Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years.

Importance: Active monitoring of health outcomes after COVID-19 vaccination provides early detection of rare outcomes that may not be identified in prelicensure trials.

Objective: To conduct near-real-time monitoring of health outcomes after COVID-19 vaccination in the US pediatric population.

Design, Setting, And Participants: This cohort study evaluated 21 prespecified health outcomes after exposure before early 2023 to BNT162b2, mRNA-1273, or NVX-CoV2373 ancestral monovalent COVID-19 vaccines in children aged 6 months to 17 years by applying a near-real-time monitoring framework using health care data from 3 commercial claims databases in the US (Optum [through April 2023], Carelon Research [through March 2023], and CVS Health [through February 2023]).

Evaluation of potential adverse events following COVID-19 mRNA vaccination among adults aged 65 years and older: Two self-controlled studies in the U.S.

Background: Our near-real-time safety monitoring of 16 adverse events (AEs) following COVID-19 mRNA vaccination identified potential elevation in risk for six AEs following primary series and monovalent booster dose administration. The crude association with AEs does not imply causality. Accordingly, we conducted robust evaluation of potential associations.

Cataract Surgery in the Medicare Merit-Based Incentive Payment System: Episode-Based Cost Measure Development and Evaluation.

Objective: To characterize the development and performance of a cataract surgery episode-based cost measure for the Medicare Quality Payment Program.

Design: Claims-based analysis.

Participants: Medicare clinicians with cataract surgery claims between June 1, 2016, and May 31, 2017.

Safety of the BNT162b2 COVID-19 Vaccine in Children Aged 5 to 17 Years.

Importance: Active monitoring of health outcomes after COVID-19 vaccination offers early detection of rare outcomes that may not be identified in prelicensure trials.

Objective: To conduct near-real-time monitoring of health outcomes following BNT162b2 COVID-19 vaccination in the US pediatric population aged 5 to 17 years.

Design, Setting, And Participants: This population-based study was conducted under a public health surveillance mandate from the US Food and Drug Administration.

Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older.

Background: Monitoring safety outcomes following COVID-19 vaccination is critical for understanding vaccine safety especially when used in key populations such as elderly persons age 65 years and older who can benefit greatly from vaccination. We present new findings from a nationally representative early warning system that may expand the safety knowledge base to further public trust and inform decision making on vaccine safety by government agencies, healthcare providers, interested stakeholders, and the public.

Methods: We evaluated 14 outcomes of interest following COVID-19 vaccination using the US Centers for Medicare & Medicaid Services (CMS) data covering 30,712,101 elderly persons.

Risk of myocarditis and pericarditis after the COVID-19 mRNA vaccination in the USA: a cohort study in claims databases.

Background: Several passive surveillance systems reported increased risks of myocarditis or pericarditis, or both, after COVID-19 mRNA vaccination, especially in young men. We used active surveillance from large health-care databases to quantify and enable the direct comparison of the risk of myocarditis or pericarditis, or both, after mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech) vaccinations.

Methods: We conducted a retrospective cohort study, examining the primary outcome of myocarditis or pericarditis, or both, identified using the International Classification of Diseases diagnosis codes, occurring 1-7 days post-vaccination, evaluated in COVID-19 mRNA vaccinees aged 18-64 years using health plan claims databases in the USA.

Seasonal influenza vaccination is associated with reduced risk of death among Medicare beneficiaries.

Background: Influenza causes substantial mortality, especially among older persons. Influenza vaccines are rarely more than 50% effective and rarely reach more than half of the US Medicare population, which is primarily an aged population. We wished to estimate the association between vaccination and mortality reduction.

Development of a Knee Arthroplasty Episode-Based Cost Measure for Evaluating Cost in the Merit-Based Incentive Payment System.

Background: Under the Merit-based Incentive Payment System (MIPS), the U.S. Centers for Medicare and Medicaid Services (CMS) evaluate clinicians who manage Medicare patients on the basis of cost and quality outcomes.

Development of Episode-Based Cost Measures for the US Medicare Merit-based Incentive Payment System.

Importance: The Merit-based Incentive Payment System (MIPS), established as part of the Quality Payment Program, is a Medicare value-based payment program that evaluates clinicians' performance across 4 categories: quality, cost, promoting interoperability, and improvement activities. The cost category includes novel episode-based measures designed for targeted evaluation of the resource use of specific conditions. This report describes the development of episode-based cost measures and their role in the shift from volume-based to value-based purchasing.

Development of the Elective Outpatient Percutaneous Coronary Intervention Episode-Based Cost Measure.

Background: The Merit-Based Incentive Payment System adjusts clinician payments based on a performance score that includes cost measures. With the Centers for Medicare & Medicaid Services, we developed a novel cost measure that compared interventional cardiologists on a targeted set of costs related to elective percutaneous coronary intervention (PCI). We describe the measure and compare it to a hypothetical version including all expenditures post-PCI.

Adjustment For Social Risk Factors Does Not Meaningfully Affect Performance On Medicare's MIPS Clinician Cost Measures.

Medicare's Merit-based Incentive Payment System (MIPS) includes episode-based cost measures that evaluate Medicare expenditures for specific conditions and procedures. These measures compare clinicians' cost performance and, along with other MIPS category scores, determine Medicare Part B clinician payment adjustments. The measures do not include risk adjustment for social risk factors.

Understanding the impact of 'cost' under MACRA: a neurointerventional imperative!

The cost of providing healthcare in the United States continues to rise. The Affordable Care Act created systems to test value-based alternative payments models. Traditionally, procedure-based specialists such as neurointerventionalists have largely functioned in, and are thus familiar with, the traditional Fee for Service system.

Hemodynamic effects of IV sodium nitrite in hospitalized comatose survivors of out of hospital cardiac arrest.

Background: Patients resuscitated from cardiac arrest have brain and cardiac injury. Recent animal studies suggest that the administration of sodium nitrite after resuscitation from 12min of asystole limits acute cardiac dysfunction and improves survival and neurologic outcomes. It has been hypothesized that low doses of IV sodium nitrite given during resuscitation of out of hospital cardiac arrest (OHCA) will improve survival.

Biomarkers and mortality in severe Chagas cardiomyopathy.

Background: Chagas cardiomyopathy is a chronic sequela of infection by the parasite, Trypanosoma cruzi. Advanced cardiomyopathy is associated with a high mortality rate, and clinical characteristics have been used to predict mortality risk. Though multiple biomarkers have been associated with Chagas cardiomyopathy, it is unknown how these are related to survival.

Sustained Domestic Vector Exposure Is Associated With Increased Chagas Cardiomyopathy Risk but Decreased Parasitemia and Congenital Transmission Risk Among Young Women in Bolivia.

Background: We studied women and their infants to evaluate risk factors for congenital transmission and cardiomyopathy in Trypanosoma cruzi-infected women.

Methods: Women provided data and blood for serology and quantitative polymerase chain reaction (PCR). Infants of infected women had blood tested at 0 and 1 month by microscopy, PCR and immunoblot, and serology at 6 and 9 months.

Biomarkers in Trypanosoma cruzi-infected and uninfected individuals with varying severity of cardiomyopathy in Santa Cruz, Bolivia.

Background: Twenty to thirty percent of persons with Trypanosoma cruzi infection eventually develop cardiomyopathy. If an early indicator were to be identified and validated in longitudinal studies, this could enable treatment to be prioritized for those at highest risk. We evaluated cardiac and extracellular matrix remodeling markers across cardiac stages in T.

Evolving targets for lipid-modifying therapy.

The pathogenesis and progression of atherosclerosis are integrally connected to the concentration and function of lipoproteins in various classes. This review examines existing and emerging approaches to modify low-density lipoprotein and lipoprotein (a), triglyceride-rich lipoproteins, and high-density lipoproteins, emphasizing approaches that have progressed to clinical evaluation. Targeting of nuclear receptors and phospholipases is also discussed.

PCSK9 Inhibitors: potential in cardiovascular therapeutics.

Despite the efficacy of statin therapy, patients treated with these agents face substantial residual risk that is associated with achieved levels of LDL cholesterol (LDL-C). These observations suggest a potential benefit of additional strategies to promote further LDL-C reduction. Proprotein convertase subtilisin/kexin type 9 (PCSK9) has emerged as an attractive target in this regard.

Nitrite therapy is neuroprotective and safe in cardiac arrest survivors.

Cardiac arrest results in significant mortality after initial resuscitation due in most cases to ischemia-reperfusion induced brain injury and to a lesser degree myocardial dysfunction. Nitrite has previously been shown to protect against reperfusion injury in animal models of focal cerebral and heart ischemia. Nitrite therapy after murine cardiac arrest improved 22 h survival through improvements in myocardial contractility.

Cardiovascular implantable electronic devices in athletes.

Cardiovascular implantable electronic device (CIED) implantation indications have greatly increased over the past decade, with use of pacemakers and implantable cardiac defibrillators now growing more common even in athletes. Management of CIEDs in this subgroup is of greater complexity due to augmented physical stressors, a longer exposure time to system components in a younger population, and less common, highly clinically variable underlying cardiac pathologies. We will review management issues specific to CIED therapy, sudden cardiac death, and consensus recommendations for physical activity.

Viable fibroblast matrix patch induces angiogenesis and increases myocardial blood flow in heart failure after myocardial infarction.

Background: This study examines a viable biodegradable three-dimensional fibroblast construct (3DFC) in a model of chronic heart failure. The viable fibroblasts, cultured on a vicryl mesh, secrete growth factors that stimulate angiogenesis.

Methods: We ligated the left coronary artery of male Sprague-Dawley rats, implanted the 3DFC 3 weeks after myocardial infarction and obtained end point data 3 weeks later, that is, 6 weeks after myocardial infarction.

Implantation of a three-dimensional fibroblast matrix improves left ventricular function and blood flow after acute myocardial infarction.

This study was designed to determine if a viable biodegradable three-dimensional fibroblast construct (3DFC) patch implanted on the left ventricle after myocardial infarction (MI) improves left ventricular (LV) function and blood flow. We ligated the left coronary artery of adult male Sprague-Dawley rats and implanted the 3DFC at the time of the infarct. Three weeks after MI, the 3DFC improved LV systolic function by increasing (p < 0.

Pretreatment with angiotensin receptor blockade prevents left ventricular dysfunction and blunts left ventricular remodeling associated with acute myocardial infarction.

Background: This study was designed to determine the effects of pretreatment with an angiotensin receptor blocker on left ventricular (LV) function and remodeling during acute myocardial infarction (MI).

Methods And Results: Sprague-Dawley rats were pretreated with candesartan (10 mg x kg(-1) x d(-1)) for 2 weeks and studied at 1, 3, and 6 minutes after MI. Compared with untreated rats, pretreatment with candesartan lowered (P<0.