TransAtlantic Inter-Society Consensus Research Articles

Treatment of Atherosclerotic Femoropopliteal Artery Disease with Supera Interwoven Nitinol Stent: A Real-World Study in China

To analyze the outcomes of Supera stent deployment in Chinese patients with atherosclerotic femoropopliteal artery (FPA) disease in a real-world setting. This retrospective cohort study collected and analyzed the medical records of 246 consecutive patients who received Supera stents for FPA disease at the China Academy of Chinese Medical Sciences Xiyuan Hospital between February 2017 and December 2019. All study patients underwent balloon angioplasty and were treated with Supera stents (Abbott Vascular, Santa Clara, CA, USA). The primary outcome was the rate of primary patency 12months after discharge. The analyses included 246 consecutive patients and 260 lesions. The mean±SD age was 73.2±9.9years and most patients (60.2%) were males. Of the 260 treated lesions, Supera stents were deployed in eight (3.1%) cases after a previous stent fracture. Critical limb ischemia was diagnosed in 87.3% of the limbs, and 84 (32.3%) and 83 (31.5%) cases were classified as TransAtlantic Inter-Society Consensus (TASC) C and D, respectively. Most of the lesions were in situ (80.8%) and located in the superficial femoral artery (45.0%) or the FPA (45.8%). The mean lesion length was 147.7mm. Nominal deployment (-10 to 10% compression) was the most common deployment scenario (84.1%). The 1-year primary patency rate was 80.6%. Lesions that occurred as restenosis (odds ratio [OR]:=3.34, 95% confidence interval [CI]: 1.03-10.85, P=0.045) or in-stent restenosis (OR:=2.88, 95% CI: 1.03-8.07, P=0.045) were independently associated with occlusion or stenosis after stent deployment. No stent fracture was observed in this study. Our study indicates that the use of Supera stents is feasible for the treatment of Chinese patients with FPA disease. The long-term results reveal high primary patency.

Clinical Effect of Revascularization Strategies and Pharmacologic Treatment on Long-Term Results in Patients with Advanced Peripheral Artery Disease with TASC C and D Femoropopliteal Lesions.

Background This study was to assess the clinical outcome and associated parameters of endovascular therapy (EVT group) and bypass surgery (bypass group) in patients with long femoropopliteal TransAtlantic Inter-Society Consensus II (TASC II) C and D peripheral artery disease (PAD). Methods 187 patients who underwent successful EVT or bypass surgery were assessed. The endpoints included the events of cardiovascular disease (CVD) and lower-extremity amputation (LEA), 3-year primary patency, and 3-year amputation-free survival (AFS). Results The 3-year primary and secondary patency rates were better in the bypass group (P=0.007 and P=0.039, respectively), while the incidences of LEA, new CVD events, and mortality were comparable between groups. Weighted multivariate Cox analyses showed that cilostazol treatment (hazard ratio (HR): 0.46, 95% confidence interval (CI): 0.3–0.72, P=0.001), statin treatment (HR: 0.54, 95% CI: 0.33–0.9, P=0.014), and direct revascularization (DR) (HR: 0.47, 95% CI: 0.29–0.74, P=0.001) were predictive factors of 3-year primary patency. Kaplan–Meier curve analyses of time-to-primary cumulative AFS showed that nondiabetes mellitus, mild PAD, and cilostazol and statin treatment were correlated with a superior 3-year AFS (log rank test, P=0.001, P < 0.001, P=0.009, and P=0.044, respectively). Conclusions Endovascular stenting based on the angiosome concept and bypass surgery provide comparable benefits for the treatment of long, advanced femoropopliteal lesions after a short follow-up period, whereas cilostazol therapy for more than 3 months, aggressive treatment of dyslipidemia, and surgical revascularization were associated with higher primary patency.

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.

Arteriographic patterns of peripheral arterial disease in lower limbs in a Peruvian cohort of patients.

There is currently no universal and uniform pattern of peripheral arterial disease (PAD) in the lower limbs; however, it is influenced by various cardiovascular factors of the individual. The objective of this study was to identify the arteriographic patterns of PAD in the lower limbs according to cardiovascular factors in a Peruvian cohort of patients. This is an analytical, observational, and retrospective study. The arteriographic patterns of PAD in the aortoiliac segment were analyzed with the TransAtlantic InterSociety Consensus (TASC-II) score and the Global Anatomic Staging System (GLASS) for the femoropopliteal (FP), infraopopliteal (IP), and pedial (P) segments in a Peruvian cohort from January 2018 to May 2021. 595 patients (833 extremities) were analyzed with a mean age of 67.54 ± 16.39years, and the main cardiovascular factor was diabetes (65.04%). The patients older than 65years with GLASS FP 4 (p = 0.042), IP 0 (p = 0.004), and P2 (p = 0.047) presented significant findings: in men and women with GLASS IP 4 (p = 0.031) and P 2 (p = 0.045); diabetes with TASC-II A (p = 0.031), GLASS FP 4 (p = 0.038), IP 4 (p = 0.009), and P2 (p = 0.003); dyslipidemia with TASC-II D (p = 0.027), GLASS FP 4 (p = 0.038), IP 0 (p = 0.009), and P0 (p = 0.003); smoking with TASC-II D (p = 0.001), GLASS FP 4 (p = 0.049) and IP 0 (p = 0.008); chronic coronary disease with GLASS IP 4 (p = 0.049) and P2 (p = 0.037); chronic kidney disease with GLASS FP 4 (p=0.047), IP 4 (p = 0.004), and P2 (p = 0.016); and previous amputation history with GLASS IP 4 (p = 0.015) and P2 (p = 0.039). The most frequent arteriographic pattern of PAD in the lower limbs of our cohort was TASC-II A, GLASS FP 0 and 4, IP 0, and P2 (p = 0.047). Our work will allow the limb salvage teams to understand the behavior of PAD affectation in the population of our environment, allowing a timely control of cardiovascular risk factors, adequate revascularization planning, and a significant reduction in the risk of loss of limb.

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.

Quality of Life (QoL) Assessment in the Patients Operated with Either Laparoscopic or an Open Aortobifemoral Bypass for Aortoiliac Occlusive Disease (AIOD): 2 Years Results of a Randomized Controlled Trial.

BackgroundQoL assessment within surgical treatment is seldom investigated and sparsely reported in the medical literature. This study aimed to compare QoL in a randomized fashion in the patients treated with either a laparoscopic aortobifemoral bypass (LABFB) or an open aortobifemoral bypass (OABFB) for the treatment of AIOD.Patients and MethodsSeventy-one consecutive patients with AIOD, Trans-Atlantic Inter-Society Consensus II Type D lesions (TASC II, Type D) were randomized to LABFB or OABFB. Thirty-five patients in the LABFB and thirty-six in the OABFB groups were compared for the changes in the QoL, with the short-form health survey (SF-36), EuroQol 5 dimensions (EQ-5D), and EQ-5D visual analog scale (VAS) preoperatively, and postoperatively at 1, 3, 6, 12 and 24 months. Mann–Whitney U-Test and Wilcoxon sign-rank test were used for group comparison. Mixed model analysis was performed to examine the effect of different variables on the QoL.ResultsIn the patients treated with LABFB, physical component score (PCS) and mental component score (MCS) in SF-36 were significantly higher than OABFB, at 1 and 3 months postoperatively. PCS was also significantly higher in the LABFB group than OABFB at 24 months postoperatively. The preoperative QoL scores for both the laparoscopy and the open group were significantly lower than the age-matched general Norwegian population. EQ-5D median scores were significantly higher in the LABFB at all postoperative follow-up time points up to 12 months. The patients in the LABFB group also had a statistically significant increase in EQ-5D VAS compared to OABFB, at 1 and 12 months postoperatively (p = 0.005, and p = 0.037, respectively).ConclusionQoL seems better in patients treated with LABFB than OABFB, particularly during the early months after surgery.

Long-Term Clinical Outcomes of Iliac Artery Endovascular Therapy in the Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA) Registry.

Limited data are available regarding long-term clinical outcomes of iliac artery endovascular therapy (EVT) in real-world practice. This study investigated long-term outcomes according to Trans-Atlantic Inter-Society Consensus (TASC) classifications. We analyzed data from 1,705 limbs of 1,364 patients from the retrospective cohort of the multicenter Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Disease registry. The primary endpoint was target lesion revascularization (TLR)-free survival. TASC A, B, C, and D lesions were present in 19.4%, 26.2%, 28.7%, and 25.7% of the treated limbs, respectively. The technical success rate was 96.2% and did not differ between TASC lesion types. Complications occurred in 6.8% of cases and more occurred in TASC D (11.8%). Iliac artery EVT showed a 5-year TLR-free survival of 89.2%. The TASC D group had the lowest TLR-free rate of 79.3%. TASC D (hazard ratio [HR], 1.75; 95% confidence interval [CI], 1.12-2.73; p=0.014), plain old balloon angioplasty (HR, 4.25; 95% CI, 2.03-8.88; p<0.001), current smoker (HR, 1.89; 95% CI, 1.26-2.83; p=0.002), previous bypass surgery (HR, 3.04; 95% CI, 1.28-7.19; p=0.011), combined femoropopliteal treatment (HR, 4.89; 95% CI, 3.19-7.50; p<0.001), combined below the knee treatment (HR, 2.20; 95% CI, 1.25-3.89; p=0.007), and complications (HR, 1.86; 95% CI, 1.07-3.24; p=0.028) were predictors for TLR. Iliac artery EVT achieved excellent technical success and 5-year TLR-free survival. TASC D showed a favorable but lower 5-year TLR-free survival rate and higher complication rate compared with other TASC groups. ClinicalTrials.gov Identifier: NCT02748226.

Eversion Endarterectomy – An Alternative Approach to Occlusive External Iliac Artery disease

While endovascular intervention is the recommended first option for management of common iliac artery (CIA) lesions, it lacks durable patency for Trans-Atlantic Inter-Society Consensus (TASC)-II C and D lesions involving the external iliac artery (EIA). Aorto-femoral bypass is a durable option but is unsuitable in patients with significant co-morbidities. Eversion endarterectomy provides an alternative to both endovascular and extensive open aortoiliac reconstruction for occlusive EIA disease. A single-center, retrospective review (2000-2020) of all patients undergoing eversion endarterectomy for EIA disease was undertaken. Demographic, clinical, operative and follow-up data were recorded. Fifty eversion endarterectomies were performed in 47 patients. The median age was 65.0 years (range 46-82) and 66.6% were male. Sixty-eight percent (n=34) were ASA grade 3. Indications for intervention were disabling claudication (44%) and critical limb ischaemia (56%). Angiography demonstrated 22 TASC C and 28 TASC D lesions. The median follow-up was 18.5 months (range 0-149). The technical success rate was 100%, and 84% (n=42) experienced an immediate symptomatic improvement. Primary and primary-assisted patency at one, three and five years was 86%, 82% and 74%, and 100%, 96% and 92%, respectively. The five-year limb salvage rate was 96%. Eight limbs required reintervention to maintain patency, either by open (n=2), endovascular (n=3) or hybrid approach (n=3). Thirty-day mortality was 2% (n=1) with 10% (n=5) experiencing a procedure-related morbidity. All-cause mortality was 38% (n=19) during the follow-up period. Eversion endarterectomy is a safe, effective alternative treatment for occlusive EIA disease. This study reports durable patency at five years and low perioperative morbidity and mortality.

Study of endovascular treatment in obstructive aortoiliac lesions: Immediate and short-term results

Objective: Aorto-iliac occlusive disease (AIOD) is a common atherosclerotic disease causing significant morbidity. Transatlantic intersociety consensus for the management of peripheral arterial disease (TASC II) recommends endovascular therapy (ET) for better management of patients with lesions type A and B. With the advent of endovascular therapy, type C and D lesions management is becoming more feasible with endovascular therapy than open surgery for aorto-iliac occlusive disease. We aimed to evaluate patients with AIOD and to describe short-term outcome of endovascular treatment for such lesions. Methods: Patients with aorto-iliac occlusive diseases who underwent endovascular therapy were enrolled in the study. Their demographic data and risk factors were recorded. Patients were followed at 3 and 6 months and their primary patency rate and symptom status were recorded. Results: We enrolled 100 patients with a mean age of 59.77 (8.75) years with the majority of patients being male. The most common presentation was claudication (59%) followed by rest pain (31%) and gangrene (20%). The majority of patients had Transatlantic inter-society consensus (TASC) II type A (44%) and type B (31%) lesions; 15% of patients had types C lesions and the remaining 10% patients had type D lesions. Access site hematoma and contrast-induced nephropathy were present in 7% and 5% of patients respectively. Stent patency rate was 97% and 95% at 3 and 6 months follow up respectively. Conclusion: Endovascular therapy in aorto-iliac occlusive disease is a safe, effective, and low-cost treatment option with a high patency rate and symptomatic improvement in the short-term.

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

Risk of post-transplant cardiovascular events in kidney transplant recipients with preexisting aortoiliac stenosis.

Prediction of the risk of cardiovascular events (CVE's) is important to optimize outcomes after kidney transplantation. Aortoiliac stenosis is frequently observed during pre‐transplant screening. We hypothesized that these patients are at higher risk of post‐transplant CVE's due to the joint underlying atherosclerotic disease. Therefore, we aimed to assess whether aortoiliac stenosis was associated with post‐transplant CVE's. This retrospective, single‐center cohort study included adult kidney transplant recipients, transplanted between 2000 and 2016, with contrast‐enhanced imaging available. Aortoiliac stenosis was classified according to the Trans‐Atlantic Inter‐Society Consensus (TASC) II classification and was defined as significant in case of ≥50% lumen narrowing. The primary outcome was CVE‐free survival. Eighty‐nine of 367 patients had significant aortoiliac stenosis and were found to have worse CVE‐free survival (median CVE‐free survival: stenosis 4.5 years (95% confidence interval (CI) 2.8–6.2), controls 8.9 years (95% CI 6.8–11.0); log‐rank test P < .001). TASC II C and D lesions were independent risk factors for a post‐transplant CVE with a hazard ratio of 2.15 (95% CI 1.05–4.38) and 6.56 (95% CI 2.74–15.70), respectively. Thus, kidney transplant recipients with TASC II C and D aortoiliac stenosis require extensive cardiovascular risk management pre‐, peri,‐ and post‐transplantation.

Outcome Analysis Using the Modified Frailty Index-5 in Patients With Complex Aortoiliac Disease

Vascular surgery patients commonly have several comorbidities that cumulatively lead to a frailty status. The cumulative comorbidities disproportionately increase the risk of adverse events and are also associated with worsened long-term prognosis. In recent years, several tools have been elaborated with the objective of quantifying a patient's frailty. One of them is the modified frailty index-5 (mFI-5), a simplified and easy to use index. There is scarce data regarding its value as a prognostic factor in aortoiliac occlusive disease. The aim of this work is to validate mFI-5 as a potential postoperative prognostic indicator in this population. From January 2013 to January 2020, 109 patients who underwent elective revascularizations, either endovascular or open surgery, having Trans-Atlantic Inter-Society Consensus II type D aortoiliac lesions in a tertiary and a regional hospital were selected from a prospective vascular registry. Demographic data was collected including diabetes mellitus, chronic heart failure, chronic obstructive pulmonary disease, arterial hypertension requiring medication and functional status. The 30-d and subsequent long-term surveillance outcomes were also collected including major adverse cardiovascular events (MACE), major adverse limb events (MALE) and all-cause mortality were assessed in the 30-d post-procedure and in the subsequent long-term surveillance period. The mFI-5 was applied to this population to evaluate the prognostic impact of this frailty marker on mortality and morbidity. In the long-term follow-up, mFI-5 was significantly associated with MACE (hazard ratio [HR] 2.469; 95% confidence interval [CI]: 1.267-4.811; P=.008) and all-cause mortality (HR 2.585; 95% CI: 1.270-5.260; P=.009). However, there was no significant association with 30-day outcomes. Along with the presence of chronic kidney disease, mFI-5 was the prognostic factor better able of predicting MACE. No prognostic value was found regarding short-term outcomes. The mFI-5 index may have a role in predicting long term outcomes, namely MACE and all-cause mortality, in the subset of patients with extensive aortoiliac occlusive disease. Its ease of use can foster its application in risk stratification and contribute for the decision-making process.

Evaluation of Long-Term Outcomes of Femoropopliteal Bypass Surgery in Patients With Chronic Limb-Threatening Ischemia in an Endovascular Era

To investigate the long-term outcomes of femoropopliteal bypass surgery in patients with chronic limb-threatening ischemia (CLTI) and TransAtlantic Inter-Society Consensus II (TASC II), type D (TASC D) femoropopliteal disease. A retrospective analysis was performed for all consecutive patients undergoing above-knee (AK) femoropopliteal bypass surgery at an academic vascular centre between January 2007 and March 2019. Patients with claudication (IC) and patients with CLTI were included. Patency rates and freedom from major adverse limb events (MALE) after 5 years were analysed. In total, 432 femoropopliteal grafts were performed. Indications for surgery were claudication and CLTI in 232 (53.7%) and 200 (46.3%) patients, respectively. Graft material was autologous vein in 186 patients (43.1%), polytetrafluoroethylene (PTFE) in 128 patients (29.6%), and heparin-bonded expanded polytetrafluoroethylene (HePTFE) in 118 patients (27.3%). At the 5-year follow-up, the primary patency rate was 58.1% and 58.3% in patients with CLTI and claudication, respectively. Secondary patency rates were 74.1% and 68.6%, respectively. Freedom from MALE was 64.5% and 61.9%, respectively. Analyses of graft material in the CLTI group showed that, at 5 years, autologous vein grafts had better long-term patency rates than PTFE and HePTFE grafts. At 5 years, the primary and secondary patency rate for autologous vein grafts were 63.2% (P= 0.324) and 83.2% (P = 0.020), respectively. Freedom from MALE was 72.0% with the use of autologous vein grafts, 47.9% using PTFE and, 52.9% using HePTFE, respectively (P= 0.021). Our study shows that femoropopliteal bypass surgery in patients with TASC D lesions is safe and effective in the long term. Autologous vein grafts remain the first choice for patients with CLTI, also for bypasses in AK position. However, prosthetic grafts in AK the position are an acceptable alternative for revascularisation when the saphenous vein is not available.

Clinical Outcome of Drug-Eluted Stenting (Zilver PTX) in Patients With Femoropopliteal Occlusive Disease a Single Center Experience

Background: Few industry sponsored trials reported satisfactory outcomes in the use of drug-eluting stents (DES) for treatment of femoropopliteal arterial disease. This study analyzed the early/late clinical outcome from a real world single center. Patient Populations/Methods: A total of 115 limbs treated with Zilver PTX were analyzed for: major adverse limb event (MALE: above ankle limb amputation/major intervention at 1 year), major adverse events (MAEs; death, amputation, and target lesion thrombosis/reintervention), primary patency (based on duplex ultrasound ± ankle brachial indexes), limb salvage, and amputation free survival rates (AFS) at 1 and 2 years. Results: Indications included claudication in 32% and critical limb threatening ischemia (CLTI) in 68%. Lesions treated included: superficial femoral artery (SFA) 66%, both SFA and popliteal artery (PA) 19% and PA 15%. Mean lesion length was 21 cm and 68% had total occlusion. 45% were Trans-Atlantic Inter-Society Consensus (TASC) TASC II D lesions and 55% A–C lesions. Mean follow-up was 18.4 months (1–76 months). Perioperative major morbidity rate was 8.7% with 0% mortality. MALE rate at 1 year was 17% (13.5% for claudication vs 19.2% for CLTI, p=0.4499). MAE rate was 30% for claudication versus 52% for CLTI (p=0.0392). Overall primary patency rates at 1 and 2 years were 75% and 54% (86% and 71% for claudication vs 70% and 46% for CLTI, respectively, p=0.0213). Primary patency rates at 1 and 2 years were 94% and 88% for TASC A-C lesions versus 50% and 16% for TASC D lesions (p<0.0001). Overall freedom from MALE rate at 1 and 2 years were 85% and 79% (86% and 86% for claudication vs 84% and 74% for CLTI, p=0.2391). These rates were 96% and 93% for TASC A-C lesions versus 70% and 50% for D lesions, respectively (p<0.0001). Limb salvage rates at 1 and 2 years were 93% and 86% (100% and 100% for claudication vs 89% and 78% for CLTI, p=0.012). Overall AFS rates at 1 and 2 years were 79% and 71% (93% and 82% for TASC A–C vs 59% and 59% for D lesions, p=0.001). Conclusion: Clinical outcomes after DES (Zilver PTX) in femoropopliteal arterial lesions were satisfactory for TASC A–C lesions but inferior/unsatisfactory for TASC D lesions.

OUTCOME OF POLYTETRAFLUOROETHYLENE VERSUS DACRON GRAFTS FOR SUPRAGENICULAR FEMOROPOPLITEAL ARTERIAL BYPASSES

Background: Long saphenous vein (LSV) is used usually as the graft of the choice in the treatment of critical limb ischemia (CLI). LSV graft in femoropopliteal and femrodistal bypasses is more durable and also associated with reduced surgical mortality ratios and good success rates in preserving the ischemic limb. Synthetic graft, i.e. Dacron /Polytetrafluoroethylene (PTFE) is a good alternative if the saphenous vein is not available. PTFE has been the most popular choice. However, the preference for PTFE over Dacron is not evidence-based. The optimum graft configuration for the above-knee femoropopliteal bypass, whether PTFE or Dacron, remains a subject of controversy. Objective: To outcome whether Dacron versus PTFE Grafts as optimum in supragenicular femoropopliteal revascularization. Patients and Methods: Fifty patients with critical limb ischemia referred to Vascular Surgery Department, Al-Azhar University, Sednawy and El-Araby Hospitals were included during the period from July 2018 to April 2020. They had foot lesions as ulcer, wound or tissue loss associated with non-palpable distal pulses, and long occlusion of superficial femoral artery (SFA) defined as TransAtlantic Inter-Society Consensus (TASC) II C or D lesions. End points were healed, healing, nonhealing wounds or amputation. Patients were divided into two groups: group A included 25 patients who underwent Dacron graft bypass “DB”, and group B included 25 patients who underwent PTFE bypass “PB”. Results: Twenty- two patients (44%) reached the end point of complete healing (10 patients did “DB” and 12 did “PB”), whereas twenty-six patients (52%) had no or inadequate healing lesions. The limb salvage after one year was 40 patients (80%): 21 of them with ‘DB’ technique, and 19 with ‘PB’ technique. The remaining 8 patients (16%) underwent major amputation (5 with ‘DB’ technique and 3 with ‘PB’ technique) and two patients (4%) died. The early patency rate at 1 and 3 months was 92.43 % in the group with ‘DB’, and 94.39% in the group with ‘PB’. The late patency rate at one year post-operatively was 63.63 % in the ‘DB’ group and 68.63 % in the ‘PB’ group. Conclusion: Both Dacron and PTFE grafts were effective regarding wound healing and limb salvage as well as patency rate in supragenicular femoropopliteal revascularization.

Screening, Management, and Acceptance of Patients with Aorto-Iliac Vascular Disease for Kidney Transplantation: A Survey among 161 Transplant Surgeons

Introduction: Aorto-iliac vascular disease (AVD) is frequently found during the workup for kidney transplantation. However, recommendations on screening and management are lacking. We aimed to assess differences in screening, management, and acceptance of these patients for transplantation by performing a survey among transplant surgeons. Second, we aimed to identify center- and surgeon-related factors associated with decline or acceptance of kidney transplant candidates with AVD. Methods: A survey was sent to transplant surgeons and urologists. The survey contained general questions (part I) and 2 patient-based cases (part II) with Trans-Atlantic Inter-Society Consensus (TASC) D and B AVD supported with videos of their CT scans. Results: One hundred ninety-one (20.3%) participants responded; 171 were currently involved in kidney transplantation: 161 (94.2%) completed part I and 145 (84.8%) part II. Screening for AVD was often (38.5%) restricted to high-risk patients. The majority of respondents (67.7%) rated “technical problems” as the most important concern in case of AVD, followed by “increased mortality risk because of cardiovascular comorbidity” (29.8%). Pretransplant vascular interventions to facilitate transplantation were infrequently performed (71.4% mentioned <10 per year). Ninety (64.3%) respondents answered that an open vascular procedure should preferably be performed prior to kidney transplantation while 42 (30.0%) respondents preferred a simultaneous open vascular procedure. The decline rate was higher in the TASC D case compared to the TASC B case (26.9% and 9.7%, respectively). Respondents from centers with expertise in pretransplant vascular interventions were more likely to accept both patients with TASC D and B for transplantation. Conclusion: There is no uniformity in the screening, management, and acceptance of patients with AVD for transplantation. If a center declines a patient with AVD because of technical concerns, the patient should be referred for a second opinion to a tertiary center with expertise in pretransplant vascular interventions. Multidisciplinary meetings including a vascular surgeon and a cardiologist could help optimize these patients for transplantation.

EndoNaut two-dimensional fusion imaging with a mobile C-arm for endovascular treatment of occlusive peripheral arterial disease

BackgroundEndovascular treatment has become the first-line strategy for peripheral arterial disease (PAD). Given the number of procedures required, any technology associated with a reduction in radiation exposure and contrast volume is highly relevant. In the present study, we evaluated whether two-dimensional (2D) fusion imaging could reduce the radiation exposure and contrast volume during endovascular treatment of occlusive PAD. MethodsOur consecutive, retrospective, single-center, nonrandomized comparative trial included patients with PAD at the femoral, popliteal, and/or tibial level, at any clinical stage, if they were candidates for endovascular revascularization. Patients were treated with or without the EndoNaut 2D fusion imaging system (Therenva, Rennes, France) in a nonhybrid room with the same Cios Alpha mobile C-arm (Siemens, Munich, Germany). The indirect dose-area product and contrast medium volume were recorded. ResultsBetween March 2018 and April 2020, 255 patients underwent endovascular femoropopliteal revascularization with (n = 124) or without (n = 131) 2D fusion imaging. The volume of injected contrast medium (34.7 ± 13.8 mL vs 51.3 ± 26.7 mL; P < .001) and dose-area product (8.9 ± 9.9 Gy/cm2 vs 13.5 ± 14.0 Gy/cm2; P = .003) were significantly lower for the 2D fusion imaging group than for the control group. A subgroup analysis of complex (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D) lesions showed similar results. Stratification of the fusion imaging group into three subgroups, according to the procedure dates, showed no effect of a potential learning curve on the operative parameters. ConclusionsThe results from the present study showed a significant reduction in the contrast volume and radiation dose for endovascular treatment of PAD when applying 2D fusion imaging technology. Overall, a reduction of >30% was observed for both operative parameters, without excessive training requirements, highlighting the potential benefits of using 2D fusion imaging when performing endovascular revascularization for PAD.

Predictive Factors of Severe Dissection after Balloon Angioplasty for Femoropopliteal Artery Disease

Arterial dissection is one of the mechanisms of balloon angioplasty. Although some degree of dissection is unavoidable, severe dissection that impedes blood flow decreases patency and increases the need for additional procedures. To improve the results of angioplasty, it is necessary to understand the factors related to severe dissection and make efforts to reduce its occurrence. This study aimed to elucidate the predictive and protective factors associated with severe dissection in femoropopliteal balloon angioplasty. This was a retrospective, single-center, nonrandomized study. A total of 409 limbs were studied in 334 patients with symptomatic femoropopliteal lesions treated between 2010 and 2019. Dissections after initial balloon angioplasty were classified according to the Kobayashi dissection classification (grade A: no dissection; B: mild dissection <1/3 of the lumen; C: severe dissection, ≥1/3 of the lumen) into the nonsevere dissection group (grades A and B), and severe dissection group (grade C). We compared clinical, procedural and lesion-related characteristics between the 2 groups. Factors with statistical significance in univariate analyses were entered into a multivariate logistic regression model to identify independent predictive factors of severe dissection. Severe dissection occurred in 237 limbs and nonsevere dissection in 172 limbs. In univariate analyses, the predictive factors of severe dissection were TransAtlantic Inter-Society Consensus II C/D grades (P < 0.001), lesion length ≥15cm (P < 0.001), chronic total occlusion (P=0.004), and degree of stenosis ≥70% (P < 0.001). Protective factors for severe dissection were end-stage renal disease (P=0.008), severe calcification >50% (P < 0.001), and the use of a scoring balloon (P=0.001). In multivariate analysis, factors associated with severe dissection were lesion length ≥15cm (OR, 2.259; 95% CI: 1.417-4-3.601), occlusion or degree of stenosis ≥70% (OR, 1.931; 95% CI: 1.255-2.971), severe calcification (OR, 0.520; 95% CI: 0.338-0.800), and the use of a scoring balloon (OR, 0.467; 95% CI: 0.263-0.830). Lesion length ≥15cm and occlusion or stenosis ≥70% were identified as independent predictive factors of severe dissection in femoropopliteal artery balloon angioplasty. Conversely, severe calcification and the use of a scoring balloon appeared to be protective factors against severe dissection.

Factors Contributing to Efficient Recanalization Procedures for Chronic Total Occlusion of the Superficial Femoral Artery

BackgroundThis study aimed to clarify the factors for efficient procedures (EP) in superficial femoral artery (SFA) chronic total occlusion (CTO). MethodsWe retrospectively analyzed 200 consecutive limbs that underwent treatment for SFA CTO. The patients were divided into three groups according to the main strategies: subintimal angioplasty (SIA) (n = 123), Crosser use (n = 50), and 0.014″ CTO guidewire (CTO-GW) (n = 27). To determine the factors for an EP (EP; contrast volume <130 mL and procedure time <20 min; derived from non-CTO [control] procedures), the variables (P < 0.2) underwent multivariate analysis. ResultsSIA included more Trans-Atlantic Inter-Society Consensus C/D lesions and contralateral femoral approaches, and additional GW use (P < 0.05). CTO-GW presented a shorter occlusion length and elapsed time, and used less retrograde approach than the other strategies (P < 0.05). Crossers had a higher incidence of perforation (P = 0.002). The prompt retrograde approach had a similar actual retrograde procedure time, but a shorter total procedure time, compared to that of the delayed adoption (P < 0.001). EP was achieved in 14 limbs (7.0%). Multivariate analysis revealed that occlusion length (adjusted odds ratio [OR], 0.89; 95% CI, 0.81–0.96; P = 0.004) and SIA (OR, 8.71; 95% CI, 1.32–175.27; P = 0.02) were associated with EP. ConclusionsSIA contributed to EP. The timing of the retrograde approach was crucial because its delay resulted in an excessive procedure time.