The Impact of Knee Bending on the Superficial Femoral Artery and Popliteal Artery Morphology Before and After Endovascular Repair of Popliteal Aneurysm.

OBJECTIVE: The aim of this study is to evaluate the deformations of the femoropopliteal (FP) arterial segment due to knee flexion in patients suffering from popliteal aneurysm before and after endovascular treatment (ET). DESIGN AND METHODS: Nine patients were prospectively evaluated. Pre-operative and post-operative computed tomography angiography (CTA) scans were performed on the leg of each patient in both a flexed and extended knee position. The images were employed to reconstruct the FP segment through segmentation and the resulting models were subsequently used to calculate the average diameter, length, and tortuosity of both the superficial femoral artery (SFA) and popliteal artery (PA). Furthermore, the overall PA tortuosity was decomposed into 2 components, ie, antero-posterior and lateral direction. RESULTS: Following knee flexion, both arterial segments experienced shortening in the pre-operative and post-operative phases. Specifically, the SFA was shortened by 3.5% in pre (p<0.001) and 1.21% in post-stenting (p<0.001), while the PA was shortened by 4.8% (p<0.001) and 5.63% (p<0.001), respectively. Tortuosity significantly increased in all considered segments; in particular, in SFA there was a pre-intervention increase of 85.2% (p=0.002) and an increase of 100% post-intervention (p=0.004), whereas in the PA, there was an increase of 128.9% (p<0.001) and 254.8% (p<0.001), respectively. The only diameter variation occurred in the SFA pre-operatively with an increase of 11.9% (p=0.007). Tortuosity decomposition revealed significant differences between the 2 planes during the pre-operative and post-operative phases in both extended and flexed configurations, confirming a change in artery position and geometry due to treatment. CONCLUSIONS: Knee flexion induces arterial shortening and increased tortuosity in both the pre- and post-operative configuration. Stent placement does not induce significant geometric differences between pre-treatment and post-treatment. These results seem to indicate that the geometry of the covered stent is not affected by the flexion of the knee joint. Despite this, a more detailed analysis of arterial tortuosity showed a change in artery deformation following treatment. CLINICAL IMPACT: This study aimed to evaluate femoropopliteal arterial deformations in nine patients with popliteal aneurysm before and after endovascular treatment (ET) during knee flexion, using a standardized protocol for CTA acquisition and analysis. The result can be useful in procedure planning and have shown that the Viabahn stent used can adapt to the morphological variations induced by limb flexion. Consequently, device failure does not be attributed to stent compression but rather to other factors, such as alterations in hemodynamic and biomechanical forces on the implant due to the significant changes in tortuosity observed, or biological causes.

Single-Center Contemporary Clinical Outcomes after Endovascular Treatment in Patients with De Novo Femoropopliteal Lesions between 2017 and 2019.

Background: Drug-coated balloons (DCBs) and drug-eluting stents (DES) were available for treating femoropopliteal disease since 2017 and 2019. However, there are few reports to investigate whether approval of DCB and DES improved primary patency in clinical practice. Materials and Methods: We divided consecutive 407 patients into 2017 (n=93), 2018 (n=128), and 2019 (n=186) groups, undergoing endovascular therapy (EVT) for de novo femoropopliteal lesions in our hospital. We retrospectively compared clinical characteristics, procedure, and one-year patency between the three groups. Results: Baseline characteristics were not different except for the lower rate of popliteal lesions in 2017 (p=0.030). Use of DCB increased from 7.5% in 2017 to 38.7% in 2019, and use of DES from 0.0% in 2018 to 24.2% in 2019. One-year primary patency increased significantly both from 2017 to 2018 (62.7% vs. 70.8%, p=0.036) and from 2018 to 2019 (70.8% vs. 80.5%, p=0.025). Cox proportional multivariate analysis revealed that restenosis was independently associated with advanced age (p=0.036) and hemodialysis (p=0.003). Conversely, use of paclitaxel-based devices (p<0.001) and larger diameter of finalized devices (p=0.005) were protective factors against restenosis. Conclusion: One-year primary patency after EVT in femoropopliteal lesions was improved annually by utilizing DCB and DES, individually.

Clinical Impact of Additional Cilostazol Treatment on Restenosis Risk following Heparin-Bonded Stent Graft Implantation: Sub-Analysis from the Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study.

AIM: The present study investigated the effects of additional cilostazol administration on the 12-month risk of restenosis after femoropopliteal heparin-bonded stent graft implantation. METHODS: This study was a sub-analysis of the Viabahn stent graft placement for femoropopliteal disease reQUIring endovaScular tHerapy (VANQUISH) study, which was a prospective multicenter study investigating patients who received Viabahn stent graft (W.L. Gore & Associates, Flagstaff, AZ, USA) and dual-antiplatelet therapy with aspirin and a thienopyridine. The comparison of clinical outcomes between subgroups with and without cilostazol treatment were performed using the propensity score-matching method to minimize the intergroup differences in baseline characteristics. RESULTS: Cilostazol-treated patients had a lower 12-month proportion of restenosis than cilostazol-free patients (8.2% vs 27.3%). The odds ratio of cilostazol for the 12-month restenosis was 0.27 [95% CI, 0.08 to 0.97] (p=0.045). Furthermore, the cumulative incidence rates of surgical reconstruction, target lesion revascularization and acute thrombotic occlusion (p values by the log-rank test) were 2.6% versus 1.8% (P=0.43), 5.3% versus 20.5% (P=0.067), and 0.0% versus 11.8% (P=0.0499), respectively. The rates of surgical reconstruction and target lesion revascularization (TLR) were not significantly different between both groups. CONCLUSIONS: Our study revealed the clinical impact of additional cilostazol treatment on the risk of restenosis and acute thrombotic occlusion following heparin-bonded stent graft implantation, while TLR and surgical reconstruction were not significantly different.

Risk Factor Analysis for Crossing Failure in Primary Antegrade Wire-Catheter Approach for Femoropopliteal Chronic Total Occlusions.

INTRODUCTION: Antegrade wire-catheter crossing remains the primary approach for femoropopliteal interventions. Nonetheless, data reporting on crossing failure are limited. Aim of this study is to identify risk factors for antegrade crossing failure in patients with femoropopliteal chronic total occlusions (CTOs). METHODS: This is a single-center, retrospective analysis. Patients with femoropopliteal CTOs treated between May 2018 and February 2020 were included into this study. Primary endpoint of this analysis was primary crossing success defined as successful antegrade crossing without the use of retrograde access, crossing or re-entry devices. The assisted crossing success was additionally analyzed. A logistic regression analysis identified risk factors for failed primary antegrade crossing. RESULTS: Data from 300 patients were analyzed. The majority (n=183, 61%) presented with lifestyle limiting claudication. The mean lesion length was 180 mm [interquartile range (IQR) 100-260 mm], whereas the median CTO length was 100 mm (IQR=50-210 mm). A chronic total occlusion crossing approach based on plaque morphology (CTOP) type I configuration was observed in 9% (n=26) of the lesions, type II in 61% (n=183), type III in 8% (n=25), and type IV in 66 CTOs (n= 66, 22%). Severe calcification based on the Peripheral Arterial Calcium Scoring Scale (PACSS), Peripheral Academic Research Consortium (PARC), and 360° grading systems was identified in 17%, 24%, and 28% of the lesions, respectively. A contralateral femoral access was used in 278 cases (93%). The primary crossing success amounted to 70% (n=210). The use of a re-entry device in 28 patients (9%) or of a combined antegrade-retrograde approach in 11% (n=34) of the cases increased the assisted crossing success to 89% (n=267). The presence of calcification (odds ratio [OR]=4.2, 95% CI=1.7-10.2) or of circumferential calcium (OR=2.5, 95% CI=1.3-4.9), a CTOP class ΙΙΙ or ΙV (OR=1.9, 95% CI=1.4-2.6), a proximal superficial femoral artery (SFA) occlusion (OR=3.5, 95% CI=1.7-7.4) and a CTO at P3 (OR=4.1, 95% CI=1.5-10.8) were associated with an increased risk for antegrade crossing failure. CONCLUSIONS: In this study, chronic total occlusions (CTO) morphology, calcification burden, and lesion's location were identified as independent risk factors for failed antegrade crossing. Nonetheless, the use of alternative crossing strategies significantly increased the overall crossing success.

Intravascular ultrasound-based decision tree model for the optimal endovascular treatment strategy selection of femoropopliteal artery disease-results from the ONION Study.

BACKGROUND: The role of catheter-based imaging in peripheral interventions for lower extremity artery disease (LEAD) has increased with percutaneous interventions. To clarify the relation between intravascular ultrasound (IVUS) information and procedure selection strategy for endovascular treatment therapy (EVT) of the femoropopliteal artery in the real-world clinical settings wherein new endovascular technologies (NETs), including drug-coated balloon (DCB), drug-eluting stent (DES), and covered stent-graft (CS). Our retrospective multicenter analysis examined symptomatic 970 patients treated by EVT for de novo femoropopliteal lesions with IVUS guidance. The decision tree analysis was performed retrospectively to determine the association of IVUS and angiography parameters with the strategy selection of endovascular procedures. We divided the study population according to the developed tree, and identified the most popular strategy selection in each subgroup. We finally examined whether the restenosis risk would be different among respective subgroups of the tree. RESULTS: During the study periods, plain old balloon angioplasty, DCB, and bare nitinol stent were most frequently selected (25.3%, 23.9%, and 23.8%, respectively). The drug-eluting stent (DES), covered stent (CS), and spot stent strategies were used in 7.3%, 11.5%, and 8.1%. NETs had the lowest restenosis risk in the overall population. The decision tree had a depth of six branches and divided the patients into 11 subgroups by IVUS and angiography parameters. The restenosis rate was similarly low among these 11 subgroups when the most popular NET in each subgroup was selected (P = 0.94). CONCLUSIONS: The use of IVUS data along with angiography data would standardize the selection of endovascular procedures and can improve patency outcomes if NETs are used properly.

Incidence of Acute Thrombotic Occlusion and Its Predictors After Contemporary Femoropopliteal Endovascular Therapy in Patients With Peripheral Artery Disease.

PURPOSE: This study investigated the incidence of acute thrombotic occlusion (ATO) and its predictors after contemporary femoropopliteal (FP) endovascular therapy (EVT) for peripheral artery disease. MATERIALS AND METHODS: We retrospectively examined 763 limbs (chronic limb-threatening ischemia [CLTI]: 44%, involving popliteal lesion: 44%) in 644 patients (mean age: 75±9 years, male: 71%, hemodialysis: 34%) who successfully underwent EVT with contemporary FP devices (drug-coated stent: n=220, stent graft: n=158, drug-eluting stent: n=150, drug-coated balloon [DCB]: n=235) from June 2012 to July 2020. The outcome measure was ATO defined as acute onset of claudication and/or signs of CLTI in combination with angiographic evidence of occlusive thrombus formation within the treated segment. Cox proportional hazards regression models were used to identify baseline characteristics associated with the incidence of ATO after EVT treated with scaffold. To determine the impact of ATO occurrence and creatine phosphokinase (CPK) elevation on the subsequent composite outcome of mortality or major amputation, we developed the Cox model in which the trichotomous variable (free from ATO, ATO without CPK elevation, and ATO with CPK elevation) was a time-dependent covariate. RESULTS: The 24-month incidence of ATO in the overall population was 4.3%±0.8% (DCB: 1.0%±0.7% vs scaffold: 5.8%±1.1%, p<0.01). Hemodialysis (hazard ratio [HR]: 2.63, p=0.02) and involving popliteal lesion (HR: 8.22, p<0.01) were independently associated with an increased risk of ATO in patients treated with scaffold. Both ATO without CPK elevation and ATO with CPK elevation were significantly associated with a composite outcome of mortality or major amputation comparing free from ATO, with an HR of 2.39 and 9.87, respectively (p=0.02 and p<0.01). CONCLUSION: We found a substantial incidence of ATO after contemporary FP-EVT, particularly with scaffold. Hemodialysis and involving popliteal lesion were significantly associated with ATO risk in patients treated with scaffold. The occurrence of ATO, particularly with CPK elevation, was associated with an increased risk of a subsequent composite outcome of mortality or major amputation. The scaffold was safely used in patients without those risk factors of ATO, but a non-scaffolding strategy should be considered for patients with more risk factors. CLINICAL IMPACT: The scaffold was safely used in patients without hemodialysis and involving popliteal lesion, but a non-scaffolding strategy should be considered for patients with those risk factors. The occurrence of ATO, particulary with CPK elevation, was of high risk of mortality or amputation.

Retrospective Multicenter Comparison Between Viabahn Covered Stent-Grafts and Supera Interwoven Nitinol Stents for Endovascular Treatment in Severely Calcified Femoropopliteal Artery Disease: The ARMADILLO Study (Adjusted Retrospective coMparison of scAffolDs In caLcified LesiOns).

PURPOSE: The previous single-arm registries showed the acceptable primary patency after endovascular therapy (EVT) using covered stent-graft (CSG) and Supera interwoven nitinol stent (Supera peripheral stent [SPS]) in calcified femoropopliteal lesions. The aim of this study was to compare the safety and efficacy between CSG and SPS in calcified femoropopliteal lesions in clinical practice. MATERIALS AND METHODS: We retrospectively analyzed 341 cases who had Rutherford class 2 to 6 peripheral artery disease and underwent EVT with either CSG (n=137) or SPS (n=204) for femoropopliteal lesions with bilateral calcification in fluoroscopic image, based on the Peripheral Arterial Calcium Scoring System (PACSS) classification, between April 2017 and February 2021 at 7 cardiovascular centers in Japan. RESULTS: After propensity score (PS) matching, the final study population consisted of 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between CSG and SPS groups (81.4% vs 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The stratification analysis demonstrated that advanced age, current smoking, diabetes mellitus, and PACSS grade 4 had a significant interaction on the association of CSG versus SPS implantation with restenosis (interaction p<0.05). CONCLUSIONS: In patients with bilaterally calcified femoropopliteal lesions, 1-year primary patency was not significantly different between treatments using CSG and SPS after the PS matching. CLINICAL IMPACT: Covered stent-graft (CSG) and Supera interwoven nitinol stent (SPS) are reliable endovascular devices in calcified femoropopliteal lesions. This retrospective multicenter study compared the clinical outcomes between the two devices. After propensity score matching, 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between the CSG and SPS group (81.4% vs. 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs. 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The two devices showed the similar efficacy in calcified femoropopliteal lesions.

[Endovascular interventions in patients with glass iii infrainguinal arterial disease: 2-year results]. / Endovaskulyarnye interventsii u patsientov s infraingvinal'nymi porazheniyami GLASS III stepeni: rezul'taty dvukhletnego nablyudeniya.

OBJECTIVE: To evaluate the results of endovascular surgery in patients with chronic limb-threatening ischemia (CLTI) with infrainguinal arterial disease GLASS III. MATERIAL AND METHODS: Treatment outcomes were analyzed for the period 2017-2018. Inclusion criteria were age over 18 years, CLTI, extended (>20 cm) stenosis de novo and occlusion of femoropopliteal segment (FPS) combined with occlusive lesion of tibial arteries. We analyzed 147 patients divided into 2 groups depending on stenting strategy. FPS-1-TA included 53 patients who underwent angioplasty (± stenting) of femoropopliteal arteries and lower leg arteries resulted at least one patent tibial artery. FPS-2-TA enrolled 94 patients who underwent angioplasty of femoropopliteal arteries and lower leg arteries resulted ≥2 patent tibial arteries. Mean age was 71.0±9.8 years. There were 75 men. Demographics and clinical characteristics of patients were similar. RESULTS: Technical success rate was 100%. Mean length of stenting was 203 ± 99 mm. Occlusion of all 3 leg arteries correlated with high incidence of femoropopliteal stenting. In the FPS-1-TA group, stents were implanted in 39 patients, in the FPS-2-TA group - in 71 patients (73.6% and 75.5%, respectively, p=0.8). Braided nitinol stents were used for stenting of the lower third of superficial femoral artery and p1-p3 segments. Mean follow-up period was 22.6±1.1 months. Two-year results were not age-specific in our study. Kaplan-Meier overall survival, freedom from amputation and amputation-free survival for the entire sample were 79.6%, 81.0%, and 66.7%, respectively. We compared these values in both groups using Mantel-Cox log-rank test and obtained significant differences (67.9% vs 86.2%, p=0.004; 64.2% vs 90%, p<0.0001; 47.2% vs 77.7%, p<0.0001, respectively). CONCLUSION: Our results are comparable with literature data regarding freedom from amputation and amputation-free survival. We obtained significant differences in overall survival and freedom from amputation depending on endovascular strategy for tibial arteries. Correction of distal vessels with recanalization of at least two tibial arteries is advisable for endovascular treatment of diffuse complex lesions.

Comparison of Angiographic Dissection Classification Systems in the Femoropopliteal Arteries Using IVUS Validation and Reliability Testing.

PURPOSE: Objective assessment of dissection severity is difficult. Recognition of this has led to the creation of classification systems. This study investigated the performance of the National Heart Lung and Blood Institute (NHLBI) and Kobayashi systems at differentiating severity of femoropopliteal dissection using intravascular ultrasound (IVUS) as the reference standard. Comparison between the 2 systems and the inter- and intra-observer reliability were also investigated. MATERIALS AND METHODS: Angiographic and IVUS imaging was assessed in 51 cases sourced from a RCT investigating the use of IVUS in femoropopliteal disease. A total of 2 readers independently scored the angiography images according to NHLBI and Kobayashi dissection classification systems and a consensus score was obtained for each system in each case. The NHLBI classification was condensed into 3 grades of dissection to allow comparison between systems. Dissection length, dissection arc, minimum lumen area, and lumen area stenosis were obtained from the IVUS imaging. IVUS parameters were compared between grades of severity for both systems. Agreement in grading between the systems was assessed and IVUS parameters for each level of dissection severity were compared between systems. Inter and intra-observer agreement tested for each system. RESULTS: Dissection was present on IVUS in 92.2% (47/51) of cases and angiography identified 78.7% (37/47) of these. No difference was present in any IVUS parameters between mild and severe dissections with either classification system. No difference in IVUS findings was present for the same grades of dissection between systems. The 2 systems agreed on severity grade in 47 of 51 cases. The inter-observer agreement was for NHLBI was k=0.549 and k=0.627 for Kobayashi. Intra-observer agreement for NHLBI was k=0.633 and k=0.633 and for Kobayashi was k=0.657 and k=0.297. CONCLUSION: The lack of difference in IVUS parameters between mild and severe dissection for the NHLBI and Kobayashi systems raises doubts about their ability to effectively differentiate dissection severity. Weak to moderate reliability suggests that variability in interpreting dissection may be higher than acceptable. IVUS imaging is more sensitive for detecting dissection than angiography and research is required to establish the value of adding IVUS to dissection classification systems.

Impact of Baseline and Postprocedural Intravascular Ultrasound Findings on 1-Year Primary Patency After Drug-Coated Balloon Treatment of Femoropopliteal Lesions.

PURPOSE: Drug-coated balloons (DCBs) are commonly used for endovascular treatment of femoropopliteal lesions. Here, we employed intravascular ultrasound (IVUS) to investigate the predictors of restenosis after DCB treatment. METHODS: This retrospective and single-center study was performed to examine 1-year primary patency after DCB treatment and to identify the risk factors for restenosis by analyzing clinical characteristics, angiographic findings, and IVUS measurements. We included 111 consecutive patients undergoing DCB treatment for de novo femoropopliteal lesions at our hospital from July 2018 to March 2020. RESULTS: The primary patency rate was found to be 80.0% at 1 year. The Cox proportional hazard multivariate analysis revealed that restenosis was independently associated with chronic total occlusion (CTO; p < 0.001), circumferential calcification (p = 0.023), and smaller postprocedural minimum lumen area (MLA; p = 0.036). Furthermore, receiver operating characteristic curve analysis showed that the cutoff value of postprocedural MLA to prevent restenosis was 12.7 mm2, with an area under the curve of 0.774 (p< 0.001). The multivariate analysis indicated that patients with a postprocedural MLA below 12.7 mm2 (n = 44) had a significantly smaller distal reference vessel size (p < 0.001) compared to those with a postprocedural MLA over 12.7 mm2 (n = 67). CONCLUSIONS: Restenosis after DCB treatment was shown to correlate with CTO, circumferential calcification, and postprocedural MLA as evaluated by IVUS. Moreover, smaller vessel sizes might represent a particular challenge to the DCB strategy due to the difficulty of restoring a sufficient postprocedural lumen area by balloon dilatation.

Parallel Wiring Using a Single Intravascular Ultrasound Catheter with Double Rapid Exchange Lumens Technique for Chronic Total Occlusions in Peripheral Artery Disease.

PURPOSE: To describe a parallel wiring using a single intravascular ultrasound catheter with double rapid exchange lumens (PASSABLE) technique for peripheral CTOs. TECHNIQUE: The technique is demonstrated in a 73-year-old patient with CTOs of the superficial femoral and popliteal artery. Intravascular ultrasound (IVUS) examination revealed the first guidewire was advanced to the intramedial space of the popliteal artery. Following insertion of the first guidewire into only the distal rapid exchange lumen of the IVUS catheter and a second guidewire into the proximal rapid exchange lumen, a guidewire torquer was passed over it and tightened close to an exit port of the proximal rapid exchange lumen to prevent it from exiting an entry port while advancing the IVUS catheter. The IVUS catheter was advanced to the intraplaque region using only the distal rapid exchange lumen and the second guidewire was then advanced to the intraplaque region under IVUS guidance. The IVUS-guided wiring using the second guidewire on both the distal and proximal rapid exchange lumen was continued and resulted in a successful guidewire crossing into the distal true lumen. CONCLUSION: This novel technique may prove beneficial in enabling operators to perform IVUS-guided parallel wiring more easily and efficiently.

"Low Echoic Area" around stent after bare and drug-coated stenting or stent graft placement for superficial femoral artery disease.

Restenosis after stent implantation in femoropopliteal lesions is still big issue. However, restenosis has been reduced by the recent new drug-eluting stent "Eluvia" (Boston Scientific, Marlborough, MA, USA). However, it was reported that "low echoic area (LEA)" finding around stent by ultrasound that they called "aneurysmal degeneration," but no blood flow was identified outside the stent was confirmed after Eluvia implantation. In this report, we describe the similar findings that were observed after other types of stents (S.M.A.R.T. bare-nitinol stent (Cordis Corporation, Hialeah, FL, USA), Zilver PTX drug-coated stent (Cook Medical, Bloomington, IN, USA), and Viabahn stent graft (W. L. Gore & Associates, Newark, Delaware, USA)) for superficial femoral artery disease. These findings did not change to "aneurysmal change" during the follow-up.

Health Care Utilization Following Inpatient Femoropopliteal Revascularization With Drug-Coated Balloon Angioplasty: A Nationwide Cohort Analysis.

PURPOSE: To examine nationwide variations in inpatient use of drug-coated balloons (DCBs) for treating femoropopliteal segment occlusive disease and whether DCBs are associated with reduced early out-of-hospital health care utilization. MATERIALS AND METHODS: The study included 24,022 patients who survived hospitalization for femoropopliteal revascularization using DCB angioplasty (n=7850) or uncoated balloon angioplasty (n=16,172) in the 2016-2017 Nationwide Readmissions Database. Differences in patient, hospitalization, and institutional characteristics were compared between treatment strategies. Adjusted logistic regression models were used to examine differences in 6-month rates of readmission, amputation, and repeat intervention. Results are presented as the odds ratio (OR) and 95% confidence interval (CI). RESULTS: Patients treated with DCBs had a higher prevalence of chronic limb-threatening ischemia, diabetes, hypertension, and tobacco use. Revascularization with a DCB was associated with shorter hospitalizations, lower median hospitalization costs, and fewer inpatient lower extremity amputations. Readmissions at 6 months were decreased in patients treated with DCBs compared with uncoated balloon angioplasty (OR 0.90, 95% CI 0.83 to 0.98, p=0.014). The most common reasons for readmission were complications related to procedures (15.4%) and diabetes (15.4%). Compared to patients treated with DCBs, patients treated with uncoated balloon angioplasty were more often readmitted with early procedure-related complications (13.3% vs 17.5%). There were no between-group differences in readmission for sepsis, myocardial infarction, or congestive heart failure. CONCLUSION: DCBs are less often used compared to uncoated balloons during inpatient femoropopliteal procedures. While DCB utilization is associated with more severe comorbidities and advanced peripheral artery disease, readmission rates are decreased through the first 6 months.

Long-term clinical effectiveness of a drug-coated balloon for in-stent restenosis in Femoropopliteal lesions.

BACKGROUND: The short-term efficacy of paclitaxel-coated balloons (PCBs) has been established in femoropopliteal in-stent restenosis (ISR) lesions. The aim of this study was to compare 5-year clinical outcomes of patients with femoropopliteal ISR lesions undergoing percutaneous transluminal angioplasty (PTA) with and without PCB. METHODS: After 1:1 propensity score matching, we extracted 50 patients with femoropopliteal ISR lesions undergoing PTA with (n = 25) and without (n = 25) IN.PACT PCB (Medtronic, Minneapolis, MN) from 106 consecutive ISR patients treated in our hospital between 2009 and 2015. We compared the 5-year outcomes between PCB and non-PCB groups. The primary endpoint was the cumulative 5-year incidence of recurrent restenosis. All-cause mortality, target lesion revascularization (TLR) and unplanned major amputation were also assessed. RESULTS: The primary patency after PCB treatment at 5 years was significantly higher than the patency after non-PCB treatment (65.7% vs. 18.7%; hazard ratio [HR]: 6.11; 95% confidence intervals [CI]: 2.57-16.82; p < 0.001), as well as freedom from TLR (77.6% vs. 53.8%; HR: 3.55; 95% CI: 1.21-12.83; p = 0.020). All-cause mortality and unplanned major amputation rates did not significantly differ between the two groups. The Cox proportional hazard multivariate analysis showed that PCB was independently associated with preventing recurrent restenosis (HR: 0.17; 95% CI: 0.06-0.41; p < 0.001). CONCLUSIONS: At 5 years, patients with femoropopliteal ISR lesions undergoing PCB treatment showed significantly lower recurrent restenosis than those that underwent non-PCB treatment. EVIDENCE-BASED MEDICINE: Level of Evidence: Level 2b, Non-randomized controlled cohort/follow-up study.

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study.

PURPOSE: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). MATERIALS AND METHODS: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). RESULTS: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. CONCLUSION: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

One-Year Outcomes of Heparin-Bonded Stent-Graft Therapy for Real-World Femoropopliteal Lesions and the Association of Patency With the Prothrombotic State Based on the Prospective, Observational, Multicenter Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study.

PURPOSE: To evaluate the real-world primary patency of heparin-bonded stent-graft therapy for femoropopliteal (FP) occlusive disease and identify any clinical factors, including the prothrombotic state, associated with the loss of patency. MATERIALS AND METHODS: This multicenter study prospectively enrolled 424 limbs of 371 patients (mean age 75±8 years; 247 men) scheduled for Viabahn stent-graft placement in the FP segment. A full-coverage strategy using only a Viabahn stent-graft was preferred, but "spot stenting" with the Viabahn was also allowed. The prothrombotic state was assessed by measuring platelet reactivity. Vascular morphology was evaluated using intravascular ultrasound (IVUS). Primary patency was estimated using the Kaplan-Meier method in the subgroup of patients having full lesion stent-graft coverage (n=343 limbs, 81.1%). The secondary outcomes were major amputation, surgical reconstruction, target lesion revascularization (TLR), and thrombotic occlusion. Regression analyses were used to explore associations of baseline and clinical variables with loss of patency; the results are given as the odds ratio (OR) and 95% confidence interval (CI). RESULTS: The 1-year primary patency estimate was 80.3% (95% CI 75.5% to 85.1%) in the full-coverage group. There were 7 surgical reconstructions, 46 TLRs, 21 acute thrombotic occlusions, and 1 major amputation during the 1-year follow-up in the full-coverage group. Only angiography- and IVUS-determined vessel diameters were significantly associated with loss of patency, with crude ORs of 0.64 (95% CI 0.45 to 0.89, p=0.009) and 0.67 (95% CI 0.51 to 0.90, p=0.009), respectively, per 1-mm increase, whereas other variables, including the prothrombotic state (p=0.74), were not. Multivariable analysis demonstrated that only IVUS-determined vessel diameter was independently associated with loss of patency (adjusted OR per 1-mm increase 0.72, 95% CI 0.52 to 1.00, p=0.049). CONCLUSION: FP stent-graft placement achieved acceptable patency at 1 year in a real-world setting. A smaller vessel size was significantly associated with loss of patency, whereas the prothrombotic state was not.

Distal Radial Artery Access for Superficial Femoral Artery Interventions.

PURPOSE: To compare the acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access for superficial femoral artery (SFA) interventions. MATERIALS AND METHODS: Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide. Secondary access was achieved through the pedal artery when necessary. The main outcomes were technical success, major adverse events (MAEs), and access site complications. Secondary outcomes were treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site. RESULTS: Overall technical success was achieved in 188 patients (96.4%): 37 of 38 patients (97.3%) in the DR group and 151 of 157 patients (96.2%) in the PR group (p=0.9). Dual (transradial and transpedal) access was used in 14 patients (36.8%) in the DR group and 28 patients (18.9%) in the PR group (p<0.01). Chronic total occlusions were recanalized in 25 of 26 DR patients (96.1%) and in 79 of 81 PR patients (92.6%) (p=0.57). The crossover rate to femoral access was 0% in the DR group vs 3.2% in the PR group (p=0.59). Stents were implanted in the SFA in 15 DR patients (39.4%) and in 39 patients (24.8%) in the PR group (p=0.1). The contrast volume, fluoroscopy time, radiation dose, and procedure time were not statistically different between the DR and PR groups, nor were the rates of access site complications (2.6% and 7.0%, respectively). The cumulative incidences of MAE at 6 months in the DR and PR groups were 15.7% vs 14.6%, respectively (p=0.8). CONCLUSION: SFA interventions can be safely and effectively performed using PR or DR access with acceptable morbidity and a high technical success rate. DR access is associated with few access site complications.

Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial.

PURPOSE: To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries. MATERIALS AND METHODS: This prospective, multicenter, single-arm trial (ClinicalTrials.gov; identifier NCT01263665) enrolled 71 patients (mean age 66.7±8.3 years; 50 men) with lifestyle-limiting claudication or rest pain (Rutherford category 2-4) and long (>20-cm) lesions of the superficial femoral and proximal popliteal arteries. Primary endpoint was primary patency at 36 months. Secondary endpoints included primary assisted patency; secondary patency; freedom from target lesion revascularization (TLR); freedom from a composite of death, target vessel revascularization (TVR), and amputation; clinical success; and freedom from device fracture. RESULTS: Primary patency estimated by Kaplan-Meier analysis was 40.6% at 36 months. Primary assisted patency and secondary patency estimates were 53.0% and 96.9%, respectively. Within 36 months, 27 patients had to undergo a TLR. Twenty-five patients (35.2%) had a TVR. Freedom from the composite of death, TVR, and amputation endpoint was 44.5%. The estimate of the sustained clinical success with stable or improved Rutherford category was 58.5%. No stent fracture was detected during follow-up. CONCLUSION: The primary patency rate without reintervention after treatment of long femoropopliteal lesions is low. However, secondary patency after implantation of a Viabahn endoprosthesis is high and seems to be superior to the use of other revascularization techniques, resulting in persistent clinical improvement.

Trans-popliteal hybrid retrograde technique for revascularization of chronic total occlusions of the superficial femoral artery.

OBJECTIVES: We present the technical description and preliminary results of a hybrid approach for the treatment of chronic total occlusions of superficial femoral artery in the setting of critical limb-threatening ischemia (CLTI). METHODS: A retrospective analysis of selected case series was performed. A trans-popliteal hybrid technique was carried out in seven limbs (six patients). Open exposure of above-the-knee popliteal artery was performed over its maximum calcification zone. After retrograde recanalization and graft-stenting of the entire superficial femoral artery, endarterectomy of the popliteal artery was performed for debulking and widening of the distal landing zone of the endoprosthesis. The latter is included in the bovine patch suture to avoid leaving a segment untreated. RESULTS: Technical success, haemodynamic and clinical improvement were achieved in all procedures. Median length of treated occlusion was 19.8 cm. After a mean follow-up of 12 months (range 6-26 months), the primary patency was 85.7% (only one asymptomatic occlusion occurred). There were no major cardiovascular or limb adverse events. No re-interventions were required. CONCLUSION: This less-invasive, one-incision technique is safe and effective for the restoration of in-line flow from groin to ankle, currently recommended in CLTI revascularization. It could be especially useful in highly calcified popliteal artery lesions, hostile groins or those at high risk of infection and in cases of vein absence for bypass surgery.

Lumen Loss at 1 Year After Bare Nitinol Stent Implantation in the Superficial Femoral Artery.

PURPOSE: To investigate lumen loss (LL) at 1 year after bare nitinol stent (BNS) implantation for de novo superficial femoral artery (SFA) lesions. MATERIALS AND METHODS: The subjects were 701 consecutive patients (mean age 74±9 years; 492 men) with 817 de novo SFA lesions treated with BNS implantation between January 2004 and September 2015. The mean lesion length was 141±88 mm and the mean vessel diameter was 5.4±0.9 mm. The endpoint was LL at 1 year after BNS implantation. Secondary outcomes were restenosis and target lesion revascularization (TLR) estimated using the Kaplan-Meier method; estimates are reported with the 95% confidence interval (CI). LL was defined as the minimum lumen diameter immediately after BNS implantation minus that at 1 year measured by angiographic quantitative vessel analysis. The distribution of LL in the overall population was estimated using an accelerated failure time model. RESULTS: Mean LL at 1 year was estimated to be 1.74±1.28 mm (95% CI 1.63 to 1.84). Current smoking was positively associated with LL (p=0.015), whereas lack of cilostazol use was correlated with an increase in LL (p=0.001). Reference vessel diameter and lesion length did not have any significant association with LL at 1 year. The 1-year cumulative estimate of restenosis was 25% (95% CI 22% to 28%); the corresponding value for TLR was 18% (95% CI 15% to 21%). CONCLUSION: Mean LL progressed by at least 1.6 mm up to 1 year after BNS implantation. The risk factors for increased LL were current smoker and lack of cilostazol use.