Magnesium 2000 postmarket evaluation : Guideline adherence and intraprocedural performance of a sirolimus-eluting resorbable magnesium scaffold

Background The Magmaris bioresorbable magnesium scaffold was successfully tested in in-vitro and in clinical premarket studies. Subsequently the Magmaris postmarket program aimed to review intraprocedural data of at least 2000 patients to assess user preferences, guideline adherence and intraprocedural performance in clinical routine. Methods This international multicentre survey encompasses data from 356 hospitals across 45 countries. As part of the certification for Magmaris implantation, each hospital had to complete consecutive post-market evaluation forms of their first 10 commercial Magmaris patients. Results From June 2016 to May 2018, data on 2018 implantations were collected. Main reasons for selecting Magmaris was patients' life expectancy (67%, n = 1359) and low or not calcified lesions, (67%, n = 1357). Magmaris was successfully deployed in 99% of cases (n = 1995), predilatation was performed in 95% (n = 1922) and post-dilatation in 87% (n = 1756). Physicians rated the overall performance and the pushability as good or very good in 96% of cases (n = 1799). Guide wire friction, trackability, and conformability were rated as good or very good in 94% of cases, and crossability in 93%. The majority of patients were scheduled to receive dual antiplatelet therapy for up to 12 months. Conclusion Generally, implantation guidelines were adhered to and theoretical advantages of the metal scaffold observed in in-vitro tests have translated into practice with good intraprocedural performance outcomes, confirming the controlled roll-out of this novel technology into clinical practice. (C) 2019 The Authors. Published by Elsevier Inc.Peer reviewe

Zero fluoroscopy catheter ablation for atrial fibrillation: a systematic review and meta-analysis

IntroductionCatheter ablation for atrial fibrillation (AF) is the most frequently performed cardiac ablation procedure worldwide. The majority of ablations can now be performed safely with minimal radiation exposure or even without the use of fluoroscopy, thanks to advances in 3-dimensional electroanatomical mapping systems and/or intracardiac echocardiography. The aim of this study was to conduct a meta-analysis to compare the effectiveness of zero fluoroscopy (ZF) versus non-zero fluoroscopy (NZF) strategies for AF ablation procedures.MethodsElectronic databases were searched and systematically reviewed for studies comparing procedural parameters and outcomes of ZF vs. NZF approaches in patients undergoing catheter ablation for AF. We used a random-effects model to derive the mean difference (MD) and risk ratios (RR) with a 95% confidence interval (CI).ResultsOur meta-analysis included seven studies comprising 1,593 patients. The ZF approach was found to be feasible in 95.1% of patients. Compared to the NZF approach, the ZF approach significantly reduced procedure time [mean difference (MD): −9.11 min (95% CI: −12.93 to −5.30 min; p < 0.01)], fluoroscopy time [MD: −5.21 min (95% CI: −5.51 to −4.91 min; p < 0.01)], and fluoroscopy dose [MD: −3.96 mGy (95% CI: −4.27 to −3.64; p < 0.01)]. However, there was no significant difference between the two groups in terms of total ablation time [MD: −104.26 s (95% CI: −183.37 to −25.14; p = 0.12)]. Furthermore, there was no significant difference in the acute [risk ratio (RR): 1.01, 95% CI: 1.00–1.02; p = 0.72] and long-term success rates (RR: 0.96, 95% CI: 0.90–1.03; p = 0.56) between the ZF and NZF methods. The complication rate was 2.76% in the entire study population and did not differ between the groups (RR: 0.94, 95% CI: 0.41–2.15; p = 0.89).ConclusionThe ZF approach is a feasible method for AF ablation procedures. It significantly reduces procedure time and radiation exposure without compromising the acute and long-term success rates or complication rates

Comparing Endovascular Approaches in Lower Extremity Artery Disease: Insights from a Network Meta-Analysis

Background: Endovascular therapy offers an alternative for treating femoropopliteal (FP) and infrapopliteal (IP) lesions related to occlusive lower extremity artery disease. Despite numerous trials, the effectiveness of restenosis prevention using local drug delivery devices remains a topic of debate. Objectives: An updated systematic review and network meta-analysis was conducted. Our overall aim was to summarize the most recent clinical evidence regarding endovascular approaches for FP and IP atherosclerotic lesions. Methods: We conducted a search for randomized trials in the MEDLINE database, and extracted data related to clinical endpoints. Our primary focus was on the rate of major adverse events (MAEs), including mortality, amputation, and target lesion revascularization (TLR). A multiple treatment network meta-analysis supplemented with component network analyses was performed to examine the impact of combined treatment. Results: Our search yielded 33 randomized controlled trials encompassing 5766 patients. This included 19 studies focused on femoropopliteal and 14 on IP lesions, accounting for 3565 and 2201 patients, respectively. Drug-coated balloons (DCBs) and drug-eluting stents (DESs) displayed a reduced MAE risk in comparison to plain old balloon angioplasty (POBA)—RR for DCB: 0.64 (95% CI: 0.52–0.77) and for DES: 0.71 (95% CI: 0.51–0.99). The bare-metal stent (BMS) group manifested the most substantial MAE risk, being 59% higher relative to the DCB cohort (BMS vs. DCB RR: 1.59; 95% CI: 1.03–2.47). For FP lesions, DES was the standout performer, curtailing MAE risk by 55% relative to POBA. Within IP lesions, DES mitigated the MAE risk by 25% versus POBA. DCB did not exhibit any notable MAE reduction when pitted against POBA. Conclusion: In FP arteries, both DESs and DCBs yielded significantly diminished MAEs, thus outpacing other techniques. Regarding IP arteries, only DESs resulted in significantly fewer MAEs. In alignment with contemporary research, our findings revealed no signs of elevated mortality in patients undergoing treatment with drug-eluting apparatuses

Effects of sildenafil treatment on cytokine expressions.

<p>Nitrocellulose based rat cytokine array assay was performed on lung homogenates of untreated (Sham), sildenagfil (Sham+SLD), MCT (PH) and MCT plus sildenafil treated (PH+SLD) rats (n = 3–4). Bar diagrams represent mean±S.E.M. pixel densities of the immunoblots. *** significantly different from Sham group (p≤0.05), +++ significantly different from PH group (p≤0.05) by ANOVA, post hoc Bonferroni test.</p

Effects of sildenafil treatment on NFκB activation and nuclear translocation.

<p>NFκB activation and nuclear translocation was assessed by immunoblotting (A) and immunohistochemistry (B) utilizing phospho-NF-κB p65 (A,B) and NF-κB (A) specific primary antibodies. Bar diagrams (A) of the mean pixel densities±S.E.M. and representative immunohistochemistry images (B) of 3 to 4 animals are presented. The phospho-NFκB p65 bands were normalized to the NFκB band. *** significantly different from Sham group (p≤0.05), +++ significantly different from PH group (p≤0.05) by ANOVA, post hoc Bonferroni test.</p

N-terminal pro-brain natriuretic peptide is a strong predictor of mortality in systemic sclerosis

Objectives: Cardiovascular involvement is a major contributor to mortality in systemic sclerosis (SSc). We examined whether N-terminal pro-brain natriuretic peptide (NT-proBNP) is a reliable predictor of mortality in SSc. Methods and results: This multicentre prospective cohort study included 523 patients presenting with SSc, whose mean age was 54 +/- 13 years, mean disease duration 8 +/- 9 years, and diffuse cutaneous form in 168. Plasma NT-proBNP was measured at baseline and the patients were followed yearly. Overall mortality was measured at 3 years. At baseline, cardiovascular involvement was present in 37 patients, including 17 with pulmonary artery hypertension (PAH) and 20 with a left ventricular ejection fraction (LVEF) <55%. At 3 years, 32 (7%) patients had died. The median [25th-75th percentile] NT-proBNP concentration was 203 ng/l [129-514] in patients who died within 3 years, versus 88 ng/l [47-167] in survivors (P < 0.001). NT-proBNP was an independent predictor of 3-years mortality in multivariate analysis (P = 0.046). The optimal cut-off derived from the ROC curve was 129 ng/l; sensitivity and specificity to predict 3 y mortality were 78.1 and 66.7%. Using the previously recommended 125-ng/l concentration as threshold value, NT-proBNP reliably and independently predicted 3 year mortality, with a sensitivity of 78.1 and a negative predictive value of 97.6%, respectively (P = 0.006). The consideration of SSc patients without PAH or LVEF < 55% at baseline yielded similar results. Conclusion: NT-proBNP appears as a reliable and independent predictor of mortality in patients with SSc. (C) 2016 Elsevier Ireland Ltd. All rights reserved

Effect of sildenafil on Akt activation.

<p>Effect of Sildenafil and MCT treatment on Akt expression (A) and activation (B) as well as on GSK-3β expression (C) and phosphorylation (D) was determined by immunoblotting utilizing protein- and phosphorylation specific primary antibodies. The bar diagrams represent pixel volumes±S.E.M. of pAkt and pGSK-3β bands. The bands were normalized to the appropriate Akt and GSK-3β bands. *** significantly different from Sham group (p≤0.05), +++ significantly different from PH group (p≤0.05) by ANOVA, post hoc Bonferroni test. Phospho-Akt and GSK-3β are denoted as pAkt and pGSK-3β.</p

Effect of sildenafil on ERK1/2 and p38 MAPK activation.

<p>Effect of Sildenafil and MCT treatment on ERK 1 and 2 expression (A) and activation (B) as well as on p38 MAPK expression (C) and phosphorylation (D) was determined by immunoblotting utilizing protein- and phosphorylation specific primary antibodies. The bar diagrams represent pixel volumes±S.E.M. of pERK1/2 and pp38 MAPK bands. The bands were normalized to the appropriate ERK1/2 and p38 MAPK bands. *** significantly different from Sham group (p≤0.05), +++ significantly different from PH group (p≤0.05) by ANOVA, post hoc Bonferroni test. Phospho-ERK1/2 and p38 MAPK are denoted as pERK1/2 and pp38 MAPK.</p