Transfemoral transcatheter aortic valve replacement with VitaFlowTM valve for pure native aortic regurgitation in patients with high surgical risk: Rationale and design of a prospective, multicenter, and randomized SEASON-AR trial.

BACKGROUND: Previous studies primarily demonstrated that transfemoral transcatheter aortic valve replacement (TAVR) with self-expanding valve appeared to be a safe and feasible treatment for patients with pure native aortic regurgitation (AR). However, the routine application of transfemoral TAVR for pure AR patients lacks support from randomized trials. TRIAL DESIGN: SEASON-AR trial is a prospective, multicenter, randomized, controlled, parallel-group, open-label trial, involving at least 20 sites in China, aiming to enroll 210 patients with pure native severe AR and high surgical risk. All enrolled patients are randomly assigned in a 1:1 fashion to undergo transfemoral TAVR with VitaFlowTM valve and receive guideline-directed medical therapy (GDMT) or to receive GDMT alone. The primary endpoint is the rate of major adverse cardiac events (MACE) at 12 months after the procedure, defined by the composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure. The major secondary endpoints encompass various measures, including procedure-related complications, device success, 6-minute walk distance, and the occurrence of each individual component of the primary endpoint. After hospital discharge, follow-up was conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes. CONCLUSION: SEASON-AR trial is the first study designed to investigate the clinical efficacy and safety of transfemoral TAVR with a self-expanding valve in patients with pure native severe AR with inoperable or high-risk, as compared to medical treatment only.

Lipidomics study of plasma phospholipid metabolism in early type 2 diabetes rats with ancient prescription Huang-Qi-San intervention by UPLC/Q-TOF-MS and correlation coefficient.

Potential impact of lipid research has been increasingly realized both in disease treatment and prevention. An effective metabolomics approach based on ultra-performance liquid chromatography/quadrupole-time-of-flight mass spectrometry (UPLC/Q-TOF-MS) along with multivariate statistic analysis has been applied for investigating the dynamic change of plasma phospholipids compositions in early type 2 diabetic rats after the treatment of an ancient prescription of Chinese Medicine Huang-Qi-San. The exported UPLC/Q-TOF-MS data of plasma samples were subjected to SIMCA-P and processed by bioMark, mixOmics, Rcomdr packages with R software. A clear score plots of plasma sample groups, including normal control group (NC), model group (MC), positive medicine control group (Flu) and Huang-Qi-San group (HQS), were achieved by principal-components analysis (PCA), partial least-squares discriminant analysis (PLS-DA) and orthogonal partial least-squares discriminant analysis (OPLS-DA). Biomarkers were screened out using student T test, principal component regression (PCR), partial least-squares regression (PLS) and important variable method (variable influence on projection, VIP). Structures of metabolites were identified and metabolic pathways were deduced by correlation coefficient. The relationship between compounds was explained by the correlation coefficient diagram, and the metabolic differences between similar compounds were illustrated. Based on KEGG database, the biological significances of identified biomarkers were described. The correlation coefficient was firstly applied to identify the structure and deduce the metabolic pathways of phospholipids metabolites, and the study provided a new methodological cue for further understanding the molecular mechanisms of metabolites in the process of regulating Huang-Qi-San for treating early type 2 diabetes.

Acute renal injury after thoracic endovascular aortic repair of Stanford type B aortic dissection: incidence, risk factors, and prognosis.

BACKGROUND/PURPOSE: Acute kidney injury (AKI) significantly increases the risk of mortality in patients following cardiovascular intervention procedures. This study was carried out to investigate the incidence, predictors, and prognostic implications of AKI after thoracic endovascular aortic repair (TEVAR) of Stanford type B aortic dissection. METHODS: A total of 156 patients with Stanford type B aortic dissection who underwent TEVAR were retrospectively analyzed between February 1, 2004 and October 31, 2011. Multivariable regression was used to predict risk factors for AKI. Association between baseline characteristics, postoperative AKI, and mortality during follow up was evaluated. RESULTS: AKI was identified in 48 (30.8%) of 156 patients, with seven (14.5%) patients requiring continuous renal replacement therapy. The in-hospital mortality rate was 0% in patients without AKI and 12.5% in those with AKI (p = 0.001). Univariate analysis identified preoperative chronic kidney disease, acute dissection, complicated dissection, malperfusion complications with comprehensive complications, and postoperative minimum estimated glomerular filtration rate within 48 hours as associated with AKI. Malperfusion complications [odds ratio (OR) = 4.828; 95% confidence interval (CI) = 1.163-20.03] were the only independent predictor of AKI. Patients suffering from AKI had a 14-fold increased risk for 30-day mortality (OR = 14.3; 95% CI = 1.7-118.4; p = 0.014) and a 10-fold increased risk for 1-year mortality (OR = 9.5; 95% CI = 2.02-44.9; p = 0.004). CONCLUSION: A significant rate of AKI was observed following TEVAR and was associated with an increase in 30-day and 1-year mortality. Malperfusion complications were identified as an independent predictor of AKI.

Comparison of long-term clinical outcome between patients with chronic versus acute type B aortic dissection treated by implantation of a stent graft: a single-center report.

BACKGROUND: Stent grafting for treatment of type B aortic dissection has been extensively used. However, the difference in the long-term clinical outcome between patients with chronic versus acute type B aortic dissection remains unknown. This study aimed to analyze the difference in long-term clinical outcome after endovascular repair for patients with chronic (≥2 weeks) versus acute (<2 weeks) type B aortic dissection. METHODS: Between May 2000 and June 2011, a total of 174 patients with type B aortic dissection (56 chronic, 118 acute) treated by endovascular repair were studied prospectively. Follow-up three-dimensional computed tomography scanning and aortoangiography were scheduled at 3-6 months after the index procedure. Propensity score matching was used to compare the difference in the endpoint between the two groups. RESULTS: The procedure-related event rate was 18.6% in the acute group and 5.4% in the chronic group (P = 0.021), but this difference became nonsignificant after propensity score matching. At the end of follow-up (mean 2.49 years), overall and aorta-related mortality was 11.0% and 7.6%, respectively, in the acute group, and was not significantly different from that in the chronic group (3.6% and 3.6%, P = 0.148 and P = 0.506, respectively). Both false and true lumina showed significant remodeling over time, with >93% complete false-lumen thrombosis. Untreated tear and type I endoleak were predictors of clinical events during follow-up. CONCLUSION: Comparable long-term clinical results were achieved in patients with chronic or acute type B aortic dissection after implantation of a stent graft.

[Clinical observation on children-sized fibreoptic bronchoscope usage in whole-lung lavage].

OBJECTIVE: To explore the effect of children-sized fibreoptic bronchoscope in improving the safety of whole-lung lavage (WLL). METHOD: Patients from May 2006 to May 2010 using children-sized fibreoptic bronchoscope to assistant the location were assigned to fibreoptic bronchoscope group. Patients from May 1998 to Nov 2004 using traditional stethoscope to help intubation were assigned to control group. The adverse reactions and complications were compared. RESULT: There were liquid leakage 1 case (0.96%), hypoxia 3 cases (2.88%) and liquid retained over 1000 ml 15 cases (14.42%) in fibreoptic bronchoscope group. In contrast, liquid leakage 24 cases (6.38%), hypoxia 42 cases (11.17%) and liquid retained over 1000 ml 135 cases (35.90%) happened in control group. The differences between the two groups were significant (P<0.05, P<0.01). CONCLUSION: Using children-sized fibreoptic bronchoscope in WLL can promote the situation of double-lumen tube, help separation the two lungs, decrease complications and improving safety.

Anti-fungal efficacy of polybutylcyanoacrylate nanoparticles of allicin and comparison with pure allicin.

Although garlic has been used in Chinese traditional medicine for its medical properties for thousands of years, investigations into its mode of action are relatively recent. The purpose of this study was to evaluate the in vitro anti-fungal efficacy of the active principle of garlic, pure allicin and polybutylcyanoacrylate (PBCA) nanoparticles (NPs) loaded with allicin. Pure allicin was prepared by reacting synthetic alliin with a stabilized process of the garlic enzyme alliinase. PBCA NPs were prepared by emulsion polymerization method and pure allicin was wrapped into it. The in vitro efficacy of pure allicin and PBCA-allicin NPs to Candida albicans, Cryputococcus neoformans, Trichophyton rubum, Microsporum gypseum, M. canis and Epidermophyton floccosum was examined and evaluated by MIC and MFC. The MIC of PBCA-allicin NPs to C. albicans (2.93 x 10(-2)mg/ml), T. rubum (1.46 x 10(-2)mg/ml) and E. floccosum (1.46 x 10(-2)mg/ml) was significantly lower than that of pure allicin (5.86 x 10(-2)mg/ml, 2.93 x 10(-2)mg/ml, 2.93 x 10(-2)mg/ml, respectively); accordingly, the MFC of PBCA-allicin NPs to C. albicans (5.86 x 10(-2)mg/ml), T. rubum (2.93 x 10(-2)mg/ml), E. floccosum (2.93 x 10(-2)mg/ml) and M. canis (2.93 x 10(-2)mg/ml) also decreased dramatically. These favourable results indicated that pure allicin has stronger in vitro anti-fungal efficacy to six tested fungi than alliinase and alliin. Moreover, it has improved significantly after pure allicin being wrapped into PBCA NP, which may be due to the NP's good prolonged release effect and nano-scale dimensions.