Covered Endovascular Reconstruction of the Iliac Artery Bifurcation (CERIB).

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL IMPACT: 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.

Comparative outcomes of arterial bypass using the human acellular vessel and great saphenous vein in patients with chronic limb ischemia.

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.

Covered Stents Versus Bare Metal Stents in the Treatment of Aorto-iliac Disease: A Systematic Review and Individual Participant Data Meta-analysis.

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. DATA SOURCES: A systematic review was conducted adhering to the PRISMA 2020 and PRISMA for Individual Participant Data 2015 guidelines. REVIEW 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). CONCLUSION: 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.

Smart Anklet Use to Measure Vascular Health Benefits of Preventive Intervention in a Nature-Based Environment-A Pilot Study.

The present study aimed to investigate the associations between nature-based intervention and peripheral pulse characteristics of patients with PAOD using new smart technology specifically designed for this purpose. A longitudinal panel study performed between 1 January 2022 and 31 December 2022 included 32 patients diagnosed with peripheral arterial occlusive disease (PAOD) who were treated in the vascular surgeons' hospital "Dobb" in Valjevo. These patients were exposed for six months to moderate-intensity physical activity (MPA) in a nature-based environment. They practiced 150 to 300 min of walking 6 km/h and cycling activities (16-20 km/h) weekly as recommended for patients with chronic conditions and those living with disability. Univariate logistic regression analysis was used to identify factors associated with major improvements in peripheral pulse characteristics of patients with PAOD. After six months of MPA, half of the patients (50%, 16/32) achieved minor, and half of them major improvements in peripheral pulse characteristics. The major improvements were associated with current smoking (OR = 9.53; 95%CI = 1.85-49.20), diabetes (OR = 4.84; 95%CI = 1.09-21.58) and cardiac failure, and concurrent pulmonary disease and diabetes (OR = 2.03; 95%CI = 1.01-4.11). Our pilot study showed that patients with PAOD along with other chronic conditions and risk factors benefited more from continuous physical activity in a nature-based environment.

Expression pattern of the bone morphogenetic protein-4 and its relationship with inflammation, vascular injury in patients suffered the arterial occlusive diseases. / åŠ¨è„‰é˜»å¡žæ€§ç–¾ç— æ‚£è€ è¡€æµ†éª¨å½¢æ€å‘ç”Ÿè›‹ç™½-4çš„è¡¨è¾¾å˜åŒ–åŠå ¶ä¸Žç‚Žç—‡å’Œè¡€ç®¡æŸä¼¤çš„ç›¸å ³æ€§.

OBJECTIVES: 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-1ß (IL-1ß), 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-1ß 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-1ß (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.

2020 JAPAN Critical Limb Ischemia Database (JCLIMB) Annual Report.

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.).

Hybrid Clampless Anastomosis in Antegrade Aorto-Superior Mesenteric Artery Bypass.

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.

Analysis of endovascular therapy for peripheral arterial disease in all German hospitals.

Background: The quality of vascular care has significantly improved in part by the expansion of endovascular techniques for the treatment of symptomatic peripheral artery disease (PAD) in recent years. In Germany these are primarily provided by the three disciplines of vascular surgery, angiology, and interventional radiology (IR). However, the relative contribute of angiologists to the total number of cases performed is unknown. Patients and methods: In the present study, we analysed the respective contribution of vascular surgery, angiology, and IR to the delivery of endovascular revascularisations in symptomatic PAD in Germany based on the legally mandatory quality reports representative for the reporting year 2018. Results: Vascular surgery is the most common speciality reporting procedures in German hospitals (n=579; 25.1%), followed by IR (n=264; 11.5%), angiology (n=189; 8.2%) and cardiology (n=17; 0.7%). The combination of vascular surgery and IR was reported in 202 (8.8%), vascular surgery and angiology in 167 (7.2%) and angiology and IR in 65 (2.8%) hospitals, and 63 (2.7%) hospitals reported the combination of all three disciplines. Not every department performed catheter interventions. The analysis of procedures per centre revealed that angiology centres provided the highest numbers for both basic procedures and more complex techniques such as atherectomy, rotational thrombectomy, lithoplasty, selective thrombolysis or the use of re-entry devices. In total, angiology centres provided 24.4% of the total procedures or 23.9% of the so-called basic procedures as a surrogate for patient numbers. Conclusions: While each of the disciplines contribute significantly to the endovascular procedures, angiology centres perform more procedures per centre and more complex procedures than the other disciplines highlighting the important quantitative and qualitative contribution of angiology specialists to the care of vascular patients. The inpatient catheter interventional care of patients with PAD is still too rarely carried out in a multi-disciplinary manner in Germany.

Digital artery reconstruction with interposition vein graft: impact on secondary Raynaud's phenomenon.

OBJECTIVE: Patients with secondary Raynaud's phenomenon 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 ischemia. 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 ischemic 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 ischemic pain and ulceration in patients with Raynaud's phenomenon. Smoking and concomitant periarterial sympathectomy were significantly associated with recurrence.

[Topicality of the fundamental and determining importance of chronic critical ischemia of the extremities and its restorative treatment using crural/pedal bypasses in Germany and in Saxony-Anhalt]. / Aktualität der grundlegenden und determinierenden Bedeutung der chronisch-kritischen Extremitätenischämie sowie ihrer sich reetablierenden Behandlung mittels kruraler/pedaler Bypässe in Deutschland und in Sachsen-Anhalt.

INTRODUCTION: Currently, there is an increase in severe stages of peripheral arterial occlusive disease (PAOD) with critical ischemia. This seems to correspond to the general demographic change as well as a consequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic of the last 3 years. The now established and accepted interventional/endovascular approach for severe lower leg PAOD in experienced hands is still considered the first-line treatment but from the authors' perspective crural/pedal venous bypass is experiencing a renaissance. MATERIAL AND METHODS: Compact narrative review of the current state of crural/pedal bypass surgery in Germany and Saxony-Anhalt (SA) combined with selective references from the current scientific medical literature and own clinical experiences. RESULTS: The current statistics of case-related diagnosis-related groups (DRG) data show that, especially with the occurrence of the corona pandemic, a decrease in inpatient case numbers of patients with PAOD stage IIB can be observed nationwide and also in SA. The severe PAOD stages have remained approximately the same in case numbers but increased in SA. The risk stratification based on the wound, ischemia and foot infection (WIFI) classification offers the possibility to be able to make statements about the risk of amputation, benefits and type of revascularization measures. The length of the occlusion, occlusion site of the affected vessels and degree of calcification are taken into account in the global limb anatomic staging system (GLASS) to assess the prognosis. The evaluation of the case-based hospital statistics from 2015 to 2020 showed a constant use of femorocrural/femoropedal bypass surgery in Germany as well as a slight increase in reconstruction using femorocrural bypasses in SA, which seems to correlate with the tendency for an increase in the number of cases of severe PAOD. Parameter-based objectification of the severity of critical limb ischemia should be included in the indications for placement of a crural/pedal bypass. The WIFI classification and GLASS are suitable for this purpose as a relative prognosis of success is also possible. The treatment of critical limb ischemia by crural/pedal bypass surgery continues to find a constant application in Germany and SA.

The value of Wound, Ischemia and foot Infection classification in patients undergoing endovascular therapy.

OBJECTIVE: This study aimed to evaluate the correlation between the Society for Vascular Surgery (SVS) Wound, Ischemia and foot infection (WIfI) classification system and clinical outcomes for 1-year limb amputation-free survival (AFS), freedom from reintervention, and wound healing rate in a cohort of patients affected by chronic limb-threatening ischemia treated exclusively by endovascular procedures. METHODS: We analyzed a prospective, consecutive cohort of 203 patients (203 limbs) who underwent infrainguinal endovascular revascularization at a single center between March 2018 and January 2021. These patients were stratified into clinical stages 1 to 4 based on the SVS WIfI classification and categorized into two groups: WIfI 1 to 3 (n = 101 limbs) and WIfI 4 (n = 102 limbs). The SVS objective performance goals of 1-year limb AFS, freedom from reintervention, and wound healing were compared between the groups and assessed using the Kaplan-Meier method. Angiographic lesion characteristics and angioplasty details were compared. RESULTS: The average age was 72.4 years (44.3% male, 85.2% had hypertension, 80.3% had diabetes, and 87.7% had tissue loss). There were statistical differences between the groups in 1-year limb AFS Kaplan-Meier rate between WIfI clinical stages 1 to 3 group and WIfI clinical stage 4 group (82% vs 66%, respectively; P < .001), but there was no statistical difference in freedom from reintervention and wound healing rates between the groups (70% vs 64% [P = .62] and 74% vs 79% [P = .90], respectively). Owing to angiographic lesion characteristics, femoropopliteal and infrapopliteal segment distributions were similar between the groups, but there was a statistical difference in target lesion location to tibial vessels (55.4% vs 71.6%, respectively; P = .025). CONCLUSIONS: In this cohort of patients with chronic limb-threatening ischemia, SVS WIfI clinical stage 4 had worse results in the 1-year limb AFS rate, but there was no statistical difference in freedom from reintervention and wound healing rates between the groups.

Case planning and execution of inframalleolar bypass for chronic limb-threatening ischemia.

Chronic limb-threatening ischemia is challenging to treat because of the complex patient population, heterogeneity of limb presentations, and complicated arterial pathology. To meet this challenge, vascular surgeons need a broad range of skills to appropriately tailor interventions to each patient's specific needs. One tool in the armamentarium for patients with extensive arterial occlusive disease below the knee is an inframalleolar bypass. However, these procedures require a systematic approach to surgical planning and a high degree of technical competence. We describe our approach to inframalleolar bypass for limb preservation in suitable patients with advanced tibial artery disease.

Common Iliac Artery to Below-Knee Popliteal Artery Bypass via Obturator Foramen in a Third-Time Reoperative Groin for Limb Salvage in Chronic Limb-Threatening Ischemia.

This case report presents the management of a 69-year-old man with an extensive history of peripheral vascular disease including 2 previous failed right femoral to distal bypasses and a left above-the-knee amputation who presented with right lower extremity rest pain and non-healing shin ulcers. A redo bypass was performed for limb salvage via the obturator foramen to avoid his extensively scarred femoral region. The postoperative course was uneventful and the bypass remained patent in the early period. This case demonstrates the usefulness of the obturator bypass to provide revascularization and avoid amputation in a patient with chronic limb-threatening ischemia and multiple failed bypasses.

Adductor canal syndrome after lesser trochanter avulsion fracture in a 19-year-old.

A rare cause of limb ischemia in young patients, adductor canal syndrome, can be debilitating and result in functional impairment. Diagnosis and treatment may be delayed due to this vascular disease's rarity in young people and because the presenting symptoms can overlap with other more common causes of leg pain in young athletes. Here, authors discuss a young athletic patient with a history of year-long claudication. The patient's reported symptoms, exam findings, and imaging results were consistent with a diagnosis of adductor canal syndrome. This case proved uniquely challenging, given the extent of disease and illustrates potential approach considerations.

Lower Limb Ischemia as Acute Onset of Primary Aortic Occlusion: CTA Imaging and Management.

Primary aortic occlusion (PAO) is defined as acute occlusion in the absence of aortic atherosclerosis or aneurysm. PAO is a rare disease with acute onset and can determine massive parenchymal ischemia and distal arterial embolization. The aim of our study was to focus on the assessment of clinical characteristic, CT signs, medical and surgical treatment, complication rates and the overall survival of PAO. MATERIALS AND METHODS: We retrospectively analyzed the data of all patients with acute lower limb ischemia and a final surgical or discharge diagnosis of PAO who underwent aortic CT angiography in ER settings in our hospital from January 2019 to November 2022. RESULTS: A total of 11 patients (8 males/3 females; male/female ratio, 2.66:1, age range 49 to 79 years-old, mean age 65.27 y/o) with acute onset of lower limb impotence or ischemia were diagnosed with PAO. The etiology was thrombosis in all patients. The aortic occlusion was always located in the abdominal aorta and extended bilaterally through the common iliac arteries. The upper limit of the thrombosis was detected in the aortic subrenal tract in 81.8% of the cases, and in the infrarenal tract in 18.2%. A total of 81.8% of the patients were referred to the ER for symptoms related to lower limb: bilateral acute pain, hypothermia and sudden onset of functional impotence. Two patients (18.2%) died before undergoing surgery for multi-organ failure determined by the severe acute ischemia. The other patients (81.8%) underwent surgical treatment that included aortoiliac embolectomy (54.5%), aortoiliac embolectomy + aorto-femoral bypass (18.2%) and aortoiliac embolectomy and right lower limb amputation (9.1%). The overall mortality was 36.4% while the estimated survival at 1 year was 63.6%. CONCLUSIONS: PAO is a rare entity with high morbidity and mortality rates if not recognized and treated promptly. Acute onset of lower limb impotence is the most common clinical presentation of PAO. Aortic CT angiography is the first-choice imaging technique for the early diagnosis of this disease and for the surgical treatment, planning and assessment of any complications. Combined with surgical treatment, anticoagulation is considered the first-line medical therapy at the time of diagnosis, during surgical treatment and after at discharge.

Safety and efficiency of femoral artery access closure using QuikClot Combat Gauze in patients with severe arterial calcification of access sites.

Background: In order to achieve better hemostasis of puncture holes in the femoral artery (FA) after an endovascular procedure, this study evaluated the effect and safety of manual compression (MC) with QuikClot Combat Gauze (QIC) and with mechanical compression (using a C-clamp) of the common access site, the FA, in patients with peripheral arterial occlusive disease (PAOD) combined with anterior femoral artery calcification (AFAC). Methods: We prospectively reviewed 100 patients receiving either MC with QIC or mechanical compression (control group) after endovascular intervention for PAOD plus AFAC from February 2014 to September 2018 in a single unit, which was assessed using computerized tomography angiography (CTA). Results: The mean time to completion of hemostasis was 30±0 minutes in the control group and 18±2.20 minutes in the QIC group (P<0.001). The time to ambulation of the QIC and control groups was 4.38±0.46 and 4.86±0.30 hours (P<0.001), respectively. Eight (16%) patients in the control group had hematoma, as compared with one patient (2%) in the QIC group (P=0.031), while sixteen (32%) patients in the control group had ecchymosis, as compared with four (8%) in the QIC group (P=0.005). Use of QIC and coronary artery disease (CAD) were identified as independent factors correlated with an increased risk of minor complications. Conclusions: QIC facilitated effective and safe hemostasis in patients with PAOD and AFAC.

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

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

2019 JAPAN Critical Limb Ischemia Database (JCLIMB) Annual Report.

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 objective of this project is to elucidate the current status of the medical practice for CLI patients 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 (NCD) 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 with surgery and/or endovascular treatment (EVT). In 2019, 1070 CLI limbs (male: 725 limbs, 68%) were registered by 83 facilities. Arteriosclerosis obliterans (ASO) accounted for 98% of the pathogenesis of these limbs. In this manuscript, the background data and the early prognosis of the registered limbs are reported. Although the registration format for the simultaneous surgery of bilateral limbs in NCD was changed to one patient and two limbs, JCLIMB still counted two patients and two limbs to eliminate discrepancy with the past annual reports. (This is a translation of Jpn J Vasc Surg 2022; 31: 157-185.).

Repetitive application of remote ischemic conditioning (RIC) in patients with peripheral arterial occlusive disease (PAOD) as a non-invasive treatment option: study protocol for a randomised controlled clinical trial.

BACKGROUND: The best medical treatment (BMT) for most patients with early stage of peripheral arterial occlusive disease (PAOD) is often limited to gait training and pharmacological therapy besides endovascular surgery. The application of remote ischemic conditioning (RIC) has been described as a promising experimental strategy for the improvement of therapeutic outcome in cardiovascular disease but has not proven beneficial effects in clinical practice and treatment of PAOD yet. METHODS: Here we describe a prospective, randomized trial for the evaluation of possible effects of repeated application of RIC in patients with PAOD. This monocentric study will enrol 200 participants distributed to an intervention group receiving RIC + BMT and a control group only receiving BMT for four weeks. Patients are at least 18 years of age and have diagnosed PAOD Fontaine stage II b. Pain-free and total walking distance will be measured via treadmill test (primary endpoints). In addition, ankle-brachial index (ABI) and quality of life (QoL) will be assessed using the SF-36 and VascuQoL-6 questionnaire. Moreover, evaluation of markers for atherosclerosis, angiogenic profiling and mononuclear cell characterization will be performed using biochemical assays, proteome profiling arrays and flow cytometry (secondary endpoints). DISCUSSION: Our prospective, randomized monocentric trial is the first of its kind to analyse the effects of chronic and repetitive treatment with RIC in patients with PAOD and might provide important novel information on the molecular mechanisms associated with RIC in PAOD patients. TRIAL REGISTRATION: Prospectively registered in the German Clinical Trials Register (Deutsche Register Klinischer Studien) Registration number: DRKS00025735; Date of registration: 01.07.2021.

Endovascular treatment of femoropopliteal arterial occlusive disease: Current techniques and limitations.

In an aging population with a rising incidence of peripheral artery disease, endovascular therapy is a favorable alternative to open surgical bypass. As a minimally invasive approach, endovascular therapy incurs less physiologic stress and periprocedural complications. Balloon angioplasty and stenting have been the predominant tools in peripheral endovascular therapy. The mechanisms of endovascular therapy have evolved beyond pneumatic dilation and forcing plaque against vessel wall with angioplasty and stenting. Technology has broadened to adjunctive local treatments with pharmaceutical agents coating balloons or eluting from stents, atherectomy to remove intimal and medial plaque, and more recently, intravascular lithotripsy to fracture and modify plaque. These technologies have performed well in curated clinical trials and in the real world for short-segment disease. Despite the excellent outcomes of treatment for short-segment occlusive disease, post-procedural patency of endovascular treatment for long-segment, highly calcified lesions remains challenging in the femoropopliteal region. The development of drug-coated balloons and stents brings the hope of improved patency. However, the results are incrementally better at best and are not superior to surgical bypass. In addition, there is controversy regarding the long-term mortality risk. With numerous devices and techniques as well as differing magnitudes of peripheral artery disease, it will be difficult to practically have a study to answer all questions regarding endovascular treatment of the femoropopliteal artery. This review examines current endovascular techniques for de novo and recurrent femoropopliteal arterial occlusive disease, as well as the applicability of intravascular ultrasound and optimal stenting strategies for long-segment disease.