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.