TransAtlantic Inter-Society Consensus Research Articles

Efficacy and Safety of Covered Stents Versus Bare-Metal Stents for Aortoiliac Occlusive Disease: A Systematic Review and Meta-Analysis.

This study aimed to assess the efficacy and safety outcome of covered stents (CSs), as compared with bare-metal stents (BMSs), for the treatment of patients with aortoiliac occlusive disease (AIOD). A systematic literature search was conducted in PubMed, Embase, and Cochrane Library up to August 2023 to identify all studies comparing efficacy and safety outcomes of CSs versus BMSs for treating AIOD. Our outcome was primary patency, secondary patency, technical success, ankle-brachial index (ABI) variation, target lesion revascularization (TLR), limb salvage, complications, and long-term survival. Dichotomous outcomes were pooled as relative risks (RR) or hazard ratio with the 95% confidence interval (CI). Continuous outcomes were pooled as weighted mean differences and 95% CI. Model selection was based on the heterogeneity of the included studies. There were 10 studies (2 randomized controlled trials, 8 retrospective cohort studies), comprising 1676 sample size. Compared with BMSs, CSs use was associated with better primary patency of patients with a Trans-Atlantic Inter-Society Consensus II (TASC) D lesion (RR, 1.15, 95% CI, 1.04 to 1.27, p=0.007), TLR (RR, 0.39, 95% CI, 0.27 to 0.56, p<0.001), technical success (RR, 1.01, 95% CI, 1.00 to 1.02, p=0.010), and long-term survival (RR, 1.06, 95% CI, 1.01 to 1.11, p=0.020). There is no difference between CSs and BMSs regarding primary patency of all patients, secondary patency, variation in ABI, limb salvage, and complications. Compared with BMSs, CSs used in AIOD was associated with more favorable primary patency in patients with TASC D lesions, TLR, technical success rates, and patient long-term survival. These results provide evidence of the advantages of using CSs for AIOD treatment. Future studies focusing on long-term variations in ABI, primary patency of different degrees of calcification, vascular segments, and TASC classification are warranted. Although several studies evaluated the clinical efficacy of CS in the context of AIOD treatment, the significance and consistency of these findings were not determined to date. We found that CS was used in AIOD associated with better technical success rate, long-term patient survival, lower target lesion revascularization, and higher primary patency of patients with a Trans-Atlantic Inter-Society Consensus II D lesion when compared with BMSs. Our study provides evidence supporting the superiority of CSs over BMSs in the treatment of AIOD, and furnishing clinicians with guidance for treatment decisions.

Predictors of Crossing Failure in Femoropopliteal Lesions: The Importance of Length of the Lesion and Calcification

IntroductionEndovascular therapy is nowadays the first choice for most patients with peripheral artery disease. The most important cause of technical failure is failure to cross the lesion with a wire. In this retrospective study we explore possible risk factors of crossing failure. PatientsWe included all consecutive patients in whom the lesion could not be crossed in the period of the 1th January 2017 to 1th January 2022. The lesions of these patients were compared with patients in whom the lesion could be crossed (2:1). The following potential anatomical risk factors were compared: location of the lesion, occlusion length, lesion length, Peripheral Arterial Calcium Scoring Scale, Peripheral Academic Research Consortium, circumferential characterization classification and the TASC II classification. ResultsIn 71 patients the lesion could not be crossed, these patients were compared with 142 patients. There were significantly more patients with hypertension and hyperlipidemia in the group with crossing failure. The following factors were risk factors for crossing failure: occlusion length, lesion length, Peripheral Arterial Calcium Scoring Scale, Peripheral Academic Research Consortium and circumferential characterization classification. Discussions and conclusionAlthough conclusions should be carefully drawn from this retrospective study, calcification and length of the lesion are associated with crossing failure in the femoropopliteal segment. The Trans-Atlantic Inter-Society Consensus (TASC) II classification was the best predictor of crossing failure.

Mid-term Results of Endovascular Reconstruction of Aortic Bifurcation Using COVERA Stent Graft.

This article aims to evaluate the short-term and mid-term performance of a self-expanding covered stent (COVERA Plus, Bard Tempe, Arizona) during the treatment of Trans-Atlantic Inter-Society Consensus (TASC) C/D aortoiliac obstructive lesions involving the aortic bifurcation. A single-center retrospective review of all patients who underwent endovascular reconstruction of the aortoiliac bifurcation for obstructive disease, with the use of Covera, from January 2018 to March 2023. All patients received a postoperative CTA (computed tomography angiography) scan within 1 month from the intervention. Precision of deployment, stent conformation, and stent symmetry were evaluated at the arterial phase of the CTA. Early outcomes were technical success and freedom from open aortic reintervention and/or mortality. Late outcomes were primary and assisted primary patency rates and freedom from reintervention. During the study period, 35 patients underwent primary endovascular treatment of obstructive lesions involving the aortic bifurcation with parallel COVERA stents. Aortoiliac lesions were classified as TASC-IIC in 23 (65.7%) patients and TASC D in 12 (34.2%). Median follow-up was 49 months (interquartile [IQR]: 18-60). Overall survival was 97.1% (95% confidence interval [CI]=91-100) at 60 months. During follow-up, there were one early stent stenosis, treated with an angioplasty and stent relining with an estimated primary patency at 60 months of 97.1% (95% CI=94-100) and a primary-assisted patency of 100%. Estimated freedom from all types of reinterventions at 60 months was 94.3% (95% CI=89-99.3). The new self-expanding covered Bard COVERA Plus stent used for endovascular treatment of TASC C/D aorto iliac disease proved to be safe and feasible with high technical procedural success rates. Comparison with other types of stents is necessary to further assess the role of the COVERA Plus stent in aortic bifurcation repair. This study investigates the safety and feasibility of the new self-expanding covered Bard Covera Plus stent used for endovascular treatment of TASC C/D aorto iliac disease. The retrospective analysis of 35 patients highlights high technical success and primary patency rate at 60 months. The geometric analysis also helped to underline how this stent can be used precisely in particular conditions. These findings suggest the need for further research to compare COVERA with other types of stents in aortic bifurcation repair.

Endovascular recanalization of infra-popliteal TASC C and TASC D lesions in patients with critical limb-threatening ischemia: a single-center experience.

The present study aims to (1) assess the technical success and limb salvage rates of endovascular therapy in patients with critical limb-threatening ischemia (CLTI) and infra-popliteal Trans-Atlantic Inter-Society Consensus (TASC) C/D lesions according to the updated 2015 TASC II classification and (2) to present our institutional experience. A single-center retrospective study was conducted on patients with TASC C/D CLTI who underwent endovascular treatment between 2012 and 2017. The follow-up protocol consisted of Doppler ultrasound conduction every 3 months for the first year unless patients showed symptoms of CLTI. Patients with at least 1 year of follow-up data were included in the study, and if applicable their 3-year results were evaluated in terms of primary patency, absence of amputation, amputation-free survival, and overall survival. A total of 248 patients and 287 limbs (238 TASC D lesions and 49 TASC C lesions) were treated via infra-popliteal percutaneous transluminal angioplasty. The overall technical success was 87%, the primary patency rate was 41.5% in the first year, and the freedom from amputation rates were 80.8% in 1 year and 67.7% in 3 years. In patients with infra-popliteal arterial occlusive diseases, endovascular treatment methods demonstrate a high rate of technical success and favorable outcomes in limb preservation.

Triglyceride-glucose index for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents.

To evaluate the triglyceride-glucose index (TyG index) for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents. Subjects with iliac artery stenosis, who underwent an iliac stent intervention and were followed up for at least 2 years were included in the study. Subjects were grouped according to TyG index (Group A, TyG index ≤8.848; Group B 8.849 ≤TyG index ≤9.382 and Group C TyG index ≥9.383). The subject's baseline characteristics, blood parameters, claudication distance, Transatlantic Intersociety Consensus classification, target lesion localization, stent direction, number of stents that were applied, and stent type were noted. Pre- and 1st and 2nd-year post-procedure Rutherford statuses, ankle-brachial index, and stenosis degree were recorded. To calculate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), Group B and Group C were combined and compared with Group A. In total, 255 subjects were evaluated (female, n=77-30.2%, male, n=178-69.8%). The mean age of the subjects was 66.00±10.00 years (range from 39 to 90 years). The pre-procedure Rutherford measurements were significantly different among the groups (p=0.001). The rates of mild claudication and resting pain in Group A were higher than those in Groups B and C. The rate of moderate claudication in Group C was higher than that in Groups A and B. The rate of severe claudication in Group B was higher than that in Groups A and C. One year after the procedure, there were more asymptomatic cases in Group A than in Groups B and C (p=0.001). The rate of mild claudication in Group C was lower than that in Groups A and B. The rate of moderate claudication in Group C was higher than that in Group A. The rate of severe claudication in Group C was higher than that in Groups A and B. Two years after the procedure, the Rutherford measurements and the rates of mild claudication in Groups A and B were higher than those in Group C. The rate of severe claudication in Group C was higher than that in Groups A and B (p=0.001). One year after the procedure, the computed tomography angiography (CTA) measurements and the rate of full patency in Group A were higher than that in Groups B and C. The rate of 0-50% stenosis in Group B was higher than that in Groups A and C. The rate of 50-70% stenosis in Group C was higher than that in Group A. Two years after the procedure, the CTA measurements and the rates of 70-99% stenosis and 100% occlusion in Group C were higher than those in Groups A and B. The TyG index has high specificity and NPV. However, specificity and PPV levels were found to be quite low. The TyG index was found to be an easy-to-use marker for predicting in-stent restenosis in patients with iliac artery stenosis after percutaneous intervention with stents.

10년간의 3차 의료기관 경험을 바탕으로 한 대동맥장골동맥 폐색 질환 혈관내 치료의 기술적 고찰: 후향적 연구.

To examine the technical considerations of endovascular treatment for aortoiliac occlusive disease (AIOD) based on a 10-year experience in Songklanagarind Hospital. This retrospective cohort study included 210 patients who underwent endovascular treatment for symptomatic AIOD between January 2010 and December 2020. The patients' clinical and lesion characteristics, including technical considerations of the procedure, were collected, analyzed, and stratified using the Transatlantic Inter-Society Consensus (TASC). Most patients (80%) in this study had chronic limb-threatening ischemia lesions, with an occlusion rate of 37%. The technical success rate of TASC C & D was lower than that of TASC A & B, 84.4% vs. 99.2% p ≤ 0.001. A technical success rate of 93.3% (14/15) was found for the femoral and brachial approach, compared with a success rate of 89.0% (57/64) for the unibifemoral approach in TASC C & D, without a statistically significant difference (p = 0.076). However, the puncture site complications in this route were up to 17.6%, which is the highest rate compared with other techniques. These complications could be treated either conservatively or minimally invasively. In cases of failed femoral access, simultaneous femoral and brachial approaches improved the technical success rate of endovascular recanalization of TASC C & D aortoiliac occlusions.

Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry.

The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of Eluvia™, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry. A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with Eluvia™ stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR). Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients. Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08-11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16-0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years. The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.

Endovascular Treatment of TASC C and D Femoropopliteal Arterial Disease With Heparin-Bonded Covered Stents: The Impact of Distal Run-Off Vessels.

In the last 2 decades, several studies in the literature evaluated the possible role of covered stents in the treatment of TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions but, despite the encouraging results, the employment of these devices was never included in clinical guidelines. The aim of this study is to evaluate the role of the technical aspects in patients with TASC C or D lesions that were treated with the GORE VIABAHN endoprosthesis and to elaborate a computerized method to objectively estimate the post-stent run-off and predict stent-graft failure. In this monocentric retrospective study, we collected the patients who were treated in our department from December 2014 to May 2021. Inclusion criteria comprised: (1) patients who underwent endovascular treatment of a TASC C or D femoropopliteal lesions using one or more heparin-bonded covered stent(s) and (2) clinical follow-up >2 years. Exclusion criteria were clinical follow-up <2 years or missing. An in-house computerized analysis to estimate the post-stent run-off, CEVERO (Computerized Estimation of VEssel Run-Off), was elaborated. Sixty-six patients were enrolled in the study. Eleven patients had a TASC type C lesion, and 55 patients presented a type D lesion. The median follow-up time was 2.6 years. Twenty-nine patients (43.9%) experienced a major adverse limb event. Primary patency after 6, 12 and 24 months was 74.2%, 60.6%, and 57.6%; primary-assisted patency was 78.8%, 65.2%, and 59.1%. The presence of <2 run-off vessels (p<0.001) was correlated with stent-graft failure. The CEVERO analysis demonstrated an accuracy of 90.0% in predicting stent-graft failure. The treatment of TASC C and D femoropopliteal lesions remains technically challenging. Our study supported the hypothesis that run-off is the most critical factor in determining the outcome of the procedure and that concomitant angioplasty of the tibial vessels might improve the patency of the covered stent. The CEVERO analysis could permit a real-time, objective estimation of the distal run-off using conventional angiographic images, and it might be employed as a tool in the intraprocedural decision-making process, but its clinical applicability should be evaluated on external validation cohorts. The endovascular treatment of TASC C and D femoropopliteal lesions is technically challenging and run-off seems to be the most critical factor in determining the outcome. Concurrent angioplasty of the tibial vessels can create adequate run-off to avoid stent failure. The CEVERO analysis is a computerized estimation of run-off that might be a useful tool in the decision-making process.

Technical Success, Midterm Primary Patency, and Factors Affecting Primary Patency of Subintimal Angioplasty Followed by Vasculomimetic Stenting for Trans-Atlantic Intersociety Consensus II C and D Femoropopliteal Arterial Disease—A Prospective Study

Abstract Background The best option among the endovascular options in long, complex femoropopliteal (FP) lesions, and factors affecting the patency have yet to be well described. There are few studies describing the mid- and long-term patency of endovascular stents in long-segment FP occlusions. Aim This study aimed to determine the technical success and mid-term patency of subintimal angioplasty with vasculomimetic stenting in Trans-Atlantic Inter-Society Consensus II (TASC) C and D FP disease. The patient and imaging factors that affect primary patency were also analyzed. Methods and Materials A single-center prospective study was performed on 52 consecutive patients undergoing endovascular treatment for TASC C and D FP disease from 2017 to 2021. Angioplasty with stenting was performed in all patients and followed up for 36 months. Endpoints were primary patency rates and amputation-free survival of the limb. Kaplan–Meier curves were used to see patency rates and amputation-free survival rates. Results A total of 52 patients underwent stenting with a technical success rate of 100% if the sub-intimal arterial flossing with antegrade-retrograde intervention (SAFARI) technique was used. Primary stent patency at 6, 12, 18, 24, and 36 months was 89.8, 81.4, 76.2, 71.4, and 62.5%, respectively. Amputation-free survival was 98, 95.6, 91.8, and 85.7% at 12, 24, 30, and 36 months, respectively. Cox proportional regression analysis showed smoking and vessel wall calcium score more than 270 degrees as independent predictors of loss of primary patency (hazard ratio 0.35 confidence interval [CI]: 0.003–0.448) and 0.102 (CI: 0.022–0.47), respectively. Conclusion Subintimal angioplasty with vasculomimetic stent has good midterm patency in and amputation-free survival in long-segment FP occlusions. Smoking and severe vessel wall calcification adversely affect patency.

Safety and efficacy of kidney transplantation in patients with aortoiliac stenosis: a retrospective cohort study.

The impact of aortoiliac occlusive disease on kidney transplantation remains unclear. This study aims to investigate the clinical outcomes of kidney transplant patients with aortoiliac atherosclerotic stenosis. Retrospective data from our transplant center were used to identify patients undergoing kidney transplantation between January 2010 and December 2020. Aortoiliac atherosclerotic stenosis was screened and stratified by the Trans-Atlantic Inter-Society Consensus (TASC) II classification. The primary outcome was patient survival. Secondary outcomes were 90-day mortality, death-censored graft survival, graft function, and arterial complications. Propensity score matching was used to match all patients in the stenosis group with patients without stenosis sharing similar characteristics. The analysis included 655 patients, 524 without stenosis and 131 with aortoiliac stenosis (95 with TASC A/B stenosis and 36 with TASC C/D stenosis). Recipient age [median (IQR), 66 (60-70) vs. 66 (59-71) years; P =0.47], sex [male: 87 (66%) vs. 355 (68%), P =0.85], and comorbidities were comparable between the stenosis and no-stenosis groups. Forty-six (35%) patients with stenosis were symptomatic. Patient survival was significantly lower in the stenosis group compared with the no-stenosis group (TASC A/B: 30.6% vs. no-stenosis: 44.1%, P =0.013; TASC C/D: 11.4% vs. no-stenosis: 44.1%, P <0.001). The incidence rates of artery dissection, lower extremity ischemia, and acute thrombosis were significantly higher in the stenosis group ( P <0.001). However, death-censored graft survival (TASC A/B: 73.6% vs. no-stenosis: 72.9%, P =0.62; TASC C/D: 58.1% vs. no-stenosis: 72.9%, P =0.16) and graft function were comparable between the groups. Aortoiliac atherosclerotic stenosis significantly impacts patient survival but not graft survival. Our analyses suggest that patients with TASC A/B stenosis have prolonged survival and enhanced quality of life through kidney transplantation. However, for patients with TASC C/D stenosis, kidney transplantation improves quality of life without bringing survival benefits.

Differences between Lower Extremity Arterial Occlusion vs. Stenosis and Predictors of Successful Endovascular Interventions.

Background and Objectives: In patients with peripheral artery disease, there is insufficient understanding of characteristics that predict successful revascularization of the lower extremity (LE) chronic total occlusions (CTOs) and baseline differences in demographic, clinical, and angiographic characteristics in patients with LE CTO vs. non-CTO. We aim to explore these differences and predictors of successful revascularization among CTO patients. Materials and Methods: Two vascular centers enrolled LE-CTO patients who underwent endovascular revascularization. Data on demographics, clinical, angiographic, and interventional characteristics were collected. LE non-CTO arterial stenosis patients were compared. A total of 256 patients with LE revascularization procedures were studied; among them, 120 had CTOs and 136 had LE stenosis but no CTOs. Results: Aspirin use (Odds ratio, OR: 3.43; CI 1.32-8.88; p = 0.011) was a positive predictor whereas a history of malignancy (OR: 0.27; CI 0.09-0.80; p = 0.018) was a negative predictor of successful crossing in the CTO group. The CTO group had a higher history of myocardial infarction (29.2 vs. 18.3%, p = 0.05), end-stage renal disease (19.2 vs. 9.6%, p = 0.03), and chronic limb-threatening ischemia as the reason for revascularization (64.2 vs. 22.8%, p < 0.001). They were more likely to have advanced TransAtlantic Inter-Society Consensus (TASC) stages, multi-vessel revascularization procedures, longer lesions, and urgent treatment. Conclusions: The use of aspirin is a positive predictor whereas a history of malignancy is a negative predictor for successful crossing in CTO lesions. Additionally, LE-CTO patients have a higher incidence of comorbidities, which is expected given their higher disease burden. Successful endovascular re-vascularization can be associated with baseline clinical variables.

Efficacy Analysis of Drug-Coated Balloons in the Treatment of Ultra-Long Segment Lesions of Femoral Popliteal Artery

PurposeTo evaluate the mid-term clinical efficacy of paclitaxel drug-coated balloons (DCBs) in the treatment of femoral artery Transatlantic Inter-Society Consensus (TASC) grades C/D lesions. MethodsThe clinical data of 73 cases with TASC grades C/D lesions of femoral artery treated with paclitaxel DCBs at the Department of Vascular Surgery, the First Hospital of Fujian Medical University from August 2016 to January 2020 were retrospectively analyzed. The primary endpoint was primary patency rate. The secondary endpoints were freedom from re-intervention, Rutherford classification, ankle branch index (ABI), amputation events, and all-cause death. ResultsA total of 73 cases of limb lesions received endoluminal treatment. The mean age of the patients including 49 males and 24 females was (72.66±11.1) years, with an initial Rutherford classification of 2-5 and an ABI of 0.4±0.1. The mean Rutherford classification was 3.70±0.95. The mean lesion length was (25.75±9.67) cm, including 61.64% chronic occlusive lesions and 27.39% stenotic lesions, the remaining 10.97% were mixed lesions, containing multiple segments of stenosis and CTO lesions. 43.8% of the lesions were associated with severe calcification. Stent implantation rate was 8%. Overall mortality at follow-up was 4% at 1 year and 8% at 2 years,and no amputations seen. The ABI was 0.83±0.07 at 1-year follow-up and 0.78±0.05 at 2-year follow-up. The Kaplan-Meier survival curve predicted 1-year phase I patency rate was 75.3%±5% and the 2-year patency rate was 63.3%±5.7%. Freedom from TLR was 78.4±4.9% at 1 year and 69.2%±3.6% at 2 years. Logistic regression analysis showed that diabetes mellitus, severe calcification, chronic renal insufficiency and restenosis were the significant factors affecting the patency of target lesions. ConclusionPaclitaxel DCBs in the treatment of femoral artery with TASC grades C/D lesions can achieve relatively satisfactory mid-term clinical safety and efficacy results, provided there is an acceptable result on completion angiogram.

Endovascular revascularization of challenging anatomical lesions: Revascularization in TASC-II C and D classes: A single-centre retrospective report

Aim: Peripheral arterial disease (PAD) is a prevalent condition that significantly impacts quality of life and that can lead to limb amputation and thromboembolic events. Treatment options for PAD include endovascular and open surgical interventions, with the choice depending on the Trans-Atlantic inter-society consensus II (TASC II) classification. Recent evidence suggests that endovascular therapy may be feasible for complex PAD lesions, but further research is needed. Material and Methods: This retrospective cohort study included 50 patients with TASC II class C and D lesions. The procedures were conducted using a state-of-the-art angiography system, and patients received appropriate antiplatelet therapy and heparin during the intervention. Data collection was performed following ethical considerations and standardization protocols. Results: This study involved 50 patients with peripheral arterial disease, characterized by an average age of 65.0 years and a prevalence of comorbidities such as coronary artery disease, hypertension, type 2 diabetes mellitus, and tobacco use. The majority of patients presented with claudication and had lesions primarily in the femoropopliteal region. The procedures performed, primarily using drug-coated balloons, resulted in high technical success rates and favorable outcomes at 30 days, with a slight decline in primary patency rates at 6 months. Some patients required readmission due to cardiac reasons, and a small portion necessitated open surgical revascularization. Conclusion: Our findings support the use of endovascular revascularization as a safe and effective option for patients with complex lesions. Further research is needed to address challenges related to dissection and optimize outcomes in this patient population. This study contributes to the growing understanding of treatment approaches for peripheral artery disease and highlights the potential benefits of endovascular therapy.

Arterial dissection during peripheral vascular interventions

ObjectiveArterial dissection (AD) is a known complication of peripheral vascular interventions (PVIs), but its incidence and significance have not been well-characterized. This study examines AD in the Vascular Quality Initiative database for patients treated for peripheral arterial disease. Our hypothesis is that AD is associated with decreased patency and worse limb outcomes. MethodsThe Vascular Quality Initiative PVI registry (2016-2021) was reviewed. Patients were divided based on the presence or absence of reported AD during the procedure. Trend of incidence and management of AD was derived. The characteristics and outcomes of patients with and without AD were compared. The primary endpoint was primary patency. ResultsThere was a total of 177,790 cases, and 3% had AD. The incidence of AD significantly increased over the study period from 2.4% to 3.6% (P = .007). Endovascular therapy was used to treat AD in 83.7% of cases, 14.5% were treated medically, and only 1.8% required open surgery. Patients with AD were significantly more likely to be female (47.4% vs 39.7%; P < .001). Patient with AD were more likely to have a history of smoking (79.7% vs 77.2%; P < .001), but were significantly less likely to be on dialysis (8.2% vs 9.3%; P < .001) compared with patients without AD. Patients with AD were more likely to have femoropopliteal disease (45.2% vs 38.0%; P < .001) and undergo treatment of more complex disease as denoted by higher mean number of lesions treated (1.95 ± 1.01 vs 1.71 ± 0.89; P < .001), longer occlusion length (8 ± 16 vs 7 ± 15 cm; P < .001), and more severe TransAtlantic Inter-Society Consensus grade (Grade D: 36.2% vs 29.1%; P < .001). The proportion of stenting as a treatment modality was higher in the dissection group (55.4% vs 41.1%; P < .001). After a mean follow-up of 828 days, patients with AD had significantly lower primary patency than patients without AD. Kaplan-Meier curves demonstrated that the AD group had lower primary patency (86.9% vs 91%; P < .001) and reintervention-free survival (79.5 % vs 84.1%; P < .001) at 1 year with difference in amputation-free survival. Cox proportional hazard regression confirmed the independent association of AD with primary patency and reintervention-free survival. ConclusionsAD is more common in women and is more likely to occur during treatment of the femoropopliteal segment. AD is associated with decreased primary patency and reintervention-free survival after PVI for peripheral arterial disease.

Outcomes of covered vs bare metal stents for the treatment of aortoiliac occlusive disease

ObjectiveWe retrospectively compared the clinical outcomes of self-expanding covered stents (CSs) and bare metal stents (BMSs) in the treatment of aortoiliac occlusive disease (AIOD) at a single center between 2016 and 2022. MethodsAll patients with AIOD receiving endovascular therapy at a single center from January 2016 to October 2022 were continuously analyzed, including patients with lesions of all classes according to the Trans-Atlantic Inter-Society Consensus II (TASC-II). Relevant clinical and baseline data were collected, and propensity score matching was performed to compare CSs and BMSs in terms of baseline characteristics, surgical factors, 30-day outcomes, 5-year primary patency, and limb salvage. The follow-up results were analyzed by Kaplan-Meier curves. Cox proportional hazard models were used to identify predictors of primary patency. ResultsA total of 209 patients with AIOD were enrolled in the study, including 135 patients (64.6%) in the CS group and 74 patients (35.4%) in the BMS group. Surgical success rates (100% vs 100%; P = 1.00), early (<30-day) mortality rates (0% vs 0%; P = 1.00), cumulative surgical complication rate (12.0% vs 8.0%; P = .891), 5-year primary patency rate (83.4% vs 86.9%; P = .330), secondary patency rate (96% vs 100%; P = .570), and limb salvage rate (100% vs 100%; P = 1.00) did not exhibit significant differences between the two groups. Patients in the CS group had a lower preoperative ankle-brachial index (0.48 ± 0.26 vs 0.52 ± 0.19; P = .032), more cases of complex AIOD (especially TASC D) (47.4% vs 9.5%; P < .001), more chronic total occlusive lesions (77.0% vs 31.1%; P < .001), and more severe calcification (20.7% vs 14.9%; P < .036). After propensity score matching, 50 patients (25 with CS and 25 with BMS) were selected. The results showed that only severe calcification (32.0% vs 8.0%; P = .034) and ankle-brachial index increase (0.45 ± 0.15 vs 0.41 ± 0.22; P = .038) were significantly different between the groups. In terms of surgical factors, patients in the CS group had more use of bilateral femoral or combined brachial artery percutaneous access (60.0% vs 12.0%; P < .001), more number of stents used (2.3 ± 1.2 vs 1.3 ± 0.7; P < .001), longer mean stent length (9.3 ± 3.3 vs 5.8 ± 2.6 cm; P < .001), and more catheter-directed thrombolysis treatment (32.0% vs 4.0%; P = .009). Multivariate Cox survival analysis showed that severe calcification (hazard ratio, 1.32; 95% confidence interval, 1.04-1.85; P = .048) was the only independent predictor of the primary patency rate. ConclusionsAll patients with AIOD who underwent endovascular therapy were included and achieved good outcomes with both CSs and BMSs. The influence of confounding factors in the two groups was minimized by propensity score matching, and the 5-year patency rates were generally similar in the unmatched and matched cohorts. Postoperative hemodynamic improvement was more obvious in patients in the CS group. For more complex lesions, CS is recommended to be preferred. Especially for severe calcification lesions, which is the only independent predictor of primary patency, CS showed obvious advantages. Further studies with more samples are needed to investigate the role of stent types in AIOD treatment.

Influence of Perioperative Factors on Patency After Endovascular and Hybrid Treatments of TASC II D Aortoiliac Occlusive Lesions

Treatment of Trans-Atlantic Inter-Society Consensus (TASC) II D aortoiliac occlusive disease (AIOD D) remains a controversial topic. Although current recommendations support conventional surgical treatment, several recent studies have reported promising results with endovascular and hybrid strategies. The purpose of this work was to describe the outcomes of endovascular and hybrid management of AIOD D and to investigate the influence of perioperative factors on patency. This was a retrospective single-center study covering the period from 2016 to 2021. The primary end point was primary patency at 12months. Secondary endpoints included technical success rate, 30-day mortality, early major complication rate, primary assisted and secondary patency at 12months, and primary patency at 24months. After descriptive statistical analysis, a survival analysis was conducted using the Kaplan-Meier method. Eighteen perioperative factors potentially associated with primary patency were studied by univariate and multivariate analysis adjusted by a Cox regression model. In all, 82 patients (112 limbs) had undergone an attempt at endovascular (n=55, 67%) or hybrid (n = 27, 33%) treatment for AIOD D over the study period. The technical success rate was 99%. The 30-day mortality rate was 3%. The early major complication rate was 11%. The primary patency rates at 12 and 24months were 87.9% [80.3; 96.3] and 77% [66.3; 89.3], respectively. The primary assisted and secondary patency rates at 12months were 92.6% [86.3; 99.2] and 96% [91.4; 100]. Among the perioperative factors studied, the heavily calcified nature of the target lesions was the only variable significantly associated with primary patency loss in the multivariate analysis (P=0.021). Although the results of endovascular and hybrid treatment of AOID D are acceptable, future studies should focus on improving patency rates in heavily calcified lesions. Specific tools of endovascular preparation (intravascular lithotripsy, atherectomy) may represent interesting ways of research.

Our Experience of Renovisceral Interventions in Patients Undergoing Aortobifemoral Bypass for Aortoiliac Occlusive Disease

Abstract Introduction: Aortobifemoral bypass is the standard recommended procedure for aortoiliac occlusive disease (AIOD). Patients of AIOD presenting with claudication pain and tissue loss require revascularization of lower limbs, with few requiring mesenteric and/or renal revascularization. Aim: The aim of this study was to assess the outcomes of patients undergoing aortobifemoral bypass with mesenteric/renal revascularization in patients of AIOD with mesenteric/renal occlusion. Objective: The objectives of this study were as follows: (1) restoration of normal renal function in terms of urine output and renal function test in patients who underwent mesenteric revascularization and (2) resolution of abdominal angina in patients who underwent mesenteric revascularization. Methods: A total of 13 patients with a mean age of 45.8 years, presenting with critical limb ischemia with renal/mesenteric occlusion due to AIOD of Trans-Atlantic Inter-Society Consensus D type, underwent aortobifemoral bypass with renal/mesenteric revascularization. The demographics of patients, Rutherford stage and WIFI stage, pre- and postoperative ABI, probable etiology, any renovisceral interventions done, duration of procedure, type of renal ischemia (warm/cold), duration of renal ischemia, postoperative complications, duration of stay, patency of graft, wound infection, amputation rates, and mortality were documented on a structured pro forma. Five (38.46%) patients presented with severe claudication, 3 (23.07%) patients with rest pain, and the remaining 5 (38.46%) patients with minor tissue loss. Along with AIOD, 3 (23.07%) patients had concomitant bilateral femoropopliteal disease and tibial vessel disease, 3 (23.07%) patients had unilateral femoropopliteal disease, and 2 (15.38%) patients had bilateral tibial vessel disease. Three (23.07%) patients had infrarenal aortoiliac occlusion and 10 (76.9%) patients had juxtarenal aortoiliac occlusion (managed using Liddicoat/Madiba–Robbs technique). Outcomes were assessed in terms of graft patency, need of dialysis in postoperative period, wound infection, limb survival, amputations, and mortality. Results: Aortic clamp was placed suprarenal (38.46%), infrarenal (53.84%), and interrenal (7.69%) of patients. Cold renal perfusion solution was used in 15.38% of patients with an ischemia time of 38.5 min. The average duration of warm renal ischemia was 5 min 24 s. Revascularization of superior mesenteric artery (SMA) was done in 15.38%, and inferior mesenteric artery in 38.46%. Renal revascularization by Madiba–Robbs technique was done in 30.76% of patients. In 92.3% of patients, bifurcated Dacron synthetic graft was used, and in 7.69%, femoral vein with bovine pericardial patch was used for revascularization. In postoperative period, 7.69% developed acute limb ischemia, 30.07% had severe metabolic acidosis, and 15.38% of patients had respiratory complications with good renal function and no bowel ischemia. Conclusion: Renal and mesenteric revascularization in addition to aortobifemoral bypass is a safe, effective, and durable procedure with acceptable postoperative complications. The effective surgical technique of renal and mesenteric revascularization including the usage of renal perfusion solution was found to be of paramount importance in our study. All patients who underwent SMA revascularization were free from abdominal angina. All patients who underwent renal revascularization were free from dialysis and also there was a decrease in the use of antihypertensive drugs in these patients.

Systematic Review and Meta-analysis of Clinical Outcomes After Endovascular Treatment in Patients With Femoropopliteal Lesions Greater Than 150 mm.

Indications for endovascular treatment of femoropopliteal (FP) lesions have steadily increased over the past decade. Accordingly, the number of devices has also increased but the choice of the best endovascular treatment remains to be defined. The aim of this meta-analysis was to summarize all studies investigating endovascular treatment of FP lesions greater than 150 mm from 2010 to 2021. Articles were searched using PubMed, Scopus, and Cochrane. Included studies were randomized controlled trials (RCTs), cohort studies, and case series (prospective and retrospective) that evaluated any endovascular procedure in patients with long FP lesions classified TASC (Trans-Atlantic Inter-Society Consensus document II on management of peripheral arterial disease) C and/or D, and a mean length >150 mm, primary outcome had to be the 1-year primary patency. Overall estimate of primary patency, secondary patency, and freedom from target lesion revascularization (TLR) at 1 year depending on the different devices were investigated. The meta-analysis was conducted following the requirements of the MOOSE (Meta-analysis of Observational Studies in Epidemiology) checklist. Forty-four papers comprising 4847 patients and 5282 treated limbs were included. Mean lesions length ranged from 150.5 to 330 mm. The pooled 1-year primary and secondary patencies, and freedom from TLR rates were 0.71 (95% CI: 0.67-0.74), 0.87 (95% CI: 0.83-0.91), and 0.79 (95% CI: 0.74-0.84), respectively. Primary permeability at 1 year were 0.68 (95% CI: 0.62-0.73), 0.67 (95% CI: 0.60-0.74), 0.74 (95% CI: 0.64-0.84), and 0.83 (95% CI: 0.78-0.88) for bare metal stents, covered stents (CSs), drug-eluting stents, and drug-coated balloons (DCBs), respectively. Lesions treated with DCB had the highest 1-year primary patency rate. At 1-year, endovascular procedures for FP lesions greater than 150 mm obtain satisfactory results. High primary patency rates were obtained with drug-coated devices, while CSs obtained less favorable results. Randomized studies comparing different devices in the treatment of long FP lesions remain necessary to determine the most optimal approach for the management of these patients. This paper highlights on the one hand the satisfactory results of endovascular treatment on complex femoropopliteal lesions formerly reserved for conventional surgery. On the other hand, among the available devices, paclitaxel-eluting devices seem to show superior results which should make them recommended as first-line treatment.

Stent Graft vs Drug-Coated Balloon in Endovascular Treatment of Complex Femoropopliteal Artery Lesions: A 2-Center Experience.

Both stent grafts (SG) and drug-coated balloons (DCBs) have shown to be effective treatments for long and complex femoropopliteal (FP) lesions. However, there has not been a clinical trial comparing the 2 treatments directly. This study aims to compare the primary patency (PP) and clinical outcomes of SG and DCB for endovascular treatment of complex FP Trans-Atlantic Inter-Society Consensus (TASC) C/D lesions in patients. From July 2013 to May 2019, a retrospective study was conducted at 2 medical centers to compare the clinical outcomes of Viabahn SG and DCB angioplasty in patients with TASC C/D FP lesions. The study used overlap weighting to adjust for differences in baseline characteristics and to reduce the impact of confounding factors and selection bias between the 2 groups. The primary endpoint was PP through 24 months, and the secondary endpoints included freedom from clinical-driven target lesion revascularization (CD-TLR), all-cause of death rate, and major amputation rate. A total of 161 limbs in 150 patients with TASC C/D FP lesions were treated either with Viabahn SGs (67 limbs, 65 patients) or DCBs (94 limbs, 85 patients). In the DCB group, 22 target vessels (23.4%) underwent directional atherectomy before DCB angioplasty and 37 target vessels (39.4%) underwent bail-out bare-metal stent implantation for early recoil or severe dissection. The SG group had significantly higher PP rates at both the 12 and 24 months than in the DCB group (75.8% vs 39.2%, p=0.02; 64.1% vs 31.9%, p=0.02), respectively. However, there were no significant differences between the 2 groups in terms of CD-TLR, death rate, and major amputation rate. According to the results of multivariate analysis, DCB angioplasty was the only independent predictor associated with restenosis (hazard ratio [HR]=0.264, 95% confidence interval [CI]=0.100-0.696, p=0.007). This study showed that SG was associated with a significantly higher PP rate in complex long FP lesions compared with DCB angioplasty. However, there was no significant difference in the freedom from CD-TLR and major amputation rate. It is important to follow the criteria for using SG strictly to avoid early restenosis, which can lead to acute thrombosis and severe limb ischemia. Closer monitoring is recommended for patients who undergo SG implantation. There has no head-to-head clinical trial that compares DCB and SG in complex long FP lesions. This study showed that SG following the criteria was associated with a significantly higher PP rate compared with DCB angioplasty. Closer monitoring is recommended for patients with SG to avoid acute thrombosis. Randomized controlled trials comparing SG and DCB are necessary.

ZILVERPASS Study: ZILVER PTX Stent versus Prosthetic Above-the-Knee Bypass Surgery in Femoropopliteal Lesions, 5-year Results

PurposeTo report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions.Materials and methodsPatients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass at 60 months. Survival rates after 5 years were also analyzed.Results220 patients (mean age 68.6 ± 10.5 years; 159 men) were included and randomized to ZILVER PTX (n = 113, 51.40%) or BYPASS group (n = 107, 48.60%). The 60-month primary patency rate was 49.3% for the ZILVER PTX group versus 40.7% for the bypass group (p = 0.6915). Freedom from TLR was 63.8% for the ZILVER PTX group versus 52.8% for the bypass group (p = 0.2637). At 5 years, no significant difference in survival rate could be seen between the ZILVER PTX and the bypass group (69.1% vs. 71% respectively, p = 0.5503).ConclusionEven at 5 years, non-inferior safety and effectiveness results of the ZILVER PTX could be seen. These findings confirmed that the use of ZILVER PTX stents can be considered as a valid alternative for bypass surgery when treating long and complex femoropopliteal lesions.Graphical