A comparison of experimental compressive axial loading testing with a numerical simulation of topologically optimized cervical implants made by selective laser melting.

In recent years, the number of cervical interventions has increased. The stress shielding effect is a serious complication in cervical spine interventions. Topological optimization is based on finite element method structural analysis and numerical simulations. The generated design of cervical implants is made from Ti6Al4V powder by selective laser melting while the optimized cage is numerically tested for compressive axial loading and the results are compared with experimental measurement. Additive manufacturing technologies and new software possibilities in the field of structural analysis, which use the finite element method tools, help to execute implant topological optimization that is useful for clinical practice. The inner structures of the implant would be impossible to make by conventional manufacturing technologies. The resulting implant design, after modification, must fulfill strict application criteria for the area of cervical spine with respect to its material and biomechanical properties. The aim of this work was to alter the mechanical properties of the cervical intervertebral cage to address the clinical concern of the stress shielding effect by topological optimization. A methodology of cervical implant compressive axial loading numerical simulation was created, and subsequent experimental testing was done to obtain real material properties after a selective laser melting process. The weight of the optimized implant was reduced by 28.92 %. Results of the experimental testing and numerical simulation of topologically optimized design showed 10-times lower stiffness compared to the solid cage design, and the real yield strength of the optimized structure is 843.8 MPa based on experimental results.

Addition of omega-3 fatty acid and coenzyme Q10 to statin therapy in patients with combined dyslipidemia.

BACKGROUND: Statins represent a group of drugs that are currently indicated in the primary and secondary prevention of cardiovascular events. Their administration can be associated with side effects and the insufficient reduction of triacylglyceride (TAG) levels. This study aimed to assess the effect of the triple combination of statins with omega-3 fatty acids and coenzyme Q10 (CoQ10) on parameters associated with atherogenesis and statin side effects. METHODS: In this pilot randomized double-blind trial, 105 subjects who met the criteria of combined dislipidemia and elevated TAG levels were randomly divided into three groups. In the control group, unaltered statin therapy was indicated. In the second and third groups, omega-3 PUFA 2.52 g/day (Zennix fa Pleuran) and omega-3 PUFA 2.52 g+CoQ10 200 mg/day (Pharma Nord ApS) were added, res//. At the end of the 3-month period (±1 week), all patients were evaluated. RESULTS: Significant reduction of hepatic enzymes activity, systolic blood preasure, inflammatory markers and TAG levels were detected in both groups in comparison to the control group. Activity of SOD and GPx increased significantly after additive therapy. Coenzyme Q10 addition significantly reduced most of the abovementioned parameters (systolic blood preasure, total cholesterol, LDL, hsCRP, IL-6, SOD) in comparison with the statin+omega-3 PUFA group. The intensity of statin adverse effects were significantly reduced in the group with the addition of CoQ10. CONCLUSIONS: The results of this pilot study suggest the possible beneficial effects of triple combination on the lipid and non-lipid parameters related to atherogenesis and side effects of statin treatment.

Slovak trial on cardiovascular risk reduction following national guidelines with CaDUET® (the STRONG DUET study).

INTRODUCTION: The efficacy and safety of single-pill amlodipine/atorvastatin for reducing blood pressure (BP), low-density lipoprotein cholesterol (LDLC), and predicted 10-year cardiovascular (CV) risk have been demonstrated in low CV risk countries. The Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (amlodipine besylate/atorvastatin calcium; Pfizer, Morrisville, PA, USA; STRONG DUET) study evaluated its clinical utility in Slovakia, one of the highest CV risk regions in Europe. METHODS: This was a two-phase study involving 100 outpatient cardiologist and internist departments in Slovakia. Phase 1 assessed BP control and CV risk profiles in adults with treated hypertension, and phase 2 was an open-label, multicenter, observational study. In the phase 2 study, patients with treated but uncontrolled hypertension and three or more coronary heart disease risk factors received single-pill amlodipine/atorvastatin (5/10 or 10/10 mg) for 12 weeks. Major outcomes were the percentage of patients achieving target BP (≤140/90 mmHg) and/or LDL-C (≤3 mmol/L) and reductions in predicted 10-year CV risk. RESULTS: Of the 4,672 phase 1 patients, 80.8% had uncontrolled hypertension and 61.4% had dyslipidemia. Of the 1,406 phase 2 patients, 90.3% of patients achieved target BP at week 12, 66.3% achieved target LDL-C, and 60.7% achieved both. The mean 10-year CV risk was reduced by 49% (P < 0.0001); treatment was well-tolerated and safe. CONCLUSION: Single-pill amlodipine/atorvastatin was associated with significant improvements in BP, LDL-C target attainment, and 10-year CV risk in patients with uncontrolled hypertension in Slovakia. The treatment was well-tolerated and safe. Use of single-pill amlodipine/atorvastatin in high CV-risk countries could lead to significant improvements in CV risk management.