Endovascular Denervation for the Improvement of Limb Ischemia in Patients with Peripheral Artery Disease: A Randomized Clinical Trial.

BACKGROUND: To evaluate the safety and efficacy of endovascular denervation (EDN) as an adjunct to percutaneous vascular intervention (PVI) for peripheral artery disease (PAD). METHODS: From August 2019 to April 2021, 38 eligible patients with PAD enrolled in this study were randomly and equally assigned into 2 groups: the PVI group and the PVI + EDN group treated with EDN at the iliac and femoral arteries before PVI. The primary endpoint was the improvement in the ankle brachial index at 6 months after the procedure. The secondary endpoints were transcutaneous oxygen pressure (TcPO2), Rutherford category, numerical rating scale score, and safety. RESULTS: The technical success rates of PVI and EDN were 100%, and no device-related or procedure-related major adverse events occurred in either group. Compared with PVI alone, PVI + EDN demonstrated a significant improvement in limb hemodynamics at 6 months (Δ ankle brachial index 0.44 ± 0.31 vs. 0.24 ± 0.15, P = 0.018). Microcirculatory perfusion of PAD was significantly better at 6 months in the PVI + EDN group (ΔTcPO2, 15.68 ± 16.72 vs. 4.95 ± 13.43, P = 0.036). The Rutherford category was significantly improved in the PVI + EDN group in comparison with the PVI group at the 3-month follow-up (100.00% vs. 68.42%, P = 0.02). The decrease in the numerical rating scale score in the PVI + EDN group was greater than that in the PVI group at 1 week following the procedure (3 [2-5] vs. 4 [4-6], P = 0.022). CONCLUSIONS: In this single-center pilot analysis of a heterogeneous cohort of patients with PAD, PVI with EDN demonstrated a significant improvement in limb ischemia at 6 months compared with PVI alone.

Risk Factors for Access-Related Adverse Events Related to the Preclose Technique in Thoracic Endovascular Aortic Repair.

PURPOSE: To analyze the risk factors for access-related adverse events (AEs) of the preclose technique in thoracic endovascular aortic repair (TEVAR). MATERIALS AND METHODS: Ninety-one patients with Stanford type B aortic dissection who underwent the preclose technique in TEVAR between January 2013 and December 2021 were included. According to the occurrence of access-related AEs, the patients were divided into 2 groups: those with AE and those without AE. Age, sex, combined diseases, body mass index, skin depth, femoral artery diameter, access calcification, iliofemoral artery tortuosity, and sheath size were recorded for risk factor analysis. The sheath-to-femoral artery ratio (SFAR), the ratio of the femoral artery inner diameter (in millimeters) to the sheath's outer diameter (in millimeters), was also included in the analysis. RESULTS: SFAR was identified as an independent risk factor for AEs using multivariable logistic analysis (odds ratio, 251.748; 95% CI, 7.004-9,048.534; P = .002). The cutoff value of SFAR was 0.85 and was related to a higher incidence of access-related AEs (5.2% vs 33.3%, P = .001), especially to a higher stenosis rate (0.0% vs 21.2%, P = .001). CONCLUSIONS: SFAR is an independent risk factor for access-related AEs of preclose in TEVAR with a cutoff value of 0.85. SFAR could be a new criterion for preoperative access evaluation in high-risk patients that may allow the detection and treatment of access-related AEs at the early stage.

Comparison of Micro-Clamping Stent-Retriever Thrombectomy with Conventional Stent-Retriever Thrombectomy in Intracranial Large Vessel Embolism.

OBJECTIVE: To evaluate the effectiveness of micro-clamping stent-retriever thrombectomy (MSRT) in patients with acute ischemic stroke with intracranial large vessel embolism (ILVE), and compare it with that of conventional stent-retriever thrombectomy (CSRT). METHODS: We retrospectively evaluated 108 patients with ILVA treated by MSRT (n = 52) or CSRT (n = 56) from the 2 participating institutions between January 2016 and November 2017. The rates of successful (Modified Thrombolysis in Cerebral Infarction [mTICI] grade 2b or 3) and complete reperfusion (mTICI grade 3), time from guide catheter placement to reperfusion, rates of first-pass success, and the number of passes for reperfusion were compared between the MSRT and CSRT groups. RESULTS: The complete reperfusion (mTICI 3) rates by MSRT were significantly higher than those achieved with CSRT (78.8% [41/52] vs. 57.1% [32/56], respectively; P = 0.016). Successful reperfusion (mTICI 2b or 3) rates were 92.3% (48/52) in the MSRT group and 83.9% (47/56) in the CSRT groups (P = 0.181). The mean number of passes for reperfusion was significantly lower with MSRT compared with CSRT (1.5 ± 0.2 vs. 2.5 ± 0.5, respectively; P = 0.001). The first-pass success rates were significantly higher in the MSRT group than in the CSRT group (65.4% [34/52] vs. 28.6% [16/56]; P = 0.0001). The mean time from guide catheter placement to reperfusion was significantly shorter in the MSRT group (20.5 ± 6.6 minutes vs. 46.3 ± 7.6 minutes; P = 0.001). CONCLUSIONS: These findings suggest that the complete reperfusion rates and mechanical thrombectomy efficiency in patients with ILVE are better after MSRT compared with CSRT.

Bariatric Embolization of the Left Gastric Arteries for the Treatment of Obesity: 9-Month Data in 5 Patients.

PURPOSE: The purpose of this study is to investigate the safety and 9-month effectiveness of transcatheter left gastric artery embolization (LGAE) for treating patients with obesity. MATERIALS AND METHODS: The protocol of this study was approved by the Institutional Ethics Review Board. Five obese patients (3 men and 2 women) with mean weight of 102.0 ± 16.19 kg (range, 82.1-125.5 kg) and mean body mass index (BMI) of 38.1 kg/m2 ± 3.8 (range, 32.9-42.4 kg/m2) underwent LGAE with polyvinyl alcohol (PVA) particles in diameter of 500-710 µm. The primary endpoint was the safety by grading the adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0) within 30 days after LGAE. The secondary endpoints were measured with serum ghrelin and leptin levels, body weight, waist circumference, waist-to-height ratio, and abdominal fat quantity on MRI at the day immediately before LGAE and every 3 months after LGAE. RESULTS: LGAE was successfully performed in all patients. A superficial linear ulceration below the cardia was seen in 1 patient 3 days after LGAE and healed within 30 days. No other serious AEs (grade III or above) occurred. Average body weight loss at 3, 6, and 9 months was 8.28 ± 7.3 kg (p = 0.074), 10.42 ± 8.21 kg (p = 0.047), and 12.9 ± 14.66 kg (p = 0.121), respectively. The level of serum ghrelin decreased by 40.83% (p = 0.009), 31.94% (p = 0.107), and 24.82% (p = 0.151) at 3, 6, and 9 months after LGAE, respectively. There was minimal reduction of leptin levels at 3 and 6 months following LGAE (decreased by 0.26%, p = 0.929, and 4.33%, p = 0.427, respectively), but it declined obviously 9 months after LGAE (decreased by 11.22%, p = 0.295). Both waist circumference and waist-to-height ratio decreased after LGAE. MRI showed the area of subcutaneous adipose tissue decreased from the baseline of 400.90 ± 79.25 to 320.36 ± 68.06 cm2 (decreased by 20.09%, p = 0.006) at 3 months, to 328.31 ± 52.67 cm2 (decreased by 18.11%, p = 0.020) at 6 months, and to 286.40 ± 55.72 cm2 (decreased by 28.52%, p = 0.101) at 9 months after LGAE, respectively. But the decrease of abdominal fat loss at 9 months after LGAE was largely due to the reduction in visceral adipose tissue. CONCLUSIONS: Our study with 9-month data in 5 patients indicates that bariatric embolization of the LGA is a safe and may be a promising strategy to suppress the production of ghrelin and results in weight loss and abdominal fat reduction. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02786108).

Endovascular Repair Compared With Medical Management of Patients With Uncomplicated Type B Acute Aortic Dissection.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) has been used in patients with uncomplicated type B acute aortic dissection (B-AAD) to reduce late morbidity and mortality. The outcomes of comparisons between TEVAR and best medical treatment (BMT) on patients with uncomplicated type B-AAD are inconsistent in the published reports. OBJECTIVES: This study sought to further clarify the early and long-term (11-year) outcomes of TEVAR in patients with uncomplicated type B-AAD compared with those with BMT treatment. METHODS: Between February 2003 and August 2014, 338 patients with uncomplicated type B-AAD were retrospectively identified in 3 tertiary medical centers. Information about baseline characteristics was collected from medical records. Images were retrieved from the imaging archiving system, and the thrombosis status of the false lumen and extent of the dissection were evaluated via computed tomography angiography. Early and late outcomes were recorded and analyzed. RESULTS: TEVAR procedures were performed on 184 patients (TEVAR group) and BMT for 154 patients (BMT group). Early events and 30-day mortality were not significantly different between the 2 groups. Patients receiving BMT had significantly higher aortic-related adverse events compared with those in the TEVAR group (p = 0.025). All-cause mortality with TEVAR was significantly lower than that of BMT (p = 0.01). CONCLUSIONS: This study confirmed the feasibility of TEVAR for uncomplicated type B aortic dissection in the acute setting with fewer aortic-related adverse events and a lower mortality rate compared with BMT.

Treatment of acute type-B aortic dissection: thoracic endovascular aortic repair or medical management alone?

OBJECTIVES: This study sought to evaluate the early and long-term effect of thoracic endovascular aortic repair (TEVAR) on type-B acute aortic dissection (AAD). BACKGROUND: Uncomplicated type-B AAD is generally treated with medical management; complicated dissections require surgery or TEVAR. Studies have demonstrated that long-term outcomes with medical management are suboptimal. Therefore, we sought to determine the long-term effect of TEVAR compared with medical management alone on type-B AAD. METHODS: From January 2004 to May 2008, 193 consecutive patients in 2 hospitals were treated and retrospectively placed into 1 of 2 groups: 1) the TEVAR group-type-B AAD treated with TEVAR and antihypertensive medications (n = 152); and the 2) medicine group-uncomplicated type-B AAD treated medically alone (n = 41). All TEVAR procedures were performed in the acute phase. RESULTS: There were no significant differences in demographics, comorbidity profiles, or early events between groups. The cumulative freedom from all late adverse events at 1, 3, and 5 years was 97%, 89%, and 67% in the TEVAR group and 97%, 63%, and 34% in the medicine group. Log-rank tests showed that medically treated patients had more late adverse events than TEVAR-treated patients did (p = 0.003). The 5-year cumulative survival rate from all-cause death was not significantly different between the 2 groups. CONCLUSIONS: Patients with type-B AAD treated with TEVAR experienced fewer late adverse events than those treated with medical management, but there was no significant difference among the groups in 5-year mortality rates. Further studies of longer-term survival rates are needed to determine whether TEVAR could be an effective treatment for type-B AAD.

[Value of imaging follow-ups in rabbit spinal metastasis model created by transplantation of VX2 carcinoma under computed tomographic guidance].

OBJECTIVE: To explore the changes of magnetic resonance imaging (MRI) and computed tomography (CT) after transplantation of VX2 carcinoma into lumbar vertebrae of rabbits under CT guidance and examine its relationship with the onset of paralysis. METHODS: A total of 52 rabbits were randomly divided into 4 groups. Under CT guidance, pieces of VX2 carcinoma were transplanted into the first or second lumbar vertebra in Groups A, B and C (n = 14 each) while sham operation was performed in Group D (n = 10). The anticipated endpoints of group A was natural death or Day 50 post-operation, group B Day 3 after onset of paralysis, group C Day 14 post-transplantation and group D natural death or Day 50 post-operation. CT and MR scans were performed at an interval of 7 days and hind limb functions monitored daily post-operation until endpoints. Pathohistological examinations of vertebrae were performed at endpoints. RESULTS: All lumbar vertebrae were successfully transplanted under CT guidance. Thirty-two rabbits with spinal tumor and 9 surviving rabbits in the control group were monitored until endpoints. Abnormal signals on target vertebrae appeared on MRI in all 41 rabbits at Day 7 post-operation while positive CT findings were absent. No abnormal MRI/CT findings were found in 9 control rabbits from Day 14 post-operation to the end of study. Significant differences (P < 0.001) existed between the rates of tumor visualization with 65.6% (21/32) on MR and 3.1% (1/32) on CT at Day 14, 100% (21/21) on MR and 42.9% (9/21) on CT at Day 21. The rates of tumor visualization were 100% on both MR and CT from Day 28 to endpoints. The average survival time of Group A was significantly shorter than Group D (40 ± 4 vs 50 days, P < 0.01). The onset time of paralysis time in Group A (22 ± 5 days) had no significant difference with Group B (22 ± 5 days) (P = 0.952). CONCLUSION: A rabbit model of spinal metastasis is established with high rates of success and reproducibility. Vertebral tumor may be located earlier on MR than CT after transplantation of VX2 carcinoma. The examinations of MRI and CT after Day 7 post-operation are controversial. The survival time of rabbits with paralysis caused by spinal tumor is significantly shortened.

[Active crop canopy sensor-based nitrogen diagnosis for potato].

In the present study, two potato experiments involving different N rates in 2011 were conducted in Wuchuan County and Linxi County, Inner Mongolia. Normalized difference vegetation index (NDVI) was collected by an active GreenSeeker crop canopy sensor to estimate N status of potato. The results show that the NDVI readings were poorly correlated with N nutrient indicators of potato at vegetative Growth stage due to the influence of soil background. With the advance of growth stages, NDVI values were exponentially related to plant N uptake (R2 = 0.665) before tuber bulking stage and were linearly related to plant N concentration (R2 = 0.699) when plant fully covered soil. In conclusion, GreenSeeker active crop sensor is a promising tool to estimate N status for potato plants. The findings from this study may be useful for developing N recommendation method based on active crop canopy sensor.

[Predictive value of serum beta 2-microglobulin level for recurrent stenosis or occlusion in patients with lower limb ischemia undergoing percutaneous transluminal angioplasty].

OBJECTIVE: To evaluate the predictive value of serum beta 2-microglobulin level for recurrent stenosis or occlusion in patient undergoing percutaneous transluminal angioplasty (PTA) for lower limb ischemia. METHODS: Between March 2009 and October 2010, 81 patients were admitted with a diagnosis of lower limb ischemia. Among them, 54 patients had a mean age of 64 ± 12 years. The baseline characteristics, stenting and post-procedure events were collected. And the serum level of beta 2-microglobulin was measured by dynamic timing nephelometry assay. Recurrent stenosis or occlusions were confirmed with color Doppler ultrasonography or CTA imaging. Cox regression univariate analysis was performed with variables with P value < 0.20 to investigate the independent predictors of recurrent stenosis or occlusions. Receiver-operating characteristics curves (ROC) were constructed to evaluate the sensitivity and specificity of this model. RESULTS: The baseline characteristics were evenly distributed in two groups. Twenty-three patients (42.5%) were found to have recurrent stenosis or occlusions. The cumulative primary patency was 85%, 69% and 34%at Month 6, 12 and 24 respectively. The serum levels of beta 2-microglobulin decreased during a follow-up period of 3 months and then increased gradually in patients with recurrent stenosis or occlusion. Cox regression analysis identified the serum level of beta 2-microglobulin as an independent predictor of recurrent stenosis or occlusion (Odds Ratio = 1.459, 95%CI 1.199 - 1.777, P = 0.000). The area under the curve (AUC) of the serum level of beta 2-microglobulin was 0.952 for recurrent stenosis or occlusion. And the sensitivity was 95.7% and the specificity 77.4% on a cut-off value 3.2 mg/L. CONCLUSION: With a cut-off value 3.2 mg/L, the serum level of beta 2-microglobulin may be useful for the prediction of recurrent stenosis or occlusion in patients after lower limb PTA.

Risk factors of incomplete thrombosis in the false lumen after endovascular treatment of extensive acute type B aortic dissection.

OBJECTIVE: This study evaluated the risk factors of incomplete thrombosis in the false lumen after thoracic endovascular aortic repair (TEVAR) in patients with extensive acute type B aortic dissection. METHODS: This was a retrospective study at Zhongda Hospital and Henan Provincial People's Hospital, China. Between January 2005 and May 2008, patients with acute type B dissection who underwent TEVAR at two centers were reviewed and 124 who met the following criteria were included in this study: (1) dissection involving the aorta below the level of the celiac artery, (2) completely patent false lumen at the time of intervention, and (3) complete initial diagnostic computed tomography (CT) scans and all follow-up CT scans available. Exclusion criteria were (1) aortic dissection secondary to trauma, (2) intramural hematoma, and (3) Marfan patients. The main outcome measures were demographics, comorbidity profiles, technical details of procedures, anatomic characteristics of dissection, and false lumen status of thrombosis during follow-up. Ordinal regression analysis was performed with variables that reached P < .20 on univariate analysis to investigate independent risk factors of incomplete thrombosis in the false lumen. RESULTS: Univariate analysis showed that the age at TEVAR, hypertension, maximum diameter of the abdominal aorta and false lumen at the abdominal level, re-entry tears, and visceral branches that arose partially or totally from the false lumen had a P < .20. Further analysis with an ordinal regression model showed that the visceral branches that arose partially or totally from the false lumen (odds ratio [OR], 10.054; P < .001), re-entry tears (OR, 30.661; P < .001), and maximum diameter of the false lumen on the abdominal aorta (OR, 1.265; P = .004) were the significant risk factors of incomplete thrombosis in the false lumen after TEVAR. CONCLUSIONS: Visceral branches that arose partially or totally from the false lumen, re-entry tears, and maximum diameter of the false lumen on the abdominal aorta were the risk factors of incomplete thrombosis in the false lumen after TEVAR in extensive acute type B dissection.

A novel biliary stent loaded with (125)I seeds in patients with malignant biliary obstruction: preliminary results versus a conventional biliary stent.

BACKGROUND & AIMS: Stenting is a palliative therapy method for relieving malignant biliary obstruction. The aim of this study was to evaluate the safety and effectiveness of an irradiation stent compared to a conventional biliary stent in patients with biliary obstruction caused by both primary and metastatic adenocarcinomas. METHODS: Participants were randomly assigned to receive treatment with a biliary irradiation stent (irradiation stent group) or a conventional biliary stent (control group). After stent implantation, the outcomes were measured in terms of relief of obstructive jaundice, survival time, complications related to the procedure. A p value of less than 0.05 indicated a significant difference. RESULTS: The stents were successfully placed in all the 23 patients. The obstructive jaundice was relieved in all patients except three in the control group. The median and mean overall survivals in the irradiation stent group were higher than those in the control group (7.40 months versus 2.50 months, 8.03 months versus 3.36 months, p=0.006). The patients with stent patent at 3, 6, and 12 months in the irradiation stent group were 11 (91.7%), 7 (58.3%), and 1 (8.3%), respectively. While in the control group, 4 (36.4%), 1 (9.1%), and 0 (0%), respectively. There were no significant differences in the complications related to stent insertion between the two groups. CONCLUSIONS: This interim analysis shows that treatment with the biliary intraluminal irradiation stent in patients with biliary obstruction caused by adenocarcinomas appears safe and technically feasible, has benefits in relieving jaundice, and seems to extend survival when compared to a conventional biliary stent.