Large simple randomized controlled trials-from drugs to medical devices: lessons from recent experience.

Randomized controlled trials (RCTs) are the cornerstone of modern evidence-based medicine. They are considered essential to establish definitive evidence of efficacy and safety for new drugs, and whenever possible they should also be the preferred method for investigating new high-risk medical devices. Well-designed studies robustly inform clinical practice guidelines and decision-making, but administrative obstacles have made it increasingly difficult to conduct informative RCTs.

On the Construct of Subjective Risk Intelligence and Its Relationships with Personality, Emotional Intelligence and Coping Strategies: A Comparison between Adolescents and Adults.

The complexity of today's scenario has made it necessary to investigate the need for individuals to make choices that entail increasing exposure to risk and uncertainty. Among the individual resources that could help people to cope with situations of uncertainty, the new construct of subjective risk intelligence (SRI), known as a person's ability to effectively weigh the pros and cons of a decision in situations where not all the outcomes are foreseen, would seem to play a prominent role. Considering that personality and coping strategies have been shown to be significantly related in previous research, the present study investigates the relationships between subjective risk intelligence, emotional intelligence, personality traits and coping strategies in both adults and adolescents.

Coronary Angiography, Intravascular Ultrasound, and Optical Coherence Tomography for Guiding of Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis.

Background: Results from multiple randomized clinical trials comparing outcomes after intravascular ultrasound (IVUS)- and optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with invasive coronary angiography (ICA)-guided PCI as well as a pivotal trial comparing the 2 intravascular imaging (IVI) techniques have provided mixed results.

Methods: Major electronic databases were searched to identify eligible trials evaluating at least 2 PCI guidance strategies among ICA, IVUS, and OCT. The 2 coprimary outcomes were target lesion revascularization and myocardial infarction.

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.

Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes.

Fully independent external validation of the Transcatheter Aortic Valve Replacement 30-day (TAVR-30) hospital readmission model.

Background: Early and late readmissions after Transcatheter Aortic Valve Replacement (TAVR) are common and associated with worse outcome. A risk prediction model (TAVR-30) was recently developed using readily available clinical variables to identify patients at risk for hospital readmission within 30 days after TAVR. We performed an independent external validation of the TAVR-30 model.

One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry.

Background: Initial data about the performance of the new-generation SAPIEN 3 Ultra (S3U) valve are highly promising. However, evidence about the longer-term performance and safety of the S3U is scarce.

Aims: We aimed to investigate the 1-year clinical and echocardiographic outcomes of transcatheter aortic valve implantation (TAVI) using the S3U compared with its predecessor, the SAPIEN 3 valve (S3).

Intracoronary Imaging of Proximal Coronary Artery Lesions A Nationwide Lesion-Level Analysis From SCAAR.

Background: Current evidence suggests that use of intracoronary imaging during percutaneous coronary intervention (PCI) of the left main coronary artery (LMCA) reduces mortality. However, there is a scarcity of data on the overall role of intracoronary imaging, particularly in other non-LMCA proximal coronary artery lesions. We aimed to investigate the association of use of intracoronary imaging on outcome in proximal lesions treated with PCI.

Sex-Related Differences in Thrombus Burden in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention.

Background: Women have a worse prognosis after ST-segment elevation myocardial infarction (STEMI) than men. The prognostic role of thrombus burden (TB) in influencing the sex-related differences in clinical outcomes after STEMI has not been clearly investigated.

Objectives: The aim of this study was to assess the sex-related differences in TB and its clinical implications in patients with STEMI.

An Agmon-Allegretto-Piepenbrink principle for Schrödinger operators.

We prove that each Borel function defined on an open subset induces a decomposition such that every function in is zero almost everywhere on and existence of nonnegative supersolutions of on each component yields nonnegativity of the associated quadratic form .

Surgical Removal of a Detached Mitral Valve Repair Clip to Resolve Cardiogenic Shock.

Transcatheter edge-to-edge mitral valve repair (TEER) with a clip device relieves symptoms and improves outcomes in patients not suitable for open heart surgery. Here, we present a patient in whom ventricular arrhythmias developed as a result of clip embolization shortly after TEER. He underwent successful emergent surgical clip removal and mitral valve replacement.

Hepatorenal Syndrome: Definitions, Diagnosis, and Management.

Hepatorenal syndrome (HRS) is a hemodynamically driven process mediated by renal dysregulation and inflammatory response. Albumin, antibiotics, and β-blockers are among therapies that have been studied in HRS prevention. There are no Food and Drug Administration-approved treatments for HRS although multiple liver societies have recommended terlipressin as first-line pharmacotherapy.

Trends in Clinical Practice and Outcomes After Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery.

Background The use of percutaneous coronary intervention (PCI) to treat unprotected left main coronary artery disease has expanded rapidly in the past decade. We aimed to describe nationwide trends in clinical practice and outcomes after PCI for left main coronary artery disease. Methods and Results Patients (n=4085) enrolled in the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) as undergoing PCI for left main coronary artery disease from 2005 to 2017 were included.

Short Duration of DAPT Versus De-Escalation After Percutaneous Coronary Intervention for Acute Coronary Syndromes.

Objectives: The aim of this study was to compare short dual antiplatelet therapy (DAPT) and de-escalation in a network meta-analysis using standard DAPT as common comparator.

Background: In patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), shortening DAPT and de-escalating to a lower potency regimen mitigate bleeding risk. These strategies have never been randomly compared.

Adaptation and Validation of the Subjective Risk Intelligence Scale for Italian Adolescents (SRIS-A).

Subjective Risk Intelligence (SRI) is the ability to consider risky and uncertain situations as opportunities rather than threats. SRI is constituted by four dimensions: attitude toward uncertainty, imaginative capability, problem solving self-efficacy and stress management. Adolescence is a period in life in which individuals face crucial life-tasks, that nowadays become complex due to uncertainty about future life and career.

Efficacy and Safety of Aspirin for Primary Cardiovascular Risk Prevention in Younger and Older Age: An Updated Systematic Review and Meta-analysis of 173,810 Subjects from 21 Randomized Studies.

Aims: The efficacy and safety of aspirin for primary cardiovascular disease (CVD) prevention is controversial. The aim of this study was to investigate the efficacy and safety of aspirin in subjects with no overt CVD, with a focus on age as a treatment modifier.

Methods And Results: Randomized trials comparing aspirin use versus no aspirin use or placebo were included.

Causes, pattern, predictors, and prognostic implications of new hospitalizations after transcatheter aortic valve implantation: a long-term nationwide observational study.

Aims: The aim of this study was to investigate the pattern, causes, and predictors of all new hospitalizations in patients who underwent transcatheter aortic valve implantation (TAVI).

Methods And Results: The nationwide Swedish TAVI registry was merged with other mandatory healthcare registries, which enabled the analysis of all TAVI procedures, new hospital admissions, and death between the years 2008 and 2017. A total of 2821 patients underwent TAVI with a mean of 2.

Outcome of PCI with Xience versus other commonly used modern drug eluting stents: A SCAAR report.

Objectives: To analyze the clinical outcome of percutaneous coronary intervention (PCI) using the Xience drug eluting stent (DES) versus other modern DES.

Methods: This retrospective study based on the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) analyzed the outcome of PCI using Xience versus other commonly used modern DES, 2007 to 2017. The primary outcome measure was a combination of all-cause death, myocardial infarction (MI) and revascularisation with PCI.

Patient-tailored antithrombotic therapy following percutaneous coronary intervention.

Dual antiplatelet therapy has long been the standard of care in preventing coronary and cerebrovascular thrombotic events in patients with chronic coronary syndrome and acute coronary syndrome undergoing percutaneous coronary intervention, but choosing the optimal treatment duration and composition has become a major challenge. Numerous studies have shown that certain patients benefit from either shortened or extended treatment duration. Furthermore, trials evaluating novel antithrombotic strategies, such as P2Y12 inhibitor monotherapy, low-dose factor Xa inhibitors on top of antiplatelet therapy, and platelet function- or genotype-guided (de-)escalation of treatment, have shown promising results.