OBJECTIVE: The purpose of this report was to describe the prespecified long-term safety objective of Micra at 12 months and electrical performance through 24 months.
METHODS: The Micra Transcatheter Pacing Study was a prospective single-arm study designed to assess the safety and efficacy of the Micra VVIR leadless/intracardiac pacemaker. Enrolled patients met class I or II guideline recommendations for de novo ventricular pacing. The long-term safety objective was freedom from a system- or procedure-related major complication at 12 months. A predefined historical control group of 2667 patients with transvenous pacemakers was used to compare major complication rates.
RESULTS: The long-term safety objective was achieved with a freedom from major complication rate of 96.0% at 12 months (95% confidence interval 94.2%-97.2%; P < .0001 vs performance goal). The risk of major complications for patients with Micra (N = 726) was 48% lower than that for patients with transvenous systems through 12 months postimplant (hazard ratio 0.52; 95% confidence interval 0.35-0.77; P = .001). Across subgroups of age, sex, and comorbidities, Micra reduced the risk of major complications compared to transvenous systems. Electrical performance was excellent through 24 months, with a projected battery longevity of 12.1 years.
CONCLUSION: Long-term performance of the Micra transcatheter pacemaker remains consistent with previously reported data. Few patients experienced major complications through 12 months of follow-up, and all patient subgroups benefited as compared to transvenous pacemaker historical control group.
AREAS COVERED: We searched multiple databases, including PubMed, Web of Knowledge, Scopus, ACM, Embase, IEEE and Ingenta. We explored various evaluation aspects of MD and EMR to gain a better understanding of their complex integration. We reviewed numerous risk management and assessment frameworks related to MD and EMR security aspects and mitigation controls and then identified their common evaluation aspects. Our review indicated that previous evaluation frameworks assessed MD and EMR independently. To address this gap, we proposed an evaluation framework based on the sociotechnical dimensions of health information systems and risk assessment approaches for MDs to evaluate MDI-EMR integratively.
EXPERT OPINION: The emergence of MDI-EMR cyber threats requires appropriate evaluation tools to ensure the safe development and application of MDI-EMR. Consequently, our proposed framework will continue to evolve through subsequent validations and refinements. This process aims to establish its applicability in informing stakeholders of the safety level and assessing its effectiveness in mitigating risks for future improvements.
BACKGROUND: Echocardiography is pivotal in the diagnosis of pericardial effusion and tamponade physiology. Ultrasound guidance for pericardiocentesis is currently considered the standard of care. Several approaches have been described recently, which differ mainly on the site of puncture (subxiphoid, apical, or parasternal). Although they share the use of low-frequency probes, there is absence of complete control of needle trajectory and real-time needle visualization. An in-plane and real-time technique has only been described anecdotally.
METHODS AND RESULTS: A retrospective analysis of 11 patients (63% men, mean age: 37.7±21.2 years) presenting with cardiac tamponade admitted to the tertiary-care emergency department and treated with parasternal medial-to-lateral in-plane pericardiocentesis was carried out. The underlying causes of cardiac tamponade were different among the population. All the pericardiocentesis were successfully performed in the emergency department, without complications, relieving the hemodynamic instability. The mean time taken to perform the eight-step procedure was 309±76.4 s, with no procedure-related complications.
CONCLUSION: The parasternal medial-to-lateral in-plane pericardiocentesis is a new technique theoretically free of complications and it enables real-time monitoring of needle trajectory. For the first time, a pericardiocentesis approach with a medial-to-lateral needle trajectory and real-time, in-plane, needle visualization was performed in a tamponade patient population.
METHOD: A descriptive, analytical quantitative with a cross-sectional approach was used in this study. The total of 95 nurses agreed to participate by using random sampling. Data collection using a structured questionnaire and observational form. The statistical model with a chi-square analysis was used in this study.
RESULTS: The result showed a correlation between knowledge and nurse practice with OR 3.257 (1.375-7.715; p=0.012), attitude and nurse practice with OR 4.286 (1.775-10.345; p=0.002) training and nurse practicewith OR value 5.455 (2.233-13.322; p=0.000).
CONCLUSIONS: Local authority in the hospital must apply patient safety standards to reduce injury rates, both nurses and patients. Nurses need to follow the current trend of nursing science focusing on patient safety.
METHODS: We conducted an exploratory qualitative study and purposefully selected people with T2D who drove and fasted during the past Ramadan period in 2019. In-depth face-to-face interviews were conducted and transcribed verbatim. Data were analysed thematically using a constant comparative method until saturation was achieved (n = 16).
RESULTS: Two major themes were identified, namely: (1) knowing oneself and (2) voluntary self-restriction. Participants described the importance of understanding how Ramadan fasting affected them and their level of alertness. As such, participants often adjusted their daily activities and tested their blood glucose levels to prevent experiencing hypoglycaemia. Other coping strategies reported include adjusting their medications and driving restrictions or driving in the mornings when they were more alert. Findings from this study shed light on participants' experiences and coping mechanisms while driving during Ramadan.
CONCLUSION: Given the risks and effects of hypoglycaemia among those who fast, there is a need to provide appropriate and focused patient education during Ramadan to people with T2D to ensure they can perform complex activities such as driving safely, especially in Muslim majority countries.