Biodegradable PTX-PLGA-coated magnesium stent for benign esophageal stricture: An experimental study.

Biodegradable stents can degrade step by step and thereby avoid secondary removal by endoscopic procedures in contrast to metal stents. Herein, a biodegradable composite stent, a magnesium (Mg)-based braided stent with a surface coating of poly (lactic-co-glycolic acid) (PLGA) containing paclitaxel (PTX), was designed and tested. By adding this drug-loaded polymer coating, the radial force of the stent increased from 33 Newton (N) to 83 N. PTX was continuously released as the stent degraded, and the in vitro cumulative drug release in phosphate-buffered saline for 28 days was 115 ± 13.5 µg/mL at pH = 7.4 and 176 ± 12 µg/mL at pH = 4.0. There was no statistically significant difference in the viability of fibroblasts of stent extracts with different concentration gradients (P > 0.05), while the PTX-loaded stents effectively promoted fibroblast apoptosis. In the animal experiment, the stents were able to maintain esophageal patency during the 3-week follow-up and to reduce the infiltration of inflammatory cells and the amount of fibrous tissue. These results showed that the PTX-PLGA-coated Mg stent has the potential to be a safe and effective approach for benign esophageal stricture. STATEMENT OF SIGNIFICANCE: We designed a biodegradable composite stent, having poly (lactic-co-glycolic acid) (PLGA) containing paclitaxel (PTX) coated the surface of the magnesium (Mg)-based braided stent. We evaluated in vitro and in vivo characteristics of the Mg esophageal stent having a PLGA coating plus a variable concentration of PTX in comparison with the absence of PTX PLGA coating. The PTX PLGA stents exerted higher radial force than stents without coating, degraded more quickly in an acid medium, and effectively promoted fibroblast apoptosis in vitro experiments. In a rabbit model of caustic-induced esophageal stricture, there was an increased lumen and decreased inflammation of the esophageal wall in the animals stented with PTX-PLGA versus the sham group, indicating a potential approach for benign esophageal stricture.

Impact of COVID-19 Pandemic on Intervals and Outcomes of Repeated Transarterial Chemoembolization in Patients With Hepatocellular Carcinoma.

PURPOSE: Given that the novel coronavirus disease (COVID-19) pandemic has disrupted operations globally, an institution's ability to repeat transarterial chemoembolization (TACE) for patients with hepatocellular carcinoma (HCC) has also been affected. The aim of this study was to evaluate the impact of the COVID-19 on the intervals and outcomes of TACE in HCC patients. MATERIALS AND METHODS: This retrospective study included 154 HCC patients who underwent follow-up after TACE treatment from January 2020 to March 2020 (n = 71, study group) and January 2019 to March 2019 (n = 83, control group) at two institutions in China. The endpoints included the follow-up interval and overall response rate (ORR). Multivariate logistic regression analyses were performed to identify independent risk factors for a worse ORR. The cut-off point was determined to divide follow-up durations into long- and short-intervals. RESULTS: The median follow-up interval was 82.0 days (IQR, 61-109) in the study group, which was significantly longer than 66.0 days (IQR, 51-94) in the control group (P = 0.004). The ORR was 23.9 and 39.8% in the study and control group, respectively (P = 0.037). The cut-off value was 95 days. The grouping (OR, 2.402; 95% CI, 1.040-5.546; P = 0.040), long interval (OR, 2.573; 95% CI, 1.022-6.478; P = 0.045), and China liver cancer staging system (OR, 2.500; 95% CI, 1.797-3.480; P <0.001) were independent predictors for the efficacy of TACE treatment. CONCLUSIONS: The COVID-19 pandemic causes a longer follow-up interval in general, which may further lead to a lower ORR in HCC patients. Those with a follow-up interval of >95 days tend to have a worse prognosis.

Nomogram and Artificial Neural Network for Prognostic Performance on the Albumin-Bilirubin Grade for Hepatocellular Carcinoma Undergoing Transarterial Chemoembolization.

PURPOSE: To construct the albumin-bilirubin (ALBI) grade and the Child-Turcotte-Pugh (CTP) score based on nomograms, as well as to develop an artificial neural network (ANN) to compare the prognostic performance of the 2 scores for hepatocellular carcinoma (HCC) that has undergone transarterial chemoembolization. MATERIALS AND METHODS: This multicentric retrospective study included patients with HCC who underwent transarterial chemoembolization monotherapy as an initial treatment at 4 institutions between January 2008 and December 2016. In the training cohort, significant risk factors associated with overall survival (OS) were identified by univariate and multivariate analyses. The prognostic nomograms and ANN were established and then validated in 2 validation cohorts. RESULTS: A total of 838 patients (548, 115, and 175 in the training cohort and validation cohorts 1 and 2, respectively) were included. The median OS was 10.4, 15.7, and 9.2 months in the training cohort and validation cohorts 1 and 2, respectively. In the training cohort, both ALBI grade and CTP score were identified as significant risk factors. The ALBI grade and CTP score based on nomograms were established separately and showed similar prognostic performance when assessed externally in validation cohorts (C-index in validation cohort 1: 0.823 vs 0.802, P = .417; in validation cohort 2: 0.716 vs 0.729, P = .793). ANN showed that ALBI grade had higher importance on survival prediction than CTP score. CONCLUSIONS: ALBI grade performs at least no worse than CTP score regarding survival prediction for HCC receiving transarterial chemoembolization. Considering the easy application, ALBI grade has the potential to be regarded as an alternative to CTP score.

Multicentric Assessment of the Hong Kong Liver Cancer Staging System in Chinese Patients Following Transarterial Chemoembolization.

PURPOSE: We aimed to validate the performance of the hepatitis B-based Hong Kong Liver Cancer (HKLC) staging system compared with the Barcelona Clinic Liver Cancer (BCLC) staging system in Chinese hepatocellular carcinoma (HCC) patients treated with conventional transarterial chemoembolization (TACE) as the initial treatment. MATERIALS AND METHODS: The study was approved by the Institutional Review Boards at all participating centers. This retrospective study included 715 patients with HCC who underwent TACE as the initial treatment between January 2008 and December 2016 at three Chinese institutions. All of the patients calculated HCC stage using 5-substage HKLC (HKLC-5), 9-substage HKLC (HKLC-9), and the BCLC system. Based on overall survival (OS), these three staging systems' performance on treatment outcome prediction were compared using C statistic, Akaike information criterion (AIC), area under the receiver operating characteristic curve (AUC), linear trend Chi-square, likelihood ratio Chi-square, and calibration plots, respectively. RESULTS: The median OS was 10.1 months. Compared with the BCLC system, the HKLC system, especially HKLC-9, showed better performance on survival prediction (HKLC-9: C = 0.689, AIC = 6646.162; HKLC-5: C = 0.683, AIC = 6662.663; BCLC: C = 0.680, AIC = 6654.146), homogeneity (likelihood ratio Chi-square: HKLC-9 = 232.38, HKLC-5 = 215.87, and BCLC = 224.39, P < 0.001), and calibration (R2: HKLC-9 = 0.923, HKLC-5 = 0.916, and BCLC = 0.914). HKLC-9 outperformed on AUC at 6-, 12-, and 24-month survival prediction than HKLC-5 and BCLC. BCLC showed better performance on monotonicity (linear trend Chi-square: HKLC-9 = 121.641, HKLC-5 = 117.389, and BCLC = 125.752; P < 0.001). CONCLUSIONS: Combining survival prediction, discrimination, and calibration, the HKLC, especially HKLC-9 system, performed better for Chinese patients treated with TACE than the BCLC system.

Correction to: Risk Prediction of New Adjacent Vertebral Fractures After PVP for Patients with Vertebral Compression Fractures: Development of a Prediction Model.

The following information in bold type should be added to the Acknowledgements section.

Nomogram for Predicting Intradiscal Cement Leakage Following Percutaneous Vertebroplasty in Patients with Osteoporotic Related Vertebral Compression Fractures.

BACKGROUND: Intradiscal cement leakage (ICL) is a common complication following percutaneous vertebroplasty (PVP). However, the risk factors for such a complication are under debate and there is no accurate predictive nomogram to predict ICL. OBJECTIVES: To establish an effective and novel nomogram for ICL following PVP in patients with osteoporotic-related vertebral compression fractures (OVCFs). STUDY DESIGN: This was a retrospective study approved by the Institutional Review Board of our institution. SETTING: This study consists of patients from a large academic center. METHODS: Patients with OVCFs who underwent their first PVP in our department between January 2007 and December 2013 were included in this study. All the potential risk factors of ICL after PVP were recorded. Univariate and multivariate analyses were used to identify the independent risk factors. The nomogram was then created based on the identified independent risk factors. RESULTS: A total of 241 patients and 330 vertebrae were included. The mean age of the patients was 73.5 (SD 7.9) years old, and the mean number of treated vertebrae was 1.4 per person. ICL was observed in 93 (28.2%) of the treated vertebrae. Greater fracture severity (P = 0.016), cortical disruption of the endplate (P < 0.0001), absence of Kummell's disease (P = 0.010), and higher computed tomography (CT) values (P = 0.050) were the independent risk factors for ICL. LIMITATIONS: The main limitation of this study is that it is a retrospective study. CONCLUSION: Greater fracture severity, cortical disruption of the endplate, absence of Kummell's disease, and higher CT values are the independent risk factors for ICL. The novel nomogram gives an accurate prediction of ICL.

Percutaneous Vertebroplasty for Symptomatic Schmorl's Nodes: 11 Cases with Long-term Follow-up and a Literature Review.

BACKGROUND: Percutaneous vertebroplasty (PVP) is commonly used to treat symptomatic vertebral compression fractures. However, its long-term effectiveness and safety for use in the treatment of symptomatic Schmorl's nodes (SNs) refractory to conservative treatment is uncertain. OBJECTIVES: To present a case series with PVP for symptomatic SNs not responding to conservative therapy and assess the effectiveness and safety for such treatment with long-term follow-up. To present a review of the literature regarding SNs and treatment options. STUDY DESIGN: Single center retrospective observational study. SETTING: This study consists of patients from a large academic center in China. METHODS: Between January 2008 and December 2013, 11 patients suffering from symptomatic SNs that were refractory to medical or physical therapy, underwent PVP procedures in our department. All patients had a definitive diagnosis of SNs by magnetic resonance imaging (MRI) and computed tomography (CT). The visual analog scale (VAS) was assessed preoperatively at 4 hours, at one month, and every 6 months postoperatively during the long-term (mean: 58.0 months) follow-up period. RESULTS: Each of the 11 patients reported an immediate and distinct relief of their back pain. No one reported a worsening of symptoms. The VAS decreased from an average preprocedural score of 7.9 to a postprocedural score of 2.1 at 4 hours. The VAS averaged 1.8 during the mean follow-up period of 58.0 (range 24.1 to 98.9) months. There were no postoperative complications during the follow-up period. At the end of the follow-up period, all 11 patients were unrestricted in their activities. LIMITATIONS: This study is a retrospective study with a small sample size. CONCLUSIONS: PVP is an effective and safe procedure for the treatment of symptomatic SNs, which are refractory to medical or physical therapy.Key words: Percutaneous vertebroplasty, symptomatic Schmorl's nodes, vertebral endplate fracture, endplate osteonecrosis, Modic changes.

Risk Prediction of New Adjacent Vertebral Fractures After PVP for Patients with Vertebral Compression Fractures: Development of a Prediction Model.

PURPOSE: We aim to determine the predictors of new adjacent vertebral fractures (AVCFs) after percutaneous vertebroplasty (PVP) in patients with osteoporotic vertebral compression fractures (OVCFs) and to construct a risk prediction score to estimate a 2-year new AVCF risk-by-risk factor condition. MATERIALS AND METHODS: Patients with OVCFs who underwent their first PVP between December 2006 and December 2013 at Hospital A (training cohort) and Hospital B (validation cohort) were included in this study. In training cohort, we assessed the independent risk predictors and developed the probability of new adjacent OVCFs (PNAV) score system using the Cox proportional hazard regression analysis. The accuracy of this system was then validated in both training and validation cohorts by concordance (c) statistic. RESULTS: 421 patients (training cohort: n = 256; validation cohort: n = 165) were included in this study. In training cohort, new AVCFs after the first PVP treatment occurred in 33 (12.9%) patients. The independent risk factors were intradiscal cement leakage and preexisting old vertebral compression fracture(s). The estimated 2-year absolute risk of new AVCFs ranged from less than 4% in patients with neither independent risk factors to more than 45% in individuals with both factors. CONCLUSIONS: The PNAV score is an objective and easy approach to predict the risk of new AVCFs.

Seroprevalence of Toxoplasma gondii in goats in Hunan province, China.

Toxoplasma gondii infections are prevalent in animals and humans worldwide. In the present investigation, the seroprevalence of T. gondii in goats was investigated in Hunan province, subtropical China between March 2014 and December 2015. A total of 1,028 serum samples collected from 14 administrative regions of Hunan province were evaluated by the indirect hemagglutination test (IHAT) for the detection of specific antibodies. Antibodies to T. gondii were detected in 124 serum samples (12%). The T. gondii seroprevalence ranged from 1.7% to 19% among different regions in subtropical China, and the differences were statistically significant (p < 0.01). The results of the present survey indicated that T. gondii infection is prevalent in goats in Hunan, which poses a potential risk for human infection with T. gondii in this province.

Sequential Transarterial Embolization Followed by Percutaneous Vertebroplasty Is Safe and Effective in Pain Management in Vertebral Metastases.

BACKGROUND: Vertebral metastases are the most frequent vertebral tumor. Transarterial embolization (TAE) devascularizes the tumor, resulting in tumor necrosis. Percutaneous vertebroplasty (PVP), a minimally invasive procedure, can effectively relieve tumor-related pain and improve spine stability. Unfortunately, the PVP technique is of limited use in controlling the progression of vertebral tumor, especially for paravertebral metastases. TAE combined with PVP may achieve a better control on vertebral metastases with paravertebral extension, but little information regarding the combination is available. OBJECTIVES: The present study is intended to assess the safety and effectiveness of the combination of TAE and PVP in patients suffering from vertebral metastases with paravertebral extension. STUDY DESIGN: Sequential TAE followed by PVP was used in 25 patients with symptomatic vertebral metastases. The safety and effectiveness of the sequential therapy were evaluated. SETTING: Three hospitals' clinical research centers. METHODS: This retrospective study was conducted with 25 consecutive patients (11 women and 14 men; mean age 59.3 years, range 38 - 80 years) with vertebral and paravertebral metastases from March 2009 to March 2014. The patients were treated with TAE, and 5 - 7 days later with the PVP procedure. The clinical outcomes were assessed by the control of pain using visual analog scale (VAS) scores, and computed tomography (CT) imaging. X2 or Fisher exact testing was performed for univariate analysis of variables. The VAS scores between groups were compared using ONE-WAY ANOVA, with a P-value of less than 0.05 considered statistically significant. RESULTS: All the TAE and PVP procedures were successfully done. Mean VAS scores decreased after TAE (from 8.64 ± 0.58 to 5.32 ± 1.46, P < 0.05) and further decreased after PVP (from 5.32 ± 1.46 to 2.36 ± 0.54, P < 0.05), and the decrease in VAS lasted until the third month (3.08 ± 1.52, P > 0.05) follow-up. However, VAS scores at the sixth month were statistically higher than those at the third month (4.8 ± 1.24 versus 3.08 ± 1.52, P < 0.05), VAS scores at the twelfth month were statistically higher than those at the sixth month (6.29 ± 1.07 versus 4.8 ± 1.24, P < 0.05). We found paravertebral cement leakage in 6 cases. No clinical or symptomatic complications were observed. In the follow-up, no patient showed further vertebral compression or spinal canal compromise. LIMITATIONS: This is a retrospective clinical study of a small number of patients. CONCLUSION: The sequential TAE followed by PVP is safe and effective in treating vertebral metastases with paravertebral extension. KEY WORDS: Spine, metastases, pain, embolization, vertebroplasty, interventional radiology, PVP, TAE.

A Modified Model for Assessment for Retreatment with Transarterial Chemoembolization in Chinese Hepatocellular Carcinoma Patients.

PURPOSE: To develop a modified assessment for retreatment with transarterial chemoembolization (mART) score that may be more suitable for Chinese patients with hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Chinese patients with HCC who were treated with transarterial chemoembolization in four hospitals were included. A univariate analysis and a multivariate forward Cox regression analysis were used to identify significant prognostic factors of overall survival (OS). A point scoring model was subsequently developed from the training cohort, and the validation process was performed in the validation cohort. RESULTS: The study included 259 patients (124 patients in the training cohort and 135 patients in the validation cohort). Increase in Child-Pugh scores relative to the baseline (P < .001), Barcelona Clinic Liver Cancer (BCLC) stage B before first transarterial chemoembolization (P = .001), and absence of radiologic tumor response (P < .001) were identified as negative prognostic factors for OS and were used to create the mART scores. BCLC staging was substituted for aspartate aminotransferase increase in the mART scores. The mART scores differentiated two groups with distinct prognosis by a cutoff score of 2.5 points (22.9 mo [95% confidence interval (CI), 17.4-28.4] vs 8.9 mo [95% CI, 7.5-10.3] in median survival; P < .001). In the validation cohort, the C index in assessment for retreatment with transarterial chemoembolization (ART) criteria was 0.64, whereas it was 0.82 in mART criteria. CONCLUSIONS: In Chinese patients with HCC, mART score of > 2.5 before second transarterial chemoembolization was associated with poor prognosis. The mART score was probably better validated compared with the ART score.

ANVCFV Score System: Assessment for Probability of New Vertebral Compression Fractures after Percutaneous Vertebroplasty in Patients with Vertebral Compression Fractures.

BACKGROUND: Percutaneous vertebroplasty (PVP) is widely used for the treatment of painful vertebral compression fractures (VCFs). However, new VCFs occur frequently after PVP. OBJECTIVES: We aim to establish an objective risk score system to assess the possibility of new vertebral fractures in patients with VCFs undergoing PVP. STUDY DESIGN: This study was a retrospective study, and it was approved by the Institutional Review Board of our 2 institutions. SETTING: This study consists of patients from 2 large academic centers. METHODS: Patients with VCFs who underwent their first PVP and met the inclusion criteria between January 2007 and December 2013 at Hospital A (training cohort) and Hospital B (validation cohort) were included. In the training cohort, the independent risk factors for new VCFs after PVP were identified by multivariate stepwise backward Cox regression analysis from the risk factors selected by univariate analysis and Harrell's C-statistics and used to develop the score system (assessment for new VCFs after PVP [ANVCFV]) to predict the probability of new VCFs. RESULTS: In total, 397 patients (training cohort: n = 241; validation cohort: n = 156) were included in this study. In the training cohort, the ANVCFV score was developed based on 5 independent risk factors for the new VCFs after PVP, including lower computed tomography (CT) values, pre-existing old VCFs, intradiscal cement leakage, more than one vertebra treated, and superior or inferior marginal cement distribution in the vertebra. The patients were divided into 2 groups by the ANVCFV score of -1.5 to 8.5 vs. > 8.5 points in the probability of new VCFs (median fracture-free time: 1846 vs. 732 days; P < 0.001) in the training cohort. The accuracy of this score system was 77.4% for the training cohort and 85.3% for the validation cohort. LIMITATIONS: The main limitations of this study are that it is a retrospective study and that there is a significant difference of the treated vertebrae of PVP per session between the 2 cohorts. CONCLUSION: Patients who underwent their first PVP with an ANVCFV score > 8.5 points may exhibit an increased chance of suffering from new VCFs.

Conventional stents versus stents loaded with (125)iodine seeds for the treatment of unresectable oesophageal cancer: a multicentre, randomised phase 3 trial.

BACKGROUND: The combination of stent insertion and single high-dose brachytherapy is a feasible and safe palliative treatment regimen in patients with unresectable oesophageal cancer. We aimed to further assess the efficacy of this treatment strategy compared to a conventional covered stent in patients with dysphagia caused by unresectable oesophageal cancer. METHODS: In this multicentre, single-blind, randomised, phase 3 trial, we enrolled patients with unresectable oesophageal cancer from 16 hospitals in China. We included adult patients (aged ≥ 20 years) with progressive dysphagia, unresectable tumours due to extensive lesions, metastases, or poor medical condition, and with clear consciousness, cooperation, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. Eligible patients were randomly assigned (in 1:1 ratio, no stratification) to receive either a stent loaded with (125)iodine radioactive seeds (irradiation group) or a conventional oesophageal stent (control group). The primary endpoint was overall survival. Survival analyses were done in a modified intention-to-treat group. This study is registered with ClinicalTrials.gov, number NCT01054274. FINDINGS: Between Nov 1, 2009, and Oct 31, 2012, 160 patients were randomly assigned to receive treatment with either an irradiation stent (n=80) or a conventional stent (n=80). During a median follow-up of 138 days (IQR 72-207), 148 stents (73 in the irradiation group and 75 in the control group) were successfully placed into the diseased oesophagus in 148 participants. Median overall survival was 177 days (95% CI 153-201) in the irradiation group versus 147 days (124-170) in the control group (p=0.0046). Major complications and side-effects of the treatment were severe chest pain (17 [23%] of 73 patients in the irradiation group vs 15 [20%] of 75 patents in the control group), fistula formation (six [8%] vs five [7%]), aspiration pneumonia (11 [15%] vs 14 [19%]), haemorrhage (five [7%] vs five [7%]), and recurrent dysphagia (21 [28%] vs 20 [27%]). INTERPRETATION: In patients with unresectable oesophageal cancer, the insertion of an oesophageal stent loaded with (125)iodine seeds prolonged survival when compared with the insertion of a conventional covered self-expandable metallic stent.

[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.

[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 for new vertebral fractures after percutaneous vertebroplasty in patients with osteoporosis: a prospective study.

PURPOSE: To determine the risk factors for new vertebral compression fractures (VCFs) following percutaneous vertebroplasty (PV) in patients with osteoporosis. MATERIALS AND METHODS: This prospective study included 132 consecutive patients with osteoporosis treated with PV in a single institution over 46 months from March 2005 to December 2008. Multivariable logistic regression and univariate analysis were employed to identify risk factors for new VCFs after PV, including patient demographic data, parameters of the initial and new fractured vertebrae, procedure-related information, and follow-up data. RESULTS: During the follow-up period (22.4 months ± 12.1), 80 new vertebral fractures occurred in 36 (27.3%) patients. Multivariate analysis showed that number of VCFs per time frame, computed tomography (CT) value of nonfractured vertebrae (T11-L2), activity level after discharge, duration of follow-up, and cement distribution in the inferior part of the vertebral body or close to the endplate were statistically correlated with new fractures (odds ratios, 2.63, 0.96, 3.59, 1.00, 0.30, and 0.05; P = .006, P = .001, P = .007, P = .004, P = .021 and P = .029). Univariate analysis showed preexisting old VCFs were correlated with new VCFs (P = .045). Subsequent compression fractures in adjacent vertebrae (45 of 80) occurred more frequently and sooner than nonadjacent vertebral fractures (both P < .05). CONCLUSIONS: The incidence of new VCFs after PV is relatively high and affected by several risk factors that are related to both the PV procedure and the natural course of osteoporosis.

[An experimental study on catheterization in rat's hepatic artery and interventional therapy through carotid artery].

OBJECTIVE: To investigate the feasibility and safety of catheterization in rat hepatic artery and interventional therapy through carotid artery. METHODS: A total of 30 Sprague-Dawley rats were randomly divided into 2 groups. All were punctured through left common carotid artery (LCCA) under intraperitoneal injection anesthesia. Microcatheter was inserted through a puncturing outer cannula into celiac artery and angiography performed to investigated the anatomical structure. Then a microcatheter was inserted into proper hepatic artery. One group was perfused with epirubicin 5 mg while another embolized with lipidol and polyvinyl (PVA). The status of vascular patency was re-examined by celiac angiography after perfusion and embolization. The 2-week survival rate (SR) and related complications were observed. RESULTS: Except for one failed case, all other cases were successfully inserted and celiac-gastroduodenal arteriography was completed with a success rate of 97% (29/30). The anastomosis between gastroduodenal artery (GDA) and superior mesenteric artery (SMA) was demonstrated in 28 cases (28/29, 96.6%). In 14 cases with perfusion therapy, arteriography demonstrated all branches of celiac artery had no occlusion while 10 embolized cases (10/15, 67%) had the main branch occlusion of gastroduodenal artery and 5 (5/15, 33%) stayed open. No postoperative abnormality was found in the limb motor function. Five had the drooping of left upper eyelid during 12 - 24 h after intervention and subsided after a week. And 10 embolized via main branch of gastroduodenal artery showed a poor appetite within 3 days postoperation and recovered gradually after 3 days. After intervention, 27 rats survived in 2 weeks. The survival rate was 93% (27/29). One died of incision infection and another neck hematoma. CONCLUSION: Catheterization in hepatic artery and interventional therapy through carotid artery is both feasible and safe. It may have a high application value.

[Cement leakages in percutaneous vertebroplasty:analysis of postoperative computed tomography].

OBJECTIVE: To evaluate the influencing factors of cement leakage in vertebroplasty for the treatment of osteoporosis vertebral compression fracture (OVCF) and vertebral metastases (VM). METHODS: Retrospective analysis was conducted for 653 vertebrae in 356 patients undergoing vertebroplasty at our hospital from May 2007 to January 2011. 251 cases had 438 vertebrae with painful OVCF while 105 cases had 215 vertebrae with VM. Pre-operative computed tomography (CT) was performed to determine the presence of cortical defects or osteolysis and within 3 days after PVP to observe the distribution of polymethylmethacrylate (PMMA) in vertebrae and whether leakage occurred. Volume of PMMA injected into each vertebral body and types of cement leakage were compared between the OVCF and VM groups by Z test or χ². The correlation between cortical defects and cement leakages around vertebrae was assessed with Pearson correlation coefficient. RESULTS: The successful rate of PVP was 100%. The mean volume of PMMA injected into each vertebra was (5.0 ± 2.0) ml and (4.0 ± 1.7) ml in the OVCF and VM groups respectively (P < 0.05). Asymptomatic PMMA leakage was demonstrated by CT in 93 vertebrae (21.2%) in the OVCF group and in 53 vertebrae (28.8%) in the VM group respectively (P < 0.05). Cement leakages into disk were found in 58 vertebrae in the OVCF group and 16 vertebrae in the VM group respectively (P = 0.025). Cement leakages into paravertebral vein were found in 12 vertebrae in the OVCF group and 26 vertebrae in the VM group respectively (P < 0.0001). Correlation was found between cortical defects and cement leakage into paravertebral soft tissues in the OVCF group (r = 0.14) or in the VM group (r = 0.27), between end-plate defects and cement leakage into disk in the OVCF group (r = 0.29) or in the VM group (r = 0.31). CONCLUSION: As a common occurrence in vertebroplasty, cement extravasation is well-tolerated in most patients. It occurs more frequently in the patients with VM than those with OVCF, especially in cases of leakage into paravertebral vein. Cement leakage into disc or paravertebral soft tissue is predisposed in vertebrae with end plate, cortical defects or osteolysis.

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.