TransAtlantic Inter-Society Consensus Research Articles

OUTCOME OF POLYTETRAFLUOROETHYLENE VERSUS DACRON GRAFTS FOR SUPRAGENICULAR FEMOROPOPLITEAL ARTERIAL BYPASSES

Background: Long saphenous vein (LSV) is used usually as the graft of the choice in the treatment of critical limb ischemia (CLI). LSV graft in femoropopliteal and femrodistal bypasses is more durable and also associated with reduced surgical mortality ratios and good success rates in preserving the ischemic limb. Synthetic graft, i.e. Dacron /Polytetrafluoroethylene (PTFE) is a good alternative if the saphenous vein is not available. PTFE has been the most popular choice. However, the preference for PTFE over Dacron is not evidence-based. The optimum graft configuration for the above-knee femoropopliteal bypass, whether PTFE or Dacron, remains a subject of controversy. Objective: To outcome whether Dacron versus PTFE Grafts as optimum in supragenicular femoropopliteal revascularization. Patients and Methods: Fifty patients with critical limb ischemia referred to Vascular Surgery Department, Al-Azhar University, Sednawy and El-Araby Hospitals were included during the period from July 2018 to April 2020. They had foot lesions as ulcer, wound or tissue loss associated with non-palpable distal pulses, and long occlusion of superficial femoral artery (SFA) defined as TransAtlantic Inter-Society Consensus (TASC) II C or D lesions. End points were healed, healing, nonhealing wounds or amputation. Patients were divided into two groups: group A included 25 patients who underwent Dacron graft bypass “DB”, and group B included 25 patients who underwent PTFE bypass “PB”. Results: Twenty- two patients (44%) reached the end point of complete healing (10 patients did “DB” and 12 did “PB”), whereas twenty-six patients (52%) had no or inadequate healing lesions. The limb salvage after one year was 40 patients (80%): 21 of them with ‘DB’ technique, and 19 with ‘PB’ technique. The remaining 8 patients (16%) underwent major amputation (5 with ‘DB’ technique and 3 with ‘PB’ technique) and two patients (4%) died. The early patency rate at 1 and 3 months was 92.43 % in the group with ‘DB’, and 94.39% in the group with ‘PB’. The late patency rate at one year post-operatively was 63.63 % in the ‘DB’ group and 68.63 % in the ‘PB’ group. Conclusion: Both Dacron and PTFE grafts were effective regarding wound healing and limb salvage as well as patency rate in supragenicular femoropopliteal revascularization.

Screening, Management, and Acceptance of Patients with Aorto-Iliac Vascular Disease for Kidney Transplantation: A Survey among 161 Transplant Surgeons

Introduction: Aorto-iliac vascular disease (AVD) is frequently found during the workup for kidney transplantation. However, recommendations on screening and management are lacking. We aimed to assess differences in screening, management, and acceptance of these patients for transplantation by performing a survey among transplant surgeons. Second, we aimed to identify center- and surgeon-related factors associated with decline or acceptance of kidney transplant candidates with AVD. Methods: A survey was sent to transplant surgeons and urologists. The survey contained general questions (part I) and 2 patient-based cases (part II) with Trans-Atlantic Inter-Society Consensus (TASC) D and B AVD supported with videos of their CT scans. Results: One hundred ninety-one (20.3%) participants responded; 171 were currently involved in kidney transplantation: 161 (94.2%) completed part I and 145 (84.8%) part II. Screening for AVD was often (38.5%) restricted to high-risk patients. The majority of respondents (67.7%) rated “technical problems” as the most important concern in case of AVD, followed by “increased mortality risk because of cardiovascular comorbidity” (29.8%). Pretransplant vascular interventions to facilitate transplantation were infrequently performed (71.4% mentioned <10 per year). Ninety (64.3%) respondents answered that an open vascular procedure should preferably be performed prior to kidney transplantation while 42 (30.0%) respondents preferred a simultaneous open vascular procedure. The decline rate was higher in the TASC D case compared to the TASC B case (26.9% and 9.7%, respectively). Respondents from centers with expertise in pretransplant vascular interventions were more likely to accept both patients with TASC D and B for transplantation. Conclusion: There is no uniformity in the screening, management, and acceptance of patients with AVD for transplantation. If a center declines a patient with AVD because of technical concerns, the patient should be referred for a second opinion to a tertiary center with expertise in pretransplant vascular interventions. Multidisciplinary meetings including a vascular surgeon and a cardiologist could help optimize these patients for transplantation.

EndoNaut two-dimensional fusion imaging with a mobile C-arm for endovascular treatment of occlusive peripheral arterial disease

BackgroundEndovascular treatment has become the first-line strategy for peripheral arterial disease (PAD). Given the number of procedures required, any technology associated with a reduction in radiation exposure and contrast volume is highly relevant. In the present study, we evaluated whether two-dimensional (2D) fusion imaging could reduce the radiation exposure and contrast volume during endovascular treatment of occlusive PAD. MethodsOur consecutive, retrospective, single-center, nonrandomized comparative trial included patients with PAD at the femoral, popliteal, and/or tibial level, at any clinical stage, if they were candidates for endovascular revascularization. Patients were treated with or without the EndoNaut 2D fusion imaging system (Therenva, Rennes, France) in a nonhybrid room with the same Cios Alpha mobile C-arm (Siemens, Munich, Germany). The indirect dose-area product and contrast medium volume were recorded. ResultsBetween March 2018 and April 2020, 255 patients underwent endovascular femoropopliteal revascularization with (n = 124) or without (n = 131) 2D fusion imaging. The volume of injected contrast medium (34.7 ± 13.8 mL vs 51.3 ± 26.7 mL; P < .001) and dose-area product (8.9 ± 9.9 Gy/cm2 vs 13.5 ± 14.0 Gy/cm2; P = .003) were significantly lower for the 2D fusion imaging group than for the control group. A subgroup analysis of complex (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D) lesions showed similar results. Stratification of the fusion imaging group into three subgroups, according to the procedure dates, showed no effect of a potential learning curve on the operative parameters. ConclusionsThe results from the present study showed a significant reduction in the contrast volume and radiation dose for endovascular treatment of PAD when applying 2D fusion imaging technology. Overall, a reduction of >30% was observed for both operative parameters, without excessive training requirements, highlighting the potential benefits of using 2D fusion imaging when performing endovascular revascularization for PAD.

Predictive Factors of Severe Dissection after Balloon Angioplasty for Femoropopliteal Artery Disease

Arterial dissection is one of the mechanisms of balloon angioplasty. Although some degree of dissection is unavoidable, severe dissection that impedes blood flow decreases patency and increases the need for additional procedures. To improve the results of angioplasty, it is necessary to understand the factors related to severe dissection and make efforts to reduce its occurrence. This study aimed to elucidate the predictive and protective factors associated with severe dissection in femoropopliteal balloon angioplasty. This was a retrospective, single-center, nonrandomized study. A total of 409 limbs were studied in 334 patients with symptomatic femoropopliteal lesions treated between 2010 and 2019. Dissections after initial balloon angioplasty were classified according to the Kobayashi dissection classification (grade A: no dissection; B: mild dissection <1/3 of the lumen; C: severe dissection, ≥1/3 of the lumen) into the nonsevere dissection group (grades A and B), and severe dissection group (grade C). We compared clinical, procedural and lesion-related characteristics between the 2 groups. Factors with statistical significance in univariate analyses were entered into a multivariate logistic regression model to identify independent predictive factors of severe dissection. Severe dissection occurred in 237 limbs and nonsevere dissection in 172 limbs. In univariate analyses, the predictive factors of severe dissection were TransAtlantic Inter-Society Consensus II C/D grades (P < 0.001), lesion length ≥15cm (P < 0.001), chronic total occlusion (P=0.004), and degree of stenosis ≥70% (P < 0.001). Protective factors for severe dissection were end-stage renal disease (P=0.008), severe calcification >50% (P < 0.001), and the use of a scoring balloon (P=0.001). In multivariate analysis, factors associated with severe dissection were lesion length ≥15cm (OR, 2.259; 95% CI: 1.417-4-3.601), occlusion or degree of stenosis ≥70% (OR, 1.931; 95% CI: 1.255-2.971), severe calcification (OR, 0.520; 95% CI: 0.338-0.800), and the use of a scoring balloon (OR, 0.467; 95% CI: 0.263-0.830). Lesion length ≥15cm and occlusion or stenosis ≥70% were identified as independent predictive factors of severe dissection in femoropopliteal artery balloon angioplasty. Conversely, severe calcification and the use of a scoring balloon appeared to be protective factors against severe dissection.

Factors Contributing to Efficient Recanalization Procedures for Chronic Total Occlusion of the Superficial Femoral Artery

BackgroundThis study aimed to clarify the factors for efficient procedures (EP) in superficial femoral artery (SFA) chronic total occlusion (CTO). MethodsWe retrospectively analyzed 200 consecutive limbs that underwent treatment for SFA CTO. The patients were divided into three groups according to the main strategies: subintimal angioplasty (SIA) (n = 123), Crosser use (n = 50), and 0.014″ CTO guidewire (CTO-GW) (n = 27). To determine the factors for an EP (EP; contrast volume <130 mL and procedure time <20 min; derived from non-CTO [control] procedures), the variables (P < 0.2) underwent multivariate analysis. ResultsSIA included more Trans-Atlantic Inter-Society Consensus C/D lesions and contralateral femoral approaches, and additional GW use (P < 0.05). CTO-GW presented a shorter occlusion length and elapsed time, and used less retrograde approach than the other strategies (P < 0.05). Crossers had a higher incidence of perforation (P = 0.002). The prompt retrograde approach had a similar actual retrograde procedure time, but a shorter total procedure time, compared to that of the delayed adoption (P < 0.001). EP was achieved in 14 limbs (7.0%). Multivariate analysis revealed that occlusion length (adjusted odds ratio [OR], 0.89; 95% CI, 0.81–0.96; P = 0.004) and SIA (OR, 8.71; 95% CI, 1.32–175.27; P = 0.02) were associated with EP. ConclusionsSIA contributed to EP. The timing of the retrograde approach was crucial because its delay resulted in an excessive procedure time.

Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery

ObjectiveWe assessed the long-term safety and efficacy of endovascular stent grafting to treat long, complex lesions in the superficial femoral artery (SFA). MethodsThe present prospective, multicenter study at 15 Japanese hospitals assessed heparin-bonded stent grafts used to treat long SFA lesions in patients with symptomatic peripheral arterial disease. The inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), an ankle brachial index of ≤0.9, and SFA lesions ≥10 cm long with ≥50% stenosis. The key efficacy and safety outcomes were primary-assisted patency and adverse events through 24 months, respectively. The secondary outcomes included primary patency, secondary patency, freedom from target lesion revascularization (fTLR), and Vascular Quality of Life questionnaire score. ResultsOf the 103 patients (mean age, 74.2 ± 7.0 years; 82.5% male), 100 (97.1%) had intermittent claudication. The average lesion length was 21.8 ± 5.8 cm; 87 lesions (84.5%) were TASC (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) C or D (65.7% chronic total occlusions). Of the 103 patients, 92 and 61 were evaluable through 24 and 60 months, respectively. At 24 months, the Kaplan-Meier–estimated primary-assisted patency, primary patency, and secondary patency rate was 85.7% (95% confidence interval [CI], 76.3%-91.5%), 78.8% (95% CI, 68.8%-85.9%), and 92.0% (95% CI, 82.4%-96.5%), respectively. The mean ankle brachial index was 0.64 ± 0.12 at baseline and 0.94 ± 0.19 at 24 months (P < .0001). At 24 and 60 months, the fTLR was 87.2% (95% CI, 78.9%-92.3%) and 79.1% (95% CI, 67.9%-86.8%), respectively. No device- or procedure-related life- or limb-threatening critical events or acute limb ischemia cases were observed through 5 years. No stent fractures were detected on the annually scheduled follow-up radiographs. The vascular quality of life questionnaire and walking impairment questionnaire scores were significantly increased at 1 through 24 months compared with the baseline scores (P < .0001 for both). One patient had required conversion to open bypass during the 5-year follow-up period. ConclusionsStent grafting of long and complex SFA lesions in patients with claudication is safe and effective through long-term follow-up, with 79.1% fTLR and no leg amputation, acute limb ischemia, or stent fractures through 5 years.

Treatment of Aortoiliac Occlusive Disease With the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique: Results of a UK Multicenter Study

Objective This UK multicenter study aims to report early- and medium-term results following covered endovascular reconstruction of aortic bifurcation (CERAB) for the treatment of aortoiliac occlusive disease (AIOD) in patients with chronic limb threatening ischemia (CLTI) or intermittent claudication (IC). Materials and Methods Retrospective case analysis was performed of patients who underwent CERAB between November 1, 2012 and March 31, 2020 in 6 centers across the United Kingdom. Anatomical data, including degree of plaque calcification, were assessed using preoperative imaging. Outcome measures included mortality, perioperative complications, target lesion reintervention (TLR), and major limb amputation. Primary, assisted primary, and secondary patencies were calculated at set intervals. Results A total of 116 patients underwent CERAB over the study period for the following reasons [48% presenting with CLTI (Rutherford 4–6) and 52% with IC (Rutherford 1–3)]; 82% presented had Trans-Atlantic Inter-Society Consensus (TASC) D AIOD disease. Median age was 65 years (range 42–90 years); 76% of the cohort were male. Severely calcified aortic and iliac lesions were noted in 90% and 80% of patients, respectively. Over a median follow-up of 18 months (range 1–91 months), 2 (1.7%) patients were lost to follow up. In total 5, (4.3%) patients died and 2 (1.7%) had a major amputation. Endovascular TLR was required in 14 (12.1%) patients at last follow up. Surgical TLR was performed in 4 (3.4%) patients at last follow-up. Seven (6%) patients developed an aortic/iliac stent occlusion at last follow-up. The Kaplan-Meier (KM) freedom from TLR at 1 year was 94% and KM 1-year primary patency, assisted primary patency, and secondary patency were 88%, 94%, and 98% respectively. Subanalysis found the following features were associated with need for TLR; TASC D disease (OR = 2.45, 95% CI 1.44 to 3.71), severe aortic calcification (OR = 2.01, 95% CI 1.03 to 2.20), and presence of tissue loss at baseline (OR = 1.43, 95% CI 1.01 to 4.63). Conclusion Perioperative (<30 days) and medium-term morbidity, mortality, and patency rates in this pragmatic cohort of patients with severe AIOD lesions show that CERAB is a valid revascularization option. A direct comparison with surgical treatments for AIOD in a randomized controlled trial is justified.

Distribution of Peripheral Arterial Disease in Patients Undergoing Endovascular Revascularization for Chronic Limb Threatening Ischaemia: Insights from the Vascular Quality Initiative in Singapore.

This study aimed to examine the distribution of lower limb atherosclerotic lesions in a multi-ethnic Asian cohort with chronic limb threatening ischemia (CLTI) from Singapore. The Society for Vascular Surgery Vascular Quality Initiative registry database was used to identify 265 CLTI patients who underwent percutaneous angioplasty between June 2019 and December 2019, of whom 171 (64.5%) were male, and the mean age was 67.9±11.0 years. The majority were diabetic (84.5%) and 145 (54.7%) had chronic kidney disease (CKD). The majority of the lower limb atherosclerotic lesions were de novo lesions (598/797, 75.0%), predominantly TransAtlantic Inter-Society Consensus II C/D (451/797, 56.6%), and were moderately to severely calcified (76.3%). The anterior tibial artery and femoral-popliteal artery were the most commonly affected vessels. The mean length of the treated lesions was 14.5±13.7 cm. There was a tendency, albeit insignificant, of multi-level disease in those who were diabetic or had CKD.

Mid-term outcomes of endovascular treatment and risk factors for recurrence in patients with Trans-Atlantic-Inter-Society II C/D femoropopliteal lesions.

The purpose of this study was to determine the efficacy of interventional endovascular treatment (EVT) and the risk factors for postoperative restenosis in patients with Trans-Atlantic Inter-Society Consensus (TASC) II C/D femoropopliteal lesions. A total of 55 patients who received EVT for TASC II C/D femoropopliteal lesions (64 affected limbs) from October 2014 to September 2017 were examined. The mean lesion length was 19.6±5.3 (range, 15.5-26.4 cm). The femoropopliteal lesions were classified as TASC II C and TASC II D in 39 and 16 cases, respectively. The ankle-brachial index (ABI), primary patency rate, secondary patency rate, and limb salvage rate were monitored in follow-up evaluations for up to 24 months. A Cox regression model was used to evaluate the correlation between each of these factors and the restenosis rate after EVT. Patent TASC II C/D femoropopliteal lesions were present in 59 of the 64 limbs. The mean ABI values for the dorsal pedal artery and posterior tibial artery increased 1 month after treatment from a baseline level of 0.35±0.12 to 0.89±0.10 and from 0.43±0.15 to 0.90±0.13, respectively (P<0.01). The mean follow-up time was 19.3 (range, 6-24) months. The cumulative primary patency rates at 1, 3, 6, 12, 18, and 24 months were 98.3%, 91.5%, 84.3%, 61.1%, 53.1%, and 31.1%, respectively. The secondary patency rates at 12 and 24 months were 70.4% and 60.0%, respectively. Factors with a high hazard ratio included male sex, TASC II D, smoking, and diabetes mellitus (DM). EVT had a safe and satisfactory mid-term therapeutic effect on TASC II C/D femoropopliteal lesions. Male sex, TASC II D (compared to TASC II C), smoking, and DM were risk factors for restenosis. EVT has a secondary patency rate comparable to that of open surgery and can be considered a first-line treatment for TASC II C/D femoropopliteal lesions.

Comparison of the endovascular therapy with drug-coated balloon and bypass surgery for Trans-Atlantic Inter-Society Consensus II C and D femoropopliteal lesions

Comparison of the endovascular therapy with drug-coated balloon and bypass surgery for Trans-Atlantic Inter-Society Consensus II C and D femoropopliteal lesions

The need for objective guidance for treating chronic limb threatening ischemia

The Global Limb Anatomic Staging System (GLASS) was developed to aid with objective assessment of the atherosclerotic occlusive disease burden in limbs with chronic limb threatening ischemia (CLTI).1 GLASS focuses on the anatomic details of the limb as a whole and is a needed update to the older TASC II (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) classification system.2 Liang et al3 present a large retrospective, single-center analysis of patient outcomes after open and endovascular treatment of CLTI when analyzed by GLASS.

COMPARATIVE STUDY BETWEEN TRANSBRACHIAL VS TRANSFEMORAL ANGIOPLASTY OF CHRONIC COMPLETE ILIAC ARTERY OCCLUSION

Background: Critical limb ischemia (CLI) is the most advanced stage of peripheral arterial occlusive disease; the prognosis is poor, with amputation rates up to 30 % and mortality up to 25% after 1 year. Objective: To compare between transbrachial approach and ipsilateral transfemoral approach either ultrasound guided or road map technique in common iliac artery occlusion angioplasty. Patients and Methods: A retrospective study conducted at the Department of Vascular Surgery, Faculty of Medicine, Al-Azhar University Hospitals from January 2019 till October 2020. The 88 patients who are candidates for study were subdivided into to three groups: Group A: Including 31 patients for whom transbrachial iliac angioplasty, Group B: Including 30 patients for whom transfemoral ultrasound guided iliac angioplasty and Group C: Including 27 patients for whom transfemoral road map guided iliac angioplasty. All lesions were categorized according to the Trans-Atlantic Inter-Society Consensus II (TASC) classification. Results: Transbrachial success rate was 90.32% compared with 96.6 in transfemoral access. No statistical difference was found. Patency rate reached 90.3%, 90.0% and 85.2% in transbrachial, transfemoral ultrasound and transfemoral road map guided groups respectively (X2:0.462; P=0.794). Peri-procedural complication rate reached 16.1%, 6.7% and 74.1% in Tran brachial, transfemoral ultrasound and transfemoral road map guided groups, respectively. Complications were statistically higher significantly in transfemoral road map guided group (X2:0.462; P=0.794). Thirty days mortality rate reached 11.1%, 23.8% and 17.4% in Tran brachial, transfemoral ultrasound and transfemoral road map guided groups, respectively. This was not statistically different among the three access groups (X2: 1.362; P=0.506). Amputation rate reached 9.7%, 6.7% and 3.7% in transbrachial, transfemoral ultrasound and transfemoral road map guided groups, respectively. No statistically significant difference was found (X2: 6.207; P=0.145). Conclusion: The technical success of all approaches is high, with higher success rate in transfemoral access. While we found more bleeding complications with transfemoral access.

Long-term results of endovascular reconstruction for aortoiliac occlusive disease.

Open surgery is the gold standard for the treatment of aortoiliac occlusive disease (AIOD). Endovascular therapy has emerged as an attractive alternative for AIOD due to its minimal invasiveness. The aims of the present study were to investigate the long-term patency of endovascular treatment and to compare the outcomes of Transatlantic Inter-Society Consensus II (TASC II) A/B and C/D lesions. Patients with AIOD (n=156) were enrolled in this retrospective cohort study. Patency rates were assessed at 12, 36, and 60 months after the procedure. Parameters for comparisons between TASC II A/B and C/D lesions included primary patency, secondary patency, freedom from target lesion revascularization (TLR), the technical success rate, the rate of complications, and risk factors for in-stent restenosis. For all patients, the technical success rate was 98.7%, the complication rate was 4.5%, and the mean follow-up period was 35.7 months. At 12, 36, and 60 months after the procedure, the primary patency rates were 96.5%, 88.3%, and 80.4%, respectively. The secondary patency rates were 99%, 96.4%, and 88%, respectively. The rates of freedom from TLR were 97.5%, 91.6%, and 89.6%. No significant differences were observed between A/B and C/D lesions in terms of primary patency (P=0.443), secondary patency (P=0.393), or freedom from TLR (P=0.481). Endovascular reconstruction is effective and safe for AIOD, and should be the first-line treatment option for patients with TASC II A-D aortoiliac lesions.

The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population.

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)'s used was 99.6% (1.60 ± 0.79 DCB's/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length.

Management of Extensive Aorto-Iliac Disease: A Systematic Review and Meta-Analysis of 9319 Patients.

Despite advances in endovascular management of aorto-iliac occlusive disease (AIOD) including covered endovascular reconstruction of aortic bifurcation (CERAB) techniques, guidelines for management of symptomatic Trans-Atlantic Inter-Society Consensus (TASC II) type C/D lesions favour open surgical revascularisation. This meta-analysis investigates outcomes in patients with TASC II C/D lesions treated with open bypass procedures (OS), standard endovascular treatments (SEV) or CERAB. Multiple databases (MEDLINE, EMBASE and the Cochrane database) were searched to identify studies reporting endovascular and open treatment of extensive AIOD. Studies were independently assessed. Outcomes reported included 30-day morbidity/mortality and patency rates. A total of 9319 patients undergoing intervention for extensive AIOD were identified from 66 studies. Median patient age was 64years (n = 3204) for SEV, 58years (n = 240) for CERAB and 59years for OS (n = 5875). Pooled meta-analysis for 30-day morbidity in patients undergoing SEV, CERAB and OS was 9, 10 and 15%, respectively. Thirty-day mortality rate was 0.79, 0 and 3% in the SEV, CERAB and OS groups, respectively. In these groups, one-year primary and secondary patency was 90, 88, 96 and 96, 97, and 97% whilst three-year primary and secondary patency was 78, 82, 93 and 93, 97, 97% respectively. Five-year primary and secondary patency was 71 and 89% for SEV and 88 and 95% for OS, respectively. CERAB data were only available to 3years. This meta-analysis shows that thirty-day morbidity and mortality favours endovascular techniques. Primary patency remains better with OS in both early and midterms;; however, secondary patency is comparable in all groups. These findings suggest that SEV/CERAB may be considered as an alternative to OS in higher-risk patients.

Midterm Outcomes on Primary Endovascular Treatment of 395 Aortoiliac Occlusive Disease Patients: A Single-Center Experience.

We report the results of endovascular treatment of Trans-Atlantic Inter-Society Consensus II (TASC) A&B, TASC C, and TASC D aortoiliac lesions in a single vascular center. In this retrospective, observational cohort study, we analyzed 395 patients (mean age 61.2 ± 9.0; 359 men) between January 2015 and December 2017. Technical success was achieved in 96.5%; in-hospital mortality was 1.2% (n = 5). Median follow-up was 36 months (range 24-49 months). After 1 and 5 years, the primary patency rates were 99% and 85% for TASC A&B, 90%, and 78% for TASC C, and 90% and 74% for TASC D. Secondary patency rates were 99% and 90% for TASC A&B, 98% and 65% for TASC C, and 97% and 65% for TASC D. Previous peripheral revascularization (hazard ratio: 1.76, 95% CI: 1.01-3.08, P = .04) was associated with decreased primary patency along with lower age, TASC C, and TASC D class. This analysis reported the acceptable effectiveness and safety of stenting for all types of aortoiliac occlusive disease in a modern setting, with few complications and excellent long-term primary and secondary patency rates.

Society for Vascular Surgery femoral runoff score is associated with limb-based patency after aortofemoral bypass

ObjectiveDespite advancements, aortofemoral bypass (AFB) remains the most durable option for aortoiliac occlusive disease. Although runoff has been shown to be associated with AFB patency, the association of the Society for Vascular Surgery (SVS) thigh runoff scoring system with patency has not been assessed. The aim of the present study was to evaluate the association between the SVS runoff scoring system and limb-based primary patency after AFB. MethodsInstitutional data for patients undergoing AFB with preoperative runoff imaging available from 2000 to 2017 were queried. Runoff scores were assigned according to the presence of occlusive disease in the superficial femoral artery and profunda femoris artery (minimum, 1; maximum, 10) as described by the 1997 SVS reporting standards for lower extremity ischemia. Limb-based patency was the primary endpoint. Kaplan-Meier analysis was used to compare the long-term limb-based patency and freedom from reintervention between limbs with runoff scores ≥6 and those with runoff scores <6. Propensity score-weighted Cox proportional hazards modeling was used to evaluate the association between a runoff score of ≥6 and primary patency loss, controlling for other factors associated with primary patency. ResultsIn 161 patients, 316 limbs had undergone revascularization. The mean patient age was 66.7 ± 11.3 years, and 51.6% were women. Most limbs had undergone revascularization for claudication (56.5%). Most (89.4%) had TransAtlantic InterSociety Consensus class D lesions, 27.3% had required suprarenal or higher clamping, and 11.2% had undergone concomitant mesenteric intervention. A femoral outflow adjunct and concurrent lower extremity bypass was required in 41.8% and 2.9% of limbs, respectively. Those with a runoff score of ≥6 had experienced greater rates of 30-day myocardial infarction (11% vs 1%; P = .005), respiratory failure (11% vs 1%; P = .005), and mortality (8% vs 0%; P ≤ .006). The median follow-up period was 4.0 years (interquartile range, 6.5 years). The 1-, 3-, and 5-year primary patency was 94.6% (95% confidence interval [CI], 91.9%-97.3%), 89.2% (95% CI, 85.4%-93.2%), and 81.4% (95% CI, 76.0%-87.1%), respectively. The 5-year primary-assisted patency, secondary patency, and freedom from reintervention were 84.9% (95% CI, 79.7%-90.5%), 91.7% (95% CI, 87.3%-96.3%), and 83.3% (95% CI, 78.3%-88.7%), respectively. Patients with a runoff score of ≥6 had lower primary (log-rank P < .01), primary-assisted (P < .01), and secondary patency (P = .01). The factors associated with the loss of primary patency included a high runoff score (runoff score of ≥6: hazard ratio [HR], 4.1; 95% CI, 2.1-8.0; P < .01), simultaneous mesenteric endarterectomy (HR, 13.5; 95% CI, 1.9-97.8; P = .01), and chronic kidney disease (HR, 4.6; 95% CI, 1.5-14.6; P = .01). Increasing age (HR, 0.94 per year; 95% CI, 0.91-0.97; P < .01) and hyperlipidemia (HR, 0.44; 95% CI, 0.23-0.85; P = .01) were protective. ConclusionsThe SVS femoral runoff score is an important factor associated with long-term AFB limb patency. Scores of ≥6 portend for worse limb outcomes and a greater incidence of operative complications. The SVS score can be determined from preoperative axial imaging studies and serve as a guide in decision-making and operative planning.

Multiple drug-coated balloons can be used effectively for peripheral arterial disease including long femoropopliteal lesions.

PurposeDrug-coated balloons have shown successful results in treating peripheral arterial occlusive disease. However, using multiple balloons for long femoropopliteal lesions (>15 cm) remains challenging; their safety and efficacy need to be explored. Therefore, we aimed to evaluate the outcomes of multiple drug-coated balloons for long femoropopliteal lesions in terms of the primary patency, freedom from clinically-driven target lesion revascularization, and mortality.MethodsBetween April 2015 and September 2018, 96 patients (117 limbs) who underwent balloon angioplasty using at least 2 drug-coated balloons for femoropopliteal lesions were retrospectively reviewed. Lesions were classified as Trans-Atlantic Inter-Society Consensus (TASC) classification C or D. The outcomes were analyzed using Kaplan-Meyer analysis.ResultsThe mean age of 96 enrolled patients was 70.8 ± 9.8 years, and 83 patients were males (86.5%). Critical limb-threatening ischemia was found in 29 cases (24.8%). The mean lesion and drug-coated balloon lengths per limb were 292.3 ± 77.8 mm and 325.0 ± 70.2 mm, respectively. The technical success rate was 99.2%. A total of 82.1% were followed-up for more than 6 months. The primary patency rates at 12 and 24 months were 71.4% and 41.7%, respectively; freedom from clinically-driven target lesion revascularization rates were 96.4% and 71.0% at 12 and 24 months, respectively. The Kaplan-Meier estimate of the 2-year overall cumulative mortality rate was 20.8%. All identified mortalities appeared to be less associated with paclitaxel.ConclusionDrug-coated balloons can be effectively used without drug-related mortality, even for long lesions, such as TASC classification C or D femoropopliteal lesions.

Korean Multicenter Registry Study of EPIC Stents for the Treatment of Iliac Artery Disease: K-EPIC Registry.

Background and ObjectivesThe EPIC™ stent is a self-expanding, nitinol stent that has been designed to enhance flexibility and provide expansion within vessels. The aim of the present study was to investigate the clinical efficacy and safety of the EPIC™ stent when used to treat iliac artery diseases in a prospective Korean multicenter registry.MethodsA total of 138 patients with iliac artery diseases who received endovascular treatment with EPIC™ stents at 9 Korean sites were enrolled in a prospective cohort and followed for 1 year. The primary endpoint was the 1-year freedom from target lesion revascularization (TLR). The secondary endpoints were 1-year clinical patency and freedom from major adverse events (MAEs).ResultsThe mean age of the study subjects was 66.8±8.5 years and most subjects were male (86.2%). The most frequent lesion type was Trans-Atlantic Inter-Society Consensus B (43.5%) and the majority (56.5%) of the target lesions were located in the common iliac artery. Procedural success was obtained in 99.3% of patients. The freedom from TLR and the clinical patency at 1-year follow-up were 94.9% and 92.3%, respectively. The 1-year rate of MAEs was 5.1%. Combined coronary artery disease (hazard ratio [HR], 5.91; 95% confidence interval [CI], 1.13–30.89; p=0.035) and smaller stent diameter (HR, 0.38; 95% CI, 0.17–0.88; p=0.023) were identified as independent risk factors of TLR after EPIC™ stent implantation.ConclusionsThe EPIC™ stents demonstrated excellent immediate and 1-year efficacy and safety outcomes in iliac artery lesions in this multicenter, prospective, registry-based study.

Endovascular Treatment for Trans-Atlantic Inter-Society Consensus II D Femoropopliteal Arterial Disease in Elderly Patients with Ulcer and Gangrene: A Retrospective Analysis

Objective: The aim of this study was to analyze the middle-term results of endovascular treatment for Trans-Atlantic Inter-Society (TASC) II D femoropopliteal arterial disease in elderly patients with ulcer and gangrene.