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New England Journal of Medicine

Harnessing Our Humanity — How Washington’s Health Care Workers Have Risen to the Pandemic Challenge
New England Journal of Medicine, Volume 382, Issue 22, Page 2069-2071, May 2020.
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Sharing Health Data and Biospecimens with Industry — A Principle-Driven, Practical Approach
New England Journal of Medicine, Volume 382, Issue 22, Page 2072-2075, May 2020.
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Flattening the Curve for Incarcerated Populations — Covid-19 in Jails and Prisons
New England Journal of Medicine, Volume 382, Issue 22, Page 2075-2077, May 2020.
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Blood Ties
New England Journal of Medicine, Volume 382, Issue 22, Page 2077-2079, May 2020.
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Heartbeat: improving risk prediction and diagnosis of aortic dissection
In patients at risk of ascending aortic dissection, timing of surgery typically is based on serial imaging measurements of aortic diameter. Clearly, the risk of dissection in an individual patient is higher at larger aortic diameters. Even so, from a population point-of-view, most acute dissections occur in patients with a diameter below the recommended threshold for prophylactic root replacement. In this issue of Heart, Heuts and colleagues1 evaluated the hypothesis that measures of aortic length and volume would be better predictors of the risk of dissection than diameter alone. (figure 1) In an observation cohort study of 477 consecutive patients with a Type A aortic dissection, 96% did not meet the surgical diameter threshold of 55 mm before dissection onset. Compared with a cohort 75 patients with an aortic aneurysm who did not suffer a dissection, the positive predictive values of aortic measurements for prediction of...
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Prediction of aortic dissection
Aortic dissection is a low-incidence, high-impact and potentially catastrophic condition if not treated adequately and in time. Acute aortic dissection is diagnosed within 2 weeks of onset of symptoms, which is the high-mortality period. Patients surviving 2 weeks are considered to have subacute disease, and chronic aortic dissection is diagnosed after 8 weeks. The anatomical classification is based on the involvement of ascending aorta (type A according to Stanford) or not (type B).1 Historical data for untreated type A aortic dissection show a mortality rate of 1%–2% per hour within the first 24 hours, resulting in a mortality rate of up to 50%–74% during the acute phase.2 Uncomplicated acute type B dissection is less frequently lethal, with survival rates for medically treated patients of 84% at 1 year. Within the risk factors, arterial hypertension is dominating. It affects arterial wall composition, causing intimal thickening, fibrosis,...
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JACC Instructions for Authors
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Evaluation of Mavacamten in Symptomatic Patients With Nonobstructive Hypertrophic Cardiomyopathy
AbstractBackground Patients with nonobstructive hypertrophic cardiomyopathy (nHCM) often experience a high burden of symptoms; however, there are no proven pharmacological therapies. By altering the contractile mechanics of the cardiomyocyte, myosin inhibitors have the potential to modify pathophysiology and improve symptoms associated with HCM. Objectives MAVERICK-HCM (Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy) explored the safety and efficacy of mavacamten, a first-in-class reversible inhibitor of cardiac-specific myosin, in nHCM. Methods The MAVERICK-HCM trial was a multicenter, double-blind, placebo-controlled, dose-ranging phase II study in adults with symptomatic nHCM (New York Heart Association functional class II/III), left ventricular ejection fraction (LVEF) ≥55%, and N-terminal pro–B-type natriuretic peptide (NT-proBNP) ≥300 pg/ml. Participants were randomized 1:1:1 to mavacamten at a pharmacokinetic-adjusted dose (targeting plasma levels of 200 or 500 ng/ml), or placebo for 16 weeks, followed by an 8-week washout. Initial dose was 5 mg daily with 1 dose titration at week 6. Results Fifty-nine participants were randomized (19, 21, 19 patients to 200 ng/ml, 500 ng/ml, placebo, respectively). Their mean age was 54 years, and 58% were women. Serious adverse events occurred in 10% of participants on mavacamten and in 21% participants on placebo. Five participants on mavacamten had reversible reduction in LVEF ≤45%. NT-proBNP geometric mean decreased by 53% in the pooled mavacamten group versus 1% in the placebo group, with geometric mean differences of –435 and –6 pg/ml, respectively (p = 0.0005). Cardiac troponin I (cTnI) geometric mean decreased by 34% in the pooled mavacamten group versus a 4% increase in the placebo group, with geometric mean differences of –0.008 and 0.001 ng/ml, respectively (p = 0.009). Conclusions Mavacamten, a novel myosin inhibitor, was well tolerated in most subjects with symptomatic nHCM. Furthermore, treatment was associated with a significant reduction in NT-proBNP and cTnI, suggesting improvement in myocardial wall stress. These results set the stage for future studies of mavacamten in this patient population using clinical parameters, including LVEF, to guide dosing. (A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy [MAVERICK-HCM]; NCT03442764)
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Lessons From MAVERICK-HCM: The Need for Less Speed
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Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation in Patients With Coronary Stent Restenosis
AbstractBackground In patients with coronary in-stent restenosis (ISR) requiring reintervention, it is unclear if the choice of treatment should depend on whether the restenotic stent was a bare-metal stent (BMS) or a drug-eluting stent (DES). Objectives This study aimed to assess the comparative efficacy and safety of the 2 most frequently used treatments — angioplasty with drug-coated balloon (DCB) and repeat stenting DES — in patients with BMS-and DES-ISR. Methods The DAEDALUS (Difference in Antirestenotic Effectiveness of Drug-Eluting Stent and Drug-Coated Balloon Angioplasty for the Occurrence of Coronary In-Stent Restenosis) study was a pooled analysis of individual patient data from all 10 existing randomized clinical trials comparing DCB angioplasty with repeat DES implantation for the treatment of coronary ISR. In this pre-specified analysis, patients were stratified according to BMS- versus DES-ISR and treatment assigned. The primary efficacy endpoint was target lesion revascularization (TLR) at 3 years. The primary safety endpoint was a composite of all-cause death, myocardial infarction, or target lesion thrombosis at 3 years. Primary analysis was performed by mixed-effects Cox models accounting for the trial of origin. Secondary analyses included nonparsimonious multivariable adjustment accounting also for multiple lesions per patient and 2-stage analyses. Results A total of 710 patients with BMS-ISR (722 lesions) and 1,248 with DES-ISR (1,377 lesions) were included. In patients with BMS-ISR, no significant difference between treatments was observed in terms of primary efficacy (9.2% vs. 10.2%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.51 to 1.37) and safety endpoints (8.7% vs. 7.5%; HR: 1.13; 95% CI: 0.65 to 1.96); results of secondary analyses were consistent. In patients with DES-ISR, the risk of the primary efficacy endpoint was higher with DCB angioplasty than with repeat DES implantation (20.3% vs. 13.4%; HR: 1.58; 95% CI: 1.16 to 2.13), whereas the risk of the primary safety endpoint was numerically lower (9.5% vs. 13.3%; HR: 0.69; 95% CI: 0.47 to 1.00); results of secondary analyses were consistent. Regardless of the treatment used, the risk of TLR was lower in BMS- versus DES-ISR (9.7% vs. 17.0%; HR: 0.56; 95% CI: 0.42 to 0.74), whereas safety was not significantly different between ISR types. Conclusions At 3-year follow-up, DCB angioplasty and repeat stenting with DES are similarly effective and safe in the treatment of BMS-ISR, whereas DCB angioplasty is significantly less effective than repeat DES implantation in the treatment DES-ISR, and associated with a nonsignificant reduction in the primary composite safety endpoint. Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR.
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Heart Rhythm