prevalence of immediate technical failures in percutaneous vascular interventions (PVIs) for complex arterial lesions associated with chronic limb-threatening ischemia. Current imaging modalities present inherent limitations in identifying these lesions, making it challenging to determine the most suitable candidates for PVI. We present a novel preprocedural magnetic resonance imaging (MRI) histology protocol for identifying lesions that might present a higher rate of immediate and midterm PVI failure. MethodsWe enrolled 22 patients (13 females, average age 65.8 ± 9.72 years) scheduled for PVI were prospectively and underwent 3T MRI using ultrashort echo time and steady-state free precession contrasts to characterize target lesions before PVI. Lesions were scored as hard if >50% of the lumen was occluded by hard components (calcium/dense collagen) on MRI in the hardest cross-section. Two readers evaluated MRI datasets. Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)/Global Limb Anatomic Staging System (GLASS)/Wound, Ischemia and Foot infection scoring was performed based on intraprocedural angiograms and chart review. The relationship between MRI scoring, TASC/GLASS scoring, and procedural outcomes was investigated using univariate analysis. Midterm follow-up (revascularization and amputation rates) was recorded at 3 and 6 months after the intervention. ResultsOur cohort of 22 patients yielded 40 target lesions. Five lesions were excluded (two for nondiagnostic image quality; three PVIs were ultimately diagnostic only). Six lesions (17%) were scored as hard. MRI-scored hard lesions had a higher proportion of immediate technical failure (hard vs soft 83% [5/6] vs 3% [1/29]; P < .001). Hard vs soft MRI scoring was the only factor significantly associated with immediate PVI technical success (P < .001), as opposed to TASC/GLASS scoring. Both at 3 months and 6 months after PVI, the reintervention rate was significantly higher among those lesions which were scored hard on MRI (3 months hard, 80% vs soft, 16% [P =.011]; 6 months hard, 80% vs soft, 27%; P = .047). ConclusionsMRI histology could be a valuable tool for optimizing PVI patient selection and treatment strategies.

Midterm Results of the Supera Stent for the Treatment of Femoropopliteal Occlusive Disease

The Supera (Abbott Vascular, Santa Clara, CA) stent is an interwoven nitinol, shape-memory stent with high strength and flexibility characteristics which are purported to increase resistance to kinking and compression. The purpose of this study was to review single-center outcomes of the use of this stent in the femoropopliteal segment. We performed a single-center, retrospective analysis of patients who underwent Supera stent placement for femoropopliteal occlusive disease from 2016-2019. Data was collected on patient demographics and procedural details. Follow-up imaging data, including duplex imaging and ankle-brachial indices, and clinical data were abstracted from encounter notes. Sixty-two patients with 72 unique Supera stent placements were identified. Mean age was 76 and 69% were male. 56% of patients had severe calcification and 11% had moderate calcification. 48% of lesions were Trans-Atlantic Inter-Society Consensus Document C or D lesions. Primary patency rates at 12, 24, and 36months were 85%, 82%, and 75%, respectively. Primary patency was not affected significantly by lesion length, degree of calcification, number of outflow vessels, concomitant interventions, or stent size. These results demonstrate sustained primary patency with the Supera stent over a 3-year interval in treatment of patients with femoropopliteal occlusive disease, including in the setting of severely calcified vessels.

Reporting Peripheral Artery Disease in Claudicants: Lessons Learned From the TASC-Ability Study

Background: The Trans-Atlantic Inter-Society Consensus Document (TASC II) aims to comprehensively describe the case scenarios of aortoiliac and femoropopliteal lesions to suggest an endovascular or a surgical approach. Over time, it has become a guide for describing the gravity of arterial lesions. Purpose: To assess the revised TASC II system for classifying arterial lesions in a large database of patients presenting with claudication. Materials and Methods: This study was a retrospective review of the arteriograms of patients with intermittent claudication. Aortoiliac and femoropopliteal lesions were classified according to the TASC II. When no consensus was reached, the lesion was rated as unTASCable. Results: In total, 1454 patients were included (male: 62.1%, 66.8±9.3 years). There were 39% aortoiliac lesions (n=960/2462) and 61% femoropopliteal lesions (n=1502/2462); 33.6% of the patients (n=489/1454) were associated with aortoiliac and femoropopliteal lesions. In addition, 20% of the lesions (n=493/2462) were unTASCable, and 26.7% of the patients (n=388/1454) had at least 1 unTASCable lesion. There were 4 categories of unTASCable lesions: (1) association with a common femoral artery lesion in 53.1% (n=262/493); (2) iliac artery lesions in 23.1% (n=114/493); (3) femoropopliteal lesions whose lengths did not fit into any category in 16.6% (n=82/493); and (4) association with an aortic lesion in 7.1% (n=35/493). The interobserver agreement was 0.97 for anatomically describing the infrarenal arterial tree and 0.85 for TASCing, with the lesions lowering to 0.69 for aortoiliac lesions. Conclusion: Using the revised TASC II case scenario, 26.7% of the patients had at least 1 unTASCable lesion. Reporting peripheral artery disease using a comprehensive anatomical description of the infrarenal arterial tree showed better interobserver reproducibility.

One-Year Outcomes of Two Different Paclitaxel-Eluting Stents (Zilver PTX and Eluvia) for Trans-Atlantic Inter-Society Consensus Document (TASC) C/D Obstructive Femoropopliteal Lesions

Background: Endovascular therapy is one of the standard treatment options for patients with peripheral arterial disease. Paclitaxel-eluting stents (PES) have shown promising results in the treatment of obstructive femoropopliteal lesions. Two types of PES, namely, Zilver PTX (Cook Medical, USA) and Eluvia (Boston Scientific, USA), are available worldwide. However, no study has yet compared the outcomes of applying both PES types in the real world. Objectives: This study aimed to assess the one-year outcomes of two different types of PES for Trans-Atlantic Inter-Society Consensus Document (TASC) C/D obstructive femoropopliteal lesions following suboptimal angioplasty. Patients and Methods: This single-center, retrospective, observational study examined 37 limbs of 34 patients (30 males and four females) with the mean age of 71.9 ± 9.1 years (range, 53-90 years), who were included consecutively from February 2017 to May 2018. In all patients, either a Zilver PTX (Cook Medical) or an Eluvia (Boston Scientific) PES was used for TASC C/D obstructive femoropopliteal lesions following suboptimal angioplasty. Moreover, the patients’ one-year primary patency rate, freedom from clinically driven target lesion revascularization (TLR), and event-free survival rates were determined. Results: The mean lesion length was measured to be 24.6 ± 6.6 cm (range, 9 - 46 cm). Based on the results, 78% of the lesions (29 limbs) showed occlusion, and 46% (17 limbs) showed more than moderate calcification. According to the TASC classification, type D lesions were detected in 25 (68%) limbs, while type C lesions were detected in 12 (32%) limbs. The mean number of stents used was 2.5 ± 0.7 per limb (range, 1 - 3) to cover a mean length of 24.3 ± 7.9 cm (range, 6-35 cm). Overall, 56 Zilver PTX stents for 23 limbs and 36 Eluvia stents for 14 limbs were used. The Kaplan-Meier estimates of one-year primary patency and freedom from TLR were 78% and 88%, respectively (Zilver PTX stent, 76.3% and 81.2%, respectively; Eluvia stent, 91.7% and 100%, respectively). Major adverse events were reported in two patients (2/37, 5.4%), including acute thrombotic occlusion of the treated lesions. Conclusion: Both types of PES showed promising one-year outcomes for TASC C/D lesions regarding safety and efficacy, without any significant differences; therefore, they can be considered as an alternative therapeutic approach for surgery.

Calcium Score Predicts Mortality After Revascularization in Critical Limb Ischemia

Purpose: The calcium score is a measure of vessel wall calcification and has clinical applications when studied in different vascular beds. The presence of vascular calcification in the arteries of the lower limbs is very common in patients with peripheral arterial disease; however, its relationship with the postoperative outcomes in patients undergoing lower limb revascularization is still poorly studied. The aim of this study is to evaluate association between the calcium score of lower limbs and the postoperative outcomes in patients with peripheral arterial disease undergoing revascularization procedures. Methodology: We retrospectively analyzed 88 lower limb revascularization procedures in 72 patients with critical limb ischemia who had enhanced computed tomography for preoperative evaluation. The calcium score was calculated, from the angiographic phase of preoperative computed tomography, in the segments of the aorta, iliac, femoropopliteal, and infrapopliteal. It was also calculated the calcium score of the operated limb, and the total calcium score using a standardized method. The outcomes evaluated were the occurrence of acute myocardial infarction, amputation, patency, technical success, and death from any cause. Patients were followed up through a 12 month period. Results: Among the 88 procedures performed, 31 (43.1%) lesions were classified as Trans-Atlantic Inter-Society Consensus Document II D. There were 66 (75%) endovascular procedures, 16 (18.2%) open surgery, and 6 (6.8%) hybrid interventions. No statistically significant relationship was found between the calcium score of the segments (aorta, iliac, femoropopliteal, infrapopliteal, the operated limb, and total calcium score) and the outcomes of acute myocardial infarction, amputation, patency, and technical success in any of the periods analyzed. The calcium score of the operated limb was higher in patients who died within 30 days and 6 months (6571 vs 2590.6; p=0.026) and (5227.8 vs 2335.3; p=0.036). Conclusion: A standardized calcium score calculation method with the angiographic phase of the computed tomography is feasible and reproducible. Higher values of the calcifications of the operated limb are related to a greater chance of death in the postoperative period. The calcium score of the operated limb can be considered as a marker of clinical severity and prognosis in this group of patients

Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery

ObjectiveWe assessed the long-term safety and efficacy of endovascular stent grafting to treat long, complex lesions in the superficial femoral artery (SFA). MethodsThe present prospective, multicenter study at 15 Japanese hospitals assessed heparin-bonded stent grafts used to treat long SFA lesions in patients with symptomatic peripheral arterial disease. The inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), an ankle brachial index of ≤0.9, and SFA lesions ≥10 cm long with ≥50% stenosis. The key efficacy and safety outcomes were primary-assisted patency and adverse events through 24 months, respectively. The secondary outcomes included primary patency, secondary patency, freedom from target lesion revascularization (fTLR), and Vascular Quality of Life questionnaire score. ResultsOf the 103 patients (mean age, 74.2 ± 7.0 years; 82.5% male), 100 (97.1%) had intermittent claudication. The average lesion length was 21.8 ± 5.8 cm; 87 lesions (84.5%) were TASC (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) C or D (65.7% chronic total occlusions). Of the 103 patients, 92 and 61 were evaluable through 24 and 60 months, respectively. At 24 months, the Kaplan-Meier–estimated primary-assisted patency, primary patency, and secondary patency rate was 85.7% (95% confidence interval [CI], 76.3%-91.5%), 78.8% (95% CI, 68.8%-85.9%), and 92.0% (95% CI, 82.4%-96.5%), respectively. The mean ankle brachial index was 0.64 ± 0.12 at baseline and 0.94 ± 0.19 at 24 months (P < .0001). At 24 and 60 months, the fTLR was 87.2% (95% CI, 78.9%-92.3%) and 79.1% (95% CI, 67.9%-86.8%), respectively. No device- or procedure-related life- or limb-threatening critical events or acute limb ischemia cases were observed through 5 years. No stent fractures were detected on the annually scheduled follow-up radiographs. The vascular quality of life questionnaire and walking impairment questionnaire scores were significantly increased at 1 through 24 months compared with the baseline scores (P < .0001 for both). One patient had required conversion to open bypass during the 5-year follow-up period. ConclusionsStent grafting of long and complex SFA lesions in patients with claudication is safe and effective through long-term follow-up, with 79.1% fTLR and no leg amputation, acute limb ischemia, or stent fractures through 5 years.

The need for objective guidance for treating chronic limb threatening ischemia

The Global Limb Anatomic Staging System (GLASS) was developed to aid with objective assessment of the atherosclerotic occlusive disease burden in limbs with chronic limb threatening ischemia (CLTI).1 GLASS focuses on the anatomic details of the limb as a whole and is a needed update to the older TASC II (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) classification system.2 Liang et al3 present a large retrospective, single-center analysis of patient outcomes after open and endovascular treatment of CLTI when analyzed by GLASS.

Optical coherence tomography and plaque morphology for revascularization of the superficial femoral artery.

The optical coherence tomography (OCT) catheter, Ocelot (Avinger Inc., Redwood City, CA), has been utilized to cross Trans-Atlantic Inter-Society Consensus Document (TASC) D lesions. Studies have assessed the characteristics of high-risk plaques in the carotid artery, but few, if any data exist evaluating OCT and plaque morphology in the superficial femoral artery (SFA). This study assessed SFA plaque morphology using OCT and lesion crossing success in chronic total occlusions (CTOs). We reviewed patients who underwent attempted infrainguinal revascularization with TASC D CTOs using the Ocelot catheter between June 2014 and June 2018, and recorded demographic information, smoking status, and medical comorbidities. A matched cohort of 44 successfully crossed lesions was compared to 44 that failed; images insufficient for analysis were excluded. The morphology of the plaque was studied using OCT at the proximal cap, midpoint of the lesion, and the distal cap. Morphologic data studied included the intima-media thickness ratio, cross-sectional area of the plaque, and gray-scale median of the plaque. A total of 140 patients who underwent lower extremity procedures for TASC D lesions of the SFA with OCT imaging were reviewed with a crossing rate of 69.0%. No significant differences were found between crossed and uncrossed lesions for intima-media thickness or cross-sectional area at the proximal cap, the midpoint, or the distal cap. A lower gray-scale median at the proximal cap was associated with the ability to cross the chronic SFA occlusion (P=0.05). Subgroup analysis stratified by smoking and calcium content also demonstrated that a lower gray-scale median at the proximal cap was associated with the ability to cross the chronic SFA occlusion (P=0.01 and P=0.04, respectively). Lower gray-scale median at the proximal cap of a chronic SFA occlusion calculated using OCT images was associated with the ability to successfully cross the lesion. Higher plaque gray-scale median is correlated with increased calcium, greater fibrous tissue, and signal-rich plaques. Gray-scale median in the proximal cap is useful marker to determine plaque composition and subsequent technical success for crossing chronic SFA occlusions. Further studies are needed to fully determine the utility of OCT images to predict successful endovascular revascularization of chronic SFA occlusions.

Real-World Experience With a Paclitaxel-Coated Balloon in Critical Limb Ischemia: 24-Month Subgroup Outcomes of BIOLUX P-III.

The aim of the BIOLUX P-III (A Prospective, International, Multi-Centre, Post-Market All-Comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III) registry was to collect real-world data on the Passeo-18 Lux paclitaxel-coated balloon. Critical limb ischemia (CLI) is a severe condition associated with high morbidity and mortality. Prospective data are needed to provide further insights on drug-eluting devices. BIOLUX P-III is a prospective, post-market, all-comers registry assessing the safety and performance of the Passeo-18 Lux. Clinical information was collected at 6, 12, and 24months. The authors report 24-month outcomes of the CLI subgroup with patients in Rutherford classes 4 to6. The CLI subgroup included 328 patients with 422 lesions. Patients were 71.1 ± 10.5 years of age, and 61.0% had diabetes. Femoropopliteal lesions were present in 53.8% (n=227), below-the-knee lesions were present in 27.0% (n=114), and lesions were moderate or heavily calcified in 45.0% (n=190). Major adverse events, defined as 30-day device- or procedure-related mortality, major target limb amputation, and clinically driven target lesion revascularization, occurred in 9.8% of patients through 6months, in 14.9% through 12months, and in 19.4% through 24months. Clinically driven target lesion revascularization occurred in 4.4%, 8.5%, and 12.1%, major amputation in 4.9%, 5.2%, and 6.1%, and mortality in 8.1%, 11.1%, and 20.1%, respectively. Predictors of mortality were age≥75 years and higher Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease class, and higher Rutherford class was associated with increased mortality and amputation rates. In a large, multimorbid patient population with complex lesions and CLI, the safety and performance of the Passeo-18 Lux paclitaxel-coated balloon has been confirmed, with low rates of major amputation and target lesion revascularization.

Invited commentary

Sharma and colleagues from the Brigham have shown that aortobilateral femoral bypass remains an important reconstruction in select patients with advanced aortoiliofemoral artery disease, despite the preferential use of endovascular therapy in these patients. Several important findings are evident from this analysis, some of which corroborate prior publications on this topic, and others that are new. First, experienced aortic surgeons can perform the operation with low mortality, less than 1% in the historic and contemporary cohorts. The mortality rate in this series is less than one-half that reported in broader practice assessments, such as the National Surgical Quality Improvement Program. Second, patency was lower in the contemporary cohort, driven by more extensive atherosclerotic disease, particularly in young patients; differences in prior aortic surgery; and a greater number of patients having aortobilateral femoral bypass for chronic limb ischemia. There is no doubt that common and deep femoral endarterectomy as an adjunct to aortobilateral femoral bypass is necessary more now than what it was two decades ago. The deep femoral artery remains the most important outflow vessel associated with long-term durability in most series. Although not mentioned by the authors, I wonder if patients whose distal anastomoses were to the superficial femoral artery had lower patency. Third, durability and limb salvage rates with this operation remain excellent. Moreover, the 10-year survival was better in the contemporary cohort, even though peripheral atherosclerotic disease burden was high. This difference likely is due to less coronary artery disease and significantly greater number of patients on statin, beta-blocker, and antiplatelet agents, as the authors note. Clearly, aggressive risk factor modification is beneficial. The study lacks in some detail, such as a comparison with matched patients treated by endovascular techniques, the extent of iliac (most had TransAtlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease class C and D disease) and infrainguinal disease, which impacts patency, surgeon choice for treatment, and specific technical details. Interestingly, more than one-half of the patients in the contemporary group had end-to-side aortic anastomoses for reasons that are unclear. Our preference has been for end-to-end aortic anastomoses except the rare circumstances in which there is a large inferior mesenteric artery, multiple renal arteries, or external iliac artery occlusions in which pelvic blood flow needs to be maintained. Configuration and length of the body of a graft sewn end-to-side is important to avoid buckling and kinking of the graft limbs, which impacts patency. No mention is made about aortoiliac occlusion versus diffuse disease, either of which may affect operative approach and choice of clamp position. Nonetheless, the clinical outcomes in this study are exemplary. The Brigham group rightly raises questions as to whether such results can be broadly applied to practices at large, and if there will be experienced open aortic surgeons to perform such operations in the future. There is no doubt that aortofemoral reconstruction is still necessary. The authors stress the importance of maintaining open aortic surgical skills, a challenge today in many training programs. The opinions or views expressed in this commentary are those of the authors and do not necessarily reflect the opinions or recommendations of the Journal of Vascular Surgery or the Society for Vascular Surgery. Thirty-year trends in aortofemoral bypass for aortoiliac occlusive diseaseJournal of Vascular SurgeryVol. 68Issue 6PreviewEndovascular intervention has supplanted open bypass as the most frequently used approach in patients with aortoiliac segment atherosclerosis. We sought to determine whether this trend together with changing demographic and clinical characteristics of patients undergoing aortobifemoral bypass (ABFB) for aortoiliac occlusive disease (AOD) have an association with postoperative outcomes. Full-Text PDF Open Archive

Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study

ObjectivesThe IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. BackgroundRandomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. MethodsThe IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. ResultsMean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. ConclusionsThis real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296)

Is the Endovascular Treatment of Mild Iliac Stenoses Worthwhile to Improve Wound Healing in Patients Undergoing Femorotibial Bypass?

After an infrapopliteal reconstruction, minor amputations are frequently required, but even in the case of successful revascularization, wound healing is a major concern. We studied the role of iliac artery inflow correction in patients undergoing infrapopliteal vein grafts to improve the heal of midfoot amputation. Thirty-eight patients affected with Rutherford grade III category 5 peripheral arterial disease, who underwent successful simultaneous iliac endovascular procedure, infrapopliteal reversed vein bypass graft, and minor amputation, were enrolled in this retrospective study. The population was divided in group 1 (20 patients) with inflow vessels Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) II type B atherosclerotic lesions and group 2 (18 patients) with TASC II type A atherosclerotic lesions determining an invasive pressure drop greater than 15mm Hg. Fifteen patients (group 3) undergoing infrapopliteal reversed vein bypass graft without associated inflow procedures (TASC II type A and invasive pressure drop greater than 15mm Hg) were matched with group 2 based on propensity score. Healing was calculated by subtracting the final ulcer area from the initial ulcer area and dividing by the number of follow-up months to obtain the total area healed per month (cm2/month). Stepwise logistic regression analysis adjusted for demographics and medical comorbid conditions was used to test the association between wound healing and treatment modalities. Forty-three patients were available for further analysis. Ten patients were excluded because of graft occlusion with consequent impairment of wound healing. After midfoot amputations, mean wound diameter was 20±8cm2, and mean healing time was 10±4months (range 3-20 months; median 9months). Wounds of groups 1 and 2 healed faster than those of group 3 at 4 and 8months (P<0.02 and P<0.001, respectively; P<0.04 and P<0.001, respectively). Multivariate analysis demonstrated the association between wound healing and inflow correction (P<0.001). An aggressive treatment is necessary to obtain the heal of the ischemic wounds. The most important predictive factor for nonhealing wounds is the absence of inflow correction. We demonstrated that the inflow should be also corrected in the presence of subclinical lesions.

Metabolic Syndrome but not Obesity Adversely Affects Outcomes after Open Aortoiliac Bypass Surgery

Although the incident risk of peripheral artery disease increases in patients with metabolic syndrome, several authors report favorable outcomes in obese patients after arterial bypass surgery. We examine the effect of the so-called "obesity paradox" and metabolic syndrome on outcomes after open aortoiliac bypass surgery. We identified patients between 2004 and 2015 who had open surgical bypass for aortoiliac occlusive disease. We excluded patients with endovascular repair and those treated primarily for aneurysmal disease. Variables that were analyzed included preoperative medical history, Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease II classification, Rutherford classification, intra-operative, and postoperative outcomes. Metabolic syndrome was defined by World Health Organization criteria: diabetes and 2 or more of dyslipidemia, hypertension, and obesity (body mass index > 30kg/m2). Data were analyzed by stratified Kaplan-Meier and multiple Cox regression for outcomes including long-term mortality and reintervention rate. There were 154 open bypass surgery patients during the study period with a median age of 60years (interquartile range [IQR] 53-68), median glomerular filtration rate 76.1mL/min (IQR 54-102), and 58% female prevalence. In all, 53 patients had metabolic syndrome (4%), and 14 patients (9%) were obese but did not have metabolic syndrome. Primary bypass graft patency was 89.0±2.7% at 1 year and 77.4±4.1% at 5 years and was not significantly different between metabolic syndrome, obese, and nonmetabolic syndrome patients. Reintervention rate for the entire cohort was 25.3±3.7% at 1 year and 40.6±4.7% at 5 years. In those with and without metabolic syndrome, reintervention rate at 1 and 5 years was 33.0±6.8% vs. 21.1±4.2% and 56.1±7.9% vs. 30.7±5.4%, respectively (log-rank P=0.003). In multivariable analyses, metabolic syndrome (hazard ratio [HR] 1.8, P=0.036) and critical limb ischemia (CLI) (HR: 3.2, P=0.001) were the only independent predictors of reintervention. Neither obesity nor the individual components comprising metabolic syndrome was a risk for reintervention. Multivariate analysis demonstrated age, female gender, CLI, and nonobesity as the independent risk factors for long-term mortality. Our study supports the "obesity paradox" that obesity by itself is not a risk factor for reintervention and was a protective factor for mortality after open aortoiliac bypass surgery. Bypass graft patency and major amputation rates were not affected. Although the individual components do not predispose to worse outcome, metabolic syndrome is a constellation of factors that, together, are associated with adverse events.

The Natural History and Outcomes of Endovascular Therapy for Claudication

The natural history of claudication is well-characterized and traditional therapy includes risk factor modification and exercise protocols with revascularization reserved for patients who are severely impaired. However, the reduced periprocedural morbidity with endovascular therapy has led physicians to broaden the indications for intervention for peripheral artery disease, and more claudicants are undergoing procedures for disease that is moderately limiting to their lifestyle. This study sought to assess the natural history of patients who have undergone peripheral vascular intervention for claudication. All patients who underwent at least 1 peripheral vascular intervention (PVI) for claudication at a single institution from January 2007 to December 2013 were identified. Patient demographics were assessed using the hospital record. Outcomes included secondary endovascular intervention, secondary bypass intervention, amputation, and survival. Cox proportional hazards models were created to assess risk factors for further intervention. Five hundred fifteen patients were identified as having undergone PVI for claudication during the study period. Forty-three percent were female, 37% had diabetes, 31% had coronary artery disease, 26% were current smokers, 6.6% had congestive heart failure, 8.2% had a tibial lesion that was intervened upon, and 35% had a Trans-Atlantic Inter-Society Consensus Document (TASC) II C/D lesion. Actuarial survival at 5years was 79.9% and 62.5% of patients had primary patency. The limb salvage rate was 97.2%. Over the follow-up period, 21.8% required some type of further intervention: either endovascular (17.7%) or open bypass (7.2%). A Cox proportional hazards model adjusting for age, sex, and other comorbidities showed that the two largest risk factors for requiring reintervention were angioplasty only (no stent; hazard ratio [HR] 1.36, P=0.02) and TASC C/D lesion (HR 1.52, P=0.03). With 5-year follow-up, patients have a primary patency that is comparable to an open prosthetic bypass to an above knee target. In addition, the secondary patency rate was over 90% and the major amputation rate as less than 3%. The presence of a TASC C/D lesion was predictive of failure of endovascular therapy, and surgical bypass should be considered in these patients.

Long Term Stability Evaluation of Prostacyclin Released from Biomedical Device through Turbiscan Lab Expert.

Therapeutic guidelines indicate prostacyclin as the first line of treatment in inflammation and vascular diseases. Prostacyclins prevent formation of the platelet plug involved in primary hemostasis by inhibiting platelet activation and, combined with thromboxane, are effective vasodilators in vascular damage.Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease II guidelines indicates prostacyclins; in particular, Iloprost, as the first therapeutic option for treating peripheral arterial disease. However, therapeutic efficacy of Iloprost has witnessed several drawbacks that have occurred in patients receiving repeated weekly administration of the drug by intravenous infusions. Adverse reactions arose under perfusion with Iloprost for 6 h and patient compliance was drastically decreased. Biomedical devices could provide a suitable alternative to overcome these drawbacks. In particular, elastomeric pumps, filled with Iloprost isotonic solution, could slowly release the drug, thus decreasing its side effects, representing a valid alternative to hospitalization of patients affected by peripheral arterial disease. However, the home therapy treatment of patients requires long-term stability of Iloprost in solution-loaded elastomeric pumps.The aim of this work was to investigate the long-term stability of Iloprost isotonic solution in biomedical devices using Turbiscan technology. Turbiscan Lab Expert (L’Union, France) predicts the long-term stability of suspensions, emulsions and colloidal formulations by measuring backscattering and transmission of particulates dispersed in solution. The formulations were evaluated by measuring the variation of physical-chemical properties of colloids and suspensions as a function of backscattering and transmission modifications. In addition, the release profile of Iloprost isotonic solution from the biomedical device was evaluated.

Technical Approach to Antegrade Femoral Access

The number of endovascular procedures for treatment of peripheral arterial disease continues to increase as minimally invasive procedures have become the first-approach solution for lower extremity arterial lesions of any complexity, including Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) II category C and D. Although the usual treatment strategy has been to access the contralateral common femoral artery (CFA), an ipsilateral, antegrade CFA approach has certain advantages. The greatest advantages are the decrease in the access-to-lesion distance, which in turn improves the mechanical advantage and responsiveness of the tools used to perform the intervention. In certain clinical situations such as prior endovascular aneurysm repair, aortobifemoral surgical bypass, iliac kissing stents, and aortoiliac occlusive disease, an antegrade approach may be mandatory. In this article, we describe our institutional thought process and techniques for performing a successful antegrade puncture of the CFA, as well as highlight some pitfalls and the associated complication rates of which to be aware.

Statement from the European Society of Vascular Surgery and the World Federation of Vascular Surgery Societies: Transatlantic Inter-Society Consensus Document (TASC) III and International Standards for Vascular Care (ISVaC)

Statement from the European Society of Vascular Surgery and the World Federation of Vascular Surgery Societies: Transatlantic Inter-Society Consensus Document (TASC) III and International Standards for Vascular Care (ISVaC)

Treatment for Critical Lower Limb Ischemia in Elderly Patients

Critical limb ischemia (CLI) has a poor outcome when left untreated. The benefits of revascularization in the very elderly might be limited because of co-morbidities and short life expectancy. Therefore, optimal management of CLI in the elderly is not straightforward. We analyzed treatment results for elderly patients with CLI (Rutherford 4 or 5/6) in our clinic. Hospital charts of all patients>70 years of age diagnosed with Rutherford stage 4-6 peripheral arterial disease between January 2006 and December 2009 were reviewed. We divided patients into two age groups (70-79 and ≥80 years) to compare treatment results. Primary interventions were defined as conservative, endovascular, reconstructive surgery, and amputation. Outcome measures were mortality, reintervention, and major amputation rates. There were 191 patients [99 (52%) were women], median age 78.4 years, range 70-98 years. Altogether, 119 (62%) patients were aged 70-79 years, and 72 (38%) were ≥80 years. The primary intervention was equally divided over the two age groups (p=0.21). Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC II) classifications of aortoiliac lesions were not significantly different regarding intervention (p=0.62) or age (p=0.39). TASC II classification of femoropopliteal lesions was significantly different relative to intervention (p<0.01) but not different between age groups (p=0.68). Mortality rate after reconstructive surgery was significant higher in the oldest age group (p<0.01). After conservative treatment, endovascular treatment, or amputation, the mortality rates were not significantly different between the two age groups (respectively, p=0.06, p=0.33, p=0.76). Reintervention rate was 51% in the 70- to 79-year group compared to 32% in the ≥80-year group. After initial treatment, major amputations were performed in 10% in the 70- to 79-year group compared to 13% in the ≥80-year group. In patients aged≥80 years, surgical revascularization resulted in a significant higher mortality rate in our clinic, whereas primary conservative, endovascular treatment and amputation resulted in similar mortality in both age groups. When considering surgical revascularization in the very elderly, surgeons should focus on careful patient selection.

One-year Clinical Outcome after Primary Stenting for Trans-Atlantic Inter-Society Consensus (TASC) C and D Femoropopliteal Lesions (The STELLA “STEnting Long de L'Artère fémorale superficielle” Cohort)

ObjectiveThe study aims to evaluate the safety and the efficacy of primary stenting for Trans-Atlantic Inter-Society Consensus Document II on Management of Peripheral Arterial Disease (TASC) C and D femoropopliteal lesions. DesignProspective cohort study. MethodsPatients with TASC C and D de novo femoropopliteal lesions were treated with the same endovascular technique by implanting a primary nitinol self-expanding stent (LifeStent®, Bard Peripheral Vascular, Tempe, AZ, USA). Patients were included in a single-centre registry and prospectively followed up. The primary end point was primary sustained clinical improvement after 12 months. Secondary end points were secondary sustained clinical improvement, primary and secondary patency rates, freedom from target lesion revascularisation (TLR), freedom from target extremity revascularisation (TER) and stent fracture rate. ResultsWe enrolled 58 patients (62 limbs) suffering from either claudication (40.3%) or critical limb ischaemia (59.7%). Lesions were either TASC C (62.9%) or TASC D (37.1%). Median length of the treated segment was 220 ± 160 mm. The mean number of stents was 2.2. Mean follow-up was 17 months, with one patient lost to follow-up. At 1 year, the primary end point was 68.6% while secondary sustained clinical improvement was 82.6%. Freedom from TLR and TER rates were 81.1% and 96.3%. Primary and secondary patencies were 66% and 80.9%. One-year primary and secondary sustained clinical improvement rates were 76.7% ± 7.2 for TASC C and 46.3% ± 11.1 for TASC D (p = 0.03) and 87.6% ± 5.9 for TASC C and 67.3% ± 11.3 for TASC D (p = 0.09), respectively. The ankle–brachial pressure index increased from 0.58 to 0.94 (p = 0.001) at 1 year and the incidence of in-stent restenosis (ISR) was 19.3%. Stent fracture and disconnection rate was 17.7%. ConclusionsPrimary stenting of TASC C and D lesions appears to be safe and efficient given the high-sustained clinical improvement and the low rate of ISR observed in our study. Endovascular treatment of such long and severe lesions exposes to high rate of stent fractures, which should not be a concern given their low clinical impact.

Lowering blood pressure with β-blockers in peripheral artery disease: the importance of comorbidity

Lowering blood pressure with β-blockers in peripheral artery disease: the importance of comorbidity