OBJECTIVE: Thromboangiitis obliterans (TAO) remains clinical challenging due to its rarity and underwhelming management outcomes. This study aimed to describe a novel TAO rabbit model that demonstrates a closer resemblance to TAO.
METHODS: Thirty-six New Zealand rabbits underwent the surgical implantation of calibrated gelatin sponge particles (CGSPs) into their right femoral artery. The CGSPs were soaked in different solutions to simulate different types of thrombi: normal (NT; normal saline); inflammatory TAO thrombus (TAO; dimethylsulfoxide [DMSO]), and DMSO with methotrexate (MTX). All groups underwent clinical assessment, digital subtraction angiography (DSA) and histopathological analysis at time points day 0 (immediate), week 1 (acute), week 2 (subacute), and week 4 (chronic).
RESULTS: The TAO rabbit presented with signs of ischemia of the right digit at week 4. On DSA, the TAO rabbits exhibited formation of corkscrew collaterals starting week 1. On H&E staining, gradual CGSP degradation was observed along with increased red blood cell aggregation and inflammatory cells migration in week 1. On week 2, disorganization of the tunica media layer and vascular smooth muscle cell (VSMC) proliferation was observed. In the TAO rabbit, migrated VSMCs, inflammatory cells, and extracellular matrix with collagen-like substances gradually occluded the lumen. On week 4, the arterial lumen of the TAO rabbit was filled with relatively-organized VSMC and endothelial cell clusters with less inflammatory cells. Neorevascularization was found in the MTX-treated group.
CONCLUSIONS: The novel TAO rabbit model shows a closer resemblance to human TAO clinically, radiographically, and histopathologically. Histological analysis of the IT progression in the TAO model suggests that it is of VSMC origin.

OBJECTIVE: The Human Acellular Vessel (HAV) is a novel, off-the-shelf biologic conduit being evaluated for arterial reconstructions. Regulatory studies in peripheral arterial disease (PAD) to date have consisted of single-arm cohorts with no comparator groups to contrast performance against established standards. This study aimed to compare outcomes of the HAV with autologous great saphenous vein (GSV) in patients with advanced PAD undergoing infrageniculate bypass.
METHODS: Patients with advanced PAD and no autologous conduit who underwent bypass with the 6-mm diameter HAV (Group 1; n = 34) (March 2021-February 2024) were compared with a multicenter historical cohort who had bypass with single-segment GSV (group 2; n = 88) (January 2017-December 2022). The HAV was used under an Investigational New Drug protocol issued by the Food and Drug Administration (FDA) under the agency\'s Expanded Access Program.
RESULTS: Demographics were comparable between groups (mean age 69 ± 10 years; 71% male). Group 1 had higher rates of tobacco use (37 pack-years vs 28 pack-years; P = .059), coronary artery disease (71% vs 43%; P = .007), and prior coronary artery bypass grafting (38% vs 14%; P = .003). Group 1 had more patients classified as wound, ischemia, and foot infection clinical stage 4 (56% vs 33%; P = .018) and with previous index leg revascularizations (97% vs 53%; P < .001). Both groups had a similar number of patients with chronic limb-threatening ischemia (Rutherford class 4-6) (88% vs 86%; P = .693) and Global Anatomic Staging System stage III (91% vs 96%; P = .346). Group 1 required a composite conduit (two HAV sewn together) in 85% of bypasses. The tibial vessels were the target in 79% of group 1 and 100% of group 2 (P < .001). Group 1 had a lower mean operative time (364 minutes vs 464 minutes; P < .001). At a median of 12 months, major amputation-free survival (73% vs 81%; P = .55) and overall survival (84% vs 88%; P = .20) were comparable. Group 1 had lower rates of primary patency (36% vs 50%; P = .044), primary-assisted patency (45% vs 72%; P = .002), and secondary patency (64% vs 72%; P = .003) compared with group 2.
CONCLUSIONS: Implanted under Food and Drug Administration Expanded Access provisions, the HAV was more likely to be used in redo operations and cases with more advanced limb ischemia than GSV. Despite modest primary patency, the HAV demonstrated resilience in a complex cohort with no autologous conduit options, achieving good secondary patency and providing major amputation-free survival comparable with GSV at 12 months.

UNASSIGNED: The aim of this study was to present the covered endovascular reconstruction of the iliac artery bifurcation (CERIB) technique as a revascularization option for aorto-iliac occlusive disease (AIOD) involving the iliac artery bifurcation.
UNASSIGNED: This was a retrospective single-center study including all patients undergoing a CERIB procedure from January 2021 until December 2022. Covered endovascular reconstruction of the iliac artery bifurcation procedures were performed percutaneously with bilateral femoral access, excepting cases where simultaneous open femoral artery reconstruction was required due to the extension of peripheral arterial occlusive disease. Standard patient, procedural, and follow-up (FU) data including survival and arterial reinterventions were gathered and analyzed.
UNASSIGNED: A total of 13 patients were included (11/13 male, median age=70 [60-76] years). Additional open and/or endovascular procedures included endarterectomy of the femoral bifurcation (n=6), rotational atherectomy (n=2), and 1 axillary artery cutdown for upper limb access (n=1). Median operating time was 2.9 hours (1.5-4.9 hours); median radiation duration and dose were 28.4 (14.3-63.3 minutes) and 4090.6 (384.4-9430.1 cGray/cm2), respectively. The stent grafts used for CERIB were BeGraft peripheral n=31, BeGraft Aortic n=4 and BeGraft peripheral plus n=1 (Bentley InnoMed GmbH, Hechingen, Germany). In 2 patients with prior stenting of the common iliac artery (CIA), only the internal and external iliac arteries (IIA and EIA) were treated in this study, and in 2 cases, additional uncovered stents were required for relining. Technical success was 100%. During a midterm FU (median 18 [4-31] months), 2 patients died from cardiovascular reasons and 1 patient with prior iliac stenting required reinterventions for recurring occlusion.
UNASSIGNED: Covered endovascular reconstruction of the iliac artery bifurcation is a straightforward option for treating AIOD involving the iliac artery bifurcation that allows preservation of internal iliac artery perfusion and shows good early and midterm results. Prior iliac artery stenting may be a risk factor for early occlusion after CERIB.
CONCLUSIONS: Aorto-iliac occlusive disease with involvement of the internal iliac artery is encountered regularly in vascular surgical practice, but the internal iliac artery is often not included in the revascularization strategy. The present article will increase the awareness for the relevance of including the internal iliac artery in revascularization strategies and presents CERIB as another method to be added to the armamentarium of (endo-)vascular surgeons and interventionalists.

OBJECTIVE: To assess the comparative safety and efficacy of covered stents (CS) and bare metal stents (BMS) in the endovascular treatment of aorto-iliac disease in patients with peripheral arterial disease.
METHODS: A systematic review was conducted adhering to the PRISMA 2020 and PRISMA for Individual Participant Data 2015 guidelines.
METHODS: A search of PubMed, Scopus, and Web of Science for articles published by December 2023 was performed. The primary endpoint was primary patency. Certainty of evidence was assessed via the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework.
RESULTS: Eleven studies, comprising 1 896 patients and 2 092 lesions, were included. Of these, nine studies reported on patients\' clinical status, with 35.5% classified as Rutherford 4 - 6. Overall primary patency for CS and BMS at 48 months was 91.2% (95% confidence interval [CI] 84.1 - 99.0%) (GRADE, moderate) and 83.5% (95% CI 70.9 - 98.3%) (GRADE, low). The one stage individual participant data meta-analyses indicated a significant risk reduction for primary patency loss favouring CS (hazard ratio [HR] 0.58, 95% CI 0.35 - 0.95) (GRADE, very low). The 48 month primary patency for CS and BMS when treating TransAtlantic Inter-Society Consensus (TASC) C and D lesions was 92.4% (95% CI 84.7 - 100%) (GRADE, moderate) and 80.8% (95% CI 64.5 - 100%) (GRADE, low), with CS displaying a decreased risk of patency loss (HR 0.39, 95% CI 0.27 - 0.57) (GRADE, moderate). While statistically non-significant differences were identified between CS and BMS regarding technical success, 30 day mortality rate, intra-operative and immediate post-operative procedure related complications, and major amputation, CS displayed a decreased re-intervention risk (risk ratio 0.59, 95% CI 0.40 - 0.87) (GRADE, low).
CONCLUSIONS: This review has illustrated the improved patency of CS compared with BMS in the treatment of TASC C and D lesions. Caution is advised in interpreting overall primary patency outcomes given the substantial inclusion of TASC C and D lesions in the analysis. Ultimately, both stent types have demonstrated comparable safety profiles.

OBJECTIVE: Bone morphogenetic protein-4 (BMP4) has been proved to be an important regulatory factor for the pathological process of atherosclerosis (AS). However, there are few related clinical studies. This study aims to investigate the levels of plasma BMP4 in patients suffering from the arterial occlusive diseases (ACD) characterized by AS, and further to test the relationship between BMP4 and inflammation and vascular injury.
METHODS: A total of 38 ACD patients (the ACD group) and 38 healthy people for the physical examination (the control group) were enrolled. The plasma in each subject from both groups was obtained to test the levels of BMP4, tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), IL-10, and vascular endothelial cadherin (VE-cadherin), and the relationship between BMP4 and the detected indicators above were further analyzed.
RESULTS: Compared with the control group, the patients in the ACD group displayed significant elevations in the neutrophil to lymphocyte ratio [NLR, 1.63 (1.26, 1.91) vs 3.43 (2.16, 6.61)] and platelet to lymphocyte ratio [PLR, 6.37 (5.26, 7.74) vs 15.79 (7.97, 20.53)], while decrease in the lymphocyte to monocyte ratio [LMR, 5.67 (4.41, 7.14) vs 3.43 (2.07, 3.74)] (all P<0.05). Besides, the ACD patients displayed significant elevations in plasma BMP4 [581.26 (389.85, 735.64) pg/mL vs 653.97(510.95, 890.43) pg/mL], TNF-α [254.16 (182.96, 340.70) pg/mL vs 293.29(238.90, 383.44) pg/mL], and VE-cadherin [1.54 (1.08, 2.13) ng/mL vs 1.85 (1.30, 2.54) ng/mL], and decrease in IL-10 [175.89 (118.39, 219.25) pg/mL vs 135.92 (95.80, 178.04) pg/mL] (all P<0.05). While the levels of IL-1β remained statistically comparable between the 2 groups (P=0.09). Furthermore, the plasma BMP4 levels were further revealed to be positively correlated with the levels of IL-1β (r=0.35), TNF-α (r=0.31) and VE-cadherin (r=0.47), while they were negatively correlated with the levels of IL-10 (r=-0.37; all P<0.01).
CONCLUSIONS: After ACD occurrence, the patients\' plasma concentrations of BMP4 would be upregulated, which may serve as a candidate to indicate the levels of inflammation and vascular injury.
目的: 骨形态发生蛋白-4(bone morphogenentic protein-4，BMP4)在动脉粥样硬化(atherosclerosis，AS)的病理过程中具有重要调节作用，但相关的临床研究较少。本研究拟观察以AS为主要病理特点的动脉阻塞性疾病(arterial occlusive disease，ACD)患者血浆BMP4的表达情况，并分析血浆中BMP4与炎症因子和血管损伤标志物之间的相关性。方法: 共招募38名诊断为ACD的患者(ACD组)和38名体检志愿者(对照组)，抽取ACD组患者术前和对照组体检时的静脉血，比较2组血常规指标的差异。采用酶联免疫吸附试验(enzyme linked immunosorbent assay，ELISA)检测血浆中BMP4、肿瘤坏死因子α(tumor necrosis factor-α，TNF-α)、白细胞介素(interleukin，IL)-1β、IL-10及血管内皮钙黏蛋白(vascular endothelial cadherin，VE-cadherin)的表达变化，并进一步分析BMP4与以上各指标之间的相关性。结果: 与对照组相比，ACD组患者血常规结果表现为中性粒细胞-淋巴细胞比值[neutrophil to lymphocyte ratio，NLR；1.63 (1.26，1.91) vs 3.43(2.16，6.61)]和血小板-淋巴细胞比值[platelet to lymphocyte ratio，PLR；6.37(5.26，7.74) vs 15.79(7.97，20.53)]升高、淋巴细胞-单核细胞比值[lymphocyte to monocyte ratio，LMR；5.67(4.41，7.14) vs 3.43(2.07，3.74)]下降(均P<0.05)；ACD组患者血浆BMP4[581.26(389.85，735.64) pg/mL vs 653.97(510.95，890.43) pg/mL]、TNF-α[254.16(182.96，340.70) pg/mL vs 293.29(238.90，383.44) pg/mL]及内皮标志物VE-cadherin[1.54 (1.08，2.13) ng/mL vs 1.85 (1.30，2.54) ng/mL]的水平均显著升高，而抗炎因子IL-10的水平显著下降[175.89 (118.39，219.25) pg/mL vs 135.92(95.80，178.04) pg/mL](均P<0.05)。2组间促炎因子IL-1β的差异无统计学意义[300.39(205.39，403.56) pg/mL vs 378.46 (243.20，448.69) pg/mL；P=0.09]。相关分析结果表明：血浆BMP4水平与促炎因子IL-1β(r=0.35)、TNF-α(r=0.31)以及内皮标志物VE-cadherin(r=0.47)呈正相关，与抗炎因子IL-10呈负相关(r=-0.37；均P<0.01)。结论: ACD患者血浆BMP4的水平升高，且与患者的炎症水平和血管损伤程度具有相关性。.

Since 2013, the Japanese Society for Vascular Surgery has started the project of nationwide registration and tracking database for patients with critical limb ischemia (CLI) who are treated by vascular surgeons. The purpose of this project is to clarify the current status of the medical practice for the patients with CLI to contribute to the improvement of the quality of medical care. This database, called JAPAN Critical Limb Ischemia Database (JCLIMB), is created on the National Clinical Database and collects data of patients\' background, therapeutic measures, early results, and long-term prognosis as long as 5 years after the initial treatment. The limbs managed conservatively are also registered in JCLIMB, together with those treated by surgery and/or endovascular treatment. In 2020, 1299 CLI limbs (male 890 limbs: 69%) were registered by 85 facilities. Arteriosclerosis obliterans has accounted for 99% of the pathogenesis of these limbs. In this manuscript, the background data and the early prognosis of the registered limbs are reported. (This is a translation of Jpn J Vasc Surg 2023; 32: 363-391.).

Lower extremity amputation (LEA), particularly in patients with diabetes or peripheral vascular disease, often results in complications such as surgical site infections (SSIs) and wound dehiscence. This study examined whether utilizing the portable and user-friendly PICO system (Smith and Nephew Medical Ltd, Hull, UK) as incisional negative-pressure wound therapy can reduce post-LEA complications. This study was conducted at a Japanese tertiary medical center and involved a retrospective analysis of LEA cases (n = 32) between January 2021 and December 2022. The PICO dressing group (n = 16) was compared to the conventional dressing group (n = 16) for post-LEA wound management. The primary outcome was the incidence of postoperative wound complications, including SSI and wound dehiscence, within 15 days of LEA. Superficial/deep SSI and wound dehiscence occurred less frequently in the PICO dressing group than in the conventional dressing group (12.5% vs 43.8%; p = .054). There were no cases of deep SSIs in the PICO dressing group. Although this study has limitations owing to its retrospective design and small sample size, the results suggest the potential of the PICO system for improving outcomes in post-LEA wound management.

BACKGROUND: Bypass surgery in severe aorto-iliac calcifications is a complex procedure. Aortic clamping can be highly risky and endovascular approach can be unsuccessful. We report our experience describing three cases of chronic mesenteric ischemia. In all three cases the preoperative computed tomography angiography revealed an ostial occlusion of the celiac trunk and of the superior mesenteric artery (SMA), a coral reef abdominal aorta, and severe calcification of the iliac arteries. An antegrade aorto-mesenteric bypass using a hybrid clampless anastomosis on the supraceliac aorta was performed.
RESULTS: The procedures were performed via laparotomy. We carried out the exposure of the anterior supraceliac aorta limited to the zone without major calcifications; then we performed a side-to-end media-adventitial anastomosis between the supraceliac aorta and a Dacron graft 7 mm without any arteriotomy or clamping. The proximal graft and the aortic anastomosis site were punctured using a 18 G needle. An introducer was then positioned over a wire through the prosthetic graft and pushed into the aorta. Balloon expandable covered stenting to open and stabilize the anastomosis site was performed. Finally, the graft was tunneled to the SMA, and an end-to-side anastomosis was performed. The postoperative courses were uneventful, and the patients were promptly discharged. The follow-up, which in the first case is 4 years, showed the complete patency of the graft in each of the cases treated.
CONCLUSIONS: The hybrid clampless anastomosis appears to be safe and useful in cases of severe aortic calcification.

OBJECTIVE: Patients with secondary RP show a wide range of symptoms depending on the condition of vascular structures. If the symptoms are localized to specific fingers and angiography reveals a discrete segment of occlusion of a proper digital artery, we perform proper digital artery reconstruction with an interposition vein graft. The objective of this study was to evaluate the results of the surgery in patients with chronic hand ischaemia.
METHODS: A retrospective chart review was performed on patients who underwent proper digital artery reconstruction. Each digit that underwent grafting was analysed separately. The results of surgical intervention and recurrence based on patient symptoms were evaluated. Cox proportional hazards regression models were used to identify independent risk factors associated with recurrence, and the Kaplan-Meier method was used to predict the 5-year recurrence-free rate.
RESULTS: A total of 79 digits from 57 patients were included in this study. The majority of patients demonstrated resolution of ischaemic pain and ulceration (97.5% and 95.3%, respectively). Recurrence occurred in 16 (20.3%) patients during the follow-up period. In two cases (2.5%) surgery had no effect. In the multivariate Cox regression analysis, smoking and concomitant periarterial sympathectomy were significant factors associated with recurrence. In the Kaplan-Meier analysis, the 5-year recurrence-free rate in the total study population was 69.3%.
CONCLUSIONS: Digital artery reconstruction using an interposition vein graft is an effective procedure for improving ischaemic pain and ulceration in patients with RP. Smoking and concomitant periarterial sympathectomy were significantly associated with recurrence.

BACKGROUND: The aim of this work is to value cost-effectiveness of complex aortoiliac occlusive disease (AIOD) revascularization, by comparing in-hospital clinical outcomes and detailed costs of hospitalization of open and endovascular techniques.
METHODS: This observational single-center retrospective cohort study included all patients who underwent AIOD revascularization from May 2008 to February 2018 and met inclusion and exclusion criteria. Patients were divided into 2 groups: open surgical repair and endovascular repair. Inclusion criteria were type C and D AIOD, and type of intervention: aorto-bifemoral bypass and covered kissing stenting. Costs were directly compared between the 2 groups, and subsequently a multivariate logistic regression model was performed to define which group most influenced major in-hospital costs. Cox proportional hazard models were used to identify predictors of long-term mortality and primary patency (PP).
RESULTS: The 2 groups included 50 patients each, and all patients had a bilateral iliac axis revascularization. Mean age was 67 ± 9 years and 71% of patients were males. The open surgical repair group had a significantly longer length of hospitalization (P < 0.001) and in-hospital medical complications rate (22%, P = 0.003). No differences were found in the total cumulative cost of hospitalization, including ward, intensive care unit, and operating room. In a multivariate logistic model, higher total hospitalization costs were not significantly associated with either one or the other type of treatment. We did not find any statistically significant differences in overall medium-term survival (P = 0.298) and PP (P = 0.188), which were not influenced by the type of revascularization on Cox proportional hazard models (overall survival: hazard ratio 2.09 confidence interval 95% [0.90-4.84] P = 0.082; PP: hazard ratio 1.82 confidence interval 95% [0.56-6.16] P = 0.302).
CONCLUSIONS: Total in-hospital stay cost analysis did not reveal significant differences between aorto-bifemoral bypasses and covered kissing stentings for AIOD revascularization.