Superficial Femoral Artery Disease Research Articles

F-18 | Comparison of the Safety and Efficacy of Endovascular Interventions for the Treatment of Superficial Femoral Artery Disease: A Network Meta-analysis

F-18 | Comparison of the Safety and Efficacy of Endovascular Interventions for the Treatment of Superficial Femoral Artery Disease: A Network Meta-analysis

Impact on Hospital Resource Utilization of Endoluminal Bypass Using the Viabahn Endoprosthesis with Heparin Bioactive Surface Compared With Surgical Femoropopliteal Bypass.

To assess the impact of heparin-bonded endoprosthesis compared with femoropopliteal bypass on key hospital resources and revenues up to 1-year follow-up. A 2-arm scenario resource consumption data analysis was modeled based on a multicentre prospective randomized controlled trial. Six centers in the Netherlands. A total of 100 patients were assigned to 2 arms (50 each arm). The first arm evaluated endovascular treatment using the heparin-bonded Viabahn endoprosthesis and the second the femoropopliteal bypass. Resource consumption rates were compared between arms. Resource consumption rates, including hospital stay for bypass procedure, operating room time, type of anesthesia, number of used (endo)grafts, use of different types of bed locations (vascular ward, medium or intensive care), readmission for wound infections, and reinterventions over a period of 12 months. Endovascular repair used fewer hospital resources, with an overall difference of €149.983. Hospital stay was 118 days less (261 vs 379), including 21 fewer days in medium/intensive care (5 vs 26) and 50 fewer operating room hours (100 vs 150). Fewer patients required general anesthesia (31 vs 39), and there were less surgical site infections (3 vs 12). In the surgical bypass group, there were 18 fewer days of hospital stay related to reinterventions (80 vs 62), and the cost of the devices was €309.996, cheaper. The total monetary difference was € 160.013, in favor of the femoropopliteal bypass (€3.200, per patient). Endovascular repair of the superficial femoral artery reduces the use of valuable hospital resources. Its major limitation is the cost of the devices, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall. These benefits may outweigh the fewer reinterventions in the surgical bypass group. The SuperB Trial was registered in clinicaltrials.gov; NCT-ID: NCT01220245. Modeling is a useful technique to predict the impact of treatment modalities on hospital resources and revenue. This study uses real-world data from the SuperB Trial to compare two treatment strategies of superficial femoral artery disease, reflecting actual clinical practice and patient outcomes. The analysis focused on direct costs associated with hospital resources and device usage without considering indirect costs or long-term cost-effectiveness. The analysis showed that endovascular repair reduces the use of valuable hospital resources. Its major limitation is device costs, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall.

Comparison of the Pre-Established and Finally Selected Treatment Strategies for Endovascular Treatment in Femoropopliteal Artery Lesions.

This study aimed to compare lower limb events associated with preplanned and finally selected treatment strategies-the validity and usefulness of the physician-chosen strategy were verified.We examined the data of 1003 patients in the registry of multicenter endovascular treatment for superficial femoral and popliteal artery disease study and prospectively enrolled patients who underwent endovascular treatment (EVT) of the femoropopliteal (FP) artery between February 2017 and June 2018 from 67 Japanese institutes. The outcome measures were major adverse limb events (MALE) and target vessel revascularization.The EVT strategies were classified into balloon angioplasty-alone (37.3%), primary stenting (26.7%), and provisional stenting (36.0%) groups. In the initial strategy analysis for the balloon angioplasty-alone, primary stenting, and provisional stenting groups, two-year rates of freedom from MALE (95% confidence interval) were 0.680 (0.620-0.732), 0.754 (0.688-0.808), and 0.798 (0.746-0.840), respectively. Additionally, the rate of MALE was significantly higher among patients in the balloon angioplasty-alone group than among those in the primary or provisional stenting groups in the initial strategy analysis (P = 0.007). Changes in treatment strategy were more frequent in the primary stenting group than in the other groups. Furthermore, the rate of MALE did not significantly differ among the three groups in the final strategy analysis (P = 0.56).Limb outcomes for the final applied strategy did not differ among the three strategies. Additionally, the physician's selection bias was mostly appropriate in the EVT of the FP artery.

DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease

ObjectivePercutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals. MethodsThe DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year. ResultsWe enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures. ConclusionsThe DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.

Comparison of complete multi-level vs. iliac-only revascularization for concomitant iliac and superficial femoral artery occlusive disease.

The aim of this study is to compare the efficacy and safety of complete multi-level vs. iliac-only revascularization for the treatment of concomitant iliac and superficial femoral artery (SFA) occlusive disease. A total of 139 consecutive adult patients with severe stenosis and occlusive iliac and SFA disease with Rutherford categories 2-5 underwent multi-level (n = 71) and iliac-only (n = 68) revascularization at the Department of Intervention Vascular Surgery, Peking University Third Hospital, and Aerospace Center Hospital, between March 2015 and June 2017. Improvement in Rutherford class, perioperative major adverse events, the length of stay, survival rate, and limb salvage rate were assessed. The neutrophil-lymphocyte ratio and platelet-lymphocyte ratio were compared between the two groups. At 48 months, improvement in the Rutherford category was observed in the two groups with no significant difference (P = 0.809). Additionally, the two groups were similar concerning the primary patency (84.0% vs. 79.1%, P = 0.717) and limb salvage rate (93.1% vs. 91.3%, P = 0.781). A higher proportion of the perioperative major adverse events (33.8% vs. 27.9%, P = 0.455), the all-cause mortality (11.3% vs. 8.8%, P = 0.632), and the average length of hospital stay [7.0 (6.0, 11.0) vs. 7.0 (5.0, 8.0), P = 0.037] were seen in the multi-level group compared with the iliac-only group. For concomitant iliac and superficial femoral artery occlusive disease, iliac-only revascularization has favorable efficacy and safety outcomes compared with complete multi-level revascularization in selected patients with patent profunda femoris artery and at least one healthy outflow tract of the infrapopliteal artery.

Surgical, Endovascular, and Multimodal Approaches to the Management of Atherosclerotic Common Femoral Artery Disease.

Common femoral artery disease is at the heart of nearly all treatment algorithms and decisions for patients with symptomatic peripheral arterial disease. Surgical endarterectomy has been the mainstay of common femoral treatment with a wealth of data supporting its safety, efficacy, and durability. Advances in endovascular technology and techniques for the management of iliac and superficial femoral artery disease has resulted in a paradigm shift in management. The common femoral artery has been aptly named a "no stent zone" due to anatomic and disease-specific challenges that have limited the role for endovascular techniques. New technology and techniques in the endovascular management of common femoral disease seek to change our treatment strategies. A multimodal approach utilizing a combination of angioplasty, atherectomy, and stenting has been shown most beneficial, although limited long-term data leave durability an unanswered question. While surgical treatment remains the gold standard, advances in the endovascular approach will certainly continue to improve outcomes. As truly isolated common femoral disease is a rarity, a collaborative approach combining all benefits of open and endovascular techniques in the treatment of peripheral arterial disease is essential.

Superficial Femoral Artery in-Stent Restenosis Treated with Paclitaxel-Coated Balloon Angioplasty - Results of Three-Year Follow-Up.

In-stent restenosis remains a common and important complication after endovascular treatment of superficial femoral artery peripheral artery disease. It occurs in 14 to 35% of cases in 1year and there is still no efficient treatment for this condition. Paclitaxel-coated balloons have shown promising results. Investigate the 3year results of superficial femoral artery in-stent restenosis treated with paclitaxel-coated balloon angioplasty, using the Lutonix™ 035 device. We conducted a retrospective observational study with patients with symptomatic (Rutherford 2 to 5) superficial femoral artery in-stent restenosis, that were treated with paclitaxel-coated balloon angioplasty using the Lutonix™ 035 device, in a single center from January 2016 to December 2020. Duplex scan was used to follow the patients. Primary patency was obtained through Kaplan-Meier analysis. Mortality, and amputation rates were also evaluated. 105 patients were included. Two patients had technical failure and required an additional stent, and were thus excluded. 103 patients were analyzed. Primary patency was 91.26, 80.47, and 67.71%, respectively, in the first, second, and third year after the procedure. There were no deaths 30days after the procedure. There were no major amputations during the 3year follow-up. Paclitaxel-coated balloon angioplasty with the Lutonix™ 035 device was a safe and effective treatment to superficial femoral artery in-stent restenoses. The results were maintained along the 3year follow-up.

Impact of calcification on clinical outcomes after drug‐coated balloon angioplasty for superficial femoral artery disease: Assessment using the peripheral artery calcification scoring system

To investigate whether the severity of calcification assessed by the peripheral artery calcification scoring system (PACSS) was associated with clinical outcomes of drug-coated balloon (DCB) angioplasty for femoropopliteal lesions. We retrospectively analyzed 733 limbs with intermittent claudication of 626 patients, who underwent DCB angioplasty for de novo femoropopliteal lesions between January 2017 and February 2021 at sevencardiovascular centers in Japan. The patients were categorized using the PACSS classification (grades 0-4: no visible calcification of the target lesion, unilateral wall calcification < 5 cm, unilateral calcification ≥ 5 cm, bilateral wall calcification < 5 cm, and bilateral calcification ≥ 5 cm, respectively). The main outcome was primary patency at 1 year. The Cox proportional hazards analysis was used to explore whether the PACSS classification was an independent predictor of clinical outcomes. The distribution of PACSS was grade 0 in 38%, grade 1 in 17%, grade 2 in 7%, grade 3 in 16%, and grade 4 in 23%. The 1-year primary patency rates in these grades, respectively, were 88.2%, 89.3%, 71.9%, 96.5%, and 82.6%, respectively (p < 0.001). Multivariate analysis disclosed that PACSS grade 4 (hazard ratio: 1.82, 95% confidence interval 1.15-2.87, p = 0.010) was associated with restenosis. The PACSS grade 4 calcification was independently associated with poor clinical outcomes after DCB angioplasty for de novo femoropopliteal lesions.

Superficial Femoral Artery Endovascular Therapy: 12-Month Primary Patency Rates of Contemporary Endovascular Devices from 25,051 Patients.

Approximately 5.8 million people experience peripheral arterial disease (PAD) in the United States today. Superficial femoral artery (SFA) disease is the most common cause of symptomatic PAD. New-generation nitinol stents, drug-coated stents, drug-coated balloons (DCB), covered stents, and directional or orbital atherectomy devices have shown promising results. However, clinical equipoise persists regarding the optimal selection of devices, largely attributable to the different inclusion criteria, study populations, length of lesions treated, definitions of "patency" and "restenosis," and follow-up methods in the up-to-date pivotal trials. A prospective protocol was developed. We performed a literature search using PubMed from January 2011 to July 2021. All published articles including endovascular interventions in the SFA with reported 12-month "primary patency" rates as endpoints were included. We identified 25,051 patients in 124 studies reporting 12-month primary patency rates in patients with SFA disease. Primary patency rates were (weighted average) 82.6% for drug-eluting stents, 77.2% for drug-coated balloons, 75.2% for covered stents, 73.9% for nitinol self-expanding stents, 66.1% for atherectomy, and 44.5% for bare balloon angioplasty. The most frequently used endovascular devices yielded various 12-month primary patency rates ranging from 44.5% to 82.6%. The increased variation in inclusion criteria, lesion length, and complexity of lesions between studies does not allow direct comparison between the individual devices. Larger randomized trials in specific patient populations comparing these modalities are needed well before we can make proper recommendations on the superiority of one device over the other.

Editor's Choice – Real World Study of Mortality After the Use of Paclitaxel Coated Devices in Peripheral Vascular Intervention

This observational cohort study examined outcomes after peripheral vascular intervention (PVI) with paclitaxel coated devices (PCD) and non-PCD, and evaluated heterogeneity of treatment effect in populations of interest. The study included patients undergoing percutaneous transluminal angioplasty and or stent placement between 1 October 2015 and 31 December 2018 in the Vascular Quality Initiative Registry linked to Medicare claims. It determined differences in patient mortality and ipsilateral major amputation after PVI with PCD and non-PCD using Kaplan-Meier analyses and Cox regressions with inverse probability weighting in three cohorts: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with or without any other concurrent treatment (n= 11 452); (B) those treated for isolated superficial femoral or popliteal artery disease (n= 5 519); and (C) patients with inclusion criteria designed to approximate RCT populations (n= 2 278). The mean age of patients was 72.3 (SD= 10.9) years, and 40.6% were female. In cohort A, patients receiving PCD had a lower mortality rate (HR 0.88, 95% CI 0.79 - 0.98) than those receiving non-PCD. There was no significant difference in mortality between groups in cohort B (HR 0.91, 95% CI 0.80 - 1.04) and cohort C (HR 1.10, 95% CI 0.84 - 1.43). Patients receiving PCD did not have a significantly elevated risk of major amputation compared with those receiving non-PCD (cohort A: HR 0.84, 95% CI 0.70 - 1.00; cohort B: HR 0.84, 95% CI 0.67 - 1.06; and cohort C: HR 1.05, 95% CI 0.51 - 2.14). No increased patient mortality or major amputation was found at three years after PVI with PCD vs. non-PCD in this large, linked registry claims study, after accounting for heterogeneity of treatment effect by population. The analysis and results from three cohorts intended to mirror the cohorts of previous studies provide robust and niche real world evidence on PCD safety and help to understand and reconcile previously discrepant findings.

A-40 | 12-Month Primary Patency Rates of Contemporary Endovascular Device Therapy for SFA Occlusive Disease

Superficial femoral artery (SFA) disease is the most common cause of symptomatic PAD which may progress to lifestyle-limiting claudication, critical limb ischemia or limb amputation. In this study, we attempted to investigate the 12—month primary patency rates of various endovascular therapies in patients with SFA PAD using published registries, case reports, and trials.

A-42 | In-Hospital Outcomes of Femoral Artery Chronic Total Occlusion Revascularization in Patients with Chronic Kidney Disease

Superficial femoral artery (SFA) disease is the most common cause of symptomatic peripheral arterial disease (PAD) with chronic total occlusion (CTO) present in 40% of patients. We describe the in-hospital outcomes of patients with and without CKD undergoing SFA CTO endovascular intervention.

Changes to Drug-Coated Balloon Reimbursement Affect Peripheral Arterial Disease Patient Care: A Single-Center Experience.

Introduction: Balloon angioplasty (BA) and stenting have long been the mainstays of endovascular therapy in peripheral arterial disease (PAD). However, the rise of drug-coated balloons (DCBs) has revolutionized care in recent years, with multiple clinical trials showing superiority over BA in maintaining primary patency and freedom from target lesion revascularization (TLR). With the recent drop of the add-on payment for DCBs, a barrier for their use and consequently reduced therapy adoption in PAD might arise. We assessed if this affected physicians' behavior and hospital administration towards stocking and using DCBs.Methods: This single-center, retrospective study evaluated DCB utilization in 2017 versus 2018. Data were collected in two groups: 1) July 1, 2017, to December 31, 2017 - with pass-through code (PTC) - prior medical billing reimbursement - and 2) January 1, 2018, to June 30, 2018 - without PTC - markedly reduced reimbursement. Patients treated for superficial femoral artery (SFA) or popliteal artery (POP) disease were included. The study aimed to determine changes in DCB utilization between the years with and without PTC, and we investigated the treatments that have replaced DCBs. Additionally, we aimed to collect data on readmissions and procedure costs compared to national data.Results: From July through December 2017, 350 DCBs were used in 209 patients (1.675 DCBs per patient), while from January through June 2018, 256 DCBs were used in 180 patients (1.422 DCBs per patient) - a 15.07% reduction in DCBs per patient. The detailed numbers of DCB-treated patients were presented as fractions of total interventions in the groups with and without PTC.Conclusion: The findings of this study show a statistically significant reduction in DCB usage following PTC withdrawal. There are several ethical implications to these findings, primarily highlighting patient beneficence and justice. Moving forward, it will be important to determine if this shift in treatment is owed to other treatment strategies such as BA, BA and atherectomy, BA and bare-metal stents (BMS), or BA and drug-eluting-stents (DES). The next steps should also include determining procedure costs and comparing readmission rates.

Antegrade Access for Peripheral Vascular Disease Intervention of the Lower Limb – Our Experience at a Tertiary Center

Purpose: Antegrade superficial femoral artery (SFA) access for peripheral artery disease reduces the time, radiation, and contrast required as compared with contralateral common femoral access (CFA). However, this technique remains underutilized and understudied in the treatment of SFA, popliteal and tibial disease, and there remains limited data on the safety and efficacy of antegrade SFA access. Materials and Methods: An observational review of lower extremity peripheral arterial interventions was conducted from January 2014 to July 2021. Interventions necessitating CFA access such as iliac, common femoral, or deep femoral artery revascularization were excluded. In addition, interventions potentially requiring large sheaths were excluded. Relevant demographic and treatment variables including postoperative complications were abstracted. Results: We identified 482 patients, who underwent revascularization of the SFA, popliteal and tibial arteries. Antegrade SFA access was chosen in all these patients. Access was attained either through ultrasound or fluoroscopy guidance in 94.6% of patients. The overall rate of complications was low (access site complications, hematoma, pseudoaneurysm, etc.). Conclusions: Percutaneous antegrade SFA access can be performed safely and remains an effective alternative to retrograde CFA access with significantly less complications and is also associated with lesser utilization of fluoroscopy and contrast.

Stents With Torsional Strength for Superficial Femoral Artery Disease: The Prospective Q3-Registry

Purpose: This postmarketing surveillance study aimed to assess effectiveness and safety of a peripheral self-expanding stent with high torsional strength (POLARIS stent) for the treatment of de novo superficial femoral artery (SFA) lesions in the routine clinical practice. Materials and Methods: Consecutive patients with symptomatic de novo SFA occlusive disease who underwent POLARIS stent implantation were enrolled into the prospective, multicenter, observational postmarket surveillance study. Primary outcome measure was freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Main secondary outcomes were procedural success, primary clinical improvement, and freedom from major adverse cardiovascular and limb events (MACLE) throughout 24 months. Results: A total of 199 participants (70±11 years, 70.4% men) were included in the study at 9 German sites from December 2014 to August 2018. Half of them (52.6%) were current smokers, 37.6% had diabetes, and 25.0% were obese. Most participants suffered from intermittent claudication (88.4%). Mean lesion length was 98±83 mm, 43.5% of lesions were occluded, and 27.3% were severely calcified. Freedom from 12 months cdTLR was 94.4% (95% confidence interval [CI], 90.6–98.2). At 24 months, freedom from cdTLR was 88.7% (95% CI, 83.0–94.4). Procedural success was achieved in 96.2% of participants. Primary clinical improvement occurred in 87.5% and 85.4% of participants at 12 and 24 months, respectively. Freedom from MACLE was 94.8% (95% CI, 91.4–98.1) and 93.8% (95% CI, 89.9–97.6) at 12 and 24 months, respectively. Conclusions: Treatment of SFA occlusive disease in a real-world setting using the POLARIS stent with high bidirectional torsional strength is efficacious and does not raise any safety concern in the medium term. The study is registered with ClinicalTrials.gov (Identifier: NCT02307292).

Antegrade Access for Peripheral Vascular Interventions of the Lower Limb: Our Experience at a Tertiary Centre

Purpose: Antegrade superficial femoral artery (SFA) access for peripheral artery disease reduces the time, radiation, and contrast required versus contralateral common femoral access (CFA). Yet, this technique remains underutilised in the treatment of SFA, popliteal, and tibial disease, and there remains limited data on the safety and efficacy of antegrade SFA access.

Smaller Superficial Femoral Artery is Associated with Worse Outcomes after Percutaneous Transluminal Angioplasty for De Novo Atherosclerotic Disease

BackgroundWith the exponential increase in the use of endovascular techniques in the treatment of peripheral artery disease, our understanding of factors that affect intervention failures continues to grow. We sought to assess the outcomes of percutaneous transluminal angioplasty for isolated de novo superficial femoral artery (SFA) disease based on balloon diameter. MethodsThe Vascular Quality Initiative database was queried for patients undergoing percutaneous balloon angioplasty for isolated de novo atherosclerotic SFA disease. Based on the diameter of the angioplasty balloon as a surrogate measure of arterial diameter, patients were stratified into 2 groups: group 1, balloon diameter <5 mm (354 patients) and group 2, balloon diameter ≥5 mm (1,550 patients). The primary patency and major adverse limb event (MALE) were estimated by the Kaplan-Meier method and compared with the log-rank test, based on vessel diameter. Multivariable Cox regression analysis was used to determine factors associated with the primary patency. ResultsFrom January 2010 through December 2018, a total of 1,904 patients met criteria for analysis, with a mean follow-up of 13.3 ± 4.5 months. The mean balloon diameters were 3.92 ± 0.26 mm and 5.47 ± 0.55 mm in group 1 and 2, respectively (P < 0.001). The mean length of treatment and distribution of TASC lesions were not statistically different between the groups. Primary patency at 18 months was significantly lower in group 1, compared with group 2 (55% vs. 67%; log-rank P < 0.001). The MALE rate was higher in group 1 than group 2 (33% vs. 26%; log-rank P < 0.001). Among patients with claudication, there was no significant difference in the primary patency (61% vs 68%; log-rank P = 0.073) and MALE (27% vs. 22%; log-rank P = 0.176) at 18 months between groups 1 and 2, respectively. However, in patients with CLTI, group 1 had significantly lower 18-month primary patency (47% vs. 64%; log-rank P < 0.014) and higher MALE rates (41% vs. 35%; log-rank P = 0.012) than group 2. Cox proportional hazard analysis confirmed that balloon diameter < 5 mm was independently associated with increased risks of primary patency loss (HR 1.35; 95% CI, 1.04–1.72; P = 0.021) and MALE (HR 1.29; 95% CI, 1–1.67; P = 0.048) at 18-months. ConclusionsIn patients undergoing isolated SFA balloon angioplasty for CLTI, smaller SFA (<5 mm) was associated with worse primary patency and MALE. Using balloon size as a surrogate, our findings suggest that patients with a smaller SFA diameter appear to be at increased risk for treatment failure and warrant closer surveillance. Furthermore, these patients may also be considered for alternative approaches, including open revascularization.

AB044. SOH21AS206. Significance of distal run-off score as a key influencer on clinical outcomes following endovascular interventions for superficial femoral artery disease

AB044. SOH21AS206. Significance of distal run-off score as a key influencer on clinical outcomes following endovascular interventions for superficial femoral artery disease

Optimizing Laser Atherectomy for Different Lesion Morphologies

Objective. To understand the impact of fluence and repetition rate on outcomes of superficial femoral artery (SFA) and popliteal artery laser atherectomy based on lesion type (calcific, homogenous, heterogeneous, and restenosis). Methods. Patients with de novo or restenotic (≥50%) SFA and popliteal artery atherosclerotic disease were enrolled. All lesions were sequentially treated with Turbo-Power laser atherectomy (Spectranetics) at 3 predetermined intensity settings: low (fluency, 40 mJ/mm2; repetition rate, 60 Hz); medium (fluency, 60 mJ/mm2; repetition rate, 40 Hz); and high (fluency, 60 mJ/mm2; repetition rate, 60 Hz). Angiography and intravascular ultrasound (IVUS) were performed to characterize plaque morphology and evaluate residual stenosis. Follow-up was 30 days and medical records were reviewed through 12 months for adverse events. Results. Forty-five patients with 57 lesions (12 homogenous, 15 heterogeneous, 15 calcific, and 15 restenotic) were enrolled. Rutherford classification ranged from 2-5, average lesion length was 98.2 ± 91.2 mm, and average diameter stenosis was 82.5 ± 17.9%. Compared with baseline, all lesion types had significant improvement in final postprocedure (atherectomy + any adjunctive therapies) diameter stenosis. Prior to adjunctive therapy, the heterogeneous and restenosis groups saw improvement in minimum lumen area following each stage of the laser treatment. However, the calcific and homogenous groups saw little change in minimum lumen area between the medium- and high-intensity laser treatments. Within 6 months, a total of 6 patients had target-lesion revascularizations. No major amputations or deaths occurred through follow-up. Conclusion. Laser intensity settings during atherectomy should be selected based on lesion morphology. IVUS was essential in defining plaque morphology.

Pre-procedural color duplex ultrasound evaluation predicts restenosis after long-segment superficial femoral artery stenting.

Restenosis after stenting for superficial femoral artery atherosclerotic disease remains a significant clinical problem, especially for long-segment lesions. We assessed predictors of in-stent restenosis in patients with long-segment superficial femoral artery disease and hypothesized that pre-procedural ultrasound assessment would predict in-stent restenosis. This single-center study retrospectively analyzed 283 limbs in 243 patients who treated with superficial femoral artery nitinol stent placement for long-segment (≥15 cm) lesions between 2015 and 2018. Color duplex ultrasound was performed pre-procedure and post-procedure at 3, 6, 12, 24, and 36 months. The endpoint was ≥50% in-stent restenosis in the superficial femoral artery. Primary patency rates were analyzed with Kaplan-Meier survival analysis and compared using the log-rank test. A multivariable Cox proportional hazards model was used to evaluate the risk factors for in-stent restenosis. The median length of lesions was 25.8 ± 8.1 cm. The cumulative freedom from ≥50% in-stent restenosis at 3, 6, 12, 24, and 36 months was 95.3%, 78.3%, 56.0%, 30.6%, and 15.9%, respectively. Univariate and multivariate Cox regression analysis showed that cumulative lesion length ≥ 25 cm (hazard ratio 1.681; p = 0.003), calcified plaque (hazard ratio 1.549, p = 0.006), poor runoff scores >10 (hazard ratio 1.870, p = 0.003), and chronic renal failure (hazard ratio 2.075, p = 0.009) were independent risk factors for in-stent restenosis. The agreement rate between ultrasound and angiography was 92.6% for cumulative lesion length (κ 0.851) and 91.9% for runoff score (κ 0.872). The results indicate that pre-procedural color duplex ultrasound evaluation is helpful for the selection of appropriate candidates for superficial femoral artery stent placement. Cumulative lesion length ≥25 cm, plaque calcification, poor distal runoff, and chronic renal failure independently predicted in-stent restenosis.