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New England Journal of Medicine

Mandatory Measles Vaccination in New York City — Reflections on a Bold Experiment
New England Journal of Medicine, Volume 381, Issue 2, Page 101-103, July 2019.
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Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines?
New England Journal of Medicine, Volume 381, Issue 2, Page 104-106, July 2019.
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Reforming the Orphan Drug Act for the 21st Century
New England Journal of Medicine, Volume 381, Issue 2, Page 106-108, July 2019.
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Sister First, Doctor Second
New England Journal of Medicine, Volume 381, Issue 2, Page 108-109, July 2019.
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Heartbeat: pacer risk in patients with right bundle branch block
A common question from primary providers is whether an ECG showing a right or left bundle branch block (RBBB or LBBB) is a cause for concern. Rasmussen et al1 estimated HRs and absolute risk of cardiovascular (CV) outcomes in over 200 000 individuals in whom 0.4% had an LBBB and 2.6% had an RBBB on ECG. Over a median follow-up of 7.8 years, the risk of heart failure was higher when LBBB was present both in men (HR 3.96, 95% CI 3.30 to 4.76) and women (HR 2.51, 95% CI 2.15 to 2.94) with a weaker association between heart failure and RBBB. In contrast, RBBB was more strongly associated with risk of pacemaker implantation in both men (HR 3.26, 95% CI 2.74 to 3.89) and women (HR 3.69, 95% CI 2.91 to 4.67). From these data, the authors provide a risk chart for heart failure and pacemaker implantation by ECG findings (
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The sEROtonergic pathway: a hERO for the brain, a zERO for the valves?
In medical school and ever since, we have been taught with the wisdom that pharmacological agents can heal, but also can harm. Medications or their metabolites that target the serotonergic pathways do not escape form this mantra. The last decades, several reports have suggested an association between serotonergic agents and valvular heart disease that eventually led to their withdrawal from the market. This was the case for the anorectic drugs fenfluramine and dexfenfluramine in the 1990s, and for the dopamine receptor agonist pergolide, a second-line Parkinson disease therapy, withdrawn in 2007 in the USA and in 2011 in Europe.1 2 As a large number of commonly prescribed medications such as antipsychotics, antidepressants, anxiolytics and antimigraine medications act on serotonergic mechanisms, concerns were and are raised that these approved agents might also cause drug-induced valvular heart disease (DIVHD). Most reports that have studied an association between serotonergic...
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JACC Instructions for Authors
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Myocardial Infarction Risk Stratification With a Single Measurement of High-Sensitivity Troponin I
AbstractBackground Limited data exist on rapid risk-stratification strategies using the U.S. Food and Drug Administration–cleared high-sensitivity cardiac troponin I (hs-cTnI) assays. Objectives This study sought to examine single measurement hs-cTnI to identify patients at low and high risk for acute myocardial infarction (MI). Methods This was a prospective, multicenter, observational study of patients with suspected acute MI enrolled across 29 U.S. sites with hs-cTnI measured using the Atellica IM TnIH and ADVIA Centaur TNIH (Siemens Healthineers) assays. To identify low-risk patients, sensitivities and negative predictive values (NPVs) for acute MI and MI or death at 30 days were examined across baseline hs-cTnI concentrations. To identify high-risk patients, positive predictive values and specificities for acute MI were evaluated. Results Among 2,212 patients, acute MI occurred in 12%. The limits of detection or quantitation resulted in excellent sensitivities (range 98.6% to 99.6%) and NPVs (range 99.5% to 99.8%) for acute MI or death at 30 days across both assays. An optimized threshold of <5 ng/l identified almost one-half of all patients as low risk, with sensitivities of 98.6% (95% confidence interval: 97.2% to 100%) and NPVs of 99.6% (95% confidence interval: 99.2% to 99.9%) for acute MI or death at 30 days across both assays. For high-risk patients, hs-cTnI ≥120 ng/l resulted in positive predictive values for acute MI of ≥70%. Conclusions Recognizing the continuous relationship between baseline hs-cTnI and risk for adverse events, using 2 Food and Drug Administration–cleared hs-cTnI assays, an optimized threshold of <5 ng/l safely identified almost one-half of all patients as low risk at presentation, with hs-cTnI ≥120 ng/l identifying high-risk patients.
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Considerations for Single-Measurement Risk-Stratification Strategies for Myocardial Infarction Using Cardiac Troponin Assays
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Transthyretin Stabilization by AG10 in Symptomatic Transthyretin Amyloid Cardiomyopathy
AbstractBackground Transthyretin (TTR) amyloidosis is an underdiagnosed disease caused by destabilization of TTR due to pathogenic mutations or aging. Both pathogenic and protective mutations illuminate mechanisms of disease and potential interventions. AG10 is a selective, oral TTR stabilizer under development for transthyretin amyloidosis cardiomyopathy (ATTR-CM) that mimics a protective TTR mutation. Objectives This randomized, double-blind, placebo-controlled study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of AG10 in ATTR-CM patients with symptomatic, chronic heart failure. Methods ATTR-CM, New York Heart Association functional class II to III subjects (n = 49, mutant or wild-type) were randomized 1:1:1 to AG10 400 mg, AG10 800 mg, or placebo twice daily for 28 days. Safety and tolerability were assessed by clinical and laboratory criteria. AG10 plasma levels were measured. TTR stability was assessed by changes in serum TTR, and 2 established ex vivo assays (fluorescent probe exclusion and Western blot). Results AG10 treatment was well-tolerated, achieved target plasma concentrations and demonstrated near-complete stabilization of TTR. TTR stabilization was more complete and less variable at the higher dose with stabilization by fluorescent probe exclusion of 92 ± 10% (mean ± SD) at trough and 96 ± 9% at peak (both p < 10–12 vs. placebo). Average serum TTR increased by 36 ± 21% and 51 ± 38% at 400 and 800 mg, respectively (both p < 0.0001 vs. placebo). Baseline serum TTR in treated subjects was below normal in 80% of mutant and 33% of wild-type subjects. AG10 treatment restored serum TTR to the normal range in all subjects. Conclusions AG10 has the potential to be a safe and effective treatment for patients with ATTR-CM. A phase 3 trial is ongoing. (Study of AG10 in Amyloid Cardiomyopathy; NCT03458130)
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Heart Rhythm