Regulatory perspectives on post-market evidence generation schemes for high-risk medical devices: a systematic review.

Introduction: The new European Medical Device Regulation has raised the bar for the clinical evaluation of medical devices to gain marketing authorization by Notified Bodies (NBs) regarding certificates of conformity in Europe. Restrictions applied for High-risk medical devices (HRMD) may require further evidence generation. Some other jurisdictions apply similar schemes that may be useful to the European Union.

Inflammaging, a targetable pathway for preventing cardiovascular diseases.

Inflammaging, characterized by persistent chronic inflammation in older adults, has emerged as a critical factor linked to age-related diseases such as cardiovascular diseases (CVDs), metabolic disorders, and cognitive decline, which collectively contribute to the leading causes of death globally. Elevated levels of cytokines, chemokines, and others inflammatory mediators characterize inflammaging and serve as indicators of biological age. Among the causes of inflammaging, deterioration of the immune system, mitochondrial dysfunction, dysbiosis, accumulation of DAMPs, together with genetic or epigenetic factors, contribute to inflammaging not only in CVD but also in other age-related conditions.

Contemporary Bridge to Heart Transplantation With Venoarterial Extracorporeal Membrane Oxygenation.

In October 2018, the United Network for Organ Sharing changed their heart allocation criteria to prioritize patients on temporary mechanical circulatory support. This study assesses outcomes of patients bridged to orthotopic heart transplantation (OHT) with venoarterial extracorporeal membrane oxygenation (VA ECMO) since this change. We conducted a retrospective single-center study of adults (≥18 years) supported with VA ECMO at the time of OHT (October 1, 2018, to December 31, 2021).

When Things Go Right: Safety II in an Academic Emergency Department.

Objectives Historically, "safety" has been defined as an absence of error. Practice variability of any kind has been viewed as a threat. This is termed Safety I.

Early outcomes of robotic versus video-thoracoscopic anatomical segmentectomy: a propensity score-matched real-world study.

Objectives: Minimally invasive anatomic segmentectomy for the resection of pulmonary nodules has significantly increased in the last few years. Nevertheless, there is limited evidence on the safety and feasibility of robotic segmentectomy compared to video-assisted thoracic surgery. This study aimed to compare the real-world early outcomes of robotic and video-thoracoscopic surgery in anatomic segmentectomy.

Gut microbiome and inflammation in response to increasing intermittent hypoxia in the neonatal rat.

Background: Intermittent hypoxia (IH) and oxidative stress play key roles in gut dysbiosis and inflammation. We tested the hypothesis that increasing numbers of daily IH episodes cause microbiome dysbiosis and severe gut injury.

Methods: Neonatal rats were exposed to hyperoxia (Hx), growth restriction, and IH.

Impella 5.5: A Systematic Review of the Current Literature.

Objective: Impella 5.5 (Abiomed, Danvers, MA, USA) is a temporary mechanical circulatory support device used for patients in cardiogenic shock. This review provides a comprehensive overview of the device's clinical effectiveness, safety profile, patient outcomes, and relevant procedural considerations.

Natural recovery of cardiac allograft diastolic function, a retrospective longitudinal report.

Cardiac allografts suffer diastolic dysfunction early post-heart transplantation (HTx) due to ischemic injury, however the natural course of diastology recovery post HTx remains unknown (Tallaj et al., 2007 [1]). We retrospectively reviewed 60 adult HTx patients between 2015 and 2021 at a single site.

Combination diuretic therapies in heart failure: Insights from GUIDE-IT.

Introduction: Diuretics are the mainstay of maintaining and restoring euvolemia in the management of heart failure. Loop diuretics are often preferred, however, combination diuretic therapy (CDT) with a thiazide diuretic is often used to overcome diuretic resistance and increase diuretic effect. We performed an analysis of the GUIDE-IT study to assess all-cause mortality and time to first hospitalizations in patients necessitating CDT.

The novel MFS efflux pump SxtP, regulated by the LysR-type transcriptional activator SxtR, is involved in the susceptibility to sulfamethoxazole/trimethoprim (SXT) and the pathogenesis of .

is a notorious opportunistic pathogen responsible for healthcare-associated infections worldwide. Efflux pumps play crucial roles in mediating antimicrobial resistance, motility, and virulence. In this study, we present the identification and characterization of the new efflux pump SxtP belonging to the MFS superfamily (ajor acilitator uperfamily), along with its associated activator ysRtype ranscriptional egulator (LTTR) SxtR, demonstrating their roles in sulfamethoxazole/trimethoprim (also known as co-trimoxazole or SXT) resistance, surface-associated motility and virulence.

Temporary mechanical support in the peripartum patient as a bridge to postpartum recovery: A report of three cases.

Cardiogenic shock (CS) is a severe complication of peripartum cardiomyopathy (PPCM). Patients with deteriorating CS often require temporary mechanical circulatory support. In PPCM, this can be used as a bridge to postpartum recovery or bridge to decision.

Assessment of Gait Patterns during Crutch Assisted Gait through Spatial and Temporal Analysis.

The use of crutches is a common method of assisting people during recovery from musculoskeletal injuries in the lower limbs. There are several different ways to walk with crutches depending on the patient's needs. The structure of crutch gaits or crutch gait patterns varies based on the delay between the aid and foot placement, the number of concurrent points of contact, and laterality.

Outcome of Patients With Systolic Heart Failure Who Underwent Sympathectomy for Ventricular Arrhythmia.

Cardiac sympathetic denervation (CSD) is a surgical procedure increasingly used for managing ventricular arrhythmia refractory to conventional medical therapy. Long-term outcomes of CSD in patients with systolic heart failure has not been well studied. This observational study aimed to evaluate the medical co-morbidities and outcomes of patients with systolic heart failure who underwent CSD performed as treatment for ventricular arrhythmia refractory to conventional therapy.

Enhancing BIM implementation in Spanish public procurement: A framework approach.

The European Union supports the use of technology to improve public procurement, acknowledging Building Information Modeling (BIM) as a catalyst for cost-effective public works and innovation. The purpose of this paper is to evaluate BIM implementation practices in Spanish public procurement. The methodology used in this study is a mixed research method involving a questionnaire survey and semi-structured expert interviews.

Comparison of Glutathione Nanoparticles, CoEnzyme Q10, and Fish Oil for Prevention of Oxygen-Induced Retinopathy in Neonatal Rats.

Notch ligands and receptors are important for cell specification and angiogenesis, but their role in oxygen-induced retinopathy (OIR) is not well studied. Delta-like ligand (DLL)-4/Notch inhibits angiogenesis, while Jagged-1/Notch promotes angiogenesis. We tested the hypothesis that early supplementation with antioxidants and/or fish oil curtails severe OIR by inducing DLL-4/Notch and reducing Jagged-1/Notch.

Early versus late caffeine and/or non-steroidal anti-inflammatory drugs (NSAIDS) for prevention of intermittent hypoxia-induced neuroinflammation in the neonatal rat.

Preterm infants often experience frequent intermittent hypoxia (IH) episodes which are associated with neuroinflammation. We tested the hypotheses that early caffeine and/or non-steroidal inflammatory drugs (NSAIDs) confer superior therapeutic benefits for protection against IH-induced neuroinflammation than late treatment. Newborn rats were exposed to IH or hyperoxia (50% O) from birth (P0) to P14.

The Rhodium Analogue of Coenzyme B as an Anti-Photoregulatory Ligand Inhibiting Bacterial CarH Photoreceptors.

Coenzyme B (AdoCbl; 5'-deoxy-5'-adenosylcobalamin), the quintessential biological organometallic radical catalyst, has a formerly unanticipated, yet extensive, role in photoregulation in bacteria. The light-responsive cobalt-corrin AdoCbl performs this nonenzymatic role by facilitating the assembly of CarH photoreceptors into DNA-binding tetramers in the dark, suppressing gene expression. Conversely, exposure to light triggers the decomposition of this AdoCbl-bound complex by a still elusive photochemical mechanism, activating gene expression.

Thrombotic and Hemorrhagic Complications Following Left Ventricular Assist Device Placement: An Emphasis on Gastrointestinal Bleeding, Stroke, and Pump Thrombosis.

The left ventricular assist device (LVAD) is a mechanical circulatory support device that supports the heart failure patient as a bridge to transplant (BTT) or as a destination therapy for those who have other medical comorbidities or complications that disqualify them from meeting transplant criteria. In patients with severe heart failure, LVAD use has extended survival and improved signs and symptoms of cardiac congestion and low cardiac output, such as dyspnea, fatigue, and exercise intolerance. However, these devices are associated with specific hematologic and thrombotic complications.

The Hepatokine RBP4 Links Metabolic Diseases to Articular Inflammation.

Objectives: This study investigates the role of retinol binding protein 4 (RBP4) in an articular context. RBP4, a vitamin A transporter, is linked to various metabolic diseases.

Methods: Synovial fluid RBP4 levels were assessed in crystalline arthritis (CA) patients using ELISA.

Hepatitis C virus point-of-care microelimination approach in a vulnerable population in the South of Spain.

Background: Since the introduction of direct-acting antivirals, thousands of chronic hepatitis C patients have been successfully treated. However, vulnerable populations have a higher prevalence of hepatitis C virus (HCV) infection and face barriers that impede their access to antivirals. We carried out an HCV microelimination program focused on vulnerable population groups in Malaga.

Innovation in surgical trauma care education: assessment of a Panamerican Trauma Society online surgical skills course hosted by the Spanish Surgical Association.

Purpose: Incorporating surgical skills education in trauma care is essential for young surgeons and surgical trainees. This study describes an innovative e-learning course for teaching trauma care surgical skills in an international cooperative setting. Furthermore, it aims to offer valuable insights on enhancing e-learning practices.