Association of right ventricular dysfunction and pulmonary hypertension with adverse 30-day outcomes in COVID-19 patients.

Background: Cardiac manifestations in COVID-19 are multifactorial and are associated with increased mortality. The clinical utility and prognostic value of echocardiography in COVID-19 inpatients is not clearly defined. We aim to identify echocardiographic parameters that are associated with 30-day clinical outcomes secondary to COVID-19 hospitalization.

Progress in the Fight Against Multidrug-Resistant Bacteria 2005-2016: Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance.

From a public health perspective, new antibacterial agents should be evaluated and approved for use before widespread resistance to existing agents emerges. However, for multidrug-resistant pathogens, demonstration of superior efficacy of a new agent over a current standard-of-care agent is routinely feasible only when epidemic spread of these dangerous organisms has already occurred. One solution to enable proactive drug development is to evaluate new antibiotics with improved in vitro activity against MDR pathogens using recently updated guidelines for active control, noninferiority trials of selected severe infections caused by more susceptible pathogens.

The evolution of the regulatory framework for antibacterial agents.

The rising tide of antibacterial resistance and the lack of a diverse, vibrant pipeline of novel antibacterial agents is a global crisis that impairs our ability to treat life-threatening infections. The recent introduction of a tiered approach to the regulatory framework in this area offers one path to resolving some of the challenges. By drawing heavily on the predictive power of the related sciences of pharmacokinetics and pharmacodynamics, smaller, focused clinical trial programs have become possible for agents that might not otherwise have been possible to progress.

A comprehensive regulatory framework to address the unmet need for new antibacterial treatments.

To bring new antibacterial drugs to the market is challenging because discovery of new agents is difficult, two large trials per indication are needed in accordance with traditional regulatory requirements, and the economic reward is limited if the use of new antibiotics is constrained. These challenges have resulted in an alarmingly thin antibiotic pipeline, despite the rapid and continued growth in the need for new drugs. Approaches that balance the quantity of data needed for registration with the unmet medical need would encourage work in this area.

Clinical utility of intraprocedural transesophageal echocardiography during transvenous lead extraction.

Background: Transvenous lead extraction carries a risk of significant complications. Although intraoperative transesophageal echocardiography (TEE) is widely used to monitor cardiac performance and structures, its utility during transvenous lead extraction has not been well described.

Objective: This study evaluates the utility of TEE during transvenous lead extraction.

Impact of the New York State Cardiac Surgery and Percutaneous Coronary Intervention Reporting System on the management of patients with acute myocardial infarction complicated by cardiogenic shock.

Background: Studies suggest that the New York State Cardiac Surgery and Percutaneous Coronary Intervention Reporting System, which makes public the operator-specific mortality for patients undergoing coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI), may deter operators from providing revascularization to high-risk cardiac patients in New York compared to other states.

Methods: We performed a retrospective analysis of 545 US patients with acute myocardial infarction and cardiogenic shock due to predominant left ventricular failure enrolled in the SHOCK Registry. Adjusting for case mix using a propensity score method, we compared the use of coronary angiography, PCI, CABG, and outcomes between 220 patients in New York and 325 in other states.