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.

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

BACKGROUND: The 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. METHODS: From 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 rate, technical success, bailout stenting, clinically-driven target lesion reintervention, improvement of ankle-brachial index (ABI), and Rutherford class. RESULTS: A 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. The mean length of these lesions 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%. CONCLUSIONS: ELA 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.

Prediction of new cerebral ischemic lesion after carotid artery stenting: a high-resolution vessel wall MRI-based radiomics analysis.

OBJECTIVES: Carotid artery stenting (CAS) is an established treatment for local stenosis. The most common complication is new ipsilateral ischemic lesions (NIILs). This study aimed to develop models considering lesion morphological and compositional features, and radiomics to predict NIILs. MATERIALS AND METHODS: One hundred and forty-six patients who underwent brain MRI and high-resolution vessel wall MR imaging (hrVWI) before and after CAS were retrospectively recruited. Lumen and outer wall boundaries were segmented on hrVWI as well as atherosclerotic components. A traditional model was constructed with patient clinical information, and lesion morphological and compositional features. Least absolute shrinkage and selection operator algorithm was performed to determine key radiomics features for reconstructing a radiomics model. The model in predicting NIILs was trained and its performance was tested. RESULTS: Sixty-one patients were NIIL-positive and eighty-five negative. Volume percentage of intraplaque hemorrhage (IPH) and patients' clinical presentation (symptomatic/asymptomatic) were risk factors of NIILs. The traditional model considering these two features achieved an area under the curve (AUC) of 0.778 and 0.777 in the training and test cohorts, respectively. Twenty-two key radiomics features were identified and the model based on these features achieved an AUC of 0.885 and 0.801 in the two cohorts. The AUCs of the combined model considering IPH volume percentage, clinical presentation, and radiomics features were 0.893 and 0.842 in the training and test cohort respectively. CONCLUSIONS: Compared with traditional features (clinical and compositional features), the combination of traditional and radiomics features improved the power in predicting NIILs after CAS. KEY POINTS: • Volume percentage of IPH and symptomatic events were independent risk factors of new ipsilateral ischemic lesions (NIILs). • Radiomics features derived from carotid artery high-resolution vessel wall imaging had great potential in predicting NIILs after CAS. • The combination model with radiomics and traditional features further improved the diagnostic performance than traditional features alone.

Predictors of Return to Work After Thoracic Endovascular Aortic Repair in Patients With Type B Aortic Dissection.

OBJECTIVE: Type B aortic dissection (TBAD) is a life-threatening condition, and it takes heavy burden to family and society. Return to work (RTW) not only means patients' physical health but also demonstrates their mental well-being. Thoracic endovascular aortic repair (TEVAR) has been successful in treatment of TBAD patients. However, less studies have addressed on the social functional recovery of TBAD after TEVAR, especially for RTW. METHODS: From January 1, 2017 to January 1, 2021, TBAD patients who underwent TEVAR and completed a 12-month follow-up were retrospectively enrolled. Primary outcome was RTW. Patients' demographic, sociological, and clinical characteristics, and so on were recorded to analyze and demonstrate independent risk factors for RTW. RESULTS: Four hundred thirty-two TBAD patients (388 males) were enrolled with a mean age of 48.3±8.9 years (ranged from 19 to 60 years). The 12-month cumulative RTW rate was 62.7% (95% confidence interval [CI]: 57.2%-67.8%). Age <50 years (odds ratio [OR]=3.675, 95% CI: 1.436-9.405) was identified as independent protective factors for RTW, while preoperative job as manual workers (OR=0.101, 95% CI: 0.029-0.353), average annual income, <30 000 Chinese Yuan (CNY) [<4400 US dollar], (OR=0.186, 95% CI: 0.054-0.637), complicated TBAD (malperfusion) (OR=0.246, 95% CI: 0.092-0.659), and distal stent graft-induced new entry (SINE) (OR=0.218, 95% CI: 0.083-0.575, p=0.002) were identified as independent risk factors. CONCLUSION: Approximately 64% of our patients were able to RTW in the 12 months post-TEVAR for TBAD. Younger patients, patients with less physically demanding jobs, and patients with less complex surgeries were more likely to RTW. Based on these results, more can be done to facilitate the patient's ability and willingness to RTW after TEVAR. CLINICAL IMPACT: Type B aortic dissection (TBAD) is a life-threatening condition that poses significant burden on both individuals and society. The ability to return to work (RTW) not only reflects the patient's physical health but also indicates their mental well-being. Therefore, identifying risk factors for RTW and promoting the reintegration of TBAD patients into the workforce is crucial in clinical practice.To our knowledge, this study is the first to elucidate and predict the RTW outcomes of TBAD patients who underwent thoracic endovascular aortic repair (TEVAR).

Clock Gene Bmal1 Disruption in Vascular Smooth Muscle Cells Worsens Carotid Atherosclerotic Lesions.

BACKGROUND: Clock system disruptions are associated with cardiovascular diseases. We previously demonstrated Bmal1 (brain muscle aryl nuclear translocase like-1) expression is significantly attenuated in plaque-derived vascular smooth muscle cells (VSMCs). However, the influence of Bmal1 disruption in VSMCs and its molecular targets are still unclear. Here, we aim to define how Bmal1 disruption in VSMCs influences the atherosclerosis lesions. METHODS: The relationship among Bmal1, neurological symptoms, and plaque stability was investigated. VSMC Bmal1-/- and VSMC Bmal1+/+mice were generated and injected with adeno associated virus encoding mutant proprotein convertase subtilisin/kexin type 9 to induce atherosclerosis. Carotid artery ligation and cuff placement were performed in these mice to confirm the role of Bmal1 in atherosclerosis progression. The relevant molecular mechanisms were then explored. RESULTS: Bmal1 expression in the carotid plague was significantly lower in symptomatic patients as well as in unstable plaques. Moreover, Bmal1 reduction is an independent risk factor for neurological symptoms and plaque instability. Besides, VSMC Bmal1-/- mice exhibit aggravated atherosclerotic lesions. Further study demonstrated that Bmal1 downregulation in VSMCs increased VSMC migration, monocyte transmigration, reactive oxygen species levels, and VSMCs apoptosis. As for the mechanism, we revealed that Bmal1 suppresses VSMCs migration by inhibiting RAC1 activity in 2 ways: by activating the transcription of RhoGDIα and by interacting with RAC1. Besides, Bmal1 was shown to preserve antioxidant function in VSMCs by activating Nrf2 (nuclear factor erythroid 2-related factor 2) and Bcl-2 transcription. CONCLUSIONS: Bmal1 disruption in VSMCs worsens atherosclerosis by promoting VSMC migration and monocyte transmigration and impairing antioxidant function. Therefore, Bmal1 may be a potential therapeutic target and biomarker of atherosclerosis in the future.

Results of Excimer Laser Ablation Combined with Drug-Coated Balloon for Atherosclerotic Obliterans of Lower Extremity and Risk Factors for Loss of Primary Patency.

BACKGROUND: The results of excimer laser ablation (ELA) combining with drug-coated balloon (DCB) in the treatment for atherosclerotic obliterans (ASO) remains unclear. METHODS: Retrospectively enrolled patients who underwent ELA combined with DCB in 2 centers. The primary endpoint was primary patency, and secondary endpoints included technical success, procedure-related complications, major amputation, clinically driven target lesions reintervention (CD-TLR), measurements of ankle-brachial index (ABI), and quality of life (QoL). RESULTS: 102 patients were enrolled. The primary patency was 86.7% (95% confidence interval [CI]: 72.9%-89.0%) at 12 months and 82.6% (95% CI: 78.2%-92.1%) at 24 months. The freedom from reintervention was 87.8% (95% CI: 79.5%-92.9%) at 12 months and 86.6% (95% CI: 78.1%-92.0%) at 24 months. The ABI measurement and QoL were significantly improved at each follow-up point. Sixteen (15.7%) patients lost the primary patency. Patients losing the primary patency demonstrated higher Rutherford class (P = 0.004), worse runoff (P < 0.001), higher Peripheral Arterial Calcium Scoring System (PACSS) (P < 0.001), and smaller ratio of tube diameter to reference vessel diameter (TD/RVD) (P < 0.001) compared with patients without losing it. The run-off ≥7 (adjusted odds ratio [aOR]: 34.3; 95% CI: 2.9-398.3; P = 0.005) and TD/RVD <4.9 (aOR: 24.7; 95% CI: 1.7-359.5; P = 0.019) were independent risk factors for loss of primary patency. CONCLUSIONS: ELA combined with DCB seemed an effective and safe treatment for ASO of lower extremity, and it could not only reduce the implantation of stent but significantly improve QoL. The run-off ≥7 and TD/RVD <4.9 were independent risk factors for loss of primary patency.

The Role of Multiple Re-Entry Tears in Type B Aortic Dissection Progression: A Longitudinal Study Using a Controlled Swine Model.

PURPOSE: False lumen (FL) expansion often occurs in type B aortic dissection (TBAD) and has been associated with the presence of re-entry tears. This longitudinal study aims to elucidate the role of re-entry tears in the progression of TBAD using a controlled swine model, by assessing aortic hemodynamics through combined imaging and computational modeling. MATERIALS AND METHODS: A TBAD swine model with a primary entry tear at 7 cm distal to the left subclavian artery was created in a previous study. In the current study, reintervention was carried out in this swine model to induce 2 additional re-entry tears of approximately 5 mm in diameter. Computed tomography (CT) and 4-dimensional (4D) flow magnetic resonance imaging (MRI) scans were taken at multiple follow-ups before and after reintervention. Changes in aortic volume were measured on CT scans, and hemodynamic parameters were evaluated based on dynamic data acquired with 4D-flow MRI and computational fluid dynamics simulations incorporating all available in vivo data. RESULTS: Morphological analysis showed FL growth of 20% following the initial TBAD-growth stabilized after the creation of additional tears and eventually FL volume reduced by 6%. Increasing the number of re-entry tears from 1 to 2 caused flow redistribution, with the percentage of true lumen (TL) flow increasing from 56% to 78%; altered local velocities; reduced wall shear stress surrounding the tears; and led to a reduction in FL pressure and pressure difference between the 2 lumina. CONCLUSION: This study combined extensive in vivo imaging data with sophisticated computational methods to show that additional re-entry tears can alter dissection hemodynamics through redistribution of flow between the TL and FL. This helps to reduce FL pressure, which could potentially stabilize aortic growth and lead to reversal of FL expansion. This work provides a starting point for further study into the use of fenestration in controlling undesirable FL expansion. CLINICAL IMPACT: Aortic growth and false lumen (FL) patency are associated with the presence of re-entry tears in type B aortic dissection (TBAD) patients. Guidelines on how to treat re-entry tears are lacking, especially with regards to the control and prevention of FL expansion. Through a combined imagining and computational hemodynamics study of a controlled swine model, we found that increasing the number of re-entry tears reduced FL pressure and cross lumen pressure difference, potentially stabilising aortic growth and leading to FL reduction. Our findings provide a starting point for further study into the use of fenestration in controlling undesirable FL expansion.

Spot Stenting Combined With False Lumen Endovascular Occlusive Repair for Post-dissection Abdominal Aortic Aneurysm.

PURPOSE: To introduce a new spot stenting, combined with a false lumen endovascular occlusive repair (SS-FLEVOR) technique for treating post-dissection abdominal aortic aneurysms. TECHNIQUE: This technique is demonstrated in a 74-year-old man who received an initial thoracic endovascular aortic repair 7 years ago and suffered from distal aortic expansion during the follow-up session. All the tears located more than 15 mm away from the orifice of visceral arteries were excluded by spot stenting in the aortic true lumen. Then, a compliant stent-graft was implanted in the false lumen to seal the tears near the visceral arteries orifice from the outside. In addition, coils were deployed to block the potential backflow from the intercostal arteries and to induce false lumen thrombosis. Moreover, visceral arteries originated from false lumen were repaired by covered-stents implanted from the true lumen. The distal iliac arteries were sealed either with iliac extensions or cover-stents. This new technique has been applied in 5 patients, resulting in 100% technical success and encouraging intermediate outcomes. CONCLUSION: SS-FLEVOR is a feasible and safe technique to promote false lumen thrombosis in selected cases.

A Comparison of Clinical Outcomes of Endovascular Repair Versus Open Surgery for Ruptured Descending Thoracic Aorta.

OBJECTIVE: The comparisons between thoracic endovascular aortic repair for ruptured thoracic aorta (TEVAR) and open surgery (OS) have not been well documented, although both procedures have been widely utilized. We performed a systematic review and meta-analysis to investigate the effectiveness and safety between TEVAR and OS in the repair of ruptured descending thoracic aorta. METHODS: PubMed, Embase, and Cochrane Library databases were searched to find relevant studies to assess TEVAR and OS outcomes. The comparative parameters were perioperative mortality (30 day/in-hospital), 1 year mortality, paraplegia or paraparesis, renal insufficiency, stroke, pulmonary embolism, re-intervention rate, pulmonary complications, and cardiac complications. A fixed-effects model was applied to calculate the odds ratio (OR) with a 95% confidence interval (CI) on pooled outcomes from different studies. RESULTS: Eighteen observational trials involving 2088 patients were evaluated (TEVAR=560; OS=1528). Meta-analysis showed that TEVAR in repairing the ruptured descending thoracic aorta was associated with lower perioperative mortality (OR=0.47; 95% CI: 0.34-0.66; p<0.01), 1 year mortality (OR=0.46; 95% CI: 0.29-0.75; p<0.01), renal insufficiency incidence (OR=0.56; 95% CI: 0.33-0.93; p=0.03), and pulmonary complications (OR=0.69; 95% CI: 0.52-0.92; p=0.01) when compared with OS. There was no significant difference between TEVAR and OS in terms of paraplegia, stroke, pulmonary embolism, cardiac complications, and early re-intervention rates. However, the late re-intervention rate was higher in the TEVAR group than that in the OS group. CONCLUSIONS: When repairing the ruptured descending thoracic aorta, TEVAR may be performed rapidly and safely. TEVAR is associated with lower rates of perioperative morbidity and early postoperative complications than OS.

Midterm Outcomes of an Adjustable Puncture Device for In Situ Fenestration During Thoracic Endovascular Aortic Repair.

OBJECTIVE: To evaluate the midterm outcomes of in situ fenestration (ISF) with an adjustable puncture device for aortic arch branch preservation during thoracic endovascular aortic repair (TEVAR). METHODS: From October 2016 to April 2019, patients with complicated type B aortic dissection, thoracic aortic aneurysm > 5.5 cm in diameter, or aortic penetrating ulcer with a base > 20 mm or depth > 15 mm, who received TEVAR requiring a proximal sealing beyond zone 3 and underwent ISF using an adjustable puncture device, were included. After the procedure, patients were monitored at one, three, six, and 12 months, and annually thereafter. Peri-operative and follow up data were collected and analysed. RESULTS: Fifty of 51 patients (98%) received successful ISFs. One, two, or three aortic arch branches were preserved in 44, six, and one patient, respectively. Intra-operatively, eight type Ia endoleaks and one type II endoleak were found on angiography. One patient died of cerebral hernia three days post-procedure from a severe stroke; one patient suffered from transient paraplegia but recovered in two weeks; one patient had a non-disabling stroke. The median follow up was 31 months (22.5 - 36.5 months). At six month follow up, all nine unmanaged endoleaks had disappeared. One new type Ia endoleak was identified in a patient at the one month follow up which resolved spontaneously one year later. All revascularised arteries were patent at the last follow up. No fractures, migrations, or bridging stent kinks were found. CONCLUSION: In this largest mechanical based ISF study to date, an adjustable puncture device was shown to facilitate the procedure of ISF during endovascular repair of aortic diseases involving the aortic arch, with high success. The midterm outcome demonstrates the efficacy and safety of the device in assisting with preservation of aortic arch branches.

Excimer laser ablation combined with drug-coated balloon versus drug-coated balloon in the treatment of de novo atherosclerotic lesions in lower extremities (ELABORATE): study protocol for a real-world clinical trial.

BACKGROUND: The efficacy and validity of excimer laser ablation (ELA) in the in-stent restenosis (ISR) has been confirmed. However, its application in de novo atherosclerotic lesions of lower extremity artery disease (LEAD) has not been clearly defined and its procedure has not been standardized. METHODS: ELABORATE is a prospective, multicenter, real-world study designed to evaluate the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in de novo atherosclerotic lesions of LEAD. DISCUSSION: ELABORATE is a prospective, multicenter, real-world study designed to assess the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in patients with de novo atherosclerotic lesions of LEAD. According to the real-world situation, eligible patients will be allocated to ELA + DCB group (group E) and DCB group (group C). Baseline and follow-up information (at 3, 6, and 12 months) will be collected. The primary efficacy point is primary patency at 12-months, and the secondary efficacy points include clinically driven target lesion reintervention (CD-TLR), change of Rutherford class, ankle-brachial index and ulcer healing rate. These indexes will be assessed and recorded at 3, 6, and 12-month follow-up. Also, safety evaluation, including major adverse event, all-cause mortality through 30-day follow-up, unplanned major amputation, bailout stent and distal embolization, will also be evaluated by an independent core laboratory. All the data will be collected and recorded by the electric data capture system. This study will be finished in 3 years and the 12-month results will be available in 2023. All the patients will be followed for 5 years. Trial registration number Chinese Clinical Trial Registry (ChiCTR2100051263). Registered 17 September 2019. http://www.chictr.org.cn/listbycreater.aspx .

Aortic-Related Readmission After Thoracic Endovascular Aortic Repair for Type B Aortic Dissection Patients: A Single-Center Retrospective Study.

OBJECTIVES: This study aimed to investigate the characteristics of and risk factors for aortic-related readmission after thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD). METHODS: Data from TBAD patients who underwent TEVAR from 2009-2018 at a Chinese tertiary center were retrospectively collected and analyzed. Enrolled patients were categorized into 2 groups according to whether aortic-related readmission occurred during follow-up, which was defined as hospitalization at least once after the initial procedure due to events that were related to or caused by aortic dissection or the initial procedure. RESULTS: A total of 1 288 TBAD patients were enrolled, and 99 patients experienced aortic-related readmissions (7.7%), among whom chronic patients had the highest readmission rate (9.8%). The yearly proportion of readmission during the first year after initial procedure revealed a decreasing trend with a -9.7% annual percentage change. Seventy-one patients underwent reintervention (71.7%). Distal aneurysmal degeneration (43.7%) and distal stent graft-induced new entries (32.4%) were 2 major causes for reintervention. Fourteen patients in the reintervention subgroup underwent a second reintervention (19.7%). In-hospital mortality was 1.0% during the readmission and 14.3% during the second readmission. The overall survival was comparable between two groups (P = 0.93). CONCLUSIONS: This study highlighted the importance of surveillance after initial procedure for TBAD patients with potential risk factors for aortic-related readmission, and the predisposition of patients with reintervention to multiple readmissions deserves attention.

A systematic review and meta-analysis on endovascular treatment as an attractive alternative for acute superior mesenteric venous thrombosis.

OBJECTIVE: This systematic review and meta-analysis evaluated the published data on the efficacy and safety of therapies for superior mesenteric venous thrombosis (SMVT), aiming to provide a reference and set of recommendations for clinical treatment. METHODS: Relevant databases were searched for studies published from 2000 to June 2020 on SMVT treated with conservative treatment, surgical treatment, or endovascular approach. Different treatment types were grouped for analysis and comparison, and odds ratios with corresponding 95% confidence intervals were calculated. The outcomes were pooled using meta-analytic methods and presented by forest plots. RESULTS: Eighteen articles, including eight on SMVT patients treated with endovascular therapies, were enrolled. The treatment effectiveness was compared between different groups according to the change of symptoms, the occurrence of complications, and mortality as well. The conservative treatment group had better efficacy compared to the surgery group (89.0% vs. 78.6%, P <0.05), and the one-year survival rate was also higher (94.4% vs. 80.0%, P >0.05), but without statistical significance. As for endovascular treatment, the effectiveness was significantly higher than the surgery group (94.8% vs. 75.2%, P <0.05), and the conservative treatment group as well (93.3% vs. 86.3%, P >0.05), which still requires further research for the lack of statistical significance. CONCLUSIONS: Present findings indicate that anticoagulation, as conservative treatment should be the preferred clinical option in the clinic for SMVT, due to its better curative effect compared to other treatment options, including lower mortality, fewer complications, and better prognosis. Moreover, endovascular treatment is a feasible and promising approach that is worth in-depth research, for it is less invasive than surgery and has relatively better effectiveness, thus can provide an alternative option for SMVT treatment and may be considered as a reliable method in clinical.

Clinical features and outcomes after endovascular therapy for penetrating aortic ulcer and intramural hematoma.

OBJECTIVES: To identify the differences between clinical features and outcomes after endovascular therapy for penetrating aortic ulcer (PAU) and intramural hematoma (IMH). METHODS: From January 2009 to March 2020, patients who underwent endovascular therapy for PAU and IMH were enrolled. Information on patient demographics, presentation, PAU and IMH morphology, laboratory examination, and clinical follow-up information was collected and analyzed. Univariate analysis was performed to identify the differences between IMH and PAU, and Kaplan-Meier was used to calculate the cumulative survival rate and freedom from reintervention. RESULTS: A total of 114 patients were enrolled; 80 (70.2%) of them were diagnosed with PAU. Compared with PAU, patients with IMH were younger (p = 0.006), more likely to be admitted emergently (p = 0.001), had longer hospital stay (p = 0.028), and had higher levels of C-reactive protein (p = 0.030). Meanwhile, patients with IMH were more likely to be associated with hypertension (p = 0.020) and pleural effusion (p < 0.001) and less likely to have a history of acute coronary syndrome (p = 0.019) and prior cardiovascular intervention (p = 0.017). The five-year freedom from reintervention and cumulative survival rate were 94.2% (95% confidential interval, 88.9%-99.9%) and 87.8% (95% confidential interval, 79.5%-96.9%) in PAU patients and 89.6% (95% confidential interval, 75.8%-99.9%) and 85.1% (95% confidential interval, 68.0%-99.9%) in IMH patients, respectively. There was no significant difference in freedom from reintervention (p = 0.795) or cumulative survival rate (p = 0.817). CONCLUSIONS: IMH appeared to occur in younger patients with hypertension and usually had an acute onset, while PAU was more likely to be found incidentally in older patients with atherosclerosis. Endovascular therapy was effective in both IMH and PAU patients with encouraging outcomes.

Preoperative high lymphocyte-to-monocyte ratio is associated with intraoperative type I endoleak in patients with TAA with TEVAR.

OBJECTIVES: Various inflammatory factors are closely associated with the incidence of thoracic aortic aneurysms (TAAs). Furthermore, the severity of inflammation is closely related to the absolute value and proportion of each leukocyte subgroup. Only few reports have analyzed the importance of lymphocyte-monocyte ratio (LMR) as a potential inflammatory marker in vascular diseases. Therefore, we aimed to investigate the effect of peripheral blood LMR on thoracic endovascular aortic repair (TEVAR) in patients with TAA. METHODS: A retrospective study of the clinical data collected in our hospital between January 2016 and January 2021 was performed on 162 patients with TAA treated with TEVAR, based on the inclusion and exclusion criteria for patient selection. Based on whether the patient had the clinical symptoms at admission and the occurrence of type I endoleaks during operation, patients were divided into two groups, respectively: an intraoperative type I endoleak group (n = 34) and a group without intraoperative type I endoleak (n = 128), and a group with clinical symptoms (n = 31) and a group without clinical symptoms (n = 131). The clinical data of these two groups were compared, the free from second intervention rates related to endoleak and the preoperatively LMR of the two groups was calculated. LMR was calculated preoperatively. Receiver-operating characteristic curve analysis was used to determine the cut-off for preoperative LMR values. Based on the cut-off point, patients were divided into a high LMR group (n = 34) and a low LMR group (n = 128). The clinical data of the two groups were compared, and further stratified analysis was performed. RESULTS: A total of 162 patients were included in the analysis. All patients were successfully implanted with a thoracic aorta stent graft. The preoperative LMR level and postoperative endoleak-related secondary intervention rate were higher in the type I endoleak group than those in the group without intraoperative type I endoleaks. The preoperative C-reactive protein (CRP) level of patients with TAA with clinical symptoms was higher than that of asymptomatic patients. There was a negative correlation between preoperative CRP and LMR levels. In addition, in symptomatic or asymptomatic patients, the LMR level was associated with the occurrence of intraoperative type I endoleaks. After excluding the influence of type of endografts, our results showed that the clinical symptoms did not affect the occurrence of the intraoperative type I endoleak, and patients with intraoperative type I endoleak had a higher rate of postoperative secondary intervention. CONCLUSION: Patients with TAA with type I endoleaks during TEVAR had an increased rate of secondary intervention related to endoleaks. Patients with TAA with high LMR levels before TEVAR were more likely to have endoleaks during operation.

Surgical outcomes and factors associated with malignancy in carotid body tumors.

OBJECTIVE: To compare the surgical outcomes of benign and malignant carotid body tumor (CBT), and to evaluate the associated factors of malignant CBT. METHODS: Patients who underwent surgical resection of CBT from 2005 to 2018 in a tertiary center were reviewed retrospectively. The common study follow-up end date was December 31, 2019. The tumor size was measured as the maximum transverse diameter on computed tomography scan. Surgical outcomes of benign and malignant CBT were compared. Associated factors of malignancy were analyzed by multivariate logistic analysis. RESULTS: There were 229 patients undergoing CBT resection. Sixteen patients were diagnosed with malignant CBT. The median follow-up time was 66 months (range, 6-142 months). Basic information including age, sex, course of disease, family history, lesion side, tumor size, and Shamblin classification showed no significant differences between the benign and malignant CBT groups. Patients with malignant CBTs showed a higher rate of preoperative symptoms (31.3% vs 12.2%; P < .05). The rates of vascular reconstruction or repair (P < .01) and neurologic complications (P < .05) were significantly higher in the malignant CBT group. In addition, a significantly longer average procedural time was required for malignant CBTs (P < .05). However, the estimated blood loss and length of hospital stay showed no significant difference. Multivariate logistic regression analysis revealed that the malignant odds of CBT with bilateral lesions (P = .0042; odds ratio, 8.30; 95% confidence interval, 1.84-35.88) or CBT with preoperative symptoms (P = .0016; odds ratio, 7.59; 95% confidence interval, 2.13-27.89) were high. CONCLUSIONS: Compared with benign CBT, malignant CBT is prone to invasive clinical behaviors, resulting in an increased possibility of vascular reconstruction or repair during the surgery as well as postoperative neurologic complications. In addition, the malignant odds of CBT with bilateral lesions or CBT with preoperative symptoms are high.

Morphologic characteristics and endovascular management of acute type B dissection patients with superior mesenteric artery involvement.

OBJECTIVE: Despite its association with static mesenteric malperfusion, the morphologic characteristics and optimal management of acute type B aortic dissection (ABAD) with superior mesenteric artery (SMA) involvement are poorly understood. We studied the associated risk factors and reported the outcomes of endovascular treatment. METHODS: From May 2016 to May 2018, we examined 212 consecutive patients with ABAD in our center. Those with SMA involvement (SMAI) were included in the present study and divided into those with and without mesenteric malperfusion (MMP) according to the clinical findings. After thoracic endovascular aortic repair (TEVAR) with or without SMA revascularization, we compared the clinical data, imaging results, and outcomes for those with and without MMP. RESULTS: Computed tomography angiography confirmed 44 cases of SMAI: 12 (27.3%) with MMP and 32 (72.7%) without MMP. The patients with MMP had presented more frequently with lower extremity malperfusion (33.3% vs 3.1%; P = .023) than had those without MMP, with an odds ratio of 14.15 (P = .047). Multivariate analysis showed that patients with a low true lumen (TL)/false lumen (FL) diameter ratio of the SMA (TL/FL-SMA <1) had a greater risk of developing MMP than those with a high TL/FL-SMA ratio of >1 (odds ratio, 8.49; 95% confidence interval, 1.24-58.26; P = .029). SMA TL thrombosis was a significant predictor of the requirement for additional SMA revascularization after TEVAR among patients with MMP (P = .045). During a mean 10-month follow-up period, complete FL thrombosis in the SMA was seen in 11 patients (25%; 33.3% with MMP vs 21.9% without MMP; P = .43). The overall mortality rate was 6.82% (16.7% in the MMP group and 3.1% in the non-MMP group; P = .09). CONCLUSIONS: In the present study, limb ischemia and the TL/FL-SMA ratio were two independent predictors for the development of MMP in patients with ABAD and SMAI. We found that TEVAR can be safely performed for these patients, and SMA TL thrombosis predicted for the need for SMA revascularization.

Outcomes of endovascular stent graft repair for penetrating aortic ulcers with or without intramural hematoma.

OBJECTIVE: We investigated the outcomes of endovascular repair for penetrating aortic ulcers (PAUs) with and without intramural hematoma (IMH). METHODS: Patients with PAUs who had undergone thoracic endovascular aortic repair (TEVAR) or endovascular abdominal aortic repair (EVAR) at our center were enrolled. Patient demographics, presenting symptoms, and anatomic characteristics were collected and analyzed to investigate the TEVAR/EVAR indications, perioperative complications, and mortality. RESULTS: We identified 138 patients with PAU. Of the 138 patients, 58 (42.0%) had also had IMH. Compared with the patients without IMH, the patients with IMH had had significantly greater emergency admission rates (P < .01), a larger aortic diameter (P = .03), and a greater incidence of stent-induced new entry development (P = .02). No significant differences were found in mortality or freedom from reintervention between patients with PAUs with and without IMH during follow-up. However, the cumulative survival rates calculated using Kaplan-Meier analysis for patients who had undergone TEVAR/EVAR during their first hospitalization were significantly greater than those who had undergone delayed TEVAR/EVAR during follow-up. CONCLUSIONS: TEVAR/EVAR was safe and effective, with encouraging outcomes for patients with PAUs with or without IMH, and can be used more aggressively for symptomatic patients. The presence of PAUs with IMH did not seem to adversely affect long-term mortality. However, but stent-induced new entry was more likely to develop.

Predictors of Ipsilateral New Ischemic Lesions on Diffusion-Weighted Imaging after Carotid Artery Stenting in Asymptomatic Patients: A Retrospective Observational Study with Conventional Multicontrast MRI.

BACKGROUND: The purpose of this study was to identify the independent risk factors for ipsilateral new ischemic lesions (NILs) during carotid artery stenting (CAS). METHODS: In patients treated with CAS, the association between postoperative ipsilateral NILs on diffusion-weighted imaging (DWI) and patient demographics, intraoperative factors, the presence of plaque components, the semiquantitative grading of component size on multicontrast magnetic resonance imaging (MRI) were retrospectively analyzed. RESULTS: Ipsilateral NILs on DWI were detected in 85 (39.2%) patients. The debris was observed on the surface embolic protection devices in 70.97% of patients. Univariate analysis showed that different stages of intraplaque hemorrhage (IPH) (along with lipid-rich necrotic core [LRNC]) (P < 0.001), size of IPH (P < 0.001), calcification (CA) (P = 0.045), and LRNC (without IPH) (P < 0.001) as well as postdilation (P < 0.001)), stent type (P = 0.001), and aortic arch ulcer (P = 0.004) were associated with postoperative ipsilateral NILs. Multivariate logistic regression analysis showed that the acute and recent IPH (along with LRNC) (odds ratio [OR]: 5.77, P < 0.002 and OR: 28.66, P < 0.001, respectively), LRNC size in Grade 2 (OR: 6.10, P < 0.001) were independent risk factors for ipsilateral NILs. Aortic arch ulcer (OR: 3.44, P = 0.002), postdilation (OR: 4.72, P = 0.04) and open cell stent (OR: 2.88, P < 0.016) were also significantly related to ipsilateral NILs on DWI after CAS. There was a significant correlation between IPH at different stages and their grade of size (correlation coefficient: 0.89; P < 0.001). CONCLUSION: The IPH and larger LRNC along with the aortic arch ulcer, postdilation and open cell stent are associated with increased risk of ipsilateral NILs on DWI after CAS procedure. Preoperative staging of IPH and semiquantitative grading of size of plaque components based on multi-contrast MRI may be useful for predicting ipsilateral cerebral ischemic events after CAS.

Efficacy and Safety of a Novel Helical Self-Expanding Nitinol Stent for Femoropopliteal Artery Obliterans Disease.

BACKGROUND: The aim of this study was to evaluate the efficacy and safety of a novel self-expanding nitinol stent (Smartflex stent) in femoropopliteal artery obliterans disease. METHODS: From June 2016 to May 2019, patients with atherosclerotic occlusion disease of the superficial femoral and popliteal arteries using the Smartflex stents were retrospectively analyzed in our institution. Patients were monitored at 1, 3, 6, and 12 months and annually thereafter. The main characteristics of the diseased vessels, perioperative and follow-up outcome were evaluated. Kaplan-Meier method was used to assess patency rate and the rate of freedom from clinically driven target lesion revascularization (CD-TLR). RESULTS: A total of 50 limbs from 48 patients (mean age 69.4 ± 8.95 years; 38 men) were included. Eighty-eight Smartflex stents (1.76 stents per limb) were deployed successfully. Of the study patients, 82% had claudication (Rutherford III), 10% had rest pain (Rutherford IV), and 8% had tissue loss (Rutherford V). Trans-Atlantic Inter-Society Consensus II C and D lesions were 26% and 42%, respectively. The mean lesion length was 18.2 ± 8.5 cm and the mean stented length was 22.3 ± 9.9 cm. The average follow-up time was 16.4 ± 8.2 months. Of these lesions, 42 (94%) were chronic total occlusions and 16 (32%) were severely calcified. The primary patency rate at 1 year per Kaplan-Meier estimating, the rate of freedom from CD-TLR at 1 year, and the second patency rate was 83.3%, 88.1%, and 94%, respectively. Among them, 90% patients had improved ankle-brachial indexes (0.47 ± 0.13 before and 0.84 ± 0.16 after). No stent fractures and kinking were identified. CONCLUSIONS: Stenting of the femoropopliteal artery diseases using the Smartflex stent appeared to be safe and effective. It performed well in long-segment and above knee joint lesions.