Effect of statins on blood pressure: Analysis on adverse events released by FDA.

OBJECTIVE: As a class of cholesterol-lowering drugs, statins have been reported to cause unexpected decrease in blood pressure (BP). However, most studies in this issue were subject to inadequate study design or very small sample size. The present study was designed to examine the BP-lowering effect of various statins. METHODS: Here we retrieved 5.9 million clinical reports submitted to FDA Adverse Event Reporting System (FAERS) from 2004 to 2015. Meta-analysis was performed to estimate the overall reporting odds ratio (ROR) of hypotension adverse events concurrent with various statins (i.e., atorvastatin, simvastatin, and rosuvastatin). RESULTS: Comparing the reporting rate of hypotension event between statins and other drugs found that atorvastatin (pooled ROR = 1.26, adjusted p-value = 8.60 × 10-4) and simvastatin (pooled ROR = 1.94, adjusted p-value = 4.16 × 10-45) were significantly associated with reduction in BP. On the other hand, the association between rosuvastatin and hypotension was observed to be nonsignificant (adjusted p-value = 0.65). CONCLUSION: To our knowledge, this is the first pooled analysis on large-scale data of adverse events to identify the BP-lowering effect of statins. The results will contribute to the development of novel statin-based antihypertensive therapies. In addition, the differential effects of individual statins can warrant subsequent research on the underlying mechanisms of BP control.

Different interventions for the treatment of patent ductus arteriosus in children: a protocol for a network meta-analysis.

INTRODUCTION: Patent ductus arteriosus (PDA) is one of the most common congenital heart diseases. Once the PDA is diagnosed, it needs to be dealt with in time. At present, main methods include pharmacological treatment, surgical closure, and interventional closure for treatment of PDA. However, the effect of different interventions in PDA management is still controversial. Thus, our study aims to assess the effectiveness of different interventions together and estimate the sequence of these therapies for PDA children. Meanwhile, it is necessary to conduct a Bayesian network meta-analysis to compare the safety of different interventions comprehensively. METHODS AND ANALYSIS: To the best of our knowledge, this is the first Bayesian network meta-analysis comparing the efficacy and safety of different interventions for the treatment of PDA. PubMed, Embase, Cochrane Library, Web of Science, gray literature, and trial registry databases were searched from inception to December 2022. We will extract and report data according to methodological guidelines for Bayesian network meta-analysis by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P). Primary PDA closure, overall PDA closure, technical success, surgical success rate, mortality during hospital stay, operation time, intensive care unit stay, intraoperative radiation dose, radiation exposure time, total postoperative complication rate, and postoperative major complication rate will be defined as the outcomes. The quality of all random studies will be assessed using ROB, and quality of evidence for all outcomes will be judged by using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). ETHICS AND DISSEMINATION: The results will be disseminated through peer-reviewed publication. Since no private and confidential patient data will be contained in the reporting, there are no ethical considerations associated with this protocol. SYSTEMATIC REVIEW REGISTRATION: INPLASY2020110067.

Transcatheter closure of multiple paravalvular leaks by a transapical approach under echocardiographic guidance: A case report.

CASE SUMMARY: A patient who underwent mechanical aortic and mitral valve replacement developed three paravalvular leaks 10 months later. We located the tracks by puncturing the apex cordis under transoesophageal echocardiography guidance alone and puncturing the femoral artery guided by fluoroscopy. Three paravalvular leaks were occluded with a hybridization method simultaneously. The patient was followed up for 24 months and maintained a good condition. CONCLUSION: Multiple paravalvular leaks after double valve replacement can be occluded in patients by the use of different approaches under echocardiographic guidance alone.

The Optimal Volume Fraction in Percutaneous Vertebroplasty Evaluated by Pain Relief, Cement Dispersion, and Cement Leakage: A Prospective Cohort Study of 130 Patients with Painful Osteoporotic Vertebral Compression Fracture in the Thoracolumbar Vertebra.

OBJECTIVE: To probe the relationship among cement volume/fraction, imaging features of cement distribution, and pain relief and then to evaluate the optimal volume during percutaneous vertebroplasty. METHODS: From January 2014 to January 2017, a total of 130 patients eligible for inclusion criteria were enrolled in this prospective cohort study. According to the different degrees of pain relief, cement leakage, and cement distribution, all patients were allocated to 2 groups. Clinical and radiologic characteristics were assessed to identify independent factors influencing pain relief, cement leakage, and cement distribution, including age, sex, fracture age, bone mineral density, operation time, fracture level, fracture type, modified semiquantitative severity grade, intravertebral cleft, cortical disruption in the vertebral wall, endplate disruption, type of nutrient foramen, fractured vertebral body volume, intravertebral cement volume, and volume fraction. A receiver operating characteristic curve was used to analyze the diagnostic value of the cement volume/fraction and then to obtain the optional cut-off value. RESULTS: The preoperative visual analog scale scores in the responders versus nonresponders patient groups were 7.37 ± 0.61 versus 7.87 ± 0.92 and the postoperative VAS scores in the responders versus nonresponders were 2.04 ± 0.61 versus 4.33 ± 0.49 at 1 week. There were no independent factors influencing pain relief. There were 95 (73.08%) patients who experienced cement leakage, and cortical disruption in the vertebral wall and cement fraction percentage were identified as independent risk factors by binary logistic regression analysis (adjusted odds ratio [OR] 2.935, 95% confidence interval [95% CI] 1.214-7.092, P = 0.017); (adjusted OR 1.134, 95% CI 1.026-1.254, P = 0.014). The area under the receiver-operating characteristic curve of volume fraction (VF%) was 0.658 (95% CI 0.549-0.768, P = 0.006 < 0.05). The cut-off value of VF% for cement leakage was 21.545%, with a sensitivity of 69.50% and a specificity of 60.00%. The incidence of favorable cement distribution was 74.62% (97/130), and VF% were identified as independent protective factors (adjusted OR 1.185, 95% CI 1.067-1.317, P = 0.002) The area under the receiver-operating characteristic curve of VF% was 0.686 (95% CI 0.571-0.802, P = 0.001 < 0.05). The cut-off value of VF% to reach a favorable cement distribution was 19.78%, with a sensitivity of 86.60% and a specificity of 51.50%. CONCLUSIONS: In osteoporotic vertebral compression fracture with mild/moderate fracture severity at the single thoracolumbar level, the intravertebral cement volume of 4-6 mL could relieve pain rapidly. The optimal VF% was 19.78%, which could achieve satisfactory cement distribution. With the increase of VF%, the incidence of cement leakage would also increase.

Comparison of transcatheter closure, mini-invasive closure, and open-heart surgical repair for treatment of perimembranous ventricular septal defects in children: A PRISMA-compliant network meta-analysis of randomized and observational studies.

OBJECTIVE: Our study was aimed to comprehensively compare the relative efficacy, safety, and the cost of transcatheter closure, mini-invasive closure, and open-heart surgical repair to treat perimembranous ventricular septal defects (pmVSDs) in children using network meta-analysis method. METHODS: Five databases were systematically searched including Chinese Biomedical Literature Database, China National Knowledge Infrastructure, PubMed, EMBASE.com, and the Cochrane Central Register of Controlled Trials from the starting date of each database to February 2017. Tools for assessing the risk of bias in nonrandomized studies of interventions (ROBINS-I) were used to evaluate the risk of bias in observational studies and Cochrane Handbook version 5.1.0 was used for randomized controlled trials (RCTs). Data were analyzed using R-3.4.0 software and Review Manager 5.2. RESULTS: Three RCTs and 24 observational studies were included in our study. Network meta-analysis result demonstrated that transcatheter closure was the most effective treatment in terms of operative time [standardized mean difference (SMD) = -2.02, 95% confidence interval (CI): -3.92 to -0.12], major complications [odds ratio (OR) = 0.52, 95% CI = 0.30-0.91], ICU stay (SMD = -1.11, 95% CI = -2.13 to -0.08), and hospital stay (SMD = -1.81, 95% CI = -2.24 to -1.39). However, open-heart surgical repair showed a higher success rate of the procedure than transcatheter closure (OR = 0.36, 95% CI = 0.17-0.77).Statistical analysis result demonstrated that transcatheter closure had the best potential to lessen major complications, ICU stay, hospital stay, operative time, and significant residual shunt. CONCLUSIONS: Transcatheter closure has more benefit than mini-invasive closure and open-heart surgical repair to treat pmVSDs.

Transcatheter closure, mini-invasive closure and open-heart surgical repair for treatment of perimembranous ventricular septal defects in children: a protocol for a network meta-analysis.

INTRODUCTION: Both transcatheter device closure and surgical repair are effective treatments with excellent midterm outcomes for perimembranous ventricular septal defects (pmVSDs) in children. The mini-invasive periventricular device occlusion technique has become prevalent in research and application, but evidence is limited for the assessment of transcatheter closure, mini-invasive closure and open-heart surgical repair. This study comprehensively compares the efficacy, safety and costs of transcatheter closure, mini-invasive closure and open-heart surgical repair for treatment of pmVSDs in children using Bayesian network meta-analysis. METHODS AND ANALYSIS: A systematic search will be performed using Chinese Biomedical Literature Database, China National Knowledge Infrastructure, PubMed, EMBASE.com and the Cochrane Central Register of Controlled Trials to include random controlled trials, prospective or retrospective cohort studies comparing the efficacy, safety and costs of transcatheter closure, mini-invasive closure and open-heart surgical repair. The risk of bias for the included prospective or retrospective cohort studies will be evaluated according to the risk of bias in non-randomised studies of interventions (ROBINS-I). For random controlled trials, we will use risk of bias tool from Cochrane Handbook version 5.1.0. A Bayesian network meta-analysis will be conducted using R-3.3.2 software. ETHICS AND DISSEMINATION: Ethical approval and patient consent are not required since this study is a network meta-analysis based on published trials. The results of this network meta-analysis will be submitted to a peer-reviewed journal for publication. PROTOCOL REGISTRATION NUMBER: CRD42016053352.