Impact of ultra-thin struts on restenosis after chronic total occlusion recanalization: Insights from the randomized PRISON IV trial

The PRISON-IV trial showed inferior outcome in patients with chronic total occlusions (CTOs) treated with the ultrathin-struts (60\u2009\u3bcm for stent diameter 643\u2009mm, 81\u3bcm >3\u2009mm) hybrid-sirolimus eluting stents (SES) compared with everolimus eluting stents (EES, 81\u2009\u3bcm). The aim of this study is to investigate if the use of smaller stents ( 643\u2009mm) was responsible for the inferior outcome reported in the trial

Laser decoating of DLC films for tribological applications

Damaged DLC coatings usually require remanufacturing of the entire coated components starting from an industrial chemical de-coating step. Alternatively, a complete or local coating repair can be considered. To pursue this approach, however, a local coating removal is needed as first operation. In this context, controlled decoating based on laser sources can be a suitable and clean alternative to achieve a pre-fixed decoating depth with high accuracy. In the present study, we investigated a laser-based decoating process executed on multilayered DLC films for advanced tribological applications (deposited via a hybrid PVD/PE-CVD technique). The results were acquired via multifocal optical digital microscopy (MF-ODM), which allowed high-resolution 3D surface reconstruction as well as digital profilometry of the lasered and unlasered surface. The study identifies the most critical process parameters which influence the effective decoating depth and the post-decoating surface roughness. In particular, the role of pulse overlap (decomposed along orthogonal directions), laser fluence, number of lasing passes and assist gas is discussed in text. A first experimental campaign was designed to identify the best conditions to obtain full decoating of the DLC + DLC:Cr layers. It was observed that decreasing the marking speed to 200 mm/s was necessary to obtain a sufficient pulse overlap and a nearly planar ablation profile. By operating with microsecond pulses and 1 J/cm2 (fairly above the ablation threshold), less than 10 passes were needed to obtain full decoating of the lasered area with an etching rate of 1.1 μm/loop. Further experiments were then executed in order to minimise the roughness of the rest surface with the best value found at around 0.2 μm. Limited oxidation but higher Ra values were observed in Ar atmosphere

Less bleeding by omitting aspirin in non-ST-segment elevation acute coronary syndrome patients: rationale and design of the LEGACY study

BackgroundEarly aspirin withdrawal, also known as P2Y12-inhibitor monotherapy, following percutaneous coronary intervention (PCI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) can reduce bleeding without a trade-off in efficacy. Still the average daily bleeding risk is highest during the first months and it remains unclear if aspirin can be omitted immediately following PCI.MethodsThe LEGACY study is an open-label, multicenter randomized controlled trial evaluating the safety and efficacy of immediate P2Y12-inhibitor monotherapy versus dual antiplatelet therapy (DAPT) for 12 months in 3,090 patients. Patients are randomized immediately following successful PCI for NSTE-ACS to 75-100 mg aspirin once daily versus no aspirin. The primary hypothesis is that immediately omitting aspirin is superior to DAPT with respect to major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, while maintaining noninferiority for the composite of all-cause mortality, myocardial infarction and stroke compared to DAPT.ConclusionsThe LEGACY study is the first randomized study that is specifically designed to evaluate the impact of immediately omitting aspirin, and thus treating patients with P2Y12-inhibitor monotherapy, as compared to DAPT for 12 months on bleeding and ischemic events within 12 months following PCI for NSTE-ACS.Cardiolog

Appropriate use criteria for optical coherence tomography guidance in percutaneous coronary interventions: Recommendations of the working group of interventional cardiology of the Netherlands Society of Cardiology

Introduction: Optical coherence tomography (OCT) enables detailed imaging of the coronary wall, lumen and intracoronary implanted devices. Responding to the lack of specific appropriate use criteria (AUC) for this technique, we conducted a literature review and a procedure for appropriate use criteria. Methods: Twenty-one of all 184 members of the Dutch Working Group on Interventional Cardiology agreed to evaluate 49 pre-specified cases. During a meeting, factual indications were established whereupon members individually rated indications on a 9-point scale, with the opportunity to substantiate their scoring. Results: Twenty-six indications were rated ‘Appropriate’, eighteen indications ‘May be appropriate’, and five ‘Rarely appropriate’. Use of OCT was unanimously considered ‘Appropriate’ in stent thrombosis, and ‘Appropriate’ for guidance in PCI, especially in distal left main coronary artery and proximal left anterior descending coronary artery, unexplained angiographic abnormalities, and use of bioresorbable vascular scaffold (BVS). OCT was considered ‘Rarely Appropriate’ on top of fractional flow reserve (FFR) for treatment indication, assessment of strut coverage, bypass anastomoses or assessment of proximal left main coronary artery. Conclusions: The use of OCT in stent thrombosis is unanimously considered ‘Appropriate’ by these experts. Varying degrees of consensus exists on the appropriate use of OCT in other settings

Appropriate use criteria for optical coherence tomography guidance in percutaneous coronary interventions Recommendations of the working group of interventional cardiology of the Netherlands Society of Cardiology

Introduction: Optical coherence tomography (OCT) enables detailed imaging of the coronary wall, lumen and intracoronary implanted devices. Responding to the lack of specific appropriate use criteria (AUC) for this technique, we conducted a literature review and a procedure for appropriate use criteria. Methods: Twenty-one of all 184 members of the Dutch Working Group on Interventional Cardiology agreed to evaluate 49 pre-specified cases. During a meeting, factual indications were established whereupon members individually rated indications on a 9-point scale, with the opportunity to substantiate their scoring. Results: Twenty-six indications were rated ‘Appropriate’, eighteen indications ‘May be appropriate’, and five ‘Rarely appropriate’. Use of OCT was unanimously considered ‘Appropriate’ in stent thrombosis, and ‘Appropriate’ for guidance in PCI, especially in distal left main coronary artery and proximal left anterior descending coronary artery, unexplained angiographic abnormalities, and use of bioresorbable vascular scaffold (BVS). OCT was considered ‘Rarely Appropriate’ on top of fractional flow reserve (FFR) for treatment indication, assessment of strut coverage, bypass anastomoses or assessment of proximal left main coronary artery. Conclusions: The use of OCT in stent thrombosis is unanimously considered ‘Appropriate’ by these experts. Varying degrees of consensus exists on the appropriate use of OCT in other settings

Prevention of congenital malformations and other adverse pregnancy outcomes with 4.0 mg of folic acid : community-based randomized clinical trial in Italy and the Netherlands

Background: In 2010 a Cochrane review confirmed that folic acid (FA) supplementation prevents the first- and second-time occurrence of neural tube defects (NTDs). At present some evidence from observational studies supports the hypothesis that FA supplementation can reduce the risk of all congenital malformations (CMs) or the risk of a specific and selected group of them, namely cardiac defects and oral clefts. Furthermore, the effects on the prevention of prematurity, foetal growth retardation and pre-eclampsia are unclear.Although the most common recommendation is to take 0.4 mg/day, the problem of the most appropriate dose of FA is still open.The aim of this project is to assess the effect a higher dose of peri-conceptional FA supplementation on reducing the occurrence of all CMs. Other aims include the promotion of pre-conceptional counselling, comparing rates of selected CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age, abruptio placentae.Methods/Design: This project is a joint effort by research groups in Italy and the Netherlands. Women of childbearing age, who intend to become pregnant within 12 months are eligible for the studies. Women are randomly assigned to receive 4 mg of FA (treatment in study) or 0.4 mg of FA (referent treatment) daily. Information on pregnancy outcomes are derived from women-and-physician information.We foresee to analyze the data considering all the adverse outcomes of pregnancy taken together in a global end point (e.g.: CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age). A total of about 1,000 pregnancies need to be evaluated to detect an absolute reduction of the frequency of 8%. Since the sample size needed for studying outcomes separately is large, this project also promotes an international prospective meta-analysis.Discussion: The rationale of these randomized clinical trials (RCTs) is the hypothesis that a higher intake of FA is related to a higher risk reduction of NTDs, other CMs and other adverse pregnancy outcomes. Our hope is that these trials will act as catalysers, and lead to other large RCTs studying the effects of this supplementation on CMs and other infant and maternal outcomes.Trial registration: Italian trial: ClinicalTrials.gov Identifier: NCT01244347.Dutch trial: Dutch Trial Register ID: NTR3161

Contemporary challenges and percutaneous cardiac interventions for patients with refractory angina

Refractory angina pectoris is a chronic disabling condition affecting a growing number of patients (10-15%) with ischemic heart disease. It is defined as debilitating anginal complaints despite optimal medical therapy due to severe and/or diffuse coronary artery disease (CAD) without options for percutaneous or surgical revascularization procedures. Patients with refractory angina have a reduced life expectancy and represent the most fragile population among those with chronic ischemic heart disease.In this thesis, we sought to explore the role of percutaneous cardiac interventions in the treatment of patients with refractory angina. We will indeed not only describe the available approaches in this setting, but we will study how recent developments and improvements in materials, techniques and devices allow for a more efficient and less invasive approach. This doctoral dissertation is divided into two major chapters. The first one (PART-I) will centre on the evolution of percutaneous coronary intervention (PCI) in chronic total occlusions (CTO) and will comprise different aspects of CTO-PCI optimization. Furthermore, a novel approach to CTO-PCI (namely the Minimalistic Hybrid Approach) is described, aiming at reducing the use of large bore guiding catheters, limiting the dual vascular access and favouring a trans-radial approach over a femoral approach. The second major chapter of this dissertation (PART-II) is dedicated to a recently introduced device for the treatment of refractory angina, namely the Coronary Sinus Reducer (CSR). After a general overview on the device characteristics, indications and mechanisms of action, we will provide new insights on the physiological consequences of CSR implantation and its efficacy in various clinical settings