Femoropopliteal Occlusive Lesions Research Articles

Single Primary Retrograde Access to Treat Femoro-Popliteal Occlusive Lesions.

The retrograde puncture of a distal artery is considered a bailout procedure in case of anterograde approach failure for peripheral artery disease (PAD) treatment. A single primary retrograde access has been suggested as an efficient and safe option. As scant data are available, we present our results using this approach. Between August 2019 and October 2022, we performed this technique in selected patients with femoro-popliteal PAD. Chronic total occlusions (CTOs) were selected on the basis of the CTOP classification. An ultrasound-guided retrograde puncture of a tibial artery at the ankle level was performed, followed by the preferential use of 4F materials. Hemostasis of the puncture site was obtained using manual compression. Postoperative duplex scan examination systematically included an evaluation of the punctured artery. Demographics, intraoperative, and follow-up data were collected retrospectively. The results are expressed as means with standard deviations and numbers with percentages when appropriate. In total, 55 procedures were performed in 46 patients (9 bilateral). Of these, 57% (N=26) were considered at risk for femoral puncture (obesity, history of groin surgery, challenging crossover approach) and 54% (N=25) presented with critical limb-threatening ischemia (CLTI). The TASC-II femoro-popliteal classification was generally B (60%) and also C (33%) or D (7%). Mean lesion length was 105.6±49.4 mm and 65% were CTOs. Most patients were operated in an outpatient setting (N=25; 54%) under potentialized local anesthesia (N=41, 89%). The punctured site was the posterior tibial artery in 73% (N=40). The procedure time was 65.1±25.7 minutes, and the fluoroscopy time was 10.7±8.5 minutes. The technical success rate was 100%. There were no intraoperative complications. All patients could walk the same day. One CLTI patient presented an erysipelas related to the puncture in postoperative period. At 30 days, the primary patency of the treated and the punctured arteries were 98% and 100%, respectively. A single primary retrograde access can be used safely to treat femoro-popliteal PAD. It represents a valuable alternative to the femoral puncture and allows fast ambulation. Prospective and long-term studies on larger populations are necessary to confirm our results. This study demonstrates that a single primary retrograde access can be used safely without damaging the punctured artery to treat femoro-popliteal lesions, especially in claudicant patients. Chronic total occlusions can be treated successfully using this technique. This approach represents a valuable alternative to the femoral puncture and allows fast ambulation without risk of major bleeding.

Treatment of Long Femoropopliteal Occlusive Lesions With Self-expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA-SIBERIA Register Trial.

The efficacy and safety of the Supera stent in superficial femoral artery (SFA) have been reported mostly in shorter lesions with relatively low proportion of occlusions. There are little data on the effectiveness of the 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 occlusive lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral artery disease. The STELLA-SUPERA-SIBERIA is a prospective, single-center, single-arm study. Patients with symptomatic (Rutherford stages 3-6) de novo and TASC C/D occlusive lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the 12 month rate of primary sustained clinical improvement (upward shift on the Rutherford classification to a one level without the need for repeated target lesion revascularization (TLR) in surviving patients without the need for unplanned amputation). Secondary endpoints were the 24 month of primary sustained clinical improvement, MALE, limb salvage, the primary patency, the secondary patency, 24 month MACE. Follow-up included clinical examination, duplex scan, and biplane x-ray up to 24 months. Between April 2019 and January 2020, 52 symptomatic patients with 55 long femoropopliteal occlusive lesions (52.7% TASC D lesions and 47.3% TASC C lesions) were treated. The mean target lesion length was 205±72 mm. All patients had total occlusions. The mean lesion length of the implanted Supera stents was 198±82 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 80.2% and 63.6%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). The primary patency rate at 12 and 24 months was 78.1% and 60.0%, respectively. At 12 and 24 months, freedom from TLR was 83.5% and 81.8%, respectively. There were no stent fractures at 24 months. Supera Stent implantation for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Head-to-head studies are mandatory to establish Supera Stent as an alternative tool to open surgery for long femoropopliteal lesions. Our study indicated, that using self-expanding interwoven nitinol stent for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Although bypass grafting is recommended for prolonged femoropopliteal lesions, open surgery is more traumatic and is associated with greater risks than endovascular procedures. Our findings suggest that the use of interwoven nitinol stents can overcome the disadvantages of traditional stents in such cases, which may help to improve patients' outcomes and reduce the risk of adverse events.

Bare metal stent in the area of drug eluting devices for long femoropopliteal lesions.

The advancement in the endovascular treatment and the introduction of novel techniques allowed treatment of more complex and longer femoropopliteal lesions. However, the optimal treatment modality is still a source of controversy. The use of bare metal stents (BMS) showed good results for long femoropopliteal lesions. In this review, we summarized all available data on the different treatment strategies of long femoro-popliteal lesions using BMS. Nevertheless, RCTs with head-to-head comparison between BMS strategies are still needed to have more clarification on the best strategy for the endovascular treatment of long femoropopliteal occlusive lesions.

Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System

A multicenter, international PQ Bypass DETOUR study was performed between 2015 and 2017. Seventy-eight patients with 82 femoropopliteal (FP) arterial lesions were treated with Torus stent grafts (PQ Bypass, Milpitas, Calif) through a transvenous route (chronic total arterial occlusion, 96%; average occlusion length, 16 cm; average lesion length, 37 cm). The technical success rate was 96%. After 2 years of follow-up, major amputations had occurred in 1% of patients and deep vein thrombosis in 3%. The 2-year Kaplan-Meier primary and secondary patency rates were 80% and 86%, respectively. The PQ Bypass DETOUR system is a safe and effective percutaneous alternative to treat long, calcified, occlusive FP lesions, with favorable 2-year results.

Supera Stent Implantation with Ultrasound Guidance for Complex Ostial Lesions of Superficial Femoral Artery by Retrograde Approach: The SUGAR Technique

Abstract Purpose The aim of this study was to describe a modified technique for accurate deployment of the Supera stent under ultrasound (US) guidance for complex lesions involving superficial femoral artery (SFA) ostium without jailing profunda femoral artery (PFA) by retrograde approach. Technique Retrograde pedal access was initially taken in all the cases. The stenotic or occlusive femoropopliteal lesions involving the SFA ostium were crossed retrogradely and additional contralateral common femoral artery (CFA) access was taken only if we failed to cross the lesion. In addition to fluoroscopy, extravascular US guidance was freely used whenever required throughout the procedure. After desired predilatation of the SFA lesion, US guidance (gray scale and color Doppler) was used to start deployment of the proximal few centimeters of Supera stent ensuring that the landing of first crown was exactly from the SFA ostium not extending into CFA or jailing the PFA ostium. The rest of the stent was deployed under fluoroscopic guidance. Retrograde pedal access site hemostasis was achieved by manual compression. The Supera stent implantation with Ultrasound Guidance for complex ostial lesions of superficial femoral Artery by Retrograde approach (SUGAR) technique was applied successfully in 35 patients (mean age 58.1 ± 4.4 years; 24 males) with critical limb ischemia via the distal pedal approach. No access site or remote complications were observed. Conclusion The SUGAR technique has superior advantage of utilizing a simple tool like extravascular US in addition to fluoroscopy for retrograde Supera stent deployment by allowing very precise landing at SFA ostium, bypassing the need for multiple oblique projections, unwanted radiation exposure, and extra contrast dye overload.

Comparison of drug-coating balloon and bare-metal stent for complex femoropopliteal artery lesions: 2-year outcome of a multicenter experience

Objectives The aim of this study was to evaluate the 24-month outcome of drug-coating balloon (DCB) versus bare-metal stent (BMS) for the treatment of disabling claudication and critical limb ischemia in patients with complex femoropopliteal lesions regarding technical success, primary patency, secondary patency, target lesion revascularization, and limb salvage rate. Background Complex femoropopliteal lesions are difficult to treat, and the effective protocols for intervention remain to be developed. Patients and methods This was a multicenter, prospective, randomized controlled two-arm blind interventional study. A total of 80 patients (92 limbs) complaining of disabling claudication or critical limb ischemia owing to complex femoropopliteal occlusive lesions were randomly assigned into two groups according to the intervention approach used from May 2016 to August 2020. Group A included 42 patients (47 limbs) who have been assigned for treatment with paclitaxel DCBs and group B included 38 patients (45 limbs) assigned for treatment with BMSs. The follow-up period was for 24 months, with regular visits at 3, 6, 9, 12, 15, 18, and 24 months or when new concerns emerged. All data were analyzed by using Statistical Package of Social Science for Windows, version 22.0 and MedCalc Windows. Results The 1-year primary patency rates in the DCB and BMS groups were 87.2 and 75.6% (P=0.15), respectively, and the corresponding 2-year rates were 76.6 and 57.8, respectively (P=0.05). However, the 1-year secondary patency rates in the DCB and BMS groups were 95.7 and 91.1% (P=0.43), respectively, and the corresponding 2-year rates were 91.4 and 75.5%, respectively (P=0.05). There is a statistically significant difference regarding the primary and secondary patency rates at 24 months between both the groups (P=0.05). The 2-year major limb amputation rate was 6.3% in DCB group versus 11.1% in BMS group (P=0.48), which was statistically insignificant. The postprocedural ankle–brachial index shows highly significant difference between both the groups at 24 months (P<0.001). Conclusion The 2-year outcomes showed superior efficacy, higher safety, and greater clinical benefits of DCBs than BMSs for the treatment of complex femoropopliteal lesions. A statistically significant lower rate of restenosis and occlusions and statistically significant higher 2-year primary and secondary patency rates were observed in the DCB group than in the BMS group. However, more studies with a larger sample and long-term follow-up are required.

Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial.

The aim of the BIOPAC trial was to determine long-term safety and efficacy of a novel microcrystalline paclitaxel-coated balloon (mcPCB) with a biocompatible polymer as an excipient in the treatment of occlusive femoropopliteal lesions. In this first-in-human prospective controlled randomized trial, 66 patients with femoropopliteal, symptomatic (Rutherford stages 2B to 5) occlusive arterial disease were randomized to either mcPCB (study group) or POBA (plain old balloon angioplasty) (control group) on a 1:1 basis. Late lumen loss (LLL) at 6 months was the primary endpoint of the study and serious adverse events (SAE: death, amputation, repeated revascularization) were considered a composite secondary endpoint. Routine angiography was scheduled for all study subjects at 6-month follow-up; outpatient appointments were scheduled at 12 and 36 months after intervention. At 6 months, the LLL was 63% lower in the mcPCB group compared to the POBA group (0.52 ± 1.2 vs 1.39 ± 1.1 mm; psup < 0.01). Binary restenosis occurred in 23% vs 52% of patients (p = 0.02). At 3 years, the prevalence of SAE was significantly lower in the mcPCB group (33.3 vs 63.3%; p = 0.02), which mainly resulted from a twofold reduction in target vessel revascularization rate (28.6 vs 59.3%; p = 0.02). The difference in mortality was nonsignificant (7.4 vs 14.3%; p = 0.42). Patients with mcPCB were less symptomatic and less likely to adhere to secondary prevention measures. In this pivotal trial, a novel mcPCB proved superior to POBA concerning LLL at 6-month follow-up, and SAE at 12 months. This result was sustained up to 3 years. There was no difference between groups regarding mortality. ClinicalTrials.gov Identifier: NCT02145065.

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Cohort

Multicenter, prospective single-arm IN.PACT Global Study from 2012 to 2014 There were 1406 patients with claudication (89%) or rest pain (11%) with complex femoropopliteal occlusive lesions who were treated with IN.PACT Admiral drug-coated balloon (DCB) angioplasty (Medtronic, Dublin, Ireland). Mean lesion length was 12 cm, and a third of the lesions were occluded. The Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization through 36 months was significantly lower in patients with chronic limb-threatening ischemia (68%) compared with claudicants (78%). Predictors of clinically driven target lesion revascularization through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, and chronic limb-threatening ischemia. DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease to treat complex lesions in a real-world population is associated with sustained clinical efficacy and low rates of reintervention at 3 years after the initial procedure.

Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial

Endovascular treatment has become the first-line revascularization technique for femoropopliteal lesions. This technique lacks reliable and accurate morphological control of the arterial segment treated. Intraoperative 2-dimensional angiogram consumes iodinated contrast media and increases X-ray exposure; this subsequently provides no 3-dimensional information on the quality of the revascularization completed, what could explain some of the early and late failures of the technique. We evaluated whether intraoperative optical coherence tomography (OCT) control in addition to standard angiogram could improve the primary patency rate at 12months in comparison to standard angiogram alone in patients with occlusive femoropopliteal lesions. The tomography by optical coherence in femoral artery trial is a multicentric, prospective, randomized, controlled, and single-blind study including patients with long de novo occlusive femoropopliteal lesions. The randomization will be achieved in 2 balanced groups of patients after crossing successfully the lesion: group 1 with intraoperative OCT control in addition to standard angiogram and group 2 with standard angiogram alone. The randomization will be stratified by center. The protocol has been submitted and approved by a French ethic's committee under reference number CPP2019-12-098. The study has been registered under the reference number NCT04434586 on the Web site of clinicaltrials.gov. The primary outcome of the study is the primary patency at 12months. The number of patients who need to be treated is 166 (83 in each group) considering 5% of no workable data. Symptoms' improvement, target lesion revascularization, target vessel revascularization, quality-of-life questionnaires, cost utility, and cost effectiveness will be analyzed as secondary end-point variables at 12months. The present study is to evaluate the potential benefit for patients on the result of endovascular revascularization of long occlusive femoropopliteal lesion at 12 months when using intraoperative OCT control.

Drug Eluting Balloon Angioplasty Versus Bare-metal Stent in Treating Chronic Total Occlusion of Femoro-popliteal Arterial Segment; A Review of One-year Outcome of 90 Patients With TASC C and D Lesion

Introduction: Bare metal stent (BMS) scaffolding of superficial femoral artery occlusive lesions has been associated with high rates of late clinical failure. Maintaining the patency of recanalized arterial segments was the main issue behind the concept of leave nothing behind to be evolved and balloon angioplasty becomes preferred option for endovascular therapy. Drug eluting balloons (DEBs) have shown to be effective alternative to BMS for patients with de novo complex superficial femoral occlusive disease.To compare the outcome of DEB versus BMS in treating complex chronic total occlusion (CTO) of superficial femoral and proximal popliteal artery in patients with disabling claudication and critical limb ischemia regarding technical success, primary patency, clinically driven target lesion revascularization (cd-TLR), and limb salvage rate. Methods: 90 patients (110 limbs) were complaining of disabling and critical limb ischemia due to complex femoro-popliteal occlusive lesions were randomly allocated into two groups according to the intervention method performed. Group (A); 48 patients (57 limbs) were submitted for treatment with paclitaxel DEB and Group (B); 42 patients (53 limbs) submitted for treatment with BMS. Follow-up period was for 1, 6 and 12. Results: BMS seems to have lower patency and higher cd-TLR rates compared to patients who received Paclitaxel DCBs but not statistically significant. The primary patency rates were 100%, 96%, 86.2%at 1, 6, 12 months respectively in DEB group, Vs 100%, 89.8%, 77.6% at 1, 6, 12 months respectively in BMS group. TLR rates were 2%, 7.8% at 6, 12 months respectively in DEB group Vs 6.1%, 14.2% at 6, 12 months respectively in BMS group. Conclusion: Percutaneous therapy for TASC C and D femoro-popliteal lesion using DEB or BMS are both safe and effective with one-year high patency rate. Paclitaxel DEBs seem to have a promising important role in prevention of restenosis and recurrence of peripheral arterial occlusive disease. However, stents are still playing important bailout role in the treatment of residual stenosis and dissection. Further follow-up is essential to obtain and document long-term outcome of percutaneous therapy for complex and long SFA lesions. Disclosure: Nothing to disclose

Drug-eluting balloon angioplasty versus bare-metal stent in treating chronic total occlusion of femoropopliteal arterial segment: a review of 1-year outcome of 90 patients with TASC C and D lesions

Background Bare-metal stent (BMS) scaffolding of superficial femoral artery occlusive lesions has been associated with high rates of late clinical failure. Maintaining the patency of recanalized arterial segments was the main issue behind the concept of leaving nothing behind to be evolved and percutaneous balloon angioplasty becomes the preferred option for endovascular therapy. Drug-eluting balloons (DEBs) have shown to be an effective alternative to BMS for patients with de novo complex superficial femoral occlusive disease. Aims The aim was to compare the outcome of DEB versus BMS in treating complex chronic total occlusion of superficial femoral and proximal popliteal artery in patients with disabling claudication and critical limb ischemia regarding technical success, primary patency, clinically driven target lesion revascularization (cd-TLR), and limb salvage rate. Materials and methods The current study is a multicenter, prospective, randomized study. Ninety patients (110 limbs) complaining of disabling and critical limb ischemia due to complex femoropopliteal occlusive lesions were randomly allocated into two groups according to the intervention method performed. Group A included 48 patients (57 limbs) who were submitted for treatment with paclitaxel DEBs and group B included 42 patients (53 limbs) submitted for treatment with BMS. The follow-up period was for 1, 6, and 12 months. Statistical analysis was performed by using the IBM SPSS Statistics version 22 for Windows Program Package (SPSS Inc., Chicago, IL, USA). Results BMSs seem to have lower patency and higher cd-TLR rates compared with patients who received paclitaxel drug-coated balloons but was not statistically significant. The primary patency rates were 100, 96, and 86.2% at 1, 6, and 12 months’ respectively’ in the DEB group versus 100, 89.8, and 77.6% at 1, 6, and 12 months, respectively, in the BMS group. Clinically driven TLR rates were 2 and 7.8% at 6 and 12 months, respectively, in the DEB group versus 6.1 and 14.2% at 6 and 12 months, respectively, in the BMS group. Conclusion Percutaneous therapy for Trans atlantic inter-societies consensus (TASC) C and D femoropopliteal lesion using DEB or BMS is safe and effective with a high patency rate of 1 year. Paclitaxel drug-eluting balloons seem to have a promising role in the prevention of restenosis and recurrence of peripheral arterial occlusive disease. However, stents are still playing important bailout role in the treatment of residual stenosis and dissection. Further follow-up is essential to obtain and document long-term outcome of different percutaneous therapy for complex and long superficial femoral artery (SFA) lesions.

The Foot Angiosomes as Integrated Level ofLower Limb Arterial Perfusion: Amendmentsfor Chronic Limb Threatening IschemiaPresentations

Introduction: The angiosome concept was initially pioneered by Taylor and Palmer in the plastic reconstructive surgery field. The authors described a reproducible model of arterial and venous distribution in humans that follows specific three-dimensional (3D) networks of tissue. The angiosome model yet represents a specific level among other staged and graduated levels of harmonious arterial irrigation in the lower extremity. Specific CLTI pathologies enhance characteristic arterial branches affectation, including the angiosomal source arteries. Evaluating main atherosclerotic lesions at peculiar Levels of arterial division may afford useful clinical information. Method: The present study proposes a description of six levels of degressive arterial division and collateral distribution in the inferior limb, including the angiosomal stage. Following succeeding perioperative 2D angiographic observations over an eight-year period, these levels (I to VI) were analyzed (including the angiosomal Level III) and summarized in attached tables. The medical files of 323 limb-threatening ischemic foot wounds (Rutherford 4-6) in 295 patients (71% men) were retrospectively reviewed. All arterial patterns were defined by preoperative Angio-CT, or Angio-MRI, associating in each case perioperative angiography. For each anatomical Level the worse atherosclerotic lesions (TASC II) were located, then compared with adjacent levels in same individual CLTI patterns. For each ramification stage the heaviest occlusive angiographic lesions (TASC “C-D”) were selected and defined as “dominant”, in comparison with parallel “associate” atherosclerotic locations. A comparison between 196 diabetic, against 127 non-diabetic CLTI patterns of atherosclerotic occlusive disease was performed. Results: Notable differences in the distribution of the dominant occlusive lesions were observed among the two Groups. Specific “Level I” iliac and common femoral lesions (10%), adding “Level II” superficial femoral (17%) also “Level II” femoro-popliteal (32%) dominant occlusive lesions in non-diabetics prevailed against correspondent iliac (3%), superficial femoral (7%), and femoro-popliteal (21%) occlusive lesions in diabetic CLTI subjects. Conversely, “Level II” distal popliteal and tibial occlusions (33%), “Level III” pedal and angiosomal branches (34%) adding “Level III” dominant foot arches occlusions (5%) in diabetic patients, overruled correspondent popliteo-tibial (30%), pedal-angiosomal (5%), and isolated foot arches (0%) lesions in non-diabetics. Conclusion: Inferior limb vasculature affords a harmonious 3D distribution of “tissueoriented” arterial axes including the angiosomal source arteries. These branches are coupled to a vast collateral compensatory system (choke-vessels, cutaneous perforators, and arterial-arterial interconnections) in a degressive array. Six Levels of arterial ramification (I-VI) can be described on angiographic analysis. To specific Levels I-II bear atherosclerotic occlusive disease location, characteristic Levels III-IV topographic occlusive disease is opposed in diabetic CLTI patients.

Comparison of Angiographic Dissection Patterns Caused by Long vs Short Balloons During Balloon Angioplasty of Chronic Femoropopliteal Occlusions

Purpose: To describe the feasibility of balloon angioplasty using a long balloon for chronic femoropopliteal occlusions by evaluating angiographic dissection patterns for optimization of outcomes in balloon angioplasty. Methods: A retrospective, single-center analysis examined 101 symptomatic patients (mean age 75.6±9.9 years; 65 men) with single de novo femoropopliteal occlusive lesions treated with balloon angioplasty between August 2012 and October 2016. The patients were classified into 2 groups for comparison of angiographic dissection patterns: 51 patients were treated with balloon angioplasty using long balloons (L-BA; defined as ≥220 mm in length) and 50 patients were treated with short balloon angioplasty (S-BA; defined as <150-mm-long balloons). Results: Severe vessel dissection patterns, defined as type C or higher, were fewer in the L-BA group (47.1% vs 70.0% in the S-BA group, p=0.019) and the total dissection length was shorter (92.7±72.6 vs 160.4±84.6 mm in the S-BA group, p<0.001). Although the results showed no significant differences between the two groups regarding the length of chronic total occlusions (L-BA: 228.6±73.2 vs S-BA: 226.0±53.8 mm, p=0.83), inflation pressure (L-BA; 8.2±2.6 vs S-BA: 8.1±2.9 atm, p=0.86), and the other lesion characteristics, inflation time was significantly longer in the L-BA group (161.2±68.7 seconds vs 51.1±54.0 seconds in the S-BA group, p<0.001). Multivariate analysis identified a balloon length ≥220 mm as an independent negative predictor of severe vessel dissection (odds ratio 0.29, 95% confidence interval 0.11 to 0.83, p=0.02). Conclusion: Using long balloons for balloon angioplasty may help prevent severe vessel dissection in chronic femoropopliteal occlusions.

Determination of Risk Factors and Establishment of a Prediction Model for Immediate Technical Failure during Endovascular Treatment of Femoropopliteal Occlusive Disease

For long femoropopliteal occlusive lesions, the immediate technical failure (ITF) of endovascular treatment (EVT) is relatively high. Therefore, this study aims to reveal risk factors and establish a prediction model of ITF of EVT in femoropopliteal occlusive disease (FPOD) patients based on preoperative clinical date that may be helpful to the clinical procedures. A retrospective analysis of 1,563 FPOD patients who underwent above-the-knee EVT was undertaken. Univariate analysis with chi-squared test was used to screen risk factors from preoperative clinical data. Multivariable analysis with logistic regression was used to generate a model for predicting the ITF rate of EVT, which was evaluated through the receiver operating characteristic curve and another independent cohort of 242 FPOD patients. Risk factors for ITF during EVT in FPOD included age (>80years, X1), the absence of diabetes mellitus (X2), low-density lipoprotein (>160mg/dL, X3), lesion calcification (X4), lesion length (>20cm, X5), ostial occlusion of superficial femoral artery (SFA) (X6), and SFA lesion involving the popliteal artery (X7). A logistic regression model was established based on the equation: -6.504+1.236X1 + 0.945X2 + 1.406X3 + 1.136X4 + 1.059X5 + 2.307X6 + 2.194X7. Scores were given to risk factors as follows: X1 (yes=12, no=0), X2 (yes=9, no=0), X3 (yes=14, no=0), X4 (yes=11, no=0), X5 (yes=11, no=0), X6 (yes=23, no=0), and X7 (yes=22, no=0). We determined that the optimal comprehensive score for predicting EVT failure was 39, with a sensitivity of 0.847 and a specificity of 0.8. Among these 242 peripheral arterial disease patients, 12 of 14 patients who had failed EVT had a comprehensive score of >39. We identified a number of risk factors of ITF during the above-the-knee EVT and established a prediction model that may be used for guidance in clinical practice.

Self-expanding nitinol stents of high versus low chronic outward force in de novo femoropopliteal occlusive arterial lesions (BIOFLEX-COF trial): study protocol for a randomized controlled trial

BackgroundSelf-expanding nitinol stents must be oversized at least by a minimal amount to ensure contact with the vessel wall and prevent migration. Once the stent is deployed it exerts a continuous force upon the vascular wall, termed chronic outward force (COF). Animal studies have found an increased neointimal hyperplasia in stents with high oversizing and thus high COF. Data about correlation between COF and neointimal hyperplasia in humans are currently lacking. The objective of the BIOFLEX-COF trial is to prospectively investigate differences in formation of intimal hyperplasia at 1 and 2 years after implantation of nitinol stents with high versus low COF in de novo femoropopliteal occlusive arterial lesions.MethodsThe BIOFLEX-COF trial is a prospective, quantitative, randomized study. Eighty subjects with symptomatic peripheral arterial lesions eligible for endovascular stent implantation will be enrolled and randomly assigned to either a high COF group (LifeStent Flexstar, Bard Peripheral Vascular Inc., Tempe, AZ, USA) or low COF group (Pulsar, Biotronik AG, Bülach, Switzerland) using an online randomization program to generate a random 1:1 group allocation (block randomization). After implantation and dilatation, COF at every 2 mm along the stent axis will be calculated from the actual stent diameter versus its nominal diameter.There will be two follow-up evaluations at 12 and 24 months. Primary endpoint is the amount of in-stent neointima at 1 year, assessed by contrast-enhanced CT angiography (CTA). In the control examinations, stent diameter and true lumen diameter will be measured on DICOM images every 2 mm along the stent axis to quantify the relative amount of in-stent restenosis.Secondary objectives are the amount of in-stent neointima at 2 years, device- and procedure-related adverse events and target lesion revascularization (TLR) rate.The scheduled time for recruitment is 2 years. Recruitment is expected to be complete in October 2017.DiscussionThis trial is the first to prospectively investigate the influence of COF on stent patency. If successful, the results will aid in a more precise selection of stent type and size in a given target vessel.The present study is challenging in that it compares two different self-expanding nitinol stents head-to-head against each other. To optimize the power of this study, traditional binary outcome parameters such as TLR and restenosis at Doppler ultrasound were dropped as primary endpoints. Instead, the amount of neointima inside the stent accessed by CTA was selected as (continuous) outcome parameter.Trial registrationClinicalTrials.gov Identifier: NCT03097679. Date of registration: 14 March 2017 (retrospectively registered).

Outcome of Surgical Management for Abdominal Aortic Pseudoaneurysm in Behçet Disease: A Shift From Open Surgery Towards Endovascular Repair

Objectives: Remote endarterectomy (RE) is a minimally invasive procedure conceived as an alternative to an above-the-knee bypass for patients with symptomatic limb ischemia. Successful RE outcome is frequently hampered by adherent plaque within and beyond the adductor canal and the insertion of a stent. We present a case series of modified RE enhanced by the addition of a distal leg incision to accomplish a longer segment plaque excision without the need for a distal stent. Methods: A retrospective record review identified RE procedures performed from May 2010 through March 2012. Adjunctive patch angioplasty was used to close the arteriotomies. Demographics, lesion characteristics, procedural details, andoutcomedatawere collected. Study endpointsweredeath, occlusion, reoperation, or last office follow-up visit. Results: REwas performed in 11 patients (5men;mean age, 68 years, 3 diabetics, 11 tobacco users). Indication for operation was claudication in 6, rest pain in 3, and gangrene in 2.REwas technically successful in all patients.Distal arterial exposure was above knee in 7 (64%), below knee in 2 (18%), and combined above-knee and below-knee exposures in 2 patients (18%). Two patients underwent concomitant balloon angioplasty in either the popliteal or anterior tibial vessels. Mean postoperative ankle-brachial index increase was .43 (P 1⁄4 .001). Operative complication of above-knee popliteal artery perforation occurred in one patient but was successfully repaired with covered stent deployment. Average procedure duration was 162 6 69 minutes (standard deviation) and average hospital stay was 4 days. All patients reported symptom resolution; both patients with tissue ulceration healed. During the 12-month follow-up period, a femoropopliteal reocclusion developed in four patients, resulting in one patient who underwent a successful femoral-popliteal bypass operation. Limb salvage rate was 100%. Conclusions: When endovascular therapies are exhausted, and should autologous saphenous vein be unavailable, the dual incision RE technique of long segment femoropopliteal occlusive lesions accomplishes effective revascularization. Symptom relief or limb salvage was achieved in all patients; the need for a subsequent bypass was rare and not adversely affected by having undergone the dual incision RE.

Dual Incision Remote Endarterectomy Is a Novel Treatment Option for Long-Segment Superficial Femoral-Popliteal Artery Occlusive Disease

Objectives: Remote endarterectomy (RE) is a minimally invasive procedure conceived as an alternative to an above-the-knee bypass for patients with symptomatic limb ischemia. Successful RE outcome is frequently hampered by adherent plaque within and beyond the adductor canal and the insertion of a stent. We present a case series of modified RE enhanced by the addition of a distal leg incision to accomplish a longer segment plaque excision without the need for a distal stent. Methods: A retrospective record review identified RE procedures performed from May 2010 through March 2012. Adjunctive patch angioplasty was used to close the arteriotomies. Demographics, lesion characteristics, procedural details, andoutcomedatawere collected. Study endpointsweredeath, occlusion, reoperation, or last office follow-up visit. Results: REwas performed in 11 patients (5men;mean age, 68 years, 3 diabetics, 11 tobacco users). Indication for operation was claudication in 6, rest pain in 3, and gangrene in 2.REwas technically successful in all patients.Distal arterial exposure was above knee in 7 (64%), below knee in 2 (18%), and combined above-knee and below-knee exposures in 2 patients (18%). Two patients underwent concomitant balloon angioplasty in either the popliteal or anterior tibial vessels. Mean postoperative ankle-brachial index increase was .43 (P 1⁄4 .001). Operative complication of above-knee popliteal artery perforation occurred in one patient but was successfully repaired with covered stent deployment. Average procedure duration was 162 6 69 minutes (standard deviation) and average hospital stay was 4 days. All patients reported symptom resolution; both patients with tissue ulceration healed. During the 12-month follow-up period, a femoropopliteal reocclusion developed in four patients, resulting in one patient who underwent a successful femoral-popliteal bypass operation. Limb salvage rate was 100%. Conclusions: When endovascular therapies are exhausted, and should autologous saphenous vein be unavailable, the dual incision RE technique of long segment femoropopliteal occlusive lesions accomplishes effective revascularization. Symptom relief or limb salvage was achieved in all patients; the need for a subsequent bypass was rare and not adversely affected by having undergone the dual incision RE.

Subintimal Recanalization of Femoropopliteal Occlusive Lesions in Patients With Critical Ischemia: 66 Cases

Subintimal recanalization allows for the treatment of percutaneously extended occlusive lesions. The aim of this study was to evaluate the feasibility and short- and mid-term results of subintimal recanalization in the treatment of femoropopliteal occlusive lesions in patients with critical ischemia. Between January 2009 and December 2010, consecutive patients with critical ischemia presenting with femoropopliteal arterial occlusion were included in this study. These patients underwent subintimal recanalization, and all patients had clinical and ultrasound follow-up. Sixty-six procedures were performed on 66 patients (mean age, 79±10 yrs). All patients were American Society of Anesthesiologists classification 3 or 4. Thirty-two patients had diabetes and 27 had chronic renal insufficiency. More than two-thirds (76%) of the lesions had a Trans-Atlantic Inter-Society Classification of C or D. The mean occlusion length was 13.5±7 cm. The rate of technical success was 85%. The peroperative complication rate was 4.5%. There were no cases of operative mortality. Occlusion length was the only predictive factor of restenosis (P=0.049). At 1 year, primary and secondary patency rates were 56% and 70%, respectively, for a 92% rate of limb salvage. The subintimal recanalization technique is feasible and minimally invasive. At 1 year postprocedure, the primary patency is poor, but this technique is associated with a high rate of limb salvage. It is suitable for the treatment of critical ischemia, taking into account the often precarious clinical backgrounds of these patients.

Early Results with the Use of Heparin-bonded Stent Graft to Rescue Failed Angioplasty of Chronic Femoropopliteal Occlusive Lesions: TASC D Lesions Have a Poor Outcome

To evaluate early patency rate of the heparin-bonded stent grafts in atherosclerotic long femoropopliteal occlusive disease, and to identify factors that affect outcome. Heparin-bonded Viabahn stent grafts were placed in 33 limbs in 33 patients during 2009-2010. The stents were deployed to rescue failed conventional balloon angioplasty. Mean age was 69 (range 44-88) years, and 67 % (22 of 33) were men. Most procedures (21 of 33, 64 %) were performed for critical limb ischemia (33 % for rest pain, 30 % tissue loss). Kaplan-Meier plots and Cox regression analysis were used to identify significant risk factors. The average length of lesions treated was 25 ± 10 cm, and they were predominantly TASC (Transatlantic Intersociety Consensus) D (n = 13) and C (n = 17) lesions. The median primary patency was 5.0 months (95 % confidence interval 1.22-8.77). The mean secondary patency was 8.6 months (95 % confidence interval 6.82-10.42). Subsequently, 4 patients underwent bypass surgery and 5 patients underwent major amputation. One patient died. There were 5 in-stent or edge-stent stenoses. Cox multivariate regression analysis identified TASC D lesions to be a significant risk factor for early occlusion (p = 0.035). TASC D lesions of femoropopliteal occlusions have poor patency rates with the use of heparin-bonded stent grafts after failed conventional angioplasty. Alternative options should be considered for these patients.

Advantages and Limitations of TASC II Classification of Femoropopliteal Lesions

78-5884/$36 a 2009 European Socie i:10.1016/j.ejvs.2009.12.022 In this issue of the Journal, T. Kukkonen et al. evaluate the reproducibility of femoropopliteal TASC II classification by reviewing 200 angiograms of patients having femoropopliteal occlusive arterial lesions. Seven investigators evaluated the first 100 angiograms with the help of the TASC II guide followed by a debate of the 25 most difficult cases with a panel of 22 vascular surgeons. After the debate, the seven investigators reviewed the 100 remaining cases independently. After the first evaluation, agreement between all observers as measured by the kappa was 0.32 [0.11e0.54] between two observers, increasing after the debate to 0.49 but remaining below the adequate inter-rater agreement of 0.70. Total agreement between all seven observers was reached only in 7% and 19%, respectively, of the cases before and after the debate. This interesting study confirms a well known weakness of the TASC II document that was predicted by the authors of TASC II when they wrote: ‘‘It must be understood that most PAD requiring intervention is characterized by more than