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New England Journal of Medicine

Drug Companies’ Liability for the Opioid Epidemic
New England Journal of Medicine, Volume 377, Issue 24, Page 2301-2305, December 2017.
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Coupling Policymaking with Evaluation — The Case of the Opioid Crisis
New England Journal of Medicine, Volume 377, Issue 24, Page 2306-2309, December 2017.
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Using Medicare Prices — Toward Equity and Affordability in the ACA Marketplace
New England Journal of Medicine, Volume 377, Issue 24, Page 2309-2311, December 2017.
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Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India
New England Journal of Medicine, Volume 377, Issue 24, Page 2313-2324, December 2017.
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Heartbeat: What is the best emergency treatment for decompensated severe aortic stenosis?
The cornerstone of treatment for patients with severe aortic stenosis (AS) is prompt valve replacement as soon as even mild symptoms are present. Even so, many patients are referred much later in the disease course, either because the primary care provider did not make the correct diagnosis or erroneously assumed the patient was ‘too old’ or ‘too sick’ to undergo valve replacement. In this situation, transfer to a heart valve centre often occurs only when the patient becomes haemodynamically unstable. Optimal emergency management of decompensated severe AS is controversial—attempts at medical stabilisation typically are futile, surgical risk is prohibitive and the decision to perform balloon aortic valvuloplasty (BAV) or transcatheter aortic valve implantation (TAVI) is not straightforward. In this issue of Heart, Bongiovanni and colleagues1 report the outcomes of 141 patients with decompensated severe AS treated with TAVI (n=23) or BAV (n=118). Procedural mortality was 8.7% for...
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Emergency interventions for the treatment of decompensated aortic stenosis
‘Whosoever wishes to know about the world must learn about it in its particular details.’ —Heraklietos of Ephesos Transcatheter aortic valve implantation (TAVI) is endorsed in both the European and North American guidelines as the treatment of choice for symptomatic severe aortic stenosis in patients considered unsuitable for surgical aortic valve replacement.1 2 Neither of these documents places an upper limit of risk precluding TAVI, although patients should have an expected post-TAVI survival of at least 1 year. In patients with acutely decompensated severe aortic stenosis where the longer-term prognosis is poor or unclear, balloon aortic valvuloplasty (BAV) may be considered either as a palliative procedure or as a potential bridge to definitive therapy. The terms used to define this subset of patients are necessarily vague, as they attempt to encompass a diverse population and avoid being overly prescriptive. A number of case series and...
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JACC Instructions for Authors
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National Trends and Outcomes in Isolated Tricuspid Valve Surgery
AbstractBackground Severe isolated disease of the tricuspid valve (TV) is increasing and results in intractable right heart failure. However, isolated TV surgery is rarely performed, and there are little data describing surgical outcomes. Objectives The purpose of this study was to evaluate contemporary utilization trends and in-hospital outcomes for isolated TV surgery in the United States. Methods Patients age >18 years who underwent TV repair or replacement from 2004 to 2013 were identified using the National Inpatient Sample. Patients with congenital heart disease, with endocarditis, and undergoing concomitant cardiac operations except for coronary bypass surgery were excluded. Results Over a 10-year period, a total of 5,005 isolated TV operations were performed nationally. Operations per year increased from 290 in 2004 to 780 in 2013 (p < 0.001 for trend). In-hospital mortality was 8.8% and did not vary across the study period. Adjusted in-hospital mortality for TV replacement was significantly higher than TV repair (odds ratio: 1.91; 95% confidence interval: 1.18 to 3.09; p = 0.009). Conclusions Isolated TV surgery is rarely performed, although utilization has increased over time. However, despite an increase in surgical volume, operative mortality has not changed. Mortality is greatest in patients undergoing valve replacement. Given the increasing prevalence of isolated TV disease in the population, research into optimal surgical timing and patient selection is critical.
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Isolated Tricuspid Valve Surgery
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5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials
AbstractBackground The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that left atrial appendage closure (LAAC) with the Watchman device (Boston Scientific, St. Paul, Minnesota) was equivalent to warfarin for preventing stroke in atrial fibrillation, but had a high rate of complications. In a second randomized trial, PREVAIL (Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), the complication rate was low. The warfarin cohort experienced an unexpectedly low ischemic stroke rate, rendering the efficacy endpoints inconclusive. However, these outcomes were based on relatively few patients followed for a relatively short time. Objectives The final results of the PREVAIL trial, both alone and as part of a patient-level meta-analysis with the PROTECT AF trial, are reported with patients in both trials followed for 5 years. Methods PREVAIL and PROTECT AF are prospective randomized clinical trials with patients randomized 2:1 to LAAC or warfarin; together, they enrolled 1,114 patients for 4,343 patient-years. Analyses are by intention-to-treat, and rates are events per 100 patient-years. Results For the PREVAIL trial, the first composite coprimary endpoint of stroke, systemic embolism (SE), or cardiovascular/unexplained death did not achieve noninferiority (posterior probability for noninferiority = 88.4%), whereas the second coprimary endpoint of post-procedure ischemic stroke/SE did achieve noninferiority (posterior probability for noninferiority = 97.5%); the warfarin arm maintained an unusually low ischemic stroke rate (0.73%). In the meta-analysis, the composite endpoint was similar between groups (hazard ratio [HR]: 0.820; p = 0.27), as were all-stroke/SE (HR: 0.961; p = 0.87). The ischemic stroke/SE rate was numerically higher with LAAC, but this difference did not reach statistical significance (HR: 1.71; p = 0.080). However, differences in hemorrhagic stroke, disabling/fatal stroke, cardiovascular/unexplained death, all-cause death, and post-procedure bleeding favored LAAC (HR: 0.20; p = 0.0022; HR: 0.45; p = 0.03; HR: 0.59; p = 0.027; HR: 0.73; p = 0.035; HR: 0.48; p = 0.0003, respectively). Conclusions These 5-year outcomes of the PREVAIL trial, combined with the 5-year outcomes of the PROTECT AF trial, demonstrate that LAAC with Watchman provides stroke prevention in nonvalvular atrial fibrillation comparable to warfarin, with additional reductions in major bleeding, particularly hemorrhagic stroke, and mortality. (WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation; NCT00129545; and Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy; NCT01182441)
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Heart Rhythm