Primary Patency Rates Research Articles

Pivotal Evaluation of Novel Dedicated Venous Stent for Iliofemoral Venous Obstruction: A Prospective Cohort Study.

The purpose was to evaluate the clinical outcomes of a dedicated venous stent with the tripartite composite segments for the treatment of iliofemoral venous obstruction (IVO) in a mixed cohort of nonthrombotic iliac vein lesion (NIVL) and post-thrombotic syndrome (PTS) over a period of 12 months. The Grency Trial is a prospective, multicenter, single-arm, open-label, pivotal study, which was conducted at 18 large tertiary hospitals in China from August 2019 to October 2020. A total of 133 hospitalized patients were screened and 110 patients with clinical, etiology, anatomical, and pathophysiology clinical class (CEAP) clinical grade C>3 and iliac vein stenosis >50% or occlusion, including 72 patients with NIVL and 38 patients with PTS, were implanted with Grency venous stents. Primary endpoint was stent patency at 12 months follow-up, and secondary outcomes were technical success; improvement in venous clinical severity score (VCSS) at 3, 6, and 12 month follow-up; and rates of clinical adverse events. Among 110 patients who were implanted with Grency venous stents, 107 patients completed the 12 month follow-up. All 129 stents were successfully implanted in 110 limbs. Twelve-month primary patency rate was 94.39% [95% confidence interval [CI]=88.19%-97.91%] overall, and 100% [94.94%-100%] and 83.33% [67.19%-93.63%] in the NIVL and PTS subgroups, respectively. Venous clinical severity score after iliac vein stenting improved significantly up to 12 months follow-up. There were 3 early major adverse events (1 intracerebral hemorrhage and 2 stent thrombosis events related to anticoagulation therapy), and 7 late major adverse events (1 cardiovascular death, 1 intracranial hemorrhage with uncontrolled hypertension, and 5 in-stent restenosis cases without stent fractures or migration). The Grency venous stent system appeared excellent preliminary safe and effective for IVO treatment. Further large-scale studies with longer-term follow-up are needed to evaluate long-term patency and durability of stent. The design of venous stents for iliofemoral venous obstruction (IVO) must address engineering challenges distinct from those encountered in arterial stenting. The Grency venous stent, a nitinol self-expanding stent specifically tailored for IVO, features a composite structure designed to meet the stent requirements of various iliac vein segments. The Grency Trial is a prospective, multicenter, single-arm, open-label pivotal study aimed at evaluating the efficacy and safety of the Grency stent system. Following a 12-month follow-up period, the Grency venous stent system has demonstrated both safety and efficacy in treating iliofemoral venous outflow obstruction.

Navigating complexity: The Supera's triumph in femoropopliteal lesions.

The femoropopliteal sector endovascular treatment is particularly challenging due to its high tortuosity and torsional forces. Better results are still needed to ensure the long-term patency of stenting in this area. The Supera stent appears to change this paradigm. This single-center retrospective cohort study aims to evaluate the efficacy and safety of femoropopliteal stenting with Supera in a real-world population. Seventy-nine patients were treated between January 2015 and December 2020, and the results are reported with a median follow-up of 28 months. Indications for revascularization were chronic limb-threatening ischemia with tissue loss (73.6%) or ischemic rest pain (17.7%) and claudication (7.6%). Thirty-six patients (45.6%) were classified as GLASS stage III according to the Global Limb Anatomic Staging System, with 65.8% and 30.4% in grades 3 and 4 of femoropopliteal and infrapopliteal sectors, respectively. The 36-month primary, primary-assisted, and secondary patency rates were 68.6%, 72.0%, and 79.0%, respectively, with an amputation-free survival rate of 86.6%. There was no significant difference between primary patency rates in GLASS stages I-II compared with GLASS stage III (36-month primary patency rates of 72% vs 63% respectively, p = 0.342) nor in amputation-free survival (88% vs 84%, p = 0.877). After adjusting for potential confounders, only the stent conformation significantly affected the primary patency rates, with a higher hazard of reintervention for the elongated (HR = 3.179; p = 0.36; CI 1.081-9.347) and the compressed (HR = 3.014; p = 0.42; CI 1.039-8.746) forms. The 36-month patency of the Supera stents in our real-world cohort was similar to other reported series. The GLASS stage did not interfere with the stent patency, proving it is a good choice even in the most adverse anatomy patients. Only the non-nominal stent conformation affected the primary patency rates in our patients.

A Systematic Review and Meta-Analysis of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Below-The-Knee Femoral Bypass Surgery

Heparin-bonded expanded polytetrafluoroethylene (hb-ePTFE) synthetic grafts are an alternative to autologous vein grafts for surgical bypass interventions in lower limb peripheral arterial disease. However, the clinical benefits of hb-ePTFE grafts have not been reviewed systematically for patients undergoing below-knee surgical bypass. This study aimed to meta-analyze available data on the utility of hb-ePTFE in patients undergoing below-knee surgical bypass. Medline, Embase, and Cochrane databases were searched, restricted to material in English with no date restriction. In addition, proceedings from relevant congresses were screened going back two years. The search was performed in December 2021. Eligible studies included prospective or retrospective comparative studies or prospective single-arm cohorts with an hb-ePTFE arm. Methodological quality was assessed with the ROBINS-I criteria. Outcomes included primary patency, amputation/limb salvage and overall survival. Clinical outcomes were expressed as event rates. Studies were compared using meta-analysis to generate a standardized mean event rate for each outcome, with its 95% confidence interval (95%CI), using a random effects model. Following de-duplication 10,263 records were identified, 261 were assessed at full text. No prospective comparative studies were identified. The level of evidence was uniformly low. Seventeen publications describing data from nine individual patient cohorts met the inclusion criteria. These cohorts included a total of 1,452 patients undergoing below-the-knee surgical bypass with hb-ePTFE. The primary patency rate was 78.9% [95% CI: 72.2 - 85.7%] at one year, 68.2% [95% CI: 62.8 - 73.6%] at two years, decreasing to 48.0% [95%CI: 27.3% - 68.7%] at five years. The secondary patency rate was 84.8% [95% CI: 77.0% - 92.5%] at one year and 68.9% [95% CI: 43.0% - 94.9%] at three years; the one-year limb salvage rate was 88.3% [95% CI: 79.6% - 97.1%] at one year and 79.0% [95% CI: 56.7% - 100%] at three years. In patients undergoing below-knee bypass surgery, hb-ePTFE synthetic grafts, compared to uncoated grafts, perform well for patency and limb salvage. However, the quality of the evidence is low and well-performed randomized clinical trials are needed to inform clinical decision making on the choice of synthetic graft.

Popliteal-to-distal extreme bypass in endovascular era

ObjectivesChronic limb-threatening ischemia (CLTI) is characterized by rest pain and tissue loss, with an annual mortality rate of 20% and amputation rate of 40%, if not treated. Open bypass surgery is recommended in CLTI, depending on the availability of good quality venous material, outflow artery patency and surgical expertise. Aim of the study is to analyze primary patency, limb salvage and survival rate in patient undergoing popliteal-to-distal bypass. MethodsAll consecutive patients who underwent popliteal-to-distal bypass surgery between January 2016 and December 2021 were enrolled in the study. Primary outcomes were primary patency, limb salvage and overall survival. Secondary outcomes included amputation-free survival and secondary patency. ResultsForty-nine patients were included during the study. Technical success was achieved in 100% of cases. Target outflow artery was in 27% (n. 13) of cases the anterior tibial artery in 27% (n. 13) dorsalis pedis, in 2% (n. 1) the peroneal artery, in 30% (n. 15) the retro-malleolar tibial artery, in 10% (n. 5) the medial plantar artery, in 4% (n. 2) the tarsal artery. Two-year primary patency was 85%±5. Secondary patency rates was 86%±3 at two years. The overall survival was 81% ±6 at 2 years, the amputation free survival was 70% ±9, and the limb salvage rate was 81% ±6. ConclusionPopliteal-to-distal bypass require high technical expertise to be performed. When a good autologous vein and adequate outflow artery are present, they can be feasible with good patency rates, and overall survival.

Rejoining veins for forced maturation of small-caliber arteriovenous fistula

ObjectivesTo evaluate the efficacy of rejoining mainstream and accessory veins for forced maturation of autogenous arteriovenous fistula (AVF) MethodsTwenty-three patients who underwent forced maturation through vein rejoining between January 2018 and September 2022 were included. In cases where AVF maturation failure due to the presence of accessory veins, rejoining was primarily considered when distinguishing the main branch becomes challenging. This difficulty typically occurs when the sizes of the two vessels are nearly equal and the combined diameters of these veins exceed 6 mm. ResultsThe mean age and follow-up duration were 57.39 ± 16.22 years and 965.65 ± 573.42 days, respectively. Rejoining of both arterial and venous cannulation sites was performed in 11 patients (47.8%), and rejoining of only the venous cannulation site or only the arterial cannulation site was performed in 11 patients (47.8%) and one patient (4.3%), respectively. The mean vein size was 0.35 ± 0.06 cm before rejoining and 0.69 ± 0.07 cm after surgery, indicating a significant increase in size (p < 0.01), whereas flow did not change significantly following rejoining surgery. Maturation and cannulation success was 100%. The 1-year primary patency rate after surgery was 82.0%. During the follow-up period, 34.8% of the patients required additional percutaneous transluminal angioplasty to maintain patency, and two patients (11.8%) had stenosis in the rejoined section. ConclusionsRejoining surgery is an effective method for achieving AVF maturation in patients with accessory veins when identification of the mainstream vein is difficult, and this method may be considered when achieving maturation by sacrificing one vein is expected to be challenging.

Acute and Mid-Term Results of Atherectomy in Femoropopliteal Lesions.

The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty. To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries. A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years. Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs. In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results. German Clinical Trials Register: DRKS00031245. The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.

Risk factors for repeated percutaneous transluminal angioplasty of hemodialysis vascular access after initial intervention.

Percutaneous transluminal angioplasty (PTA) is a significant intervention to deal with occlusion and stenosis of vascular access. The study aimed to explore the risk factors of repeated PTA (re-PTA) after the initial intervention in patients undergoing hemodialysis. This retrospective study included 180 patients who underwent successful PTA for the first time between March 2016 and December 2020. Information on demographic, clinical, anatomical, and medication variables was collected. Survival curves were plotted using Kaplan-Meier analysis and the risk factors associated with re-PTA were analyzed using univariate and multivariate Cox proportional hazards analyses. The primary clinical patency rates at 6, 12, and 24months after PTA were found to be 85.2%, 70.7%, and 58.6%, respectively. The univariate Cox proportion hazards analysis revealed the association of non-antiplatelet agents (HR 2.368 95% CI 1.351 to 4.150, p = .003) and arteriovenous graft (AVG) (HR 2.096 95% CI 1.147 to 3.831, p = .016) with re-PTA. However, only non-antiplatelet therapy showed statistical significance (HR 2.368 95% CI 1.351 to 4.150, p = .003) in multivariate Cox proportional hazards analysis. Among the patients undergoing hemodialysis, the use of antiplatelet agents was associated with a lower risk of re-PTA. Therefore, the use of antiplatelet drugs may reduce the rates of re-PTA and help in maintaining the patency of vascular access.

Combination of BeGraft and Solaris Stent Grafts for the Covered Endovascular Reconstruction of Aortic Bifurcation-BS-CERAB Technique.

Background: This study examines the impact of the use of the combination of BeGraft and Solaris stent grafts on the outcomes during the covered endovascular reconstruction of aortic bifurcation (BS-CERAB) technique and extension to the iliac arteries. Methods: Consecutive patients with aortoiliac occlusive disease who underwent endovascular treatment using BS-CERAB between January 2020 and December 2023 were included. Patient demographics, symptoms, lesion characteristics, and procedural and follow-up details were collected and analyzed. Perioperative complications and reinterventions were also identified. Results: A total of 42 patients met the inclusion criteria (32 men, 76.2%, median age 72 years, range 59-85). Indications for treatment were intermittent claudication (42.9%) and critical limb ischemia (57.1%). Procedure success was achieved in all cases. The median patient follow-up time was 14 months (1-36). One patient died at a 10-month follow-up due to lung cancer. The mean pre-operative ABI increased from 0.37 ± 0.19 before intervention to 0.71 ± 1.23 post-operatively at 12 months (p = 0.037). The estimated primary patency rates at 3, 6, and 12 months were 90.5%, 85.7%, and 81.0% and primary assisted patency rates were 90.5%, 90.5%, and 85.7%, respectively. Secondary patency was 95.2% at 3 and 6 months and 90.5% at a 12-month follow-up. Active cancer (p = 0.023, OR 2.12 95%CI 1.14-3.25) was a risk factor for restenosis. Conclusions: This mid-term experience shows that the CERAB technique using the combination of BeGraft and Solaris stents grafts, for the endovascular treatment of severe aortoiliac atherosclerotic disease, may allow an effective reconstruction of the aortic bifurcation and iliac arteries related to high-patency and lower-reintervention rates.

The TOPOS study.

Background: We aimed to study the long-term safety and efficacy of oblique venous stents for post-thrombotic syndrome (PTS) with iliac vein compression. Patients and methods: In the multinational, prospective, single-arm TOPOS study, PTS patients scheduled for endovascular therapy with the sinus-Obliquus® stent and optional distal extension with the sinus-Venous® or sinus-XL Flex® stent were enrolled at eight European vascular centres between October 2016 and December 2020. The primary outcome was primary stent patency at 24 months, and secondary outcomes included the clinical course of PTS (Villalta score, revised Venous Clinical Severity Score [rVCSS], Visual Analog Scale [VAS] of pain), quality of life changes (Chronic Venous Insufficiency Quality of Life Questionnaire, CIVIQ-20), and device-related complications. Results: We enrolled 60 patients (mean age 46±15 years, 68% women, 13% active ulcers): 80% required stent extension (70% below the inguinal ligament). The primary patency rate at 24 months was 80.7% (95%CI 68.1-90.0%); it was higher in patients without vs. those with stent extension (90.9% vs. 78.3%, p=.01). Compared to baseline, the Villalta, rVCSS, pain VAS, and CIVIQ-20 decreased by a median of 8 (interquartile range (IQR): 4-11), 5 (IQR: 3-7), 3 (IQR: 2-5), and 17 (IQR: 6-22) points, respectively; p<.001 for all parameters. Overall, 9 events of acute stent occlusion, 4 symptomatic stent stenosis, and 1 pulmonary embolism occurred. We did not observe major bleeding events or contralateral thrombosis. Conclusions: Endovascular treatment with the oblique stent and optional stent extension was safe and resulted in high patency rates at 24 months. The reduction in PTS severity was substantial and persisted over 2-year follow-up.

Pull-through technique through antegrade radial artery puncture without sheath insertion in balloon-assisted radiocephalic arteriovenous fistulas maturation

PurposeThe aim of this study was to investigate the effectiveness and safety of the pull-through technique through antegrade radial artery puncture without sheath insertion in balloon-assisted radiocephalic AVF maturation.MethodsWe retrospective studied a total of 62 patients with immature radiocephalic AVF, who received balloon-assisted maturation in our hospital. 15 patients received pull-through technique through radial artery without sheath insertion and 47 patients received treatment through a regular venous approach.ResultsThe success rate of pull-through technique group and control group was 86.7% (13 out of 15), 89.1% (41 out of 46) respectively. There was no significant difference between two groups (P > 0.05). In our study, there were 2 patients in the pull-through technique group and 3 patients in the control group, which had hematoma in the vein puncture site (P = 0.59). There were also no differences in the primary patency rate between two groups at 6 months and 12 months (76.9% vs 70.7%, 38.4% vs 41.5%, respectively, P > 0.05).ConclusionThe pull-through technique through antegrade radial artery without sheath insertion in promoting radiocephalic AVF maturation is effective and safe.

Outcomes of Excimer Laser Ablation Combined with Drug-coated Balloon in Atherosclerotic Lesions of the Popliteal Artery

BackgroundThe treatment of atherosclerotic lesions in the popliteal artery is challenging. This study aims to investigate the efficacy and safety of excimer laser ablation (ELA) combined with drug-coated balloon (DCB) for these lesions. MethodsFrom June 2019 to December 2021, data of patients who underwent ELA combined with DCB in the popliteal artery were retrospectively reviewed. Demographics, lesion characteristics, periprocedural complications and follow-up information were analyzed. The primary endpoint was primary patency. Secondary endpoints included major amputation-free survival (MAFS) rate, technical success, bailout stenting, clinically-driven target lesion reintervention (CD-TLR), improvement of ankle-brachial index (ABI) and Rutherford class. ResultsA total of 61 patients were enrolled. The mean age was 73.4 ± 11.7 years. 20 (32.8%) patients had stenotic lesions while 41 (67.2%) patients had chronic total occlusions (CTOs). The mean length of these lesion was 7.3 ± 2.8 cm. Procedure technical success rate was 95.1%. Bailout stent was performed in 3 (4.9%) patients. Intraprocedural distal embolization occurred in 3 (4.9%) patients, while flow limiting dissections occurred in 3 (4.9%) patients. The mean ABI was significantly improved from 0.45 ± 0.13 at baseline to 0.90 ± 0.12 after ELA, 0.88 ± 0.11 at 6 months and 0.85 ± 0.12 at 12 months. during the follow-up period. The median follow-up time was 28.2 ± 6.1 months. Reintervention was performed in 5 (8.2%) patients. The 2-year primary patency was 83.5%. ConclusionELA combined with DCB is a safe and effective strategy in the treatment of popliteal artery atherosclerotic lesions with low rates of bail-out stenting and high primary patency.

Endovascular Treatment as an Alternative to Bypass Surgery for Juxtarenal Aortic Occlusion: Results from the CHAOS (CHronic Abdominal Aortic Occlusion, ASian Multicenter) Registry

Juxtarenal aortic occlusion (JRAO), in which the occlusion of the aorta extends to just below the renal artery, is often treated by bypass surgery because of concerns about the risk of procedural failure and fatal embolization to abdominal organs when treated with endovascular treatment (EVT). This study assessed the outcome of EVT for JRAO compared with aorto-biiliac /aorto-bifemoral (AOB) or axillo-bifemoral (AXB) bypass. A retrospective review of an international database created by 30 centers in Asia (CHronic Abdominal Aortic Occlusion, ASian Multicenter registry) was performed for patients who underwent revascularization for chronic total occlusion of the infrarenal aorta from 2007 to 2017. Of the 436 patients, 130 with JRAO (Forty-seven AOBs, 32 AXBs, and 51 EVTs) from 25 institutions were included in this study. Patients were significantly older in the AXB and EVT groups and more malnourished in the EVT group than the AOB group. EVT was attempted but failed in 1 patient. Seven patients (1 [2.1%] in the AOB group, 1 [3.1%] in the AXB group, and 5 [9.8%] in the EVT group) died during hospitalization, but most of the causes in the EVT group were not related to the revascularization procedure. No visceral embolism was observed, which had been concerned, even though protection was performed only in 2 cases of the EVT group. At the latest follow-up (median duration 3.0years), the ankle-brachial pressure index was significantly higher in the order of AOB, EVT, and AXB. At 4years, the estimated primary and secondary patency rates of the AOB group (87.5% and 90.3%, respectively) were significantly higher than the AXB group (66.7% and 68.6%, respectively). AOB remains the gold standard and should be the first choice for acceptable risk patients. For frail patients, EVT is a good option and likely preferable as a first-line treatment compared to AXB.

Early outcomes of fenestrated and/or branched endovascular repair of complex aortic aneurysms (F/B-EVAR); A single-center experience

Background: Open surgical repair of juxta-, para- and thoracoabdominal aortic aneurysms (TAAA) has been the gold-standard for patients fit for surgery. However, endovascular repair of complex aortic aneurysms using devices implementing directional branches or fenestrations for incorporation of reno-visceral target vessels (TV) has gained widespread attention, due to its lower mortality and complication rate and its more attractive profile for high-risk patients. Nonetheless, complex endovascular technologies require meticulous abidance to protocols for successful application. Methods: A retrospective analysis of prospectively collected data from a single, tertiary center was undertaken, including all patients undergoing complex aortic endovascular repair with fenestrated (F-EVAR) of branched devices (B-EVAR) from a 5-year time period (2018-2023). Primary outcomes included 30-day mortality, while secondary outcomes included primary TV patency, acute kidney injury (AKI), spinal cord ischemia (SCI), myocardial infarction (MI) and stroke rates. Results: Of 74 patients (mean age: 69 ± 5.6 years-old, 98% males), 31 (42.6) and 43 (57.6%) were treated by F-EVAR and B-EVAR, respectively.  Mean aneurysm diameter was 68 ± 1.8cm, with 15 (20.5%) juxtarenal AAA, 27 (35.6%) pararenal AAA, 16 (21.9%) type IV TAAA, 6 (8.2%) type III TAAA, and 10 (13.7%) type II TAAA treated.  Sixteen (21.6%) patients were treated due to failed-EVAR. In total, 272 TV were successfully revascularized. Thirty-day mortality was 8.1%. Primary TV patency rate was 99.2% (270/272). Endoleak rate was 8.1% (6/74). No cases of AKI or MI were observed. One (1.3%) case of hemorrhagic stroke was observed. Three cases (4%) of SCI were observed, including one temporary paraparesis and two permanent paraplegia cases. Reintervention rate was 5.4%, including two cases of renal artery stent thrombosis revascularization procedures. Conclusions: Endovascular repair of complex aortic aneurysms is feasible, with good perioperative outcomes. Adherence to precise protocols covering every technical aspect of patient care is warranted for satisfactory outcomes.

Short-term patency of iliofemoral to tibial bypass with vascular allografts in a minority population: A retrospective analysis of a single center acute care facility.

The aim of this study was to examine the short-term patency rates and associated factors of open lower limb, iliofemoral to tibial bypass using cryopreserved saphenous vein (CSV) in a minority population at an acute care hospital in New York City. A retrospective analysis of patients undergoing infra-inguinal bypass from iliofemoral vessels to tibial arteries with CSV between March 2020-April 2022 at an acute care facility (Harlem Hospital Center, Harlem, New York) was performed. Data including patient demographics, comorbidities, type of operation, follow-up surveillance, and salvage procedures were collected. Results were presented in patency line graphs and a life table. Target limb revascularization (TLR) and amputation free survival (AFS) were also calculated. Eleven bypass procedures were included in the analysis. Patients were followed for a mean of 10.8months. Cumulative primary patency rates at 1, 6, and 12months were 72.7%, 54.5%, and 40.9%, respectively. TLR was 36.4% and the AFS was 66.67% at the mean 10.8-month follow-up. The patency rates of minority patients undergoing bypass with CSV were analyzed with creation of a life table and calculation of patency rates, TLR and AFS. The short-term primary patency rates and post-operative outcomes were found to be comparable to larger studies in non-minority cohorts. These results suggest that larger studies as well as prospective analyses and randomized controlled trials in this patient cohort and demographic are needed, as well as optimal selection of patients to determine true clinical implications.

Application of Freehand 3D Ultrasound Guidance in Percutaneous Transluminal Angioplasty for Autogenous Arteriovenous Fistula Stenosis

Objective: Using freehand three dimensional (3D) ultrasound imaging to evaluate arteriovenous fistula stenosis. Comparing the value of freehand 3D ultrasound and Doppler ultrasound in the application of percutaneous transluminal angioplasty (PTA) treatment for stenosis of an arteriovenous fistula. Methods: A retrospective analysis was conducted on 34 patients with arteriovenous fistula (AVF) stenosis who were treated at the 903RD Hospital of PLA and the Kidney Center of Zhejiang Provincial People's Hospital from August 2021 to August 2022. Based on the different types of surgical assistance, the patients were divided into two groups: the Doppler ultrasound group (Group A, n = 17) and the freehand 3D ultrasound imaging group (Group B, n = 17). Freehand 3D ultrasound and Doppler ultrasound were used to assess the narrowing of arteriovenous fistulas, and images and relevant data were collected before and after the PTA procedure. The differences in the time of puncture and sheath placement, guidewire insertion time, the duration of the procedure, complications, and methods to measure stenosis were compared between the two groups of patients, as well as the technical success rate, the initial patency rate, and the primary patency rates at 1, 3, 6 and 9 months post-surgery. This study discusses the clinical efficacy of using these two types of ultrasound to assist in the PTA treatment of arteriovenous fistula stenosis. Results: The differences in baseline demographics between the conventional ultrasound group (Group A) and the 3D ultrasound group (Group B) were not statistically significant (p &gt; 0.05). The intraoperative guidewire insertion time (4.647 ± 1.347 min vs. 2.824 ± 0.326 min) and the operating times (75.941 ± 7.557 min vs. 59.824 ± 8.175 min) between the two groups were statistically significant (t = 2.788, 3.069, p &lt; 0.01). The technical success rates for the two groups were 94.1% vs. 100%, not statistically significant (t = 1.03, p = 0.31). The first-time patency rates were 88.2% vs. 94.1%, with no statistically significant difference (t = 0.366, p = 0.545). No complications occurred in Group A, while one case of hematoma occurred postoperatively in Group B, with an incidence of 5.9% (1/17), which was not statistically significant (t = 1.03, p &gt; 0.05). Comparing the primary patency rates at 1, 3, 6 and 9 months post-surgery between Groups A and B, there were no statistically significant differences (p &gt; 0.05). However, the patency rates at different time points for Group B were consistently higher than Group A (94.1%, 82.4%, 82.4%, 82.4% vs. 88.2%, 82.4%, 76.5%, 76.5%). Conclusion: Freehand 3D ultrasound imaging can provide more intuitive, high-resolution, and high-definition three-dimensional images, clearly defining the lesion site and vascular structures. Its accuracy in assessing complications of arteriovenous fistulas is similar to that with conventional ultrasound. When used as an adjunct to PTA treatment, its efficacy is equivalent. It can significantly reduce guidewire insertion time and operation time, decrease postoperative recovery time, and alleviate the patients' concerns regarding surgical risks. It can be considered a new method for diagnosing, treating, and patients with AVF stenosis.

COMPARATIVE OUTCOMES OF AORTOBIFEMORAL BYPASS WITH OR WITHOUT PREVIOUS ENDOVASCULAR KISSING STENTING OF THE AORTOILIAC BIFURCATION

The aim of this multicenter national study was to compare the outcomes of primary open surgery (OS) by aortobifemoral bypass (ABFB) with those performed after a failed endovascular treatment (EVT) by Kissing Stent (KS) technique for complex aortoiliac occlusive disease (AIOD) lesions (TASC II C and D). All consecutive ABFB cases carried out at twelve vascular surgery centers between 2016 and 2021 were retrospectively collected and analyzed. Data included patients' baseline demographics and clinical characteristics, procedural details, peri-operative outcomes, and follow-up results (survival, patency, amputation). The study cohort was divided in two groups based on indications for ABFB: primary treatment vs secondary treatment after EVT failure. Overall, 329 patients underwent ABFB during the study period (71% males, mean age 64 years), of which 285 as primary treatment and 44 after prior EVT. At baseline, no significant differences were found between study groups in demographics and clinical characteristics. TASC C and D lesions were similarly represented in the study groups (TASC C: 22% vs 78%; TASC D: 16% vs 84%). No major differences were found between study groups in terms of procedural details, early mortality, and peri-operative complications. At five years, primary patency rates were significantly higher for primary ABFB (88%, CI 93.2%-84%) as compared to ABFB after prior EVT (69%, CI 84.9%-55%, log rank p value <.001); however, the five-year rates of secondary patency (100% vs 95% CI 100%-86%) and limb salvage (97%, CI 99%-96 vs 97%, CI 100%-94%) were similar between study groups. Surgical treatment of TASC C/D AIOD with ABFB seems to be equally safe and effective when performed after prior EVT, although primary ABFB seemed to have higher primary patency rates. Despite the need for more frequent reinterventions, secondary patency and limb salvage rates were similar. However, future large prospective trials are required to confirm these findings.

Thoracoabdominal aneurysm repair using the Unitary Manifold Device

To present a single-center prospective study of 126 consecutively treated patients who underwent endovascular repair of thoracoabdominal aortic aneurysm (TAAA) with the physician-modified, non-anatomically based Unitary Manifold (UM) device. Data was collected from 126 consecutive all-comer patients treated with the physician-modified, non-anatomically based UM from 2015 to 2023. Treatment was performed at a single center by a single physician under a Physician Sponsored Investigation Exemption (PSIDE) G140207. The UM was indicated for repair of all Crawford extents including juxtarenal, pararenal, and short-neck infrarenal aneurysms (<10 mm) in 126 consecutive patients. Patients were not excluded from the study based on presentation, extent of aneurysm or dissection, or history of spinal cord event. TAAA patients were categorized by Crawford classification: Type I and V (3.3%, n = 4), Type II (3.3%, n = 4), Type III (1%, n = 1), and Type IV (93.3%, n = 117). The Type IV classification patients were further categorized with 33 (28.2%) true Type IV, 68 (58.1%) pararenal or infrarenal, and 16 (13.7%) with dissection. Technical success was 99.2% (n=125). The most common MAE within both 30 days and within 365 days of all patients was respiratory failure (11.9%, n = 15) and (13.5%, n = 17), respectively. One patient (0.8%) experienced persistent paraplegia at 365 days. Reintervention for patients at 365 days was 5.6% (n=7). Of the 444 branches stented, the primary patency rate is remarkably high as only 3 patients (2.4%) required reintervention due to loss of limb patency within 365 days. Aneurysm enlargement (greater than or equal to 5 mm) occurred in 1.6% (n = 2) patients and no patients experienced aneurysm rupture. No patients underwent conversion to open repair. The aneurysm-related mortality at 365 days for all patients was 4.0% (n = 5) while all-cause mortality was 16.7% (n = 21). PMEG device integrity failure was not observed in any patient. The Unitary Manifold device demonstrated remarkable technical surgical success, treatment success, and device patency rates with very reasonable major adverse events and reintervention rates. This study is the most representative example of the general population in comparison to other studies of off-the-shelf devices, with 126 consecutive all-comer patients with diverse pathologies.

Aorto-bifemoral bypass versus covered endovascular reconstruction of aortic bifurcation

BACKGROUNDCovered endovascular reconstruction of aortic bifurcation (CERAB) is increasingly utilized as a first line treatment in patients with aorto-iliac occlusive disease (AIOD). We sought to compare the outcomes of patients undergoing CERAB compared to the gold standard of aorto-bifemoral bypass (ABF). METHODSThe Vascular Quality Initiative was queried for patients undergoing ABF or CERAB from 2009-2021. Propensity scores were generated using demographics, comorbidities, Rutherford class, and urgency. The two groups were matched using 5-to-1 nearest neighbor match. Our primary outcomes were 1-year estimates of primary patency, major adverse limb events (MALE), MALE-free survival, reintervention-free survival, and amputation-free survival. Standard statistical methods were utilized. RESULTS3,944 ABF and 281 CERAB cases in total were identified. Of all patients with AIOD, the proportion of CERAB increased from 0% to 17.9% between 2009-2021. Compared to ABF, patients undergoing CERAB were more likely to be older (64.7 vs. 60.2; p<.001) and more often had diabetes (40.9% vs. 24.1%; p<.001) and end-stage renal disease (1.1% vs. 0.3%; P=.03). In the matched analysis (229 CERAB vs. 929 ABF), ABF patients had improved MALE-free survival (93.2% [±0.9%] vs. 83.2% [±3%]; p<.001) and lower rates of MALE (5.2% [±0.9%] vs. 14.1% [±3%]; p<.001), with comparable primary patency rates (98.3% [±0.3%] vs. 96.6% [±1%]; p=.6) and amputation-free survival (99.3% [±0.3%] vs. 99.4% [±0.6%]; p=.9). Patients in the CERAB group had significantly lower reintervention-free survival (62.5% ± [6%] vs. 92.9% ± [0.9%]; p<.001). Matched analysis also revealed shorter LOS (1 vs. 7 days; p<.001), as well as lower pulmonary (1.2% vs. 6.6%; p=.01), renal (1.8% vs. 10%; p<.001), and cardiac (1.8% vs. 12.8%; p<.001) complications among CERAB patients. CONCLUSIONCERAB had lower perioperative morbidity compared to ABF with a similar primary patency 1-year estimates. However, patients undergoing CERAB experienced more major adverse limb events and reinterventions. Although CERAB is an effective treatment of patients with AIOD, further studies are needed to determine the long-term outcomes of CERAB compared to the established durability of ABF and further define the role of CEARB in treatment of AIOD.

Repeat drug-coated balloon angioplasty for femoropopliteal lesions: 12-month results from a retrospective observational study

BackgroundThe clinical implications of restenosis after drug-coated balloon (DCB) treatment remain unclear. We compared the clinical outcomes between DCB angioplasty for restenosis and de novo femoropopliteal artery lesions. This single-center retrospective study included 571 patients (737 limbs) who underwent either repeat (54 patients, 64 limbs) or de novo DCB (517 patients, 673 limbs) without bailout stenting. After propensity score matching, 49 matched pairs were analyzed. The primary endpoint was the 1-year primary patency, with secondary endpoints including the freedom from target lesion revascularization (TLR), major adverse limb events (MALE), and early restenosis. Predictors of restenosis were identified using multivariable Cox regression analysis.ResultsThe repeat-DCB group displayed significantly lower rates of 1-year primary patency and freedom from TLR compared to those of the de novo-DCB group (50.1% vs. 77.4%, p = 0.029 and 54.9% vs. 83.6%, p = 0.0.44, respectively). No significant differences were observed in early restenosis or MALE (10.7% vs. 5.9%, p = 0.455 and 48.3% vs. 73.4%, p = 0.055, respectively). Restenosis after DCB angioplasty was associated with repeat DCB (hazard ratio [HR], 5.13; 95% confidence interval [CI], 1.43–18.4; p = 0.012) and small vessel size of < 4.5 mm (HR, 6.25; 95% CI, 1.17–33.4; p = 0.032). Furthermore, restenosis after repeat DCB angioplasty was associated with the Peripheral Artery Calcification Scoring System (PACSS) grade 4 (HR, 4.20; 95% CI, 1.08–16.3; p = 0.038), small vessel size of < 4.5 mm (HR, 9.44; 95% CI, 1.21–73.7; p = 0.032), and intravascular ultrasound (IVUS) use (HR, 0.05; 95% CI, 0.01–0.44; p = 0.007).ConclusionsThe 1-year primary patency rate following repeat DCB angioplasty for femoropopliteal lesions was notably lower than that of DCB treatment for de novo lesions. Repeat DCB strategy was associated with an increased risk of patency loss. Regarding repeat restenosis after DCB treatments, PACSS grade 4 calcification and small vessel diameter of < 4.5 mm were associated with an increased risk of restenosis, whereas IVUS use correlated with a decreased risk of restenosis.

Outcomes of Alprostadil As an Adjuvant Therapy with Indirect Angiosomal Revascularization in Patients with Critical Limb Ischemia after Failure of Direct Revascularization

This study was carried out to assess the effectiveness of alprostadil (prostaglandin E1) when used as an adjuvant therapy with indirect revascularization in patients with critical limb ischemia (CLI) after the failure of direct revascularization (DR). At our centers, 120 patients suffering from infrainguinal peripheral arterial disease with CLI underwent a failed trial of DR procedure, all revascularization procedures were endovascular. Median follow-up was 2years and 2.5years for patients with and without diabetes mellitus (DM). In the alprostadil group, the mean age was 63.41±12.52; 36 (60%) for males and 24 (40%) for females. Post-endovascular intervention alprostadil was administrated immediately postoperatively by intravenous infusion of 40μg alprostadil diluted in 100ml of normal saline, over 2hr every 12hr for 6days. In the alprostadil group, the mean±standard deviation (SD) of the baseline ankle-brachial index (ABI) was 0.45±0.175, while the mean±SD of ABI at the end of our study was 0.65±0.216 with a difference from the baseline of 0.2±0.041 (P value=0.08, <0.05 meaning that it is significant). Our 1-month primary patency rate was 93.3%, while our 3- and 6-month patency rate was 92.9%. In the control group, the mean±SD of the baseline ABI was 0.68±0.22, while the mean±SD of ABI at the end of our study was 0.69±0.23 with a difference from the baseline of 0.01±0.01 (P value >0.05 meaning that it is nonsignificant) 1-month patency rate was 89%, while 3- and 6-month patency rate was 75%. When we compared the patient's leg vessels before and after our intervention, we found that the percentage of the no-runoff-vessels group decreased from 10 (16.7%) to 4 (6.67%). One-runoff-vessel group percentage dropped from 40 (66.7%) to 36 (60%), whereas, in the two-runoff-vessel group, the percentage increased from 10 (16.7%) to 20 (33.3%). We evaluate leg arteries; we do no pedal arch intervention in the alpostradil group. Out of the total of 60 patients, limb salvage occurred in 58 (96.7%) patients, and 2 (3.3%) patients underwent below-the-knee amputation before the study ended. Our results show the efficacy and safety of alprostadil as an adjuvant therapy with indirect angiosomal revascularization in patients with tissue loss due to CLI.