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Purpose To assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population. Methods This is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7 ± 8.8) to drug-coated balloon group ( n = 30) or percutaneous transluminal angioplasty group ( n = 30). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety end point was freedom from perioperative death at 30 days and freedom from limb-related death and major amputation at 12 months. Results Baseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p = 0.005) and lower CD-TLR rates (3.5% vs. 27.6%; p = 0.001) versus percutaneous transluminal angioplasty group at 12 months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86 ± 0.13 vs. 0.72 ± 0.18, p = 0.025). There were no perioperative death at 30 days, no limb-related death and no major amputation at 12 months in either group. Conclusions The randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.

Objective The objective of this study was to evaluate the efficacy and safety of radiofrequency-induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP) in the treatment of lower limb varicose veins (VVs) in comparison with high ligation and stripping (HLS) combined with TIPP. Methods The patients with lower limb VVs were randomly assigned to RFiTT combined with TIPP or HLS combined with TIPP. The primary end point was total closure rate of the great saphenous vein at 12 months. Secondary end points included Venous Clinical Severity Score and 14-item Chronic Venous Insufficiency Questionnaire score changes at 12 months and perioperative complications. Results The total closure rate of the great saphenous vein at 12 months was slightly lower in the RFiTT group (90.9% [90/99]) than in the HLS group (97.0% [98/101]) but not statistically significant (χ2 = 0.068; P = .08). Operation time, intraoperative blood loss, duration in hospital, duration in bed, and resumption of activities were statistically significantly better with RFiTT than with HLS. There were no significant differences between the groups in deep venous thrombosis, phlebitis, hematomas, pain, and infection. However, skin pigmentation and paresthesia were statistically significantly better with RFiTT than with HLS. At 12 months, both groups showed similar improvement from baseline in Venous Clinical Severity Score (1.28 ± 0.57 in the RFiTT group vs 1.33 ± 0.61 in the HLS group) and 14-item Chronic Venous Insufficiency Questionnaire score (67.32 ± 1.29 in the RFiTT group vs 67.45 ± 1.32 in the HLS group); however, neither group was superior to the other. Conclusions RFiTT combined with TIPP is an effective treatment method for lower limb VVs and had a more satisfactory clinical outcome in surgical data, skin pigmentation, and paresthesia than HLS at the 12-month follow-up.

PurposeTo analyze the clinical character of giant pediatric supratentorial tumor (GPST) and explore prognostic factors.Materials and MethodsWe analyzed the clinical data comprising of 35 cases of GPST from a single center between January 2015 and December 2020. The tumor volume was measured by 3D slicer software based on preoperative magnetic resonance imaging (MRI). Glasgow Outcome Scale (GOS) was used to evaluate the short-term prognosis.ResultThe tumor volume varied from 27.3 to 632.8 ml (mean volume 129.8 ml/ median volume 82.8 ml). Postoperative histopathological types include ependymoma, pilocytic astrocytoma, choroid plexus papilloma (CPP), craniopharyngioma, primitive neuroectoderm tumor (PNET), choroid plexus carcinoma (CPC), immature teratoma, atypical teratoid rhabdoid tumor (AT/RT), anaplastic astrocytoma, and gangliocytoma. Tumors in children younger than 3 years and tumors located at the hemispheres appeared to be larger than their respective counterparts, though no statistical significance was found. A patient with giant immature teratoma died during the operation because of excessive bleeding. Postoperative complications include cerebrospinal fluid subgaleal collection/effusion, infection, neurological deficits, and seizures. The mean GOS score of patients with GPST in 6 months is 3.43 ± 1.12, and 83% of patients (29/35) showed improvement. Favorable GPST characteristics to indicated better GOS included small tumor (≤100 ml) (p = 0.029), low-grade (WHO I-II) (p = 0.001), and gross total resection (GTR) (p = 0.015). WHO grade was highly correlated with GOS score (correlation coefficient = −0.625, p < 0.001). GTR and tumor volume were also correlated (correlation coefficient = −0.428, p = 0.010).ConclusionThe prognosis of GPST is highly correlated with the histopathological type. Smaller tumors are more likely to achieve GTR and might lead to a higher GOS score. Early diagnosis and GTR of the tumor are important for GPST management.

Background: The use of thrombolysis with tissue-plasminogen activator (t-PA) in patients with acute ischemic stroke (AIS) is limited by increased levels of matrix metalloproteinase-9 (MMP-9) and by the increased risk of hemorrhagic transformation (HT). In this study, we investigated the effects of simvastatin pretreatment on t-PA-induced MMP-9/tissue inhibitor of metalloproteinase-1 (TIMP-1) imbalance and HT aggravation in a rat AIS model. Methods: The rat AIS model was established by autologous blood emboli. Two weeks before surgery, rats were pretreated with simvastatin (60 mg/kg/d), and three hours after surgery, t-PA (10 mg/kg) was administered. MMP-9 and TIMP-1 levels in the infarcted zone and plasma were evaluated by Western blot analysis and ELISA; the level of HT was quantified by determining the hemoglobin content. RhoA activation was determined to clarify the potential effect. Results: The results suggested that pretreatment with simvastatin suppressed the increase in t-PA-induced MMP-9 levels and neutralized the elevated MMP-9/TIMP-1 ratio, but had no effect on TIMP-1 levels. Thrombolysis with t-PA after ischemia improved neurological outcome, but increased intracranial hemorrhage. Moreover, t-PA-induced HT aggravation was reduced by simvastatin pretreatment. In addition, we showed that t-PA-induced activation of RhoA was suppressed by simvastatin, and that t-PA-induced MMP-9/TIMP-1 imbalance and hemorrhage was reduced by Rho kinases (ROCK) inhibitor Y-27632. Conclusion: In this study, we showed that simvastatin pretreatment ameliorated t-PA-induced HT and MMP-9/TIMP-1 imbalance, and demonstrated that the RhoA/ROCK pathway was implicated.

Objective We investigated whether endothelial progenitor cells (EPCs) derived exosomes (EPC-exo) could improve angiogenesis in a rat hindlimb ischemia model to evaluate whether the EPC-exo may represent a potential therapeutic strategy for lower limb ischemia (LLI).MethodsEPCs were obtained from SD rats using the method of density gradient centrifugation, and identified by DIL-AC-LDL and FITC-UEA-l uptake test and flow cytometry. EPC-exo was isolated and purified from EPCs using ultracentrifugation method, and identified by transmission electron microscopy and western blot analysis. Rat chronic hindlimb ischemia model were divided randomly into three groups, the experimental group (n=5) was intramuscularly injected with 30ul EPC-exo through four points in ischemic hindlimb, while the EPC group (n=5) was injected with 30ul EPCs, and the control group (n=5) was injected with 30ul PBS. Laser doppler perfusion imaging (LDPI) was used to assessment blood flow perfusion of rat hindlimb at baseline, 7 day, 28 day after intramuscularly injection. Capillary density of muscle tissue was evaluated by immunofluorescence analysis at 28 day. Quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) was used to detect the expression change of vascular related genes in endothelial cells (ECs) induced by EPC-exo. ResultsDIL-AC-LDL and FITC-UEA-l uptake test showed that more than 90% of the EPCs were double-positive. Flow cytometry showed that in our cultured EPCs, the positive rates of CD31, CD34, CD133 and VEGFR-2 were 97.8%, 85.3%, 83.2% and 91.3%, respectively, but the positive rate of CD45 was only 1.3%. EPC-exo with a size ranging from 30 to 100 nm and western blot analysis confirmed the presence of exosomes markers, including CD9, CD63 and CD81. Compared with non ischemic limbs, EPC-exo group recovered about 80% of the blood perfusion after 28 days, while the EPC group had a recovery rate of about 60%, and the control group had a recovery rate of about 40% only. Capillary density of muscle tissue in EPC-exo group increased significantly than EPC group and control group. qRT-PCR detected the expression of vascular related genes (VEGFA, VEGFR2, HIF-1a, eNOS, ANG1, ANG2, CXCL-16) increased significantly in EPC-exo group than control group.ConclusionThe study results suggest that transplantation of EPC-exo could significantly improve angiogenesis in a rat hindlimb ischemia model, which may be a potential therapeutic strategy for LLI.

Background To assess the efficacy and safety of Orchid drug-coated balloon (DCB) for treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) in Chinese patients. Methods The study is a prospective, single center, single-blinded, randomized controlled trial (RCT) that randomized (1:1) 74 patients to DCB group (N.=38) and PTA group (N.=36). The primary efficacy endpoint was primary patency of the target lesion at 12 months. Second efficacy endpoint included clinically-driven target-lesion revascularization (CD-TLR) and ABI change at 12 months. The primary safety endpoint included peri-operative death at 30 days, all-cause death, major amputation, and other major adverse events (MAEs) at 12 months. The primary functional endpoint included Walking Impairment Questionnaire (WIQ), quality-of-life measures (EQ-5D) and 6-minute walking test (6MWT). Results The DCB group had higher primary patency (87.9% vs. 51.6%; P=0.001) and lower rates of CD-TLR (6.1% vs. 35.5%; P=0.003) than the PTA group at 12 months. There were no peri-operative deaths, and no major amputations at 12 months in two groups. There were 1(2.6%) in the DCB group and 2 (5.6%) in the PTA group of all-cause deaths (P=0.524). Conclusions Results from the study showed superior treatment effect with Orchid DCB versus PTA for the treatment of FP ISR, and without an apparent difference in safety.

Objective To assess the efficacy and safety of the LEGFLOW OTW drug coated balloon (DCB; coated with paclitaxel) for the treatment of femoropopliteal artery disease vs. standard percutaneous transluminal angioplasty (PTA) in a Chinese population. Methods LEFGLOW OTW China is prospective single centre, single blinded randomised controlled trial (RCT) that randomised (1:1) 60 patients (38 men; mean age 68.7 ± 8.8 years) to the DCB ( n = 30) or PTA group ( n = 30). The primary endpoint was primary patency of the target lesion and clinically driven target lesion revascularisation (CD-TLR) at 12 months; primary patency was defined as freedom from CD-TLR or restenosis (> 50%). The primary end point was a composite of freedom from peri-operative death at 30 days and freedom from limb related death at 12 months (death from a medical complication related to a limb), amputation, and target vessel thrombosis. Results Baseline characteristics were similar between the two groups. Patients in the DCB group had higher primary patency (82.8% vs. 48.3%; p = .005) and lower rates of CD-TLR (3.5% vs. 27.6%; p = .001) than in patients in the PTA group during a 12 month follow up. Ankle brachial index was significantly higher in patients in the DCB group than in those in the PTA group (0.86 ± 0.13 vs. 0.72 ± 0.18; p = .025). There were no procedure or device related deaths, no all cause death, and no major amputations in 12 months in either group. Despite improvement in functional outcomes in both groups, eight times more patients in the PTA group required a CD-TLR to achieve the same levels of functional outcomes as those in the DCB group. Conclusion Results from the RCT showed a superior treatment effect with DCB vs. PTA, with remarkably higher patency and lower CD-TLR rates. These results are consistent with other former DCB trials and demonstrate the safety and efficacy of the LEGFLOW OTW DCB for the treatment of femoropopliteal artery disease.

The optimal treatment method for femoropopliteal (FP) artery in-stent restenosis (ISR) remains controversial. We assess the efficacy and safety of combination of Rotarex thrombectomy and drug-coated balloon (DCB) for the treatment of FP ISR.From June 2016 to July 2017, 32 patients with FP ISR who underwent combination of Rotarex thrombectomy and DCB angioplasty were included in a prospective registry. The primary end point was primary patency of the target lesion defined as a peak systolic velocity ratio2.4 documented by duplex ultrasound at 12 months without clinically driven target lesion revascularization (CD-TLR). The secondary outcome measure was the rate of major adverse limb events. The primary functional end point was assessed using the Walking Impairment Questionnaire (WIQ).Twenty-nine (90.6%) patients completed 12-month follow-up. Mean ankle-brachial index was 0.45 ± 0.14 at baseline and 0.84 ± 0.12 at 12 months (P 0.05). The WIQ score was 30.45 ± 21.14 at baseline and 52.68 ± 29.75 at 12 months (P 0.05). The Kaplan-Meier estimate of the primary patency rate at 12 months was 86.2% (25/29), and freedom from CD-TLR rate at 12 months was 89.7% (26/29).The data suggest that combination of Rotarex thrombectomy and DCB for treatment of FP ISR is safe and effective with satisfying primary patency rate and freedom from CD-TLR rate at 12-month follow-up.

The aim of the present study was to quantitatively analyze the expression of platelet-derived growth factor (PDGF)-A and PDGF-B in the vascular walls of patients with lower extremity arterial occlusive disease (LEAOD). The expression levels of PDGF-A and PDGF-B in the lower extremity arteries of 19 LEAOD patients (case group) and three healthy subjects (control group) was determined using quantitative polymerase chain reaction. Intergroup comparisons revealed that the relative mRNA expression levels were higher in the case group, as compared with the control group, for PDGF-A (34.38±5.80 vs. 21.94±1.05; P

Endovascular therapy is a treatment option for localized occlusion of the subclavian artery. In this report the long-term experience with 59 patients is presented.Between June 1998 and September 2008, we used endovascular therapy to treat 61 subclavian arterial obstructive lesions in 59 patients (46 males and 13 females, 34 - 82 years of age with a mean age (61.9 + or - 11.0) years). Twenty patients (34%) had clinical symptoms due to vertebrobasilar insufficiency, 26 (44%) had disabling arm ischemia, and 13 (22%) had both symptoms. We performed all procedures under local anesthesia. The approaches were from the femoral artery (n = 47), brachial artery (n = 1, involving bilateral subclavian disease) or both (n = 11). Sixty stents were implanted. All patients were followed-up at 1, 3, 6, and 12 months post-procedure, and annually thereafter.We achieved technical success in 58 (95.1%) arteries, all of which were stented. There were three technical failures; two were due to the inability to cross over an occlusion, necessitating the switch to an axillo-axillary bypass, and the third was due to shock after digital subtraction angiography and prior to stenting. Arterial stenosis pre- and post-stenting was (83.6 + or - 10.8)% and (2.5 + or - 12.5)% (P0.01). Clinical success was achieved in 55 of the 59 patients (93.4%). Of the four clinical failures, three were technical and the remaining patient had a stent thrombosis. Systolic blood pressure difference between the two brachial arteries was (44.7 + or - 18.5) vs. (2.2 + or - 3.9) mmHg (P0.01). Primary patency was 98% at 12 months, 93% at 24 months, and 82% at 5 years. Five patients were lost to follow-up by 12 months post-stenting. Significant recurrent obstruction developed in five patients with resumption of clinical symptoms. The overall survival rate was 98.2% at 12 months, 89.5% at 24 months, and 84.5% at 5 years.Endovascular therapy for proximal subclavian arterial obstructive lesions is effective and successful. This minimally invasive treatment may be the first choice of treatment for proximal subclavical arterial obstructive lesions.

To evaluate therapeutic efficacy of minimally invasive rotary varicotomy (TriVex) for superficial varicosities of low limbs and summarize our therapeutic experiences.One hundred and eighty-two cases (totally 216 lower limbs) were applied minimally invasive rotary varicotomy (TriVex) and relative clinical data was analyzed.The average operation time for each limb was 48 min. Discomfort and pain of lower limbs disappeared in all of patients after operation. There was no residual of superficial varicosities. There was no severe complication and recurrence of varicosities. The postoperative complication rate was 21.3%.For treatment of superficial varicosities of low limbs, minimally invasive rotary varicotomy (TriVex) have many advantages including minimal invasion, quick recovery, safety and cosmetic effect. In addition, it has extensive indications and satisfactory therapeutic efficacy. It would be beneficial to master the operative techniques of key procedures. It could decrease complications and get better curative effects.

To investigate the effect of endovascular therapy and artery bypass for subclavian artery occlusion disease and to explore a suitable therapeutic procedure.Thirty-nine patients with subclavian artery occlusive disease received endovascular therapy or arterial bypass from June 1997 to May 2004. Twenty-seven endovascular stenting were performed on 26 patients through the femoral artery (n = 14) or combined brachial artery (n = 12). Retrograde endovascular balloon angioplasty and stent placement were performed on 12 patients. Eight subclavian arteries were punctured with ultrasound localization. On account of unsuccessful stenting, 13 cases received arterial bypass. In addition, endovascular stenting were performed on 9 cases with carotid or vertebrarterial stenoses.The blood pressure difference was less than 10 mm Hg between the treated and the healthy arms in all 39 patients. The ratio of healthy/diseased side of the mean blood pressure index increased from 0.62 +/- 0.11 preoperatively to 0.98 +/- 0.04 postoperatively (P0.01). The mean patency time for endovascular therapy and arterial bypass was (57.6 +/- 3.7) and (60.2 +/- 7.2) months, respectively.Both endovascular therapy and arterial bypass have good curative effect for subclavian artery occlusion. Endovascular therapy is the preferred treatment for subclavian artery occlusion with mini-trauma and safety.

To evaluate the safety and efficacy of endovascular therapy for renal artery stenosis.Percutaneous transluminal renal angioplasty with stent (PTRAS) was performed on 33 consecutive patients with severe renal artery stenosis who suffered from poorly controlled hypertension or renal dysfunction. They were subsequently underwent 7 to 49 months clinical follow up for the effect of the procedure on renal function, blood pressure control, mortality.Angiographic success was obtained in 32 (97.0%) of the 33 patients. The mortality was 18.2%. After PTRAS, two (6.1%) died of myocardial infarction within 4 months. Four (12.1%) patients with preoperative serum creatinine (Scr)or = 177 micromol/L died of uraemia within 17 approximately 28 months. Twelve and twenty-four months after the procedure, systolic and diastolic blood pressure of 26 (78.8%) cases with preoperative Scr177 micromol/L significantly decreased (P0.05), with less antihypertensive medications taken and satisfactory renal function.For patients without serious cardiorenal disease, PTRAS has a beneficial effect on blood pressure and renal function. For patients with serious cardiorenal disease or preoperative Scror = 177 micromol/L, the mortality is higher. PTRAS should be performed prudently. The preservation of renal function may be enhance by using renal protection device.

To study the effect of rosiglitazone, which is a ligand of peroxisome proliferator-activated receptor gamma (PPARgamma), on the expression of PPARgamma in hepatic stellate cells (HSCs) and on the biological characteristics of HSCs.The activated HSCs were divided into three groups: control group, 3 micromol/L rosiglitazone group, and 10 micromol/L rosiglitazone group. The expression of PPARgamma, alpha-smooth muscle actin (alpha-SMA), and type I and III collagen was detected by RT-PCR, Western blot and immunocytochemical staining, respectively. Cell proliferation was determined with methylthiazolyltetrazolium (MTT) colorimetric assay. Cell apoptosis was demonstrated with flow cytometry.The expression of PPARgamma at mRNA and protein level markedly increased in HSCs of 10 micromol/L rosiglitazone group (t value was 10.870 and 4.627 respectively, P0.01 in both). The proliferation of HSCs in 10 micromol/L rosiglitazone group decreased significantly (t = 5.542, P0.01), alpha-SMA expression level and type I collagen synthesis ability were also reduced vs controls (t value = 10.256 and 14.627 respectively, P0.01 in both). The apoptotic rate of HSCs significantly increased in 10 micromol/L rosiglitazone group vs control (chi(2) = 16.682, P0.01).By increasing expression of PPARgamma in activated HSCs, rosiglitazone, an agonist of PPARgamma, decreases alpha-SMA expression and type I collagen synthesis, inhibits cell proliferation, and induces cell apoptosis.

To investigate the regulatory effect of interleukin-10 (IL10) on the activation of hepatic stellate cells (HSC) through platelet derived growth factor (PDGF) and mitogen-activated protein kinase (MAPK) pathways.HSC were divided randomly into 4 groups. Group 1 served as a control. HSC were incubated with 1 ng/ml, 5 ng/ml, and 25 ng/ml IL-10 in groups 2, 3 and 4. RT-PCR and western blot were used to detect the expression of PDGF and MAPK protein ERK and p38 and alpha-SMA.Compared with the control group, expressions of ERK, p38 and alpha-SMA of groups 2, 3 and 4 were significantly lower (F values were 240.47, 21.39, 28.86 respectively. IL-10 inhibited PDGF and MAPK protein ERK and p38 and alpha-SMA expression in a dose-dependent way.IL-10 inhibits activation of HSC through the PDGF/MAPK pathway.

To investigate the effect of somatostatin analogue-octreotide (OCT) on expression of connective tissue growth factor (CTGF) gene of murine hepatic stellate cells (HSCs) in vitro.HSCs separated from Sprague Dawley rats by in situ perfusion and Nycodenz gradient were divided into 5 groups. HSCs in 4 out of 5 groups were co-cultured with octreotide at different dosages, and the remaining group served as control. The expression of CTGF and TGF-beta mRNA were assessed by reverse transcription-polymerase chain reaction (RT-PCR).OCT down-regulates the expression of CTGF and TGF-beta mRNA in HSCs. The effect is increased with a dose dependent manner.OCT could exert the inhibitory effect on HSCs by down-regulating the expression of CTGF and TGF-beta. This provides a potential for the prevention and management of hepatic fibrosis.

AIM: To elucidate the mechanism by which somatostatin and its analogue exert the influence on liver fibrosis, and to investigate the mRNA expression of somatostatin receptors subtypes (SSTRs) and the distribution of somatostatin analogue octreotide in rat hepatic stellate cells (HSCs). METHODS: HSCs were isolated from Sprague Dawley (SD) rats by in situ perfusion and density gradient centrifugation. After several passages, the mRNA expression of 5 subtypes of SSTRs were assessed by reverse transcription-polymerase chain reaction (RT-PCR). HSCs were planted on coverslip and co-cultured with octreotide tagged by FITC. Then the distribution of FITC fluorescence was observed under laser scanning confocal microscope (LSCM) in 12-24 h. RESULTS: There were mRNA expression of SSTR2, SSTR3 and SSTR5 but not SSTR1 and SSTR4 in SD rat HSCs. The mRNA expression level of SSTR2 was significantly higher than that of other subtypes (P < 0.01). FITC fluorescence of octreotide was clearly observed on the surface and in the cytoplasm, but not in the nuclei of HSCs under LSCM. CONCLUSION: The effect exerted by somatostatin and its analogues on HSCs may mainly depend on the expression of SSTR2, SSTR3 and SSTR5. Octreotide can perfectly combine with HSCs, and thereby exerts its biological activity on regulating the characters of active HSCs. This provides a potential prevention and management against liver fibrosis.