Risk of recurrent venous thromboembolism and major bleeding according to risk factor profiles in Asian patients: a subgroup analysis EINSTEIN-Extension and EINSTEIN-CHOICE.

BACKGROUND: Risks of recurrence and major bleeding with extended anticoagulation in Asian patients with venous thromboembolism (VTE) are similar to those in non-Asian patients but risks according to baseline risk factor profiles is not well documented. METHODS: Subgroup analysis of two randomized trials, which compared once-daily rivaroxaban (20 mg or 10 mg) with placebo or aspirin (100 mg) for extended treatment in Asian patients with VTE who had completed 6-12 months of anticoagulation. Index events were classified as unprovoked, provoked by major persistent risk factors, minor persistent risk factors, minor transient risk factors, or major transient risk factors. One-year cumulative risks of recurrent VTE were calculated for these risk factor profiles. RESULTS: 367 patients received rivaroxaban, 159 aspirin, and 48 placebo. For patients with unprovoked VTE, one-year cumulative incidences of recurrence in the 202 patients given rivaroxaban, the 89 given aspirin and the 28 given placebo were 1.6%, 5.8%, and 14.8%, respectively. For patients with VTE provoked by minor persistent risk factors, these incidences were 0% in the 74 patients given rivaroxaban, 9.3% in the 36 given aspirin, and 0% in the 12 given placebo. No recurrent VTE occurred in patients with VTE provoked by major persistent or transient risk factors or minor transient risk factors. Rivaroxaban was not associated with a significant increase in major bleeding. CONCLUSIONS: Rivaroxaban seems to be an effective and safe option for extended treatment in Asian patients, especially those presenting with unprovoked VTE. Subgroups of patients with provoked risk factors were too small to draw meaningful conclusions. TRIAL REGISTRATION: NCT00439725 and NCT02064439.

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

PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. CLINICAL IMPACT: 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.

A Multicenter Study of the Mid-term Outcomes of Patients with Uncomplicated Type B Aortic Dissection After Distal Porous Talos Stent-Graft Implantation.

BACKGROUND: The Talos stent-graft has extended length to improve aortic remodeling, and distal porous design to decrease the rate of spinal cord ischemia (SCI). This study retrospectively analyzed its mid-term outcomes for uncomplicated type B aortic dissection in a multicenter study. METHODS: The primary safety end point was 30-day major adverse events, including all-cause mortality, dissection-related mortality, conversion to open surgery, and device-related adverse events. The primary efficacy end point was treatment success at 12 months postoperation, defined as no technical failure or secondary dissection-related reintervention. The survival status of the patients was visualized using the Kaplan-Meier curve. Aortic growth was assessed at 4 levels, and SCI was evaluated at 12 months. RESULTS: 113 patients participated with a mean age of 54.4 (11.1) years and 71.7% (81/113) were male. The 30-day mortality was 0.9% (1/113), no conversions to open surgery or device-related adverse events were recorded. The 12-month treatment success rate was 99.1% (112/113), with no dissection-related reinterventions. There was no spinal cord or visceral ischemia at 12 months. At a median of 34 months follow-up, 9 further deaths were recorded and the 3-year survival rate was 91.7%. The percentage of aortic growth was 1.8% (2/111) at the tracheal bifurcation, 3.6% (4/111) below the left atrium, 6.0% (5/83) above the celiac artery, and 12.1% (9/74) below the lower renal artery. The total thrombosis rate of the false lumen at the stented segment was 80.5% (91/113). CONCLUSIONS: The results showed satisfactory results of Talos stent-graft in terms of safety and efficacy. More data are needed to confirm the long-term performance.

Midterm Outcomes of Multicenter Castor Single-Branch Stent Graft Use in the Treatment of Thoracic Aortic Diseases.

PURPOSE: The aim of this study was to evaluate the midterm efficacy and safety of a single-branch Castor stent graft in the treatment of thoracic aortic disease. MATERIALS AND METHODS: Clinical data of 106 patients with thoracic aortic disease treated with Castor single-branch stent graft at 3 centers were collected between May 2018 and June 2023. The indicators included technical success, stent-related complication, reintervention, retrograde dissection, endoleak, distal stent graft-induced entry (dSINE), branch patency, and mortality. The outcomes of the Castor stent graft for multibranch reconstruction above the arch was also analyzed. RESULTS: The technical success was 98.1% (104/106), while the surgical success was 93.4% (99/106). The reintervention was 2.8% (3/106), consisting of a case of retrograde type A dissection, an endoleak, and a dSINE. The retrograde dissection was 1.9% (2/106), while type I endoleak was 1.9% (2/106). The new dSINE was 2.8% (3/106), and the branch patency rate was 100%. The mortality was 1.9% (2/106). The mean follow-up time was 29.1±17.7 months. The 2-year post-surgery cumulative survival rate was 91.0%±3.1%, while the cumulative branch patency rate was 96.2%±2.2%. In addition, the cumulative freedom from stent-related reintervention rate was 93.2%±2.8%. A comparison showed no significant difference in the stent-related complication, branch patency, endoleak, reintervention, and mortality when the proximal end of the Castor stent graft was anchored to zones 1 or 2 of the aorta. CONCLUSION: Castor single-branch stent graft showed favorable early and midterm outcomes in the treatment of thoracic aortic disease. In addition, it was feasible to combine Castor stent graft with other advanced techniques for multibranch aortic arch reconstruction. CLINICAL IMPACT: The Castor single-branch stent graft was approval by the Chinese Food and Drug Administration in 2017. However, there were few studies on the mid-term outcomes for thoracic aortic disease after launching, which mainly focused on small single-center retrospective study. In the study, we assessed the mid-term outcomes of Castor stent graft through multi-center cases, Castor stent graft combined with other advanced techniques (such as fenestration and hybrid) for multi-branch reconstruction of aortic arch were also conducted. We found Castor single-branch stent graft showed favorable early and mid-term outcomes in the treatment of thoracic aortic disease. Additionally, it was feasible to combine Castor stent graft with other advanced technique for multi-branch aortic arch reconstruction. As an off-the-shelf branched stent graft with a wide range of models, it could be also used in most emergent situation. The Castor stent graft was expected to become more widely used in the future.

Safety and Efficacy of Stent-Graft in the Treatment of Aortoiliac Artery Occlusive Disease: A Multicenter Study of Short-Term and Medium-Term Outcomes.

BACKGROUND: To evaluate the short-term and mid-term safety and efficacy of stent-graft compared with bare stents for treatment of aortoiliac occlusive disease (AIOD). METHODS: One hundred eighty three patients diagnosed with AIOD who received stent implantation at 3 vascular centers in north China between January 2019 and December 2021 were enrolled. Patients were divided into those undergoing stent-graft (Group A; n = 67) or bare stent (Group B; n = 116) implantation for retrospective cohort analysis. Efficacy was assessed as surgical success rate and rate of freedom from clinically driven target lesion reintervention at each follow-up time point. Safety was assessed by the rate of perioperative complication, major limb amputation, and aortoiliac artery-related mortality. RESULTS: There were no preoperative baseline differences between the 2 groups (P > 0.05). The surgical success was 91.04% for Group A, significantly higher than that for Group B (79.31%; P < 0.05). Incidence of perioperative complications was 2.98% for Group A, significantly lower than that for Group B (9.48%, P < 0.05), as was the rate of major limb amputation (A: 1.49% vs. B: 5.17%) and aortoiliac artery-related mortality (A: 1.49% vs. B: 4.31%), although these 2 indicators were not significantly different (P > 0.05). Follow-up rates were 91.8% for the total follow-up time of 3 years. Kaplan-Meier survival curve analysis gave significantly higher 1-year and 2-year freedom from clinically driven target lesion reintervention for Group A (98.51% and 95.52%) than for Group B (95.69% and 89.66%, P < 0.05). CONCLUSIONS: Stent-graft is more effective and safer than bare stent in the treatment of AIOD.

A New Drug-Coated Balloon for the Treatment of Superficial Femoropopliteal Artery Disease: 12-Month Results from the IN-DEPT SFA Trial.

PURPOSE: To report the outcomes of the IN-DEPT trial assessing the feasibility, preliminary safety data, and 12-month outcomes of a new drug-coated balloon (DCB) product for peripheral artery disease (PAD) in Chinese patients. MATERIALS AND METHODS: This is a prospective, multicenter, single-arm clinical trial. A total of 160 patients with superficial femoral artery (SFA) and/or proximal popliteal artery lesions were treated with a new paclitaxel-coated DCB. The preliminary effectiveness end point was 12-month primary patency. The primary safety end point was freedom from device- and procedure-related mortality over 30 days and freedom from major target limb amputation and clinically driven target lesion revascularization (CD-TLR) within 12 months after the index procedure. RESULTS: In total, 160 patients presented with 162 target lesions. A total of 139 lesions (85.8%) were treated with 1 DCB, whereas the other 23 lesions (14.2%) were treated with 2 devices. The device success rate was 100%. A total of 135 subjects reached the preliminary effectiveness end point, with a 12-month primary patency rate of 84.4%. There was no 30-day device- or procedure-related death or unplanned major target limb amputation at 12 months. Five CD-TLRs (3.1%) occurred during the 12-month follow-up period. CONCLUSIONS: Results from the IN-DEPT SFA trial showed satisfactory feasibility and safety of the new DCB over 12 months in Chinese patients with PAD and femoropopliteal de novo lesions, including both stenoses and total occlusions.

Hyperhomocysteinemia may aggravate abdominal aortic aneurysm formation by up-regulating RASSF2.

Abdominal aortic aneurysm (AAA) is a fatal cardiovascular disorder with high mortality and morbidity rates. To date, no drug has shown to significantly alleviate the risk of AAA. Previous studies have indicated that hyperhomocysteinemia (HHcy) significantly increases the incidence of AAA by disrupting endothelial cell homeostasis; however, the potential molecular mechanisms require clarification. Herein, we aimed to integrate transcriptomics analysis and molecular biology experiments to explore the potential molecular targets by which HHcy may increase the incidence of AAA. We integrated two AAA data profiles (GSE57691 and GSE7084) based on previously published microarray ribonucleic acid sequencing (RNAseq) data from the GEO database. Additionally, 500 µM homocysteine-treated human aorta endothelium cells microarray dataset (GSE175748) was downloaded and processed. Subsequently, single-cell RNA-seq profiles of the aortic aneurysms (GSE155468) were downloaded, scaled, and processed for further analysis. The microarray profiles analysis demonstrated that the Ras association domain family member 2 (RASSF2) and interleukin (IL)-1ß are potentially the target genes involved in the HHcy-mediated aggravation of AAA formation. Single-cell RNAseq analysis revealed that RASSF2 might impair endothelial cell function by increasing inflammatory cell infiltration to participate in AAA formation. Finally, we conducted reverse transcription quantitative polymerase chain reaction and immunofluorescence analysis to validate the up-regulated mRNA expression of RASSF2 (p = 0.008) and IL-1ß (p = 0.002) in AAA tissue compared to control tissue. Immunofluorescence staining revealed overexpression of RASSF2 protein in AAA tissue sections compared to control tissue (p = 0.037). Co-localization of RASSF2 and the aortic endothelium cell marker, CD31, was observed in tissue sections, indicating the potential involvement of RASSF2 in aortic endothelial cells. To summarise, our preliminary study revealed that HHcy may worsen AAA formation by up-regulating the expression of RASSF2 and IL-1ß in aortic endothelium cells.

Ganglioside GM3 Protects Against Abdominal Aortic Aneurysm by Suppressing Ferroptosis.

BACKGROUND: Abdominal aortic aneurysm (AAA) is a potentially life-threatening vascular condition, but approved medical therapies to prevent AAA progression and rupture are currently lacking. Sphingolipid metabolism disorders are associated with the occurrence and development of AAA. It has been discovered that ganglioside GM3, a sialic acid-containing type of glycosphingolipid, plays a protective role in atherosclerosis, which is an important risk factor for AAA; however, the potential contribution of GM3 to AAA development has not been investigated. METHODS: We performed a metabolomics study to evaluated GM3 level in plasma of human patients with AAA. We profiled GM3 synthase (ST3GAL5) expression in the mouse model of aneurysm and human AAA tissues through Western blotting and immunofluorescence staining. RNA sequencing, affinity purification and mass spectrometry, proteomic analysis, surface plasmon resonance analysis, and functional studies were used to dissect the molecular mechanism of GM3-regulating ferroptosis. We conditionally deleted and overexpressed St3gal5 in smooth muscle cells (SMCs) in vivo to investigate its role in AAA. RESULTS: We found significantly reduced plasma levels of GM3 in human patients with AAA. GM3 content and ST3GAL5 expression were decreased in abdominal aortic vascular SMCs in patients with AAA and an AAA mouse model. RNA sequencing analysis showed that ST3GAL5 silencing in human aortic SMCs induced ferroptosis. We showed that GM3 interacted directly with the extracellular domain of TFR1 (transferrin receptor 1), a cell membrane protein critical for cellular iron uptake, and disrupted its interaction with holo-transferrin. SMC-specific St3gal5 knockout exacerbated iron accumulation at lesion sites and significantly promoted AAA development in mice, whereas GM3 supplementation suppressed lipid peroxidation, reduced iron deposition in aortic vascular SMCs, and markedly decreased AAA incidence. CONCLUSIONS: Together, these results suggest that GM3 dysregulation promotes ferroptosis of vascular SMCs in AAA. Furthermore, GM3 may constitute a new therapeutic target for AAA.

Systematic Review and Meta-analysis of Short-term and Mid-term Outcomes After Use of t-Branch Off-the-shelf Multibranched Endograft for Elective and Urgent Treatment of Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: To conduct a meta-analysis to assess the safety and efficacy of t-Branch off-the-shelf multibranched endograft for the treatment of thoracoabdominal aortic aneurysm (TAAA). DATA SOURCES: PubMed, Embase, and Web of Science. REVIEW METHODS: Online databases were searched from June 2012 to March 2023. The data were pooled together using a random-effects model of proportions. The outcomes overall included technical success, spinal cord ischemia, target vessel occlusion, type I or III endoleak, reintervention, early mortality (30-day), and mid-term outcomes. Subgroup meta-analyses and meta-regression were performed to explore variation among studies. RESULTS: A total of 15 studies containing 1238 patients were included in the meta-analysis. The overall study quality assessment was found to be moderate to good. The pooled technical success was 97.0% (95% confidence interval [CI]=95.5-98.6, I2=53.01%, 1185/1238 cases, 15 studies). Overall, early mortality was 7.3% (95% CI=4.4-10.1, I2=74.48%, 124/1238 cases, 15 studies). Early spinal cord ischemia was 13.4% (95% CI=9.6-17.2, I2=67.24%, 160/1238 cases, 15 studies), and early type I or III endoleak was 6.0% (95% CI=3.4-8.5, I2=53.71%, 68/1032 cases, 9 studies). Mid-term outcomes showed target vessel occlusion was 4% (95% CI=1.4-6.5, I2=65.18%, 28/528 cases, 10 studies, 5-21.2 months), type I or III endoleak was 4.7% (95% CI=2-7.5, I2=49.74%, 38/512 cases, 10 studies, 5-21.2 months), reintervention was 11.2% (95% CI=8.1-14.3, I2=31.06%, 85/650 cases, 10 studies, 5-21.2 months), and pooled mortality was 13.9% (95% CI=7.2-20.7, I2=76.32%, 84/550 cases, 11 studies, 5-21.2 months). Meta-regression found a significant linear association between higher technical success and earlier publication year (p=0.014) and studies with anatomic inclusion criteria (p=0.037). Urgent patients (p=0.021) and later publication year (p=0.048) were significantly associated with higher early mortality. CONCLUSION: The use of the off-the-shelf t-Branch multibranched endograft for elective or urgent endovascular TAAA repair is associated with high technical success rates and proved to be safe and effective at early and mid-term follow-up. However, the heterogeneity between the included studies is high, and prospective, randomized studies along with future larger studies with long-term follow-up are needed. CLINICAL IMPACT: The Zenith t-Branch (Cook Medical, Bloomington, Ind) was approved as a commercially available device in Europe in June 2012. Although a decade has past, the outcomes of t-Branch have rarely been synthesized at the global level. This meta-analysis included 15 studies containing 1238 patients. The meta-analyses included technical success, major adverse events, reintervention, early mortality, and mid-term outcomes. The outcome was very meaningful and representative for the use of t-Branch. It is helpful for endovascular surgeons to make decisions on the treatment of TAAA patients.

Midterm Results of Drug-Coated Balloon and Bare Metal Stent in the Treatment of TASCII C/D Femoropopliteal Artery Occlusive Disease: A Retrospective Multicenter Study.

PURPOSE: This study aimed to compare midterm efficacy between drug-coated balloon (DCB) and bare metal stent (BMS) in the treatment of TASCII C/D femoropopliteal artery lesions. METHODS: The clinical data of patients with TASCII C/D femoropopliteal artery disease admitted to 3 vascular surgery centers from January 2018 to January 2021 were retrospectively analyzed. Patients were divided into DCB group and BMS group. The DCB group was further subdivided into DCB alone subgroup and DCB+BMS subgroup. Study primary outcomes were freedom from clinical-driven target lesion reintervention (FCD-TLR) at 24 months postprocedure. Secondary outcomes included ankle brachial index (ABI), Rutherford classification, major amputation rate, and mortality. RESULTS: A total of 410 consecutive patients were enrolled. At 24 months follow-up, in DCB group (114 patients) relative to BMS group (296 patients), FCD-TLR (86.00% vs 71.91%, p=0.039), and ABI (0.53±0.11 vs 0.47±0.19, p=0.007) were higher; mean Rutherford class was lower (1.57±0.68 vs 3.31±1.39, p=0.000); and major amputation rate (0.87% vs 4.05%, p>0.05) and all-cause mortality (8.92% vs 6.41%, p>0.05) were statistically similar. In DCB alone, subgroup relative to DCB+BMS subgroup, FCD-TLR (90.00% vs 85.00%, p>0.05), major amputation rate (0 vs 1.08%, p>0.05), and all-cause mortality rate (9.09% vs 8.69%, p>0.05) were statistically similar, while FCD-TLR was higher in the DCB+BMS subgroup (90.00% vs 71.91%, p=0.045). CONCLUSION: At midterm follow-up of patients treated for TASCII C/D femoropopliteal artery disease, use of DCB or of DCB combined with rescue BMS appeared similarly efficacious, and yielded more favorable outcomes than use of BMS. CLINICAL IMPACT: The efficacy of drug-coated balloons relative to that of bare metal stents for the treatment of complex femoropopliteal artery lesions, particularly TASCII grade D lesions, remains uncertain. There is a scarcity of multicenter comparative studies, and in this multicenter retrospective study with up to 24-month follow-up, use of drug-coated balloon alone or combined with rescue bare metal stent appeared similarly efficacious while yielding more favorable outcomes than use of bare metal stent alone in the treatment of TASCII grade C/D femoropopliteal artery lesions. Randomized studies are warranted.

A Chinese expert consensus on thoracic endovascular aortic repair of type B aortic dissection with a single-branched stent graft for revascularization of the left subclavian artery.

Thoracic endovascular repair (TEVAR) is currently the recommended and most widely used treatment for type B aortic dissection. A major challenge is revascularization of the left subclavian artery in order to extend the landing zone to zone 2 (Ishimaru classification). Various strategies have been used for revascularization, including branched stent graft, fenestrated stent graft, the chimney technique, the parallel technique, and bypass surgery. Single-branched stent graft is one of the most promising strategies, and several products have recently been reported as potential candidates for use with this approach. The Castor single-branched stent graft is the only off-the-shelf product available; this product has been developed through collaboration between Chinese corporations and clinicians. In this Perspective article, clinical experience and data obtained from TEVAR with the Castor single-branched stent graft are summarized by experienced Chinese experts.

Fibrin Glue Sac Filling for Preventing Type II Endoleak, Short-Term Outcomes of a Prospective Randomized Controlled Trial.

OBJECTIVE: Type II endoleak (T2EL) worsens the long-term results of endovascular aneurysm repair (EVAR). How to prevent T2ELs remains controversial. This study aimed to evaluate the efficacy and safety of fibrin glue sac filling (FGSF) to prevent T2ELs after EVAR. METHODS: A prospective randomized controlled trial was conducted. Patients were randomly divided into group A (standard EVAR + FGSF) and group B (standard EVAR). The follow-up plans included outpatient or telephone consultation at 1 and 3 months and computed tomography (CT) angiography at 6 months, 1 year, and once a year after EVAR. RESULTS: A total of 64 abdominal aortic aneurysm (AAA) patients were randomized to the 2 groups. All patients were followed up for more than 6 months. The 2 groups showed similar baseline characteristics. The rate of T2ELs on immediate angiography in group A (9.6%) was significantly lower than that in group B (33.3%, p=0.033). Moreover, the sac area change was significantly reduced in group A at 6 months after EVAR (p=0.021). However, T2EL incidence was similar at the 6-month (p=0.055) and 1-year (p=0.057) follow-ups, and AAA diameter change was also similar at 1 year. There were similar operation times, radiation doses, severe adverse events (SAEs), and reinterventions between the 2 groups. CONCLUSION: Fibrin glue sac filling could prevent short-term type II endoleaks and promote AAA shrinkage after 6 months. The FGSF procedure is swift and straightforward; however, patients are at risk of bowel ischemia, especially after previous bowel resections or concomitant superior mesenteric artery (SMA) disease. CLINICAL IMPACT: Standard endovascular aneurysm repair (EVAR) couldn't prevent type II endoleak (T2EL). In this study, we found fibrin glue sac filling (FGSF) could prevent T2EL and promote AAA shrinkage in a short term. And the FGSF procedure is easy, it will be a useful supplement to standard EVAR for clinicians. And FGSF might have potential usefulness on ruptured aneurysms, although without direct evidence.Fibrin glue is often used to hemostasis and tissue adhesion in surgical patients and burn patients, we firstly carry out a randomized controlled study and prove that fibrin glue sac filling could prevent T2EL and promote sac remodeling.

A nomogram risk assessment model to predict the possibility of type II endoleak-related re-intervention after endovascular aneurysm repair (EVAR).

This study aimed to develop and validate a novel nomogram risk assessment model to predict the possibility of type II endoleak (T2EL)-related re-intervention. The data of 455 patients with abdominal aortic aneurysms who underwent elective endovascular aneurysm repair (EVAR) procedures between January 2018 and December 2021 at our single center were retrospectively reviewed. Following the implementation of exclusion criteria, 283 patients were finally included and divided into T2EL-related re-intervention (n = 42) and non-T2EL (n = 241) groups. The overall T2EL-related re-intervention rate for 283 patients was 14.8% (42/283). Using multivariate analysis, significant risk factors for re-intervention included age (OR, 1.172; 95% CI, 1.051-1.307; P = 0.004), smoking (OR, 13.418; 95% CI, 2.362-76.215; P = 0.003), diameter of inferior mesenteric artery (IMA) (OR, 21.380; 95% CI, 3.060-149.390; P = 0.002), and number of patent lumbar arteries (OR, 9.736; 95% CI, 3.175-29.857; P < 0.001). The discrimination ability of this risk-predictive model was reasonable (concordance index [C-index] = 0.921; 95% CI, 0.878-0.964). The Hosmer-Lemeshow goodness of fit test was performed on the model, and the chi-square value was 3.210 (P = 0.920), presenting an excellent agreement between the model-predicted and observed values. The receiver operating characteristic (ROC) curve identified that the risk thresholds of re-intervention were a diameter of > 2.77 mm for the diameter of the inferior mesenteric artery and a proportion of < 45.5% for thrombus volume in the aneurysm sac. This novel nomogram risk assessment model for predicting the possibility of patients' T2EL-related re-interventions after EVAR should be helpful in discriminating high-risk patients. Two novel risk thresholds may imply a higher possibility of T2EL-related re-intervention after EVAR.

Mid-term Outcomes of Endovascular and Hybrid Procedures to Treat Complex Aortic Arch Pathologies.

PURPOSE: To compare the mid-term outcomes of endovascular and hybrid procedures in treating aortic arch pathologies with an unfavorable proximal landing zone, and analyze the different indications of the 2 methods. METHODS: We collected the clinical data from 59 patients with complex aortic arch pathologies who underwent endovascular or hybrid surgery from March 2018 to April 2020 at a single center. Among the patients, 45 were treated by branched or fenestrated surgery and 14 by hybrid surgery. The clinical data of preoperative, perioperative, and postoperative results were retrospectively analyzed and compared. The main study indexes were the branch patency rate and endoleakage rate during the follow-up period. The secondary study indexes included the operation success rate, operative time, hospital expenses, complication incidence, freedom from reintervention rate, mortality, etc. RESULTS: The operation success rate of all the groups was 100%. The hospital expenses of the hybrid group were lower than those of the endovascular group (p<0.05). The operative time of the hybrid group was longer than that of the endovascular group (p<0.05). The incidence of anatomic variants in the hybrid group was 28.6%, which was significantly higher than that in the endovascular group (2.2%, p=0.011). However, there were no significant differences in operative bleeding, ventilator use duration, and treatment time in intensive care units between the 2 groups (p>0.05). Follow-up was conducted for a period of 12 to 34 months. Four patients of the hybrid group experienced numbness of the upper limb (28.57%); the proportion was higher than the endovascular group (0%, p=0.002). There were no significant differences in the occurrence of endoleaks, retrograde aortic dissection, target lesion, secondary operation, branch patency rate, paraplegia, cerebral apoplexy, renal failure, or other complications in either group (p>0.05). The mortality of the endovascular group was 6.67% (3/45). Overall cumulative survival at 1 year was 100% in the hybrid group and 93.3% in the endovascular group. There was no statistical difference in the increase of the true lumen between the 2 groups for vascular remodeling (p>0.05). CONCLUSION: The hybrid surgery costs less and proves more suitable for treating variants of the aortic arch. The endovascular treatment still has limitations due to anatomical conditions.

Construction of a canine model with acute type B aortic dissection using a self-made pressure-driven flow device.

A reproducible canine aortic dissection (AD) model would be useful for evaluating the performance of novel endovascular treatment devices. Therefore, we attempted to create a reproducible canine model of Stanford type B AD (TBAB) by a surgical method. Computed tomography angiography was performed 2 h after the procedure to determine if a false lumen was present, and follow-up imaging was performed 10 d after the procedure using digital subtraction angiography, intravascular ultrasound (IVUS), and color Doppler flow imaging (CDFI) to confirm stable persistence of the false lumen. The success rate of model construction was 88.8% (16/18). All surviving dogs had distal re-entries (16/16). The number of re-entries in the dogs was 1.50 ± 0.52, and the mean length of the false lumen was 175.37 ± 16.98 mm. IVUS showed the area of the false lumen at the narrowest part of the arterial lumen was 84.88 ± 1.27%. The CDFI showed that the peak systolic velocity in the false lumen (10.89 ± 0.74 cm/s) was significantly slower than that in the true lumen (25.31 ± 1.72 cm/s; P<0.001). Moreover, the direction of blood flow in the true lumen was consistent, whereas that in the false lumen was disordered. We optimized the traditional surgical method to construct a canine model of TBAD to improve the success rate of model construction, and designed a novel device to lengthen the false lumen. The proposed model has wide implications in evaluating the performance of novel endovascular treatment devices and studying the AD-related hemodynamics.

Comparative clinical study of short-term outcomes between table fenestrated and chimney endovascular aneurysm repair for hostile neck aneurysms.

OBJECTIVES: Hostile neck abdominal aortic aneurysm (AAA) is challenging for standard endovascular aneurysm repair (EVAR). We sought to compare fenestrated endovascular aneurysm repair (fEVAR) and chimney endovascular aneurysm repair (chEVAR) for hostile neck AAA. METHODS: Patients were identified retrospectively. Hostile neck anatomy was defined as a proximal neck length of <15 mm or angulation >60°. The choice of fEVAR or chEVAR was based on neck anatomy and physician preference. Type I endoleak (T1EL) was the primary outcome. Other outcomes included type III endoleak (T3EL), visceral stent occlusion, renal insufficiency, reintervention, and mortality. RESULTS: A total of 84 patients were included from April 2012 to December 2021. fEVAR and chEVAR patients were 48 and 36 cases, respectively. Both groups showed similar rate of T1EL, T3EL, visceral stent occlusion, renal insufficiency, reintervention, and mortality. However, chEVAR patients had a more tortuous neck (61.1% vs. 16.7%, p < 0.001), while fEVAR patients had a greater neck size (29.5 ± 6.3 mm vs. 24.5 ± 4.8 mm, p < 0.001) and more reconstructing target arteries (2.2 ± 1.1 vs 1.3 ± 0.6, p < 0.001). CONCLUSIONS: fEVAR and chEVAR show similar safe and effective outcomes in well-selected hostile neck. fEVAR might be able to reconstruct multiple visceral arteries, and chEVAR seems justified in patients with poor anatomical suitability for fEVAR.

1-Year Outcomes of a Multicenter Randomized Controlled Trial of the Ankura II Thoracic Endoprosthesis for the Endovascular Treatment of Stanford Type B Aortic Dissections.

Background: The Ankura II Thoracic Stent Graft System (Lifetech, Shenzhen, China) is an evolution of the Ankura stent graft. This study reports one-year outcomes of the Ankura II Thoracic Stent Graft System for endovascular treatment of Stanford type B aortic dissections. Methods: The Ankura II Thoracic Aortic Endovascular Trial was a randomized, single-blinded, clinical trial conducted at 12 Chinese institutes. The enrolled patients diagnosed with Stanford type B aortic dissections (TBADs) were randomly assigned to the Ankura group or Ankura II group. Standard follow-up examinations were performed at 1, 6, and 12 months. Safety and efficacy data were analyzed. Results: 132 patients with TBADs were enrolled. The outcomes for the primary safety end points revealed that the Ankura II stent graft was statistically non-inferior compared to the Ankura stent graft. The 1-month device-related major adverse events (1.6 vs. 0%; p = 0.48), 1-month all-cause mortality (1.7 vs. 4.5%; p = 0.621), 12-month survival rate (95.2 ± 2.7% vs. 94.1 ± 2.9%; p = 0.769), and major adverse event (MAE) rate (5.1 vs. 4.7% at 1 month; p = 0.73 and 5.8 vs. 8.9% at 12 months; p = 0.718) of Ankura II group are all comparable to Ankura group. The two groups showed similar primary effectiveness and true lumen expansion effect, and false lumen remodeling was improved in Ankura II group (-100.0 vs. -48.5%; p = 0.08). Conclusions: The one-year outcomes from this prospective, randomized, multicenter study demonstrate that Ankura II stent graft shows comparable results to Ankura for treating TBADs, resulting in low mortality rates, MAEs and reintervention rates. Clinical Trial Registration: ChiCTR-TRC-12002844.

Disruption of USP9X in macrophages promotes foam cell formation and atherosclerosis.

Subendothelial macrophage internalization of modified lipids and foam cell formation are hallmarks of atherosclerosis. Deubiquitinating enzymes (DUBs) are involved in various cellular activities; however, their role in foam cell formation is not fully understood. Here, using a loss-of-function lipid accumulation screening, we identified ubiquitin-specific peptidase 9 X-linked (USP9X) as a factor that suppressed lipid uptake in macrophages. We found that USP9X expression in lesional macrophages was reduced during atherosclerosis development in both humans and rodents. Atherosclerotic lesions from macrophage USP9X-deficient mice showed increased macrophage infiltration, lipid deposition, and necrotic core content than control apolipoprotein E-KO (Apoe-/-) mice. Additionally, loss-of-function USP9X exacerbated lipid uptake, foam cell formation, and inflammatory responses in macrophages. Mechanistically, the class A1 scavenger receptor (SR-A1) was identified as a USP9X substrate that removed the K63 polyubiquitin chain at the K27 site. Genetic or pharmacological inhibition of USP9X increased SR-A1 cell surface internalization after binding of oxidized LDL (ox-LDL). The K27R mutation of SR-A1 dramatically attenuated basal and USP9X knockdown-induced ox-LDL uptake. Moreover, blocking binding of USP9X to SR-A1 with a cell-penetrating peptide exacerbated foam cell formation and atherosclerosis. In this study, we identified macrophage USP9X as a beneficial regulator of atherosclerosis and revealed the specific mechanisms for the development of potential therapeutic strategies for atherosclerosis.