Superficial Femoral Artery Lesions Research Articles

Recanalization of superficial femoral artery chronic total occlusion through retrograde popliteal approach Recanalization of superficial femoral artery chronic total occlusion

PurposeThis retrospective study aims to evaluate the safety, practicality, and efficacy of the independent retrograde popliteal approach for recanalization superficial femoral artery (SFA) occlusions when the bilateral common femoral artery approach is unavailable, such as after endovascular aneurysm repair or common iliac artery stenting. MethodsThis treatment was considered for patients with contralateral iliac artery occlusion, severe iliac tortuosity, or those who had previously undergone endovascular aneurysm repair or common iliac stenting. Patients with SFA lesions extending into the P1-P2 segment of the popliteal artery or with calcification in the P3 segment were excluded. Angioplasty and stenting were conducted via the popliteal artery approach, with hemostasis at the puncture site achieved using an EXOSEAL vascular closure device. Patients were routinely followed up at 3, 6, and 12 months, and annually thereafter. ResultsForty-eight consecutive patients with SFA occlusion who underwent endovascular treatment via the retrograde popliteal artery approach were included in this study. Retrograde puncture of the popliteal artery was successful in all cases. Six-French sheaths were utilized in all procedures. The EXOSEAL vascular closure device was successfully applied in all 48 cases. No instances of pseudoaneurysms, arteriovenous fistulas, major bleeding, or embolic complications were observed. The technical success rate for SFA recanalization was 100%. All patients experienced clinical improvement. The ankle-brachial index significantly increased from an initial 0.33±0.11 at admission to 0.81±0.19 at discharge (P<0.001). The mean follow-up period was 25.1±11.7 months. Kaplan-Meier analysis revealed primary patency rates of 82.5% at 12 months and 71.8% at 24 months. No patients required major amputation during the follow-up period. ConclusionThe endovascular treatment of SFA occlusions via the independent retrograde popliteal approach is a viable alternative, demonstrating a low incidence of puncture-related complications and a high success rate of recanalization.

Long-Term Outcomes of a Japanese Prospective Multicenter Registry Using a Heparin-Bonded Expanded Polytetrafluoroethylene Graft for Above-the-Knee Femoropopliteal Bypasses.

Despite the widespread use of PROPATEN®, a bioactive heparin-bonded expanded polytetrafluoroethylene graft, in bypass surgery, there are only a few reports of long-term results. We evaluated the long-term results of PROPATEN®use for above-knee femoropopliteal bypass (AKFPB).Methods and Results: After PROPATEN®-based AKFPB, patients were prospectively registered at 20 Japanese institutions between July 2014 and October 2017 to evaluate long-term results. During the median follow-up of 76 months (interquartile range 36-88 months) for 120 limbs (in 113 patients; mean [±SD] age 72.7±8.1 years; 66.7% male; ankle-brachial index [ABI] 0.45±0.27; lesion length 26.2±5.7 cm; chronic limb-threatening ischemia in 45 limbs), there were 8 major amputations; however, clinical improvement was sustained (mean [±SD] ABI 0.87±0.23) and the Rutherford classification grade improved in 105 (87.5%) limbs at the latest follow-up. At 8 years, the primary patency, freedom from target-lesion revascularization, secondary patency, survival, and amputation-free survival, as estimated by the Kaplan-Meier method, were 66.3±4.8%, 71.5±4.4%, 86.5±3.4%, 53.1±5.0%, and 47.4±5.3%, respectively. This multicenter prospective registry-based analysis showed sustained excellent clinical improvement and secondary patency for up to 8 years following PROPATEN®-based AKFPB. PROPATEN®constitutes a durable and good revascularization option for complex superficial femoral artery lesions, especially when endovascular treatment is inappropriate or an adequate venous conduit is unavailable.

Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions

ObjectiveIn two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn, SECS) or drug-eluting stents (ZilverPTX, DES) are related to similar clinical outcomes at one-year follow-up. MethodsIn a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at one-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality. ResultsA total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up there were no significant differences in primary patency (ITT 63.4% vs 71.1%: p=0.183 and PP 60.8% vs 71.1%; p=0.100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; p=0.054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS 85.6% versus DES 95.1%; p=0.038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%, p=0.481). No major amputations were performed in the SECS group and two in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after one-year follow-up (p=0.106). Based on diagnosis (IC versus CLTI) no differences between IC and CLTI patients were observed in primary, secondary patency and freedom from TLR. ConclusionsTreatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at one-year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.

Endovascular treatment with interwoven nitinol stent for common femoral artery lesions: 2-year outcomes of a single center experience.

The study aimed was to report 2-year outcomes of endovascular treatment with interwoven nitinol (Supera™) stent for common femoral artery (CFA) lesions. We reviewed the clinical data of 20 patients who presented with CFA stenosis or occlusion and underwent balloon angioplasty followed by Supera™ stenting in CFA between February 2016 and January 2022. The outcomes were evaluated in these patients in terms of technical success, post-intervention complications, reintervention, and cumulative patency (1year, and 2years). The study included 20 patients (22 lesions) who presented with isolated CFA lesions (3), iliac lesions involving CFA (6), superficial femoral artery (SFA) lesions involving CFA (8), and extensive lesions from the iliac artery to SFA (5). There were 16 men (80%) with a mean age of 69.7years (range, 34-83). Hypertension, smoking, and diabetes were found in 15 (75%), 7 (35%), and 7 patients (35%), respectively. Clinical presentations were Rutherford stage 5 (9, 45%), Rutherford stage 4 (5, 25%), Rutherford stage 6 (4, 20%), and Rutherford stage 3 (2, 10%). Technical success was achieved in all patients (100%). The procedures for treatment were isolated CFA Supera™ stenting (1, 4.5%), CFA plus DFA Supera™ stenting (jailed SFA) (2, 9.1%), CFA plus SFA Supera™ stenting (jailed DFA) (8, 36.4%), CFA Supera™ stenting plus bare iliac stenting (Astron) (6, 27.3%), CFA plus SFA Supera™ stenting (jailed DFA) plus bare iliac stenting (Astron) (5, 22.7%), and additional DFA angioplasty (7, 31.8%). The rate of in-hospital mortality and morbidity were 0% and 10%, respectively. Distal embolization after pre-dilatation occurred in 1 patient, and cerebral infarction occurred 12h after the procedure in 1 patient. The mean follow-up time was 23months (range, 2-64). During the follow-up period, in-stent occlusion occurred in 2 patients at 9 and 46months. Re-intervention was performed in 1 patient due to recurrent symptom of claudication. The cumulative primary patency at 1year and 2years were 93.3% and 93.3%, respectively. Endovascular treatment with interwoven nitinol (Supera™) stent for CFA lesions was associated with acceptable outcomes at 2years.

Multicenter Registry of Common Femoral Artery Disease Treated With Endovascular Revascularization Using Interwoven Nitinol Stents: An Observational Retrospective Study.

Surgical thromboendarterectomy has been the gold standard treatment for common femoral artery (CFA) disease. However, endovascular therapy (EVT) is conducted in certain patients with CFA lesions because of multiple comorbidities. The interwoven nitinol stent (IWS) has been developed to prevent stent fracture. Thus, this study aimed to evaluate the feasibility of EVT using IWS for CFA lesions in clinical practice. This retrospective multicenter registry analyzed patients who had symptomatic lower-extremity artery disease due to CFA lesions and underwent EVT using IWS between 2019 and 2021. The primary endpoint was restenosis 2 years after EVT. This study enrolled a total of 177 patients with 196 CFA lesions. The 2-year estimate of freedom from restenosis was 88.0%. The 2-year freedom rates from the target-lesion revascularization, major amputation, and all-cause death were 92.9%, 99.0%, and 75.2%, respectively. The clinical features significantly associated with restenosis risk were the reference vessel diameter (RVD, per 1.0 mm, hazard ratio [HR], 0.24 [0.08-0.70]; p=0.009), external iliac artery (EIA) involvement (HR=4.03 [1.56-10.4]; p=0.004), superficial femoral artery (SFA) involvement (HR=3.05 [1.00-9.25]; p=0.049), body mass index (BMI; per 1.0, HR=0.85 [0.73-0.99]; p=0.032), occlusion of deep femoral arteries (DFAs) at baseline (HR=7.89 [2.04-30.5]; p=0.003), and chronic limb-threatening ischemia (CLTI, HR=2.63 [1.02-6.78]; p=0.045). Their significant association was also confirmed by the random survival forest analysis. During a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases (37.2%), and no patients had cannulation-related complications, such as failed hemostasis, fracture of IWS, and stent occlusion. Endovascular therapy using IWS in CFA lesions showed acceptable 2-year patency rates at 88.0% and might preserve the arterial access via the ipsilateral CFAs. Small RVD, involving EIA and SFA lesions, emaciation, occluded DFA, and CLTI are associated with poor 2-year patency rates following EVT, thus, IWS implantation in CFA lesions may be an option for patients unsuitable for surgical revascularization. This retrospective multicenter registry enrolled 177 patients with 199 CFA lesions treated with EVT using interwoven nitinol stents, because surgical thromboendarterectomy was difficult due to their multiple comorbidities. The 2-year estimate of freedom from restenosis was acceptable at 88.0%. The 2-year freedom rate from major amputation was also high at 99.0%. Moreover, during a median follow-up of 12.0 months, guiding sheaths were inserted via CFAs implanted IWSs in 73 cases, and no patients had cannulation-related complications such as failed hemostasis, fracture of IWS, and stent occlusion.

Using Isolated Femoral Bifurcation Endarterectomy or Combined with Bypass Surgery for Patients with Chronic Limb-Threatening Ischemia.

Background and Objectives: The aim of this study was to evaluate the clinical outcomes of patients suffering from chronic limb-threatening ischemia (CLTI) and tissue loss treated with primary isolated femoral bifurcation endarterectomy (FBE) or with FBE combined with bypass surgery. Materials and Methods: This retrospective study was performed in a tertiary university-based care centre. Between January 2008 and December 2019, a prospectively collected database of patients suffering from CLTI and tissue loss and undergoing either primary FBE (group A) or FBE in combination with bypass surgery (group B) was analysed. Study endpoints were ulcer healing, primary and secondary patency rate, limb salvage, and survival. Results: In total, FBE was performed in 73 patients and FBE with bypass in 60 patients. Between both groups, there were no significant differences regarding demographic data or the Global Limb Anatomic Staging System (GLASS) grade III and IV of femoropopliteal lesions. After 3 years, ulcer healing could be achieved in 72% of FBE and in 75% of FBE with bypass patients. The primary patency rate was 95% and 91% for FBE and 83% and 80% for FBE with bypass after one and three years, respectively. The 3-year limb-salvage rate was 78% for FBE and 84% for FBE with bypass. The secondary patency rate after one and three years was 99% and 97% for FBE and 93% and 88% for FBE with bypass. Conclusions: FBE and FBE with bypass are equally effective for ulcer healing in cases of combined CFA and superficial femoral artery lesions. There was no significant difference between both groups regarding primary and secondary patency rates, limb salvage rates and ulcer healing. Isolated FBE could be an alternative strategy in patients with higher operative risk.

Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis.

The treatment of complex infra-inguinal disease with drug-coated balloons (DCBs) is associated with a significant number of patients undergoing provisional stenting to treat a suboptimal result. To determine the potential long-term impact of DCB treatment with provisional bare metal stenting in complex lesions in real-world patients, a post hoc analysis was performed on data from the IN.PACT Global Study (The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral Drug-Eluting Balloon). Five-year outcomes were compared between participants who were stented after DCB treatment versus those treated with DCB alone. The IN.PACT Global Study enrolled 1535 participants with intermittent claudication and/or ischemic rest pain caused by femoropopliteal lesions; 1397 patients were included in this subgroup analysis (353 stented and 1044 nonstented). Effectiveness was assessed as freedom from clinically driven target lesion revascularization through 60 months. The primary safety composite end point was defined as freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and clinically driven target vessel revascularization through 60 months. Lesions in the stented group were longer (15.37 versus 10.98 cm; P<0.001) and had more total occlusions (54.7% versus 28.6%; P<0.001) compared with the nonstented group. The 5-year Kaplan-Meier estimated freedom from clinically driven target lesion revascularization was similar between groups (66.8% stented versus 70.0% nonstented group, log-rank P=0.22). The safety composite end point was achieved in 64.5% stented versus 68.2% nonstented participants (log-rank P=0.19) as estimated by the Kaplan-Meier method. No significant difference was observed in the cumulative incidence of major adverse events (49.1% stented versus 45.0% nonstented; log-rank P=0.17), including all-cause death (19.6% stented versus 19.3% nonstented, log-rank P=0.99). In this real-world study, revascularization of complex femoropopliteal artery lesions with DCB angioplasty alone or DCB followed by provisional bare metal stenting in certain lesions achieved comparable long-term safety and clinical effectiveness. URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609296.

A New Drug-Coated Balloon for the Treatment of Superficial Femoropopliteal Artery Disease: 12-Month Results from the IN-DEPT SFA Trial

PurposeTo report the outcomes of the IN-DEPT trial assessing the feasibility, preliminary safety data, and 12-month outcomes of a new drug-coated balloon (DCB) product for peripheral artery disease (PAD) in Chinese patients. Materials and MethodsThis is a prospective, multicenter, single-arm clinical trial. A total of 160 patients with superficial femoral artery (SFA) and/or proximal popliteal artery lesions were treated with a new paclitaxel-coated DCB. The preliminary effectiveness end point was 12-month primary patency. The primary safety end point was freedom from device- and procedure-related mortality over 30 days and freedom from major target limb amputation and clinically driven target lesion revascularization (CD-TLR) within 12 months after the index procedure. ResultsIn total, 160 patients presented with 162 target lesions. A total of 139 lesions (85.8%) were treated with 1 DCB, whereas the other 23 lesions (14.2%) were treated with 2 devices. The device success rate was 100%. A total of 135 subjects reached the preliminary effectiveness end point, with a 12-month primary patency rate of 84.4%. There was no 30-day device- or procedure-related death or unplanned major target limb amputation at 12 months. Five CD-TLRs (3.1%) occurred during the 12-month follow-up period. ConclusionsResults from the IN-DEPT SFA trial showed satisfactory feasibility and safety of the new DCB over 12 months in Chinese patients with PAD and femoropopliteal de novo lesions, including both stenoses and total occlusions.

Middle Aortic Syndrome in an Elderly Patient : Description of a Surgical Case

The middle aortic syndrome is a rare form of presentation of aortic coarctation that represents 0.5-2% of this same entity. It usually presents in the pediatric or young adult population; therefore, the age of this patient is of interest. It mainly affects women with an estimated ratio of 4:1. Renal involvement is the most prevalent, and idiopathic etiology is the most frequent. This pathology presents clinically with hypertension challenging to control along with intermittent claudication. This article comprises the case of an 81-year-old female patient with a history of hypertension, sedentary lifestyle, smoking, osteoporosis, cholecystectomy in 2010, and appendectomy in childhood. On this occasion, the patient had a stenosis of the infrarenal abdominal aorta and a simultaneous superficial femoral artery lesion and was treated in a hybrid approach with a balloon expandable stent and a suprapatellar femoral-popliteal bypass.

The relationship between plasma atherogenic index and long-term outcomes after endovascular intervention in superficial femoral artery lesions.

Peripheral arterial disease (PAD) results from the systemic atherosclerotic process. In this study, we aimed to determine the relationship between plasma atherogenic index (AIP), a ratio of molar concentrations of triglycerides to HDL-cholesterol, and long-term outcomes after endovascular therapy (EVT) in patients with superficial femoral artery (SFA) stenosis. We retrospectively evaluated 673 patients who underwent EVT for PAD in our tertiary center between January 2015 and December 2020. In the receiver operating characteristic (ROC) curve analysis, the AIP value with the optimum cutoff value was determined as 0.576 to detect the presence of major adverse limb events (MALEs). Patients were divided into two groups according to low AIP (<0.576 as group 1) and high AIP (>0.576 as group 2). Among the major endpoints, long-term restenosis rates were significantly higher in patients in the high-AIP group than in the low-AIP group (p<.001). The lower extremity amputation rate was not statistically significant between the two groups. All-cause mortality rate (54 (31.6) versus 117 (68.4), p<.001) was significantly higher in patients in the high-AIP group than in the low-AIP group. In addition, the MALE rate (94 (29.2) versus 218 (62.1), p<.001) was significantly higher in patients in the high-AIP group than in those in the low-AIP group. In conclusion, we found that AIP is a significant independent predictor of long-term MALE in patients who underwent EVT for SFA.

IVUS Improves Outcomes With SUPERA Stents for the Treatment of Superficial Femoral-Popliteal Artery Disease.

Nitinol interwoven bare metal stents represent an advancement in stent technology; however, nominal deployment remains an area of focus. Intravascular ultrasound (IVUS) has been shown to improve outcomes in both the coronary and peripheral vasculature by providing the operator with greater vessel detail; however, the use of adjunctive IVUS with nitinol bare metal stents has not been widely studied. This studies aims to determine the effect of IVUS when used adjunctively with nitinol interwoven bare metal stents in the management of femoropopliteal lesions. Retrospective study. This study included a cohort of 200 consecutive patients with peripheral artery disease. All patients were treated with ≥1 Supera bare metal stent, and 91 received adjunctive IVUS imaging prior to stent deployment. Deployment conditions of nominal, compressed, and elongated were measured, and the primary clinical outcomes included target lesion reintervention, amputation, and mortality. This study also showed that 8.3 number needed to treat (NNT) patients must be treated with IVUS to avoid an additional revascularization event. The patients who received IVUS had a significantly greater number of nominally deployed stents (p<0.001). Patients who had IVUS imaging also had significantly lower reintervention rates compared with those who did not receive IVUS imaging (p=0.047). The IVUS and angiography decreases clinically-driven target lesion reintervention and increases nominal deployment compared with angiography alone in femoropopliteal lesions treated with interwoven bare metal nitinol stents. Endovascular surgones may conisder the adjuctive use of IVUS when using the Supera stent for the treatment of infra inguinal superficial femoral artery lesions. The adjunct use of IVUS may lead to improved sizing, vessel prep, deployment, and ultiamtely reduction in CD-TLR.

Long-term Results of a Heparin-bonded Expanded Polytetrafluoroethylene Grafts for Above-the-knee Femoropopliteal Bypasses: A Japanese Prospective Multicenter Registry

Propaten (WL Gore & Associates, Flagstaff, AZ) is a bioactive heparin-bonded expanded polytetrafluoroethylene graft widely used for bypass surgery; however, its long-term results are yet to be established. In this study, we evaluated the long-term results of Propaten for above-the-knee femoropopliteal bypasses (AKFPB) using a Japanese prospective multicenter registry. In this prospective single-arm multicenter registry, 120 limbs (113 patients) underwent AKFPB for superficial femoral artery (SFA) lesion in 20 Japanese institutions between July 2014 and October 2017. We evaluated the long-term results by estimating primary patency (PP), secondary patency (SP), freedom from target lesion revascularization (TLR), and freedom from death at 6 years using the Kaplan-Meier method. Factors associated with the risk for the loss of PP were investigated using the Cox proportional hazards regression model. Baseline characteristics of 120 limbs are summarized in Table. Mean lesion length was 26.2 ± 5.7 cm, chronic limb-threatening ischemia was present in 45 limbs (37.5%), and only 35 limbs (29.2%) had all three runoff vessels patent. Technical success was achieved in all cases, and 49 limbs (40.8%) had concomitant additional procedure, mainly endovascular treatment (EVT), and cuffed distal anastomosis was employed in 93 limbs (77.5%). There were eight perioperative complications (6.7%), however, mean ankle brachial index (ABI) improved from 0.45 ± 0.27 to 0.96 ± 0.14, and improvement in Rutherford classification (RC) was achieved in 98 limbs (81.7%) at 30 days. Clinical improvement was sustained at the latest follow-up as mean ABI was 0.87 ± 0.23, and improvement in RC was achieved in 105 limbs (87.5%). PP, freedom from TLR, SP, and freedom from death at 6 years were 66.1% ± 4.9%, 72.4% ± 4.5%, 85.6% ± 3.6%, and 62.9% ± 4.8%, respectively (Fig 1). As for the factors associated with the risk for the loss of PP, prior coronary disease (unadjusted hazard ratio [HR], 2.57; 95% confidence interval [CI], 1.09-4.36; P = .006), hemodialysis (unadjusted HR, 2.62; 95% CI, 1.19-5.57; P = .02), three runoff vessels patent (unadjusted HR, 0.48; 95% CI, 0.22-1.06; P = .07), and cuffed distal anastomosis (unadjusted HR, 0.51; 95% CI, 0.25-1.07; P = .08) were selected for the multivariate analysis from the result of univariate analysis; however, only prior coronary disease remained significant (adjusted HR, 2.18; 95% CI, 1.09-4.36; P = .03). Long-term sustained clinical improvement and acceptable SP was achieved for AKFPB using Propaten. When good venous conduit is unavailable, AKFPB using Propaten is a reasonable revascularization option for complex SFA lesions, especially when EVT is inappropriate.TablePatients’ demographics and characteristicsVariableN = 120 limbsAge, years72.7 ± 8.1Male sex81 (67.5%)Body mass index, kg/m222.5 ± 3.8Rutherford classification 230 (25.0%) 345 (37.5%) 413 (10.8%) 531 (25.8%) 61 (0.8%)Ankle brachial index0.45 ± 0.27Number of runoff vessels 01 (0.8) 143 (35.8) 241 (34.2) 335 (29.2)TASC II classifications A0 (0.0) B6 (5.0) C20 (16.7) D94 (78.3)Lesion length, cm26.2 ± 5.7Outflow popliteal artery diameter, mm4.9 ± 1.1Key comorbidities and medical history Smoking, current31 (25.8%) Smoking, former67 (55.8%) Prior superficial femoral artery treatment32 (26.7%) Arterial hypertension91 (75.8%) Diabetes mellitus63 (52.5%) Dyslipidemia57 (47.5%) Chronic kidney disease (eGFR <60 mL/min)69 (57.5%) Hemodialysis17 (14.2%) Prior coronary disease38 (31.7%) Prior cerebrovascular disease24 (20.8%) Serum albumin <3.0 g/dL24 (20.8%)eGFR, Estimated glomular filtration rate.Categorical variables are presented as number (%), and continuous variables are presented as mean ± standard deviation. Open table in a new tab

Adherence to Society for Vascular Surgery Guidelines for Claudication in the Society for Vascular Surgery Vascular Quality Initiative

Current Society for Vascular Surgery (SVS) guidelines recommend 51 specific factors related to the management of intermittent claudication as quality measures. It was the objective of this study to assess rates of adherence to these guidelines for patients treated with suprainguinal or infrainguinal bypass or percutaneous vascular intervention and to determine if this was associated with a difference in the periprocedural outcomes. All patients from the SVS Vascular Quality Initiative (VQI) undergoing infrainguinal bypass (INFRA), suprainguinal bypass (SUPRA), and percutaneous vascular intervention (PVI) for claudication from 2018 were included. Nonelective procedures for other than chronic atherosclerotic disease were excluded. The rates of adherence to each assessable guideline were evaluated. For outcomes analysis, individuals were classified as “adherent” to the guidelines vs not and compared. Of the 51 SVS recommendations, 12 could be evaluated using VQI registries; these included first-line ankle-brachial index, smoking cessation, statin therapy, antiplatelet therapy with aspirin, optimal medical therapy after intervention, anatomic imaging studies before intervention, optimizing diabetes control, Plavix as second-line antiplatelet, adjunct stenting in intermediate superficial femoral artery lesions, annual follow-up, covered stents for the treatment of aortoiliac disease, and no recommended endovascular treatment for isolated infrapopliteal disease. The rates of overall “adherence” were 38.2% for INFRA, 17.1% for SUPRA, and 32.2% for PVI. There were a surprising number of isolated tibial (n = 1431, 3.1%) and pedal (n = 12, 0.03%) endovascular interventions performed for claudication. There were 784 tibial bypasses (19.3%), 30 (0.7%) at the ankle, 2 of which were tarsal/plantar bypasses for claudication. It appears that for the most part, there do not seem to be important clinical differences in outcomes based on the study definition of adherence for all outcomes assessed. Among factors such as survival (Fig 1), time to amputation (Fig 2), primary patency (Fig 3), and time to reoperation/reintervention for occlusion (Fig 4) for INFRA, SUPRA, and PVI, there were no differences between individuals meeting the study definition of adherence vs those not adherent for all outcomes was assessed. Overall adherence rates to SVS guidelines for the management of intermittent claudication are low and may be an opportunity for improvement in patient outcomes. An absence of differences noted in this study may reflect unmeasured factors in patient selection or in outcomes. Adding more of the SVS recommendations for the management of intermittent claudication to the VQI registry may serve as a future focus for quality improvement projects.

Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication

Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n = 48) or BMT alone (n = 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. At the 36 month follow up, the stent group (n = 32) had statistically significantly better scores in the SF-36 domain “Role Physical” (p = .023) and the Physical Component Summary (p = .032) compared with the control group (n = 30); however, there was no statistically significant difference in EQ5D scores (p = .52). WIQ was statistically significantly better in the stent group compared with the control group (p = .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n = 31) and control groups (n = 32). Crossover from the control group to the stent group was 25% at 60 months. There were no differences in progression to CLTI, amputation (2.1% vs. 1.9%), or mortality (14.6% vs. 15.4%) between groups. In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.

Three-Year Patency Results following Endovascular Transvenous Femoropopliteal Bypass

Background and Objectives: Peripheral artery disease is one of the most common vascular pathologies. There is an ongoing debate among specialists on whether open or endovascular revascularization is preferred in cases of complex superficial femoral artery (SFA) lesions. The purpose of this study was to assess patency results of a relatively new transvenous endovascular bypass device. This could add to existing evidence and aid in comparison between open and endovascular bypass. Materials and Methods: Patients with complex TASC-C and D SFA lesions who had indications for revascularization were identified. Prospective analysis of stent graft patency from 54 transvenous femoropopliteal bypass procedures was performed. Patency was assessed by Duplex ultrasound every six months. Kaplan-Meier analysis was performed to assess primary, primary-assisted, and secondary patency of transvenous bypass. Results: Following endovascular transvenous femoropopliteal bypass, 3-year graft primary, primary-assisted, and secondary patency was 43.8%, 66.3%, and 73.9%, respectively. Conclusions: Transvenous endovascular femoropopliteal bypass is a viable option for selected patients who lack adequate saphenous vein or have comorbidities that increase the risk of open femoropopliteal bypass. Strict post-operative follow-up is necessary to improve patency rates.

Abstract No. 578 Outcome of Directional Atherectomy in Long Segment Superficial Femoral Artery Lesions: Experience from Developing Country

Abstract No. 578 Outcome of Directional Atherectomy in Long Segment Superficial Femoral Artery Lesions: Experience from Developing Country

Use of stents with medication coating for the treatment of occlusive-stenotic lesions of the superficial femoral artery

Objective ‒ to analyze the results of endovascular revascularization of the femoropopliteal segment with drug-eluting stents. Materials and methods. Endovascular intervention was performed in 23 patients with stenotic lesions of the superficial femoral artery (SFA). Paclitaxel-eluting stents were used. There were 10 men (43.5 %), 13 women (56.5 %). The mean age of the patients was (66.0 ± 3.5) years. There were 16 (69.6 %) patients with diabetes mellitus type 2 and diabetic angiopathy, and 7 (23.4 %) patients had obliterating atherosclerosis of the arteries of the lower limbs. Critical ischemia of the lower extremities was diagnosed in 18 (56.5 %) cases, intermittent claudication ‒ in 5 (21.7 %). Isolated lesions of the femoral-popliteal segment were noted in 3 (13.4 %) patients, lesions of the iliac and femoral-popliteal segments ‒ in 4 (17.4 %), lesions of the femoral-popliteal and ankle segments ‒ in 16 (69.6 %). Results. Twenty (86.6 %) scheduled procedures for stenting of the SFA were technically successful. Among postoperative complications, 3 (13.04 %) patients had puncture site hematomas that did not require surgical evacuation. In 6 (26.1 %) patients, signs of reperfusion syndrome were observed, which were treated with conservative treatment. During follow-up period (3 months), there were no cases of reocclusion or clinically significant restenosis at the stented level. In 1 (5.0 %) case, a hemodynamically significant stenosis of the SFA was observed outside the implanted stent. The patient successfully underwent angioplasty of SFA stenosis. There were no «major» amputations during follow-up period. «Small» ankle amputations were performed in 7 (35.0 %) patients with diabetic gangrene, where endovascular revascularization of the femoro-popliteal and ankle segments was the stage of surgical treatment. Conclusions. Implantation of drug-eluting stents is an effective method of endovascular revascularization in patients with SFA lesions. To compare the results of implantation of drug-eluting stents with other methods of revascularization of the lesions of the femoro-popliteal segment, it is necessary to accumulate more data and increase the duration of the follow-up period.

[Application and value of intravascular ultrasound for excimer laser ablation combined with drug-coated balloon in the treatment of lower limb arteriosclerotic obliterans].

Objective: To examine the value of intravascular ultrasound (IVUS) for excimer laser ablation (ELA) combined with drug-coated balloon (DCB) in treating lower limb arteriosclerotic obliterans (ASO). Methods: As a prospective case series study, patients who underwent ELA combined with DCB for lower limb ASO with the guidance of IVUS from September 2021 to March 2022 at Department of Vascular Surgery, Zhongshan Hospital, Fudan University were enrolled prospectively. Lesion characteristics, procedure-related outcomes and complications were collected. The therapy outcomes were compared with baseline data by paired t test. Results: There were 8 males and 2 females, aged (72.0±5.9) years (range: 61 to 81 years). Of all the 11 lesions, there were 8 lesions in superficial femoral artery and 3 in popliteal artery. The lesion length was (7.0±2.4) cm (range: 3.2 to 9.8 cm). There were 4 chronic totally occlusion and 7 severe stenosis. All patients underwent the operation successfully. The technical success rate was 10/11. Bailout stenting was performed in one lesion because of flow-limiting dissection. Four lesions were grade 3 to 4 in peripheral artery calcium score system, and 9 lesions with calcification arc≥180°. Larger diameter drug-coated balloons were selected in 5 lesions after measurement of intravascular ultrasound. The follow-up time was (6.0±1.9) months (range: 3 to 9 months). The ankle-brachial index of the patient was significantly improved immediately after surgery (0.97±0.13 vs. 0.48±0.18, t=-7.60, P<0.01) and at 3 months after surgery (0.95±0.12 vs. 0.48±0.18, t=-7.17, P<0.01). The 3-month primary patency rate was 11/11, the target lesion reintervention was 0 and ulcer healing rate was 3/4. Conclusion: IVUS assisted ELA in the treatment of lower limb artery lesions is safe and effective in early stage.

Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication

Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n= 48) or BMT alone (n= 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. At the 36 month follow up, the stent group (n= 32) had statistically significantly better scores in the SF-36 domain "Role Physical" (p= .023) and the Physical Component Summary (p= .032) compared with the control group (n= 30); however, there was no statistically significant difference in EQ5D scores (p= .52). WIQ was statistically significantly better in the stent group compared with the control group (p= .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n= 31) and control groups (n= 32). Crossover from the control group to the stent group was 25% at 60 months. There were no differences in progression to CLTI, amputation (2.1% vs. 1.9%), or mortality (14.6% vs. 15.4%) between groups. In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.

DRUG-ELUTING STENTS IN THE TREATMENT OF PATIENTS WITH OCCLUSIVE-STENOTIC LESIONS OF THE SUPERFICIAL FEMORAL ARTER.

The aim: To analyze the results of endovascular revascularization of the femoropopliteal segment using drug-eluting stents. Materials and methods: Endovascular intervention was performed in 23 patients with occlusive-stenotic lesions of the superficial femoral artery (SFA). Paclitaxel-eluting stents were used. There were 16 (69.6%) patients with diabetes mellitus type 2 and diabetic angiopathy, and 7 (30.4%) patients had obliterating atherosclerosis of the arteries of the lower limbs. Critical ischemia of the lower extremities was diagnosed in 18 (78.3%) cases, and intermittent claudication - in 5 (21.7%). Results: Twenty (86.6 %) scheduled procedures for stenting of the SFA were technically successful. During follow-up period (3 months), there were no cases of reocclusion or clinically significant restenosis at the stented level. There were no "major" amputations during follow -up period. "Small" ankle amputations were performed in 7 (35%) patients with diabetic gangrene. Conclusions: Implantation of drug-eluting stents is an effective method of endovascular revascularization in patients with SFA lesions. To compare the results of implantation of drug-eluting stents with other methods of revascularization of the lesions of the femoro-popliteal segment, it is necessary to accumulate more data and increase the duration of the follow-up period.